Trial Outcomes & Findings for Study of Efficacy and Safety of Canakinumab in Patients With Hereditary Periodic Fevers (NCT NCT02059291)
NCT ID: NCT02059291
Last Updated: 2018-05-17
Results Overview
Resolution of the initial disease flare is defined as: Physician's Global Assessment of Disease activity (PGA) \<2 and C-reactive protein (CRP) within normal range (\<= 10 mg/L) or reduction by at least 70% from baseline. The PGA was evaluated by the investigator based on a 5-point scale: 0 = None (no) disease associated with clinical signs and symptoms; 1 = minimal disease associated signs and symptoms; 2 = mild disease associated signs and symptoms; 3 = moderate disease associated signs and symptoms; and 5 = severe disease associated signs and symptoms.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
203 participants
Primary outcome timeframe
16 weeks
Results posted on
2018-05-17
Participant Flow
This study consists of 4 study epochs. A total of 203 participants ((181randomized + 4 non-randomized open-label participants in Epoch 2) + (18 TRAPS rollover participants from ACZ885D2203 (NCT01242813) and ACZ885D2207M in Epoch 3)) have been enrolled into this study.
126 patients, randomized in Epoch 2, were not re-randomized in Epoch 3. These patients were switched to open-label (OL) treatment. Six patients discontinued OL treatment (1 due to physician decision, 1 due to subject/guardian decision, 3 due to lack of efficacy and 1 due to an adverse event).
Participant milestones
| Measure |
Epoch 2: crFMF: 150 mg
During Epoch 2, participants received canakinumab 150mg (or 2mg/kg for participants weighing \<= 40kg) q4w for 16 weeks. If participants were eligible for blinded escape, they received a single add-on dose of canakinumab (150 mg or 2mg/kg for participants weighing \<= 40kg) between day 8 and day 28, and then received blinded uptitration to canakinumab 300 mg q4w from day 29 through day 112. If patients on the highest allowed canakinumab dose of 300 mg (or 4 mg/kg for patients weighing ≤ 40 kg) q4w and re-flared (PGA ≥ 2 and CRP ≥ 30 mg/L) were not eligible for further up-titration.
|
Epoch 2: crCMF: Placebo
During epoch 2, participants received matching placebo to canakinumab 150 mg Participants who required blinded escape,they received a single add-on dose of canakinumab (150 mg or 2mg/kg for participants weighing \<= 40kg) between day 8 and day 28, and then received blinded one dose of placebo and one dose of canakinumab q4w from day 29 through day 112. If flare or re-flare still occurred after receipt of canakinumab.
150mg, participants were uptitrated to open-label canakinumab 300 mg
|
Epoch 2: HIDS/MKD: 150 mg
During Epoch 2, participants received canakinumab 150mg (or 2mg/kg for participants weighing \<= 40kg) q4w for 16 weeks. If participants were eligible for blinded escape, they received a single add-on dose of canakinumab (150 mg or 2mg/kg for participants weighing \<= 40kg) between day 8 and day 28, and then received blinded uptitration to canakinumab 300 mg q4w from day 29 through day 112. If patients on the highest allowed canakinumab dose of 300 mg (or 4 mg/kg for patients weighing ≤ 40 kg) q4w and re-flared (PGA ≥ 2 and CRP ≥ 30 mg/L) were not eligible for further up-titration.
|
Epoch 2: HIDS/MKD: Placebo
During epoch 2, participants received matching placebo to canakinumab 150 mg qw4. Participants who required blinded escape, they received a single add-on dose of canakinumab (150 mg or 2mg/kg for participants weighing \<= 40kg) between day 8 and day 28 and then received blinded one dose of placebo and one dose of canakinumab q4w from day 29 through day 112. If flare or re-flare still occurred after receipt of canakinumab 150mg, participants were uptitrated to open-label canakinumab 300 mg.
|
Epoch 2: TRAPS: 150 mg
During Epoch 2, participants received canakinumab 150mg (or 2mg/kg for participants weighing \<= 40kg) q4w for 16 weeks. If participants were eligible for blinded escape, they received a single add-on dose of canakinumab (150 mg or 2mg/kg for participants weighing \<= 40kg) between day 8 and day 28, and then received blinded uptitration to canakinumab 300 mg q4w from day 29 through day 112. If patients on the highest allowed canakinumab dose of 300 mg (or 4 mg/kg for patients weighing ≤ 40 kg) q4w and re-flared (PGA ≥ 2 and CRP ≥ 30 mg/L) were not eligible for further up-titration
|
Epoch 2: TRAPS: Placebo
During epoch 2, participants received matching placebo to canakinumab 150 mg qw4. Participants who required blinded escape,they received a single add-on dose of canakinumab (150 mg or 2mg/kg for participants weighing \<= 40kg) between Day 8 and 28 and then received blinded one dose of placebo and one dose of canakinumab q4w from day 29 through day 112. If flare or re-flare still occurred after receipt of canakinumab 150mg, participants were uptitrated to open-label canakinumab 300 mg.
|
Epoch 2: Non-randomized Open Label Treatment - crFMF
Canakinumab-naïve Japanese patients with non-exon 10 mutations received open-label canakinumab 150 mg (or 2 mg/kg for patients weighing
≤ 40 kg) q4w .
|
Epoch 2: Non-randomized Open Label HIDS/MKD
Participants in the 28 days to less than 2 years old cohort who received open-label canakinumab 150 mg (or 2mg/kg for patients weighing
≤ 40 kg) q4w.
|
Epoch 2 (Epoch 3) - Non-randomized Open Label TRAPS
Open-label treatment in Epoch 3 was initiated for TRAPS patients who rolled over from CACZ885D2203 or CACZ885D2207M.
|
Epoch 3: crFMF Re-randomized From Epoch 2 - 150 mg
Canakinumab responders who were initially randomized to canakinumab 150 mg q4w and did not re-flare in Epoch 2 were re-randomized at the start of Epoch 3 to canakinumab 150 mg q8w for 24 weeks.
|
Epoch 3: crFMF Re-randomized From Epoch 2 - Placebo
Canakinumab responders who were initially randomized to canakinumab 150 mg q4w and did not re-flare in Epoch 2 were re-randomized at the start of Epoch 3 to placebo for 24 weeks.
|
Epoch 3: HIDs/MKD Re-randomized From Epoch 2 - 150 mg
Canakinumab responders who were initially randomized to canakinumab 150 mg q4w and did not re-flare in Epoch 2 were re-randomized at the start of Epoch 3 to canakinumab 150 mg q8w for 24 weeks.
|
Epoch 3: HIDS/MKD Re-randomized From Epoch 2 - Placebo
Canakinumab responders who were initially randomized to canakinumab 150 mg q4w and did not re-flare in Epoch 2 were re-randomized at the start of Epoch 3 to placebo for 24 weeks.
|
Epoch 3: TRAPS Re-randomized From Epoch 2 - 150 mg
Canakinumab responders who were initially randomized to canakinumab 150 mg q4w and did not re-flare in Epoch 2 were re-randomized at the start of Epoch 3 to canakinumab 150 mg q8w for 24 weeks.
|
Epoch 3: TRAPS Re-randomized From Epoch 2 - Placebo
Canakinumab responders who were initially randomized to canakinumab 150 mg q4w and did not re-flare in Epoch 2 were re-randomized at the start of Epoch 3 to placebo for 24 weeks.
|
Epoch 3: crFMF, HIDS/MKD, TRAPS - Not Re-randomized
All Epoch 2 non-responders were switched to canakinumab q8w at the start of Epoch 3 for 24 weeks,
|
Epoch 4: crFMF - Open Label Cumulative Dose <2700 mg
During epoch 4, participants received open label treatment according to the dose regimen administered in epoch 3. Cumulative dose received was less than 2700 mg.
|
Epoch 4: crFMF - Open Label Cumulative Dose 2700 mg - <5400 mg
During epoch 4, participants received open label treatment according to the dose regimen administered in epoch 3. Cumulative dose received was \>= 2700 mg and \< 5400 mg.
|
Epoch 4: crFMF - Open Label Cumulative Dose >=5400 mg
During epoch 4, participants received open label treatment according to the dose regimen administered in epoch 3. Cumulative dose received was \> 5400 mg.
|
Epoch 4: HIDS/MKD - Open Label Cumulative Dose <2700 mg
During epoch 4, participants received open label treatment according to the dose regimen administered in epoch 3. Cumulative dose received was less than 2700 mg.
|
Epoch 4: HIDS/MKD - OL Cumulative Dose 2700 - <=5400 mg
During epoch 4, participants received open label treatment according to the dose regimen administered in epoch 3. Cumulative dose received was \>= 2700 mg and \< 5400 mg.
|
Epoch 4: HIDS/MKD - Open Label Cumulative Dose >=5400 mg
During epoch 4, participants received open label treatment according to the dose regimen administered in epoch 3. Cumulative dose received was \> 5400 mg.
|
Epoch 4: TRAPS - Open Label Cumulative Dose < 2700 mg
During epoch 4, participants received open label treatment according to the dose regimen administered in epoch 3. Cumulative dose received was less than 2700 mg.
|
Epoch 4: TRAPS - Open Label Cumulative Dose 2700 - <5400 mg
During epoch 4, participants received open label treatment according to the dose regimen administered in epoch 3. Cumulative dose received was \>= 2700 mg and \< 5400 mg.
|
Epoch 4: TRAPS - Open Label Cumulative Dose >=5400 mg
During epoch 4, participants received open label treatment according to the dose regimen administered in epoch 3. Cumulative dose received was \> 5400 mg.
|
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Epoch 2
STARTED
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Epoch 2
COMPLETED
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Epoch 2
NOT COMPLETED
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Epoch 3
STARTED
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Epoch 3
COMPLETED
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Epoch 3
NOT COMPLETED
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Epoch 4
STARTED
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Epoch 4
COMPLETED
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Epoch 4
NOT COMPLETED
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Reasons for withdrawal
| Measure |
Epoch 2: crFMF: 150 mg
During Epoch 2, participants received canakinumab 150mg (or 2mg/kg for participants weighing \<= 40kg) q4w for 16 weeks. If participants were eligible for blinded escape, they received a single add-on dose of canakinumab (150 mg or 2mg/kg for participants weighing \<= 40kg) between day 8 and day 28, and then received blinded uptitration to canakinumab 300 mg q4w from day 29 through day 112. If patients on the highest allowed canakinumab dose of 300 mg (or 4 mg/kg for patients weighing ≤ 40 kg) q4w and re-flared (PGA ≥ 2 and CRP ≥ 30 mg/L) were not eligible for further up-titration.
|
Epoch 2: crCMF: Placebo
During epoch 2, participants received matching placebo to canakinumab 150 mg Participants who required blinded escape,they received a single add-on dose of canakinumab (150 mg or 2mg/kg for participants weighing \<= 40kg) between day 8 and day 28, and then received blinded one dose of placebo and one dose of canakinumab q4w from day 29 through day 112. If flare or re-flare still occurred after receipt of canakinumab.
