Trial Outcomes & Findings for Efficacy and Safety of BIO101 in the Prevention of Respiratory Deterioration in Hospitalized COVID-19 Patients (NCT NCT04472728)
NCT ID: NCT04472728
Last Updated: 2026-08-12
Results Overview
Negative events were defined as: all-cause mortality, respiratory failure requiring mechanical ventilation (including cases that were not intubated due to resource restrictions and triage), respiratory failure requiring extracorporeal membrane oxygenation (ECMO), and respiratory failure requiring high-flow oxygen (HFO2). Only the first occurrence of any negative event up to day 28 was considered for the analysis.
Recruitment status
TERMINATED
Study phase
PHASE2/PHASE3
Target enrollment
238 participants
Primary outcome timeframe
Up to 28 days
Results posted on
2026-08-12
Participant Flow
Participants were enrolled at 37 study centers in the following countries: United States (13 study centers), Belgium (3 study centers), Brazil (14 study centers), and France (7 study centers) between August 2020 and June 2022.
Participants with coronavirus disease 2019 (COVID-19) were randomized in a 1:1 ratio to receive either BIO101, or the matching placebo. A total of 3 participants in the BIO101 group and 2 participants in the placebo group did not receive the first dose of study medication and therefore were not included in the analysis.
Participant milestones
| Measure |
350mg BIO101
Participants with COVID-19 were randomized to receive 350 mg twice daily (BID) of BIO101 administered orally (PO) as a capsule form for a maximum duration of 28 days.
|
Placebo
Participants with COVID-19 were randomized to receive placebo BID administered PO as a capsule form for a maximum duration of 28 days.
|
|---|---|---|
|
Overall Study
STARTED
|
129
|
109
|
|
Overall Study
Intent-to-treat Population
|
126
|
107
|
|
Overall Study
Safety Population
|
128
|
104
|
|
Overall Study
COMPLETED
|
102
|
78
|
|
Overall Study
NOT COMPLETED
|
27
|
31
|
Reasons for withdrawal
| Measure |
350mg BIO101
Participants with COVID-19 were randomized to receive 350 mg twice daily (BID) of BIO101 administered orally (PO) as a capsule form for a maximum duration of 28 days.
|
Placebo
Participants with COVID-19 were randomized to receive placebo BID administered PO as a capsule form for a maximum duration of 28 days.
|
|---|---|---|
|
Overall Study
Adverse Event
|
4
|
5
|
|
Overall Study
Lost to Follow-up
|
2
|
1
|
|
Overall Study
Withdrawal by Subject
|
3
|
2
|
|
Overall Study
Sponsor's Decision
|
1
|
0
|
|
Overall Study
Physician Decision
|
1
|
0
|
|
Overall Study
Death
|
13
|
18
|
|
Overall Study
Transfer to another site; protocol deviation
|
0
|
3
|
|
Overall Study
No treatment administration
|
3
|
2
|
Baseline Characteristics
Efficacy and Safety of BIO101 in the Prevention of Respiratory Deterioration in Hospitalized COVID-19 Patients
Baseline characteristics by cohort
| Measure |
350mg BIO101
n=126 Participants
Participants with COVID-19 were randomized to receive 350 mg BID of BIO101 administered PO as a capsule form for a maximum duration of 28 days.
|
Placebo
n=107 Participants
Participants with COVID-19 were randomized to receive placebo BID administered PO as a capsule form for a maximum duration of 28 days.
|
Total
n=233 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63.0 years
STANDARD_DEVIATION 9.82 • n=1 Participants
|
62.5 years
STANDARD_DEVIATION 8.46 • n=1 Participants
|
62.8 years
STANDARD_DEVIATION 9.21 • n=1 Participants
|
|
Sex: Female, Male
Female
|
42 Participants
n=1 Participants
|
43 Participants
n=1 Participants
|
85 Participants
n=1 Participants
|
|
Sex: Female, Male
Male
|
84 Participants
n=1 Participants
|
64 Participants
n=1 Participants
|
148 Participants
n=1 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
70 Participants
n=1 Participants
|
60 Participants
n=1 Participants
|
130 Participants
n=1 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
36 Participants
n=1 Participants
|
26 Participants
n=1 Participants
|
62 Participants
n=1 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
20 Participants
n=1 Participants
|
21 Participants
n=1 Participants
|
41 Participants
n=1 Participants
|
|
Race/Ethnicity, Customized
White or Caucasian
|
86 Participants
n=1 Participants
|
65 Participants
n=1 Participants
|
151 Participants
n=1 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
11 Participants
n=1 Participants
|
11 Participants
n=1 Participants
|
22 Participants
n=1 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska native
|
0 Participants
n=1 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=1 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=1 Participants
|
0 Participants
n=1 Participants
|
1 Participants
n=1 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or other pacific islander
|
0 Participants
n=1 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=1 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 Participants
n=1 Participants
|
3 Participants
n=1 Participants
|
5 Participants
n=1 Participants
|
|
Race/Ethnicity, Customized
Not reported
|
26 Participants
n=1 Participants
|
28 Participants
n=1 Participants
|
54 Participants
n=1 Participants
|
PRIMARY outcome
Timeframe: Up to 28 daysPopulation: ITT analysis set: All participants randomized into the study and who received at least one dose of study medication.
