Trial Outcomes & Findings for CORIMUNO-ANA: Trial Evaluating Efficacy Of Anakinra In Patients With Covid-19 Infection (NCT NCT04341584)
NCT ID: NCT04341584
Last Updated: 2025-06-06
Results Overview
Survival without needs of ventilator utilization (including non invasive ventilation and high flow) at day 14. Percentage of non-invasive ventilation, mechanical ventilation or death. Thus, events considered are needing ventilator utilization (mechanical or non-invasive ventilation including high flow oxygen), or death. New do-not-resuscitate (DNR) order (if given after the inclusion of the patient) will be considered as an event at the date of the DNR.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
161 participants
Primary outcome timeframe
Day 1 to Day 14
Results posted on
2025-06-06
Participant Flow
Participant milestones
| Measure |
ANAKINRA -- Severe COVID Population (WHO-CPS =5)
Treatment includes the administration of Two IV infusions / day of ANAKINRA KINERET® 200mg (Total 400 mg) at day 1 (D1), D2 and D3, two IV infusions / day of ANAKINRA KINERET® 100mg (Total 200 mg) at day 4 (D4), and one IV infusion of ANAKINRA KINERET® 100mg (Total 100 mg) at day 5 (D5).
In case of absence of improvement at D4 (absence of clinical improvement AND absence of decrease of CRP level \> 50%), 3 supplementary days of treatment at 400 mg/day will be done at D4, D5, D6 followed by a decrease at 200 mg/day at D7 and 100 mg/day at D8 and stop thereafter
Anakinra: Treatment includes the administration of Two IV infusions / day of ANAKINRA KINERET® 200mg (Total 400 mg) at day 1 (D1), D2 and D3, two IV infusions / day of ANAKINRA KINERET® 100mg (Total 200 mg) at day 4 (D4), and one IV infusion of ANAKINRA KINERET® 100mg (Total 100 mg) at day 5 (D5).
In case of absence of improvement at D4 (absence of clinical improvement AND absence of decrease of CRP level \> 50%), 3 supplementary days of treatment at 400 mg/day will be done at D4, D5, D6 followed by a decrease at 200 mg/day at D7 and 100 mg/day at D8 and stop thereafter
|
Standard of Care -- Severe COVID Population (WHO-CPS =5)
Usual care was provided at the discretion of the site clinicians
|
ANAKINRA -- Critical COVID Population (WHO-CPS >5)
Treatment includes the administration of Two IV infusions / day of ANAKINRA KINERET® 200mg (Total 400 mg) at day 1 (D1), D2 and D3, two IV infusions / day of ANAKINRA KINERET® 100mg (Total 200 mg) at day 4 (D4), and one IV infusion of ANAKINRA KINERET® 100mg (Total 100 mg) at day 5 (D5).
In case of absence of improvement at D4 (absence of clinical improvement AND absence of decrease of CRP level \> 50%), 3 supplementary days of treatment at 400 mg/day will be done at D4, D5, D6 followed by a decrease at 200 mg/day at D7 and 100 mg/day at D8 and stop thereafter
Anakinra: Treatment includes the administration of Two IV infusions / day of ANAKINRA KINERET® 200mg (Total 400 mg) at day 1 (D1), D2 and D3, two IV infusions / day of ANAKINRA KINERET® 100mg (Total 200 mg) at day 4 (D4), and one IV infusion of ANAKINRA KINERET® 100mg (Total 100 mg) at day 5 (D5).
In case of absence of improvement at D4 (absence of clinical improvement AND absence of decrease of CRP level \> 50%), 3 supplementary days of treatment at 400 mg/day will be done at D4, D5, D6 followed by a decrease at 200 mg/day at D7 and 100 mg/day at D8 and stop thereafter
|
Standard of Care -- Critical COVID Population (WHO-CPS >5)
Usual care was provided at the discretion of the site clinicians
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
59
|
57
|
24
|
21
|
|
Overall Study
COMPLETED
|
59
|
55
|
22
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
2
|
1
|
Reasons for withdrawal
| Measure |
ANAKINRA -- Severe COVID Population (WHO-CPS =5)
Treatment includes the administration of Two IV infusions / day of ANAKINRA KINERET® 200mg (Total 400 mg) at day 1 (D1), D2 and D3, two IV infusions / day of ANAKINRA KINERET® 100mg (Total 200 mg) at day 4 (D4), and one IV infusion of ANAKINRA KINERET® 100mg (Total 100 mg) at day 5 (D5).
In case of absence of improvement at D4 (absence of clinical improvement AND absence of decrease of CRP level \> 50%), 3 supplementary days of treatment at 400 mg/day will be done at D4, D5, D6 followed by a decrease at 200 mg/day at D7 and 100 mg/day at D8 and stop thereafter
Anakinra: Treatment includes the administration of Two IV infusions / day of ANAKINRA KINERET® 200mg (Total 400 mg) at day 1 (D1), D2 and D3, two IV infusions / day of ANAKINRA KINERET® 100mg (Total 200 mg) at day 4 (D4), and one IV infusion of ANAKINRA KINERET® 100mg (Total 100 mg) at day 5 (D5).
In case of absence of improvement at D4 (absence of clinical improvement AND absence of decrease of CRP level \> 50%), 3 supplementary days of treatment at 400 mg/day will be done at D4, D5, D6 followed by a decrease at 200 mg/day at D7 and 100 mg/day at D8 and stop thereafter
|
Standard of Care -- Severe COVID Population (WHO-CPS =5)
Usual care was provided at the discretion of the site clinicians
|
ANAKINRA -- Critical COVID Population (WHO-CPS >5)
Treatment includes the administration of Two IV infusions / day of ANAKINRA KINERET® 200mg (Total 400 mg) at day 1 (D1), D2 and D3, two IV infusions / day of ANAKINRA KINERET® 100mg (Total 200 mg) at day 4 (D4), and one IV infusion of ANAKINRA KINERET® 100mg (Total 100 mg) at day 5 (D5).
In case of absence of improvement at D4 (absence of clinical improvement AND absence of decrease of CRP level \> 50%), 3 supplementary days of treatment at 400 mg/day will be done at D4, D5, D6 followed by a decrease at 200 mg/day at D7 and 100 mg/day at D8 and stop thereafter
Anakinra: Treatment includes the administration of Two IV infusions / day of ANAKINRA KINERET® 200mg (Total 400 mg) at day 1 (D1), D2 and D3, two IV infusions / day of ANAKINRA KINERET® 100mg (Total 200 mg) at day 4 (D4), and one IV infusion of ANAKINRA KINERET® 100mg (Total 100 mg) at day 5 (D5).
In case of absence of improvement at D4 (absence of clinical improvement AND absence of decrease of CRP level \> 50%), 3 supplementary days of treatment at 400 mg/day will be done at D4, D5, D6 followed by a decrease at 200 mg/day at D7 and 100 mg/day at D8 and stop thereafter
|
Standard of Care -- Critical COVID Population (WHO-CPS >5)
Usual care was provided at the discretion of the site clinicians
|
|---|---|---|---|---|
|
Overall Study
Withdrew consent
|
0
|
2
|
2
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
ANAKINRA -- Severe COVID Population (WHO-CPS =5)
n=59 Participants
Treatment includes the administration of Two IV infusions / day of ANAKINRA KINERET® 200mg (Total 400 mg) at day 1 (D1), D2 and D3, two IV infusions / day of ANAKINRA KINERET® 100mg (Total 200 mg) at day 4 (D4), and one IV infusion of ANAKINRA KINERET® 100mg (Total 100 mg) at day 5 (D5).
In case of absence of improvement at D4 (absence of clinical improvement AND absence of decrease of CRP level \> 50%), 3 supplementary days of treatment at 400 mg/day will be done at D4, D5, D6 followed by a decrease at 200 mg/day at D7 and 100 mg/day at D8 and stop thereafter
Anakinra: Treatment includes the administration of Two IV infusions / day of ANAKINRA KINERET® 200mg (Total 400 mg) at day 1 (D1), D2 and D3, two IV infusions / day of ANAKINRA KINERET® 100mg (Total 200 mg) at day 4 (D4), and one IV infusion of ANAKINRA KINERET® 100mg (Total 100 mg) at day 5 (D5).
In case of absence of improvement at D4 (absence of clinical improvement AND absence of decrease of CRP level \> 50%), 3 supplementary days of treatment at 400 mg/day will be done at D4, D5, D6 followed by a decrease at 200 mg/day at D7 and 100 mg/day at D8 and stop thereafter
|
Standard of Care -- Severe COVID Population (WHO-CPS =5)
n=55 Participants
Usual care was provided at the discretion of the site clinicians
|
ANAKINRA -- Critical COVID Population (WHO-CPS >5)
n=22 Participants
Treatment includes the administration of Two IV infusions / day of ANAKINRA KINERET® 200mg (Total 400 mg) at day 1 (D1), D2 and D3, two IV infusions / day of ANAKINRA KINERET® 100mg (Total 200 mg) at day 4 (D4), and one IV infusion of ANAKINRA KINERET® 100mg (Total 100 mg) at day 5 (D5).
In case of absence of improvement at D4 (absence of clinical improvement AND absence of decrease of CRP level \> 50%), 3 supplementary days of treatment at 400 mg/day will be done at D4, D5, D6 followed by a decrease at 200 mg/day at D7 and 100 mg/day at D8 and stop thereafter Anakinra: Treatment includes the administration of Two IV infusions / day of ANAKINRA KINERET® 200mg (Total 400 mg) at day 1 (D1), D2 and D3, two IV infusions / day of ANAKINRA KINERET® 100mg (Total 200 mg) at day 4 (D4), and one IV infusion of ANAKINRA KINERET® 100mg (Total 100 mg) at day 5 (D5).
In case of absence of improvement at D4 (absence of clinical improvement AND absence of decrease of CRP level \> 50%), 3 supplementary days of treatment at 400 mg/day will be done at D4, D5, D6 followed by a decrease at 200 mg/day at D7 and 100 mg/day at D8 and stop thereafter
|
Standard of Care -- Critical COVID Population (WHO-CPS >5)
n=20 Participants
Usual care was provided at the discretion of the site clinicians
|
Total
n=156 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
67 years
n=59 Participants
|
64.9 years
n=55 Participants
|
59.6 years
n=22 Participants
|
61.5 years
n=20 Participants
|
64.7 years
n=156 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=59 Participants
|
18 Participants
n=55 Participants
|
7 Participants
n=22 Participants
|
5 Participants
n=20 Participants
|
46 Participants
n=156 Participants
|
|
Sex: Female, Male
Male
|
43 Participants
n=59 Participants
|
37 Participants
n=55 Participants
|
15 Participants
n=22 Participants
|
15 Participants
n=20 Participants
|
110 Participants
n=156 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Body Mass Index >= 30 kg/m²
|
13 Participants
n=58 Participants • Missing data are possible
|
15 Participants
n=55 Participants • Missing data are possible
|
7 Participants
n=22 Participants • Missing data are possible
|
8 Participants
n=20 Participants • Missing data are possible
|
43 Participants
n=155 Participants • Missing data are possible
|
|
Weight
|
78 kg
n=59 Participants • Missing data are possible
|
77.5 kg
n=46 Participants • Missing data are possible
|
81 kg
n=22 Participants • Missing data are possible
|
85 kg
n=20 Participants • Missing data are possible
|
80 kg
n=147 Participants • Missing data are possible
|
|
SPO2
|
95 %
n=59 Participants
|
95 %
n=55 Participants
|
94.5 %
n=22 Participants
|
94.5 %
n=20 Participants
|
95 %
n=156 Participants
|
|
Temperature
|
37.8 °C
n=59 Participants
|
37.6 °C
n=55 Participants
|
37.8 °C
n=22 Participants
|
38.3 °C
n=20 Participants
|
37.8 °C
n=156 Participants
|
|
Respiratory rate
|
28 breaths/min
n=55 Participants • Missing data are possible
|
28 breaths/min
n=50 Participants • Missing data are possible
|
30 breaths/min
n=22 Participants • Missing data are possible
|
26 breaths/min
n=19 Participants • Missing data are possible
|
28 breaths/min
n=146 Participants • Missing data are possible
|
PRIMARY outcome
Timeframe: Day 1 to Day 14Population: Severe COVID population ((WHO clinical progression scale =5 at baseline)
Survival without needs of ventilator utilization (including non invasive ventilation and high flow) at day 14. Percentage of non-invasive ventilation, mechanical ventilation or death. Thus, events considered are needing ventilator utilization (mechanical or non-invasive ventilation including high flow oxygen), or death. New do-not-resuscitate (DNR) order (if given after the inclusion of the patient) will be considered as an event at the date of the DNR.
