Time Frame |
From the first IMP administration up to 6 weeks after the last administration of the IMP (i.e., in Part 1: up to 42 weeks for ROW, up to 58 weeks for Japanese participants; in Part 2 DB period: up to 60 weeks; in Part 2 LTFU period: up to 164 weeks).
|
Adverse Event Reporting Description |
Reported AEs and deaths were TEAEs that developed/worsened in grade or became serious during TEAE period (defined as the time from the first dose of the IMP to the last dose of IMP + 6 weeks). Analysis was performed on safety population.
|
|
Arm/Group Title
|
Part 1: Placebo (ROW)
|
Part 1: Venglustat 4 mg (ROW)
|
Part 1: Venglustat 8 mg (ROW)
|
Part 1: Venglustat 15 mg (ROW)
|
Part 1: Placebo (Japan Only)
|
Part 1: Venglustat 4 mg (Japan Only)
|
Part 1: Venglustat 8 mg (Japan Only)
|
Part 1: Venglustat 15 mg (Japan Only)
|
Part 2, DB Period: Placebo
|
Part 2, DB Period: Venglustat 15 mg
|
Part 2, DB Period: Placebo (Re-randomized From Part 1)
|
Part 2, DB Period: Venglustat 15 mg (Re-randomized From Part 1)
|
Part 2, LTFU Period: Placebo Then Venglustat 15 mg
|
Part 2, LTFU Period: Venglustat 15 mg
|
Part 2, LTFU: Placebo Then Veng 15 mg (Re-randomized From Part 1)
|
Part 2, LTFU: Venglustat 15 mg (Re-randomized From Part 1)
|
Arm/Group Description |
Participants from rest of world (RO...
|
Participants from ROW (except Japan...
|
Participants from ROW (except Japan...
|
Participants from ROW (except Japan...
|
Japanese participants received plac...
|
Japanese participants received veng...
|
Japanese participants received veng...
|
Japanese participants received veng...
|
Participants received placebo (matc...
|
Participants received venglustat 15...
|
Participants who completed Part 1 w...
|
Participants who completed Part 1 w...
|
Participants who were enrolled in t...
|
Participants who were enrolled in t...
|
Participants from Part 1 who were r...
|
Participants from Part 1 who were r...
|
Arm/Group Description |
Participants from rest of world (ROW, except Japan), received placebo (matched to venglustat) capsule orally once daily (QD) for up to 36 weeks in Part 1.
|
Participants from ROW (except Japan), received venglustat 4 milligrams (mg) capsule orally QD for up to 36 weeks in Part 1.
|
Participants from ROW (except Japan), received venglustat 8 mg capsule orally QD for up to 36 weeks in Part 1.
|
Participants from ROW (except Japan), received venglustat 15 mg capsule orally QD for up to 36 weeks in Part 1.
|
Japanese participants received placebo (matched to venglustat) capsule orally QD for up to 52 weeks in Part 1.
|
Japanese participants received venglustat 4 mg capsule orally QD for up to 52 weeks in Part 1.
|
Japanese participants received venglustat 8 mg capsule orally QD for up to 52 weeks in Part 1.
|
Japanese participants received venglustat 15 mg capsule orally QD for up to 52 weeks in Part 1.
|
Participants received placebo (matched to venglustat) capsule orally QD for 52 weeks in Part 2 DB period.
|
Participants received venglustat 15 mg capsule orally QD for 52 weeks in Part 2 DB period.
|
Participants who completed Part 1 with placebo (matched to venglustat) or venglustat 4/8/15 mg, met eligibility criteria for Part 2 and agreed to continue in the study, were re-randomized to receive placebo (matched to venglustat) capsule orally QD for 52 weeks in Part 2 DB period.
|
Participants who completed Part 1 with placebo (matched to venglustat) or venglustat 4/8/15 mg, met eligibility criteria for Part 2 and agreed to continue in the study, were re-randomized to receive venglustat 15 mg capsule orally QD for 52 weeks in Part 2 DB period.
|
Participants who were enrolled in the study in Part 2, received placebo (matched to venglustat), completed Part 2 DB period, entered long-term follow-up (LTFU) period to receive venglustat 15 mg capsule orally QD for 156 weeks.
|
Participants who were enrolled in the study in Part 2, received venglustat 15 mg, completed Part 2 DB period, entered LTFU period to receive venglustat 15 mg capsule orally QD for 156 weeks.
|
Participants from Part 1 who were re-randomized in the study in Part 2, received placebo (matched to venglustat) and completed Part 2 DB period, entered LTFU period to receive venglustat (Veng) 15 mg capsule orally QD for 156 weeks.
|
Participants from Part 1 who were re-randomized in the study in Part 2, received venglustat 15 mg and completed Part 2 DB period, entered LTFU period to receive venglustat 15 mg capsule orally QD for 156 weeks.
|
|
|
Part 1: Placebo (ROW)
|
Part 1: Venglustat 4 mg (ROW)
|
Part 1: Venglustat 8 mg (ROW)
|
Part 1: Venglustat 15 mg (ROW)
|
Part 1: Placebo (Japan Only)
|
Part 1: Venglustat 4 mg (Japan Only)
|
Part 1: Venglustat 8 mg (Japan Only)
|
Part 1: Venglustat 15 mg (Japan Only)
|
Part 2, DB Period: Placebo
|
Part 2, DB Period: Venglustat 15 mg
|
Part 2, DB Period: Placebo (Re-randomized From Part 1)
|
Part 2, DB Period: Venglustat 15 mg (Re-randomized From Part 1)
|
Part 2, LTFU Period: Placebo Then Venglustat 15 mg
|
Part 2, LTFU Period: Venglustat 15 mg
|
Part 2, LTFU: Placebo Then Veng 15 mg (Re-randomized From Part 1)
|
Part 2, LTFU: Venglustat 15 mg (Re-randomized From Part 1)
|
|
Affected / at Risk (%) |
|
Affected / at Risk (%) |
|
Affected / at Risk (%) |
|
Affected / at Risk (%) |
|
Affected / at Risk (%) |
|
Affected / at Risk (%) |
|
Affected / at Risk (%) |
|
Affected / at Risk (%) |
|
Affected / at Risk (%) |
|
Affected / at Risk (%) |
|
Affected / at Risk (%) |
|
Affected / at Risk (%) |
|
Affected / at Risk (%) |
|
Affected / at Risk (%) |
|
Affected / at Risk (%) |
|
Affected / at Risk (%) |
|
Total |
0/4 (0.00%)
|
|
0/4 (0.00%)
|
|
0/5 (0.00%)
|
|
0/4 (0.00%)
|
|
0/3 (0.00%)
|
|
0/3 (0.00%)
|
|
0/3 (0.00%)
|
|
0/3 (0.00%)
|
|
0/111 (0.00%)
|
|
1/110 (0.91%)
|
|
0/10 (0.00%)
|
|
0/13 (0.00%)
|
|
1/87 (1.15%)
|
|
0/75 (0.00%)
|
|
0/10 (0.00%)
|
|
0/11 (0.00%)
|
|
|
|
Part 1: Placebo (ROW)
|
Part 1: Venglustat 4 mg (ROW)
|
Part 1: Venglustat 8 mg (ROW)
|
Part 1: Venglustat 15 mg (ROW)
|
Part 1: Placebo (Japan Only)
|
Part 1: Venglustat 4 mg (Japan Only)
|
Part 1: Venglustat 8 mg (Japan Only)
|
Part 1: Venglustat 15 mg (Japan Only)
|
Part 2, DB Period: Placebo
|
Part 2, DB Period: Venglustat 15 mg
|
Part 2, DB Period: Placebo (Re-randomized From Part 1)
|
Part 2, DB Period: Venglustat 15 mg (Re-randomized From Part 1)
|
Part 2, LTFU Period: Placebo Then Venglustat 15 mg
|
Part 2, LTFU Period: Venglustat 15 mg
|
Part 2, LTFU: Placebo Then Veng 15 mg (Re-randomized From Part 1)
|
Part 2, LTFU: Venglustat 15 mg (Re-randomized From Part 1)
|
|
Affected / at Risk (%) |
# Events
|
Affected / at Risk (%) |
# Events
|
Affected / at Risk (%) |
# Events
|
Affected / at Risk (%) |
# Events
|
Affected / at Risk (%) |
# Events
|
Affected / at Risk (%) |
# Events
|
Affected / at Risk (%) |
# Events
|
Affected / at Risk (%) |
# Events
|
Affected / at Risk (%) |
# Events
|
Affected / at Risk (%) |
# Events
|
Affected / at Risk (%) |
# Events
|
Affected / at Risk (%) |
# Events
|
Affected / at Risk (%) |
# Events
|
Affected / at Risk (%) |
# Events
|
Affected / at Risk (%) |
# Events
|
Affected / at Risk (%) |
# Events
|
Total |
0/4 (0.00%)
|
|
0/4 (0.00%)
|
|
0/5 (0.00%)
|
|
0/4 (0.00%)
|
|
0/3 (0.00%)
|
|
0/3 (0.00%)
|
|
0/3 (0.00%)
|
|
0/3 (0.00%)
|
|
12/111 (10.81%)
|
|
12/110 (10.91%)
|
|
0/10 (0.00%)
|
|
3/13 (23.08%)
|
|
15/87 (17.24%)
|
|
9/75 (12.00%)
|
|
3/10 (30.00%)
|
|
1/11 (9.09%)
|
|
Blood and lymphatic system disorders |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Anaemia |
0/4 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/5 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/111 (0.00%)
|
0 |
0/110 (0.00%)
|
0 |
0/10 (0.00%)
|
0 |
0/13 (0.00%)
|
0 |
1/87 (1.15%)
|
1 |
0/75 (0.00%)
|
0 |
0/10 (0.00%)
|
0 |
0/11 (0.00%)
|
0 |
Cardiac disorders |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Atrial Fibrillation |
0/4 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/5 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/111 (0.00%)
|
0 |
1/110 (0.91%)
|
1 |
0/10 (0.00%)
|
0 |
0/13 (0.00%)
|
0 |
0/87 (0.00%)
|
0 |
1/75 (1.33%)
|
1 |
0/10 (0.00%)
|
0 |
0/11 (0.00%)