Negative events were defined as: all-cause mortality, respiratory failure requiring mechanical ventilation (including cases that were not intubated due to resource restrictions and triage), respiratory failure requiring extracorporeal membrane oxygenation (ECMO), and respiratory failure requiring high-flow oxygen (HFO2). Only the first occurrence of any negative event up to day 28 was considered for the analysis.
Outcome measures
| Measure |
350mg BIO101
n=126 Participants
Participants with COVID-19 were randomized to receive 350 mg BID of BIO101 administered PO as a capsule form for a maximum duration of 28 days.
|
Placebo
n=107 Participants
Participants with COVID-19 were randomized to receive placebo BID administered PO as a capsule form for a maximum duration of 28 days.
|
|---|---|---|
|
Percentage of Participants Experiencing Negative Events
All-cause mortality
|
3 Participants
|
9 Participants
|
|
Percentage of Participants Experiencing Negative Events
Respiratory failure requiring mechanical ventilation
|
14 Participants
|
15 Participants
|
|
Percentage of Participants Experiencing Negative Events
Respiratory failure requiring ECMO
|
0 Participants
|
0 Participants
|
|
Percentage of Participants Experiencing Negative Events
Respiratory failure requiring HFO2
|
2 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: Up to 28 daysPopulation: ITT analysis set: All participants randomized into the study and who received at least one dose of study medication.
Positive events were defined as participants being officially discharged from hospital care by the department due to improvement in participant condition (self-discharge by participant was not considered a positive event).
Outcome measures
| Measure |
350mg BIO101
n=126 Participants
Participants with COVID-19 were randomized to receive 350 mg BID of BIO101 administered PO as a capsule form for a maximum duration of 28 days.
|
Placebo
n=107 Participants
Participants with COVID-19 were randomized to receive placebo BID administered PO as a capsule form for a maximum duration of 28 days.
|
|---|---|---|
|
Number of Participants Experiencing Positive Events
|
93 Participants
|
71 Participants
|
SECONDARY outcome
Timeframe: Day 3, Day 7, Day 14, and Day 28Population: ITT analysis set: All participants randomized into the study and who received at least one dose of study medication. Data were included in the analysis if participants had both SpO2 and FiO2 measurements collected on the same day. The baseline value included participants with the last available and non-missing value before the first administration of study drug. For the change from baseline, only participants with a value at both baseline and the specific post-baseline visits, were included.
SpO2/fraction of inspired oxygen (FiO2). Oxygen saturation in arterial blood, measured by pulse-oximetry (SpO2). Peripheral arterial oxygen saturation (SpO2) estimates the amount of oxygen in the blood, expressing the percentage of oxygenated hemoglobin compared to the total amount of hemoglobin It will be measured by pulse oximetry, an indirect and non-invasive method. The FiO2 and the oxygen delivery system (e.g., simple facial mask; partial rebreather mask; nasal cannula; C-PAP machine) are to be recorded. If FiO2 cannot be read directly from the device, the volume (in liters) and % of oxygen the system delivers (e.g., 100%) should be recorded instead. Ratio between SpO2 and FiO2 is calculated
Outcome measures
| Measure |
350mg BIO101
n=115 Participants
Participants with COVID-19 were randomized to receive 350 mg BID of BIO101 administered PO as a capsule form for a maximum duration of 28 days.
|
Placebo
n=94 Participants
Participants with COVID-19 were randomized to receive placebo BID administered PO as a capsule form for a maximum duration of 28 days.
