Trial Outcomes & Findings for Randomized, Controlled Study of IFX-1 in Patients With Severe COVID-19 Pneumonia (NCT NCT04333420)
NCT ID: NCT04333420
Last Updated: 2023-06-05
Results Overview
Relative change (%) from baseline in Oxygenation Index (OI; partial pressure of oxygen in the arterial blood (PaO2) / fractional inspired oxygen (FiO2)) in supine position for ≥2 hours at day 5 (FAS)
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
399 participants
Primary outcome timeframe
Baseline and Day 5
Results posted on
2023-06-05
Participant Flow
Participant milestones
| Measure |
Phase II: IFX-1 + BSC
Phase II study part: IFX-1: 800mg intravenously administered, BSC: Best supportive care
|
Phase II: BSC
Phase II study part: BSC: Best supportive care
|
Phase III: IFX-1 + SOC
Phase III study part: IFX-1: 800mg intravenously administered, SOC: Standard of care
|
Phase III: Placebo + SOC
Phase III study part: Placebo: placebo infusion intravenously administered, SOC: Standard of care
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
15
|
15
|
178
|
191
|
|
Overall Study
Contributed to Full Analysis Set (FAS)
|
15
|
15
|
177
|
191
|
|
Overall Study
Contributed to Safety Analysis Set (SAF)
|
15
|
15
|
175
|
189
|
|
Overall Study
COMPLETED
|
13
|
11
|
103
|
93
|
|
Overall Study
NOT COMPLETED
|
2
|
4
|
75
|
98
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Randomized, Controlled Study of IFX-1 in Patients With Severe COVID-19 Pneumonia
Baseline characteristics by cohort
| Measure |
Phase II: IFX-1 + BSC
n=15 Participants
Phase II study part: IFX-1: 800mg intravenously administered, BSC: Best supportive care
|
Phase II: BSC
n=15 Participants
Phase II study part: BSC: Best supportive care
|
Phase III: IFX-1 + SOC
n=177 Participants
Phase III study part: IFX-1: 800mg intravenously administered, SOC: Standard of care
|
Phase III: Placebo + SOC
n=191 Participants
Phase III study part: Placebo: placebo infusion intravenously administered, SOC: Standard of care
|
Total
n=398 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
57.5 years
STANDARD_DEVIATION 8.6 • n=5 Participants
|
62.8 years
STANDARD_DEVIATION 8.1 • n=7 Participants
|
56.7 years
STANDARD_DEVIATION 13.2 • n=5 Participants
|
55.9 years
STANDARD_DEVIATION 14.5 • n=4 Participants
|
56.6 years
STANDARD_DEVIATION 13.6 • n=21 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
64 Participants
n=4 Participants
|
124 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
125 Participants
n=5 Participants
|
127 Participants
n=4 Participants
|
274 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
8 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
115 Participants
n=5 Participants
|
119 Participants
n=4 Participants
|
253 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
16 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Race · Black or African American
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
17 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Race · American Indian or Alaskan Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
46 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Race · 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
|
|
Race/Ethnicity, Customized
Race · Multiple
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
35 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Race · Not reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
30 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
68 Participants
n=4 Participants
|
128 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Not Hispanic or Latino
|
15 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
73 Participants
n=4 Participants
|
173 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
35 Participants
n=4 Participants
|
63 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Unknown
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
22 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Missing
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
|
Intubation status
No
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
|
Intubation status
Yes
|
8 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
177 Participants
n=5 Participants
|
191 Participants
n=4 Participants
|
386 Participants
n=21 Participants
|
|
Oxygenation index
|
137.9 index
STANDARD_DEVIATION 51.1 • n=5 Participants
|
144.2 index
STANDARD_DEVIATION 41.5 • n=7 Participants
|
131.9 index
STANDARD_DEVIATION 39.2 • n=5 Participants
|
130.6 index
STANDARD_DEVIATION 44.8 • n=4 Participants
|
131.9 index
STANDARD_DEVIATION 42.5 • n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline and Day 5Population: Full Analysis Set (FAS) including all randomized patients according to intention-to-treat principle.
Relative change (%) from baseline in Oxygenation Index (OI; partial pressure of oxygen in the arterial blood (PaO2) / fractional inspired oxygen (FiO2)) in supine position for ≥2 hours at day 5 (FAS)
Outcome measures
| Measure |
Phase II: IFX-1 + BSC
n=15 Participants
Phase II study part: IFX-1: 800mg intravenously administered, BSC: Best supportive care
|
Phase II: BSC
n=15 Participants
Phase II study part: BSC: Best supportive care
|
|---|---|---|
|
Phase II: Relative Change From Baseline in Oxygenation Index in Supine Position at Day 5 (FAS)
|
15.5 percentage of change
Interval -11.4 to 42.4
|
31.9 percentage of change
Interval 6.0 to 57.9
|
PRIMARY outcome
Timeframe: Day 28Population: Full Analysis Set (FAS) including all randomized patients according to intention-to-treat principle except for patients who were randomized in error AND did not receive IMP.
Number and percentage of deaths (all-cause) until Day 28 (FAS)
Outcome measures
| Measure |
Phase II: IFX-1 + BSC
n=177 Participants
Phase II study part: IFX-1: 800mg intravenously administered, BSC: Best supportive care
|
Phase II: BSC
n=191 Participants
Phase II study part: BSC: Best supportive care
|
|---|---|---|
|
Phase III: 28-day All-cause Mortality (FAS)
Dead
|
54 Participants
|
77 Participants
|
|
Phase III: 28-day All-cause Mortality (FAS)
Alive
|
115 Participants
|
105 Participants
|
|
Phase III: 28-day All-cause Mortality (FAS)
Missing
|
8 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: Day 28Population: Full Analysis Set (FAS) including all randomized patients according to intention-to-treat principle.
Number and percentage of deaths (all-cause) until Day 28 (FAS)
Outcome measures
| Measure |
Phase II: IFX-1 + BSC
n=15 Participants
Phase II study part: IFX-1: 800mg intravenously administered, BSC: Best supportive care
|
Phase II: BSC
n=15 Participants
Phase II study part: BSC: Best supportive care
|
|---|---|---|
|
Phase II: All-cause 28-day Mortality (FAS)
|
2 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Day 7Population: The analysis of early response as planned in the protocol was not performed because the necessary data were not collected.