|
0 |
Cardiac Arrest |
0/4 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/5 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/111 (0.00%)
|
0 |
0/110 (0.00%)
|
0 |
0/10 (0.00%)
|
0 |
0/13 (0.00%)
|
0 |
1/87 (1.15%)
|
1 |
0/75 (0.00%)
|
0 |
0/10 (0.00%)
|
0 |
0/11 (0.00%)
|
0 |
Cardio-Respiratory Arrest |
0/4 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/5 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/111 (0.00%)
|
0 |
1/110 (0.91%)
|
1 |
0/10 (0.00%)
|
0 |
0/13 (0.00%)
|
0 |
0/87 (0.00%)
|
0 |
0/75 (0.00%)
|
0 |
0/10 (0.00%)
|
0 |
0/11 (0.00%)
|
0 |
Gastrointestinal disorders |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Abdominal Pain |
0/4 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/5 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
1/111 (0.90%)
|
1 |
0/110 (0.00%)
|
0 |
0/10 (0.00%)
|
0 |
0/13 (0.00%)
|
0 |
0/87 (0.00%)
|
0 |
0/75 (0.00%)
|
0 |
0/10 (0.00%)
|
0 |
0/11 (0.00%)
|
0 |
Impaired Gastric Emptying |
0/4 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/5 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/111 (0.00%)
|
0 |
1/110 (0.91%)
|
1 |
0/10 (0.00%)
|
0 |
0/13 (0.00%)
|
0 |
0/87 (0.00%)
|
0 |
0/75 (0.00%)
|
0 |
0/10 (0.00%)
|
0 |
0/11 (0.00%)
|
0 |
Inguinal Hernia |
0/4 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/5 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/111 (0.00%)
|
0 |
0/110 (0.00%)
|
0 |
0/10 (0.00%)
|
0 |
1/13 (7.69%)
|
1 |
0/87 (0.00%)
|
0 |
0/75 (0.00%)
|
0 |
0/10 (0.00%)
|
0 |
0/11 (0.00%)
|
0 |
Intestinal Obstruction |
0/4 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/5 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/111 (0.00%)
|
0 |
0/110 (0.00%)
|
0 |
0/10 (0.00%)
|
0 |
0/13 (0.00%)
|
0 |
1/87 (1.15%)
|
1 |
0/75 (0.00%)
|
0 |
0/10 (0.00%)
|
0 |
0/11 (0.00%)
|
0 |
Nausea |
0/4 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/5 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/111 (0.00%)
|
0 |
0/110 (0.00%)
|
0 |
0/10 (0.00%)
|
0 |
0/13 (0.00%)
|
0 |
1/87 (1.15%)
|
1 |
0/75 (0.00%)
|
0 |
0/10 (0.00%)
|
0 |
0/11 (0.00%)
|
0 |
Volvulus |
0/4 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/5 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/111 (0.00%)
|
0 |
0/110 (0.00%)
|
0 |
0/10 (0.00%)
|
0 |
0/13 (0.00%)
|
0 |
1/87 (1.15%)
|
1 |
0/75 (0.00%)
|
0 |
0/10 (0.00%)
|
0 |
0/11 (0.00%)
|
0 |
Infections and infestations |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Abdominal Abscess |
0/4 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/5 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/111 (0.00%)
|
0 |
0/110 (0.00%)
|
0 |
0/10 (0.00%)
|
0 |
0/13 (0.00%)
|
0 |
1/87 (1.15%)
|
1 |
0/75 (0.00%)
|
0 |
0/10 (0.00%)
|
0 |
0/11 (0.00%)
|
0 |
Covid-19 |
0/4 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/5 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/111 (0.00%)
|
0 |
0/110 (0.00%)
|
0 |
0/10 (0.00%)
|
0 |
0/13 (0.00%)
|
0 |
0/87 (0.00%)
|
0 |
0/75 (0.00%)
|
0 |
1/10 (10.00%)
|
1 |
0/11 (0.00%)
|
0 |
Colonic Abscess |
0/4 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/5 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/111 (0.00%)
|
0 |
1/110 (0.91%)
|
1 |
0/10 (0.00%)
|
0 |
0/13 (0.00%)
|
0 |
0/87 (0.00%)
|
0 |
0/75 (0.00%)
|
0 |
0/10 (0.00%)
|
0 |
0/11 (0.00%)
|
0 |
Diverticulitis |
0/4 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/5 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/111 (0.00%)
|
0 |
1/110 (0.91%)
|
1 |
0/10 (0.00%)
|
0 |
0/13 (0.00%)
|
0 |
0/87 (0.00%)
|
0 |
0/75 (0.00%)
|
0 |
0/10 (0.00%)
|
0 |
0/11 (0.00%)
|
0 |
Osteomyelitis |
0/4 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/5 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
1/111 (0.90%)
|
1 |
0/110 (0.00%)
|
0 |
0/10 (0.00%)
|
0 |
0/13 (0.00%)
|
0 |
0/87 (0.00%)
|
0 |
0/75 (0.00%)
|
0 |
0/10 (0.00%)
|
0 |
0/11 (0.00%)
|
0 |
Pneumonia |
0/4 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/5 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/111 (0.00%)
|
0 |
0/110 (0.00%)
|
0 |
0/10 (0.00%)
|
0 |
1/13 (7.69%)
|
1 |
0/87 (0.00%)
|
0 |
0/75 (0.00%)
|
0 |
0/10 (0.00%)
|
0 |
0/11 (0.00%)
|
0 |
Sepsis |
0/4 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/5 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/111 (0.00%)
|
0 |
0/110 (0.00%)
|
0 |
0/10 (0.00%)
|
0 |
1/13 (7.69%)
|
1 |
0/87 (0.00%)
|
0 |
0/75 (0.00%)
|
0 |
0/10 (0.00%)
|
0 |
0/11 (0.00%)
|
0 |
Subacute Endocarditis |
0/4 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/5 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
1/111 (0.90%)
|
1 |
0/110 (0.00%)
|
0 |
0/10 (0.00%)
|
0 |
0/13 (0.00%)
|
0 |
0/87 (0.00%)
|
0 |
0/75 (0.00%)
|
0 |
0/10 (0.00%)
|
0 |
0/11 (0.00%)
|
0 |
Urinary Tract Infection |
0/4 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/5 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/111 (0.00%)
|
0 |
0/110 (0.00%)
|
0 |
0/10 (0.00%)
|
0 |
1/13 (7.69%)
|
1 |
1/87 (1.15%)
|
2 |
0/75 (0.00%)
|
0 |
0/10 (0.00%)
|
0 |
0/11 (0.00%)
|
0 |
Injury, poisoning and procedural complications |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Anastomotic Leak |
0/4 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/5 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/111 (0.00%)
|
0 |
0/110 (0.00%)
|
0 |
0/10 (0.00%)
|
0 |
0/13 (0.00%)
|
0 |
1/87 (1.15%)
|
1 |
0/75 (0.00%)
|
0 |
0/10 (0.00%)
|
0 |
0/11 (0.00%)
|
0 |
Fall |
0/4 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/5 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/111 (0.00%)
|
0 |
1/110 (0.91%)
|
2 |
0/10 (0.00%)
|
0 |
0/13 (0.00%)
|
0 |
0/87 (0.00%)
|
0 |
0/75 (0.00%)
|
0 |
0/10 (0.00%)
|
0 |
0/11 (0.00%)
|
0 |
Femoral Neck Fracture |
0/4 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/5 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
1/111 (0.90%)
|
1 |
0/110 (0.00%)
|
0 |
0/10 (0.00%)
|
0 |
0/13 (0.00%)
|
0 |
0/87 (0.00%)
|
0 |
0/75 (0.00%)
|
0 |
0/10 (0.00%)
|
0 |
0/11 (0.00%)
|
0 |
Intentional Overdose |
0/4 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/5 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/111 (0.00%)
|
0 |
0/110 (0.00%)
|
0 |
0/10 (0.00%)
|
0 |
0/13 (0.00%)
|
0 |
0/87 (0.00%)
|
0 |
0/75 (0.00%)
|
0 |
0/10 (0.00%)
|
0 |
1/11 (9.09%)
|
1 |
Post Lumbar Puncture Syndrome |
0/4 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/5 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
2/111 (1.80%)
|
3 |
0/110 (0.00%)
|
0 |
0/10 (0.00%)
|
0 |
0/13 (0.00%)
|
0 |
1/87 (1.15%)
|
1 |
0/75 (0.00%)
|
0 |
0/10 (0.00%)
|
0 |
0/11 (0.00%)
|
0 |
Postoperative Delirium |
0/4 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/5 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
1/111 (0.90%)
|
1 |
0/110 (0.00%)
|
0 |
0/10 (0.00%)
|
0 |
0/13 (0.00%)
|
0 |
0/87 (0.00%)
|
0 |
0/75 (0.00%)
|
0 |
0/10 (0.00%)
|
0 |
0/11 (0.00%)
|
0 |
Radius Fracture |
0/4 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/5 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/111 (0.00%)
|
0 |
0/110 (0.00%)
|
0 |
0/10 (0.00%)
|
0 |
0/13 (0.00%)
|
0 |
0/87 (0.00%)
|
0 |
1/75 (1.33%)
|
1 |
0/10 (0.00%)
|
0 |
0/11 (0.00%)
|
0 |
Rib Fracture |
0/4 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/5 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
1/111 (0.90%)
|
1 |
0/110 (0.00%)
|
0 |
0/10 (0.00%)
|
0 |
0/13 (0.00%)
|
0 |
0/87 (0.00%)
|
0 |
0/75 (0.00%)
|
0 |
0/10 (0.00%)
|
0 |
0/11 (0.00%)
|
0 |
Skin Laceration |
0/4 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/5 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/111 (0.00%)
|
0 |
1/110 (0.91%)
|
1 |
0/10 (0.00%)
|
0 |
0/13 (0.00%)
|
0 |
0/87 (0.00%)
|
0 |
0/75 (0.00%)
|
0 |
0/10 (0.00%)
|
0 |
0/11 (0.00%)
|
0 |
Subdural Haematoma |
0/4 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/5 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/111 (0.00%)
|
0 |
0/110 (0.00%)
|
0 |
0/10 (0.00%)
|
0 |
0/13 (0.00%)
|
0 |
1/87 (1.15%)
|
1 |
0/75 (0.00%)
|
0 |
0/10 (0.00%)
|
0 |
0/11 (0.00%)
|
0 |
Musculoskeletal and connective tissue disorders |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Back Pain |
0/4 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/5 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/111 (0.00%)
|
0 |
0/110 (0.00%)
|
0 |
0/10 (0.00%)
|
0 |
0/13 (0.00%)
|
0 |
0/87 (0.00%)
|
0 |
1/75 (1.33%)
|
1 |
0/10 (0.00%)
|
0 |
0/11 (0.00%)
|
0 |
Muscle Rigidity |
0/4 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/5 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
1/111 (0.90%)
|
1 |
0/110 (0.00%)
|
0 |
0/10 (0.00%)
|
0 |
0/13 (0.00%)
|
0 |
0/87 (0.00%)
|
0 |
0/75 (0.00%)
|
0 |
0/10 (0.00%)
|
0 |
0/11 (0.00%)
|
0 |
Spinal Pain |
0/4 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/5 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/111 (0.00%)
|
0 |
0/110 (0.00%)
|
0 |
0/10 (0.00%)
|
0 |
0/13 (0.00%)
|
0 |
0/87 (0.00%)
|
0 |
1/75 (1.33%)
|
1 |
0/10 (0.00%)
|
0 |
0/11 (0.00%)
|
0 |
Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basal Cell Carcinoma |
0/4 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/5 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
1/111 (0.90%)
|
1 |
1/110 (0.91%)
|
1 |
0/10 (0.00%)
|
0 |
0/13 (0.00%)
|
0 |
0/87 (0.00%)
|
0 |
0/75 (0.00%)
|
0 |
0/10 (0.00%)
|
0 |
0/11 (0.00%)
|
0 |
Breast Cancer Female |
0/4 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/5 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
1/111 (0.90%)
|
1 |
0/110 (0.00%)
|
0 |
0/10 (0.00%)
|
0 |
0/13 (0.00%)
|
0 |
0/87 (0.00%)
|
0 |
0/75 (0.00%)
|
0 |
0/10 (0.00%)
|
0 |
0/11 (0.00%)
|
0 |
Malignant Melanoma |
0/4 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/5 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/111 (0.00%)
|
0 |
0/110 (0.00%)
|
0 |
0/10 (0.00%)
|
0 |
0/13 (0.00%)
|
0 |
1/87 (1.15%)
|
1 |
0/75 (0.00%)
|
0 |
0/10 (0.00%)
|
0 |
0/11 (0.00%)
|
0 |
Malignant Melanoma In Situ |
0/4 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/5 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
1/111 (0.90%)
|
1 |
0/110 (0.00%)
|
0 |
0/10 (0.00%)
|
0 |
0/13 (0.00%)
|
0 |
0/87 (0.00%)
|
0 |
0/75 (0.00%)
|
0 |
0/10 (0.00%)
|
0 |
0/11 (0.00%)
|
0 |
Non-Small Cell Lung Cancer |
0/4 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/5 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
1/111 (0.90%)
|
1 |
0/110 (0.00%)
|
0 |
0/10 (0.00%)
|
0 |
0/13 (0.00%)
|
0 |
0/87 (0.00%)
|
0 |
0/75 (0.00%)
|
0 |
0/10 (0.00%)
|
0 |
0/11 (0.00%)
|
0 |
Ovarian Epithelial Cancer |
0/4 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/5 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/111 (0.00%)
|
0 |
0/110 (0.00%)
|
0 |
0/10 (0.00%)
|
0 |
0/13 (0.00%)
|
0 |
1/87 (1.15%)
|
1 |
0/75 (0.00%)
|
0 |
0/10 (0.00%)
|
0 |
0/11 (0.00%)
|
0 |
Prostate Cancer |
0/4 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/5 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
1/111 (0.90%)
|
1 |
0/110 (0.00%)
|
0 |
0/10 (0.00%)
|
0 |
0/13 (0.00%)
|
0 |
0/87 (0.00%)
|
0 |
0/75 (0.00%)
|
0 |
0/10 (0.00%)
|
0 |
0/11 (0.00%)
|
0 |
Nervous system disorders |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cerebellar Haemorrhage |
0/4 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/5 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/111 (0.00%)
|
0 |
1/110 (0.91%)
|
1 |
0/10 (0.00%)
|
0 |
0/13 (0.00%)
|
0 |
0/87 (0.00%)
|
0 |
0/75 (0.00%)
|
0 |
0/10 (0.00%)
|
0 |
0/11 (0.00%)
|
0 |
Cognitive Disorder |
0/4 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/5 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/111 (0.00%)
|
0 |
1/110 (0.91%)
|
1 |
0/10 (0.00%)
|
0 |
0/13 (0.00%)
|
0 |
0/87 (0.00%)
|
0 |
0/75 (0.00%)
|
0 |
1/10 (10.00%)
|
1 |
0/11 (0.00%)
|
0 |
Freezing Phenomenon |
0/4 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/5 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
1/111 (0.90%)
|
1 |
1/110 (0.91%)
|
1 |
0/10 (0.00%)
|
0 |
0/13 (0.00%)
|
0 |
0/87 (0.00%)
|
0 |
0/75 (0.00%)
|
0 |
0/10 (0.00%)
|
0 |
0/11 (0.00%)
|
0 |
Lumbar Radiculopathy |
0/4 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/5 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/111 (0.00%)
|
0 |
0/110 (0.00%)
|
0 |
0/10 (0.00%)
|
0 |
0/13 (0.00%)
|
0 |
0/87 (0.00%)
|
0 |
1/75 (1.33%)
|
1 |
0/10 (0.00%)
|
0 |
0/11 (0.00%)
|
0 |
On And Off Phenomenon |
0/4 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/5 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/111 (0.00%)
|
0 |
0/110 (0.00%)
|
0 |
0/10 (0.00%)
|
0 |
0/13 (0.00%)
|
0 |
1/87 (1.15%)
|
1 |
0/75 (0.00%)
|
0 |
0/10 (0.00%)
|
0 |
0/11 (0.00%)
|
0 |
Parkinson's Disease |
0/4 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/5 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/111 (0.00%)
|
0 |
0/110 (0.00%)
|
0 |
0/10 (0.00%)
|
0 |
0/13 (0.00%)
|
0 |
3/87 (3.45%)
|
4 |
1/75 (1.33%)
|
2 |
0/10 (0.00%)
|
0 |
0/11 (0.00%)
|
0 |
Posterior Reversible Encephalopathy Syndrome |
0/4 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/5 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/111 (0.00%)
|
0 |
1/110 (0.91%)
|
1 |
0/10 (0.00%)
|
0 |
0/13 (0.00%)
|
0 |
0/87 (0.00%)
|
0 |
0/75 (0.00%)
|
0 |
0/10 (0.00%)
|
0 |
0/11 (0.00%)
|
0 |
Syncope |
0/4 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/5 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
1/111 (0.90%)
|
1 |
3/110 (2.73%)
|
4 |
0/10 (0.00%)
|
0 |
0/13 (0.00%)
|
0 |
2/87 (2.30%)
|
2 |
0/75 (0.00%)
|
0 |
0/10 (0.00%)
|
0 |
0/11 (0.00%)
|
0 |
Transient Ischaemic Attack |
0/4 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/5 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/111 (0.00%)
|
0 |
1/110 (0.91%)
|
1 |
0/10 (0.00%)
|
0 |
1/13 (7.69%)
|
1 |
0/87 (0.00%)
|
0 |
0/75 (0.00%)
|
0 |
0/10 (0.00%)
|
0 |
0/11 (0.00%)
|
0 |
Psychiatric disorders |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Confusional State |
0/4 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/5 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/111 (0.00%)
|
0 |
0/110 (0.00%)
|
0 |
0/10 (0.00%)
|
0 |
0/13 (0.00%)
|
0 |
0/87 (0.00%)
|
0 |
1/75 (1.33%)
|
1 |
1/10 (10.00%)
|
1 |
0/11 (0.00%)
|
0 |
Hallucination |
0/4 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/5 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/111 (0.00%)
|
0 |
0/110 (0.00%)
|
0 |
0/10 (0.00%)
|
0 |
0/13 (0.00%)
|
0 |
1/87 (1.15%)
|
1 |
0/75 (0.00%)
|
0 |
0/10 (0.00%)
|
0 |
0/11 (0.00%)
|
0 |
Psychotic Disorder |
0/4 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/5 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/111 (0.00%)
|
0 |
0/110 (0.00%)
|
0 |
0/10 (0.00%)
|
0 |
0/13 (0.00%)
|
0 |
0/87 (0.00%)
|
0 |
1/75 (1.33%)
|
1 |
0/10 (0.00%)
|
0 |
0/11 (0.00%)
|
0 |
Suicide Attempt |
0/4 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/5 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/111 (0.00%)
|
0 |
0/110 (0.00%)
|
0 |
0/10 (0.00%)
|
0 |
0/13 (0.00%)
|
0 |
0/87 (0.00%)
|
0 |
0/75 (0.00%)
|
0 |
0/10 (0.00%)
|
0 |
1/11 (9.09%)
|
1 |
Renal and urinary disorders |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Acute Kidney Injury |
0/4 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/5 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/111 (0.00%)
|
0 |
1/110 (0.91%)
|
1 |
0/10 (0.00%)
|
0 |
0/13 (0.00%)
|
0 |
1/87 (1.15%)
|
1 |
0/75 (0.00%)
|
0 |
0/10 (0.00%)
|
0 |
0/11 (0.00%)
|
0 |
Micturition Urgency |
0/4 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/5 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
1/111 (0.90%)
|
1 |
0/110 (0.00%)
|
0 |
0/10 (0.00%)
|
0 |
0/13 (0.00%)
|
0 |
0/87 (0.00%)
|
0 |
0/75 (0.00%)
|
0 |
0/10 (0.00%)
|
0 |
0/11 (0.00%)
|
0 |
Ureterolithiasis |
0/4 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/5 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/111 (0.00%)
|
0 |
1/110 (0.91%)
|
1 |
0/10 (0.00%)
|
0 |
0/13 (0.00%)
|
0 |
0/87 (0.00%)
|
0 |
0/75 (0.00%)
|
0 |
0/10 (0.00%)
|
0 |
0/11 (0.00%)
|
0 |
Respiratory, thoracic and mediastinal disorders |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Hypoxia |
0/4 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/5 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/111 (0.00%)
|
0 |
0/110 (0.00%)
|
0 |
0/10 (0.00%)
|
0 |
1/13 (7.69%)
|
1 |
0/87 (0.00%)
|
0 |
0/75 (0.00%)
|
0 |
0/10 (0.00%)
|
0 |
0/11 (0.00%)
|
0 |
Pulmonary Embolism |