|
|---|---|---|
|
Change From Baseline in Saturation by Pulse Oximetry (SpO2)/Fraction of Inspired Oxygen (FiO2) Ratio
Day 3
|
0.1256 ratio
Standard Deviation 0.71959
|
-0.0753 ratio
Standard Deviation 0.56231
|
|
Change From Baseline in Saturation by Pulse Oximetry (SpO2)/Fraction of Inspired Oxygen (FiO2) Ratio
Day 7
|
0.2335 ratio
Standard Deviation 1.19831
|
0.1186 ratio
Standard Deviation 0.95506
|
|
Change From Baseline in Saturation by Pulse Oximetry (SpO2)/Fraction of Inspired Oxygen (FiO2) Ratio
Day 14
|
0.2704 ratio
Standard Deviation 0.97047
|
-0.8334 ratio
Standard Deviation 1.60596
|
|
Change From Baseline in Saturation by Pulse Oximetry (SpO2)/Fraction of Inspired Oxygen (FiO2) Ratio
Day 28
|
0.2331 ratio
Standard Deviation 1.04228
|
-0.0670 ratio
Standard Deviation 0.81144
|
SECONDARY outcome
Timeframe: Day 3, Day 7, Day 14, and Day 28Population: ITT analysis set: All participants randomized into the study and who received at least one dose of study medication. The baseline value included participants with the last available and non-missing value before the first administration of study drug. For the change from baseline, only participants with a value at both baseline and the specific post-baseline visits, were included.
Oxygen saturation in arterial blood, measured by pulse-oximetry (SpO2). Peripheral arterial oxygen saturation (SpO2) estimates the amount of oxygen in the blood, expressing the percentage of oxygenated hemoglobin compared to the total amount of hemoglobin It will be measured by pulse oximetry, an indirect and non-invasive method.
Outcome measures
| Measure |
350mg BIO101
n=126 Participants
Participants with COVID-19 were randomized to receive 350 mg BID of BIO101 administered PO as a capsule form for a maximum duration of 28 days.
|
Placebo
n=106 Participants
Participants with COVID-19 were randomized to receive placebo BID administered PO as a capsule form for a maximum duration of 28 days.
|
|---|---|---|
|
Change From Baseline in Oxygen Saturation in Arterial Blood as Measured by SpO2
Day 3
|
1.53 percentage of O2
Standard Deviation 3.828
|
1.02 percentage of O2
Standard Deviation 4.519
|
|
Change From Baseline in Oxygen Saturation in Arterial Blood as Measured by SpO2
Day 7
|
1.48 percentage of O2
Standard Deviation 4.725
|
0.90 percentage of O2
Standard Deviation 3.993
|
|
Change From Baseline in Oxygen Saturation in Arterial Blood as Measured by SpO2
Day 14
|
2.43 percentage of O2
Standard Deviation 4.354
|
2.64 percentage of O2
Standard Deviation 5.143
|
|
Change From Baseline in Oxygen Saturation in Arterial Blood as Measured by SpO2
Day 28
|
2.28 percentage of O2
Standard Deviation 4.340
|
1.62 percentage of O2
Standard Deviation 4.563
|
SECONDARY outcome
Timeframe: Up to 90 daysPopulation: ITT analysis set: All participants randomized into the study and who received at least one dose of study medication. Participants with a missing outcome were considered to have experienced an event of death.
All-cause mortality refers to the overall death rate in a population, irrespective of the specific reasons for the deaths, covering mortality from all possible causes.
Outcome measures
| Measure |
350mg BIO101
n=126 Participants
Participants with COVID-19 were randomized to receive 350 mg BID of BIO101 administered PO as a capsule form for a maximum duration of 28 days.
|
Placebo
n=107 Participants
Participants with COVID-19 were randomized to receive placebo BID administered PO as a capsule form for a maximum duration of 28 days.
|
|---|---|---|
|
Number of Participants Experiencing All-cause Mortality
|
15 Participants
|
21 Participants
|
SECONDARY outcome
Timeframe: Up to 28 daysPopulation: ITT analysis set: All participants randomized into the study and who received at least one dose of study medication. If no event was reported, the data from participants were censored at the last available assessment/measurement date. Only participants who experienced an event were included in the analysis.
Negative events were defined as: all-cause mortality, respiratory failure requiring mechanical ventilation (including cases that were not intubated due to resource restrictions and triage), respiratory failure requiring ECMO, and respiratory HFO2. Only the first occurrence of any event up to day 28 was considered for the analysis. Median and 95% CI estimates of survival time were based on the Kaplan-Meier analysis.
Outcome measures
| Measure |
350mg BIO101
n=15 Participants
Participants with COVID-19 were randomized to receive 350 mg BID of BIO101 administered PO as a capsule form for a maximum duration of 28 days.
|
Placebo
n=21 Participants
Participants with COVID-19 were randomized to receive placebo BID administered PO as a capsule form for a maximum duration of 28 days.
|
|---|---|---|
|
Time to Reach a Negative Event
All-cause mortality
|
NA days
Median and confidence interval (CI) were not reached due to the low number of observations.
|
NA days
Median and CI were not reached due to the low number of observations.
|
|
Time to Reach a Negative Event
Respiratory failure requiring mechanical ventilation or ECMO
|
NA days
Median and CI were not reached due to the low number of observations.
|
NA days
Median and CI were not reached due to the low number of observations.
|
|
Time to Reach a Negative Event
Respiratory failure requiring HFO2
|
NA days
Median and CI were not reached due to the low number of observations.
|
NA days
Median and CI were not reached due to the low number of observations.
|
SECONDARY outcome
Timeframe: Up to 28 daysPopulation: ITT analysis set: All participants randomized into the study and who received at least one dose of study medication. If no event was reported, the data from participants were censored at the last available assessment/measurement date. Only participants who experienced an event were included in the analysis.