Number of patients (%) achieving an early response at day 7 after enrollment (FAS)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline until Day 28Population: The analysis of late response as planned in the protocol was not performed because the necessary data were not collected.
Number of patients (%) reaching a late response until day 28 (FAS)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Day 3, Day 7, Day 9, Day 11, Day 15Population: Full Analysis Set (FAS) including all randomized patients according to intention-to-treat principle.
Relative change (%) from baseline in Oxygenation Index (OI) in supine position for ≥2 hours at days 3, 7, 9, 11, and 15 (FAS)
Outcome measures
| Measure |
Phase II: IFX-1 + BSC
n=15 Participants
Phase II study part: IFX-1: 800mg intravenously administered, BSC: Best supportive care
|
Phase II: BSC
n=15 Participants
Phase II study part: BSC: Best supportive care
|
|---|---|---|
|
Phase II: Relative Change From Baseline in Oxygenation Index in Supine Position (FAS)
Day 3
|
7.1 percentage of change
Interval -10.3 to 24.4
|
17.6 percentage of change
Interval 0.8 to 34.4
|
|
Phase II: Relative Change From Baseline in Oxygenation Index in Supine Position (FAS)
Day 7
|
13.1 percentage of change
Interval -23.4 to 49.6
|
36.0 percentage of change
Interval 0.8 to 71.2
|
|
Phase II: Relative Change From Baseline in Oxygenation Index in Supine Position (FAS)
Day 9
|
20.7 percentage of change
Interval -15.5 to 56.9
|
27.8 percentage of change
Interval -7.2 to 62.8
|
|
Phase II: Relative Change From Baseline in Oxygenation Index in Supine Position (FAS)
Day 11
|
45.5 percentage of change
Interval 2.1 to 88.9
|
43.5 percentage of change
Interval 1.7 to 85.4
|
|
Phase II: Relative Change From Baseline in Oxygenation Index in Supine Position (FAS)
Day 15
|
78.5 percentage of change
Interval 19.1 to 138.0
|
82.6 percentage of change
Interval 25.2 to 140.0
|
SECONDARY outcome
Timeframe: Day 60Population: Full Analysis Set (FAS) including all randomized patients according to intention-to-treat principle except for patients who were randomized in error AND did not receive IMP.
Number and percentage of deaths (all-cause) until Day 60 (FAS)
Outcome measures
| Measure |
Phase II: IFX-1 + BSC
n=177 Participants
Phase II study part: IFX-1: 800mg intravenously administered, BSC: Best supportive care
|
Phase II: BSC
n=191 Participants
Phase II study part: BSC: Best supportive care
|
|---|---|---|
|
Phase III: 60-day All-cause Mortality (FAS)
Dead
|
62 Participants
|
87 Participants
|
|
Phase III: 60-day All-cause Mortality (FAS)
Alive
|
102 Participants
|
93 Participants
|
|
Phase III: 60-day All-cause Mortality (FAS)
Missing
|
13 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: Day 15, Day 28Population: Full Analysis Set (FAS) including all randomized patients according to intention-to-treat principle except for patients who were randomized in error AND did not receive IMP.
Percentage of patients with an improvement in the 8-point ordinal scale (Day 15, Day 28), the scale ranges from 0 = 'No clinical or virological evidence of infection' to 8 = 'Death' with higher scores meaning greater limitation and ventilation/organ support
Outcome measures
| Measure |
Phase II: IFX-1 + BSC
n=177 Participants
Phase II study part: IFX-1: 800mg intravenously administered, BSC: Best supportive care
|
Phase II: BSC
n=191 Participants
Phase II study part: BSC: Best supportive care
|
|---|---|---|
|
Phase III: Percentage of Patients With an Improvement in the 8-point Ordinal Scale (FAS)
Improved
|
82 Participants
|
77 Participants
|
|
Phase III: Percentage of Patients With an Improvement in the 8-point Ordinal Scale (FAS)
Not improved
|
86 Participants
|
104 Participants
|
|
Phase III: Percentage of Patients With an Improvement in the 8-point Ordinal Scale (FAS)
Not evaluable
|
9 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: Day 28Population: Full Analysis Set (FAS) including all randomized patients according to intention-to-treat principle except for patients who were randomized in error AND did not receive IMP.
Percentage of patients developing acute kidney failure (estimated glomerular filtration rate \[eGFR\] \< 15 mL/min/1.73m², assessed by the Chronic Kidney Disease Epidemiology Collaboration \[CKD-EPI\] equation requiring race information) until Day 28 (FAS)
Outcome measures
| Measure |
Phase II: IFX-1 + BSC
n=177 Participants
Phase II study part: IFX-1: 800mg intravenously administered, BSC: Best supportive care
|
Phase II: BSC
n=191 Participants
Phase II study part: BSC: Best supportive care
|
|---|---|---|
|
Phase III: Percentage of Patients Developing Acute Kidney Failure Until Day 28 (FAS)
Acute kidney failure
|
8 Participants
|
12 Participants
|
|
Phase III: Percentage of Patients Developing Acute Kidney Failure Until Day 28 (FAS)
No acute kidney failure
|
158 Participants
|
168 Participants
|
|
Phase III: Percentage of Patients Developing Acute Kidney Failure Until Day 28 (FAS)
Not evaluable
|
11 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: Day 28Population: Full Analysis Set (FAS) including all randomized patients according to intention-to-treat principle except for patients who were randomized in error AND did not receive IMP.