150mg, participants were uptitrated to open-label canakinumab 300 mg
|
Epoch 2: HIDS/MKD: 150 mg
During Epoch 2, participants received canakinumab 150mg (or 2mg/kg for participants weighing \<= 40kg) q4w for 16 weeks. If participants were eligible for blinded escape, they received a single add-on dose of canakinumab (150 mg or 2mg/kg for participants weighing \<= 40kg) between day 8 and day 28, and then received blinded uptitration to canakinumab 300 mg q4w from day 29 through day 112. If patients on the highest allowed canakinumab dose of 300 mg (or 4 mg/kg for patients weighing ≤ 40 kg) q4w and re-flared (PGA ≥ 2 and CRP ≥ 30 mg/L) were not eligible for further up-titration.
|
Epoch 2: HIDS/MKD: Placebo
During epoch 2, participants received matching placebo to canakinumab 150 mg qw4. Participants who required blinded escape, they received a single add-on dose of canakinumab (150 mg or 2mg/kg for participants weighing \<= 40kg) between day 8 and day 28 and then received blinded one dose of placebo and one dose of canakinumab q4w from day 29 through day 112. If flare or re-flare still occurred after receipt of canakinumab 150mg, participants were uptitrated to open-label canakinumab 300 mg.
|
Epoch 2: TRAPS: 150 mg
During Epoch 2, participants received canakinumab 150mg (or 2mg/kg for participants weighing \<= 40kg) q4w for 16 weeks. If participants were eligible for blinded escape, they received a single add-on dose of canakinumab (150 mg or 2mg/kg for participants weighing \<= 40kg) between day 8 and day 28, and then received blinded uptitration to canakinumab 300 mg q4w from day 29 through day 112. If patients on the highest allowed canakinumab dose of 300 mg (or 4 mg/kg for patients weighing ≤ 40 kg) q4w and re-flared (PGA ≥ 2 and CRP ≥ 30 mg/L) were not eligible for further up-titration
|
Epoch 2: TRAPS: Placebo
During epoch 2, participants received matching placebo to canakinumab 150 mg qw4. Participants who required blinded escape,they received a single add-on dose of canakinumab (150 mg or 2mg/kg for participants weighing \<= 40kg) between Day 8 and 28 and then received blinded one dose of placebo and one dose of canakinumab q4w from day 29 through day 112. If flare or re-flare still occurred after receipt of canakinumab 150mg, participants were uptitrated to open-label canakinumab 300 mg.
|
Epoch 2: Non-randomized Open Label Treatment - crFMF
Canakinumab-naïve Japanese patients with non-exon 10 mutations received open-label canakinumab 150 mg (or 2 mg/kg for patients weighing
≤ 40 kg) q4w .
|
Epoch 2: Non-randomized Open Label HIDS/MKD
Participants in the 28 days to less than 2 years old cohort who received open-label canakinumab 150 mg (or 2mg/kg for patients weighing
≤ 40 kg) q4w.
|
Epoch 2 (Epoch 3) - Non-randomized Open Label TRAPS
Open-label treatment in Epoch 3 was initiated for TRAPS patients who rolled over from CACZ885D2203 or CACZ885D2207M.
|
Epoch 3: crFMF Re-randomized From Epoch 2 - 150 mg
Canakinumab responders who were initially randomized to canakinumab 150 mg q4w and did not re-flare in Epoch 2 were re-randomized at the start of Epoch 3 to canakinumab 150 mg q8w for 24 weeks.
|
Epoch 3: crFMF Re-randomized From Epoch 2 - Placebo
Canakinumab responders who were initially randomized to canakinumab 150 mg q4w and did not re-flare in Epoch 2 were re-randomized at the start of Epoch 3 to placebo for 24 weeks.
|
Epoch 3: HIDs/MKD Re-randomized From Epoch 2 - 150 mg
Canakinumab responders who were initially randomized to canakinumab 150 mg q4w and did not re-flare in Epoch 2 were re-randomized at the start of Epoch 3 to canakinumab 150 mg q8w for 24 weeks.
|
Epoch 3: HIDS/MKD Re-randomized From Epoch 2 - Placebo
Canakinumab responders who were initially randomized to canakinumab 150 mg q4w and did not re-flare in Epoch 2 were re-randomized at the start of Epoch 3 to placebo for 24 weeks.
|
Epoch 3: TRAPS Re-randomized From Epoch 2 - 150 mg
Canakinumab responders who were initially randomized to canakinumab 150 mg q4w and did not re-flare in Epoch 2 were re-randomized at the start of Epoch 3 to canakinumab 150 mg q8w for 24 weeks.
|
Epoch 3: TRAPS Re-randomized From Epoch 2 - Placebo
Canakinumab responders who were initially randomized to canakinumab 150 mg q4w and did not re-flare in Epoch 2 were re-randomized at the start of Epoch 3 to placebo for 24 weeks.
|
Epoch 3: crFMF, HIDS/MKD, TRAPS - Not Re-randomized
All Epoch 2 non-responders were switched to canakinumab q8w at the start of Epoch 3 for 24 weeks,
|
Epoch 4: crFMF - Open Label Cumulative Dose <2700 mg
During epoch 4, participants received open label treatment according to the dose regimen administered in epoch 3. Cumulative dose received was less than 2700 mg.
|
Epoch 4: crFMF - Open Label Cumulative Dose 2700 mg - <5400 mg
During epoch 4, participants received open label treatment according to the dose regimen administered in epoch 3. Cumulative dose received was \>= 2700 mg and \< 5400 mg.
|
Epoch 4: crFMF - Open Label Cumulative Dose >=5400 mg
During epoch 4, participants received open label treatment according to the dose regimen administered in epoch 3. Cumulative dose received was \> 5400 mg.
|
Epoch 4: HIDS/MKD - Open Label Cumulative Dose <2700 mg
During epoch 4, participants received open label treatment according to the dose regimen administered in epoch 3. Cumulative dose received was less than 2700 mg.
|
Epoch 4: HIDS/MKD - OL Cumulative Dose 2700 - <=5400 mg
During epoch 4, participants received open label treatment according to the dose regimen administered in epoch 3. Cumulative dose received was \>= 2700 mg and \< 5400 mg.
|
Epoch 4: HIDS/MKD - Open Label Cumulative Dose >=5400 mg
During epoch 4, participants received open label treatment according to the dose regimen administered in epoch 3. Cumulative dose received was \> 5400 mg.
|
Epoch 4: TRAPS - Open Label Cumulative Dose < 2700 mg
During epoch 4, participants received open label treatment according to the dose regimen administered in epoch 3. Cumulative dose received was less than 2700 mg.
|
Epoch 4: TRAPS - Open Label Cumulative Dose 2700 - <5400 mg
During epoch 4, participants received open label treatment according to the dose regimen administered in epoch 3. Cumulative dose received was \>= 2700 mg and \< 5400 mg.
|
Epoch 4: TRAPS - Open Label Cumulative Dose >=5400 mg
During epoch 4, participants received open label treatment according to the dose regimen administered in epoch 3. Cumulative dose received was \> 5400 mg.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
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Epoch 3
Physician Decision
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Epoch 2
Lack of Efficacy
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1
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1
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Epoch 2
Adverse Event
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1
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1
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1
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0
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0
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Epoch 2
Withdrawal by Subject
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1
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1
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1
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0
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Epoch 3
Adverse Event
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0
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1
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0
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0
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0
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0
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0
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0
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0
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0
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0
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Epoch 3
Lack of Efficacy
|
0
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0
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0
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0
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0
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3
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0
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0
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0
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Epoch 3
Withdrawal by Subject
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0
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0
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0
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0
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1
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0
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0
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0
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0
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0
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0
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Epoch 4
Adverse Event
|
0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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1
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0
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0
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0
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0
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1
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0
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0
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Epoch 4
Pregnancy
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0
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1
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0
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0
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0
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0
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0
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0
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0
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0
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Epoch 4
Withdrawal by Subject
|
0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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1
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0
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0
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0
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0
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Epoch 4
Lack of Efficacy
|
0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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1
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0
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Baseline Characteristics
Study of Efficacy and Safety of Canakinumab in Patients With Hereditary Periodic Fevers
Baseline characteristics by cohort
| Measure |
Epoch 2: crFMF: 150 mg
n=31 Participants
During Epoch 2, participants received canakinumab 150mg (or 2mg/kg for participants weighing \<= 40kg) q4w for 16 weeks. If participants were eligible for blinded escape, they received a single add-on dose of canakinumab (150 mg or 2mg/kg for participants weighing \<= 40kg) between day 8 and day 28, and then received blinded uptitration to canakinumab 300 mg q4w from day 29 through day 112. If patients on the highest allowed canakinumab dose of 300 mg (or 4 mg/kg for patients weighing ≤ 40 kg) q4w and re-flared (PGA ≥ 2 and CRP ≥ 30 mg/L) were not eligible for further up-titration.
|
Epoch 2: crCMF: Placebo
n=32 Participants
During epoch 2, participants received matching placebo to canakinumab 150 mg Participants who required blinded escape,they received a single add-on dose of canakinumab (150 mg or 2mg/kg for participants weighing \<= 40kg) between day 8 and day 28, and then received blinded one dose of placebo and one dose of canakinumab q4w from day 29 through day 112. If flare or re-flare still occurred after receipt of canakinumab.