Positive events were defined as the participants being officially discharged from hospital care by the department due to improvement in participant condition (self-discharge by participant was not considered a positive event).
Outcome measures
| Measure |
350mg BIO101
n=93 Participants
Participants with COVID-19 were randomized to receive 350 mg BID of BIO101 administered PO as a capsule form for a maximum duration of 28 days.
|
Placebo
n=71 Participants
Participants with COVID-19 were randomized to receive placebo BID administered PO as a capsule form for a maximum duration of 28 days.
|
|---|---|---|
|
Time to Reach a Positive Event
|
9.0 days
Interval 8.0 to 13.0
|
9.0 days
Interval 8.0 to 12.0
|
SECONDARY outcome
Timeframe: Day 3, Day 7, Day 14, and Day 28Population: ITT analysis set: All participants randomized into the study and who received at least one dose of study medication. The baseline value included participants with the last available and non-missing value before the first administration of study drug. For the change from baseline, only participants with a value at both baseline and the specific post-baseline visits were included.
The NEWS2 is based on a simple aggregating scoring system in which scores allocated to physiological measurements (e.g., respiratory rate, oxygen saturation, systolic blood pressure, heart rate, level of consciousness, and temperature) are added up together to provide the clinical status of a patient. The total score of NEWS2 is interpreted as follows: * 0 to 4: Low risk - Usually indicates the participant is stable, with no immediate cause for concern. * 5 to 6: Medium risk - Suggests the participant may require closer monitoring and further assessment. * 7 to 20: High risk - Indicates the participant is at significant risk of clinical deterioration and may require urgent medical intervention, including escalation of care to a higher level or immediate medical review.
Outcome measures
| Measure |
350mg BIO101
n=107 Participants
Participants with COVID-19 were randomized to receive 350 mg BID of BIO101 administered PO as a capsule form for a maximum duration of 28 days.
|
Placebo
n=91 Participants
Participants with COVID-19 were randomized to receive placebo BID administered PO as a capsule form for a maximum duration of 28 days.
|
|---|---|---|
|
Change From Baseline in National Early Warning Score 2 (NEWS2)
Day 3
|
-0.7 score on scale
Standard Deviation 2.28
|
-1.3 score on scale
Standard Deviation 2.41
|
|
Change From Baseline in National Early Warning Score 2 (NEWS2)
Day 7
|
-0.8 score on scale
Standard Deviation 2.51
|
-1.8 score on scale
Standard Deviation 2.51
|
|
Change From Baseline in National Early Warning Score 2 (NEWS2)
Day 14
|
-1.6 score on scale
Standard Deviation 2.68
|
-3.0 score on scale
Standard Deviation 2.21
|
|
Change From Baseline in National Early Warning Score 2 (NEWS2)
Day 28
|
-2.3 score on scale
Standard Deviation 3.28
|
-2.1 score on scale
Standard Deviation 3.45
|
SECONDARY outcome
Timeframe: Up to 90 daysPopulation: Safety analysis set (SAS): All participants included in the ITT analysis set and who had at least one post-baseline safety assessment were included in the safety analysis set. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
An AE is any untoward medical occurrence associated with the use of a study medication in humans, whether or not considered study-medication-related. A TEAE was defined as an AE that occurred or worsened in the period from the first dose of study treatment to 30 days after the last dose of the IP. An AE was considered serious if it resulted in any of the following outcomes: death, life-threatening, caused inpatient hospitalization or prolonged existing hospitalization, persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, a congenital abnormality/birth defect, or was an important medical event. AE severity was rated according to the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0: grade 1 (mild), grade 2 (moderate), grade 3 (severe), grade 4 (life-threatening), grade 5 (death).