Percentage of patients free of any renal replacement therapy (RRT) within 28 days upon randomization (FAS), number of patients free of any RRT = number of patients - number of patients with RRT initiated after randomization until Day 28
Outcome measures
| Measure |
Phase II: IFX-1 + BSC
n=177 Participants
Phase II study part: IFX-1: 800mg intravenously administered, BSC: Best supportive care
|
Phase II: BSC
n=191 Participants
Phase II study part: BSC: Best supportive care
|
|---|---|---|
|
Phase III: Percentage of Patients Free of Any Renal Replacement Therapy Within 28 Days Upon Randomization (FAS)
|
160 Participants
|
161 Participants
|
Adverse Events
Phase II: IFX-1 + BSC
Serious events: 9 serious events
Other events: 14 other events
Deaths: 2 deaths
Phase II: BSC
Serious events: 7 serious events
Other events: 14 other events
Deaths: 4 deaths
Phase III: IFX-1 + SOC
Serious events: 103 serious events
Other events: 147 other events
Deaths: 62 deaths
Phase III: Placebo + SOC
Serious events: 122 serious events
Other events: 154 other events
Deaths: 86 deaths
Phase III: Randomized Non-treated Patients
Serious events: 2 serious events
Other events: 0 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Phase II: IFX-1 + BSC
n=15 participants at risk
Phase II study part: IFX-1: 800mg intravenously administered, BSC: Best supportive care
|
Phase II: BSC
n=15 participants at risk
Phase II study part: BSC: Best supportive care
|
Phase III: IFX-1 + SOC
n=175 participants at risk
Phase III study part: IFX-1: 800mg intravenously administered, SOC: Standard of care; with at least one IMP administration;
|
Phase III: Placebo + SOC
n=189 participants at risk
Phase III study part: Placebo: placebo infusion intravenously administered, SOC: Standard of care; with at least one IMP administration;
|
Phase III: Randomized Non-treated Patients
n=5 participants at risk
Phase III study part: patients who were randomized but never treated.
|
|---|---|---|---|---|---|
|
Infections and infestations
Providencia infection
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.57%
1/175 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/189 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Infections and infestations
Pseudomonal bacteraemia
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/175 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.53%
1/189 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Infections and infestations
Severe acute respiratory syndrome
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.57%
1/175 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/189 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/175 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.53%
1/189 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Infections and infestations
Stenotrophomonas sepsis
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/175 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.53%
1/189 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Infections and infestations
Pneumonia
|
6.7%
1/15 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
20.0%
3/15 • Number of events 3 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
12.0%
21/175 • Number of events 29 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
8.5%
16/189 • Number of events 18 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Infections and infestations
Device related sepsis
|
6.7%
1/15 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.57%
1/175 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/189 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Infections and infestations
Pseudomonas infection
|
6.7%
1/15 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.57%
1/175 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.53%
1/189 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Infections and infestations
Sepsis
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
6.7%
1/15 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
2.9%
5/175 • Number of events 5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.53%
1/189 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Infections and infestations
Staphylococcal infection
|
6.7%
1/15 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
2.3%
4/175 • Number of events 4 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
2.6%
5/189 • Number of events 5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Infections and infestations
Urinary tract infection
|
6.7%
1/15 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
3.4%
6/175 • Number of events 8 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
1.6%
3/189 • Number of events 3 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Infections and infestations
Vascular device infection
|
6.7%
1/15 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.57%
1/175 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
1.1%
2/189 • Number of events 2 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Infections and infestations
Septic shock
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
13.7%
24/175 • Number of events 29 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
15.9%
30/189 • Number of events 34 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Infections and infestations
Pulmonary sepsis
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
8.0%
14/175 • Number of events 21 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
5.8%
11/189 • Number of events 14 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Infections and infestations
Klebsiella infection
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
2.3%
4/175 • Number of events 4 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
4.8%
9/189 • Number of events 9 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Infections and infestations
Pneumonia staphylococcal
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
5.7%
10/175 • Number of events 11 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
1.6%
3/189 • Number of events 3 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Infections and infestations
Bronchopulmonary aspergillosis
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
3.4%
6/175 • Number of events 6 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
3.7%
7/189 • Number of events 7 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Infections and infestations
Pneumonia klebsiella
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
3.4%
6/175 • Number of events 6 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
2.1%
4/189 • Number of events 5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Infections and infestations
Acinetobacter infection
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
2.3%
4/175 • Number of events 4 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
2.1%
4/189 • Number of events 4 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Infections and infestations
Pneumonia acinetobacter
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
2.9%
5/175 • Number of events 5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
1.6%
3/189 • Number of events 3 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Infections and infestations
Pneumonia pseudomonal
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
1.7%
3/175 • Number of events 3 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
1.6%
3/189 • Number of events 4 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Infections and infestations
Staphylococcal sepsis
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
2.9%
5/175 • Number of events 7 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.53%
1/189 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Infections and infestations
Enterococcal sepsis
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
2.3%
4/175 • Number of events 4 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.53%
1/189 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Infections and infestations
Urosepsis
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
1.7%
3/175 • Number of events 3 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
1.1%
2/189 • Number of events 2 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Infections and infestations
Aspergillus infection
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
1.1%
2/175 • Number of events 2 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
1.6%
3/189 • Number of events 3 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Infections and infestations
Tracheobronchitis
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
1.1%
2/175 • Number of events 2 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
1.1%
2/189 • Number of events 2 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Infections and infestations
Device related bacteraemia
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
1.1%
2/175 • Number of events 2 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.53%
1/189 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Infections and infestations
Enterococcal infection
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
1.1%
2/175 • Number of events 2 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.53%
1/189 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Infections and infestations
Herpes simplex pneumonia
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/175 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
1.6%
3/189 • Number of events 3 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Infections and infestations
Pneumonia escherichia
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
1.1%
2/175 • Number of events 3 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.53%
1/189 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Infections and infestations
Pseudomonal sepsis
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
1.1%
2/175 • Number of events 2 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.53%
1/189 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Infections and infestations
Stenotrophomonas infection
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
1.1%
2/175 • Number of events 2 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.53%
1/189 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Infections and infestations
Urinary tract infection enterococcal
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/175 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
1.6%
3/189 • Number of events 3 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Infections and infestations
Acinetobacter sepsis
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
1.1%
2/175 • Number of events 2 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/189 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Infections and infestations
COVID-19 pneumonia
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
1.1%
2/175 • Number of events 2 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/189 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Infections and infestations
Citrobacter infection
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.57%
1/175 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.53%
1/189 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Infections and infestations
Enterobacter pneumonia
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.57%
1/175 • Number of events 2 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.53%
1/189 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Infections and infestations
Enterococcal bacteraemia
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/175 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
1.1%
2/189 • Number of events 2 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Infections and infestations
Escherichia infection
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.57%
1/175 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.53%
1/189 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.57%
1/175 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.53%
1/189 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Infections and infestations
Klebsiella sepsis
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.57%
1/175 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.53%
1/189 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Infections and infestations
Lung abscess
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
1.1%
2/175 • Number of events 2 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/189 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Infections and infestations
Nosocomial infection
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.57%
1/175 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.53%
1/189 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Infections and infestations
Pneumonia aspiration
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.57%
1/175 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.53%
1/189 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.57%
1/175 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.53%
1/189 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Infections and infestations
Pneumonia cytomegaloviral
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.57%
1/175 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.53%
1/189 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Infections and infestations
Pneumonia serratia