Outcome measures
| Measure |
ANAKINRA -- Severe COVID Population (WHO-CPS =5)
n=59 Participants
Treatment includes the administration of Two IV infusions / day of ANAKINRA KINERET® 200mg (Total 400 mg) at day 1 (D1), D2 and D3, two IV infusions / day of ANAKINRA KINERET® 100mg (Total 200 mg) at day 4 (D4), and one IV infusion of ANAKINRA KINERET® 100mg (Total 100 mg) at day 5 (D5).
In case of absence of improvement at D4 (absence of clinical improvement AND absence of decrease of CRP level \> 50%), 3 supplementary days of treatment at 400 mg/day will be done at D4, D5, D6 followed by a decrease at 200 mg/day at D7 and 100 mg/day at D8 and stop thereafter
Anakinra: Treatment includes the administration of Two IV infusions / day of ANAKINRA KINERET® 200mg (Total 400 mg) at day 1 (D1), D2 and D3, two IV infusions / day of ANAKINRA KINERET® 100mg (Total 200 mg) at day 4 (D4), and one IV infusion of ANAKINRA KINERET® 100mg (Total 100 mg) at day 5 (D5).
In case of absence of improvement at D4 (absence of clinical improvement AND absence of decrease of CRP level \> 50%), 3 supplementary days of treatment at 400 mg/day will be done at D4, D5, D6 followed by a decrease at 200 mg/day at D7 and 100 mg/day at D8 and stop thereafter
|
Standard of Care -- Severe COVID Population (WHO-CPS =5)
n=55 Participants
Usual care was provided at the discretion of the site clinicians
|
ANAKINRA -- Critical COVID Population (WHO-CPS >5)
Treatment includes the administration of Two IV infusions / day of ANAKINRA KINERET® 200mg (Total 400 mg) at day 1 (D1), D2 and D3, two IV infusions / day of ANAKINRA KINERET® 100mg (Total 200 mg) at day 4 (D4), and one IV infusion of ANAKINRA KINERET® 100mg (Total 100 mg) at day 5 (D5).
In case of absence of improvement at D4 (absence of clinical improvement AND absence of decrease of CRP level \> 50%), 3 supplementary days of treatment at 400 mg/day will be done at D4, D5, D6 followed by a decrease at 200 mg/day at D7 and 100 mg/day at D8 and stop thereafter
Anakinra: Treatment includes the administration of Two IV infusions / day of ANAKINRA KINERET® 200mg (Total 400 mg) at day 1 (D1), D2 and D3, two IV infusions / day of ANAKINRA KINERET® 100mg (Total 200 mg) at day 4 (D4), and one IV infusion of ANAKINRA KINERET® 100mg (Total 100 mg) at day 5 (D5).
In case of absence of improvement at D4 (absence of clinical improvement AND absence of decrease of CRP level \> 50%), 3 supplementary days of treatment at 400 mg/day will be done at D4, D5, D6 followed by a decrease at 200 mg/day at D7 and 100 mg/day at D8 and stop thereafter
|
Standard of Care -- Critical COVID Population (WHO-CPS >5)
Usual care was provided at the discretion of the site clinicians
|
|---|---|---|---|---|
|
Percentage of Participants With Non-invasive Ventilation, Mechanical Ventilation or Death at Day 14 -- Severe COVID Population (WHO Clinical Progression Scale =5 at Baseline)
|
47 percentage of participants
Interval 33.0 to 59.0
|
51 percentage of participants
Interval 36.0 to 62.0
|
—
|
—
|
PRIMARY outcome
Timeframe: 4 daysPopulation: Severe COVID population (WHO clinical progression scale =5 at baseline)
Percentage of participants who has died or needed non-invasive or mechanical ventilation by day 4 (WHO clinical progression scale \> 5). A patient with new do-not-resuscitate order at day 4 will be considered as with a score \> 5.
Outcome measures
| Measure |
ANAKINRA -- Severe COVID Population (WHO-CPS =5)
n=59 Participants
Treatment includes the administration of Two IV infusions / day of ANAKINRA KINERET® 200mg (Total 400 mg) at day 1 (D1), D2 and D3, two IV infusions / day of ANAKINRA KINERET® 100mg (Total 200 mg) at day 4 (D4), and one IV infusion of ANAKINRA KINERET® 100mg (Total 100 mg) at day 5 (D5).
In case of absence of improvement at D4 (absence of clinical improvement AND absence of decrease of CRP level \> 50%), 3 supplementary days of treatment at 400 mg/day will be done at D4, D5, D6 followed by a decrease at 200 mg/day at D7 and 100 mg/day at D8 and stop thereafter
Anakinra: Treatment includes the administration of Two IV infusions / day of ANAKINRA KINERET® 200mg (Total 400 mg) at day 1 (D1), D2 and D3, two IV infusions / day of ANAKINRA KINERET® 100mg (Total 200 mg) at day 4 (D4), and one IV infusion of ANAKINRA KINERET® 100mg (Total 100 mg) at day 5 (D5).
In case of absence of improvement at D4 (absence of clinical improvement AND absence of decrease of CRP level \> 50%), 3 supplementary days of treatment at 400 mg/day will be done at D4, D5, D6 followed by a decrease at 200 mg/day at D7 and 100 mg/day at D8 and stop thereafter
|
Standard of Care -- Severe COVID Population (WHO-CPS =5)
n=55 Participants
Usual care was provided at the discretion of the site clinicians
|
ANAKINRA -- Critical COVID Population (WHO-CPS >5)
Treatment includes the administration of Two IV infusions / day of ANAKINRA KINERET® 200mg (Total 400 mg) at day 1 (D1), D2 and D3, two IV infusions / day of ANAKINRA KINERET® 100mg (Total 200 mg) at day 4 (D4), and one IV infusion of ANAKINRA KINERET® 100mg (Total 100 mg) at day 5 (D5).
In case of absence of improvement at D4 (absence of clinical improvement AND absence of decrease of CRP level \> 50%), 3 supplementary days of treatment at 400 mg/day will be done at D4, D5, D6 followed by a decrease at 200 mg/day at D7 and 100 mg/day at D8 and stop thereafter
Anakinra: Treatment includes the administration of Two IV infusions / day of ANAKINRA KINERET® 200mg (Total 400 mg) at day 1 (D1), D2 and D3, two IV infusions / day of ANAKINRA KINERET® 100mg (Total 200 mg) at day 4 (D4), and one IV infusion of ANAKINRA KINERET® 100mg (Total 100 mg) at day 5 (D5).
In case of absence of improvement at D4 (absence of clinical improvement AND absence of decrease of CRP level \> 50%), 3 supplementary days of treatment at 400 mg/day will be done at D4, D5, D6 followed by a decrease at 200 mg/day at D7 and 100 mg/day at D8 and stop thereafter
|
Standard of Care -- Critical COVID Population (WHO-CPS >5)
Usual care was provided at the discretion of the site clinicians
|
|---|---|---|---|---|
|
Percentage of Participants With WHO Clinical Progression Scale > 5 at Day 4 -- Severe COVID Population (WHO Clinical Progression Scale =5 at Baseline)
|
36 percentage of participants
|
38 percentage of participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 to Day 14Population: Critical COVID population (WHO clinical progression scale \>5 at baseline)
Cumulative incidence (percentage) of successful tracheal extubation (defined as duration extubation \> 48h) at day 14 if patients have been intubated before day 14 ; or removal of non invasive ventilation or high flow (for \> 48h) if they were included under oxygen by non invasive ventilation or High flow (score 6) and remained without intubation. Death or new do-not-resuscitate order (if given after the inclusion of the patient) will be considered as a competing event.
Outcome measures
| Measure |
ANAKINRA -- Severe COVID Population (WHO-CPS =5)
n=22 Participants
Treatment includes the administration of Two IV infusions / day of ANAKINRA KINERET® 200mg (Total 400 mg) at day 1 (D1), D2 and D3, two IV infusions / day of ANAKINRA KINERET® 100mg (Total 200 mg) at day 4 (D4), and one IV infusion of ANAKINRA KINERET® 100mg (Total 100 mg) at day 5 (D5).
In case of absence of improvement at D4 (absence of clinical improvement AND absence of decrease of CRP level \> 50%), 3 supplementary days of treatment at 400 mg/day will be done at D4, D5, D6 followed by a decrease at 200 mg/day at D7 and 100 mg/day at D8 and stop thereafter
Anakinra: Treatment includes the administration of Two IV infusions / day of ANAKINRA KINERET® 200mg (Total 400 mg) at day 1 (D1), D2 and D3, two IV infusions / day of ANAKINRA KINERET® 100mg (Total 200 mg) at day 4 (D4), and one IV infusion of ANAKINRA KINERET® 100mg (Total 100 mg) at day 5 (D5).
In case of absence of improvement at D4 (absence of clinical improvement AND absence of decrease of CRP level \> 50%), 3 supplementary days of treatment at 400 mg/day will be done at D4, D5, D6 followed by a decrease at 200 mg/day at D7 and 100 mg/day at D8 and stop thereafter
|
Standard of Care -- Severe COVID Population (WHO-CPS =5)
n=20 Participants
Usual care was provided at the discretion of the site clinicians
|
ANAKINRA -- Critical COVID Population (WHO-CPS >5)
Treatment includes the administration of Two IV infusions / day of ANAKINRA KINERET® 200mg (Total 400 mg) at day 1 (D1), D2 and D3, two IV infusions / day of ANAKINRA KINERET® 100mg (Total 200 mg) at day 4 (D4), and one IV infusion of ANAKINRA KINERET® 100mg (Total 100 mg) at day 5 (D5).
In case of absence of improvement at D4 (absence of clinical improvement AND absence of decrease of CRP level \> 50%), 3 supplementary days of treatment at 400 mg/day will be done at D4, D5, D6 followed by a decrease at 200 mg/day at D7 and 100 mg/day at D8 and stop thereafter
Anakinra: Treatment includes the administration of Two IV infusions / day of ANAKINRA KINERET® 200mg (Total 400 mg) at day 1 (D1), D2 and D3, two IV infusions / day of ANAKINRA KINERET® 100mg (Total 200 mg) at day 4 (D4), and one IV infusion of ANAKINRA KINERET® 100mg (Total 100 mg) at day 5 (D5).
In case of absence of improvement at D4 (absence of clinical improvement AND absence of decrease of CRP level \> 50%), 3 supplementary days of treatment at 400 mg/day will be done at D4, D5, D6 followed by a decrease at 200 mg/day at D7 and 100 mg/day at D8 and stop thereafter
|
Standard of Care -- Critical COVID Population (WHO-CPS >5)
Usual care was provided at the discretion of the site clinicians
|
|---|---|---|---|---|
|
Cumulative Incidence (Percentage) of Participants With Successful Tracheal Extubation at Day 14 -- Critical COVID Population (WHO Clinical Progression Scale >5 at Baseline)
|
50 percentage of participants
Interval 28.0 to 69.0
|
40 percentage of participants
Interval 19.0 to 61.0
|
—
|
—
|
PRIMARY outcome
Timeframe: 4 daysPopulation: Critical COVID population (WHO clinical progression scale \>5)
Percentage of patients with a decrease of WHO score of at least 1 point at day 4
Outcome measures
| Measure |
ANAKINRA -- Severe COVID Population (WHO-CPS =5)
n=22 Participants
Treatment includes the administration of Two IV infusions / day of ANAKINRA KINERET® 200mg (Total 400 mg) at day 1 (D1), D2 and D3, two IV infusions / day of ANAKINRA KINERET® 100mg (Total 200 mg) at day 4 (D4), and one IV infusion of ANAKINRA KINERET® 100mg (Total 100 mg) at day 5 (D5).