0/4 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/5 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/111 (0.00%)
|
0 |
1/110 (0.91%)
|
1 |
0/10 (0.00%)
|
0 |
0/13 (0.00%)
|
0 |
0/87 (0.00%)
|
0 |
0/75 (0.00%)
|
0 |
0/10 (0.00%)
|
0 |
0/11 (0.00%)
|
0 |
Vascular disorders |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Deep Vein Thrombosis |
0/4 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/5 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
1/111 (0.90%)
|
1 |
0/110 (0.00%)
|
0 |
0/10 (0.00%)
|
0 |
0/13 (0.00%)
|
0 |
0/87 (0.00%)
|
0 |
0/75 (0.00%)
|
0 |
0/10 (0.00%)
|
0 |
0/11 (0.00%)
|
0 |
Hypertension |
0/4 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/5 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/111 (0.00%)
|
0 |
0/110 (0.00%)
|
0 |
0/10 (0.00%)
|
0 |
0/13 (0.00%)
|
0 |
0/87 (0.00%)
|
0 |
1/75 (1.33%)
|
1 |
0/10 (0.00%)
|
0 |
0/11 (0.00%)
|
0 |
Hypertensive Urgency |
0/4 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/5 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/111 (0.00%)
|
0 |
0/110 (0.00%)
|
0 |
0/10 (0.00%)
|
0 |
1/13 (7.69%)
|
1 |
0/87 (0.00%)
|
0 |
0/75 (0.00%)
|
0 |
0/10 (0.00%)
|
0 |
0/11 (0.00%)
|
0 |
Hypotension |
0/4 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/5 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/111 (0.00%)
|
0 |
0/110 (0.00%)
|
0 |
0/10 (0.00%)
|
0 |
1/13 (7.69%)
|
1 |
1/87 (1.15%)
|
1 |
0/75 (0.00%)
|
0 |
0/10 (0.00%)
|
0 |
0/11 (0.00%)
|
0 |
Orthostatic Hypotension |
0/4 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/5 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/111 (0.00%)
|
0 |
1/110 (0.91%)
|
3 |
0/10 (0.00%)
|
0 |
0/13 (0.00%)
|
0 |
1/87 (1.15%)
|
1 |
0/75 (0.00%)
|
0 |
0/10 (0.00%)
|
0 |
0/11 (0.00%)
|
0 |
Term from vocabulary, MedDRA24.0
Indicates events were collected by systematic assessment
|
|
Frequency Threshold for Reporting Other Adverse Events
|
5%
|
|
Part 1: Placebo (ROW)
|
Part 1: Venglustat 4 mg (ROW)
|
Part 1: Venglustat 8 mg (ROW)
|
Part 1: Venglustat 15 mg (ROW)
|
Part 1: Placebo (Japan Only)
|
Part 1: Venglustat 4 mg (Japan Only)
|
Part 1: Venglustat 8 mg (Japan Only)
|
Part 1: Venglustat 15 mg (Japan Only)
|
Part 2, DB Period: Placebo
|
Part 2, DB Period: Venglustat 15 mg
|
Part 2, DB Period: Placebo (Re-randomized From Part 1)
|
Part 2, DB Period: Venglustat 15 mg (Re-randomized From Part 1)
|
Part 2, LTFU Period: Placebo Then Venglustat 15 mg
|
Part 2, LTFU Period: Venglustat 15 mg
|
Part 2, LTFU: Placebo Then Veng 15 mg (Re-randomized From Part 1)
|
Part 2, LTFU: Venglustat 15 mg (Re-randomized From Part 1)
|
|
Affected / at Risk (%) |
# Events
|
Affected / at Risk (%) |
# Events
|
Affected / at Risk (%) |
# Events
|
Affected / at Risk (%) |
# Events
|
Affected / at Risk (%) |
# Events
|
Affected / at Risk (%) |
# Events
|
Affected / at Risk (%) |
# Events
|
Affected / at Risk (%) |
# Events
|
Affected / at Risk (%) |
# Events
|
Affected / at Risk (%) |
# Events
|
Affected / at Risk (%) |
# Events
|
Affected / at Risk (%) |
# Events
|
Affected / at Risk (%) |
# Events
|
Affected / at Risk (%) |
# Events
|
Affected / at Risk (%) |
# Events
|
Affected / at Risk (%) |
# Events
|
Total |
4/4 (100.00%)
|
|
4/4 (100.00%)
|
|
4/5 (80.00%)
|
|
4/4 (100.00%)
|
|
2/3 (66.67%)
|
|
3/3 (100.00%)
|
|
3/3 (100.00%)
|
|
2/3 (66.67%)
|
|
87/111 (78.38%)
|
|
95/110 (86.36%)
|
|
8/10 (80.00%)
|
|
11/13 (84.62%)
|
|
53/87 (60.92%)
|
|
39/75 (52.00%)
|
|
7/10 (70.00%)
|
|
8/11 (72.73%)
|
|
Ear and labyrinth disorders |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Tinnitus |
0/4 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/5 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
1/111 (0.90%)
|
1 |
0/110 (0.00%)
|
0 |
0/10 (0.00%)
|
0 |
0/13 (0.00%)
|
0 |
0/87 (0.00%)
|
0 |
0/75 (0.00%)
|
0 |
1/10 (10.00%)
|
1 |
0/11 (0.00%)
|
0 |
Tympanic Membrane Perforation |
0/4 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/5 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/111 (0.00%)
|
0 |
0/110 (0.00%)
|
0 |
1/10 (10.00%)
|
1 |
0/13 (0.00%)
|
0 |
0/87 (0.00%)
|
0 |
0/75 (0.00%)
|
0 |
0/10 (0.00%)
|
0 |
0/11 (0.00%)
|
0 |
Vertigo |
0/4 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/5 (0.00%)
|
0 |
1/4 (25.00%)
|
1 |
0/3 (0.00%)
|
0 |
1/3 (33.33%)
|
1 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
2/111 (1.80%)
|
2 |
0/110 (0.00%)
|
0 |
1/10 (10.00%)
|
1 |
0/13 (0.00%)
|
0 |
1/87 (1.15%)
|
1 |
0/75 (0.00%)
|
0 |
0/10 (0.00%)
|
0 |
0/11 (0.00%)
|
0 |
Endocrine disorders |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Hypothyroidism |
0/4 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/5 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/111 (0.00%)
|
0 |
0/110 (0.00%)
|
0 |
0/10 (0.00%)
|
0 |
0/13 (0.00%)
|
0 |
0/87 (0.00%)
|
0 |
0/75 (0.00%)
|
0 |
1/10 (10.00%)
|
1 |
0/11 (0.00%)
|
0 |
Eye disorders |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Blepharitis |
0/4 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/5 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
4/111 (3.60%)
|
4 |
2/110 (1.82%)
|
2 |
0/10 (0.00%)
|
0 |
1/13 (7.69%)
|
1 |
1/87 (1.15%)
|
1 |
0/75 (0.00%)
|
0 |
0/10 (0.00%)
|
0 |
0/11 (0.00%)
|
0 |
Borderline Glaucoma |
0/4 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/5 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/111 (0.00%)
|
0 |
0/110 (0.00%)
|
0 |
0/10 (0.00%)
|
0 |
0/13 (0.00%)
|
0 |
0/87 (0.00%)
|
0 |
0/75 (0.00%)
|
0 |
0/10 (0.00%)
|
0 |
1/11 (9.09%)
|
1 |
Cataract Cortical |
1/4 (25.00%)
|
1 |
1/4 (25.00%)
|
1 |
0/5 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
7/111 (6.31%)
|
7 |
4/110 (3.64%)
|
5 |
1/10 (10.00%)
|
1 |
1/13 (7.69%)
|
2 |
5/87 (5.75%)
|
6 |
3/75 (4.00%)
|
4 |
0/10 (0.00%)
|
0 |
0/11 (0.00%)
|
0 |
Cataract Nuclear |
0/4 (0.00%)
|
0 |
1/4 (25.00%)
|
1 |
0/5 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
6/111 (5.41%)
|
7 |
9/110 (8.18%)
|
9 |
1/10 (10.00%)
|
1 |
1/13 (7.69%)
|
1 |
11/87 (12.64%)
|
11 |
4/75 (5.33%)
|
4 |
0/10 (0.00%)
|
0 |
2/11 (18.18%)
|
2 |
Corneal Infiltrates |
0/4 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/5 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/111 (0.00%)
|
0 |
0/110 (0.00%)
|
0 |
0/10 (0.00%)
|
0 |
0/13 (0.00%)
|
0 |
0/87 (0.00%)
|
0 |
0/75 (0.00%)
|
0 |
0/10 (0.00%)
|
0 |
1/11 (9.09%)
|
1 |
Dry Eye |
0/4 (0.00%)
|
0 |
1/4 (25.00%)
|
1 |
0/5 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
1/111 (0.90%)
|
1 |
1/110 (0.91%)
|
1 |
0/10 (0.00%)
|
0 |
0/13 (0.00%)
|
0 |
0/87 (0.00%)
|
0 |
0/75 (0.00%)
|
0 |
0/10 (0.00%)
|
0 |
1/11 (9.09%)
|
1 |
Eczema Eyelids |
0/4 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/5 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/111 (0.00%)
|
0 |
0/110 (0.00%)
|
0 |
1/10 (10.00%)
|
1 |
0/13 (0.00%)
|
0 |
0/87 (0.00%)
|
0 |
0/75 (0.00%)
|
0 |
0/10 (0.00%)
|
0 |
0/11 (0.00%)
|
0 |
Eye Irritation |
0/4 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/5 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/111 (0.00%)
|
0 |
0/110 (0.00%)
|
0 |
0/10 (0.00%)
|
0 |
1/13 (7.69%)
|
2 |
0/87 (0.00%)
|
0 |
0/75 (0.00%)
|
0 |
0/10 (0.00%)
|
0 |
0/11 (0.00%)
|
0 |
Glaucoma |
0/4 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/5 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
1/3 (33.33%)
|
1 |
0/3 (0.00%)
|
0 |
0/111 (0.00%)
|
0 |
1/110 (0.91%)
|
1 |
0/10 (0.00%)
|
0 |
0/13 (0.00%)
|
0 |
0/87 (0.00%)
|
0 |
1/75 (1.33%)
|
1 |
0/10 (0.00%)
|
0 |
0/11 (0.00%)
|
0 |
Hypermetropia |
0/4 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
1/5 (20.00%)
|
1 |
0/4 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/111 (0.00%)
|
0 |
0/110 (0.00%)
|
0 |
0/10 (0.00%)
|
0 |
0/13 (0.00%)
|
0 |
0/87 (0.00%)
|
0 |
0/75 (0.00%)
|
0 |
0/10 (0.00%)
|
0 |
0/11 (0.00%)
|
0 |
Vision Blurred |
0/4 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/5 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
1/111 (0.90%)
|
1 |
3/110 (2.73%)
|
3 |
0/10 (0.00%)
|
0 |
1/13 (7.69%)
|
1 |
2/87 (2.30%)
|
2 |
0/75 (0.00%)
|
0 |
0/10 (0.00%)
|
0 |
0/11 (0.00%)
|
0 |
Gastrointestinal disorders |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Abdominal Discomfort |
0/4 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/5 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
1/3 (33.33%)
|
1 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/111 (0.00%)
|
0 |
0/110 (0.00%)
|
0 |
0/10 (0.00%)
|
0 |
0/13 (0.00%)
|
0 |
0/87 (0.00%)
|
0 |
0/75 (0.00%)
|
0 |
0/10 (0.00%)
|
0 |
0/11 (0.00%)
|
0 |
Abdominal Distension |
0/4 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/5 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/111 (0.00%)
|
0 |
0/110 (0.00%)
|
0 |
0/10 (0.00%)
|
0 |
0/13 (0.00%)
|
0 |
0/87 (0.00%)
|
0 |
0/75 (0.00%)
|
0 |
1/10 (10.00%)
|
1 |
0/11 (0.00%)
|
0 |
Anal Haemorrhage |
0/4 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/5 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/111 (0.00%)
|
0 |
0/110 (0.00%)
|
0 |
0/10 (0.00%)
|
0 |
0/13 (0.00%)
|
0 |
0/87 (0.00%)
|
0 |
0/75 (0.00%)
|
0 |
0/10 (0.00%)
|
0 |
1/11 (9.09%)
|
1 |
Chronic Gastritis |
0/4 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/5 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/111 (0.00%)
|
0 |
1/110 (0.91%)
|
1 |
0/10 (0.00%)
|
0 |
0/13 (0.00%)
|
0 |
0/87 (0.00%)
|
0 |
0/75 (0.00%)
|
0 |
1/10 (10.00%)
|
1 |
0/11 (0.00%)
|
0 |
Constipation |
0/4 (0.00%)
|
0 |
1/4 (25.00%)
|
2 |
0/5 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
1/3 (33.33%)
|
1 |
8/111 (7.21%)
|
8 |
23/110 (20.91%)
|
25 |
0/10 (0.00%)
|
0 |
0/13 (0.00%)
|
0 |
3/87 (3.45%)
|
3 |
3/75 (4.00%)
|
4 |
1/10 (10.00%)
|
1 |
0/11 (0.00%)
|
0 |
Cyclic Vomiting Syndrome |
0/4 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/5 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
1/3 (33.33%)
|
1 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/111 (0.00%)
|
0 |
0/110 (0.00%)
|
0 |
0/10 (0.00%)
|
0 |
1/13 (7.69%)
|
1 |
0/87 (0.00%)
|
0 |
0/75 (0.00%)
|
0 |
0/10 (0.00%)
|
0 |
0/11 (0.00%)
|
0 |
Dental Caries |
1/4 (25.00%)
|
1 |
0/4 (0.00%)
|
0 |
0/5 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
1/111 (0.90%)
|
1 |
0/110 (0.00%)
|
0 |
1/10 (10.00%)
|
1 |
0/13 (0.00%)
|
0 |
1/87 (1.15%)
|
1 |
0/75 (0.00%)
|
0 |
0/10 (0.00%)
|
0 |
0/11 (0.00%)
|
0 |
Diarrhoea |
0/4 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
2/5 (40.00%)
|
2 |
0/4 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
4/111 (3.60%)
|
4 |
5/110 (4.55%)
|
5 |
0/10 (0.00%)
|
0 |
0/13 (0.00%)
|
0 |
1/87 (1.15%)
|
1 |
1/75 (1.33%)
|
1 |
0/10 (0.00%)
|
0 |
0/11 (0.00%)
|
0 |
Dry Mouth |
0/4 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/5 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
1/111 (0.90%)
|
1 |
7/110 (6.36%)
|
7 |
0/10 (0.00%)
|
0 |
0/13 (0.00%)
|
0 |
1/87 (1.15%)
|
1 |
0/75 (0.00%)
|
0 |
0/10 (0.00%)
|
0 |
0/11 (0.00%)
|
0 |
Dysphagia |
0/4 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/5 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/111 (0.00%)
|
0 |
0/110 (0.00%)
|
0 |
0/10 (0.00%)
|
0 |
0/13 (0.00%)
|
0 |
1/87 (1.15%)
|
1 |
0/75 (0.00%)
|
0 |
1/10 (10.00%)
|
1 |
0/11 (0.00%)
|
0 |
Eructation |
1/4 (25.00%)
|
1 |
0/4 (0.00%)
|
0 |
0/5 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/111 (0.00%)
|
0 |
0/110 (0.00%)
|
0 |
0/10 (0.00%)
|
0 |
0/13 (0.00%)
|
0 |
0/87 (0.00%)
|
0 |
0/75 (0.00%)
|
0 |
0/10 (0.00%)
|
0 |
0/11 (0.00%)
|
0 |
Gastritis |
0/4 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/5 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
2/111 (1.80%)
|
2 |
0/110 (0.00%)
|
0 |
0/10 (0.00%)
|
0 |
0/13 (0.00%)
|
0 |
0/87 (0.00%)
|
0 |
0/75 (0.00%)
|
0 |
1/10 (10.00%)
|
1 |
0/11 (0.00%)
|
0 |
Nausea |
1/4 (25.00%)
|
1 |
1/4 (25.00%)
|
1 |
0/5 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
2/3 (66.67%)
|
3 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
8/111 (7.21%)
|
9 |
23/110 (20.91%)
|
27 |
0/10 (0.00%)
|
0 |
1/13 (7.69%)
|
1 |
5/87 (5.75%)
|
5 |
0/75 (0.00%)
|
0 |
0/10 (0.00%)
|
0 |
1/11 (9.09%)
|
1 |
Periodontal Disease |
0/4 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/5 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/111 (0.00%)
|
0 |
0/110 (0.00%)
|
0 |
1/10 (10.00%)
|
1 |
0/13 (0.00%)
|
0 |
0/87 (0.00%)
|
0 |
0/75 (0.00%)
|
0 |
0/10 (0.00%)
|
0 |
0/11 (0.00%)
|
0 |
Vomiting |
0/4 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/5 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
2/3 (66.67%)
|
2 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
3/111 (2.70%)
|
3 |
9/110 (8.18%)
|
12 |
0/10 (0.00%)
|
0 |
0/13 (0.00%)
|
0 |
4/87 (4.60%)
|
4 |
0/75 (0.00%)
|
0 |
0/10 (0.00%)
|
0 |
0/11 (0.00%)
|
0 |
General disorders |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fatigue |
0/4 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
1/5 (20.00%)
|
1 |
0/4 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
4/111 (3.60%)
|
4 |
12/110 (10.91%)
|
13 |
0/10 (0.00%)
|
0 |
1/13 (7.69%)
|
1 |
3/87 (3.45%)
|
3 |
1/75 (1.33%)
|
1 |
0/10 (0.00%)
|
0 |
0/11 (0.00%)
|
0 |
Oedema Peripheral |
0/4 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/5 (0.00%)
|
0 |
1/4 (25.00%)
|
1 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
7/111 (6.31%)
|
8 |
1/110 (0.91%)
|
1 |
0/10 (0.00%)
|
0 |
0/13 (0.00%)
|
0 |
1/87 (1.15%)
|
1 |
2/75 (2.67%)
|
2 |
0/10 (0.00%)
|
0 |
0/11 (0.00%)
|
0 |
Pain |
0/4 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/5 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
3/111 (2.70%)
|
4 |
1/110 (0.91%)
|
1 |
0/10 (0.00%)
|
0 |
1/13 (7.69%)
|
1 |
0/87 (0.00%)
|
0 |
0/75 (0.00%)
|
0 |
0/10 (0.00%)
|
0 |
0/11 (0.00%)
|
0 |
Infections and infestations |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Covid-19 |
0/4 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/5 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
1/111 (0.90%)
|
1 |
0/110 (0.00%)
|
0 |
0/10 (0.00%)
|
0 |
0/13 (0.00%)
|
0 |
1/87 (1.15%)
|
1 |
4/75 (5.33%)
|
4 |
0/10 (0.00%)
|
0 |
0/11 (0.00%)
|
0 |
Conjunctivitis |
0/4 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/5 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/111 (0.00%)
|
0 |
2/110 (1.82%)
|
5 |
0/10 (0.00%)
|
0 |
0/13 (0.00%)
|
0 |
1/87 (1.15%)
|
1 |
2/75 (2.67%)
|
2 |
0/10 (0.00%)
|
0 |
1/11 (9.09%)
|
1 |
Empyema |
0/4 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/5 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/111 (0.00%)
|
0 |
0/110 (0.00%)
|
0 |
0/10 (0.00%)
|
0 |
0/13 (0.00%)
|
0 |
0/87 (0.00%)
|
0 |
0/75 (0.00%)
|
0 |
1/10 (10.00%)
|
1 |
0/11 (0.00%)
|
0 |
Fungal Skin Infection |
0/4 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/5 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/111 (0.00%)
|
0 |
0/110 (0.00%)
|
0 |
0/10 (0.00%)
|
0 |
1/13 (7.69%)
|
1 |
0/87 (0.00%)
|
0 |
0/75 (0.00%)
|
0 |
0/10 (0.00%)
|
0 |
0/11 (0.00%)
|
0 |
Gastroenteritis |
0/4 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/5 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
1/111 (0.90%)
|
2 |
0/110 (0.00%)
|
0 |
0/10 (0.00%)
|
0 |
0/13 (0.00%)
|
0 |
0/87 (0.00%)
|
0 |
0/75 (0.00%)
|
0 |
0/10 (0.00%)
|
0 |
1/11 (9.09%)
|
1 |
Nasopharyngitis |
0/4 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/5 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
1/3 (33.33%)
|
1 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
1/3 (33.33%)
|
1 |
11/111 (9.91%)
|
11 |
10/110 (9.09%)
|
13 |
3/10 (30.00%)
|
4 |
0/13 (0.00%)
|
0 |
1/87 (1.15%)
|
1 |
0/75 (0.00%)
|
0 |
1/10 (10.00%)
|
1 |
0/11 (0.00%)
|
0 |
Pulpitis Dental |
0/4 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/5 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
1/111 (0.90%)
|
1 |
0/110 (0.00%)
|
0 |
0/10 (0.00%)
|
0 |
0/13 (0.00%)
|
0 |
1/87 (1.15%)
|
1 |
0/75 (0.00%)
|
0 |
1/10 (10.00%)
|
1 |
0/11 (0.00%)
|
0 |
Retinitis |
0/4 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/5 (0.00%)
|
0 |
1/4 (25.00%)
|
1 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/111 (0.00%)
|
0 |
0/110 (0.00%)
|
0 |
0/10 (0.00%)
|
0 |
0/13 (0.00%)
|
0 |
0/87 (0.00%)
|
0 |
0/75 (0.00%)
|
0 |
0/10 (0.00%)
|
0 |
0/11 (0.00%)
|
0 |
Tinea Pedis |
0/4 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/5 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/111 (0.00%)
|
0 |
0/110 (0.00%)
|
0 |
0/10 (0.00%)
|
0 |
1/13 (7.69%)
|
1 |
0/87 (0.00%)
|
0 |
0/75 (0.00%)
|
0 |
0/10 (0.00%)
|
0 |
0/11 (0.00%)
|
0 |
Upper Respiratory Tract Infection |
0/4 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/5 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
1/3 (33.33%)
|
1 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/111 (0.00%)
|
0 |
2/110 (1.82%)
|
4 |
2/10 (20.00%)
|
2 |
0/13 (0.00%)
|
0 |
1/87 (1.15%)
|
1 |
0/75 (0.00%)
|
0 |
1/10 (10.00%)
|
1 |
0/11 (0.00%)
|
0 |
Urinary Tract Infection |
0/4 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/5 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
1/3 (33.33%)
|
1 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
6/111 (5.41%)
|
6 |
11/110 (10.00%)
|
17 |
0/10 (0.00%)
|
0 |
0/13 (0.00%)
|
0 |
2/87 (2.30%)
|
2 |
3/75 (4.00%)
|
3 |
0/10 (0.00%)
|
0 |
0/11 (0.00%)
|
0 |
Injury, poisoning and procedural complications |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Arthropod Bite |
0/4 (0.00%)
|
0 |
1/4 (25.00%)
|
1 |
0/5 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/111 (0.00%)
|
0 |
0/110 (0.00%)
|
0 |
0/10 (0.00%)
|
0 |
0/13 (0.00%)
|
0 |
0/87 (0.00%)
|
0 |
0/75 (0.00%)
|
0 |
0/10 (0.00%)
|
0 |
0/11 (0.00%)
|
0 |
Eyelid Injury |
0/4 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/5 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
1/3 (33.33%)
|
1 |
0/111 (0.00%)
|
0 |
0/110 (0.00%)
|
0 |
0/10 (0.00%)
|
0 |
0/13 (0.00%)
|
0 |
0/87 (0.00%)
|
0 |
0/75 (0.00%)
|
0 |
0/10 (0.00%)
|
0 |
0/11 (0.00%)
|
0 |
Fall |
0/4 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/5 (0.00%)
|
0 |
1/4 (25.00%)
|
1 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
18/111 (16.22%)
|
24 |
10/110 (9.09%)
|
12 |
0/10 (0.00%)
|
0 |
1/13 (7.69%)
|
4 |
9/87 (10.34%)
|
12 |
2/75 (2.67%)
|
3 |
0/10 (0.00%)
|
0 |
3/11 (27.27%)
|
3 |
Ligament Rupture |
0/4 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/5 (0.00%)
|
0 |
1/4 (25.00%)
|
1 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/111 (0.00%)
|
0 |
0/110 (0.00%)
|
0 |
0/10 (0.00%)
|
0 |
0/13 (0.00%)
|
0 |
0/87 (0.00%)
|
0 |
0/75 (0.00%)
|
0 |
0/10 (0.00%)
|
0 |
0/11 (0.00%)
|
0 |
Limb Injury |
0/4 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/5 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
1/111 (0.90%)
|
1 |
0/110 (0.00%)
|
0 |
0/10 (0.00%)
|
0 |
0/13 (0.00%)
|
0 |
0/87 (0.00%)
|
0 |
0/75 (0.00%)
|
0 |
0/10 (0.00%)
|
0 |
1/11 (9.09%)
|
1 |
Post Lumbar Puncture Syndrome |
0/4 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/5 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
1/3 (33.33%)
|
1 |
1/3 (33.33%)
|
1 |
3/111 (2.70%)
|
4 |
4/110 (3.64%)
|
4 |
0/10 (0.00%)
|
0 |
0/13 (0.00%)
|
0 |
2/87 (2.30%)
|
2 |
3/75 (4.00%)
|
3 |
0/10 (0.00%)
|
0 |
0/11 (0.00%)
|
0 |
Procedural Nausea |
0/4 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/5 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
1/3 (33.33%)
|
1 |
0/3 (0.00%)
|
0 |
0/111 (0.00%)
|
0 |
0/110 (0.00%)
|
0 |
0/10 (0.00%)
|
0 |
0/13 (0.00%)
|
0 |
1/87 (1.15%)
|
1 |
0/75 (0.00%)
|
0 |
0/10 (0.00%)
|
0 |
0/11 (0.00%)
|
0 |
Procedural Pain |
0/4 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
1/5 (20.00%)
|
1 |
0/4 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/111 (0.00%)
|
0 |
0/110 (0.00%)
|
0 |
0/10 (0.00%)
|
0 |
0/13 (0.00%)
|
0 |
0/87 (0.00%)
|
0 |
1/75 (1.33%)
|
1 |
0/10 (0.00%)
|
0 |
0/11 (0.00%)
|
0 |
Procedural Vomiting |
0/4 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/5 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
1/3 (33.33%)
|
1 |
1/3 (33.33%)
|
1 |
0/111 (0.00%)
|
0 |
1/110 (0.91%)
|
1 |
0/10 (0.00%)
|
0 |
0/13 (0.00%)
|
0 |
0/87 (0.00%)
|
0 |
0/75 (0.00%)
|
0 |
0/10 (0.00%)
|
0 |
0/11 (0.00%)
|
0 |
Rib Fracture |
0/4 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/5 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/111 (0.00%)
|
0 |
1/110 (0.91%)
|
2 |
0/10 (0.00%)
|
0 |
0/13 (0.00%)
|
0 |
0/87 (0.00%)
|
0 |
0/75 (0.00%)
|
0 |
1/10 (10.00%)
|
1 |
0/11 (0.00%)
|
0 |
Thermal Burn |
0/4 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/5 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/111 (0.00%)
|
0 |
0/110 (0.00%)
|
0 |
0/10 (0.00%)
|
0 |
0/13 (0.00%)
|
0 |
0/87 (0.00%)
|
0 |
0/75 (0.00%)
|
0 |
1/10 (10.00%)
|
1 |
0/11 (0.00%)
|
0 |
Investigations |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Alanine Aminotransferase Increased |
0/4 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/5 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
1/111 (0.90%)
|
1 |
1/110 (0.91%)
|
1 |
1/10 (10.00%)
|
1 |
0/13 (0.00%)
|
0 |
0/87 (0.00%)
|
0 |
1/75 (1.33%)
|
1 |
0/10 (0.00%)
|
0 |
0/11 (0.00%)
|
0 |
Blood Creatine Phosphokinase Increased |
0/4 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/5 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
1/111 (0.90%)
|
1 |
1/110 (0.91%)
|
1 |
0/10 (0.00%)
|
0 |
1/13 (7.69%)
|
1 |
0/87 (0.00%)
|
0 |
1/75 (1.33%)
|
1 |
0/10 (0.00%)
|
0 |
0/11 (0.00%)
|
0 |
Cardiac Murmur |
0/4 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
1/5 (20.00%)
|
1 |
0/4 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
1/111 (0.90%)
|
1 |
1/110 (0.91%)
|
1 |
0/10 (0.00%)
|
0 |
0/13 (0.00%)
|
0 |
0/87 (0.00%)
|
0 |
0/75 (0.00%)
|
0 |
0/10 (0.00%)
|
0 |
0/11 (0.00%)
|
0 |
Hepatic Enzyme Increased |
0/4 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/5 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
1/3 (33.33%)
|
1 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/111 (0.00%)
|
0 |
0/110 (0.00%)
|
0 |
0/10 (0.00%)
|
0 |
1/13 (7.69%)
|
1 |
0/87 (0.00%)
|
0 |
0/75 (0.00%)
|
0 |
0/10 (0.00%)
|
0 |
0/11 (0.00%)
|
0 |
Weight Decreased |
0/4 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/5 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
3/111 (2.70%)
|
3 |
2/110 (1.82%)
|
2 |
0/10 (0.00%)
|
0 |
1/13 (7.69%)
|
1 |
2/87 (2.30%)
|
2 |
2/75 (2.67%)
|
2 |
0/10 (0.00%)
|
0 |
1/11 (9.09%)
|
1 |
Metabolism and nutrition disorders |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Decreased Appetite |
0/4 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/5 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/111 (0.00%)
|
0 |
6/110 (5.45%)
|
7 |
0/10 (0.00%)
|
0 |
0/13 (0.00%)
|
0 |
0/87 (0.00%)
|
0 |
0/75 (0.00%)
|
0 |
0/10 (0.00%)
|
0 |
0/11 (0.00%)
|
0 |
Type 2 Diabetes Mellitus |
0/4 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/5 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/111 (0.00%)
|
0 |
1/110 (0.91%)
|
1 |
0/10 (0.00%)
|
0 |
1/13 (7.69%)
|
1 |
0/87 (0.00%)
|
0 |
0/75 (0.00%)
|
0 |
0/10 (0.00%)
|
0 |
0/11 (0.00%)
|
0 |
Musculoskeletal and connective tissue disorders |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Arthralgia |
0/4 (0.00%)
|
0 |
2/4 (50.00%)
|
2 |
0/5 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
7/111 (6.31%)
|
7 |
5/110 (4.55%)
|
5 |
1/10 (10.00%)
|
1 |
1/13 (7.69%)
|
1 |
0/87 (0.00%)
|
0 |
4/75 (5.33%)
|
4 |
0/10 (0.00%)
|
0 |
0/11 (0.00%)
|
0 |
Back Pain |
0/4 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
1/5 (20.00%)
|
1 |
0/4 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
8/111 (7.21%)
|
12 |
9/110 (8.18%)
|
14 |
0/10 (0.00%)
|
0 |
2/13 (15.38%)
|
2 |
1/87 (1.15%)
|
1 |
2/75 (2.67%)
|
2 |
0/10 (0.00%)
|
0 |
0/11 (0.00%)
|
0 |
Extremity Contracture |
0/4 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/5 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/111 (0.00%)
|
0 |
0/110 (0.00%)
|
0 |
0/10 (0.00%)
|
0 |
0/13 (0.00%)
|
0 |
0/87 (0.00%)
|
0 |
0/75 (0.00%)
|
0 |
0/10 (0.00%)
|
0 |
1/11 (9.09%)
|
1 |
Muscle Spasms |
0/4 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/5 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
2/111 (1.80%)
|
3 |
2/110 (1.82%)
|
2 |
0/10 (0.00%)
|
0 |
0/13 (0.00%)
|
0 |
1/87 (1.15%)
|
1 |
0/75 (0.00%)
|
0 |
0/10 (0.00%)
|
0 |
1/11 (9.09%)
|
1 |
Pain In Extremity |
0/4 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/5 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
8/111 (7.21%)
|
8 |
5/110 (4.55%)
|
5 |
0/10 (0.00%)
|
0 |
0/13 (0.00%)
|
0 |
2/87 (2.30%)
|
2 |
1/75 (1.33%)
|
1 |
0/10 (0.00%)
|
0 |
0/11 (0.00%)
|
0 |
Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Skin Papilloma |
0/4 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/5 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/111 (0.00%)
|
0 |
0/110 (0.00%)
|
0 |
0/10 (0.00%)
|
0 |
1/13 (7.69%)
|
1 |
0/87 (0.00%)
|
0 |
0/75 (0.00%)
|
0 |
0/10 (0.00%)
|
0 |
0/11 (0.00%)
|
0 |
Nervous system disorders |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Amnesia |
0/4 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/5 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
1/111 (0.90%)
|
1 |
1/110 (0.91%)
|
1 |
0/10 (0.00%)
|
0 |
1/13 (7.69%)
|
1 |
0/87 (0.00%)
|
0 |
0/75 (0.00%)
|
0 |
0/10 (0.00%)
|
0 |
0/11 (0.00%)
|
0 |
Chorea |
0/4 (0.00%)
|
0 |
1/4 (25.00%)
|
1 |
0/5 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/111 (0.00%)
|
0 |
0/110 (0.00%)
|
0 |
0/10 (0.00%)
|
0 |
0/13 (0.00%)
|
0 |
0/87 (0.00%)
|
0 |
0/75 (0.00%)
|
0 |
0/10 (0.00%)
|
0 |
0/11 (0.00%)
|
0 |
Cognitive Disorder |
0/4 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/5 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
4/111 (3.60%)
|
4 |
3/110 (2.73%)
|
3 |
0/10 (0.00%)
|
0 |
0/13 (0.00%)
|
0 |
3/87 (3.45%)
|
3 |
1/75 (1.33%)
|
1 |
1/10 (10.00%)
|
1 |
0/11 (0.00%)
|
0 |
Dizziness |
1/4 (25.00%)
|
1 |
0/4 (0.00%)
|
0 |
0/5 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
10/111 (9.01%)
|
10 |
12/110 (10.91%)
|
14 |
0/10 (0.00%)
|
0 |
0/13 (0.00%)
|
0 |
6/87 (6.90%)
|
6 |
1/75 (1.33%)
|
1 |
0/10 (0.00%)
|
0 |
1/11 (9.09%)
|
1 |
Headache |
2/4 (50.00%)
|
2 |
0/4 (0.00%)
|
0 |
1/5 (20.00%)
|
1 |
0/4 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
1/3 (33.33%)
|
1 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
15/111 (13.51%)
|
20 |
22/110 (20.00%)
|
31 |
0/10 (0.00%)
|
0 |
3/13 (23.08%)
|
3 |
2/87 (2.30%)
|
2 |
3/75 (4.00%)
|
3 |
0/10 (0.00%)
|
0 |
0/11 (0.00%)
|
0 |
Hyperreflexia |
0/4 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/5 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/111 (0.00%)
|
0 |
0/110 (0.00%)
|
0 |
0/10 (0.00%)
|
0 |
1/13 (7.69%)
|
1 |
0/87 (0.00%)
|
0 |
0/75 (0.00%)
|
0 |
0/10 (0.00%)
|
0 |
0/11 (0.00%)
|
0 |
Hypoaesthesia |
0/4 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/5 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/111 (0.00%)
|
0 |
2/110 (1.82%)
|
2 |
0/10 (0.00%)
|
0 |
1/13 (7.69%)
|
1 |
3/87 (3.45%)
|
3 |
0/75 (0.00%)
|
0 |
0/10 (0.00%)
|
0 |
0/11 (0.00%)
|
0 |
Loss Of Consciousness |
0/4 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/5 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
1/111 (0.90%)
|
1 |
0/110 (0.00%)
|
0 |
0/10 (0.00%)
|
0 |
0/13 (0.00%)
|
0 |
0/87 (0.00%)
|
0 |
0/75 (0.00%)
|
0 |
0/10 (0.00%)
|
0 |
1/11 (9.09%)
|
1 |
Memory Impairment |
0/4 (0.00%)
|
0 |
1/4 (25.00%)
|
1 |
0/5 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
2/111 (1.80%)
|
2 |
0/110 (0.00%)
|
0 |
0/10 (0.00%)
|
0 |
0/13 (0.00%)
|
0 |
0/87 (0.00%)
|
0 |
0/75 (0.00%)
|
0 |
0/10 (0.00%)
|
0 |
0/11 (0.00%)
|
0 |
Paraesthesia |
0/4 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/5 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
2/111 (1.80%)
|
2 |
1/110 (0.91%)
|
1 |
0/10 (0.00%)
|
0 |
1/13 (7.69%)
|
2 |
0/87 (0.00%)
|
0 |
1/75 (1.33%)
|
1 |
0/10 (0.00%)
|
0 |
0/11 (0.00%)
|
0 |
Parkinson's Disease |
0/4 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
1/5 (20.00%)
|
1 |
0/4 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
6/111 (5.41%)
|
7 |
8/110 (7.27%)
|
8 |
0/10 (0.00%)
|
0 |
2/13 (15.38%)
|
2 |
11/87 (12.64%)
|
11 |
4/75 (5.33%)
|
4 |
0/10 (0.00%)
|
0 |
1/11 (9.09%)
|
1 |
Peripheral Sensory Neuropathy |
0/4 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/5 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/111 (0.00%)
|
0 |
0/110 (0.00%)
|
0 |
0/10 (0.00%)
|
0 |
1/13 (7.69%)
|
1 |
0/87 (0.00%)
|
0 |
0/75 (0.00%)
|
0 |
0/10 (0.00%)
|
0 |
0/11 (0.00%)
|
0 |
Radial Nerve Palsy |
0/4 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/5 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/111 (0.00%)
|
0 |
0/110 (0.00%)
|
0 |
0/10 (0.00%)
|
0 |
0/13 (0.00%)
|
0 |
0/87 (0.00%)
|
0 |
0/75 (0.00%)
|
0 |
1/10 (10.00%)
|
1 |
0/11 (0.00%)
|
0 |
Resting Tremor |
0/4 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/5 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
1/111 (0.90%)
|
1 |
0/110 (0.00%)
|
0 |
0/10 (0.00%)
|
0 |
1/13 (7.69%)
|
1 |
0/87 (0.00%)
|
0 |
0/75 (0.00%)
|
0 |
0/10 (0.00%)
|
0 |
0/11 (0.00%)
|
0 |
Restless Legs Syndrome |
0/4 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/5 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/111 (0.00%)
|
0 |
4/110 (3.64%)
|
4 |
0/10 (0.00%)
|
0 |
0/13 (0.00%)
|
0 |
1/87 (1.15%)
|
1 |
1/75 (1.33%)
|
1 |
0/10 (0.00%)
|
0 |
1/11 (9.09%)
|
1 |
Sciatica |
0/4 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/5 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/111 (0.00%)
|
0 |
0/110 (0.00%)
|
0 |
1/10 (10.00%)
|
1 |
0/13 (0.00%)
|
0 |
1/87 (1.15%)
|
1 |
0/75 (0.00%)
|
0 |
0/10 (0.00%)
|
0 |
0/11 (0.00%)
|
0 |
Sleep Deficit |
0/4 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
1/5 (20.00%)
|
1 |
0/4 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/111 (0.00%)
|
0 |
0/110 (0.00%)
|
0 |
0/10 (0.00%)
|
0 |
0/13 (0.00%)
|
0 |
0/87 (0.00%)
|
0 |
0/75 (0.00%)
|
0 |
0/10 (0.00%)
|
0 |
0/11 (0.00%)
|
0 |
Somnolence |
1/4 (25.00%)
|
1 |
0/4 (0.00%)
|
0 |
0/5 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
3/111 (2.70%)
|
3 |
6/110 (5.45%)
|
6 |
0/10 (0.00%)
|
0 |
0/13 (0.00%)
|
0 |
0/87 (0.00%)
|
0 |
3/75 (4.00%)
|
3 |
0/10 (0.00%)
|
0 |
1/11 (9.09%)
|
1 |
Tremor |
0/4 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/5 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
5/111 (4.50%)
|
6 |
8/110 (7.27%)
|
9 |
0/10 (0.00%)
|
0 |
0/13 (0.00%)
|
0 |
3/87 (3.45%)
|
3 |
0/75 (0.00%)
|
0 |
0/10 (0.00%)
|
0 |
0/11 (0.00%)
|
0 |
Psychiatric disorders |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Anxiety |
0/4 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/5 (0.00%)
|
0 |
2/4 (50.00%)
|
2 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
6/111 (5.41%)
|
6 |
5/110 (4.55%)
|
5 |
0/10 (0.00%)
|
0 |
2/13 (15.38%)
|
2 |
7/87 (8.05%)
|
7 |
2/75 (2.67%)
|
3 |
1/10 (10.00%)
|
1 |
0/11 (0.00%)
|
0 |
Confusional State |
0/4 (0.00%)
|
0 |
1/4 (25.00%)
|
1 |
0/5 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
2/111 (1.80%)
|
2 |
1/110 (0.91%)
|
1 |
0/10 (0.00%)
|
0 |
1/13 (7.69%)
|
1 |
0/87 (0.00%)
|
0 |
0/75 (0.00%)
|
0 |
0/10 (0.00%)
|
0 |
0/11 (0.00%)
|
0 |
Delirium |
0/4 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/5 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
1/3 (33.33%)
|
1 |
0/3 (0.00%)
|
0 |
0/111 (0.00%)
|
0 |
0/110 (0.00%)
|
0 |
0/10 (0.00%)
|
0 |
0/13 (0.00%)
|
0 |
1/87 (1.15%)
|
1 |
0/75 (0.00%)
|
0 |
0/10 (0.00%)
|
0 |
0/11 (0.00%)
|
0 |
Depressed Mood |
0/4 (0.00%)
|
0 |
1/4 (25.00%)
|
1 |
1/5 (20.00%)
|
1 |
0/4 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
2/111 (1.80%)
|
2 |
6/110 (5.45%)
|
8 |
0/10 (0.00%)
|
0 |
0/13 (0.00%)
|
0 |
1/87 (1.15%)
|
1 |
0/75 (0.00%)
|
0 |
0/10 (0.00%)
|
0 |
0/11 (0.00%)
|
0 |
Depression |
0/4 (0.00%)
|
0 |
1/4 (25.00%)
|
1 |
0/5 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
6/111 (5.41%)
|
9 |
9/110 (8.18%)
|
10 |
1/10 (10.00%)
|
1 |
0/13 (0.00%)
|
0 |
6/87 (6.90%)
|
6 |
3/75 (4.00%)
|
3 |
0/10 (0.00%)
|
0 |
0/11 (0.00%)
|
0 |
Drug Abuse |
0/4 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/5 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/111 (0.00%)
|
0 |
0/110 (0.00%)
|
0 |
0/10 (0.00%)
|
0 |
0/13 (0.00%)
|
0 |
0/87 (0.00%)
|
0 |
0/75 (0.00%)
|
0 |
1/10 (10.00%)
|
1 |
0/11 (0.00%)
|
0 |
Hallucination |
0/4 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/5 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
1/3 (33.33%)
|
1 |
0/3 (0.00%)
|
0 |
3/111 (2.70%)
|
3 |
3/110 (2.73%)
|
3 |
0/10 (0.00%)
|
0 |
0/13 (0.00%)
|
0 |
2/87 (2.30%)
|
2 |
2/75 (2.67%)
|
2 |
0/10 (0.00%)
|
0 |
0/11 (0.00%)
|
0 |
Hallucination, Visual |
0/4 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
2/5 (40.00%)
|
3 |
0/4 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/111 (0.00%)
|
0 |
1/110 (0.91%)
|
1 |
0/10 (0.00%)
|
0 |
1/13 (7.69%)
|
1 |
1/87 (1.15%)
|
1 |
1/75 (1.33%)
|
1 |
1/10 (10.00%)
|
1 |
0/11 (0.00%)
|
0 |
Impulsive Behaviour |
0/4 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/5 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
2/111 (1.80%)
|
2 |
1/110 (0.91%)
|
1 |
0/10 (0.00%)
|
0 |
1/13 (7.69%)
|
1 |
0/87 (0.00%)
|
0 |
0/75 (0.00%)
|
0 |
0/10 (0.00%)
|
0 |
0/11 (0.00%)
|
0 |
Insomnia |
0/4 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/5 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
1/3 (33.33%)
|
2 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
6/111 (5.41%)
|
6 |
9/110 (8.18%)
|
10 |
0/10 (0.00%)
|
0 |
0/13 (0.00%)
|
0 |
5/87 (5.75%)
|
6 |
3/75 (4.00%)
|
3 |
1/10 (10.00%)
|
1 |
0/11 (0.00%)
|
0 |
Panic Attack |
0/4 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/5 (0.00%)
|
0 |
1/4 (25.00%)
|
1 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/111 (0.00%)
|
0 |
3/110 (2.73%)
|
3 |
0/10 (0.00%)
|
0 |
0/13 (0.00%)
|
0 |
0/87 (0.00%)
|
0 |
1/75 (1.33%)
|
1 |
0/10 (0.00%)
|
0 |
0/11 (0.00%)
|
0 |
Poor Quality Sleep |
0/4 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
1/5 (20.00%)
|
1 |
0/4 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
1/111 (0.90%)
|
2 |
1/110 (0.91%)
|
1 |
0/10 (0.00%)
|
0 |
1/13 (7.69%)
|
1 |
1/87 (1.15%)
|
1 |
1/75 (1.33%)
|
1 |
0/10 (0.00%)
|
0 |
0/11 (0.00%)
|
0 |
Rapid Eye Movement Sleep Behaviour Disorder |
0/4 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/5 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/111 (0.00%)
|
0 |
0/110 (0.00%)
|
0 |
0/10 (0.00%)
|
0 |
0/13 (0.00%)
|
0 |
0/87 (0.00%)
|
0 |
0/75 (0.00%)
|
0 |
1/10 (10.00%)
|
1 |
0/11 (0.00%)
|
0 |
Renal and urinary disorders |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dysuria |
0/4 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/5 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/111 (0.00%)
|
0 |
2/110 (1.82%)
|
2 |
0/10 (0.00%)
|
0 |
0/13 (0.00%)
|
0 |
0/87 (0.00%)
|
0 |
0/75 (0.00%)
|
0 |
0/10 (0.00%)
|
0 |
1/11 (9.09%)
|
1 |
Hypertonic Bladder |
0/4 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/5 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/111 (0.00%)
|
0 |
1/110 (0.91%)
|
1 |
0/10 (0.00%)
|
0 |
1/13 (7.69%)
|
1 |
0/87 (0.00%)
|
0 |
0/75 (0.00%)
|
0 |
0/10 (0.00%)
|
0 |
0/11 (0.00%)
|
0 |
Micturition Urgency |
0/4 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/5 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
1/3 (33.33%)
|
1 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
2/111 (1.80%)
|
2 |
3/110 (2.73%)
|
3 |
0/10 (0.00%)
|
0 |
0/13 (0.00%)
|
0 |
1/87 (1.15%)
|
1 |
1/75 (1.33%)
|
1 |
0/10 (0.00%)
|
0 |
0/11 (0.00%)
|
0 |
Nocturia |
0/4 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/5 (0.00%)
|
0 |
1/4 (25.00%)
|
1 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
1/111 (0.90%)
|
1 |
1/110 (0.91%)
|
1 |
0/10 (0.00%)
|
0 |
0/13 (0.00%)
|
0 |
0/87 (0.00%)
|
0 |
0/75 (0.00%)
|
0 |
0/10 (0.00%)
|
0 |
0/11 (0.00%)
|
0 |
Pollakiuria |
0/4 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/5 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
1/3 (33.33%)
|
1 |
1/111 (0.90%)
|
1 |
1/110 (0.91%)
|
1 |
0/10 (0.00%)
|
0 |
1/13 (7.69%)
|
1 |
0/87 (0.00%)
|
0 |
0/75 (0.00%)
|
0 |
0/10 (0.00%)
|
0 |
0/11 (0.00%)
|
0 |
Urinary Incontinence |
0/4 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/5 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
1/111 (0.90%)
|
1 |
0/110 (0.00%)
|
0 |
0/10 (0.00%)
|
0 |
0/13 (0.00%)
|
0 |
1/87 (1.15%)
|
1 |
1/75 (1.33%)
|
1 |
1/10 (10.00%)
|
1 |
0/11 (0.00%)
|
0 |
Reproductive system and breast disorders |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Ovarian Failure |
0/4 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/5 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/111 (0.00%)
|
0 |
0/110 (0.00%)
|
0 |
0/10 (0.00%)
|
0 |
0/13 (0.00%)
|
0 |
0/87 (0.00%)
|
0 |
0/75 (0.00%)
|
0 |
1/10 (10.00%)
|
1 |
0/11 (0.00%)
|
0 |
Uterine Haemorrhage |
0/4 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/5 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/111 (0.00%)
|
0 |
0/110 (0.00%)
|
0 |
0/10 (0.00%)
|
0 |
0/13 (0.00%)
|
0 |
0/87 (0.00%)
|
0 |
0/75 (0.00%)
|
0 |
1/10 (10.00%)
|
1 |
0/11 (0.00%)
|
0 |
Respiratory, thoracic and mediastinal disorders |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cough |
0/4 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/5 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
1/111 (0.90%)
|
1 |
10/110 (9.09%)
|
11 |
0/10 (0.00%)
|
0 |
1/13 (7.69%)
|
1 |
2/87 (2.30%)
|
3 |
0/75 (0.00%)
|
0 |
0/10 (0.00%)
|
0 |
1/11 (9.09%)
|
1 |
Dyspnoea |
0/4 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/5 (0.00%)
|
0 |
1/4 (25.00%)
|
1 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/111 (0.00%)
|
0 |
1/110 (0.91%)
|
1 |
0/10 (0.00%)
|
0 |
0/13 (0.00%)
|
0 |
1/87 (1.15%)
|
1 |
1/75 (1.33%)
|
1 |
0/10 (0.00%)
|
0 |
0/11 (0.00%)
|
0 |
Oropharyngeal Pain |
0/4 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/5 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
1/111 (0.90%)
|
1 |
1/110 (0.91%)
|
1 |
0/10 (0.00%)
|
0 |
0/13 (0.00%)
|
0 |
0/87 (0.00%)
|
0 |
0/75 (0.00%)
|
0 |
0/10 (0.00%)
|
0 |
1/11 (9.09%)
|
1 |
Sleep Apnoea Syndrome |
0/4 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/5 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
2/111 (1.80%)
|
2 |
0/110 (0.00%)
|
0 |
1/10 (10.00%)
|
1 |
0/13 (0.00%)
|
0 |
0/87 (0.00%)
|
0 |
0/75 (0.00%)
|
0 |
0/10 (0.00%)
|
0 |
0/11 (0.00%)
|
0 |
Tonsillar Cyst |
0/4 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/5 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/111 (0.00%)
|
0 |
0/110 (0.00%)
|
0 |
0/10 (0.00%)
|
0 |
1/13 (7.69%)
|
1 |
0/87 (0.00%)
|
0 |
0/75 (0.00%)
|
0 |
0/10 (0.00%)
|
0 |
0/11 (0.00%)
|
0 |
Skin and subcutaneous tissue disorders |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Eczema |
0/4 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/5 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
1/111 (0.90%)
|
1 |
0/110 (0.00%)
|
0 |
0/10 (0.00%)
|
0 |
1/13 (7.69%)
|
1 |
0/87 (0.00%)
|
0 |
0/75 (0.00%)
|
0 |
0/10 (0.00%)
|
0 |
0/11 (0.00%)
|
0 |
Rash |
0/4 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/5 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
2/111 (1.80%)
|
2 |
2/110 (1.82%)
|
3 |
1/10 (10.00%)
|
1 |
0/13 (0.00%)
|
0 |
0/87 (0.00%)
|
0 |
2/75 (2.67%)
|
2 |
0/10 (0.00%)
|
0 |
0/11 (0.00%)
|
0 |
Rash Papular |
0/4 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/5 (0.00%)
|
0 |
1/4 (25.00%)
|
1 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/111 (0.00%)
|
0 |
0/110 (0.00%)
|
0 |
0/10 (0.00%)
|
0 |
0/13 (0.00%)
|
0 |
0/87 (0.00%)
|
0 |
0/75 (0.00%)
|
0 |
0/10 (0.00%)
|
0 |
0/11 (0.00%)
|
0 |
Skin Ulcer |
0/4 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/5 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/111 (0.00%)
|
0 |
0/110 (0.00%)
|
0 |
0/10 (0.00%)
|
0 |
1/13 (7.69%)
|
1 |
0/87 (0.00%)
|
0 |
0/75 (0.00%)
|
0 |
0/10 (0.00%)
|
0 |
0/11 (0.00%)
|
0 |
Urticaria |
0/4 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/5 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
1/3 (33.33%)
|
1 |
0/3 (0.00%)
|
0 |
0/111 (0.00%)
|
0 |
0/110 (0.00%)
|
0 |
0/10 (0.00%)
|
0 |
0/13 (0.00%)
|
0 |
0/87 (0.00%)
|
0 |
0/75 (0.00%)
|
0 |
0/10 (0.00%)
|
0 |
0/11 (0.00%)
|
0 |
Vascular disorders |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Hypertension |
0/4 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/5 (0.00%)
|
0 |
1/4 (25.00%)
|
1 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
4/111 (3.60%)
|
5 |
3/110 (2.73%)
|
3 |
0/10 (0.00%)
|
0 |
1/13 (7.69%)
|
1 |
3/87 (3.45%)
|
3 |
0/75 (0.00%)
|
0 |
1/10 (10.00%)
|
1 |
0/11 (0.00%)
|
0 |
Orthostatic Hypotension |
0/4 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/5 (0.00%)
|
0 |
0/4 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
0/3 (0.00%)
|
0 |
3/111 (2.70%)
|
3 |
3/110 (2.73%)
|
3 |
0/10 (0.00%)
|
0 |
1/13 (7.69%)
|
1 |
2/87 (2.30%)
|
2 |
0/75 (0.00%)
|
0 |
0/10 (0.00%)
|
0 |
0/11 (0.00%)
|
0 |
Term from vocabulary, MedDRA24.0
Indicates events were collected by systematic assessment
|