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.57%
1/175 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.53%
1/189 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Infections and infestations
Superinfection bacterial
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.57%
1/175 • Number of events 2 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.53%
1/189 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Infections and infestations
Tracheobronchitis bacterial
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/175 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
1.1%
2/189 • Number of events 2 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/175 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.53%
1/189 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Infections and infestations
Bacterial infection
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/175 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
1.1%
2/189 • Number of events 2 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.57%
1/175 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/189 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Infections and infestations
Candida sepsis
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.57%
1/175 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/189 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Infections and infestations
Cholangitis infective
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/175 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.53%
1/189 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Infections and infestations
Corynebacterium sepsis
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/175 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.53%
1/189 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Infections and infestations
Device related infection
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/175 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.53%
1/189 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Infections and infestations
Empyema
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.57%
1/175 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/189 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Infections and infestations
Enterobacter infection
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.57%
1/175 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/189 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Infections and infestations
Enterobacter sepsis
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/175 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.53%
1/189 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Infections and infestations
Enterobacter tracheobronchitis
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.57%
1/175 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/189 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Infections and infestations
Epstein-Barr virus infection
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/175 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.53%
1/189 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Infections and infestations
Herpes simplex reactivation
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/175 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.53%
1/189 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Infections and infestations
Infectious pleural effusion
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/175 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.53%
1/189 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Infections and infestations
Klebsiella bacteraemia
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.57%
1/175 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/189 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Infections and infestations
Liver abscess
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/175 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.53%
1/189 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Infections and infestations
Morganella infection
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/175 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.53%
1/189 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Infections and infestations
Peritonitis
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/175 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.53%
1/189 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Infections and infestations
Pneumonia haemophilus
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/175 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.53%
1/189 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Infections and infestations
Pneumonia streptococcal
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.57%
1/175 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/189 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Infections and infestations
Streptococcal sepsis
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/175 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.53%
1/189 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Infections and infestations
Systemic candida
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.57%
1/175 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/189 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Infections and infestations
Urinary tract infection pseudomonal
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.57%
1/175 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/189 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
13.3%
2/15 • Number of events 2 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
40.0%
6/15 • Number of events 6 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
6.9%
12/175 • Number of events 12 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
7.4%
14/189 • Number of events 14 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
13.3%
2/15 • Number of events 2 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
6.7%
1/15 • Number of events 2 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
11.4%
20/175 • Number of events 23 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
12.7%
24/189 • Number of events 25 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
13.3%
2/15 • Number of events 2 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
2.9%
5/175 • Number of events 5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
1.6%
3/189 • Number of events 3 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
6.7%
1/15 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/175 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/189 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
2.3%
4/175 • Number of events 4 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
3.7%
7/189 • Number of events 8 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
2.3%
4/175 • Number of events 4 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
1.6%
3/189 • Number of events 4 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal oedema
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.57%
1/175 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
1.1%
2/189 • Number of events 2 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumomediastinum
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
1.7%
3/175 • Number of events 3 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/189 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
1.1%
2/175 • Number of events 2 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/189 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.57%
1/175 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.53%
1/189 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/175 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
1.1%
2/189 • Number of events 2 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/175 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.53%
1/189 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Anoxia
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/175 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.53%
1/189 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial obstruction
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.57%
1/175 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/189 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopleural fistula
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.57%
1/175 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/189 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.57%
1/175 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/189 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.57%
1/175 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/189 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Hypercapnia
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.57%
1/175 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/189 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Lung opacity
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/175 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.53%
1/189 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Mediastinal shift
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.57%
1/175 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/189 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Organising pneumonia
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/175 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.53%
1/189 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/175 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.53%
1/189 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/175 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.53%
1/189 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/175 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.53%
1/189 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary infarction
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.57%
1/175 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/189 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary necrosis
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.57%
1/175 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/189 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Sputum retention
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.57%
1/175 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/189 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
6.7%
1/15 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
9.1%
16/175 • Number of events 16 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
16.4%
31/189 • Number of events 32 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
6.7%
1/15 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
1.7%
3/175 • Number of events 3 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
1.1%
2/189 • Number of events 2 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
1.1%
2/175 • Number of events 2 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
1.1%
2/189 • Number of events 2 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Renal and urinary disorders
Anuria
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.57%
1/175 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/189 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Renal and urinary disorders
Oliguria
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/175 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.53%
1/189 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
26.7%
4/15 • Number of events 4 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
9.1%
16/175 • Number of events 16 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
11.1%
21/189 • Number of events 21 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
General disorders
Hyperthermia
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
1.1%
2/175 • Number of events 2 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/189 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
General disorders
Fibrosis
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.57%
1/175 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/189 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
General disorders
Medical device site haemorrhage
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.57%
1/175 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/189 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
General disorders
Oedema peripheral
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.57%
1/175 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/189 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
2.9%
5/175 • Number of events 5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
1.1%
2/189 • Number of events 2 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.57%
1/175 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
2.6%
5/189 • Number of events 7 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/175 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
1.6%
3/189 • Number of events 3 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.57%
1/175 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.53%
1/189 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Cardiac disorders
Cardiogenic shock
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/175 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