150mg, participants were uptitrated to open-label canakinumab 300 mg
|
Epoch 2: HIDS/MKD: 150 mg
n=37 Participants
During Epoch 2, participants received canakinumab 150mg (or 2mg/kg for participants weighing \<= 40kg) q4w for 16 weeks. If participants were eligible for blinded escape, they received a single add-on dose of canakinumab (150 mg or 2mg/kg for participants weighing \<= 40kg) between day 8 and day 28, and then received blinded uptitration to canakinumab 300 mg q4w from day 29 through day 112. If patients on the highest allowed canakinumab dose of 300 mg (or 4 mg/kg for patients weighing ≤ 40 kg) q4w and re-flared (PGA ≥ 2 and CRP ≥ 30 mg/L) were not eligible for further up-titration.
|
Epoch 2: HIDS/MKD: Placebo
n=35 Participants
During epoch 2, participants received matching placebo to canakinumab 150 mg qw4. Participants who required blinded escape, they received a single add-on dose of canakinumab (150 mg or 2mg/kg for participants weighing \<= 40kg) between day 8 and day 28 and then received blinded one dose of placebo and one dose of canakinumab q4w from day 29 through day 112. If flare or re-flare still occurred after receipt of canakinumab 150mg, participants were uptitrated to open-label canakinumab 300 mg.
|
Epoch 2: TRAPS: 150 mg
n=22 Participants
During Epoch 2, participants received canakinumab 150mg (or 2mg/kg for participants weighing \<= 40kg) q4w for 16 weeks. If participants were eligible for blinded escape, they received a single add-on dose of canakinumab (150 mg or 2mg/kg for participants weighing \<= 40kg) between day 8 and day 28, and then received blinded uptitration to canakinumab 300 mg q4w from day 29 through day 112. If patients on the highest allowed canakinumab dose of 300 mg (or 4 mg/kg for patients weighing ≤ 40 kg) q4w and re-flared (PGA ≥ 2 and CRP ≥ 30 mg/L) were not eligible for further up-titration
|
Epoch 2: TRAPS: Placebo
n=24 Participants
During epoch 2, participants received matching placebo to canakinumab 150 mg qw4. Participants who required blinded escape,they received a single add-on dose of canakinumab (150 mg or 2mg/kg for participants weighing \<= 40kg) between Day 8 and 28 and then received blinded one dose of placebo and one dose of canakinumab q4w from day 29 through day 112. If flare or re-flare still occurred after receipt of canakinumab 150mg, participants were uptitrated to open-label canakinumab 300 mg.
|
Epoch 2: Non-randomized Open Label Treatment - crFMF
n=2 Participants
Canakinumab-naïve Japanese patients with non-exon 10 mutations received open-label canakinumab 150 mg (or 2 mg/kg for patients weighing
≤ 40 kg) q4w
|
Epoch 2: Non-randomized Open Label HIDS/MKD
n=2 Participants
Participants in the 28 days to less than 2 years old cohort who received open-label canakinumab 150 mg (or 2mg/kg for patients weighing
≤ 40 kg) q4w.
|
Epoch 2 (Epoch 3) - Non-randomized Open Label TRAPS
n=18 Participants
Open-label treatment in Epoch 3 was initiated for TRAPS patients who rolled over from CACZ885D2203 or CACZ885D2207M.
|
Total
n=203 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
crFMF cohort - randomized
|
18.0 Years
FULL_RANGE 15.02 • n=5 Participants
|
18.0 Years
FULL_RANGE 13.38 • n=7 Participants
|
NA Years
FULL_RANGE NA • n=5 Participants
|
NA Years
FULL_RANGE NA • n=4 Participants
|
NA Years
FULL_RANGE NA • n=21 Participants
|
NA Years
FULL_RANGE NA • n=8 Participants
|
NA Years
n=8 Participants
|
NA Years
n=24 Participants
|
NA Years
n=42 Participants
|
18 Years
FULL_RANGE 14.10 • n=42 Participants
|
|
Age, Continuous
HIDS/MKD cohort - randomized
|
NA Years
FULL_RANGE NA • n=5 Participants
|
NA Years
FULL_RANGE NA • n=7 Participants
|
12.0 Years
FULL_RANGE 8.49 • n=5 Participants
|
9.0 Years
FULL_RANGE 11.64 • n=4 Participants
|
NA Years
FULL_RANGE NA • n=21 Participants
|
NA Years
FULL_RANGE NA • n=8 Participants
|
NA Years
n=8 Participants
|
NA Years
n=24 Participants
|
NA Years
n=42 Participants
|
11.0 Years
FULL_RANGE 10.08 • n=42 Participants
|
|
Age, Continuous
TRAPS cohort - randomized
|
NA Years
FULL_RANGE NA • n=5 Participants
|
NA Years
FULL_RANGE NA • n=7 Participants
|
NA Years
FULL_RANGE NA • n=5 Participants
|
NA Years
FULL_RANGE NA • n=4 Participants
|
13.5 Years
FULL_RANGE 19.22 • n=21 Participants
|
16.5 Years
FULL_RANGE 18.25 • n=8 Participants
|
NA Years
n=8 Participants
|
NA Years
n=24 Participants
|
NA Years
n=42 Participants
|
15.5 Years
FULL_RANGE 18.55 • n=42 Participants
|
|
Age, Continuous
crFMF - non-randomized
|
NA Years
n=5 Participants
|
NA Years
n=7 Participants
|
NA Years
n=5 Participants
|
NA Years
n=4 Participants
|
NA Years
n=21 Participants
|
NA Years
n=8 Participants
|
24.5 Years
n=8 Participants
|
NA Years
n=24 Participants
|
NA Years
n=42 Participants
|
24.5 Years
n=42 Participants
|
|
Age, Continuous
HIDS/MKD - non-randomized
|
NA Years
n=5 Participants
|
NA Years
n=7 Participants
|
NA Years
n=5 Participants
|
NA Years
n=4 Participants
|
NA Years
n=21 Participants
|
NA Years
n=8 Participants
|
NA Years
n=8 Participants
|
1.0 Years
n=24 Participants
|
NA Years
n=42 Participants
|
1.0 Years
n=42 Participants
|
|
Age, Continuous
roll-over TRAPS - non-randomized
|
NA Years
n=5 Participants
|
NA Years
n=7 Participants
|
NA Years
n=5 Participants
|
NA Years
n=4 Participants
|
NA Years
n=21 Participants
|
NA Years
n=8 Participants
|
NA Years
n=8 Participants
|
NA Years
n=24 Participants
|
42.5 Years
n=42 Participants
|
42.5 Years
n=42 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
13 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
7 Participants
n=42 Participants
|
104 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
11 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
11 Participants
n=42 Participants
|
99 Participants
n=42 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
11 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
White
|
27 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
31 Participants
n=4 Participants
|
20 Participants
n=21 Participants
|
18 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
16 Participants
n=42 Participants
|
174 Participants
n=42 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
18 Participants
n=42 Participants
|
PRIMARY outcome
Timeframe: 16 weeksPopulation: The Full Analysis Set (FAS), which consisted of all randomized participants in the randomized treatment epoch who received at least one dose of study drug in Epoch 2, was analyzed.
Resolution of the initial disease flare is defined as: Physician's Global Assessment of Disease activity (PGA) \<2 and C-reactive protein (CRP) within normal range (\<= 10 mg/L) or reduction by at least 70% from baseline. The PGA was evaluated by the investigator based on a 5-point scale: 0 = None (no) disease associated with clinical signs and symptoms; 1 = minimal disease associated signs and symptoms; 2 = mild disease associated signs and symptoms; 3 = moderate disease associated signs and symptoms; and 5 = severe disease associated signs and symptoms.
Outcome measures
| Measure |
Epoch 2: crFMF: 150 mg
n=31 Participants
During Epoch 2, participants received canakinumab 150mg (or 2mg/kg for participants weighing \<= 40kg) q4w for 16 weeks. If participants were eligible for blinded escape, they received a single add-on dose of canakinumab (150 mg or 2mg/kg for participants weighing \<= 40kg) between day 8 and day 28, and then received blinded uptitration to canakinumab 300 mg q4w from day 29 through day 112. If patients on the highest allowed canakinumab dose of 300 mg (or 4 mg/kg for patients weighing ≤ 40 kg) q4w and re-flared (PGA ≥ 2 and CRP ≥ 30 mg/L) were not eligible for further up-titration.
|
Epoch 2: crCMF: Placebo
n=32 Participants
During epoch 2, participants received matching placebo to canakinumab 150 mg Participants who required blinded escape,they received a single add-on dose of canakinumab (150 mg or 2mg/kg for participants weighing \<= 40kg) between day 8 and day 28, and then received blinded one dose of placebo and one dose of canakinumab q4w from day 29 through day 112. If flare or re-flare still occurred after receipt of canakinumab.
150mg, participants were uptitrated to open-label canakinumab 300 mg
|
Epoch 2: HIDS/MKD: 150 mg
n=37 Participants
During Epoch 2, participants received canakinumab 150mg (or 2mg/kg for participants weighing \<= 40kg) q4w for 16 weeks. If participants were eligible for blinded escape, they received a single add-on dose of canakinumab (150 mg or 2mg/kg for participants weighing \<= 40kg) between day 8 and day 28, and then received blinded uptitration to canakinumab 300 mg q4w from day 29 through day 112. If patients on the highest allowed canakinumab dose of 300 mg (or 4 mg/kg for patients weighing ≤ 40 kg) q4w and re-flared (PGA ≥ 2 and CRP ≥ 30 mg/L) were not eligible for further up-titration.
|
Epoch 2: HIDS/MKD: Placebo
n=35 Participants
During epoch 2, participants received matching placebo to canakinumab 150 mg qw4. Participants who required blinded escape, they received a single add-on dose of canakinumab (150 mg or 2mg/kg for participants weighing \<= 40kg) between day 8 and day 28 and then received blinded one dose of placebo and one dose of canakinumab q4w from day 29 through day 112. If flare or re-flare still occurred after receipt of canakinumab 150mg, participants were uptitrated to open-label canakinumab 300 mg.
|
Epoch 2: TRAPS: 150 mg
n=22 Participants
During Epoch 2, participants received canakinumab 150mg (or 2mg/kg for participants weighing \<= 40kg) q4w for 16 weeks. If participants were eligible for blinded escape, they received a single add-on dose of canakinumab (150 mg or 2mg/kg for participants weighing \<= 40kg) between day 8 and day 28, and then received blinded uptitration to canakinumab 300 mg q4w from day 29 through day 112. If patients on the highest allowed canakinumab dose of 300 mg (or 4 mg/kg for patients weighing ≤ 40 kg) q4w and re-flared (PGA ≥ 2 and CRP ≥ 30 mg/L) were not eligible for further up-titration
|
Epoch 2: TRAPS: Placebo
n=24 Participants
During epoch 2, participants received matching placebo to canakinumab 150 mg qw4. Participants who required blinded escape,they received a single add-on dose of canakinumab (150 mg or 2mg/kg for participants weighing \<= 40kg) between Day 8 and 28 and then received blinded one dose of placebo and one dose of canakinumab q4w from day 29 through day 112. If flare or re-flare still occurred after receipt of canakinumab 150mg, participants were uptitrated to open-label canakinumab 300 mg.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With Resolution of Initial Flare and Absence of New Flares up to the End of the Randomized Treatment Epoch (16 Weeks)
|
61.29 Percentage of participants
|
6.25 Percentage of participants
|
35.14 Percentage of participants
|
5.71 Percentage of participants
|
45.45 Percentage of participants
|
8.33 Percentage of participants
|
SECONDARY outcome
Timeframe: 16 weeksPopulation: The Full Analysis Set (FAS), which consisted of all randomized participants in the randomized treatment epoch who received at least one dose of study drug in Epoch 2, was analyzed.
The PGA was evaluated by the investigator based on a 5-point scale: 0 = None (no) disease associated with clinical signs and symptoms; 1 = minimal disease associated signs and symptoms; 2 = mild disease associated signs and symptoms; 3 = moderate disease associated signs and symptoms; and 5 = severe disease associated signs and symptoms.