In case of absence of improvement at D4 (absence of clinical improvement AND absence of decrease of CRP level \> 50%), 3 supplementary days of treatment at 400 mg/day will be done at D4, D5, D6 followed by a decrease at 200 mg/day at D7 and 100 mg/day at D8 and stop thereafter
Anakinra: Treatment includes the administration of Two IV infusions / day of ANAKINRA KINERET® 200mg (Total 400 mg) at day 1 (D1), D2 and D3, two IV infusions / day of ANAKINRA KINERET® 100mg (Total 200 mg) at day 4 (D4), and one IV infusion of ANAKINRA KINERET® 100mg (Total 100 mg) at day 5 (D5).
In case of absence of improvement at D4 (absence of clinical improvement AND absence of decrease of CRP level \> 50%), 3 supplementary days of treatment at 400 mg/day will be done at D4, D5, D6 followed by a decrease at 200 mg/day at D7 and 100 mg/day at D8 and stop thereafter
|
Standard of Care -- Severe COVID Population (WHO-CPS =5)
n=20 Participants
Usual care was provided at the discretion of the site clinicians
|
ANAKINRA -- Critical COVID Population (WHO-CPS >5)
Treatment includes the administration of Two IV infusions / day of ANAKINRA KINERET® 200mg (Total 400 mg) at day 1 (D1), D2 and D3, two IV infusions / day of ANAKINRA KINERET® 100mg (Total 200 mg) at day 4 (D4), and one IV infusion of ANAKINRA KINERET® 100mg (Total 100 mg) at day 5 (D5).
In case of absence of improvement at D4 (absence of clinical improvement AND absence of decrease of CRP level \> 50%), 3 supplementary days of treatment at 400 mg/day will be done at D4, D5, D6 followed by a decrease at 200 mg/day at D7 and 100 mg/day at D8 and stop thereafter
Anakinra: Treatment includes the administration of Two IV infusions / day of ANAKINRA KINERET® 200mg (Total 400 mg) at day 1 (D1), D2 and D3, two IV infusions / day of ANAKINRA KINERET® 100mg (Total 200 mg) at day 4 (D4), and one IV infusion of ANAKINRA KINERET® 100mg (Total 100 mg) at day 5 (D5).
In case of absence of improvement at D4 (absence of clinical improvement AND absence of decrease of CRP level \> 50%), 3 supplementary days of treatment at 400 mg/day will be done at D4, D5, D6 followed by a decrease at 200 mg/day at D7 and 100 mg/day at D8 and stop thereafter
|
Standard of Care -- Critical COVID Population (WHO-CPS >5)
Usual care was provided at the discretion of the site clinicians
|
|---|---|---|---|---|
|
Percentage of Participants With a Decrease of at Least One Point in WHO Clinical Progression Scale Score at Day 4 -- Critical COVID Population (WHO Clinical Progression Scale >5)
|
36 percentage of participants
|
10 percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 4, 7, 14, 28 daysPopulation: No comparison was planned at Day 7 in the Severe COVID Population (WHO clinical progression scale =5) so no descriptive/comparative data were done. No comparison was planned at Day 28 in Critical COVID Population (WHO clinical progression scale \>5) so no descriptive/comparative data were done.
WHO clinical progression scale: Uninfected; non viral RNA detected: 0 Asymptomatic; viral RNA detected: 1 Symptomatic; Independent: 2 Symptomatic; Assistance needed: 3 Hospitalized; No oxygen therapy: 4 Hospitalized; oxygen by mask or nasal prongs: 5 Hospitalized; oxygen by Non invasive Ventilation or High flow: 6 Intubation and Mechanical ventilation, pO2/FIO2\>=150 OR SpO2/FIO2\>=200: 7 Mechanical ventilation, (pO2/FIO2\<150 OR SpO2/FIO2\<200) OR vasopressors (norepinephrine \>0.3 microg/kg/min): 8 Mechanical ventilation, pO2/FIO2\<150 AND vasopressors (norepinephrine \>0.3 microg/kg/min), OR Dialysis OR ECMO: 9 Dead: 10.
Outcome measures
| Measure |
ANAKINRA -- Severe COVID Population (WHO-CPS =5)
n=59 Participants
Treatment includes the administration of Two IV infusions / day of ANAKINRA KINERET® 200mg (Total 400 mg) at day 1 (D1), D2 and D3, two IV infusions / day of ANAKINRA KINERET® 100mg (Total 200 mg) at day 4 (D4), and one IV infusion of ANAKINRA KINERET® 100mg (Total 100 mg) at day 5 (D5).
In case of absence of improvement at D4 (absence of clinical improvement AND absence of decrease of CRP level \> 50%), 3 supplementary days of treatment at 400 mg/day will be done at D4, D5, D6 followed by a decrease at 200 mg/day at D7 and 100 mg/day at D8 and stop thereafter
Anakinra: Treatment includes the administration of Two IV infusions / day of ANAKINRA KINERET® 200mg (Total 400 mg) at day 1 (D1), D2 and D3, two IV infusions / day of ANAKINRA KINERET® 100mg (Total 200 mg) at day 4 (D4), and one IV infusion of ANAKINRA KINERET® 100mg (Total 100 mg) at day 5 (D5).
In case of absence of improvement at D4 (absence of clinical improvement AND absence of decrease of CRP level \> 50%), 3 supplementary days of treatment at 400 mg/day will be done at D4, D5, D6 followed by a decrease at 200 mg/day at D7 and 100 mg/day at D8 and stop thereafter
|
Standard of Care -- Severe COVID Population (WHO-CPS =5)
n=55 Participants
Usual care was provided at the discretion of the site clinicians
|
ANAKINRA -- Critical COVID Population (WHO-CPS >5)
n=22 Participants
Treatment includes the administration of Two IV infusions / day of ANAKINRA KINERET® 200mg (Total 400 mg) at day 1 (D1), D2 and D3, two IV infusions / day of ANAKINRA KINERET® 100mg (Total 200 mg) at day 4 (D4), and one IV infusion of ANAKINRA KINERET® 100mg (Total 100 mg) at day 5 (D5).
In case of absence of improvement at D4 (absence of clinical improvement AND absence of decrease of CRP level \> 50%), 3 supplementary days of treatment at 400 mg/day will be done at D4, D5, D6 followed by a decrease at 200 mg/day at D7 and 100 mg/day at D8 and stop thereafter
Anakinra: Treatment includes the administration of Two IV infusions / day of ANAKINRA KINERET® 200mg (Total 400 mg) at day 1 (D1), D2 and D3, two IV infusions / day of ANAKINRA KINERET® 100mg (Total 200 mg) at day 4 (D4), and one IV infusion of ANAKINRA KINERET® 100mg (Total 100 mg) at day 5 (D5).
In case of absence of improvement at D4 (absence of clinical improvement AND absence of decrease of CRP level \> 50%), 3 supplementary days of treatment at 400 mg/day will be done at D4, D5, D6 followed by a decrease at 200 mg/day at D7 and 100 mg/day at D8 and stop thereafter
|
Standard of Care -- Critical COVID Population (WHO-CPS >5)
n=20 Participants
Usual care was provided at the discretion of the site clinicians
|
|---|---|---|---|---|
|
WHO Clinical Progression Scale
Day 4
|
5 units on a scale
Interval 5.0 to 6.0
|
5 units on a scale
Interval 5.0 to 6.0
|
7 units on a scale
Interval 6.0 to 8.0
|
6 units on a scale
Interval 6.0 to 8.0
|
|
WHO Clinical Progression Scale
Day 7
|
NA units on a scale
No comparison was planned at Day 7 in the Severe COVID Population (WHO clinical progression scale =5) so no descriptive/comparative data were done.
|
NA units on a scale
No comparison was planned at Day 7 in the Severe COVID Population (WHO clinical progression scale =5) so no descriptive/comparative data were done.
|
7 units on a scale
Interval 6.0 to 8.0
|
7 units on a scale
Interval 5.0 to 8.0
|
|
WHO Clinical Progression Scale
Day 14
|
5 units on a scale
Interval 5.0 to 7.0
|
5 units on a scale
Interval 5.0 to 7.0
|
6 units on a scale
Interval 4.0 to 8.0
|
6 units on a scale
Interval 5.0 to 8.0
|
|
WHO Clinical Progression Scale
Day 28
|
5 units on a scale
Interval 2.0 to 8.0
|
5 units on a scale
Interval 3.0 to 8.0
|
NA units on a scale
No comparison was planned at Day 28 in Critical COVID Population (WHO clinical progression scale \>5) so no descriptive/comparative data were done.
|
NA units on a scale
No comparison was planned at Day 28 in Critical COVID Population (WHO clinical progression scale \>5) so no descriptive/comparative data were done.
|
SECONDARY outcome
Timeframe: 14, 28 and 90 daysPercentage of participants surviving at 14, 28 and 90 days
Outcome measures
| Measure |
ANAKINRA -- Severe COVID Population (WHO-CPS =5)
n=59 Participants
Treatment includes the administration of Two IV infusions / day of ANAKINRA KINERET® 200mg (Total 400 mg) at day 1 (D1), D2 and D3, two IV infusions / day of ANAKINRA KINERET® 100mg (Total 200 mg) at day 4 (D4), and one IV infusion of ANAKINRA KINERET® 100mg (Total 100 mg) at day 5 (D5).
In case of absence of improvement at D4 (absence of clinical improvement AND absence of decrease of CRP level \> 50%), 3 supplementary days of treatment at 400 mg/day will be done at D4, D5, D6 followed by a decrease at 200 mg/day at D7 and 100 mg/day at D8 and stop thereafter
Anakinra: Treatment includes the administration of Two IV infusions / day of ANAKINRA KINERET® 200mg (Total 400 mg) at day 1 (D1), D2 and D3, two IV infusions / day of ANAKINRA KINERET® 100mg (Total 200 mg) at day 4 (D4), and one IV infusion of ANAKINRA KINERET® 100mg (Total 100 mg) at day 5 (D5).
In case of absence of improvement at D4 (absence of clinical improvement AND absence of decrease of CRP level \> 50%), 3 supplementary days of treatment at 400 mg/day will be done at D4, D5, D6 followed by a decrease at 200 mg/day at D7 and 100 mg/day at D8 and stop thereafter
|
Standard of Care -- Severe COVID Population (WHO-CPS =5)
n=55 Participants
Usual care was provided at the discretion of the site clinicians
|
ANAKINRA -- Critical COVID Population (WHO-CPS >5)
n=22 Participants
Treatment includes the administration of Two IV infusions / day of ANAKINRA KINERET® 200mg (Total 400 mg) at day 1 (D1), D2 and D3, two IV infusions / day of ANAKINRA KINERET® 100mg (Total 200 mg) at day 4 (D4), and one IV infusion of ANAKINRA KINERET® 100mg (Total 100 mg) at day 5 (D5).
In case of absence of improvement at D4 (absence of clinical improvement AND absence of decrease of CRP level \> 50%), 3 supplementary days of treatment at 400 mg/day will be done at D4, D5, D6 followed by a decrease at 200 mg/day at D7 and 100 mg/day at D8 and stop thereafter
Anakinra: Treatment includes the administration of Two IV infusions / day of ANAKINRA KINERET® 200mg (Total 400 mg) at day 1 (D1), D2 and D3, two IV infusions / day of ANAKINRA KINERET® 100mg (Total 200 mg) at day 4 (D4), and one IV infusion of ANAKINRA KINERET® 100mg (Total 100 mg) at day 5 (D5).