1.6%
3/189 • Number of events 3 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/175 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
1.1%
2/189 • Number of events 2 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/175 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.53%
1/189 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.57%
1/175 • Number of events 3 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/189 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Cardiac disorders
Atrioventricular block
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.57%
1/175 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/189 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Cardiac disorders
Atrioventricular block complete
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/175 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.53%
1/189 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/175 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.53%
1/189 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Cardiac disorders
Cardiac failure acute
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.57%
1/175 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/189 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
20.0%
1/5 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Cardiac disorders
Cardiac perforation
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/175 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.53%
1/189 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Cardiac disorders
Cardiomyopathy
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/175 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.53%
1/189 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Cardiac disorders
Cardiopulmonary failure
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.57%
1/175 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/189 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.57%
1/175 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/189 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.57%
1/175 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/189 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Cardiac disorders
Ventricular arrhythmia
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/175 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.53%
1/189 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.57%
1/175 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/189 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Cardiac disorders
Ventricular fibrillation
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/175 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.53%
1/189 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Nervous system disorders
Epilepsy
|
6.7%
1/15 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/175 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/189 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Nervous system disorders
Ischaemic cerebral infarction
|
6.7%
1/15 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/175 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/189 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Nervous system disorders
Depressed level of consciousness
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
2.3%
4/175 • Number of events 4 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
2.1%
4/189 • Number of events 4 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
1.1%
2/175 • Number of events 2 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.53%
1/189 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Nervous system disorders
Autonomic nervous system imbalance
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
1.1%
2/175 • Number of events 2 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/189 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.57%
1/175 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.53%
1/189 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Nervous system disorders
Haemorrhagic cerebral infarction
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/175 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.53%
1/189 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Nervous system disorders
Seizure
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/175 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.53%
1/189 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Nervous system disorders
Stroke in evolution
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.57%
1/175 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/189 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/175 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.53%
1/189 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Nervous system disorders
Toxic encephalopathy
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.57%
1/175 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/189 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.57%
1/175 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/189 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Vascular disorders
Peripheral artery thrombosis
|
6.7%
1/15 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/175 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/189 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Vascular disorders
Shock haemorrhagic
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
1.7%
3/175 • Number of events 3 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.53%
1/189 • Number of events 2 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Vascular disorders
Distributive shock
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
1.1%
2/175 • Number of events 2 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.53%
1/189 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.57%
1/175 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.53%
1/189 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Vascular disorders
Jugular vein thrombosis
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.57%
1/175 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.53%
1/189 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Vascular disorders
Thrombosis
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
1.1%
2/175 • Number of events 2 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/189 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Vascular disorders
Circulatory collapse
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.57%
1/175 • Number of events 2 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/189 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Vascular disorders
Hypertensive crisis
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.57%
1/175 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/189 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Vascular disorders
Obstructive shock
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.57%
1/175 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.53%
1/189 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Vascular disorders
Shock
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/175 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.53%
1/189 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Hepatobiliary disorders
Liver injury
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
1.1%
2/175 • Number of events 2 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
1.1%
2/189 • Number of events 2 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Hepatobiliary disorders
Acute hepatic failure
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.57%
1/175 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.53%
1/189 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/175 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
1.1%
2/189 • Number of events 2 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Hepatobiliary disorders
Ischaemic hepatitis
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/175 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
1.1%
2/189 • Number of events 2 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Hepatobiliary disorders
Cholangitis sclerosing
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/175 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.53%
1/189 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Hepatobiliary disorders
Drug-induced liver injury
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.57%
1/175 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/189 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.57%
1/175 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/189 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Hepatobiliary disorders
Hepatic infarction
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/175 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.53%
1/189 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Gastrointestinal disorders
Dysphagia
|
6.7%
1/15 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/175 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/189 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Gastrointestinal disorders
Salivary hypersecretion
|
6.7%
1/15 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/175 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/189 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Gastrointestinal disorders
Intra-abdominal haemorrhage
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.57%
1/175 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.53%
1/189 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.57%
1/175 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.53%
1/189 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Gastrointestinal disorders
Diverticulum intestinal haemorrhagic
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/175 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.53%
1/189 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Gastrointestinal disorders
Duodenal ulcer haemorrhage
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.57%
1/175 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/189 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.57%
1/175 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/189 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Gastrointestinal disorders
Gastrointestinal necrosis
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/175 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.53%
1/189 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Gastrointestinal disorders
Intestinal ischaemia
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/175 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.53%
1/189 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Gastrointestinal disorders
Mouth haemorrhage
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.57%
1/175 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/189 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.57%
1/175 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/189 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Gastrointestinal disorders
Pancreatitis necrotising
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.57%
1/175 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/189 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/175 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.53%
1/189 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Investigations
End-tidal CO2 increased
|
6.7%
1/15 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/175 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/189 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Investigations
Oxygen saturation decreased
|
6.7%
1/15 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/175 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/189 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Investigations
Staphylococcus test positive
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
6.7%
1/15 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/175 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/189 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Investigations
Bronchoalveolar lavage abnormal
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
1.1%
2/175 • Number of events 4 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.53%
1/189 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Investigations
Aspergillus test positive
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.57%
1/175 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.53%
1/189 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Investigations
Herpes simplex test positive
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
1.1%
2/175 • Number of events 2 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/189 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Investigations
Blood culture positive
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/175 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.53%
1/189 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Investigations
Glutamate dehydrogenase increased
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/175 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.53%
1/189 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Investigations
Hepatic enzyme abnormal