Outcome measures
| Measure |
Epoch 2: crFMF: 150 mg
n=31 Participants
During Epoch 2, participants received canakinumab 150mg (or 2mg/kg for participants weighing \<= 40kg) q4w for 16 weeks. If participants were eligible for blinded escape, they received a single add-on dose of canakinumab (150 mg or 2mg/kg for participants weighing \<= 40kg) between day 8 and day 28, and then received blinded uptitration to canakinumab 300 mg q4w from day 29 through day 112. If patients on the highest allowed canakinumab dose of 300 mg (or 4 mg/kg for patients weighing ≤ 40 kg) q4w and re-flared (PGA ≥ 2 and CRP ≥ 30 mg/L) were not eligible for further up-titration.
|
Epoch 2: crCMF: Placebo
n=32 Participants
During epoch 2, participants received matching placebo to canakinumab 150 mg Participants who required blinded escape,they received a single add-on dose of canakinumab (150 mg or 2mg/kg for participants weighing \<= 40kg) between day 8 and day 28, and then received blinded one dose of placebo and one dose of canakinumab q4w from day 29 through day 112. If flare or re-flare still occurred after receipt of canakinumab.
150mg, participants were uptitrated to open-label canakinumab 300 mg
|
Epoch 2: HIDS/MKD: 150 mg
n=37 Participants
During Epoch 2, participants received canakinumab 150mg (or 2mg/kg for participants weighing \<= 40kg) q4w for 16 weeks. If participants were eligible for blinded escape, they received a single add-on dose of canakinumab (150 mg or 2mg/kg for participants weighing \<= 40kg) between day 8 and day 28, and then received blinded uptitration to canakinumab 300 mg q4w from day 29 through day 112. If patients on the highest allowed canakinumab dose of 300 mg (or 4 mg/kg for patients weighing ≤ 40 kg) q4w and re-flared (PGA ≥ 2 and CRP ≥ 30 mg/L) were not eligible for further up-titration.
|
Epoch 2: HIDS/MKD: Placebo
n=35 Participants
During epoch 2, participants received matching placebo to canakinumab 150 mg qw4. Participants who required blinded escape, they received a single add-on dose of canakinumab (150 mg or 2mg/kg for participants weighing \<= 40kg) between day 8 and day 28 and then received blinded one dose of placebo and one dose of canakinumab q4w from day 29 through day 112. If flare or re-flare still occurred after receipt of canakinumab 150mg, participants were uptitrated to open-label canakinumab 300 mg.
|
Epoch 2: TRAPS: 150 mg
n=22 Participants
During Epoch 2, participants received canakinumab 150mg (or 2mg/kg for participants weighing \<= 40kg) q4w for 16 weeks. If participants were eligible for blinded escape, they received a single add-on dose of canakinumab (150 mg or 2mg/kg for participants weighing \<= 40kg) between day 8 and day 28, and then received blinded uptitration to canakinumab 300 mg q4w from day 29 through day 112. If patients on the highest allowed canakinumab dose of 300 mg (or 4 mg/kg for patients weighing ≤ 40 kg) q4w and re-flared (PGA ≥ 2 and CRP ≥ 30 mg/L) were not eligible for further up-titration
|
Epoch 2: TRAPS: Placebo
n=24 Participants
During epoch 2, participants received matching placebo to canakinumab 150 mg qw4. Participants who required blinded escape,they received a single add-on dose of canakinumab (150 mg or 2mg/kg for participants weighing \<= 40kg) between Day 8 and 28 and then received blinded one dose of placebo and one dose of canakinumab q4w from day 29 through day 112. If flare or re-flare still occurred after receipt of canakinumab 150mg, participants were uptitrated to open-label canakinumab 300 mg.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Who Achieve Physician's Global Assessment (PGA) < 2
|
64.52 Percentage of participants
|
9.38 Percentage of participants
|
45.95 Percentage of participants
|
5.71 Percentage of participants
|
45.45 Percentage of participants
|
4.17 Percentage of participants
|
SECONDARY outcome
Timeframe: 16 weeksPopulation: The Full Analysis Set (FAS), which consisted of all randomized participants in the randomized treatment epoch who received at least one dose of study drug in Epoch 2, was analyzed.
Serologic remission was defined as C-reactive protein \<= 10 mg/L.
Outcome measures
| Measure |
Epoch 2: crFMF: 150 mg
n=31 Participants
During Epoch 2, participants received canakinumab 150mg (or 2mg/kg for participants weighing \<= 40kg) q4w for 16 weeks. If participants were eligible for blinded escape, they received a single add-on dose of canakinumab (150 mg or 2mg/kg for participants weighing \<= 40kg) between day 8 and day 28, and then received blinded uptitration to canakinumab 300 mg q4w from day 29 through day 112. If patients on the highest allowed canakinumab dose of 300 mg (or 4 mg/kg for patients weighing ≤ 40 kg) q4w and re-flared (PGA ≥ 2 and CRP ≥ 30 mg/L) were not eligible for further up-titration.
|
Epoch 2: crCMF: Placebo
n=32 Participants
During epoch 2, participants received matching placebo to canakinumab 150 mg Participants who required blinded escape,they received a single add-on dose of canakinumab (150 mg or 2mg/kg for participants weighing \<= 40kg) between day 8 and day 28, and then received blinded one dose of placebo and one dose of canakinumab q4w from day 29 through day 112. If flare or re-flare still occurred after receipt of canakinumab.
150mg, participants were uptitrated to open-label canakinumab 300 mg
|
Epoch 2: HIDS/MKD: 150 mg
n=37 Participants
During Epoch 2, participants received canakinumab 150mg (or 2mg/kg for participants weighing \<= 40kg) q4w for 16 weeks. If participants were eligible for blinded escape, they received a single add-on dose of canakinumab (150 mg or 2mg/kg for participants weighing \<= 40kg) between day 8 and day 28, and then received blinded uptitration to canakinumab 300 mg q4w from day 29 through day 112. If patients on the highest allowed canakinumab dose of 300 mg (or 4 mg/kg for patients weighing ≤ 40 kg) q4w and re-flared (PGA ≥ 2 and CRP ≥ 30 mg/L) were not eligible for further up-titration.
|
Epoch 2: HIDS/MKD: Placebo
n=35 Participants
During epoch 2, participants received matching placebo to canakinumab 150 mg qw4. Participants who required blinded escape, they received a single add-on dose of canakinumab (150 mg or 2mg/kg for participants weighing \<= 40kg) between day 8 and day 28 and then received blinded one dose of placebo and one dose of canakinumab q4w from day 29 through day 112. If flare or re-flare still occurred after receipt of canakinumab 150mg, participants were uptitrated to open-label canakinumab 300 mg.
|
Epoch 2: TRAPS: 150 mg
n=22 Participants
During Epoch 2, participants received canakinumab 150mg (or 2mg/kg for participants weighing \<= 40kg) q4w for 16 weeks. If participants were eligible for blinded escape, they received a single add-on dose of canakinumab (150 mg or 2mg/kg for participants weighing \<= 40kg) between day 8 and day 28, and then received blinded uptitration to canakinumab 300 mg q4w from day 29 through day 112. If patients on the highest allowed canakinumab dose of 300 mg (or 4 mg/kg for patients weighing ≤ 40 kg) q4w and re-flared (PGA ≥ 2 and CRP ≥ 30 mg/L) were not eligible for further up-titration
|
Epoch 2: TRAPS: Placebo
n=24 Participants
During epoch 2, participants received matching placebo to canakinumab 150 mg qw4. Participants who required blinded escape,they received a single add-on dose of canakinumab (150 mg or 2mg/kg for participants weighing \<= 40kg) between Day 8 and 28 and then received blinded one dose of placebo and one dose of canakinumab q4w from day 29 through day 112. If flare or re-flare still occurred after receipt of canakinumab 150mg, participants were uptitrated to open-label canakinumab 300 mg.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With the Serologic Remission
|
67.74 Percentage of participants
|
6.25 Percentage of participants
|
40.54 Percentage of participants
|
5.71 Percentage of participants
|
36.36 Percentage of participants
|
8.33 Percentage of participants
|
SECONDARY outcome
Timeframe: 16 weeksPopulation: The Full Analysis Set (FAS), which consisted of all randomized participants in the randomized treatment epoch who received at least one dose of study drug in Epoch 2, was analyzed.
Normalized SAA was defined as SAA \<= 10 mg/L.
Outcome measures
| Measure |
Epoch 2: crFMF: 150 mg
n=31 Participants
During Epoch 2, participants received canakinumab 150mg (or 2mg/kg for participants weighing \<= 40kg) q4w for 16 weeks. If participants were eligible for blinded escape, they received a single add-on dose of canakinumab (150 mg or 2mg/kg for participants weighing \<= 40kg) between day 8 and day 28, and then received blinded uptitration to canakinumab 300 mg q4w from day 29 through day 112. If patients on the highest allowed canakinumab dose of 300 mg (or 4 mg/kg for patients weighing ≤ 40 kg) q4w and re-flared (PGA ≥ 2 and CRP ≥ 30 mg/L) were not eligible for further up-titration.
|
Epoch 2: crCMF: Placebo
n=32 Participants
During epoch 2, participants received matching placebo to canakinumab 150 mg Participants who required blinded escape,they received a single add-on dose of canakinumab (150 mg or 2mg/kg for participants weighing \<= 40kg) between day 8 and day 28, and then received blinded one dose of placebo and one dose of canakinumab q4w from day 29 through day 112. If flare or re-flare still occurred after receipt of canakinumab.
150mg, participants were uptitrated to open-label canakinumab 300 mg
|
Epoch 2: HIDS/MKD: 150 mg
n=37 Participants
During Epoch 2, participants received canakinumab 150mg (or 2mg/kg for participants weighing \<= 40kg) q4w for 16 weeks. If participants were eligible for blinded escape, they received a single add-on dose of canakinumab (150 mg or 2mg/kg for participants weighing \<= 40kg) between day 8 and day 28, and then received blinded uptitration to canakinumab 300 mg q4w from day 29 through day 112. If patients on the highest allowed canakinumab dose of 300 mg (or 4 mg/kg for patients weighing ≤ 40 kg) q4w and re-flared (PGA ≥ 2 and CRP ≥ 30 mg/L) were not eligible for further up-titration.
|
Epoch 2: HIDS/MKD: Placebo
n=35 Participants
During epoch 2, participants received matching placebo to canakinumab 150 mg qw4. Participants who required blinded escape, they received a single add-on dose of canakinumab (150 mg or 2mg/kg for participants weighing \<= 40kg) between day 8 and day 28 and then received blinded one dose of placebo and one dose of canakinumab q4w from day 29 through day 112. If flare or re-flare still occurred after receipt of canakinumab 150mg, participants were uptitrated to open-label canakinumab 300 mg.
|
Epoch 2: TRAPS: 150 mg
n=22 Participants
During Epoch 2, participants received canakinumab 150mg (or 2mg/kg for participants weighing \<= 40kg) q4w for 16 weeks. If participants were eligible for blinded escape, they received a single add-on dose of canakinumab (150 mg or 2mg/kg for participants weighing \<= 40kg) between day 8 and day 28, and then received blinded uptitration to canakinumab 300 mg q4w from day 29 through day 112. If patients on the highest allowed canakinumab dose of 300 mg (or 4 mg/kg for patients weighing ≤ 40 kg) q4w and re-flared (PGA ≥ 2 and CRP ≥ 30 mg/L) were not eligible for further up-titration
|
Epoch 2: TRAPS: Placebo
n=24 Participants
During epoch 2, participants received matching placebo to canakinumab 150 mg qw4. Participants who required blinded escape,they received a single add-on dose of canakinumab (150 mg or 2mg/kg for participants weighing \<= 40kg) between Day 8 and 28 and then received blinded one dose of placebo and one dose of canakinumab q4w from day 29 through day 112. If flare or re-flare still occurred after receipt of canakinumab 150mg, participants were uptitrated to open-label canakinumab 300 mg.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With Normalized Serum Amyloid A (SAA) Level
|
25.81 Percentage of participants
|
0.00 Percentage of participants
|
13.51 Percentage of participants
|
2.86 Percentage of participants
|
27.27 Percentage of participants
|
0.00 Percentage of participants
|
SECONDARY outcome
Timeframe: 40 weeksPopulation: The re-randomized set was analyzed.