Outcome measures
| Measure |
350mg BIO101
n=128 Participants
Participants with COVID-19 were randomized to receive 350 mg BID of BIO101 administered PO as a capsule form for a maximum duration of 28 days.
|
Placebo
n=104 Participants
Participants with COVID-19 were randomized to receive placebo BID administered PO as a capsule form for a maximum duration of 28 days.
|
|---|---|---|
|
Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
All TEAEs
|
75 Participants
|
68 Participants
|
|
Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
Serious TEAEs
|
32 Participants
|
34 Participants
|
|
Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
Non-serious TEAEs
|
59 Participants
|
53 Participants
|
|
Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
Grade 3 or higher
|
33 Participants
|
33 Participants
|
|
Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
Fatal TEAEs
|
16 Participants
|
19 Participants
|
|
Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
Treatment-related TEAEs
|
12 Participants
|
14 Participants
|
|
Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
Serious treatment-related TEAEs
|
0 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Up to 90 daysPopulation: SAS: All participants included in the ITT analysis set and who had at least one post-baseline safety assessment were included in the safety analysis set. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
The TEAE of special interest in this study included documented events of orthostatic hypotension (OHT) with supine and standing blood pressure measurements, where OHT is defined as a drop in blood pressure from supine to standing position: * of ≥20 mmHg in systolic blood pressure (SBP), and/or * of ≥10 mmHg in diastolic blood pressure (DBP).
Outcome measures
| Measure |
350mg BIO101
n=128 Participants
Participants with COVID-19 were randomized to receive 350 mg BID of BIO101 administered PO as a capsule form for a maximum duration of 28 days.
|
Placebo
n=104 Participants
Participants with COVID-19 were randomized to receive placebo BID administered PO as a capsule form for a maximum duration of 28 days.
|
|---|---|---|
|
Number of Participants Experiencing TEAEs of Special Interest (EOI)
|
9 Participants
|
8 Participants
|
Adverse Events
350mg BIO101
Serious events: 32 serious events
Other events: 59 other events
Deaths: 16 deaths
Placebo
Serious events: 34 serious events
Other events: 53 other events
Deaths: 21 deaths
Serious adverse events
| Measure |
350mg BIO101
n=128 participants at risk
Participants with COVID-19 were randomized to receive 350 mg BID of BIO101 administered PO as a capsule form for a maximum duration of 28 days.
|
Placebo
n=104 participants at risk
Participants with COVID-19 were randomized to receive placebo BID administered PO as a capsule form for a maximum duration of 28 days.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
8.6%
11/128 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
17.3%
18/104 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
3.1%
4/128 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
0.96%
1/104 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
2.3%
3/128 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
2.9%
3/104 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
2.3%
3/128 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
4.8%
5/104 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.6%
2/128 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
3.8%
4/104 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.78%
1/128 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
0.00%
0/104 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Increased bronchial secretion
|
0.78%
1/128 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
0.00%
0/104 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.78%
1/128 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
1.9%
2/104 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Respiration abnormal
|
0.78%
1/128 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
0.00%
0/104 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.78%
1/128 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
0.96%
1/104 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
0.00%
0/128 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
0.96%
1/104 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
|
Infections and infestations
Bacterial sepsis
|
2.3%
3/128 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
0.96%
1/104 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
|
Infections and infestations
Pneumonia
|
2.3%
3/128 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
0.00%
0/104 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
|
Infections and infestations
Septic shock
|
1.6%
2/128 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
3.8%
4/104 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
|
Infections and infestations
Pulmonary sepsis
|
0.78%
1/128 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
0.96%
1/104 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
|
Infections and infestations
Urinary tract infection
|
0.78%
1/128 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
0.00%
0/104 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
|
Infections and infestations
Urinary tract infection bacterial
|
0.78%
1/128 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
0.00%
0/104 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/128 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
0.96%
1/104 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
|
Infections and infestations
Sepsis
|
0.00%
0/128 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
1.9%
2/104 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
|
Infections and infestations
Urosepsis
|
0.00%
0/128 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
0.96%
1/104 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
|
Vascular disorders
Embolism venous
|
0.78%
1/128 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
0.00%
0/104 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
|
Vascular disorders
Femoral artery embolism
|
0.78%
1/128 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
0.00%
0/104 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
|
Vascular disorders
Peripheral ischaemia
|
0.78%
1/128 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
0.00%
0/104 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
|
Vascular disorders
Shock haemorrhagic
|
0.78%
1/128 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
0.00%
0/104 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/128 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
0.96%
1/104 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/128 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
0.96%
1/104 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.78%
1/128 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
0.00%
0/104 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
|
Blood and lymphatic system disorders
Thrombocytosis
|
0.78%
1/128 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
0.00%
0/104 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
|
Investigations
Hepatic enzyme increased
|
0.78%
1/128 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
0.00%
0/104 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
|
Investigations
International normalised ratio increased
|
0.78%
1/128 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
0.00%
0/104 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
|
Investigations
Lipase increased
|
0.00%
0/128 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
0.96%
1/104 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
|
Renal and urinary disorders
Acute kidney injury
|
1.6%
2/128 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
3.8%
4/104 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
|
Cardiac disorders
Atrial fibrillation
|
0.78%
1/128 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
0.96%
1/104 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
|
Cardiac disorders
Cardiac failure
|
0.78%
1/128 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
0.00%
0/104 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/128 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
0.96%
1/104 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
|
Cardiac disorders
Atrioventricular block complete
|
0.00%
0/128 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
0.96%
1/104 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.00%
0/128 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
0.96%
1/104 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
|
Cardiac disorders
Cardiogenic shock
|
0.00%
0/128 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
0.96%
1/104 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
|
General disorders
Sudden death
|
0.78%
1/128 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
0.00%
0/104 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.00%
0/128 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
0.96%
1/104 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/128 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
0.96%
1/104 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
|
Nervous system disorders
Haemorrhagic stroke
|
0.00%
0/128 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
0.96%
1/104 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
Other adverse events
| Measure |
350mg BIO101
n=128 participants at risk
Participants with COVID-19 were randomized to receive 350 mg BID of BIO101 administered PO as a capsule form for a maximum duration of 28 days.