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.57%
1/175 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/189 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/175 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.53%
1/189 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Investigations
Klebsiella test positive
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.57%
1/175 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/189 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Investigations
Sputum culture positive
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.57%
1/175 • Number of events 2 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/189 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Investigations
Transaminases increased
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.57%
1/175 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/189 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.57%
1/175 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.53%
1/189 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
1.1%
2/175 • Number of events 2 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/189 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Blood and lymphatic system disorders
Heparin-induced thrombocytopenia
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/175 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.53%
1/189 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Blood and lymphatic system disorders
Splenic infarction
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/175 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.53%
1/189 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/175 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
1.1%
2/189 • Number of events 3 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Metabolism and nutrition disorders
Acid-base balance disorder mixed
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/175 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.53%
1/189 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Metabolism and nutrition disorders
Acidosis
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/175 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.53%
1/189 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Metabolism and nutrition disorders
Hyperglycaemic hyperosmolar nonketotic syndrome
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/175 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.53%
1/189 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/175 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.53%
1/189 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Injury, poisoning and procedural complications
Endotracheal intubation complication
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.57%
1/175 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.53%
1/189 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.57%
1/175 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/189 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.57%
1/175 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/189 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Skin and subcutaneous tissue disorders
Subcutaneous emphysema
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.57%
1/175 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.53%
1/189 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Musculoskeletal and connective tissue disorders
Muscle haemorrhage
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/175 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.53%
1/189 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Product Issues
Device leakage
|
6.7%
1/15 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/175 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/189 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Product Issues
Device dislocation
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/175 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.53%
1/189 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Psychiatric disorders
Delirium
|
13.3%
2/15 • Number of events 2 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/175 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/189 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Psychiatric disorders
Agitation
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.57%
1/175 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/189 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Infections and infestations
Pneumococcal sepsis
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/175 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.53%
1/189 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Blood and lymphatic system disorders
Coagulopathy
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/175 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.53%
1/189 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Cardiac disorders
Right ventricular failure
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/175 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.53%
1/189 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Injury, poisoning and procedural complications
Overdose
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/175 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.53%
1/189 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Vascular disorders
Hypertensive emergency
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/175 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/189 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
20.0%
1/5 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
Other adverse events
| Measure |
Phase II: IFX-1 + BSC
n=15 participants at risk
Phase II study part: IFX-1: 800mg intravenously administered, BSC: Best supportive care
|
Phase II: BSC
n=15 participants at risk
Phase II study part: BSC: Best supportive care
|
Phase III: IFX-1 + SOC
n=175 participants at risk
Phase III study part: IFX-1: 800mg intravenously administered, SOC: Standard of care; with at least one IMP administration;
|
Phase III: Placebo + SOC
n=189 participants at risk
Phase III study part: Placebo: placebo infusion intravenously administered, SOC: Standard of care; with at least one IMP administration;
|
Phase III: Randomized Non-treated Patients
n=5 participants at risk
Phase III study part: patients who were randomized but never treated.
|
|---|---|---|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
6.7%
1/15 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
6.7%
1/15 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
7.4%
13/175 • Number of events 13 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
10.6%
20/189 • Number of events 20 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Nervous system disorders
Hypoaesthesia
|
6.7%
1/15 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/175 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/189 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
6.7%
1/15 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.57%
1/175 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/189 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Infections and infestations
Enterococcal infection
|
6.7%
1/15 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
4.6%
8/175 • Number of events 9 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
3.7%
7/189 • Number of events 7 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
General disorders
Pyrexia
|
20.0%
3/15 • Number of events 4 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
6.7%
1/15 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
8.6%
15/175 • Number of events 18 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
9.0%
17/189 • Number of events 31 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
General disorders
Chest discomfort
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
6.7%
1/15 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/175 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/189 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
General disorders
Chills
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
6.7%
1/15 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/175 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/189 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
General disorders
Face oedema
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
6.7%
1/15 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
1.1%
2/175 • Number of events 2 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/189 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Infections and infestations
Pneumonia
|
6.7%
1/15 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
13.3%
2/15 • Number of events 2 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
12.6%
22/175 • Number of events 27 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
6.3%
12/189 • Number of events 16 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Infections and infestations
Aspergillus infection
|
6.7%
1/15 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.57%
1/175 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/189 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Infections and infestations
Bronchopulmonary aspergillosis
|
6.7%
1/15 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
2.9%
5/175 • Number of events 5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.53%
1/189 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Infections and infestations
Fungal infection
|
6.7%
1/15 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.57%
1/175 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.53%
1/189 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Infections and infestations
Staphylococcal infection
|
6.7%
1/15 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
2.9%
5/175 • Number of events 7 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
5.8%
11/189 • Number of events 13 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Infections and infestations
Vascular device infection
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
4.0%
7/175 • Number of events 8 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
5.8%
11/189 • Number of events 12 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Infections and infestations
Herpes simplex
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
6.3%
11/175 • Number of events 11 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
2.6%
5/189 • Number of events 5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Vascular disorders
Deep vein thrombosis
|
20.0%
3/15 • Number of events 3 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
20.0%
3/15 • Number of events 3 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
6.3%
11/175 • Number of events 11 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
4.2%
8/189 • Number of events 8 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Vascular disorders
Hypertension
|
13.3%
2/15 • Number of events 2 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
13.3%
2/15 • Number of events 2 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
9.7%
17/175 • Number of events 18 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
6.9%
13/189 • Number of events 13 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Vascular disorders
Phlebitis
|
13.3%
2/15 • Number of events 2 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
6.7%
1/15 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
2.3%
4/175 • Number of events 4 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.53%
1/189 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Vascular disorders
Thrombophlebitis
|
13.3%
2/15 • Number of events 2 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
1.1%
2/175 • Number of events 2 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
1.1%
2/189 • Number of events 2 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Vascular disorders
Hypotension
|
6.7%
1/15 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
4.0%
7/175 • Number of events 8 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
2.6%
5/189 • Number of events 9 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Vascular disorders
Jugular vein thrombosis
|
6.7%
1/15 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
1.1%
2/175 • Number of events 2 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/189 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Vascular disorders
Shock
|
6.7%
1/15 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/175 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/189 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Vascular disorders
Systolic hypertension
|
6.7%
1/15 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/175 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/189 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
26.7%
4/15 • Number of events 4 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
33.3%
5/15 • Number of events 5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
6.3%
11/175 • Number of events 12 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
6.9%
13/189 • Number of events 15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
26.7%
4/15 • Number of events 5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
33.3%
5/15 • Number of events 6 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