A responder was defined as a participant who had no flare between week 16 and week 40.
Outcome measures
| Measure |
Epoch 2: crFMF: 150 mg
n=9 Participants
During Epoch 2, participants received canakinumab 150mg (or 2mg/kg for participants weighing \<= 40kg) q4w for 16 weeks. If participants were eligible for blinded escape, they received a single add-on dose of canakinumab (150 mg or 2mg/kg for participants weighing \<= 40kg) between day 8 and day 28, and then received blinded uptitration to canakinumab 300 mg q4w from day 29 through day 112. If patients on the highest allowed canakinumab dose of 300 mg (or 4 mg/kg for patients weighing ≤ 40 kg) q4w and re-flared (PGA ≥ 2 and CRP ≥ 30 mg/L) were not eligible for further up-titration.
|
Epoch 2: crCMF: Placebo
n=10 Participants
During epoch 2, participants received matching placebo to canakinumab 150 mg Participants who required blinded escape,they received a single add-on dose of canakinumab (150 mg or 2mg/kg for participants weighing \<= 40kg) between day 8 and day 28, and then received blinded one dose of placebo and one dose of canakinumab q4w from day 29 through day 112. If flare or re-flare still occurred after receipt of canakinumab.
150mg, participants were uptitrated to open-label canakinumab 300 mg
|
Epoch 2: HIDS/MKD: 150 mg
n=6 Participants
During Epoch 2, participants received canakinumab 150mg (or 2mg/kg for participants weighing \<= 40kg) q4w for 16 weeks. If participants were eligible for blinded escape, they received a single add-on dose of canakinumab (150 mg or 2mg/kg for participants weighing \<= 40kg) between day 8 and day 28, and then received blinded uptitration to canakinumab 300 mg q4w from day 29 through day 112. If patients on the highest allowed canakinumab dose of 300 mg (or 4 mg/kg for patients weighing ≤ 40 kg) q4w and re-flared (PGA ≥ 2 and CRP ≥ 30 mg/L) were not eligible for further up-titration.
|
Epoch 2: HIDS/MKD: Placebo
n=7 Participants
During epoch 2, participants received matching placebo to canakinumab 150 mg qw4. Participants who required blinded escape, they received a single add-on dose of canakinumab (150 mg or 2mg/kg for participants weighing \<= 40kg) between day 8 and day 28 and then received blinded one dose of placebo and one dose of canakinumab q4w from day 29 through day 112. If flare or re-flare still occurred after receipt of canakinumab 150mg, participants were uptitrated to open-label canakinumab 300 mg.
|
Epoch 2: TRAPS: 150 mg
n=4 Participants
During Epoch 2, participants received canakinumab 150mg (or 2mg/kg for participants weighing \<= 40kg) q4w for 16 weeks. If participants were eligible for blinded escape, they received a single add-on dose of canakinumab (150 mg or 2mg/kg for participants weighing \<= 40kg) between day 8 and day 28, and then received blinded uptitration to canakinumab 300 mg q4w from day 29 through day 112. If patients on the highest allowed canakinumab dose of 300 mg (or 4 mg/kg for patients weighing ≤ 40 kg) q4w and re-flared (PGA ≥ 2 and CRP ≥ 30 mg/L) were not eligible for further up-titration
|
Epoch 2: TRAPS: Placebo
n=5 Participants
During epoch 2, participants received matching placebo to canakinumab 150 mg qw4. Participants who required blinded escape,they received a single add-on dose of canakinumab (150 mg or 2mg/kg for participants weighing \<= 40kg) between Day 8 and 28 and then received blinded one dose of placebo and one dose of canakinumab q4w from day 29 through day 112. If flare or re-flare still occurred after receipt of canakinumab 150mg, participants were uptitrated to open-label canakinumab 300 mg.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants of Canakinumab Responders From Epoch 2 Who Maintained a Clinically Meaningful Response (Absence of New Flares) (40 Weeks)
|
77.8 Percentage of participants
|
30.0 Percentage of participants
|
50.0 Percentage of participants
|
14.3 Percentage of participants
|
75.0 Percentage of participants
|
40.0 Percentage of participants
|
Adverse Events
Non-randomized Open Label crFMF, HIDS/MKD Patients
Serious events: 3 serious events
Other events: 4 other events
Deaths: 0 deaths
Non-randomized Open Label TRAPS Patients
Serious events: 1 serious events
Other events: 18 other events
Deaths: 0 deaths
Randomized ACZ and Placebo TRAPS Patients - Placebo Events
Serious events: 1 serious events
Other events: 14 other events
Deaths: 0 deaths
Randomized ACZ and Placebo TRAPS Pts - No Medication Events
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Randomized ACZ and Placebo TRAPS Patients - ACZ Events
Serious events: 8 serious events
Other events: 43 other events
Deaths: 0 deaths
Randomized ACZ and Placebo HIDS/MKD Pts - Placebo Events
Serious events: 6 serious events
Other events: 25 other events
Deaths: 0 deaths
Randomized ACZ and Placebo HIDS/MKD Pts - No Medication Events
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Randomized ACZ and Placebo HIDS/MKD Patients - ACZ Events
Serious events: 16 serious events
Other events: 68 other events
Deaths: 0 deaths
Randomized ACZ and Placebo crFMF Patients - Placebo Events
Serious events: 5 serious events
Other events: 29 other events
Deaths: 0 deaths
Randomized ACZ and Placebo crFMF Pts - No Medication Events
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Randomized ACZ and Placebo crFMF Patients - ACZ Events
Serious events: 16 serious events
Other events: 54 other events
Deaths: 0 deaths
Any ACZ TRAPS Patients - Placebo Events
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Any ACZ TRAPS Patients - no Medication Events
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Any ACZ TRAPS Patients - ACZ Events
Serious events: 9 serious events
Other events: 61 other events
Deaths: 0 deaths
Any ACZ HIDS/MKD Patients - Placebo Events
Serious events: 3 serious events
Other events: 7 other events
Deaths: 0 deaths
Any ACZ HIDS/MKD Patients - No Medication Events
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Any ACZ HIDS/MKD Patients - ACZ Events
Serious events: 18 serious events
Other events: 70 other events
Deaths: 0 deaths
Any ACZ crFMF Patients - Placebo Events
Serious events: 3 serious events
Other events: 10 other events
Deaths: 0 deaths
Any ACZ crFMF Patients - No Medication Events
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Any ACZ crFMF Patients - ACZ Events
Serious events: 17 serious events
Other events: 56 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Non-randomized Open Label crFMF, HIDS/MKD Patients
n=4 participants at risk
Canakinumab-naïve Japanese patients with non-exon 10 mutations with cr-FMF who received open-label canakinumab 150 mg (or 2 mg/kg for patients weighing ≤ 40 kg) q4w; and patients in the 28 days to less than 2 years old cohort with HIDS/MKD who received open-label canakinumab 150 mg (or 2mg/kg for patients weighing
≤ 40 kg) q4w
|
Non-randomized Open Label TRAPS Patients
n=18 participants at risk
Open-label treatment in Epoch 3 was initiated for TRAPS patients who rolled over from CACZ885D2203 or CACZ885D2207M
|
Randomized ACZ and Placebo TRAPS Patients - Placebo Events
n=46 participants at risk
Patients who received ACZ885 and/or placebo during epoch 2 and/or epoch 3.
|
Randomized ACZ and Placebo TRAPS Pts - No Medication Events
n=46 participants at risk
Patients who received ACZ885 and/or placebo during epoch 2 and/or epoch 3 .