|
Placebo
n=104 participants at risk
Participants with COVID-19 were randomized to receive placebo BID administered PO as a capsule form for a maximum duration of 28 days.
|
|---|---|---|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
2.3%
3/128 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
1.9%
2/104 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
1.6%
2/128 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
0.00%
0/104 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
1.6%
2/128 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
0.00%
0/104 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
1.6%
2/128 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
0.96%
1/104 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
|
Gastrointestinal disorders
Constipation
|
8.6%
11/128 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
15.4%
16/104 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
5.5%
7/128 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
8.7%
9/104 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
5.5%
7/128 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
1.9%
2/104 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
2.3%
3/128 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
4.8%
5/104 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
1.6%
2/128 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
1.9%
2/104 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
|
Metabolism and nutrition disorders
Diabetic metabolic decompensation
|
0.78%
1/128 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
0.00%
0/104 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.78%
1/128 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
0.96%
1/104 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.78%
1/128 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
0.96%
1/104 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
|
Metabolism and nutrition disorders
Hypoproteinaemia
|
0.78%
1/128 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
0.00%
0/104 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.78%
1/128 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
0.00%
0/104 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.78%
1/128 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
0.00%
0/104 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/128 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
0.96%
1/104 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
|
Metabolism and nutrition disorders
Dyslipidaemia
|
0.00%
0/128 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
0.96%
1/104 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
0.00%
0/128 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
0.96%
1/104 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.00%
0/128 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
0.96%
1/104 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
|
Metabolism and nutrition disorders
Metabolic alkalosis
|
0.00%
0/128 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
0.96%
1/104 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
|
Gastrointestinal disorders
Nausea
|
3.1%
4/128 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
1.9%
2/104 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
|
Gastrointestinal disorders
Diarrhoea
|
1.6%
2/128 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
0.00%
0/104 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
|
Gastrointestinal disorders
Vomiting
|
1.6%
2/128 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
0.00%
0/104 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.78%
1/128 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
0.00%
0/104 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
|
Gastrointestinal disorders
Anal incontinence
|
0.78%
1/128 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
0.00%
0/104 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/128 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
0.96%
1/104 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/128 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
0.96%
1/104 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/128 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
1.9%
2/104 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/128 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
0.96%
1/104 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
|
Infections and infestations
Urinary tract infection
|
3.1%
4/128 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
2.9%
3/104 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
|
Infections and infestations
Oral fungal infection
|
1.6%
2/128 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
0.96%
1/104 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
|
Infections and infestations
Pneumonia
|
1.6%
2/128 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
1.9%
2/104 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
|
Infections and infestations
Septic shock
|
1.6%
2/128 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
1.9%
2/104 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
|
Infections and infestations
Aspergillus infection
|
0.78%
1/128 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
0.00%
0/104 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
|
Infections and infestations
Bacteraemia
|
0.78%
1/128 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
0.00%
0/104 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
|
Infections and infestations
Bronchitis
|
0.78%
1/128 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
0.00%
0/104 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
|
Infections and infestations
Clostridium difficile infection
|
0.78%
1/128 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
0.00%
0/104 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
|
Infections and infestations
Labyrinthitis
|
0.78%
1/128 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
0.00%
0/104 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
|
Infections and infestations
Oral candidiasis
|
0.78%
1/128 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
0.96%
1/104 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
|
Infections and infestations
Pneumonia pseudomonal
|
0.78%
1/128 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
0.00%
0/104 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
|
Infections and infestations
Pyuria
|
0.78%
1/128 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
0.00%
0/104 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
|
Infections and infestations
Tooth infection
|
0.78%
1/128 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
0.00%
0/104 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
|
Infections and infestations
COVID-19
|
0.00%
0/128 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
0.96%
1/104 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
|
Infections and infestations
COVID-19 pneumonia
|
0.00%
0/128 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
0.96%
1/104 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
|
Infections and infestations
Fungal foot infection
|
0.00%
0/128 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
0.96%
1/104 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
|
Infections and infestations
Genital infection fungal
|
0.00%
0/128 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
0.96%
1/104 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
|
Infections and infestations
Pneumonia acinetobacter
|
0.00%
0/128 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
0.96%
1/104 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
|
Infections and infestations
Sepsis
|
0.00%
0/128 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
0.96%
1/104 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
|
Infections and infestations
Tinea versicolour
|
0.00%
0/128 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
0.96%
1/104 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
|
Infections and infestations