In case of absence of improvement at D4 (absence of clinical improvement AND absence of decrease of CRP level \> 50%), 3 supplementary days of treatment at 400 mg/day will be done at D4, D5, D6 followed by a decrease at 200 mg/day at D7 and 100 mg/day at D8 and stop thereafter
|
Standard of Care -- Critical COVID Population (WHO-CPS >5)
n=20 Participants
Usual care was provided at the discretion of the site clinicians
|
|---|---|---|---|---|
|
Percentage of Participants Surviving (Overall Survival)
Day 14
|
85 percentage of participants
Interval 76.0 to 94.0
|
76 percentage of participants
Interval 66.0 to 88.0
|
91 percentage of participants
Interval 80.0 to 100.0
|
85 percentage of participants
Interval 71.0 to 100.0
|
|
Percentage of Participants Surviving (Overall Survival)
Day 28
|
78 percentage of participants
Interval 68.0 to 89.0
|
76 percentage of participants
Interval 66.0 to 88.0
|
96 percentage of participants
Interval 73.0 to 100.0
|
85 percentage of participants
Interval 71.0 to 100.0
|
|
Percentage of Participants Surviving (Overall Survival)
Day 90
|
72 percentage of participants
Interval 61.0 to 85.0
|
72 percentage of participants
Interval 62.0 to 85.0
|
73 percentage of participants
Interval 56.0 to 94.0
|
80 percentage of participants
Interval 64.0 to 100.0
|
SECONDARY outcome
Timeframe: 28 daysPopulation: Critical COVID Population (WHO clinical progression scale \>5 at baseline)
28-day Ventilator Free-days
Outcome measures
| Measure |
ANAKINRA -- Severe COVID Population (WHO-CPS =5)
n=22 Participants
Treatment includes the administration of Two IV infusions / day of ANAKINRA KINERET® 200mg (Total 400 mg) at day 1 (D1), D2 and D3, two IV infusions / day of ANAKINRA KINERET® 100mg (Total 200 mg) at day 4 (D4), and one IV infusion of ANAKINRA KINERET® 100mg (Total 100 mg) at day 5 (D5).
In case of absence of improvement at D4 (absence of clinical improvement AND absence of decrease of CRP level \> 50%), 3 supplementary days of treatment at 400 mg/day will be done at D4, D5, D6 followed by a decrease at 200 mg/day at D7 and 100 mg/day at D8 and stop thereafter
Anakinra: Treatment includes the administration of Two IV infusions / day of ANAKINRA KINERET® 200mg (Total 400 mg) at day 1 (D1), D2 and D3, two IV infusions / day of ANAKINRA KINERET® 100mg (Total 200 mg) at day 4 (D4), and one IV infusion of ANAKINRA KINERET® 100mg (Total 100 mg) at day 5 (D5).
In case of absence of improvement at D4 (absence of clinical improvement AND absence of decrease of CRP level \> 50%), 3 supplementary days of treatment at 400 mg/day will be done at D4, D5, D6 followed by a decrease at 200 mg/day at D7 and 100 mg/day at D8 and stop thereafter
|
Standard of Care -- Severe COVID Population (WHO-CPS =5)
n=20 Participants
Usual care was provided at the discretion of the site clinicians
|
ANAKINRA -- Critical COVID Population (WHO-CPS >5)
Treatment includes the administration of Two IV infusions / day of ANAKINRA KINERET® 200mg (Total 400 mg) at day 1 (D1), D2 and D3, two IV infusions / day of ANAKINRA KINERET® 100mg (Total 200 mg) at day 4 (D4), and one IV infusion of ANAKINRA KINERET® 100mg (Total 100 mg) at day 5 (D5).
In case of absence of improvement at D4 (absence of clinical improvement AND absence of decrease of CRP level \> 50%), 3 supplementary days of treatment at 400 mg/day will be done at D4, D5, D6 followed by a decrease at 200 mg/day at D7 and 100 mg/day at D8 and stop thereafter
Anakinra: Treatment includes the administration of Two IV infusions / day of ANAKINRA KINERET® 200mg (Total 400 mg) at day 1 (D1), D2 and D3, two IV infusions / day of ANAKINRA KINERET® 100mg (Total 200 mg) at day 4 (D4), and one IV infusion of ANAKINRA KINERET® 100mg (Total 100 mg) at day 5 (D5).
In case of absence of improvement at D4 (absence of clinical improvement AND absence of decrease of CRP level \> 50%), 3 supplementary days of treatment at 400 mg/day will be done at D4, D5, D6 followed by a decrease at 200 mg/day at D7 and 100 mg/day at D8 and stop thereafter
|
Standard of Care -- Critical COVID Population (WHO-CPS >5)
Usual care was provided at the discretion of the site clinicians
|
|---|---|---|---|---|
|
Mean of Ventilator Free-days at Day 28 -- Critical COVID Population (WHO-clinical Progression Scale >5 at Baseline)
|
14.4 days
Standard Deviation 11.9
|
14.8 days
Standard Deviation 12.6
|
—
|
—
|
SECONDARY outcome
Timeframe: day 1 to day 14Population: No statistical comparison was performed due to the limited number of patients with available follow-up data.
Evolution of PaO2/FiO2 ratio
Outcome measures
| Measure |
ANAKINRA -- Severe COVID Population (WHO-CPS =5)
n=11 Participants
Treatment includes the administration of Two IV infusions / day of ANAKINRA KINERET® 200mg (Total 400 mg) at day 1 (D1), D2 and D3, two IV infusions / day of ANAKINRA KINERET® 100mg (Total 200 mg) at day 4 (D4), and one IV infusion of ANAKINRA KINERET® 100mg (Total 100 mg) at day 5 (D5).
In case of absence of improvement at D4 (absence of clinical improvement AND absence of decrease of CRP level \> 50%), 3 supplementary days of treatment at 400 mg/day will be done at D4, D5, D6 followed by a decrease at 200 mg/day at D7 and 100 mg/day at D8 and stop thereafter
Anakinra: Treatment includes the administration of Two IV infusions / day of ANAKINRA KINERET® 200mg (Total 400 mg) at day 1 (D1), D2 and D3, two IV infusions / day of ANAKINRA KINERET® 100mg (Total 200 mg) at day 4 (D4), and one IV infusion of ANAKINRA KINERET® 100mg (Total 100 mg) at day 5 (D5).
In case of absence of improvement at D4 (absence of clinical improvement AND absence of decrease of CRP level \> 50%), 3 supplementary days of treatment at 400 mg/day will be done at D4, D5, D6 followed by a decrease at 200 mg/day at D7 and 100 mg/day at D8 and stop thereafter
|
Standard of Care -- Severe COVID Population (WHO-CPS =5)
n=10 Participants
Usual care was provided at the discretion of the site clinicians
|
ANAKINRA -- Critical COVID Population (WHO-CPS >5)
Treatment includes the administration of Two IV infusions / day of ANAKINRA KINERET® 200mg (Total 400 mg) at day 1 (D1), D2 and D3, two IV infusions / day of ANAKINRA KINERET® 100mg (Total 200 mg) at day 4 (D4), and one IV infusion of ANAKINRA KINERET® 100mg (Total 100 mg) at day 5 (D5).
In case of absence of improvement at D4 (absence of clinical improvement AND absence of decrease of CRP level \> 50%), 3 supplementary days of treatment at 400 mg/day will be done at D4, D5, D6 followed by a decrease at 200 mg/day at D7 and 100 mg/day at D8 and stop thereafter
Anakinra: Treatment includes the administration of Two IV infusions / day of ANAKINRA KINERET® 200mg (Total 400 mg) at day 1 (D1), D2 and D3, two IV infusions / day of ANAKINRA KINERET® 100mg (Total 200 mg) at day 4 (D4), and one IV infusion of ANAKINRA KINERET® 100mg (Total 100 mg) at day 5 (D5).
In case of absence of improvement at D4 (absence of clinical improvement AND absence of decrease of CRP level \> 50%), 3 supplementary days of treatment at 400 mg/day will be done at D4, D5, D6 followed by a decrease at 200 mg/day at D7 and 100 mg/day at D8 and stop thereafter
|
Standard of Care -- Critical COVID Population (WHO-CPS >5)
Usual care was provided at the discretion of the site clinicians
|
|---|---|---|---|---|
|
PaO2/FiO2 Ratio -- Critical COVID Population (WHO Clinical Progression Scale >5 at Baseline)
Day 1
|
175.0 mmHg
Interval 117.9 to 225.0
|
118.7 mmHg
Interval 96.9 to 172.5
|
—
|
—
|
|
PaO2/FiO2 Ratio -- Critical COVID Population (WHO Clinical Progression Scale >5 at Baseline)
Day 4
|
114.5 mmHg
Interval 103.0 to 154.6
|
136.1 mmHg
Interval 98.1 to 282.1
|
—
|
—
|
|
PaO2/FiO2 Ratio -- Critical COVID Population (WHO Clinical Progression Scale >5 at Baseline)
Day 7
|
182.0 mmHg
Interval 163.0 to 262.6
|
142.0 mmHg
Interval 79.3 to 192.5
|
—
|
—
|
|
PaO2/FiO2 Ratio -- Critical COVID Population (WHO Clinical Progression Scale >5 at Baseline)
Day 14
|
180.0 mmHg
Interval 175.0 to 276.7
|
218.3 mmHg
Interval 139.4 to 272.5
|
—
|
—
|
SECONDARY outcome
Timeframe: 28 and 90 daysTime to oxygen supply independency
Outcome measures
| Measure |
ANAKINRA -- Severe COVID Population (WHO-CPS =5)
n=59 Participants
Treatment includes the administration of Two IV infusions / day of ANAKINRA KINERET® 200mg (Total 400 mg) at day 1 (D1), D2 and D3, two IV infusions / day of ANAKINRA KINERET® 100mg (Total 200 mg) at day 4 (D4), and one IV infusion of ANAKINRA KINERET® 100mg (Total 100 mg) at day 5 (D5).
In case of absence of improvement at D4 (absence of clinical improvement AND absence of decrease of CRP level \> 50%), 3 supplementary days of treatment at 400 mg/day will be done at D4, D5, D6 followed by a decrease at 200 mg/day at D7 and 100 mg/day at D8 and stop thereafter
Anakinra: Treatment includes the administration of Two IV infusions / day of ANAKINRA KINERET® 200mg (Total 400 mg) at day 1 (D1), D2 and D3, two IV infusions / day of ANAKINRA KINERET® 100mg (Total 200 mg) at day 4 (D4), and one IV infusion of ANAKINRA KINERET® 100mg (Total 100 mg) at day 5 (D5).
In case of absence of improvement at D4 (absence of clinical improvement AND absence of decrease of CRP level \> 50%), 3 supplementary days of treatment at 400 mg/day will be done at D4, D5, D6 followed by a decrease at 200 mg/day at D7 and 100 mg/day at D8 and stop thereafter
|
Standard of Care -- Severe COVID Population (WHO-CPS =5)
n=55 Participants
Usual care was provided at the discretion of the site clinicians
|
ANAKINRA -- Critical COVID Population (WHO-CPS >5)
n=22 Participants
Treatment includes the administration of Two IV infusions / day of ANAKINRA KINERET® 200mg (Total 400 mg) at day 1 (D1), D2 and D3, two IV infusions / day of ANAKINRA KINERET® 100mg (Total 200 mg) at day 4 (D4), and one IV infusion of ANAKINRA KINERET® 100mg (Total 100 mg) at day 5 (D5).
In case of absence of improvement at D4 (absence of clinical improvement AND absence of decrease of CRP level \> 50%), 3 supplementary days of treatment at 400 mg/day will be done at D4, D5, D6 followed by a decrease at 200 mg/day at D7 and 100 mg/day at D8 and stop thereafter
Anakinra: Treatment includes the administration of Two IV infusions / day of ANAKINRA KINERET® 200mg (Total 400 mg) at day 1 (D1), D2 and D3, two IV infusions / day of ANAKINRA KINERET® 100mg (Total 200 mg) at day 4 (D4), and one IV infusion of ANAKINRA KINERET® 100mg (Total 100 mg) at day 5 (D5).
In case of absence of improvement at D4 (absence of clinical improvement AND absence of decrease of CRP level \> 50%), 3 supplementary days of treatment at 400 mg/day will be done at D4, D5, D6 followed by a decrease at 200 mg/day at D7 and 100 mg/day at D8 and stop thereafter
|
Standard of Care -- Critical COVID Population (WHO-CPS >5)
n=20 Participants
Usual care was provided at the discretion of the site clinicians
|
|---|---|---|---|---|
|
Cumulative Incidence (Percentage of Participants) of Oxygen Supply Independency
Day 90
|
NA percentage of participants
No assessment in Severe COVID Population (WHO Clinical Progression Scale =5 at baseline) at Day 90
|
NA percentage of participants
No assessment in Severe COVID Population (WHO Clinical Progression Scale =5 at baseline) at Day 90
|
77 percentage of participants
Interval 48.0 to 91.0
|
70 percentage of participants
Interval 43.0 to 86.0
|
|
Cumulative Incidence (Percentage of Participants) of Oxygen Supply Independency
Day 28
|
63 percentage of participants
Interval 49.0 to 74.0
|
69 percentage of participants
Interval 55.0 to 80.0
|
59 percentage of participants
Interval 35.0 to 77.0
|
50 percentage of participants
Interval 26.0 to 70.0
|
SECONDARY outcome
Timeframe: 28 daysTime to discharge from hospital
Outcome measures
| Measure |
ANAKINRA -- Severe COVID Population (WHO-CPS =5)
n=59 Participants
Treatment includes the administration of Two IV infusions / day of ANAKINRA KINERET® 200mg (Total 400 mg) at day 1 (D1), D2 and D3, two IV infusions / day of ANAKINRA KINERET® 100mg (Total 200 mg) at day 4 (D4), and one IV infusion of ANAKINRA KINERET® 100mg (Total 100 mg) at day 5 (D5).
In case of absence of improvement at D4 (absence of clinical improvement AND absence of decrease of CRP level \> 50%), 3 supplementary days of treatment at 400 mg/day will be done at D4, D5, D6 followed by a decrease at 200 mg/day at D7 and 100 mg/day at D8 and stop thereafter
Anakinra: Treatment includes the administration of Two IV infusions / day of ANAKINRA KINERET® 200mg (Total 400 mg) at day 1 (D1), D2 and D3, two IV infusions / day of ANAKINRA KINERET® 100mg (Total 200 mg) at day 4 (D4), and one IV infusion of ANAKINRA KINERET® 100mg (Total 100 mg) at day 5 (D5).
In case of absence of improvement at D4 (absence of clinical improvement AND absence of decrease of CRP level \> 50%), 3 supplementary days of treatment at 400 mg/day will be done at D4, D5, D6 followed by a decrease at 200 mg/day at D7 and 100 mg/day at D8 and stop thereafter
|
Standard of Care -- Severe COVID Population (WHO-CPS =5)
n=55 Participants
Usual care was provided at the discretion of the site clinicians
|
ANAKINRA -- Critical COVID Population (WHO-CPS >5)
n=22 Participants
Treatment includes the administration of Two IV infusions / day of ANAKINRA KINERET® 200mg (Total 400 mg) at day 1 (D1), D2 and D3, two IV infusions / day of ANAKINRA KINERET® 100mg (Total 200 mg) at day 4 (D4), and one IV infusion of ANAKINRA KINERET® 100mg (Total 100 mg) at day 5 (D5).
In case of absence of improvement at D4 (absence of clinical improvement AND absence of decrease of CRP level \> 50%), 3 supplementary days of treatment at 400 mg/day will be done at D4, D5, D6 followed by a decrease at 200 mg/day at D7 and 100 mg/day at D8 and stop thereafter
Anakinra: Treatment includes the administration of Two IV infusions / day of ANAKINRA KINERET® 200mg (Total 400 mg) at day 1 (D1), D2 and D3, two IV infusions / day of ANAKINRA KINERET® 100mg (Total 200 mg) at day 4 (D4), and one IV infusion of ANAKINRA KINERET® 100mg (Total 100 mg) at day 5 (D5).
In case of absence of improvement at D4 (absence of clinical improvement AND absence of decrease of CRP level \> 50%), 3 supplementary days of treatment at 400 mg/day will be done at D4, D5, D6 followed by a decrease at 200 mg/day at D7 and 100 mg/day at D8 and stop thereafter
|
Standard of Care -- Critical COVID Population (WHO-CPS >5)
n=20 Participants
Usual care was provided at the discretion of the site clinicians
|
|---|---|---|---|---|
|
Cumulative Incidence (Percentage of Participants) of Discharge From Hospital
Day 28
|
58 percentage of participants
Interval 44.0 to 69.0
|
62 percentage of participants
Interval 47.0 to 73.0
|
41 percentage of participants
Interval 20.0 to 61.0
|
40 percentage of participants
Interval 18.0 to 61.0
|
|
Cumulative Incidence (Percentage of Participants) of Discharge From Hospital
Day 90
|
NA percentage of participants
No assessment in Severe COVID Population (WHO-CPS =5) at Day 90
|
NA percentage of participants
No assessment in Severe COVID Population (WHO-CPS =5) at Day 90
|
68 percentage of participants
Interval 42.0 to 84.0
|
65 percentage of participants
Interval 39.0 to 82.0
|
SECONDARY outcome
Timeframe: 28 and 90 daysPopulation: Patients in the intensive care unit at inclusion
Time to discharge from Intensive Care Unit
Outcome measures
| Measure |
ANAKINRA -- Severe COVID Population (WHO-CPS =5)
n=17 Participants
Treatment includes the administration of Two IV infusions / day of ANAKINRA KINERET® 200mg (Total 400 mg) at day 1 (D1), D2 and D3, two IV infusions / day of ANAKINRA KINERET® 100mg (Total 200 mg) at day 4 (D4), and one IV infusion of ANAKINRA KINERET® 100mg (Total 100 mg) at day 5 (D5).
In case of absence of improvement at D4 (absence of clinical improvement AND absence of decrease of CRP level \> 50%), 3 supplementary days of treatment at 400 mg/day will be done at D4, D5, D6 followed by a decrease at 200 mg/day at D7 and 100 mg/day at D8 and stop thereafter
Anakinra: Treatment includes the administration of Two IV infusions / day of ANAKINRA KINERET® 200mg (Total 400 mg) at day 1 (D1), D2 and D3, two IV infusions / day of ANAKINRA KINERET® 100mg (Total 200 mg) at day 4 (D4), and one IV infusion of ANAKINRA KINERET® 100mg (Total 100 mg) at day 5 (D5).
In case of absence of improvement at D4 (absence of clinical improvement AND absence of decrease of CRP level \> 50%), 3 supplementary days of treatment at 400 mg/day will be done at D4, D5, D6 followed by a decrease at 200 mg/day at D7 and 100 mg/day at D8 and stop thereafter
|
Standard of Care -- Severe COVID Population (WHO-CPS =5)
n=17 Participants
Usual care was provided at the discretion of the site clinicians
|
ANAKINRA -- Critical COVID Population (WHO-CPS >5)
Treatment includes the administration of Two IV infusions / day of ANAKINRA KINERET® 200mg (Total 400 mg) at day 1 (D1), D2 and D3, two IV infusions / day of ANAKINRA KINERET® 100mg (Total 200 mg) at day 4 (D4), and one IV infusion of ANAKINRA KINERET® 100mg (Total 100 mg) at day 5 (D5).
In case of absence of improvement at D4 (absence of clinical improvement AND absence of decrease of CRP level \> 50%), 3 supplementary days of treatment at 400 mg/day will be done at D4, D5, D6 followed by a decrease at 200 mg/day at D7 and 100 mg/day at D8 and stop thereafter
Anakinra: Treatment includes the administration of Two IV infusions / day of ANAKINRA KINERET® 200mg (Total 400 mg) at day 1 (D1), D2 and D3, two IV infusions / day of ANAKINRA KINERET® 100mg (Total 200 mg) at day 4 (D4), and one IV infusion of ANAKINRA KINERET® 100mg (Total 100 mg) at day 5 (D5).
In case of absence of improvement at D4 (absence of clinical improvement AND absence of decrease of CRP level \> 50%), 3 supplementary days of treatment at 400 mg/day will be done at D4, D5, D6 followed by a decrease at 200 mg/day at D7 and 100 mg/day at D8 and stop thereafter
|
Standard of Care -- Critical COVID Population (WHO-CPS >5)
Usual care was provided at the discretion of the site clinicians
|
|---|---|---|---|---|
|
Cumulative Incidence (Percentage of Participants) of Intensive Care Unit Discharge -- Critical COVID Population (WHO Clinical Progression Scale >5 at Baseline)
Day 28
|
65 percentage of participants
Interval 36.0 to 83.0
|
65 percentage of participants
Interval 36.0 to 93.0
|
—
|
—
|
|
Cumulative Incidence (Percentage of Participants) of Intensive Care Unit Discharge -- Critical COVID Population (WHO Clinical Progression Scale >5 at Baseline)
Day 90
|
88 percentage of participants
Interval 47.0 to 98.0
|
82 percentage of participants
Interval 49.0 to 95.0
|
—
|
—
|
Adverse Events
ANAKINRA -- Severe COVID Population (WHO-CPS =5)
Serious events: 27 serious events
Other events: 0 other events
Deaths: 16 deaths
Standard of Care -- Severe COVID Population (WHO-CPS =5)
Serious events: 21 serious events
Other events: 0 other events
Deaths: 16 deaths
ANAKINRA -- Critical COVID Population (WHO-CPS >5)
Serious events: 14 serious events
Other events: 0 other events
Deaths: 6 deaths
Standard of Care -- Critical COVID Population (WHO-CPS >5)
Serious events: 9 serious events
Other events: 0 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
ANAKINRA -- Severe COVID Population (WHO-CPS =5)
n=59 participants at risk
Treatment includes the administration of Two IV infusions / day of ANAKINRA KINERET® 200mg (Total 400 mg) at day 1 (D1), D2 and D3, two IV infusions / day of ANAKINRA KINERET® 100mg (Total 200 mg) at day 4 (D4), and one IV infusion of ANAKINRA KINERET® 100mg (Total 100 mg) at day 5 (D5).
In case of absence of improvement at D4 (absence of clinical improvement AND absence of decrease of CRP level \> 50%), 3 supplementary days of treatment at 400 mg/day will be done at D4, D5, D6 followed by a decrease at 200 mg/day at D7 and 100 mg/day at D8 and stop thereafter
Anakinra: Treatment includes the administration of Two IV infusions / day of ANAKINRA KINERET® 200mg (Total 400 mg) at day 1 (D1), D2 and D3, two IV infusions / day of ANAKINRA KINERET® 100mg (Total 200 mg) at day 4 (D4), and one IV infusion of ANAKINRA KINERET® 100mg (Total 100 mg) at day 5 (D5).
In case of absence of improvement at D4 (absence of clinical improvement AND absence of decrease of CRP level \> 50%), 3 supplementary days of treatment at 400 mg/day will be done at D4, D5, D6 followed by a decrease at 200 mg/day at D7 and 100 mg/day at D8 and stop thereafter
|
Standard of Care -- Severe COVID Population (WHO-CPS =5)
n=55 participants at risk
Usual care was provided at the discretion of the site clinicians
|
ANAKINRA -- Critical COVID Population (WHO-CPS >5)
n=22 participants at risk
Treatment includes the administration of Two IV infusions / day of ANAKINRA KINERET® 200mg (Total 400 mg) at day 1 (D1), D2 and D3, two IV infusions / day of ANAKINRA KINERET® 100mg (Total 200 mg) at day 4 (D4), and one IV infusion of ANAKINRA KINERET® 100mg (Total 100 mg) at day 5 (D5).
In case of absence of improvement at D4 (absence of clinical improvement AND absence of decrease of CRP level \> 50%), 3 supplementary days of treatment at 400 mg/day will be done at D4, D5, D6 followed by a decrease at 200 mg/day at D7 and 100 mg/day at D8 and stop thereafter
Anakinra: Treatment includes the administration of Two IV infusions / day of ANAKINRA KINERET® 200mg (Total 400 mg) at day 1 (D1), D2 and D3, two IV infusions / day of ANAKINRA KINERET® 100mg (Total 200 mg) at day 4 (D4), and one IV infusion of ANAKINRA KINERET® 100mg (Total 100 mg) at day 5 (D5).
In case of absence of improvement at D4 (absence of clinical improvement AND absence of decrease of CRP level \> 50%), 3 supplementary days of treatment at 400 mg/day will be done at D4, D5, D6 followed by a decrease at 200 mg/day at D7 and 100 mg/day at D8 and stop thereafter
|
Standard of Care -- Critical COVID Population (WHO-CPS >5)
n=20 participants at risk
Usual care was provided at the discretion of the site clinicians
|
|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrom
|
18.6%
11/59 • Number of events 11 • Adverse events were systematically assessed at Days 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 and 14 while participants were inpatient, and at Days 28 and 60 and 90.
Only deaths and serious adverse events were reported. "0" total Number of Participants at Risk means " Other (Not Including Serious) Adverse Events were not monitored/analyzed ".
|
21.8%
12/55 • Number of events 13 • Adverse events were systematically assessed at Days 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 and 14 while participants were inpatient, and at Days 28 and 60 and 90.
Only deaths and serious adverse events were reported. "0" total Number of Participants at Risk means " Other (Not Including Serious) Adverse Events were not monitored/analyzed ".
|
13.6%
3/22 • Number of events 3 • Adverse events were systematically assessed at Days 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 and 14 while participants were inpatient, and at Days 28 and 60 and 90.
Only deaths and serious adverse events were reported. "0" total Number of Participants at Risk means " Other (Not Including Serious) Adverse Events were not monitored/analyzed ".
|
20.0%
4/20 • Number of events 4 • Adverse events were systematically assessed at Days 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 and 14 while participants were inpatient, and at Days 28 and 60 and 90.
Only deaths and serious adverse events were reported. "0" total Number of Participants at Risk means " Other (Not Including Serious) Adverse Events were not monitored/analyzed ".
|
|
Infections and infestations
Bacterial sepsis
|
11.9%
7/59 • Number of events 10 • Adverse events were systematically assessed at Days 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 and 14 while participants were inpatient, and at Days 28 and 60 and 90.
Only deaths and serious adverse events were reported. "0" total Number of Participants at Risk means " Other (Not Including Serious) Adverse Events were not monitored/analyzed ".
|
3.6%
2/55 • Number of events 4 • Adverse events were systematically assessed at Days 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 and 14 while participants were inpatient, and at Days 28 and 60 and 90.
Only deaths and serious adverse events were reported. "0" total Number of Participants at Risk means " Other (Not Including Serious) Adverse Events were not monitored/analyzed ".
|
27.3%
6/22 • Number of events 8 • Adverse events were systematically assessed at Days 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 and 14 while participants were inpatient, and at Days 28 and 60 and 90.
Only deaths and serious adverse events were reported. "0" total Number of Participants at Risk means " Other (Not Including Serious) Adverse Events were not monitored/analyzed ".
|
25.0%
5/20 • Number of events 10 • Adverse events were systematically assessed at Days 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 and 14 while participants were inpatient, and at Days 28 and 60 and 90.
Only deaths and serious adverse events were reported. "0" total Number of Participants at Risk means " Other (Not Including Serious) Adverse Events were not monitored/analyzed ".
|
|
Hepatobiliary disorders
Hepatic cytolysis
|
11.9%
7/59 • Number of events 7 • Adverse events were systematically assessed at Days 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 and 14 while participants were inpatient, and at Days 28 and 60 and 90.
Only deaths and serious adverse events were reported. "0" total Number of Participants at Risk means " Other (Not Including Serious) Adverse Events were not monitored/analyzed ".
|
0.00%
0/55 • Adverse events were systematically assessed at Days 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 and 14 while participants were inpatient, and at Days 28 and 60 and 90.
Only deaths and serious adverse events were reported. "0" total Number of Participants at Risk means " Other (Not Including Serious) Adverse Events were not monitored/analyzed ".
|
0.00%
0/22 • Adverse events were systematically assessed at Days 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 and 14 while participants were inpatient, and at Days 28 and 60 and 90.
Only deaths and serious adverse events were reported. "0" total Number of Participants at Risk means " Other (Not Including Serious) Adverse Events were not monitored/analyzed ".
|
0.00%
0/20 • Adverse events were systematically assessed at Days 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 and 14 while participants were inpatient, and at Days 28 and 60 and 90.
Only deaths and serious adverse events were reported. "0" total Number of Participants at Risk means " Other (Not Including Serious) Adverse Events were not monitored/analyzed ".
|
|
General disorders
Multiple organ failure
|
5.1%
3/59 • Number of events 3 • Adverse events were systematically assessed at Days 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 and 14 while participants were inpatient, and at Days 28 and 60 and 90.
Only deaths and serious adverse events were reported. "0" total Number of Participants at Risk means " Other (Not Including Serious) Adverse Events were not monitored/analyzed ".
|
1.8%
1/55 • Number of events 1 • Adverse events were systematically assessed at Days 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 and 14 while participants were inpatient, and at Days 28 and 60 and 90.
Only deaths and serious adverse events were reported. "0" total Number of Participants at Risk means " Other (Not Including Serious) Adverse Events were not monitored/analyzed ".
|
0.00%
0/22 • Adverse events were systematically assessed at Days 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 and 14 while participants were inpatient, and at Days 28 and 60 and 90.
Only deaths and serious adverse events were reported. "0" total Number of Participants at Risk means " Other (Not Including Serious) Adverse Events were not monitored/analyzed ".
|
0.00%
0/20 • Adverse events were systematically assessed at Days 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 and 14 while participants were inpatient, and at Days 28 and 60 and 90.
Only deaths and serious adverse events were reported. "0" total Number of Participants at Risk means " Other (Not Including Serious) Adverse Events were not monitored/analyzed ".
|
|
Vascular disorders
Pulmonary embolism
|
3.4%
2/59 • Number of events 3 • Adverse events were systematically assessed at Days 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 and 14 while participants were inpatient, and at Days 28 and 60 and 90.
Only deaths and serious adverse events were reported. "0" total Number of Participants at Risk means " Other (Not Including Serious) Adverse Events were not monitored/analyzed ".
|
1.8%
1/55 • Number of events 1 • Adverse events were systematically assessed at Days 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 and 14 while participants were inpatient, and at Days 28 and 60 and 90.
Only deaths and serious adverse events were reported. "0" total Number of Participants at Risk means " Other (Not Including Serious) Adverse Events were not monitored/analyzed ".
|
4.5%
1/22 • Number of events 1 • Adverse events were systematically assessed at Days 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 and 14 while participants were inpatient, and at Days 28 and 60 and 90.
Only deaths and serious adverse events were reported. "0" total Number of Participants at Risk means " Other (Not Including Serious) Adverse Events were not monitored/analyzed ".
|
0.00%
0/20 • Adverse events were systematically assessed at Days 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 and 14 while participants were inpatient, and at Days 28 and 60 and 90.
Only deaths and serious adverse events were reported. "0" total Number of Participants at Risk means " Other (Not Including Serious) Adverse Events were not monitored/analyzed ".
|
|
Renal and urinary disorders
Acute renal failure
|
1.7%
1/59 • Number of events 1 • Adverse events were systematically assessed at Days 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 and 14 while participants were inpatient, and at Days 28 and 60 and 90.
Only deaths and serious adverse events were reported. "0" total Number of Participants at Risk means " Other (Not Including Serious) Adverse Events were not monitored/analyzed ".
|
3.6%
2/55 • Number of events 2 • Adverse events were systematically assessed at Days 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 and 14 while participants were inpatient, and at Days 28 and 60 and 90.
Only deaths and serious adverse events were reported. "0" total Number of Participants at Risk means " Other (Not Including Serious) Adverse Events were not monitored/analyzed ".
|
0.00%
0/22 • Adverse events were systematically assessed at Days 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 and 14 while participants were inpatient, and at Days 28 and 60 and 90.
Only deaths and serious adverse events were reported. "0" total Number of Participants at Risk means " Other (Not Including Serious) Adverse Events were not monitored/analyzed ".
|
0.00%
0/20 • Adverse events were systematically assessed at Days 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 and 14 while participants were inpatient, and at Days 28 and 60 and 90.
Only deaths and serious adverse events were reported. "0" total Number of Participants at Risk means " Other (Not Including Serious) Adverse Events were not monitored/analyzed ".
|
|
Blood and lymphatic system disorders
Anemia
|
1.7%
1/59 • Number of events 1 • Adverse events were systematically assessed at Days 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 and 14 while participants were inpatient, and at Days 28 and 60 and 90.
Only deaths and serious adverse events were reported. "0" total Number of Participants at Risk means " Other (Not Including Serious) Adverse Events were not monitored/analyzed ".
|
3.6%
2/55 • Number of events 2 • Adverse events were systematically assessed at Days 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 and 14 while participants were inpatient, and at Days 28 and 60 and 90.
Only deaths and serious adverse events were reported. "0" total Number of Participants at Risk means " Other (Not Including Serious) Adverse Events were not monitored/analyzed ".
|
13.6%
3/22 • Number of events 3 • Adverse events were systematically assessed at Days 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 and 14 while participants were inpatient, and at Days 28 and 60 and 90.
Only deaths and serious adverse events were reported. "0" total Number of Participants at Risk means " Other (Not Including Serious) Adverse Events were not monitored/analyzed ".
|
0.00%
0/20 • Adverse events were systematically assessed at Days 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 and 14 while participants were inpatient, and at Days 28 and 60 and 90.
Only deaths and serious adverse events were reported. "0" total Number of Participants at Risk means " Other (Not Including Serious) Adverse Events were not monitored/analyzed ".
|
|
Cardiac disorders
Coronary syndrome
|
1.7%
1/59 • Number of events 1 • Adverse events were systematically assessed at Days 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 and 14 while participants were inpatient, and at Days 28 and 60 and 90.
Only deaths and serious adverse events were reported. "0" total Number of Participants at Risk means " Other (Not Including Serious) Adverse Events were not monitored/analyzed ".
|
0.00%
0/55 • Adverse events were systematically assessed at Days 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 and 14 while participants were inpatient, and at Days 28 and 60 and 90.
Only deaths and serious adverse events were reported. "0" total Number of Participants at Risk means " Other (Not Including Serious) Adverse Events were not monitored/analyzed ".
|
0.00%
0/22 • Adverse events were systematically assessed at Days 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 and 14 while participants were inpatient, and at Days 28 and 60 and 90.
Only deaths and serious adverse events were reported. "0" total Number of Participants at Risk means " Other (Not Including Serious) Adverse Events were not monitored/analyzed ".
|
0.00%
0/20 • Adverse events were systematically assessed at Days 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 and 14 while participants were inpatient, and at Days 28 and 60 and 90.
Only deaths and serious adverse events were reported. "0" total Number of Participants at Risk means " Other (Not Including Serious) Adverse Events were not monitored/analyzed ".
|
|
Hepatobiliary disorders
Cholestatis
|
1.7%
1/59 • Number of events 1 • Adverse events were systematically assessed at Days 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 and 14 while participants were inpatient, and at Days 28 and 60 and 90.
Only deaths and serious adverse events were reported. "0" total Number of Participants at Risk means " Other (Not Including Serious) Adverse Events were not monitored/analyzed ".
|
0.00%
0/55 • Adverse events were systematically assessed at Days 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 and 14 while participants were inpatient, and at Days 28 and 60 and 90.
Only deaths and serious adverse events were reported. "0" total Number of Participants at Risk means " Other (Not Including Serious) Adverse Events were not monitored/analyzed ".
|
0.00%
0/22 • Adverse events were systematically assessed at Days 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 and 14 while participants were inpatient, and at Days 28 and 60 and 90.
Only deaths and serious adverse events were reported. "0" total Number of Participants at Risk means " Other (Not Including Serious) Adverse Events were not monitored/analyzed ".
|
0.00%
0/20 • Adverse events were systematically assessed at Days 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 and 14 while participants were inpatient, and at Days 28 and 60 and 90.
Only deaths and serious adverse events were reported. "0" total Number of Participants at Risk means " Other (Not Including Serious) Adverse Events were not monitored/analyzed ".
|
|
Blood and lymphatic system disorders
Neutropenia
|
1.7%
1/59 • Number of events 1 • Adverse events were systematically assessed at Days 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 and 14 while participants were inpatient, and at Days 28 and 60 and 90.
Only deaths and serious adverse events were reported. "0" total Number of Participants at Risk means " Other (Not Including Serious) Adverse Events were not monitored/analyzed ".
|
0.00%
0/55 • Adverse events were systematically assessed at Days 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 and 14 while participants were inpatient, and at Days 28 and 60 and 90.
Only deaths and serious adverse events were reported. "0" total Number of Participants at Risk means " Other (Not Including Serious) Adverse Events were not monitored/analyzed ".
|
0.00%
0/22 • Adverse events were systematically assessed at Days 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 and 14 while participants were inpatient, and at Days 28 and 60 and 90.
Only deaths and serious adverse events were reported. "0" total Number of Participants at Risk means " Other (Not Including Serious) Adverse Events were not monitored/analyzed ".
|
0.00%
0/20 • Adverse events were systematically assessed at Days 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 and 14 while participants were inpatient, and at Days 28 and 60 and 90.
Only deaths and serious adverse events were reported. "0" total Number of Participants at Risk means " Other (Not Including Serious) Adverse Events were not monitored/analyzed ".
|
|
Infections and infestations
Fungal sepsis
|
1.7%
1/59 • Number of events 1 • Adverse events were systematically assessed at Days 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 and 14 while participants were inpatient, and at Days 28 and 60 and 90.
Only deaths and serious adverse events were reported. "0" total Number of Participants at Risk means " Other (Not Including Serious) Adverse Events were not monitored/analyzed ".
|
0.00%
0/55 • Adverse events were systematically assessed at Days 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 and 14 while participants were inpatient, and at Days 28 and 60 and 90.
Only deaths and serious adverse events were reported. "0" total Number of Participants at Risk means " Other (Not Including Serious) Adverse Events were not monitored/analyzed ".
|
4.5%
1/22 • Number of events 1 • Adverse events were systematically assessed at Days 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 and 14 while participants were inpatient, and at Days 28 and 60 and 90.
Only deaths and serious adverse events were reported. "0" total Number of Participants at Risk means " Other (Not Including Serious) Adverse Events were not monitored/analyzed ".
|
0.00%
0/20 • Adverse events were systematically assessed at Days 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 and 14 while participants were inpatient, and at Days 28 and 60 and 90.
Only deaths and serious adverse events were reported. "0" total Number of Participants at Risk means " Other (Not Including Serious) Adverse Events were not monitored/analyzed ".
|
|
Gastrointestinal disorders
Gastrointestinal bleeding
|
1.7%
1/59 • Number of events 1 • Adverse events were systematically assessed at Days 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 and 14 while participants were inpatient, and at Days 28 and 60 and 90.
Only deaths and serious adverse events were reported. "0" total Number of Participants at Risk means " Other (Not Including Serious) Adverse Events were not monitored/analyzed ".
|
0.00%
0/55 • Adverse events were systematically assessed at Days 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 and 14 while participants were inpatient, and at Days 28 and 60 and 90.
Only deaths and serious adverse events were reported. "0" total Number of Participants at Risk means " Other (Not Including Serious) Adverse Events were not monitored/analyzed ".
|
0.00%
0/22 • Adverse events were systematically assessed at Days 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 and 14 while participants were inpatient, and at Days 28 and 60 and 90.
Only deaths and serious adverse events were reported. "0" total Number of Participants at Risk means " Other (Not Including Serious) Adverse Events were not monitored/analyzed ".
|
5.0%
1/20 • Number of events 1 • Adverse events were systematically assessed at Days 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 and 14 while participants were inpatient, and at Days 28 and 60 and 90.
Only deaths and serious adverse events were reported. "0" total Number of Participants at Risk means " Other (Not Including Serious) Adverse Events were not monitored/analyzed ".
|
|
Blood and lymphatic system disorders
Myelomia
|
1.7%
1/59 • Number of events 1 • Adverse events were systematically assessed at Days 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 and 14 while participants were inpatient, and at Days 28 and 60 and 90.
Only deaths and serious adverse events were reported. "0" total Number of Participants at Risk means " Other (Not Including Serious) Adverse Events were not monitored/analyzed ".
|
0.00%
0/55 • Adverse events were systematically assessed at Days 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 and 14 while participants were inpatient, and at Days 28 and 60 and 90.
Only deaths and serious adverse events were reported. "0" total Number of Participants at Risk means " Other (Not Including Serious) Adverse Events were not monitored/analyzed ".
|
0.00%
0/22 • Adverse events were systematically assessed at Days 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 and 14 while participants were inpatient, and at Days 28 and 60 and 90.
Only deaths and serious adverse events were reported. "0" total Number of Participants at Risk means " Other (Not Including Serious) Adverse Events were not monitored/analyzed ".
|
0.00%
0/20 • Adverse events were systematically assessed at Days 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 and 14 while participants were inpatient, and at Days 28 and 60 and 90.
Only deaths and serious adverse events were reported. "0" total Number of Participants at Risk means " Other (Not Including Serious) Adverse Events were not monitored/analyzed ".
|
|
Cardiac disorders
Sudden death
|
0.00%
0/59 • Adverse events were systematically assessed at Days 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 and 14 while participants were inpatient, and at Days 28 and 60 and 90.
Only deaths and serious adverse events were reported. "0" total Number of Participants at Risk means " Other (Not Including Serious) Adverse Events were not monitored/analyzed ".
|
1.8%
1/55 • Number of events 1 • Adverse events were systematically assessed at Days 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 and 14 while participants were inpatient, and at Days 28 and 60 and 90.
Only deaths and serious adverse events were reported. "0" total Number of Participants at Risk means " Other (Not Including Serious) Adverse Events were not monitored/analyzed ".
|
0.00%
0/22 • Adverse events were systematically assessed at Days 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 and 14 while participants were inpatient, and at Days 28 and 60 and 90.
Only deaths and serious adverse events were reported. "0" total Number of Participants at Risk means " Other (Not Including Serious) Adverse Events were not monitored/analyzed ".
|
5.0%
1/20 • Number of events 1 • Adverse events were systematically assessed at Days 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 and 14 while participants were inpatient, and at Days 28 and 60 and 90.
Only deaths and serious adverse events were reported. "0" total Number of Participants at Risk means " Other (Not Including Serious) Adverse Events were not monitored/analyzed ".
|
|
Cardiac disorders
Arterial ischaemia
|
0.00%
0/59 • Adverse events were systematically assessed at Days 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 and 14 while participants were inpatient, and at Days 28 and 60 and 90.
Only deaths and serious adverse events were reported. "0" total Number of Participants at Risk means " Other (Not Including Serious) Adverse Events were not monitored/analyzed ".
|
1.8%
1/55 • Number of events 1 • Adverse events were systematically assessed at Days 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 and 14 while participants were inpatient, and at Days 28 and 60 and 90.
Only deaths and serious adverse events were reported. "0" total Number of Participants at Risk means " Other (Not Including Serious) Adverse Events were not monitored/analyzed ".
|
0.00%
0/22 • Adverse events were systematically assessed at Days 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 and 14 while participants were inpatient, and at Days 28 and 60 and 90.
Only deaths and serious adverse events were reported. "0" total Number of Participants at Risk means " Other (Not Including Serious) Adverse Events were not monitored/analyzed ".
|
0.00%
0/20 • Adverse events were systematically assessed at Days 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 and 14 while participants were inpatient, and at Days 28 and 60 and 90.
Only deaths and serious adverse events were reported. "0" total Number of Participants at Risk means " Other (Not Including Serious) Adverse Events were not monitored/analyzed ".
|
|
Blood and lymphatic system disorders
Thombopenia
|
0.00%
0/59 • Adverse events were systematically assessed at Days 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 and 14 while participants were inpatient, and at Days 28 and 60 and 90.
Only deaths and serious adverse events were reported. "0" total Number of Participants at Risk means " Other (Not Including Serious) Adverse Events were not monitored/analyzed ".
|
1.8%
1/55 • Number of events 1 • Adverse events were systematically assessed at Days 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 and 14 while participants were inpatient, and at Days 28 and 60 and 90.
Only deaths and serious adverse events were reported. "0" total Number of Participants at Risk means " Other (Not Including Serious) Adverse Events were not monitored/analyzed ".
|
4.5%
1/22 • Number of events 1 • Adverse events were systematically assessed at Days 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 and 14 while participants were inpatient, and at Days 28 and 60 and 90.
Only deaths and serious adverse events were reported. "0" total Number of Participants at Risk means " Other (Not Including Serious) Adverse Events were not monitored/analyzed ".
|
0.00%
0/20 • Adverse events were systematically assessed at Days 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 and 14 while participants were inpatient, and at Days 28 and 60 and 90.
Only deaths and serious adverse events were reported. "0" total Number of Participants at Risk means " Other (Not Including Serious) Adverse Events were not monitored/analyzed ".
|
|
Respiratory, thoracic and mediastinal disorders
Complication of intubation
|
0.00%
0/59 • Adverse events were systematically assessed at Days 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 and 14 while participants were inpatient, and at Days 28 and 60 and 90.
Only deaths and serious adverse events were reported. "0" total Number of Participants at Risk means " Other (Not Including Serious) Adverse Events were not monitored/analyzed ".
|
1.8%
1/55 • Number of events 1 • Adverse events were systematically assessed at Days 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 and 14 while participants were inpatient, and at Days 28 and 60 and 90.
Only deaths and serious adverse events were reported. "0" total Number of Participants at Risk means " Other (Not Including Serious) Adverse Events were not monitored/analyzed ".
|
0.00%
0/22 • Adverse events were systematically assessed at Days 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 and 14 while participants were inpatient, and at Days 28 and 60 and 90.
Only deaths and serious adverse events were reported. "0" total Number of Participants at Risk means " Other (Not Including Serious) Adverse Events were not monitored/analyzed ".
|
0.00%
0/20 • Adverse events were systematically assessed at Days 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 and 14 while participants were inpatient, and at Days 28 and 60 and 90.
Only deaths and serious adverse events were reported. "0" total Number of Participants at Risk means " Other (Not Including Serious) Adverse Events were not monitored/analyzed ".
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic progression
|
0.00%
0/59 • Adverse events were systematically assessed at Days 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 and 14 while participants were inpatient, and at Days 28 and 60 and 90.
Only deaths and serious adverse events were reported. "0" total Number of Participants at Risk means " Other (Not Including Serious) Adverse Events were not monitored/analyzed ".
|
1.8%
1/55 • Number of events 1 • Adverse events were systematically assessed at Days 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 and 14 while participants were inpatient, and at Days 28 and 60 and 90.
Only deaths and serious adverse events were reported. "0" total Number of Participants at Risk means " Other (Not Including Serious) Adverse Events were not monitored/analyzed ".
|
0.00%
0/22 • Adverse events were systematically assessed at Days 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 and 14 while participants were inpatient, and at Days 28 and 60 and 90.
Only deaths and serious adverse events were reported. "0" total Number of Participants at Risk means " Other (Not Including Serious) Adverse Events were not monitored/analyzed ".
|
0.00%
0/20 • Adverse events were systematically assessed at Days 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 and 14 while participants were inpatient, and at Days 28 and 60 and 90.
Only deaths and serious adverse events were reported. "0" total Number of Participants at Risk means " Other (Not Including Serious) Adverse Events were not monitored/analyzed ".
|
|
Respiratory, thoracic and mediastinal disorders
Herpetic pneumonia
|
0.00%
0/59 • Adverse events were systematically assessed at Days 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 and 14 while participants were inpatient, and at Days 28 and 60 and 90.
Only deaths and serious adverse events were reported. "0" total Number of Participants at Risk means " Other (Not Including Serious) Adverse Events were not monitored/analyzed ".
|
0.00%
0/55 • Adverse events were systematically assessed at Days 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 and 14 while participants were inpatient, and at Days 28 and 60 and 90.
Only deaths and serious adverse events were reported. "0" total Number of Participants at Risk means " Other (Not Including Serious) Adverse Events were not monitored/analyzed ".
|
4.5%
1/22 • Number of events 1 • Adverse events were systematically assessed at Days 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 and 14 while participants were inpatient, and at Days 28 and 60 and 90.
Only deaths and serious adverse events were reported. "0" total Number of Participants at Risk means " Other (Not Including Serious) Adverse Events were not monitored/analyzed ".
|
0.00%
0/20 • Adverse events were systematically assessed at Days 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 and 14 while participants were inpatient, and at Days 28 and 60 and 90.
Only deaths and serious adverse events were reported. "0" total Number of Participants at Risk means " Other (Not Including Serious) Adverse Events were not monitored/analyzed ".
|
|
Gastrointestinal disorders
Olgivie syndrome
|
0.00%
0/59 • Adverse events were systematically assessed at Days 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 and 14 while participants were inpatient, and at Days 28 and 60 and 90.
Only deaths and serious adverse events were reported. "0" total Number of Participants at Risk means " Other (Not Including Serious) Adverse Events were not monitored/analyzed ".
|
0.00%
0/55 • Adverse events were systematically assessed at Days 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 and 14 while participants were inpatient, and at Days 28 and 60 and 90.
Only deaths and serious adverse events were reported. "0" total Number of Participants at Risk means " Other (Not Including Serious) Adverse Events were not monitored/analyzed ".
|
4.5%
1/22 • Number of events 1 • Adverse events were systematically assessed at Days 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 and 14 while participants were inpatient, and at Days 28 and 60 and 90.
Only deaths and serious adverse events were reported. "0" total Number of Participants at Risk means " Other (Not Including Serious) Adverse Events were not monitored/analyzed ".
|
0.00%
0/20 • Adverse events were systematically assessed at Days 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 and 14 while participants were inpatient, and at Days 28 and 60 and 90.
Only deaths and serious adverse events were reported. "0" total Number of Participants at Risk means " Other (Not Including Serious) Adverse Events were not monitored/analyzed ".
|
|
Cardiac disorders
Hypotension
|
0.00%
0/59 • Adverse events were systematically assessed at Days 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 and 14 while participants were inpatient, and at Days 28 and 60 and 90.
Only deaths and serious adverse events were reported. "0" total Number of Participants at Risk means " Other (Not Including Serious) Adverse Events were not monitored/analyzed ".
|
0.00%
0/55 • Adverse events were systematically assessed at Days 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 and 14 while participants were inpatient, and at Days 28 and 60 and 90.
Only deaths and serious adverse events were reported. "0" total Number of Participants at Risk means " Other (Not Including Serious) Adverse Events were not monitored/analyzed ".
|
4.5%
1/22 • Number of events 1 • Adverse events were systematically assessed at Days 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 and 14 while participants were inpatient, and at Days 28 and 60 and 90.
Only deaths and serious adverse events were reported. "0" total Number of Participants at Risk means " Other (Not Including Serious) Adverse Events were not monitored/analyzed ".
|
0.00%
0/20 • Adverse events were systematically assessed at Days 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 and 14 while participants were inpatient, and at Days 28 and 60 and 90.
Only deaths and serious adverse events were reported. "0" total Number of Participants at Risk means " Other (Not Including Serious) Adverse Events were not monitored/analyzed ".
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/59 • Adverse events were systematically assessed at Days 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 and 14 while participants were inpatient, and at Days 28 and 60 and 90.
Only deaths and serious adverse events were reported. "0" total Number of Participants at Risk means " Other (Not Including Serious) Adverse Events were not monitored/analyzed ".
|
0.00%
0/55 • Adverse events were systematically assessed at Days 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 and 14 while participants were inpatient, and at Days 28 and 60 and 90.
Only deaths and serious adverse events were reported. "0" total Number of Participants at Risk means " Other (Not Including Serious) Adverse Events were not monitored/analyzed ".
|
4.5%
1/22 • Number of events 1 • Adverse events were systematically assessed at Days 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 and 14 while participants were inpatient, and at Days 28 and 60 and 90.
Only deaths and serious adverse events were reported. "0" total Number of Participants at Risk means " Other (Not Including Serious) Adverse Events were not monitored/analyzed ".
|
0.00%
0/20 • Adverse events were systematically assessed at Days 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 and 14 while participants were inpatient, and at Days 28 and 60 and 90.
Only deaths and serious adverse events were reported. "0" total Number of Participants at Risk means " Other (Not Including Serious) Adverse Events were not monitored/analyzed ".
|
|
Infections and infestations
Undertermined sepsis
|
0.00%
0/59 • Adverse events were systematically assessed at Days 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 and 14 while participants were inpatient, and at Days 28 and 60 and 90.
Only deaths and serious adverse events were reported. "0" total Number of Participants at Risk means " Other (Not Including Serious) Adverse Events were not monitored/analyzed ".
|
0.00%
0/55 • Adverse events were systematically assessed at Days 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 and 14 while participants were inpatient, and at Days 28 and 60 and 90.
Only deaths and serious adverse events were reported. "0" total Number of Participants at Risk means " Other (Not Including Serious) Adverse Events were not monitored/analyzed ".
|
4.5%
1/22 • Number of events 1 • Adverse events were systematically assessed at Days 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 and 14 while participants were inpatient, and at Days 28 and 60 and 90.
Only deaths and serious adverse events were reported. "0" total Number of Participants at Risk means " Other (Not Including Serious) Adverse Events were not monitored/analyzed ".
|
0.00%
0/20 • Adverse events were systematically assessed at Days 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 and 14 while participants were inpatient, and at Days 28 and 60 and 90.
Only deaths and serious adverse events were reported. "0" total Number of Participants at Risk means " Other (Not Including Serious) Adverse Events were not monitored/analyzed ".
|
|
Endocrine disorders
Diabete
|
0.00%
0/59 • Adverse events were systematically assessed at Days 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 and 14 while participants were inpatient, and at Days 28 and 60 and 90.
Only deaths and serious adverse events were reported. "0" total Number of Participants at Risk means " Other (Not Including Serious) Adverse Events were not monitored/analyzed ".
|
0.00%
0/55 • Adverse events were systematically assessed at Days 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 and 14 while participants were inpatient, and at Days 28 and 60 and 90.
Only deaths and serious adverse events were reported. "0" total Number of Participants at Risk means " Other (Not Including Serious) Adverse Events were not monitored/analyzed ".
|
4.5%
1/22 • Number of events 1 • Adverse events were systematically assessed at Days 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 and 14 while participants were inpatient, and at Days 28 and 60 and 90.
Only deaths and serious adverse events were reported. "0" total Number of Participants at Risk means " Other (Not Including Serious) Adverse Events were not monitored/analyzed ".
|
10.0%
2/20 • Number of events 2 • Adverse events were systematically assessed at Days 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 and 14 while participants were inpatient, and at Days 28 and 60 and 90.
Only deaths and serious adverse events were reported. "0" total Number of Participants at Risk means " Other (Not Including Serious) Adverse Events were not monitored/analyzed ".
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/59 • Adverse events were systematically assessed at Days 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 and 14 while participants were inpatient, and at Days 28 and 60 and 90.
Only deaths and serious adverse events were reported. "0" total Number of Participants at Risk means " Other (Not Including Serious) Adverse Events were not monitored/analyzed ".
|
0.00%
0/55 • Adverse events were systematically assessed at Days 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 and 14 while participants were inpatient, and at Days 28 and 60 and 90.
Only deaths and serious adverse events were reported. "0" total Number of Participants at Risk means " Other (Not Including Serious) Adverse Events were not monitored/analyzed ".
|
0.00%
0/22 • Adverse events were systematically assessed at Days 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 and 14 while participants were inpatient, and at Days 28 and 60 and 90.
Only deaths and serious adverse events were reported. "0" total Number of Participants at Risk means " Other (Not Including Serious) Adverse Events were not monitored/analyzed ".
|
5.0%
1/20 • Number of events 1 • Adverse events were systematically assessed at Days 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 and 14 while participants were inpatient, and at Days 28 and 60 and 90.
Only deaths and serious adverse events were reported. "0" total Number of Participants at Risk means " Other (Not Including Serious) Adverse Events were not monitored/analyzed ".
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer
|
0.00%
0/59 • Adverse events were systematically assessed at Days 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 and 14 while participants were inpatient, and at Days 28 and 60 and 90.
Only deaths and serious adverse events were reported. "0" total Number of Participants at Risk means " Other (Not Including Serious) Adverse Events were not monitored/analyzed ".
|
0.00%
0/55 • Adverse events were systematically assessed at Days 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 and 14 while participants were inpatient, and at Days 28 and 60 and 90.
Only deaths and serious adverse events were reported. "0" total Number of Participants at Risk means " Other (Not Including Serious) Adverse Events were not monitored/analyzed ".
|
0.00%
0/22 • Adverse events were systematically assessed at Days 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 and 14 while participants were inpatient, and at Days 28 and 60 and 90.
Only deaths and serious adverse events were reported. "0" total Number of Participants at Risk means " Other (Not Including Serious) Adverse Events were not monitored/analyzed ".
|
5.0%
1/20 • Number of events 1 • Adverse events were systematically assessed at Days 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 and 14 while participants were inpatient, and at Days 28 and 60 and 90.
Only deaths and serious adverse events were reported. "0" total Number of Participants at Risk means " Other (Not Including Serious) Adverse Events were not monitored/analyzed ".
|
|
Nervous system disorders
Meningo-radiculitus
|
0.00%
0/59 • Adverse events were systematically assessed at Days 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 and 14 while participants were inpatient, and at Days 28 and 60 and 90.
Only deaths and serious adverse events were reported. "0" total Number of Participants at Risk means " Other (Not Including Serious) Adverse Events were not monitored/analyzed ".
|
0.00%
0/55 • Adverse events were systematically assessed at Days 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 and 14 while participants were inpatient, and at Days 28 and 60 and 90.
Only deaths and serious adverse events were reported. "0" total Number of Participants at Risk means " Other (Not Including Serious) Adverse Events were not monitored/analyzed ".
|
0.00%
0/22 • Adverse events were systematically assessed at Days 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 and 14 while participants were inpatient, and at Days 28 and 60 and 90.
Only deaths and serious adverse events were reported. "0" total Number of Participants at Risk means " Other (Not Including Serious) Adverse Events were not monitored/analyzed ".
|
5.0%
1/20 • Number of events 1 • Adverse events were systematically assessed at Days 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 and 14 while participants were inpatient, and at Days 28 and 60 and 90.
Only deaths and serious adverse events were reported. "0" total Number of Participants at Risk means " Other (Not Including Serious) Adverse Events were not monitored/analyzed ".
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/59 • Adverse events were systematically assessed at Days 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 and 14 while participants were inpatient, and at Days 28 and 60 and 90.
Only deaths and serious adverse events were reported. "0" total Number of Participants at Risk means " Other (Not Including Serious) Adverse Events were not monitored/analyzed ".
|
0.00%
0/55 • Adverse events were systematically assessed at Days 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 and 14 while participants were inpatient, and at Days 28 and 60 and 90.
Only deaths and serious adverse events were reported. "0" total Number of Participants at Risk means " Other (Not Including Serious) Adverse Events were not monitored/analyzed ".
|
4.5%
1/22 • Number of events 1 • Adverse events were systematically assessed at Days 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 and 14 while participants were inpatient, and at Days 28 and 60 and 90.
Only deaths and serious adverse events were reported. "0" total Number of Participants at Risk means " Other (Not Including Serious) Adverse Events were not monitored/analyzed ".
|
10.0%
2/20 • Number of events 2 • Adverse events were systematically assessed at Days 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 and 14 while participants were inpatient, and at Days 28 and 60 and 90.
Only deaths and serious adverse events were reported. "0" total Number of Participants at Risk means " Other (Not Including Serious) Adverse Events were not monitored/analyzed ".
|
|
Cardiac disorders
Heart failure
|
0.00%
0/59 • Adverse events were systematically assessed at Days 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 and 14 while participants were inpatient, and at Days 28 and 60 and 90.
Only deaths and serious adverse events were reported. "0" total Number of Participants at Risk means " Other (Not Including Serious) Adverse Events were not monitored/analyzed ".
|
0.00%
0/55 • Adverse events were systematically assessed at Days 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 and 14 while participants were inpatient, and at Days 28 and 60 and 90.
Only deaths and serious adverse events were reported. "0" total Number of Participants at Risk means " Other (Not Including Serious) Adverse Events were not monitored/analyzed ".
|
4.5%
1/22 • Number of events 1 • Adverse events were systematically assessed at Days 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 and 14 while participants were inpatient, and at Days 28 and 60 and 90.
Only deaths and serious adverse events were reported. "0" total Number of Participants at Risk means " Other (Not Including Serious) Adverse Events were not monitored/analyzed ".
|
0.00%
0/20 • Adverse events were systematically assessed at Days 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 and 14 while participants were inpatient, and at Days 28 and 60 and 90.
Only deaths and serious adverse events were reported. "0" total Number of Participants at Risk means " Other (Not Including Serious) Adverse Events were not monitored/analyzed ".
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place