|
Randomized ACZ and Placebo TRAPS Patients - ACZ Events
n=46 participants at risk
Patients who received ACZ885 and/or placebo during epoch 2 and/or epoch 3
|
Randomized ACZ and Placebo HIDS/MKD Pts - Placebo Events
n=72 participants at risk
Patients who received ACZ885 and/or placebo during epoch 2 and/or epoch 3
|
Randomized ACZ and Placebo HIDS/MKD Pts - No Medication Events
n=72 participants at risk
Patients who received ACZ885 and/or placebo during epoch 2 and/or epoch 3
|
Randomized ACZ and Placebo HIDS/MKD Patients - ACZ Events
n=72 participants at risk
Patients who received ACZ885 and/or placebo during epoch 2 and/or epoch 3
|
Randomized ACZ and Placebo crFMF Patients - Placebo Events
n=63 participants at risk
Patients who received ACZ885 and/or placebo during epoch 2 and/or epoch 3
|
Randomized ACZ and Placebo crFMF Pts - No Medication Events
n=63 participants at risk
Patients who received ACZ885 and/or placebo during epoch 2 and/or epoch 3
|
Randomized ACZ and Placebo crFMF Patients - ACZ Events
n=63 participants at risk
Patients who received ACZ885 and/or placebo during epoch 2 and/or epoch 3
|
Any ACZ TRAPS Patients - Placebo Events
n=61 participants at risk
Patients who received ACZ885 during epoch 2 and/or epoch 3
|
Any ACZ TRAPS Patients - no Medication Events
n=61 participants at risk
Patients who received ACZ885 during epoch 2 and/or epoch 3
|
Any ACZ TRAPS Patients - ACZ Events
n=61 participants at risk
Patients who received ACZ885 during epoch 2 and/or epoch 3
|
Any ACZ HIDS/MKD Patients - Placebo Events
n=71 participants at risk
Patients who received ACZ885 during epoch 2 and/or epoch 3
|
Any ACZ HIDS/MKD Patients - No Medication Events
n=71 participants at risk
Patients who received ACZ885 during epoch 2 and/or epoch 3
|
Any ACZ HIDS/MKD Patients - ACZ Events
n=71 participants at risk
Patients who received ACZ885 during epoch 2 and/or epoch 3
|
Any ACZ crFMF Patients - Placebo Events
n=61 participants at risk
Patients who received ACZ885 during epoch 2 and/or epoch 3
|
Any ACZ crFMF Patients - No Medication Events
n=61 participants at risk
Patients who received ACZ885 during epoch 2 and/or epoch 3
|
Any ACZ crFMF Patients - ACZ Events
n=61 participants at risk
Patients who received ACZ885 during epoch 2 and/or epoch 3
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/4 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/18 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.4%
1/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.4%
1/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
|
Infections and infestations
Infectious colitis
|
0.00%
0/4 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/18 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.6%
1/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.6%
1/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
|
Infections and infestations
Influenza
|
0.00%
0/4 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/18 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.4%
1/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.4%
1/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/4 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/18 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.4%
1/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.4%
1/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/4 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/18 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.4%
1/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
25.0%
1/4 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/18 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.4%
1/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/4 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/18 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.6%
1/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.6%
1/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/4 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/18 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.4%
1/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.4%
1/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
|
Congenital, familial and genetic disorders
Familial mediterranean fever
|
0.00%
0/4 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/18 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.4%
1/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
4.8%
3/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
3.2%
2/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.4%
1/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
3.3%
2/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
3.3%
2/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
|
Congenital, familial and genetic disorders
Hyper IgD syndrome
|
25.0%
1/4 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/18 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.4%
1/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
4.2%
3/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.4%
1/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
5.6%
4/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
|
Congenital, familial and genetic disorders
Tumour necrosis factor receptor-associated periodic syndrome
|
0.00%
0/4 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/18 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
2.2%
1/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
6.5%
3/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
4.9%
3/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
|
Endocrine disorders
Thyroiditis
|
0.00%
0/4 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/18 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.6%
1/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.6%
1/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/4 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/18 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.4%
1/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.6%
1/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.6%
1/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/4 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/18 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.6%
1/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.6%
1/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/4 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/18 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.6%
1/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.6%
1/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/4 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
5.6%
1/18 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
2.2%
1/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
3.3%
2/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/4 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/18 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
2.2%
1/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.6%
1/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
|
Gastrointestinal disorders
Ileal ulcer
|
0.00%
0/4 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/18 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.6%
1/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.6%
1/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/4 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/18 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.6%
1/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.6%
1/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.00%
0/4 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/18 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.6%
1/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
3.2%
2/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.6%
1/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
3.3%
2/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/4 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/18 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
2.2%
1/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.6%
1/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
|
General disorders
Hyperpyrexia
|
0.00%
0/4 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/18 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.4%
1/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.4%
1/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
|
General disorders
Polyserositis
|
0.00%
0/4 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/18 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.4%
1/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.4%
1/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
|
General disorders
Pyrexia
|
0.00%
0/4 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
5.6%
1/18 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
6.5%
3/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
2.8%
2/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.6%
1/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.6%
1/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
6.6%
4/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
2.8%
2/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.6%
1/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.6%
1/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
|
Hepatobiliary disorders
Bile duct stone
|
0.00%
0/4 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/18 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.6%
1/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.6%
1/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
|
Hepatobiliary disorders
Granulomatous liver disease
|
0.00%
0/4 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/18 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.6%
1/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.6%
1/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
0.00%
0/4 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/18 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.6%
1/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.6%
1/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
|
Hepatobiliary disorders
Hepatic failure
|
25.0%
1/4 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/18 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.4%
1/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/4 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/18 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.4%
1/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.4%
1/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
|
Infections and infestations
Acute sinusitis
|
0.00%
0/4 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/18 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.6%
1/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.6%
1/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
|
Infections and infestations
Anal abscess
|
0.00%
0/4 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/18 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.4%
1/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.4%
1/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/4 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/18 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.4%
1/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.4%
1/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
|
Infections and infestations
Atypical pneumonia
|
0.00%
0/4 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/18 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.6%
1/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/4 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/18 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.4%
1/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.4%
1/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/4 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/18 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
3.2%
2/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
3.3%
2/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/4 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/18 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.4%
1/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.4%
1/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
|
Infections and infestations
Diarrhoea infectious
|
0.00%
0/4 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/18 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.4%
1/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.4%
1/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/4 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/18 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.6%
1/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.6%
1/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
|
Infections and infestations
Gastroenteritis rotavirus
|
0.00%
0/4 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/18 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.4%
1/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.4%
1/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
|
Infections and infestations
Herpes virus infection
|
0.00%
0/4 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/18 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.4%
1/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.4%
1/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
|
Infections and infestations
Laryngitis
|
25.0%
1/4 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/18 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.4%
1/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
|
Infections and infestations
Orchitis
|
0.00%
0/4 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/18 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.4%
1/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.4%
1/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
|
Infections and infestations
Pelvic abscess
|
0.00%
0/4 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/18 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.6%
1/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.6%
1/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
|
Infections and infestations
Peritonitis
|
0.00%
0/4 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/18 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.6%
1/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.6%
1/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/4 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/18 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.4%
1/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.4%
1/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
|
Infections and infestations
Pharyngotonsillitis
|
0.00%
0/4 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/18 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.6%
1/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.6%
1/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/4 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/18 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.4%
1/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
5.6%
4/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.4%
1/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
5.6%
4/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/4 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/18 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.4%
1/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.4%
1/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
|
Infections and infestations
Septic shock
|
0.00%
0/4 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/18 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
2.2%
1/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.6%
1/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/4 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/18 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.4%
1/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.4%
1/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/4 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/18 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.6%
1/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.6%
1/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
|
Infections and infestations
Vulval abscess
|
0.00%
0/4 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/18 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
2.2%
1/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.6%
1/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
|
Injury, poisoning and procedural complications
Scar
|
0.00%
0/4 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/18 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.4%
1/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.4%
1/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/4 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/18 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.4%
1/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.6%
1/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.4%
1/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.6%
1/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/4 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
5.6%
1/18 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.6%
1/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/4 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/18 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.6%
1/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.6%
1/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
|
Metabolism and nutrition disorders
Obesity
|
0.00%
0/4 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/18 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.6%
1/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.6%
1/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/4 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/18 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.6%
1/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.6%
1/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/4 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/18 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.6%
1/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.6%
1/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
|
Nervous system disorders
Seizure
|
0.00%
0/4 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/18 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.4%
1/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.4%
1/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.4%
1/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
|
Psychiatric disorders
Depression
|
0.00%
0/4 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/18 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.4%
1/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.4%
1/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
|
Psychiatric disorders
Intentional self-injury
|
0.00%
0/4 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/18 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.4%
1/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.4%
1/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
|
Psychiatric disorders
Schizophrenia
|
0.00%
0/4 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/18 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.6%
1/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.6%
1/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/4 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/18 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.4%
1/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.4%
1/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/4 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/18 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.4%
1/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.4%
1/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/4 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
5.6%
1/18 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.6%
1/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/4 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/18 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.6%
1/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal stenosis
|
0.00%
0/4 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/18 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
2.2%
1/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.6%
1/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/4 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/18 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
2.2%
1/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.6%
1/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.00%
0/4 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/18 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.6%
1/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.6%
1/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
|
Respiratory, thoracic and mediastinal disorders
Vocal cord polyp
|
0.00%
0/4 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/18 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.6%
1/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.6%
1/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.00%
0/4 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/18 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
2.2%
1/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.6%
1/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
|
Skin and subcutaneous tissue disorders
Granulomatous rosacea
|
0.00%
0/4 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/18 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.4%
1/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.4%
1/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
|
Skin and subcutaneous tissue disorders
Pyoderma gangrenosum
|
25.0%
1/4 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/18 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.6%
1/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
Other adverse events
| Measure |
Non-randomized Open Label crFMF, HIDS/MKD Patients
n=4 participants at risk
Canakinumab-naïve Japanese patients with non-exon 10 mutations with cr-FMF who received open-label canakinumab 150 mg (or 2 mg/kg for patients weighing ≤ 40 kg) q4w; and patients in the 28 days to less than 2 years old cohort with HIDS/MKD who received open-label canakinumab 150 mg (or 2mg/kg for patients weighing
≤ 40 kg) q4w
|
Non-randomized Open Label TRAPS Patients
n=18 participants at risk
Open-label treatment in Epoch 3 was initiated for TRAPS patients who rolled over from CACZ885D2203 or CACZ885D2207M
|
Randomized ACZ and Placebo TRAPS Patients - Placebo Events
n=46 participants at risk
Patients who received ACZ885 and/or placebo during epoch 2 and/or epoch 3.
|
Randomized ACZ and Placebo TRAPS Pts - No Medication Events
n=46 participants at risk
Patients who received ACZ885 and/or placebo during epoch 2 and/or epoch 3 .
|
Randomized ACZ and Placebo TRAPS Patients - ACZ Events
n=46 participants at risk
Patients who received ACZ885 and/or placebo during epoch 2 and/or epoch 3
|
Randomized ACZ and Placebo HIDS/MKD Pts - Placebo Events
n=72 participants at risk
Patients who received ACZ885 and/or placebo during epoch 2 and/or epoch 3
|
Randomized ACZ and Placebo HIDS/MKD Pts - No Medication Events
n=72 participants at risk
Patients who received ACZ885 and/or placebo during epoch 2 and/or epoch 3
|
Randomized ACZ and Placebo HIDS/MKD Patients - ACZ Events
n=72 participants at risk
Patients who received ACZ885 and/or placebo during epoch 2 and/or epoch 3
|
Randomized ACZ and Placebo crFMF Patients - Placebo Events
n=63 participants at risk
Patients who received ACZ885 and/or placebo during epoch 2 and/or epoch 3
|
Randomized ACZ and Placebo crFMF Pts - No Medication Events
n=63 participants at risk
Patients who received ACZ885 and/or placebo during epoch 2 and/or epoch 3
|
Randomized ACZ and Placebo crFMF Patients - ACZ Events
n=63 participants at risk
Patients who received ACZ885 and/or placebo during epoch 2 and/or epoch 3
|
Any ACZ TRAPS Patients - Placebo Events
n=61 participants at risk
Patients who received ACZ885 during epoch 2 and/or epoch 3
|
Any ACZ TRAPS Patients - no Medication Events
n=61 participants at risk
Patients who received ACZ885 during epoch 2 and/or epoch 3
|
Any ACZ TRAPS Patients - ACZ Events
n=61 participants at risk
Patients who received ACZ885 during epoch 2 and/or epoch 3
|
Any ACZ HIDS/MKD Patients - Placebo Events
n=71 participants at risk
Patients who received ACZ885 during epoch 2 and/or epoch 3
|
Any ACZ HIDS/MKD Patients - No Medication Events
n=71 participants at risk
Patients who received ACZ885 during epoch 2 and/or epoch 3
|
Any ACZ HIDS/MKD Patients - ACZ Events
n=71 participants at risk
Patients who received ACZ885 during epoch 2 and/or epoch 3
|
Any ACZ crFMF Patients - Placebo Events
n=61 participants at risk
Patients who received ACZ885 during epoch 2 and/or epoch 3
|
Any ACZ crFMF Patients - No Medication Events
n=61 participants at risk
Patients who received ACZ885 during epoch 2 and/or epoch 3
|
Any ACZ crFMF Patients - ACZ Events
n=61 participants at risk
Patients who received ACZ885 during epoch 2 and/or epoch 3
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Investigations
Serum amyloid A protein increased
|
25.0%
1/4 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
16.7%
3/18 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
4.3%
2/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
8.7%
4/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.4%
1/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
11.5%
7/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
2.8%
2/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
|
Investigations
White blood cell count increased
|
25.0%
1/4 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
5.6%
1/18 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.4%
1/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.6%
1/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.6%
1/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
2.8%
2/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
|
Gastrointestinal disorders
Vomiting
|
25.0%
1/4 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
5.6%
1/18 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
2.2%
1/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
13.0%
6/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
2.8%
2/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
16.7%
12/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.6%
1/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
7.9%
5/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
11.5%
7/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.4%
1/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
16.9%
12/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
9.8%
6/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
|
Investigations
Neutrophil count decreased
|
25.0%
1/4 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/18 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.4%
1/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
2.8%
2/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
|
General disorders
Asthenia
|
0.00%
0/4 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
5.6%
1/18 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
6.5%
3/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
8.3%
6/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
3.2%
2/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
6.6%
4/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
8.5%
6/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
3.3%
2/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
|
Investigations
Neutrophil count increased
|
25.0%
1/4 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
5.6%
1/18 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.4%
1/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.6%
1/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.6%
1/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
2.8%
2/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
|
General disorders
Fatigue
|
0.00%
0/4 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/18 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
2.2%
1/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
6.5%
3/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
8.3%
6/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.6%
1/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.6%
1/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
4.9%
3/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
8.5%
6/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.6%
1/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.6%
1/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/4 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
5.6%
1/18 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.4%
1/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
5.6%
4/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.6%
1/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
4.8%
3/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.6%
1/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
5.6%
4/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
4.9%
3/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/4 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/18 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
2.2%
1/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
8.7%
4/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.4%
1/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
25.0%
18/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
7.9%
5/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
6.6%
4/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
25.4%
18/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
8.2%
5/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/4 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/18 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
6.5%
3/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.4%
1/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
5.6%
4/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
4.8%
3/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
4.9%
3/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
5.6%
4/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
4.9%
3/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/4 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
5.6%
1/18 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.6%
1/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/4 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
5.6%
1/18 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
3.2%
2/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.6%
1/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
3.3%
2/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
|
Congenital, familial and genetic disorders
Familial mediterranean fever
|
25.0%
1/4 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/18 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.4%
1/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
23.8%
15/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
3.2%
2/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
30.2%
19/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.4%
1/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
8.2%
5/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
3.3%
2/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
32.8%
20/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
|
Congenital, familial and genetic disorders
Hyper IgD syndrome
|
25.0%
1/4 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/18 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
6.9%
5/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.4%
1/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
26.4%
19/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.4%
1/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.4%
1/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
28.2%
20/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
|
Congenital, familial and genetic disorders
Tumour necrosis factor receptor-associated periodic syndrome
|
0.00%
0/4 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/18 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
4.3%
2/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
13.0%
6/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
9.8%
6/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/4 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/18 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
4.3%
2/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
13.9%
10/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.6%
1/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
3.3%
2/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
14.1%
10/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.6%
1/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/4 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
5.6%
1/18 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.6%
1/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
|
Eye disorders
Eye allergy
|
25.0%
1/4 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/18 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.4%
1/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
|
Eye disorders
Eye pain
|
25.0%
1/4 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/18 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
4.3%
2/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
2.8%
2/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
3.3%
2/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
4.2%
3/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
|
Eye disorders
Scleritis
|
25.0%
1/4 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/18 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.6%
1/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/4 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
16.7%
3/18 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
2.2%
1/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
2.2%
1/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
6.6%
4/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/4 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
22.2%
4/18 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
4.3%
2/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
30.4%
14/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
4.2%
3/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
34.7%
25/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
6.3%
4/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
25.4%
16/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.6%
1/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
29.5%
18/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.4%
1/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
35.2%
25/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.6%
1/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
26.2%
16/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/4 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
5.6%
1/18 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
2.2%
1/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
2.2%
1/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
10.9%
5/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.4%
1/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
19.4%
14/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
9.5%
6/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.6%
1/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
9.8%
6/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
19.7%
14/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
9.8%
6/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
|
Gastrointestinal disorders
Aphthous ulcer
|
25.0%
1/4 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/18 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
22.2%
16/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
3.2%
2/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
23.9%
17/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
3.3%
2/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
|
Gastrointestinal disorders
Constipation
|
25.0%
1/4 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
5.6%
1/18 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
2.2%
1/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
4.3%
2/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
6.9%
5/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
6.3%
4/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
4.9%
3/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
7.0%
5/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
8.2%
5/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
|
Gastrointestinal disorders
Dental caries
|
25.0%
1/4 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/18 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
2.8%
2/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.6%
1/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
2.8%
2/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
3.3%
2/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
|
Gastrointestinal disorders
Diarrhoea
|
50.0%
2/4 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
22.2%
4/18 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
2.2%
1/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
2.2%
1/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
17.4%
8/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
2.8%
2/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
30.6%
22/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.6%
1/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
19.0%
12/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.6%
1/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
19.7%
12/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
32.4%
23/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
21.3%
13/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/4 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
11.1%
2/18 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
2.2%
1/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
2.8%
2/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
3.2%
2/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
4.9%
3/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
2.8%
2/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
3.3%
2/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
|
Gastrointestinal disorders
Gastric dilatation
|
0.00%
0/4 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
5.6%
1/18 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.6%
1/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
|
Gastrointestinal disorders
Gastritis
|
25.0%
1/4 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/18 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
6.5%
3/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.4%
1/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.6%
1/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
4.9%
3/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.4%
1/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
3.3%
2/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
|
Gastrointestinal disorders
Haemorrhoids
|
25.0%
1/4 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/18 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
2.2%
1/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
2.2%
1/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.6%
1/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.6%
1/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.6%
1/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/4 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/18 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
2.2%
1/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.4%
1/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
5.6%
4/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.6%
1/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.6%
1/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
5.6%
4/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.6%
1/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
|
Gastrointestinal disorders
Nausea
|
25.0%
1/4 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/18 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
8.7%
4/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
11.1%
8/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
7.9%
5/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
6.6%
4/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
11.3%
8/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
9.8%
6/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
|
Gastrointestinal disorders
Proctitis
|
0.00%
0/4 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
5.6%
1/18 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.6%
1/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
|
Gastrointestinal disorders
Stomatitis
|
25.0%
1/4 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/18 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
2.2%
1/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
2.8%
2/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.6%
1/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
2.8%
2/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.6%
1/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
|
Gastrointestinal disorders
Teething
|
25.0%
1/4 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/18 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.4%
1/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/4 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
5.6%
1/18 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
4.3%
2/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
2.8%
2/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.6%
1/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
3.2%
2/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
4.9%
3/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
2.8%
2/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.6%
1/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
3.3%
2/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
|
General disorders
Influenza like illness
|
0.00%
0/4 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/18 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
4.3%
2/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
2.8%
2/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
4.8%
3/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
9.5%
6/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
3.3%
2/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
2.8%
2/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
9.8%
6/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
|
General disorders
Injection site reaction
|
0.00%
0/4 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
5.6%
1/18 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
15.2%
7/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.4%
1/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
12.5%
9/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
17.5%
11/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
13.1%
8/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
12.7%
9/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
18.0%
11/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
|
General disorders
Malaise
|
25.0%
1/4 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
5.6%
1/18 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
2.2%
1/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
5.6%
4/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
3.3%
2/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
5.6%
4/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.6%
1/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/4 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/18 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
8.7%
4/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
4.2%
3/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
11.1%
7/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
6.6%
4/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
4.2%
3/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
11.5%
7/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
|
General disorders
Pyrexia
|
25.0%
1/4 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
27.8%
5/18 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
2.2%
1/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
2.2%
1/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
30.4%
14/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
15.3%
11/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
54.2%
39/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
4.8%
3/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
20.6%
13/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.6%
1/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
31.1%
19/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
5.6%
4/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
56.3%
40/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
3.3%
2/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
21.3%
13/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
|
Infections and infestations
Bronchitis
|
50.0%
2/4 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
5.6%
1/18 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
2.2%
1/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
2.2%
1/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
13.9%
10/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.6%
1/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.6%
1/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
3.3%
2/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
15.5%
11/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.6%
1/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.6%
1/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
|
Infections and infestations
Conjunctivitis
|
50.0%
2/4 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
5.6%
1/18 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
8.7%
4/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
2.8%
2/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.6%
1/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.6%
1/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
8.2%
5/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
4.2%
3/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.6%
1/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
3.3%
2/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
|
Infections and infestations
Cystitis
|
0.00%
0/4 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
5.6%
1/18 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
2.2%
1/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
2.2%
1/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
2.8%
2/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.6%
1/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.6%
1/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.6%
1/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
2.8%
2/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
|
Infections and infestations
Ear infection
|
25.0%
1/4 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
5.6%
1/18 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
2.2%
1/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
9.7%
7/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
3.2%
2/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
3.3%
2/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
11.3%
8/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
3.3%
2/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
|
Infections and infestations
Gastroenteritis
|
50.0%
2/4 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
5.6%
1/18 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
10.9%
5/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.4%
1/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
13.9%
10/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.6%
1/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
12.7%
8/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
9.8%
6/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.4%
1/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
15.5%
11/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.6%
1/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
14.8%
9/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
|
Infections and infestations
Influenza
|
25.0%
1/4 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
11.1%
2/18 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
2.2%
1/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
10.9%
5/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
19.4%
14/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.6%
1/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
15.9%
10/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.6%
1/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
11.5%
7/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
19.7%
14/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
18.0%
11/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/4 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
5.6%
1/18 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
2.2%
1/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
2.8%
2/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
3.2%
2/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
3.3%
2/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
2.8%
2/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
3.3%
2/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
|
Infections and infestations
Nasopharyngitis
|
25.0%
1/4 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/18 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.4%
1/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
5.6%
4/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
4.8%
3/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
7.0%
5/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
4.9%
3/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/4 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
5.6%
1/18 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
8.7%
4/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
4.2%
3/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
3.2%
2/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
4.8%
3/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
8.2%
5/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
4.2%
3/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
4.9%
3/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
|
Infections and infestations
Otitis media
|
0.00%
0/4 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/18 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
8.7%
4/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
12.5%
9/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
6.6%
4/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
12.7%
9/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
|
Infections and infestations
Otitis media acute
|
0.00%
0/4 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/18 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.4%
1/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
6.9%
5/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.4%
1/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
7.0%
5/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
|
Infections and infestations
Paronychia
|
0.00%
0/4 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/18 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
5.6%
4/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
5.6%
4/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/4 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/18 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
2.2%
1/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
9.7%
7/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
12.7%
8/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.6%
1/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
9.9%
7/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
13.1%
8/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
|
Infections and infestations
Pharyngotonsillitis
|
0.00%
0/4 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/18 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
6.9%
5/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.6%
1/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
7.0%
5/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.6%
1/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
|
Infections and infestations
Pilonidal cyst
|
0.00%
0/4 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
5.6%
1/18 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.4%
1/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.6%
1/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.4%
1/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/4 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/18 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
2.2%
1/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
5.6%
4/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
4.8%
3/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.6%
1/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
5.6%
4/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
4.9%
3/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/4 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
5.6%
1/18 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
4.3%
2/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.4%
1/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
11.1%
8/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.6%
1/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
4.9%
3/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
11.3%
8/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.6%
1/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
|
Infections and infestations
Rhinitis
|
25.0%
1/4 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
11.1%
2/18 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
17.4%
8/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
19.4%
14/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.6%
1/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
4.8%
3/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
16.4%
10/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
21.1%
15/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
4.9%
3/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
|
Infections and infestations
Sialoadenitis
|
25.0%
1/4 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/18 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.6%
1/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/4 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
5.6%
1/18 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
4.3%
2/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
4.2%
3/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
3.2%
2/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
4.9%
3/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
4.2%
3/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
3.3%
2/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/4 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
5.6%
1/18 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
6.5%
3/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.4%
1/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
4.2%
3/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.6%
1/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
12.7%
8/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
6.6%
4/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.4%
1/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
4.2%
3/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.6%
1/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
13.1%
8/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
|
Infections and infestations
Tonsillitis bacterial
|
25.0%
1/4 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/18 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.4%
1/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
|
Infections and infestations
Tracheitis
|
0.00%
0/4 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
11.1%
2/18 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
3.3%
2/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/4 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
16.7%
3/18 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
4.3%
2/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
21.7%
10/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
4.2%
3/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
30.6%
22/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.6%
1/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
19.0%
12/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.6%
1/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
21.3%
13/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.4%
1/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
31.0%
22/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.6%
1/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
19.7%
12/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/4 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/18 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
2.2%
1/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
8.7%
4/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
2.8%
2/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
14.3%
9/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
6.6%
4/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
2.8%
2/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
14.8%
9/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
|
Infections and infestations
Viral infection
|
0.00%
0/4 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
5.6%
1/18 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
4.3%
2/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
9.7%
7/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
9.5%
6/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
4.9%
3/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
9.9%
7/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
9.8%
6/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
|
Infections and infestations
Viral tonsillitis
|
25.0%
1/4 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/18 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.4%
1/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
2.8%
2/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
25.0%
1/4 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
27.8%
5/18 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
2.2%
1/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
23.9%
11/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
27.8%
20/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
11.1%
7/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.6%
1/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
26.2%
16/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
28.2%
20/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
13.1%
8/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
|
Infections and infestations
Vulvovaginal candidiasis
|
0.00%
0/4 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/18 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
8.3%
6/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
8.5%
6/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/4 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
5.6%
1/18 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
2.8%
2/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.6%
1/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
2.8%
2/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/4 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/18 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
2.2%
1/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
5.6%
4/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
3.2%
2/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.6%
1/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
5.6%
4/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
3.3%
2/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/4 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
5.6%
1/18 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.6%
1/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.6%
1/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.6%
1/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/4 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
5.6%
1/18 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.4%
1/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.6%
1/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.6%
1/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.4%
1/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/4 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
5.6%
1/18 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.6%
1/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
|
Investigations
Alanine aminotransferase increased
|
25.0%
1/4 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
5.6%
1/18 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
2.2%
1/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
2.8%
2/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
3.3%
2/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
4.2%
3/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
|
Investigations
Aspartate aminotransferase increased
|
25.0%
1/4 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/18 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.4%
1/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
2.8%
2/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/4 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
5.6%
1/18 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
2.2%
1/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
4.2%
3/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.6%
1/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
3.3%
2/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
4.2%
3/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.6%
1/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
|
Investigations
C-reactive protein increased
|
25.0%
1/4 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/18 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
2.8%
2/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
4.2%
3/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
|
Investigations
Eosinophil count increased
|
0.00%
0/4 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
5.6%
1/18 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.6%
1/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
|
Investigations
Glomerular filtration rate decreased
|
0.00%
0/4 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
5.6%
1/18 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.6%
1/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
|
Metabolism and nutrition disorders
Dehydration
|
25.0%
1/4 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/18 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.6%
1/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
3.3%
2/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
25.0%
1/4 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/18 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.4%
1/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
25.0%
1/4 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/18 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.4%
1/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
25.0%
1/4 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
27.8%
5/18 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
4.3%
2/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
13.0%
6/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.4%
1/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
25.0%
18/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
3.2%
2/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
17.5%
11/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.6%
1/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
18.0%
11/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.4%
1/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
25.4%
18/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
19.7%
12/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/4 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
5.6%
1/18 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.4%
1/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.6%
1/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.6%
1/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.4%
1/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.6%
1/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
25.0%
1/4 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
11.1%
2/18 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
13.0%
6/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
13.9%
10/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
20.6%
13/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
13.1%
8/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
14.1%
10/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
23.0%
14/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc disorder
|
0.00%
0/4 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
5.6%
1/18 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.6%
1/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/4 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/18 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.4%
1/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
6.3%
4/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.4%
1/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
6.6%
4/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/4 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
5.6%
1/18 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.4%
1/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.6%
1/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.4%
1/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/4 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
11.1%
2/18 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
4.3%
2/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
6.5%
3/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.4%
1/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
8.3%
6/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.6%
1/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
6.3%
4/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
8.2%
5/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.4%
1/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
8.5%
6/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
6.6%
4/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/4 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
16.7%
3/18 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
8.7%
4/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
9.7%
7/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.6%
1/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
11.1%
7/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
11.5%
7/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
9.9%
7/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
11.5%
7/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/4 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/18 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
6.5%
3/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.4%
1/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.6%
1/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
4.9%
3/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.4%
1/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.6%
1/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
25.0%
1/4 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
16.7%
3/18 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
2.2%
1/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
10.9%
5/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
9.7%
7/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
3.2%
2/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
12.7%
8/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
13.1%
8/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
9.9%
7/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.6%
1/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
14.8%
9/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
0.00%
0/4 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
5.6%
1/18 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.4%
1/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.6%
1/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.6%
1/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.4%
1/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.6%
1/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
|
Musculoskeletal and connective tissue disorders
Tendon pain
|
0.00%
0/4 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
5.6%
1/18 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.6%
1/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
|
Musculoskeletal and connective tissue disorders
Tenosynovitis stenosans
|
0.00%
0/4 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
5.6%
1/18 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.6%
1/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pyogenic granuloma
|
25.0%
1/4 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/18 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.6%
1/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/4 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/18 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
4.3%
2/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.4%
1/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
6.3%
4/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
3.3%
2/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.4%
1/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
6.6%
4/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
|
Nervous system disorders
Headache
|
25.0%
1/4 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
11.1%
2/18 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
6.5%
3/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
26.1%
12/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
5.6%
4/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
41.7%
30/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
3.2%
2/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
25.4%
16/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.6%
1/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
23.0%
14/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.4%
1/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
43.7%
31/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
26.2%
16/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
|
Nervous system disorders
Somnolence
|
25.0%
1/4 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/18 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.6%
1/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
|
Reproductive system and breast disorders
Breast mass
|
0.00%
0/4 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
5.6%
1/18 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.6%
1/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
|
Reproductive system and breast disorders
Polycystic ovaries
|
0.00%
0/4 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
5.6%
1/18 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
2.2%
1/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
3.3%
2/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/4 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
5.6%
1/18 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.6%
1/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/4 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
16.7%
3/18 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
19.6%
9/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
4.2%
3/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
29.2%
21/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
3.2%
2/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
9.5%
6/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
19.7%
12/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
29.6%
21/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
3.3%
2/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
9.8%
6/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/4 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/18 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
6.5%
3/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
8.3%
6/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
3.2%
2/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
4.9%
3/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
8.5%
6/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
3.3%
2/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/4 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
5.6%
1/18 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
13.0%
6/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
2.8%
2/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
30.6%
22/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
3.2%
2/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
12.7%
8/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
11.5%
7/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.4%
1/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
31.0%
22/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.6%
1/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
13.1%
8/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/4 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
5.6%
1/18 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.6%
1/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/4 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
5.6%
1/18 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.6%
1/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/4 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
5.6%
1/18 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
2.2%
1/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
2.2%
1/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.4%
1/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.6%
1/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
3.3%
2/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.4%
1/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/4 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/18 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
4.3%
2/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.4%
1/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
9.7%
7/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
3.3%
2/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
9.9%
7/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
25.0%
1/4 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/18 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.4%
1/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.4%
1/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.6%
1/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
50.0%
2/4 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/18 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
3.3%
2/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
25.0%
1/4 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/18 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
4.3%
2/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
8.3%
6/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
3.2%
2/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
3.3%
2/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
9.9%
7/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
3.3%
2/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/4 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/18 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
2.2%
1/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.4%
1/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
7.9%
5/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.6%
1/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.4%
1/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
8.2%
5/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
|
Skin and subcutaneous tissue disorders
Keloid scar
|
25.0%
1/4 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/18 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.6%
1/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
25.0%
1/4 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/18 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.6%
1/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
|
Skin and subcutaneous tissue disorders
Pyoderma gangrenosum
|
25.0%
1/4 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/18 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.6%
1/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/4 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/18 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
2.2%
1/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
17.4%
8/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.4%
1/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
6.9%
5/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.6%
1/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
4.8%
3/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
13.1%
8/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
7.0%
5/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
4.9%
3/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
25.0%
1/4 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/18 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.4%
1/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.4%
1/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.6%
1/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
25.0%
1/4 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/18 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.6%
1/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
25.0%
1/4 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/18 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
2.2%
1/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
8.7%
4/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
4.2%
3/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.6%
1/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
6.6%
4/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
4.2%
3/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
3.3%
2/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
|
Vascular disorders
Hypertension
|
0.00%
0/4 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
11.1%
2/18 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.4%
1/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
3.3%
2/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.4%
1/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
|
Vascular disorders
Hypotension
|
0.00%
0/4 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
5.6%
1/18 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/46 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/72 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/63 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
1.6%
1/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/71 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
0.00%
0/61 • up to week 112
Cohort groups were analyzed according to the occurrence of events corresponding to treatments given during epochs 2, 3 and 4. 'No medication' events cover events that occurred during epoch 4 when no treatment was given.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety.
- Publication restrictions are in place
Restriction type: OTHER