Urinary tract infection enterococcal
|
0.00%
0/128 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
0.96%
1/104 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
|
Vascular disorders
Orthostatic hypotension
|
7.0%
9/128 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
7.7%
8/104 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
|
Vascular disorders
Deep vein thrombosis
|
1.6%
2/128 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
0.96%
1/104 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
|
Vascular disorders
Hypertension
|
1.6%
2/128 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
1.9%
2/104 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
|
Vascular disorders
Hypotension
|
1.6%
2/128 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
0.00%
0/104 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
|
Vascular disorders
Haematoma
|
0.78%
1/128 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
0.00%
0/104 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
|
Vascular disorders
Peripheral ischaemia
|
0.78%
1/128 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
0.00%
0/104 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
|
Vascular disorders
Thrombosis
|
0.00%
0/128 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
0.96%
1/104 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
2.3%
3/128 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
0.96%
1/104 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Aphonia
|
0.78%
1/128 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
0.00%
0/104 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma-chronic obstructive pulmonary disease overlap syndrome
|
0.78%
1/128 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
0.00%
0/104 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.78%
1/128 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
1.9%
2/104 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
0.78%
1/128 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
0.00%
0/104 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Hypercapnia
|
0.78%
1/128 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
0.00%
0/104 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Lung infiltration
|
0.78%
1/128 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
0.96%
1/104 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.78%
1/128 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
0.00%
0/104 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.78%
1/128 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
0.00%
0/104 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.78%
1/128 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
0.96%
1/104 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Tracheomalacia
|
0.78%
1/128 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
0.00%
0/104 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.00%
0/128 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
0.96%
1/104 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/128 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
0.96%
1/104 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/128 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
0.96%
1/104 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic respiratory failure
|
0.00%
0/128 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
0.96%
1/104 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/128 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
0.96%
1/104 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/128 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
0.96%
1/104 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/128 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
0.96%
1/104 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/128 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
0.96%
1/104 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/128 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
0.96%
1/104 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/128 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
0.96%
1/104 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Rales
|
0.00%
0/128 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
0.96%
1/104 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/128 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
0.96%
1/104 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/128 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
0.96%
1/104 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
|
Investigations
Blood triglycerides increased
|
0.78%
1/128 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
0.00%
0/104 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
|
Investigations
C-reactive protein increased
|
0.78%
1/128 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
0.00%
0/104 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
|
Investigations
Candida test positive
|
0.78%
1/128 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
0.00%
0/104 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
|
Investigations
Citrobacter test positive
|
0.78%
1/128 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
0.00%
0/104 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.78%
1/128 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
0.96%
1/104 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
|
Investigations
Hepatic enzyme increased
|
0.78%
1/128 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
0.00%
0/104 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
|
Investigations
Oxygen saturation decreased
|
0.78%
1/128 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
0.00%
0/104 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
|
Investigations
Transaminases increased
|
0.78%
1/128 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
0.00%
0/104 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
|
Investigations
Troponin increased
|
0.78%
1/128 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
0.00%
0/104 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/128 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
0.96%
1/104 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
|
Investigations
Liver function test increased
|
0.00%
0/128 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
1.9%
2/104 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
|
Psychiatric disorders
Anxiety
|
3.1%
4/128 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
3.8%
4/104 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
|
Psychiatric disorders
Agitation
|
0.78%
1/128 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
0.96%
1/104 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
|
Psychiatric disorders
Confusional state
|
0.78%
1/128 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
1.9%
2/104 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
|
Psychiatric disorders
Insomnia
|
0.78%
1/128 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
0.96%
1/104 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
|
Psychiatric disorders
Poor quality sleep
|
0.78%
1/128 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
0.00%
0/104 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
|
Psychiatric disorders
Nervousness
|
0.00%
0/128 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
0.96%
1/104 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
|
Psychiatric disorders
Sleep disorder
|
0.00%
0/128 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
0.96%
1/104 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
|
Nervous system disorders
Headache
|
1.6%
2/128 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
1.9%
2/104 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
|
Nervous system disorders
Tremor
|
1.6%
2/128 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
0.00%
0/104 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
|
Nervous system disorders
Anosmia
|
0.78%
1/128 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
0.00%
0/104 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