1.1%
2/175 • Number of events 2 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
4.2%
8/189 • Number of events 8 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
26.7%
4/15 • Number of events 4 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
26.7%
4/15 • Number of events 4 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
4.0%
7/175 • Number of events 9 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
4.2%
8/189 • Number of events 12 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
26.7%
4/15 • Number of events 4 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
20.0%
3/15 • Number of events 3 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
3.4%
6/175 • Number of events 7 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
5.8%
11/189 • Number of events 20 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
6.7%
1/15 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
6.7%
1/15 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
1.1%
2/175 • Number of events 2 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/189 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
6.7%
1/15 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
6.7%
1/15 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
2.3%
4/175 • Number of events 4 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
2.1%
4/189 • Number of events 4 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
13.3%
2/15 • Number of events 2 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
6.7%
1/15 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
1.7%
3/175 • Number of events 3 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/189 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
6.7%
1/15 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/175 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/189 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Metabolism and nutrition disorders
Hyperchloraemia
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
6.7%
1/15 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.57%
1/175 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.53%
1/189 • Number of events 2 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Metabolism and nutrition disorders
Hypermagnesaemia
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
6.7%
1/15 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/175 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/189 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
6.7%
1/15 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.57%
1/175 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
1.1%
2/189 • Number of events 2 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Metabolism and nutrition disorders
Metabolic alkalosis
|
6.7%
1/15 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
1.1%
2/175 • Number of events 2 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/189 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Metabolism and nutrition disorders
Refeeding syndrome
|
6.7%
1/15 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/175 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/189 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Psychiatric disorders
Delirium
|
20.0%
3/15 • Number of events 4 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
26.7%
4/15 • Number of events 4 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
8.0%
14/175 • Number of events 15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
6.9%
13/189 • Number of events 13 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
6.7%
1/15 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.57%
1/175 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
2.1%
4/189 • Number of events 4 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Psychiatric disorders
Hallucination
|
6.7%
1/15 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.57%
1/175 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.53%
1/189 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Psychiatric disorders
Nightmare
|
6.7%
1/15 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/175 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/189 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Psychiatric disorders
Panic attack
|
6.7%
1/15 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/175 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/189 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Psychiatric disorders
Restlessness
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
5.1%
9/175 • Number of events 9 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
4.8%
9/189 • Number of events 9 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Psychiatric disorders
Intensive care unit delirium
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
5.1%
9/175 • Number of events 9 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
3.7%
7/189 • Number of events 7 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
General disorders
Oedema peripheral
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
26.7%
4/15 • Number of events 4 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
5.7%
10/175 • Number of events 19 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
4.8%
9/189 • Number of events 21 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
General disorders
Hypothermia
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
6.7%
1/15 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/175 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/189 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
General disorders
Infusion site discolouration
|
6.7%
1/15 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/175 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/189 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
General disorders
Infusion site extravasation
|
6.7%
1/15 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.57%
1/175 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/189 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
General disorders
Infusion site vesicles
|
6.7%
1/15 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/175 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/189 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
General disorders
Medical device site haemorrhage
|
6.7%
1/15 • Number of events 2 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/175 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.53%
1/189 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Investigations
Hepatic enzyme increased
|
6.7%
1/15 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
20.0%
3/15 • Number of events 3 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
5.1%
9/175 • Number of events 9 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
4.2%
8/189 • Number of events 8 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Investigations
Blood bicarbonate increased
|
6.7%
1/15 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
6.7%
1/15 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/175 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/189 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Investigations
Blood potassium decreased
|
6.7%
1/15 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
6.7%
1/15 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/175 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/189 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Investigations
Electrocardiogram QT prolonged
|
6.7%
1/15 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
6.7%
1/15 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/175 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.53%
1/189 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Investigations
Fluid balance positive
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
13.3%
2/15 • Number of events 2 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/175 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.53%
1/189 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Investigations
Blood alkaline phosphatase increased
|
6.7%
1/15 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/175 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.53%
1/189 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Investigations
Blood culture positive
|
6.7%
1/15 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
1.1%
2/175 • Number of events 2 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
2.1%
4/189 • Number of events 4 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Investigations
Blood fibrinogen increased
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
6.7%
1/15 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/175 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/189 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Investigations
Blood phosphorus decreased
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
6.7%
1/15 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/175 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
1.1%
2/189 • Number of events 2 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Investigations
Blood urea increased
|
6.7%
1/15 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.57%
1/175 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/189 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Investigations
Computerised tomogram abnormal
|
6.7%
1/15 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/175 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/189 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Investigations
Culture negative
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
6.7%
1/15 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/175 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/189 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Investigations
Culture urine
|
6.7%
1/15 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/175 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.53%
1/189 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Investigations
Cytomegalovirus test positive
|
6.7%
1/15 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.57%
1/175 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/189 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Investigations
Enterococcus test positive
|
6.7%
1/15 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.57%
1/175 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
1.6%
3/189 • Number of events 4 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Investigations
Eosinophil count increased
|
6.7%
1/15 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/175 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/189 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Investigations
Fibrin D dimer increased
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
6.7%
1/15 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/175 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/189 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Investigations
Gamma-glutamyltransferase increased
|
6.7%
1/15 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.57%
1/175 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.53%
1/189 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Investigations
Liver function test abnormal
|
6.7%
1/15 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
2.3%
4/175 • Number of events 4 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.53%
1/189 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Investigations
Oxygen saturation decreased
|
6.7%
1/15 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
1.1%
2/175 • Number of events 2 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.53%
1/189 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Investigations
Platelet count increased
|
6.7%
1/15 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/175 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/189 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Investigations
Protein urine present
|
6.7%
1/15 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/175 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/189 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Investigations
Sputum culture positive
|
6.7%
1/15 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
2.3%
4/175 • Number of events 4 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
2.1%
4/189 • Number of events 5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Investigations
Staphylococcus test positive
|
6.7%
1/15 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
2.9%
5/175 • Number of events 5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
4.2%
8/189 • Number of events 11 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Cardiac disorders
Supraventricular tachycardia
|
6.7%
1/15 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
13.3%
2/15 • Number of events 2 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
3.4%
6/175 • Number of events 6 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.53%
1/189 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Cardiac disorders
Atrioventricular block second degree
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
6.7%
1/15 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/175 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/189 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
6.7%
1/15 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
1.1%
2/175 • Number of events 2 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
1.1%
2/189 • Number of events 2 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
6.7%
1/15 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/175 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/189 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Cardiac disorders
Defect conduction intraventricular
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
6.7%
1/15 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/175 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/189 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Cardiac disorders
Sinus tachycardia
|
6.7%
1/15 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
2.9%
5/175 • Number of events 9 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
2.1%
4/189 • Number of events 11 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
6.7%
1/15 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/175 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
1.1%
2/189 • Number of events 2 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Gastrointestinal disorders
Impaired gastric emptying
|
26.7%
4/15 • Number of events 4 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
46.7%
7/15 • Number of events 7 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
2.3%
4/175 • Number of events 4 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
1.6%
3/189 • Number of events 3 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Gastrointestinal disorders
Constipation
|
13.3%
2/15 • Number of events 2 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
26.7%
4/15 • Number of events 4 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
3.4%
6/175 • Number of events 6 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
1.6%
3/189 • Number of events 3 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Gastrointestinal disorders
Diarrhoea
|
6.7%
1/15 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
6.7%
1/15 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
2.9%
5/175 • Number of events 5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
1.6%
3/189 • Number of events 3 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
6.7%
1/15 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/175 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.53%
1/189 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Gastrointestinal disorders
Frequent bowel movements
|
6.7%
1/15 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/175 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/189 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
6.7%
1/15 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/175 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/189 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
6.7%
1/15 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
1.1%
2/175 • Number of events 2 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
1.1%
2/189 • Number of events 2 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Gastrointestinal disorders
Ileus paralytic
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
6.7%
1/15 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/175 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/189 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Gastrointestinal disorders
Mouth ulceration
|
6.7%
1/15 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/175 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/189 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
6.7%
1/15 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.57%
1/175 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.53%
1/189 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
6.7%
1/15 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
1.1%
2/175 • Number of events 2 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.53%
1/189 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
6.7%
1/15 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
3.4%
6/175 • Number of events 9 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
2.6%
5/189 • Number of events 6 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
26.7%
4/15 • Number of events 4 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
6.7%
1/15 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
5.7%
10/175 • Number of events 10 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
3.2%
6/189 • Number of events 6 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
6.7%
1/15 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
13.3%
2/15 • Number of events 2 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
1.1%
2/175 • Number of events 2 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.53%
1/189 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
6.7%
1/15 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
6.7%
1/15 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
1.7%
3/175 • Number of events 4 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
1.6%
3/189 • Number of events 3 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Bradypnoea
|
6.7%
1/15 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/175 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/189 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoventilation
|
6.7%
1/15 • Number of events 2 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/175 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/189 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
6.7%
1/15 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
5.7%
10/175 • Number of events 10 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
2.6%
5/189 • Number of events 6 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
6.7%
1/15 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/175 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/189 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Blood and lymphatic system disorders
Anaemia
|
13.3%
2/15 • Number of events 2 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
13.3%
2/15 • Number of events 2 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
8.0%
14/175 • Number of events 18 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
9.0%
17/189 • Number of events 18 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Renal and urinary disorders
Acute kidney injury
|
13.3%
2/15 • Number of events 2 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
20.0%
3/15 • Number of events 3 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
12.0%
21/175 • Number of events 22 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
7.9%
15/189 • Number of events 15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Renal and urinary disorders
Oliguria
|
13.3%
2/15 • Number of events 2 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/175 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.53%
1/189 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Renal and urinary disorders
Glycosuria
|
6.7%
1/15 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/175 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/189 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Renal and urinary disorders
Urinary retention
|
6.7%
1/15 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/175 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/189 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
26.7%
4/15 • Number of events 5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
40.0%
6/15 • Number of events 6 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
2.3%
4/175 • Number of events 4 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
2.6%
5/189 • Number of events 7 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Skin and subcutaneous tissue disorders
Actinic keratosis
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
6.7%
1/15 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/175 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/189 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
6.7%
1/15 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/175 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/189 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
6.7%
1/15 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/175 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/189 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
6.7%
1/15 • Number of events 2 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/175 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/189 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Injury, poisoning and procedural complications
Fall
|
6.7%
1/15 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
1.7%
3/175 • Number of events 3 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/189 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
6.7%
1/15 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/175 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/189 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
6.7%
1/15 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/175 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/189 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Injury, poisoning and procedural complications
Post procedural haematoma
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
6.7%
1/15 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/175 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/189 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Nervous system disorders
Headache
|
6.7%
1/15 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/175 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/189 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Nervous system disorders
Hemiparesis
|
6.7%
1/15 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/175 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/189 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Nervous system disorders
Intensive care unit acquired weakness
|
6.7%
1/15 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
1.1%
2/175 • Number of events 3 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
3.2%
6/189 • Number of events 6 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Nervous system disorders
Metabolic encephalopathy
|
6.7%
1/15 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/175 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/189 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Nervous system disorders
Peripheral nerve lesion
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
6.7%
1/15 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/175 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/189 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Nervous system disorders
Somnolence
|
6.7%
1/15 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/175 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/189 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
6.7%
1/15 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/175 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/189 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.7%
1/15 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/175 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/189 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
6.7%
1/15 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/175 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/189 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Eye disorders
Ocular hyperaemia
|
6.7%
1/15 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
6.7%
1/15 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/175 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/189 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Eye disorders
Eye irritation
|
6.7%
1/15 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/175 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/189 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Eye disorders
Miosis
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
6.7%
1/15 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/175 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/189 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Eye disorders
Pupils unequal
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
6.7%
1/15 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/175 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/189 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
6.7%
1/15 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.57%
1/175 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/189 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Product Issues
Device leakage
|
6.7%
1/15 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/175 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/189 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
|
Ear and labyrinth disorders
Vertigo
|
6.7%
1/15 • Number of events 1 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/15 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/175 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/189 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
0.00%
0/5 • Phase II study part: 4 weeks; Phase III study part: 60 days;
All adverse events are reported including non-treatment-emergent adverse events.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place