|
Nervous system disorders
Dizziness
|
0.78%
1/128 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
0.00%
0/104 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
|
Nervous system disorders
Dysgeusia
|
0.78%
1/128 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
0.00%
0/104 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.78%
1/128 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
0.00%
0/104 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
|
Nervous system disorders
Amnesia
|
0.00%
0/128 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
0.96%
1/104 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
|
Nervous system disorders
Essential tremor
|
0.00%
0/128 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
0.96%
1/104 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/128 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
0.96%
1/104 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
|
Nervous system disorders
Syncope
|
0.00%
0/128 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
0.96%
1/104 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.78%
1/128 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
0.96%
1/104 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
|
Blood and lymphatic system disorders
Blood loss anaemia
|
0.78%
1/128 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
0.00%
0/104 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.78%
1/128 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
0.00%
0/104 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
|
Blood and lymphatic system disorders
Normocytic anaemia
|
0.78%
1/128 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
0.00%
0/104 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
|
Blood and lymphatic system disorders
Thrombocytosis
|
0.78%
1/128 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
0.00%
0/104 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
|
Blood and lymphatic system disorders
Eosinophilia
|
0.00%
0/128 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
0.96%
1/104 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/128 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
0.96%
1/104 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
|
Cardiac disorders
Bradycardia
|
1.6%
2/128 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
0.00%
0/104 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
|
Cardiac disorders
Atrial fibrillation
|
0.78%
1/128 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
0.00%
0/104 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
|
Cardiac disorders
Supraventricular extrasystoles
|
0.78%
1/128 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
0.00%
0/104 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/128 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
0.96%
1/104 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/128 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
0.96%
1/104 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
|
Renal and urinary disorders
Dysuria
|
1.6%
2/128 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
0.00%
0/104 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
|
Renal and urinary disorders
Haematuria
|
0.78%
1/128 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
0.00%
0/104 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
|
Renal and urinary disorders
Urinary retention
|
0.78%
1/128 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
0.00%
0/104 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/128 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
0.96%
1/104 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/128 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
0.96%
1/104 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/128 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
0.96%
1/104 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
|
Skin and subcutaneous tissue disorders
Dermatitis bullous
|
0.78%
1/128 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
0.00%
0/104 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.78%
1/128 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
0.00%
0/104 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.78%
1/128 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
0.96%
1/104 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
|
Skin and subcutaneous tissue disorders
Subcutaneous emphysema
|
0.78%
1/128 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
0.00%
0/104 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/128 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
0.96%
1/104 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.00%
0/128 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
0.96%
1/104 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/128 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
0.96%
1/104 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
|
General disorders
Chest pain
|
0.78%
1/128 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
0.00%
0/104 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
|
General disorders
Oedema peripheral
|
0.78%
1/128 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
0.00%
0/104 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
|
General disorders
Pyrexia
|
0.78%
1/128 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
0.00%
0/104 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
|
General disorders
Systemic inflammatory response syndrome
|
0.00%
0/128 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
0.96%
1/104 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
|
Injury, poisoning and procedural complications
Drug dispensed to wrong patient
|
1.6%
2/128 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
0.00%
0/104 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
|
Injury, poisoning and procedural complications
Buttock injury
|
0.00%
0/128 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
0.96%
1/104 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
|
Injury, poisoning and procedural complications
Extra dose administered
|
0.00%
0/128 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
0.96%
1/104 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.78%
1/128 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
0.00%
0/104 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.78%
1/128 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
0.00%
0/104 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.78%
1/128 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
0.00%
0/104 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.78%
1/128 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
0.00%
0/104 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.78%
1/128 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
0.00%
0/104 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/128 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
0.96%
1/104 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
|
Eye disorders
Dry eye
|
0.00%
0/128 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
0.96%
1/104 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
|
Eye disorders
Myopia
|
0.00%
0/128 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
0.96%
1/104 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
|
Immune system disorders
Anaphylactic reaction
|
0.00%
0/128 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
0.96%
1/104 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/128 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
0.96%
1/104 • Up to 90 days
All-cause mortality is presented for the whole randomized population. Serious and other AEs are presented for the safety analysis set: all participants included in the ITT analysis set and who had at least one post-baseline safety assessment. Participants were analysed according to the treatment received. Two participants randomized to Placebo inadvertently received 350 mg BIO101 and are reported by actual treatment received.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER