Trial Outcomes & Findings for Reparixin add-on Therapy to Standard Care to Limit Progression in Pts With COVID19 & Other Community Acquired Pneumonia (NCT NCT05254990)
NCT ID: NCT05254990
Last Updated: 2026-02-24
Results Overview
The primary endpoint was based on NIAID-OS ordinal scale (National Institute of Allergy and Infectious Disease) with score OS 7 which means patients "hospitalized, on invasive mechanical ventilation or ECMO". The scores on this scale of Disease severity range from OS 1 (best outcome) to OS 8 (worst outcome). NIAID-OS (National Institute of Allergy and Infectious Disease Ordinal Scale) SCORE Descriptor: * OS 1 Not hospitalized, no limitations on activities; * OS 2 Not hospitalized, limitation on activities and/or requiring home O2; * OS 3 Hospitalized, no supplemental O2 - no longer requires ongoing medical care; * OS 4 Hospitalized, no supplemental O2 - requiring ongoing medical care; * OS 5 Hospitalized, requiring supplemental O2; * OS 6 Hospitalized, on non-invasive ventilation or high-flow oxygen devices; * OS 7 Hospitalized, on invasive mechanical ventilation or ECMO; * OS 8 Death;
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
414 participants
Primary outcome timeframe
Day 28
Results posted on
2026-02-24
Participant Flow
A total of 444 participants were screened and 414 were enrolled; 409 (98.8%) were randomized 1:1 to receive investigational products (reparixin \[N = 205\] or placebo \[N = 204\]). A total of 186 participants (45.5%) completed the study; 223 (54.5%) discontinued the study prematurely.
The pre-planned interim analyses for efficacy and safety were carried out, per protocol, for evaluation by the DMC when the first 250 participants had reached day 28 or died or experienced IMV or ECMO by day 28. The p-value from the interim analysis of the primary endpoint met the pre-specified criteria for futility. In accordance with DMC, Dompé decided to terminate the study early (not for safety reasons), resulting in a lower-than-planned no. of participants enrolled
Participant milestones
| Measure |
Reparixin + Standard of Care
Reparixin was administered orally at the dose of 1200 mg (2 x 600 mg tablets) TID (6 tablets daily) for up to 21 days.
The three daily doses were administered maintaining an interval between doses of about 8 hours.
Reparixin: Reparixin 600 mg tablets, administered orally at the dose of 1200 mg TID (2 tablets TID) as add-on therapy to standard of care up to 21 days. IMP was taken with a glass of water (about 250 mL) and a light meal or snack, as it was preferable that reparixin was taken with food. However, If the patient was unwilling or unable to administer oral tablets, investigator could decide a nasogastric tube as an alternative route.
|
Placebo + Standard of Care
Placebo tablets are identical in appearance to the active formulation. Placebo was administered with the same treatment schedule.
Placebo: Administered orally three times a day (TID) as add-on therapy to standard of care up to 21 days.
Placebo was taken with a glass of water (about 250 mL) and a light meal or snack, as it was preferable that placebo was taken with food. However, If the patient was unwilling or unable to administer oral tablets, investigator could decide a nasogastric tube as an alternative route.
|
|---|---|---|
|
Overall Study
STARTED
|
205
|
204
|
|
Overall Study
FAS Population
|
201
|
193
|
|
Overall Study
SAF Population
|
201
|
193
|
|
Overall Study
PP Population
|
139
|
133
|
|
Overall Study
COMPLETED
|
90
|
96
|
|
Overall Study
NOT COMPLETED
|
115
|
108
|
Reasons for withdrawal
| Measure |
Reparixin + Standard of Care
Reparixin was administered orally at the dose of 1200 mg (2 x 600 mg tablets) TID (6 tablets daily) for up to 21 days.
The three daily doses were administered maintaining an interval between doses of about 8 hours.
Reparixin: Reparixin 600 mg tablets, administered orally at the dose of 1200 mg TID (2 tablets TID) as add-on therapy to standard of care up to 21 days. IMP was taken with a glass of water (about 250 mL) and a light meal or snack, as it was preferable that reparixin was taken with food. However, If the patient was unwilling or unable to administer oral tablets, investigator could decide a nasogastric tube as an alternative route.
|
Placebo + Standard of Care
Placebo tablets are identical in appearance to the active formulation. Placebo was administered with the same treatment schedule.
Placebo: Administered orally three times a day (TID) as add-on therapy to standard of care up to 21 days.
Placebo was taken with a glass of water (about 250 mL) and a light meal or snack, as it was preferable that placebo was taken with food. However, If the patient was unwilling or unable to administer oral tablets, investigator could decide a nasogastric tube as an alternative route.
|
|---|---|---|
|
Overall Study
sponsor's decision to terminate the study early
|
53
|
43
|
|
Overall Study
Death
|
16
|
19
|
|
Overall Study
Lost to Follow-up
|
24
|
22
|
|
Overall Study
Withdrawal by Subject
|
17
|
10
|
|
Overall Study
Adverse Event
|
1
|
1
|
|
Overall Study
Physician Decision
|
2
|
4
|
|
Overall Study
Other
|
2
|
9
|
Baseline Characteristics
Reparixin add-on Therapy to Standard Care to Limit Progression in Pts With COVID19 & Other Community Acquired Pneumonia
Baseline characteristics by cohort
| Measure |
Reparixin + Standard of Care
n=201 Participants
Reparixin was administered orally at the dose of 1200 mg (2 x 600 mg tablets) TID (6 tablets daily) for up to 21 days.
The three daily doses were administered maintaining an interval between doses of about 8 hours.
Reparixin: Reparixin 600 mg tablets, administered orally at the dose of 1200 mg TID (2 tablets TID) as add-on therapy to standard of care up to 21 days. IMP was taken with a glass of water (about 250 mL) and a light meal or snack, as it was preferable that reparixin was taken with food. However, If the patient was unwilling or unable to administer oral tablets, investigator could decide a nasogastric tube as an alternative route.
|
Placebo + Standard of Care
n=193 Participants
Placebo tablets are identical in appearance to the active formulation. Placebo was administered with the same treatment schedule.
Placebo: Administered orally three times a day (TID) as add-on therapy to standard of care up to 21 days.
Placebo was taken with a glass of water (about 250 mL) and a light meal or snack, as it was preferable that placebo was taken with food. However, If the patient was unwilling or unable to administer oral tablets, investigator could decide a nasogastric tube as an alternative route.
|
Total
n=394 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=58 Participants
|
0 Participants
|
0 Participants
n=1 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
84 Participants
n=58 Participants
|
79 Participants
|
163 Participants
n=1 Participants
|
|
Age, Categorical
>=65 years
|
117 Participants
n=58 Participants
|
114 Participants
|
231 Participants
n=1 Participants
|
|
Age, Continuous
|
64.3 years
STANDARD_DEVIATION 15.7 • n=58 Participants
|
65.9 years
STANDARD_DEVIATION 14.9
|
65.1 years
STANDARD_DEVIATION 15.3 • n=1 Participants
|
|
Sex: Female, Male
Female
|
97 Participants
n=58 Participants
|
76 Participants
|
173 Participants
n=1 Participants
|
|
Sex: Female, Male
Male
|
104 Participants
n=58 Participants
|
117 Participants
|
221 Participants
n=1 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
33 Participants
n=58 Participants
|
39 Participants
|
72 Participants
n=1 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
168 Participants
n=58 Participants
|
154 Participants
|
322 Participants
n=1 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=58 Participants
|
0 Participants
|
0 Participants
n=1 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=58 Participants
|
1 Participants
|
2 Participants
n=1 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=58 Participants
|
4 Participants
|
6 Participants
n=1 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=58 Participants
|
0 Participants
|
0 Participants
n=1 Participants
|
|
Race (NIH/OMB)
Black or African American
|
18 Participants
n=58 Participants
|
14 Participants
|
32 Participants
n=1 Participants
|
|
Race (NIH/OMB)
White
|
176 Participants
n=58 Participants
|
168 Participants
|
344 Participants
n=1 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=58 Participants
|
0 Participants
|
0 Participants
n=1 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=58 Participants
|
6 Participants
|
10 Participants
n=1 Participants
|
|
Region of Enrollment
Austria
|
19 participants
n=58 Participants
|
16 participants
|
35 participants
n=1 Participants
|
|
Region of Enrollment
Argentina
|
28 participants
n=58 Participants
|
29 participants
|
57 participants
n=1 Participants
|
|
Region of Enrollment
Turkey
|
21 participants
n=58 Participants
|
19 participants
|
40 participants
n=1 Participants
|
|
Region of Enrollment
United States
|
79 participants
n=58 Participants
|
80 participants
|
159 participants
n=1 Participants
|
|
Region of Enrollment
Italy
|
47 participants
n=58 Participants
|
43 participants
|
90 participants
n=1 Participants
|
|
Region of Enrollment
Australia
|
2 participants
n=58 Participants
|
3 participants
|
5 participants
n=1 Participants
|
|
Region of Enrollment
Germany
|
5 participants
n=58 Participants
|
3 participants
|
8 participants
n=1 Participants
|
PRIMARY outcome
Timeframe: Day 28Population: FAS: All randomized patients who received at least one dose of the investigational product. FAS population was analyzed according to intention-to-treat principle, ie, by treatment allocation regardless of happening of intercurrent events. The FAS population was used to analyze results on efficacy data. Of 394 participants in the FAS, 312 had primary endpoint data (n=160 in the reparixin arm and n=152 in the placebo arm).
The primary endpoint was based on NIAID-OS ordinal scale (National Institute of Allergy and Infectious Disease) with score OS 7 which means patients "hospitalized, on invasive mechanical ventilation or ECMO". The scores on this scale of Disease severity range from OS 1 (best outcome) to OS 8 (worst outcome). NIAID-OS (National Institute of Allergy and Infectious Disease Ordinal Scale) SCORE Descriptor: * OS 1 Not hospitalized, no limitations on activities; * OS 2 Not hospitalized, limitation on activities and/or requiring home O2; * OS 3 Hospitalized, no supplemental O2 - no longer requires ongoing medical care; * OS 4 Hospitalized, no supplemental O2 - requiring ongoing medical care; * OS 5 Hospitalized, requiring supplemental O2; * OS 6 Hospitalized, on non-invasive ventilation or high-flow oxygen devices; * OS 7 Hospitalized, on invasive mechanical ventilation or ECMO; * OS 8 Death;
Outcome measures
| Measure |
Reparixin + Standard of Care
n=160 Participants
Reparixin was administered orally at the dose of 1200 mg (2 x 600 mg tablets) TID (6 tablets daily) for up to 21 days.
The three daily doses were administered maintaining an interval between doses of about 8 hours.
Reparixin: Reparixin 600 mg tablets, administered orally at the dose of 1200 mg TID (2 tablets TID) as add-on therapy to standard of care up to 21 days. IMP was taken with a glass of water (about 250 mL) and a light meal or snack, as it was preferable that reparixin was taken with food. However, If the patient was unwilling or unable to administer oral tablets, investigator could decide a nasogastric tube as an alternative route.
|
Placebo + Standard of Care
n=152 Participants
Placebo tablets are identical in appearance to the active formulation. Placebo was administered with the same treatment schedule.
Placebo: Administered orally three times a day (TID) as add-on therapy to standard of care up to 21 days.
Placebo was taken with a glass of water (about 250 mL) and a light meal or snack, as it was preferable that placebo was taken with food. However, If the patient was unwilling or unable to administer oral tablets, investigator could decide a nasogastric tube as an alternative route.
|
|---|---|---|
|
Proportion of Patients Dead or Requiring Invasive Mechanical Ventilation (IMV) or Extracorporeal Membrane Oxygenation (ECMO) by Day 28 [NIAID-OS 7].
|
7 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: Day 180Population: FAS:All randomized patients who received at least one dose of the investigational product. FAS population was analyzed according to intention-to-treat principle, ie, by treatment allocation regardless of happening of intercurrent events. The FAS population was used to analyze results on efficacy data. Of 394 participants in the FAS, 212 had available all-cause mortality data at day 180 (n=104 for reparixin arm and n=108 for placebo arm)
Key secondary endpoint. All-cause mortality is a measurement of the total number of deaths from any cause within a specific population over a defined period. It is a broad metric used in medical research and public health to assess overall population health, identify risk factors for premature death, and evaluate the effectiveness of interventions. The number of participants (in the form of unadjusted proportion) who met the endpoint is reported.
Outcome measures
| Measure |
Reparixin + Standard of Care
n=104 Participants
Reparixin was administered orally at the dose of 1200 mg (2 x 600 mg tablets) TID (6 tablets daily) for up to 21 days.
The three daily doses were administered maintaining an interval between doses of about 8 hours.
Reparixin: Reparixin 600 mg tablets, administered orally at the dose of 1200 mg TID (2 tablets TID) as add-on therapy to standard of care up to 21 days. IMP was taken with a glass of water (about 250 mL) and a light meal or snack, as it was preferable that reparixin was taken with food. However, If the patient was unwilling or unable to administer oral tablets, investigator could decide a nasogastric tube as an alternative route.
|
Placebo + Standard of Care
n=108 Participants
Placebo tablets are identical in appearance to the active formulation. Placebo was administered with the same treatment schedule.
Placebo: Administered orally three times a day (TID) as add-on therapy to standard of care up to 21 days.
Placebo was taken with a glass of water (about 250 mL) and a light meal or snack, as it was preferable that placebo was taken with food. However, If the patient was unwilling or unable to administer oral tablets, investigator could decide a nasogastric tube as an alternative route.
|
|---|---|---|
|
All-cause Mortality by Day 180
|
16 Participants
|
18 Participants
|
SECONDARY outcome
Timeframe: Day 28Population: FAS: All randomized patients who received at least one dose of the investigational product. FAS population was analyzed according to intention-to-treat principle, ie, by treatment allocation regardless of happening of intercurrent events.The FAS population was used to analyze results on efficacy data. Of 394 participants in the FAS, only 350 had available endpoint data (n=179 for reparixin arm and n=171 for placebo arm).
Key secondary endpoint. The number of participants alive or discharged, expressed in the form of unadjusted proportion, who met the endpoint at the final analysis at day 28 is provided.
Outcome measures
| Measure |
Reparixin + Standard of Care
n=179 Participants
Reparixin was administered orally at the dose of 1200 mg (2 x 600 mg tablets) TID (6 tablets daily) for up to 21 days.
The three daily doses were administered maintaining an interval between doses of about 8 hours.
Reparixin: Reparixin 600 mg tablets, administered orally at the dose of 1200 mg TID (2 tablets TID) as add-on therapy to standard of care up to 21 days. IMP was taken with a glass of water (about 250 mL) and a light meal or snack, as it was preferable that reparixin was taken with food. However, If the patient was unwilling or unable to administer oral tablets, investigator could decide a nasogastric tube as an alternative route.
|
Placebo + Standard of Care
n=171 Participants
Placebo tablets are identical in appearance to the active formulation. Placebo was administered with the same treatment schedule.
Placebo: Administered orally three times a day (TID) as add-on therapy to standard of care up to 21 days.
Placebo was taken with a glass of water (about 250 mL) and a light meal or snack, as it was preferable that placebo was taken with food. However, If the patient was unwilling or unable to administer oral tablets, investigator could decide a nasogastric tube as an alternative route.
|
|---|---|---|
|
Proportion of Patients Alive and Discharged From the Hospital by Day 28
|
170 Participants
|
159 Participants
|
SECONDARY outcome
Timeframe: Day 28Population: FAS: All randomized patients who received at least one dose of the investigational product. FAS population was analyzed according to intention-to-treat principle, ie, by treatment allocation regardless of happening of intercurrent events.The FAS population was used to analyze results on efficacy data. A total of 179 participants in the reparixin group and 171 participants in the placebo group were evaluable for the endpoint of ventilatory-free days at day 28.
Key secondary endpoint. Number of days from Day 0 to Day 28 when the patient was alive and free of invasive ventilation is reported. In case of multiple periods of IMV during the first 28 days, the total duration of ventilation considered all periods of ventilation during the index admission. Patients who died within 28 days or who still were on invasive ventilation after 28 days were scored 0 VFDs.
Outcome measures
| Measure |
Reparixin + Standard of Care
n=179 Participants
Reparixin was administered orally at the dose of 1200 mg (2 x 600 mg tablets) TID (6 tablets daily) for up to 21 days.
The three daily doses were administered maintaining an interval between doses of about 8 hours.
Reparixin: Reparixin 600 mg tablets, administered orally at the dose of 1200 mg TID (2 tablets TID) as add-on therapy to standard of care up to 21 days. IMP was taken with a glass of water (about 250 mL) and a light meal or snack, as it was preferable that reparixin was taken with food. However, If the patient was unwilling or unable to administer oral tablets, investigator could decide a nasogastric tube as an alternative route.
|
Placebo + Standard of Care
n=171 Participants
Placebo tablets are identical in appearance to the active formulation. Placebo was administered with the same treatment schedule.
Placebo: Administered orally three times a day (TID) as add-on therapy to standard of care up to 21 days.
Placebo was taken with a glass of water (about 250 mL) and a light meal or snack, as it was preferable that placebo was taken with food. However, If the patient was unwilling or unable to administer oral tablets, investigator could decide a nasogastric tube as an alternative route.
|
|---|---|---|
|
Ventilatory-free Days (VFD) by Day 28
|
27.4 number of days
Standard Deviation 4.2
|
26.5 number of days
Standard Deviation 6.3
|
SECONDARY outcome
Timeframe: Day 28Population: FAS: All randomized patients who received at least one dose of the investigational product. FAS population was analyzed according to intention-to-treat principle, ie, by treatment allocation regardless of happening of intercurrent events.The FAS population was used to analyze results on efficacy data. Of 394 participants in the FAS, 309 had available endpoint data (n=159 in the reparixin arm and n= 150 in the placebo group).
Key secondary endpoint.The number of participants, expressed in the form of unadjusted proportion, who met the endpoint at the final analysis is reported.
Outcome measures
| Measure |
Reparixin + Standard of Care
n=159 Participants
Reparixin was administered orally at the dose of 1200 mg (2 x 600 mg tablets) TID (6 tablets daily) for up to 21 days.
The three daily doses were administered maintaining an interval between doses of about 8 hours.
Reparixin: Reparixin 600 mg tablets, administered orally at the dose of 1200 mg TID (2 tablets TID) as add-on therapy to standard of care up to 21 days. IMP was taken with a glass of water (about 250 mL) and a light meal or snack, as it was preferable that reparixin was taken with food. However, If the patient was unwilling or unable to administer oral tablets, investigator could decide a nasogastric tube as an alternative route.
|
Placebo + Standard of Care
n=150 Participants
Placebo tablets are identical in appearance to the active formulation. Placebo was administered with the same treatment schedule.
Placebo: Administered orally three times a day (TID) as add-on therapy to standard of care up to 21 days.
Placebo was taken with a glass of water (about 250 mL) and a light meal or snack, as it was preferable that placebo was taken with food. However, If the patient was unwilling or unable to administer oral tablets, investigator could decide a nasogastric tube as an alternative route.
|
|---|---|---|
|
Proportion of Patients With IMV (or ECMO) by Day 28
|
6 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: Day 180Population: FAS: All randomized patients who received at least one dose of the investigational product. FAS population was analyzed according to intention-to-treat principle, ie, by treatment allocation regardless of happening of intercurrent events.The FAS population was used to analyze results on efficacy data. A total of 191 participants in the reparixin group and 184 participants in the placebo group were evaluable for the endpoint.
Key secondary endpoint. The duration of primary hospital stay, expressed in days, are reported. This parameter is included in the set of final evaluation, which comprises: no. of days of hospitalization, etiologic agents (if identified), ICU admission and total days in ICU, occurrence, and duration of IMV and/or ECMO, if any.
Outcome measures
| Measure |
Reparixin + Standard of Care
n=191 Participants
Reparixin was administered orally at the dose of 1200 mg (2 x 600 mg tablets) TID (6 tablets daily) for up to 21 days.
The three daily doses were administered maintaining an interval between doses of about 8 hours.
Reparixin: Reparixin 600 mg tablets, administered orally at the dose of 1200 mg TID (2 tablets TID) as add-on therapy to standard of care up to 21 days. IMP was taken with a glass of water (about 250 mL) and a light meal or snack, as it was preferable that reparixin was taken with food. However, If the patient was unwilling or unable to administer oral tablets, investigator could decide a nasogastric tube as an alternative route.
|
Placebo + Standard of Care
n=184 Participants
Placebo tablets are identical in appearance to the active formulation. Placebo was administered with the same treatment schedule.
Placebo: Administered orally three times a day (TID) as add-on therapy to standard of care up to 21 days.
Placebo was taken with a glass of water (about 250 mL) and a light meal or snack, as it was preferable that placebo was taken with food. However, If the patient was unwilling or unable to administer oral tablets, investigator could decide a nasogastric tube as an alternative route.
|
|---|---|---|
|
Length of Primary Hospital Stay (in Days)
|
8.7 days of hospital stay
Standard Deviation 6.3
|
8.7 days of hospital stay
Standard Deviation 7.0
|
SECONDARY outcome
Timeframe: Day 3 and Day 7Population: FAS: All randomized patients who received at least one dose of the investigational product. FAS population was analyzed according to intention-to-treat principle, ie, by treatment allocation regardless of happening of intercurrent events.The FAS population was used to analyze results on efficacy data. No. of evaluable patients by day 3: n=195 in the reparixin group and n=186 in the placebo group. No. of evaluable patients by day 7: n=184 in the reparixin group and n=177 in the placebo group.
Clinical failure was defined as the occurrence of IMV/ECMO or vasopressor, or death. IMV= invasive mechanical ventilation. ECMO=extracorporeal membrane oxygenation.
Outcome measures
| Measure |
Reparixin + Standard of Care
n=195 Participants
Reparixin was administered orally at the dose of 1200 mg (2 x 600 mg tablets) TID (6 tablets daily) for up to 21 days.
The three daily doses were administered maintaining an interval between doses of about 8 hours.
Reparixin: Reparixin 600 mg tablets, administered orally at the dose of 1200 mg TID (2 tablets TID) as add-on therapy to standard of care up to 21 days. IMP was taken with a glass of water (about 250 mL) and a light meal or snack, as it was preferable that reparixin was taken with food. However, If the patient was unwilling or unable to administer oral tablets, investigator could decide a nasogastric tube as an alternative route.
|
Placebo + Standard of Care
n=186 Participants
Placebo tablets are identical in appearance to the active formulation. Placebo was administered with the same treatment schedule.
Placebo: Administered orally three times a day (TID) as add-on therapy to standard of care up to 21 days.
Placebo was taken with a glass of water (about 250 mL) and a light meal or snack, as it was preferable that placebo was taken with food. However, If the patient was unwilling or unable to administer oral tablets, investigator could decide a nasogastric tube as an alternative route.
|
|---|---|---|
|
Clinical Failure by Day 3 and Day 7
Day 7
|
5 Participants
|
9 Participants
|
|
Clinical Failure by Day 3 and Day 7
Day 3
|
2 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: Day 28Population: FAS: All randomized patients who received at least one dose of the investigational product. FAS population was analyzed according to intention-to-treat principle, ie, by treatment allocation regardless of happening of intercurrent events.The FAS population was used to analyze results on efficacy data. A total of 179 participants in the reparixin group and 171 participants in the placebo group were evaluable for the endpoint.
ICU-free days = days of hospitalization out of the Intensive Care Unit. Death within Day 28 was handled as an unfavorable event and ICU-free days were set at 0.
Outcome measures
| Measure |
Reparixin + Standard of Care
n=179 Participants
Reparixin was administered orally at the dose of 1200 mg (2 x 600 mg tablets) TID (6 tablets daily) for up to 21 days.
The three daily doses were administered maintaining an interval between doses of about 8 hours.
Reparixin: Reparixin 600 mg tablets, administered orally at the dose of 1200 mg TID (2 tablets TID) as add-on therapy to standard of care up to 21 days. IMP was taken with a glass of water (about 250 mL) and a light meal or snack, as it was preferable that reparixin was taken with food. However, If the patient was unwilling or unable to administer oral tablets, investigator could decide a nasogastric tube as an alternative route.
|
Placebo + Standard of Care
n=171 Participants
Placebo tablets are identical in appearance to the active formulation. Placebo was administered with the same treatment schedule.
Placebo: Administered orally three times a day (TID) as add-on therapy to standard of care up to 21 days.
Placebo was taken with a glass of water (about 250 mL) and a light meal or snack, as it was preferable that placebo was taken with food. However, If the patient was unwilling or unable to administer oral tablets, investigator could decide a nasogastric tube as an alternative route.
|
|---|---|---|
|
28-day ICU-free Days
|
26.3 days
Standard Deviation 5.0
|
25.7 days
Standard Deviation 6.8
|
SECONDARY outcome
Timeframe: Day 28Population: FAS: All randomized patients who received at least one dose of the investigational product. FAS population was analyzed according to intention-to-treat principle, ie, by treatment allocation regardless of happening of intercurrent events. The FAS population was used to analyze results on efficacy data. Of 394 participants in the FAS, 179 in the reparixin group and 169 in the placebo group were evaluable for this endpoint at day 28.
These parameters are expressed as number of days with NIAID-OS score not equal to 7 or 8, where NIAID-OS is the National Institute of Allergy and Infectious Disease Ordinal Scale; a scale ranging from 1 to 8, where the lower the score, the better the outcome. The IMV/ECMO-free days at Day 28 were analyzed according to MI approach and ANOVA model. Death due to progression of the respiratory disease within Day 28 was handled as an unfavorable event and IMV/ECMO-free days at Day 28 was set at 0.
Outcome measures
| Measure |
Reparixin + Standard of Care
n=179 Participants
Reparixin was administered orally at the dose of 1200 mg (2 x 600 mg tablets) TID (6 tablets daily) for up to 21 days.
The three daily doses were administered maintaining an interval between doses of about 8 hours.
Reparixin: Reparixin 600 mg tablets, administered orally at the dose of 1200 mg TID (2 tablets TID) as add-on therapy to standard of care up to 21 days. IMP was taken with a glass of water (about 250 mL) and a light meal or snack, as it was preferable that reparixin was taken with food. However, If the patient was unwilling or unable to administer oral tablets, investigator could decide a nasogastric tube as an alternative route.
|
Placebo + Standard of Care
n=169 Participants
Placebo tablets are identical in appearance to the active formulation. Placebo was administered with the same treatment schedule.
Placebo: Administered orally three times a day (TID) as add-on therapy to standard of care up to 21 days.
Placebo was taken with a glass of water (about 250 mL) and a light meal or snack, as it was preferable that placebo was taken with food. However, If the patient was unwilling or unable to administer oral tablets, investigator could decide a nasogastric tube as an alternative route.
|
|---|---|---|
|
Days Free of IMV or ECMO (Number of Days With NIAID-OS 1-6) by Day 28
|
27.4 days
Standard Deviation 4.2
|
26.8 days
Standard Deviation 5.6
|
SECONDARY outcome
Timeframe: Day 28Population: FAS: All randomized patients who received at least one dose of the investigational product. FAS population was analyzed according to intention-to-treat principle, ie, by treatment allocation regardless of happening of intercurrent events. The FAS population was used to analyze results on efficacy data. Of 394 participants in the FAS, 175 in the reparixin group and 163 in the placebo group were evaluable for this endpoint.
A descriptive summary of duration of antibiotic therapy (days) at day 28 for the FAS is reported.
Outcome measures
| Measure |
Reparixin + Standard of Care
n=175 Participants
Reparixin was administered orally at the dose of 1200 mg (2 x 600 mg tablets) TID (6 tablets daily) for up to 21 days.
The three daily doses were administered maintaining an interval between doses of about 8 hours.
Reparixin: Reparixin 600 mg tablets, administered orally at the dose of 1200 mg TID (2 tablets TID) as add-on therapy to standard of care up to 21 days. IMP was taken with a glass of water (about 250 mL) and a light meal or snack, as it was preferable that reparixin was taken with food. However, If the patient was unwilling or unable to administer oral tablets, investigator could decide a nasogastric tube as an alternative route.
|
Placebo + Standard of Care
n=163 Participants
Placebo tablets are identical in appearance to the active formulation. Placebo was administered with the same treatment schedule.
Placebo: Administered orally three times a day (TID) as add-on therapy to standard of care up to 21 days.
Placebo was taken with a glass of water (about 250 mL) and a light meal or snack, as it was preferable that placebo was taken with food. However, If the patient was unwilling or unable to administer oral tablets, investigator could decide a nasogastric tube as an alternative route.
|
|---|---|---|
|
Duration of Antibiotic Therapy (Days) by Day 28
|
9.6 days
Standard Deviation 8.3
|
9.2 days
Standard Deviation 8.6
|
SECONDARY outcome
Timeframe: Day 28Population: FAS: All randomized patients who received at least one dose of the investigational product. FAS population was analyzed according to intention-to-treat principle, ie, by treatment allocation regardless of happening of intercurrent events.The FAS population was used to analyze results on efficacy data. A total of 179 participants in the reparixin group and 171 participants in the placebo group were evaluable for this endpoint.
Results for hospital-free days at day 28 in the FAS are presented through an unadjusted descriptive summary.
Outcome measures
| Measure |
Reparixin + Standard of Care
n=179 Participants
Reparixin was administered orally at the dose of 1200 mg (2 x 600 mg tablets) TID (6 tablets daily) for up to 21 days.
The three daily doses were administered maintaining an interval between doses of about 8 hours.
Reparixin: Reparixin 600 mg tablets, administered orally at the dose of 1200 mg TID (2 tablets TID) as add-on therapy to standard of care up to 21 days. IMP was taken with a glass of water (about 250 mL) and a light meal or snack, as it was preferable that reparixin was taken with food. However, If the patient was unwilling or unable to administer oral tablets, investigator could decide a nasogastric tube as an alternative route.
|
Placebo + Standard of Care
n=171 Participants
Placebo tablets are identical in appearance to the active formulation. Placebo was administered with the same treatment schedule.
Placebo: Administered orally three times a day (TID) as add-on therapy to standard of care up to 21 days.
Placebo was taken with a glass of water (about 250 mL) and a light meal or snack, as it was preferable that placebo was taken with food. However, If the patient was unwilling or unable to administer oral tablets, investigator could decide a nasogastric tube as an alternative route.
|
|---|---|---|
|
Hospital Free Days
|
18.3 days
Standard Deviation 6.7
|
18.2 days
Standard Deviation 7.6
|
SECONDARY outcome
Timeframe: days 3, 7, 14, 21, 28, and hospital discharge (Up to Day 41)Population: FAS: All randomized patients who received at least one dose of the investigational product. FAS population was analyzed according to ITT principle, ie, by treatment allocation regardless of happening of intercurrent events.The FAS population was used to analyze results on efficacy data. No of patients evaluable: Day 3: n=184 REP; n=178 Placebo (P) Day 7: n=129 REP; n=128 P Day 14: n=165 REP; n=159 P Day 21: n=40 REP; n=38 P Day 28: n=159 REP; n=154 P HD: n=183 REP; n=177 P
Results for the proportion of participants recovered at fixed timepoints in the FAS are presented. Recovering was defined as a downward shift from screening of ≤2 points on the NIAID-OS or live discharge from hospital. Unadjusted proportion is reported.
Outcome measures
| Measure |
Reparixin + Standard of Care
n=184 Participants
Reparixin was administered orally at the dose of 1200 mg (2 x 600 mg tablets) TID (6 tablets daily) for up to 21 days.
The three daily doses were administered maintaining an interval between doses of about 8 hours.
Reparixin: Reparixin 600 mg tablets, administered orally at the dose of 1200 mg TID (2 tablets TID) as add-on therapy to standard of care up to 21 days. IMP was taken with a glass of water (about 250 mL) and a light meal or snack, as it was preferable that reparixin was taken with food. However, If the patient was unwilling or unable to administer oral tablets, investigator could decide a nasogastric tube as an alternative route.
|
Placebo + Standard of Care
n=178 Participants
Placebo tablets are identical in appearance to the active formulation. Placebo was administered with the same treatment schedule.
Placebo: Administered orally three times a day (TID) as add-on therapy to standard of care up to 21 days.
Placebo was taken with a glass of water (about 250 mL) and a light meal or snack, as it was preferable that placebo was taken with food. However, If the patient was unwilling or unable to administer oral tablets, investigator could decide a nasogastric tube as an alternative route.
|
|---|---|---|
|
Proportion of Patients Recovered
Day 3
|
11 Participants
|
15 Participants
|
|
Proportion of Patients Recovered
Day 7
|
40 Participants
|
49 Participants
|
|
Proportion of Patients Recovered
Day 14
|
138 Participants
|
135 Participants
|
|
Proportion of Patients Recovered
Day 21
|
31 Participants
|
24 Participants
|
|
Proportion of Patients Recovered
Day 28
|
151 Participants
|
139 Participants
|
|
Proportion of Patients Recovered
Hospital discharge (Up to Day 41)
|
146 Participants
|
145 Participants
|
SECONDARY outcome
Timeframe: days 3, 7, 14, 21, 28, and hospital discharge (Up to Day 41)Population: FAS: All randomized patients who received at least one dose of the investigational product. FAS population was analyzed according to ITT principle, ie, by treatment allocation regardless of happening of intercurrent events.The FAS population was used to analyze results on efficacy data. No of patients evaluable: Day 3: n=184 REP; n=178 Placebo (P) Day 7: n=129 REP; n=128 P Day 14: n=165 REP; n=159 P Day 21: n=40 REP; n=38 P Day 28: n=159 REP; n=154 P HD: n=183 REP; n=177 P
Results for the proportion of participants worsening at fixed timepoints in the FAS are presented. Worsening was expressed as upward shift from screening of at least \>1 point of the NIAID-OS or if patient died before X Visit Day. An unadjusted proportion is reported.
Outcome measures
| Measure |
Reparixin + Standard of Care
n=184 Participants
Reparixin was administered orally at the dose of 1200 mg (2 x 600 mg tablets) TID (6 tablets daily) for up to 21 days.
The three daily doses were administered maintaining an interval between doses of about 8 hours.
Reparixin: Reparixin 600 mg tablets, administered orally at the dose of 1200 mg TID (2 tablets TID) as add-on therapy to standard of care up to 21 days. IMP was taken with a glass of water (about 250 mL) and a light meal or snack, as it was preferable that reparixin was taken with food. However, If the patient was unwilling or unable to administer oral tablets, investigator could decide a nasogastric tube as an alternative route.
|
Placebo + Standard of Care
n=178 Participants
Placebo tablets are identical in appearance to the active formulation. Placebo was administered with the same treatment schedule.
Placebo: Administered orally three times a day (TID) as add-on therapy to standard of care up to 21 days.
Placebo was taken with a glass of water (about 250 mL) and a light meal or snack, as it was preferable that placebo was taken with food. However, If the patient was unwilling or unable to administer oral tablets, investigator could decide a nasogastric tube as an alternative route.
|
|---|---|---|
|
Proportion of Patients Worsening
Day 3
|
6 Participants
|
10 Participants
|
|
Proportion of Patients Worsening
Day 7
|
4 Participants
|
6 Participants
|
|
Proportion of Patients Worsening
Day 14
|
2 Participants
|
6 Participants
|
|
Proportion of Patients Worsening
Day 21
|
3 Participants
|
7 Participants
|
|
Proportion of Patients Worsening
Day 28
|
5 Participants
|
10 Participants
|
|
Proportion of Patients Worsening
Hospital discharge (Up to Day 41)
|
5 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: days 3, 7, 14, 21, 28, and hospital discharge (Up to Day 41)Population: FAS: All randomized patients who received at least one dose of the investigational product. FAS population was analyzed according to ITT principle, ie, by treatment allocation regardless of happening of intercurrent events.The FAS population was used to analyze results on efficacy data. No of patients evaluable: Day 3: n=180 REP; n=178 Placebo (P) Day 7: n=124 REP; n=126 P Day 14: n=108 REP; n=98 P Day 21: n=27 REP; n=18 P Day 28: n=82 REP; n=75 P HD: n=3 REP; n=2 P
Descriptive statistics for the change from baseline in arterial partial pressure of oxygen (PaO2) at fixed timepoints are reported.
Outcome measures
| Measure |
Reparixin + Standard of Care
n=180 Participants
Reparixin was administered orally at the dose of 1200 mg (2 x 600 mg tablets) TID (6 tablets daily) for up to 21 days.
The three daily doses were administered maintaining an interval between doses of about 8 hours.
Reparixin: Reparixin 600 mg tablets, administered orally at the dose of 1200 mg TID (2 tablets TID) as add-on therapy to standard of care up to 21 days. IMP was taken with a glass of water (about 250 mL) and a light meal or snack, as it was preferable that reparixin was taken with food. However, If the patient was unwilling or unable to administer oral tablets, investigator could decide a nasogastric tube as an alternative route.
|
Placebo + Standard of Care
n=178 Participants
Placebo tablets are identical in appearance to the active formulation. Placebo was administered with the same treatment schedule.
Placebo: Administered orally three times a day (TID) as add-on therapy to standard of care up to 21 days.
Placebo was taken with a glass of water (about 250 mL) and a light meal or snack, as it was preferable that placebo was taken with food. However, If the patient was unwilling or unable to administer oral tablets, investigator could decide a nasogastric tube as an alternative route.
|
|---|---|---|
|
Change From Baseline in the Arterial Partial Pressure of Oxygen (PaO2)
Hospital discharge (Up to Day 41)
|
25.45 mmHg
Standard Deviation 17.57
|
24.52 mmHg
Standard Deviation 6.20
|
|
Change From Baseline in the Arterial Partial Pressure of Oxygen (PaO2)
To day 3
|
15.80 mmHg
Standard Deviation 27.96
|
9.08 mmHg
Standard Deviation 22.18
|
|
Change From Baseline in the Arterial Partial Pressure of Oxygen (PaO2)
To day 7
|
15.44 mmHg
Standard Deviation 29.50
|
11.10 mmHg
Standard Deviation 27.94
|
|
Change From Baseline in the Arterial Partial Pressure of Oxygen (PaO2)
To day 14
|
20.09 mmHg
Standard Deviation 30.42
|
18.28 mmHg
Standard Deviation 20.62
|
|
Change From Baseline in the Arterial Partial Pressure of Oxygen (PaO2)
To day 21
|
8.63 mmHg
Standard Deviation 37.04
|
21.88 mmHg
Standard Deviation 26.43
|
|
Change From Baseline in the Arterial Partial Pressure of Oxygen (PaO2)
To day 28
|
23.65 mmHg
Standard Deviation 30.02
|
25.98 mmHg
Standard Deviation 21.54
|
SECONDARY outcome
Timeframe: days 3, 7, 14, 21, 28, and hospital discharge (Up to Day 41)Population: FAS: All randomized patients who received at least one dose of the investigational product. FAS population was analyzed according to ITT principle, ie, by treatment allocation regardless of happening of intercurrent events.The FAS population was used to analyze results on efficacy data. No. of patients evaluable: Day 3: n=180 REP; n=177 Placebo (P) Day 7: n=123 REP; n=124 P Day 14: n=107 REP; n=98 P Day 21: n=27 REP; n=18 P Day 28: n=82 REP; n=75 P HD: n=3 REP; n=2 P
Descriptive statistics for the change from baseline in pulse oximetry, measured as peripheral arterial oxygen saturation (SpO2), at fixed timepoints are reported.
Outcome measures
| Measure |
Reparixin + Standard of Care
n=180 Participants
Reparixin was administered orally at the dose of 1200 mg (2 x 600 mg tablets) TID (6 tablets daily) for up to 21 days.
The three daily doses were administered maintaining an interval between doses of about 8 hours.
Reparixin: Reparixin 600 mg tablets, administered orally at the dose of 1200 mg TID (2 tablets TID) as add-on therapy to standard of care up to 21 days. IMP was taken with a glass of water (about 250 mL) and a light meal or snack, as it was preferable that reparixin was taken with food. However, If the patient was unwilling or unable to administer oral tablets, investigator could decide a nasogastric tube as an alternative route.
|
Placebo + Standard of Care
n=177 Participants
Placebo tablets are identical in appearance to the active formulation. Placebo was administered with the same treatment schedule.
Placebo: Administered orally three times a day (TID) as add-on therapy to standard of care up to 21 days.
Placebo was taken with a glass of water (about 250 mL) and a light meal or snack, as it was preferable that placebo was taken with food. However, If the patient was unwilling or unable to administer oral tablets, investigator could decide a nasogastric tube as an alternative route.
|
|---|---|---|
|
Change From Baseline in Pulse Oximetry (SpO2)
To day 3
|
3.86 percent hemoglobin oxygen saturation
Standard Deviation 5.90
|
2.79 percent hemoglobin oxygen saturation
Standard Deviation 6.48
|
|
Change From Baseline in Pulse Oximetry (SpO2)
To day 7
|
4.37 percent hemoglobin oxygen saturation
Standard Deviation 6.53
|
2.45 percent hemoglobin oxygen saturation
Standard Deviation 7.79
|
|
Change From Baseline in Pulse Oximetry (SpO2)
To day 14
|
5.41 percent hemoglobin oxygen saturation
Standard Deviation 5.87
|
4.09 percent hemoglobin oxygen saturation
Standard Deviation 7.05
|
|
Change From Baseline in Pulse Oximetry (SpO2)
To day 21
|
4.32 percent hemoglobin oxygen saturation
Standard Deviation 6.62
|
3.12 percent hemoglobin oxygen saturation
Standard Deviation 4.55
|
|
Change From Baseline in Pulse Oximetry (SpO2)
To day 28
|
5.95 percent hemoglobin oxygen saturation
Standard Deviation 5.42
|
5.46 percent hemoglobin oxygen saturation
Standard Deviation 7.19
|
|
Change From Baseline in Pulse Oximetry (SpO2)
Hospital discharge (Up to Day 41)
|
4.53 percent hemoglobin oxygen saturation
Standard Deviation 2.20
|
9.25 percent hemoglobin oxygen saturation
Standard Deviation 0.35
|
SECONDARY outcome
Timeframe: days 3, 7, 14, 21, 28, and hospital discharge (Up to Day 41)Population: FAS: All randomized patients who received at least one dose of the investigational product. FAS population was analyzed according to ITT principle, ie, by treatment allocation regardless of happening of intercurrent events. The FAS population was used to analyze results on efficacy data. Subjects who contributed data per row Day 3: REP n=167; P n=171 Day 7±1: REP n=116; P n=123 Day 14±2: REP n=102; P n=93 Day 21±2: REP n=27; P n=18 Day 28±2: REP n=75; P n=71 HD: REP n=2; P n=1
FiO2 is a parameter of lung function representing the fraction of oxygen in the inspired air, ranging from 0.21 (room air) to 1.00 (100% oxygen). The endpoint assesses the change from baseline in FiO2 levels at predefined timepoints during the study.
Outcome measures
| Measure |
Reparixin + Standard of Care
n=167 Participants
Reparixin was administered orally at the dose of 1200 mg (2 x 600 mg tablets) TID (6 tablets daily) for up to 21 days.
The three daily doses were administered maintaining an interval between doses of about 8 hours.
Reparixin: Reparixin 600 mg tablets, administered orally at the dose of 1200 mg TID (2 tablets TID) as add-on therapy to standard of care up to 21 days. IMP was taken with a glass of water (about 250 mL) and a light meal or snack, as it was preferable that reparixin was taken with food. However, If the patient was unwilling or unable to administer oral tablets, investigator could decide a nasogastric tube as an alternative route.
|
Placebo + Standard of Care
n=171 Participants
Placebo tablets are identical in appearance to the active formulation. Placebo was administered with the same treatment schedule.
Placebo: Administered orally three times a day (TID) as add-on therapy to standard of care up to 21 days.
Placebo was taken with a glass of water (about 250 mL) and a light meal or snack, as it was preferable that placebo was taken with food. However, If the patient was unwilling or unable to administer oral tablets, investigator could decide a nasogastric tube as an alternative route.
|
|---|---|---|
|
Change From Baseline in Inspired Oxygen (FiO2) Levels
Day 3
|
-0.010 fraction (0.21-1.00)
Standard Deviation 0.144
|
-0.038 fraction (0.21-1.00)
Standard Deviation 0.140
|
|
Change From Baseline in Inspired Oxygen (FiO2) Levels
Day 7
|
-0.061 fraction (0.21-1.00)
Standard Deviation 0.151
|
-0.072 fraction (0.21-1.00)
Standard Deviation 0.169
|
|
Change From Baseline in Inspired Oxygen (FiO2) Levels
Day 14
|
-0.071 fraction (0.21-1.00)
Standard Deviation 0.135
|
-0.071 fraction (0.21-1.00)
Standard Deviation 0.180
|
|
Change From Baseline in Inspired Oxygen (FiO2) Levels
Day 21
|
-0.061 fraction (0.21-1.00)
Standard Deviation 0.131
|
-0.082 fraction (0.21-1.00)
Standard Deviation 0.111
|
|
Change From Baseline in Inspired Oxygen (FiO2) Levels
Day 28
|
-0.078 fraction (0.21-1.00)
Standard Deviation 0.119
|
-0.086 fraction (0.21-1.00)
Standard Deviation 0.097
|
|
Change From Baseline in Inspired Oxygen (FiO2) Levels
Hospital discharge (Up to Day 41)
|
-0.055 fraction (0.21-1.00)
Standard Deviation 0.078
|
0.000 fraction (0.21-1.00)
|
SECONDARY outcome
Timeframe: days 3, 7, 14, 21, 28, and hospital discharge (Up to Day 41)Population: FAS: All randomized patients who received at least one dose of the investigational product. FAS population was analyzed according to ITT principle, ie, by treatment allocation regardless of happening of intercurrent events. The FAS population was used to analyze results on efficacy data. Only those participants with data available at specified timepoints have been presented.
The PaO2/FiO2 ratio is a parameter of lung function that reflects the efficiency of oxygen transfer from the lungs to the blood. It is calculated as the ratio between the arterial partial pressure of oxygen (PaO2, measured in mmHg) and the fraction of inspired oxygen (FiO2, expressed as a fraction ranging from 0.21 to 1.00). This endpoint assesses the change from baseline in the PaO2/FiO2 ratio at predefined timepoints during the study.
Outcome measures
| Measure |
Reparixin + Standard of Care
n=167 Participants
Reparixin was administered orally at the dose of 1200 mg (2 x 600 mg tablets) TID (6 tablets daily) for up to 21 days.
The three daily doses were administered maintaining an interval between doses of about 8 hours.
Reparixin: Reparixin 600 mg tablets, administered orally at the dose of 1200 mg TID (2 tablets TID) as add-on therapy to standard of care up to 21 days. IMP was taken with a glass of water (about 250 mL) and a light meal or snack, as it was preferable that reparixin was taken with food. However, If the patient was unwilling or unable to administer oral tablets, investigator could decide a nasogastric tube as an alternative route.
|
Placebo + Standard of Care
n=171 Participants
Placebo tablets are identical in appearance to the active formulation. Placebo was administered with the same treatment schedule.
Placebo: Administered orally three times a day (TID) as add-on therapy to standard of care up to 21 days.
Placebo was taken with a glass of water (about 250 mL) and a light meal or snack, as it was preferable that placebo was taken with food. However, If the patient was unwilling or unable to administer oral tablets, investigator could decide a nasogastric tube as an alternative route.
|
|---|---|---|
|
Change From Baseline in PaO2/FiO2 Ratio
Hospital discharge (Up to Day 41)
|
172.34 ratio
Standard Deviation 196.54
|
137.62 ratio
|
|
Change From Baseline in PaO2/FiO2 Ratio
Day 3
|
66.51 ratio
Standard Deviation 115.49
|
54.52 ratio
Standard Deviation 97.65
|
|
Change From Baseline in PaO2/FiO2 Ratio
Day 7
|
105.38 ratio
Standard Deviation 122.94
|
109.57 ratio
Standard Deviation 138.44
|
|
Change From Baseline in PaO2/FiO2 Ratio
Day 14
|
148.84 ratio
Standard Deviation 128.09
|
146.72 ratio
Standard Deviation 129.19
|
|
Change From Baseline in PaO2/FiO2 Ratio
Day 21
|
101.87 ratio
Standard Deviation 134.94
|
180.14 ratio
Standard Deviation 164.18
|
|
Change From Baseline in PaO2/FiO2 Ratio
Day 28
|
177.58 ratio
Standard Deviation 133.95
|
192.55 ratio
Standard Deviation 116.18
|
SECONDARY outcome
Timeframe: Days 3, 7, 14, 21, and 28Population: FAS: All randomized patients who received at least one dose of the investigational product. FAS population was analyzed according to ITT principle, ie, by treatment allocation regardless of happening of intercurrent events. The FAS population was used to analyze results on efficacy data. Only those participants with data available at specified timepoints have been presented.
The SpO2/FiO2 ratio is a noninvasive indicator of lung function and oxygenation efficiency, calculated as the ratio between peripheral oxygen saturation (SpO2, expressed as a percentage) and the fraction of inspired oxygen (FiO2, expressed as a fraction ranging from 0.21 to 1.00). This endpoint assesses the change from baseline in the SpO2/FiO2 ratio at predefined timepoints during the study.
Outcome measures
| Measure |
Reparixin + Standard of Care
n=165 Participants
Reparixin was administered orally at the dose of 1200 mg (2 x 600 mg tablets) TID (6 tablets daily) for up to 21 days.
The three daily doses were administered maintaining an interval between doses of about 8 hours.
Reparixin: Reparixin 600 mg tablets, administered orally at the dose of 1200 mg TID (2 tablets TID) as add-on therapy to standard of care up to 21 days. IMP was taken with a glass of water (about 250 mL) and a light meal or snack, as it was preferable that reparixin was taken with food. However, If the patient was unwilling or unable to administer oral tablets, investigator could decide a nasogastric tube as an alternative route.
|
Placebo + Standard of Care
n=169 Participants
Placebo tablets are identical in appearance to the active formulation. Placebo was administered with the same treatment schedule.
Placebo: Administered orally three times a day (TID) as add-on therapy to standard of care up to 21 days.
Placebo was taken with a glass of water (about 250 mL) and a light meal or snack, as it was preferable that placebo was taken with food. However, If the patient was unwilling or unable to administer oral tablets, investigator could decide a nasogastric tube as an alternative route.
|
|---|---|---|
|
Change From Baseline in SpO2/FiO2 Ratio
Day 3
|
19.63 ratio (SpO2 [%] / FiO2 [fraction])
Standard Deviation 103.39
|
38.01 ratio (SpO2 [%] / FiO2 [fraction])
Standard Deviation 104.26
|
|
Change From Baseline in SpO2/FiO2 Ratio
Day 7
|
67.42 ratio (SpO2 [%] / FiO2 [fraction])
Standard Deviation 108.71
|
81.50 ratio (SpO2 [%] / FiO2 [fraction])
Standard Deviation 131.69
|
|
Change From Baseline in SpO2/FiO2 Ratio
Day14
|
98.30 ratio (SpO2 [%] / FiO2 [fraction])
Standard Deviation 97.90
|
96.20 ratio (SpO2 [%] / FiO2 [fraction])
Standard Deviation 122.21
|
|
Change From Baseline in SpO2/FiO2 Ratio
Day 21
|
74.69 ratio (SpO2 [%] / FiO2 [fraction])
Standard Deviation 107.88
|
101.45 ratio (SpO2 [%] / FiO2 [fraction])
Standard Deviation 94.49
|
|
Change From Baseline in SpO2/FiO2 Ratio
Day 28
|
109.34 ratio (SpO2 [%] / FiO2 [fraction])
Standard Deviation 93.37
|
118.75 ratio (SpO2 [%] / FiO2 [fraction])
Standard Deviation 82.93
|
SECONDARY outcome
Timeframe: Days 28, 60 and 90Population: FAS: All randomized patients who received at least one dose of the investigational product. FAS population was analyzed according to intention-to-treat principle, ie, by treatment allocation regardless of happening of intercurrent events.The FAS population was used to analyze results on efficacy data. These are also the numbers of patients considered in the model.
Results for all-cause mortality rates in the FAS are reported, at day 28, day 60, and day 90. Analysis was based on logistic regression model with Multiple Imputation using retrieve dropouts with proportion of patients died up to Day 28 as dependent variable, treatment, disease severity at baseline (NIAID-OS \<=5 vs. NIAID-OS 6), age class (\<65, \>= 65 years), sex and presence of concomitant disease at baseline as qualitative independent variables.
Outcome measures
| Measure |
Reparixin + Standard of Care
n=201 Participants
Reparixin was administered orally at the dose of 1200 mg (2 x 600 mg tablets) TID (6 tablets daily) for up to 21 days.
The three daily doses were administered maintaining an interval between doses of about 8 hours.
Reparixin: Reparixin 600 mg tablets, administered orally at the dose of 1200 mg TID (2 tablets TID) as add-on therapy to standard of care up to 21 days. IMP was taken with a glass of water (about 250 mL) and a light meal or snack, as it was preferable that reparixin was taken with food. However, If the patient was unwilling or unable to administer oral tablets, investigator could decide a nasogastric tube as an alternative route.
|
Placebo + Standard of Care
n=193 Participants
Placebo tablets are identical in appearance to the active formulation. Placebo was administered with the same treatment schedule.
Placebo: Administered orally three times a day (TID) as add-on therapy to standard of care up to 21 days.
Placebo was taken with a glass of water (about 250 mL) and a light meal or snack, as it was preferable that placebo was taken with food. However, If the patient was unwilling or unable to administer oral tablets, investigator could decide a nasogastric tube as an alternative route.
|
|---|---|---|
|
All-cause Mortality
Day 28
|
2.608 % participants
Interval to 5.219
Insufficient number of participants with events-12 deaths before day 28, only 4 in the Reparixin arm. Interpretable proportion values should be 0-100%. A small number of events combined with normal approximation can produce a negative lower bound, which is not interpretable and therefore reported as NA.
|
5.701 % participants
Interval 1.612 to 9.79
|
|
All-cause Mortality
Day 60
|
6.990 % participants
Interval 2.326 to 11.653
|
11.310 % participants
Interval 4.956 to 17.664
|
|
All-cause Mortality
Day 90
|
7.898 % participants
Interval 2.89 to 12.906
|
11.910 % participants
Interval 5.448 to 18.371
|
SECONDARY outcome
Timeframe: Days 90 and 180Population: FAS: All randomized patients who received at least one dose of the investigational product. FAS population was analyzed according to intention-to-treat principle, ie, by treatment allocation regardless of happening of intercurrent events.The FAS population was used to analyze results on efficacy data. Of 394 participants in the FAS, 298 had available endpoint data by day 90, and 209 had available endpoint data by day 180.
Hospital Re-admission by Day 90 and 180 in the FAS is presented. The number of participants is expressed as unadjusted proportion.
Outcome measures
| Measure |
Reparixin + Standard of Care
n=152 Participants
Reparixin was administered orally at the dose of 1200 mg (2 x 600 mg tablets) TID (6 tablets daily) for up to 21 days.
The three daily doses were administered maintaining an interval between doses of about 8 hours.
Reparixin: Reparixin 600 mg tablets, administered orally at the dose of 1200 mg TID (2 tablets TID) as add-on therapy to standard of care up to 21 days. IMP was taken with a glass of water (about 250 mL) and a light meal or snack, as it was preferable that reparixin was taken with food. However, If the patient was unwilling or unable to administer oral tablets, investigator could decide a nasogastric tube as an alternative route.
|
Placebo + Standard of Care
n=146 Participants
Placebo tablets are identical in appearance to the active formulation. Placebo was administered with the same treatment schedule.
Placebo: Administered orally three times a day (TID) as add-on therapy to standard of care up to 21 days.
Placebo was taken with a glass of water (about 250 mL) and a light meal or snack, as it was preferable that placebo was taken with food. However, If the patient was unwilling or unable to administer oral tablets, investigator could decide a nasogastric tube as an alternative route.
|
|---|---|---|
|
Hospital Re-admission by Day 90 and 180
Day 90
|
30 Participants
|
29 Participants
|
|
Hospital Re-admission by Day 90 and 180
Day 180
|
34 Participants
|
37 Participants
|
SECONDARY outcome
Timeframe: Day 28Population: FAS: All randomized patients who received at least one dose of the investigational product. FAS population was analyzed according to intention-to-treat principle, ie, by treatment allocation regardless of happening of intercurrent events.The FAS population was used to analyze results on efficacy data.
The median time to discharge or to a NEWS (National Early Warning Score) of ≤ 2 (for 24 hours), whichever occurs first, was expressed using a "time to event" approach, and measured in days. NIAID-OS, National Early Warning Score (NEWS) was evaluated daily until day 28 (or hospital discharge). In a scored system standardizing the assessment of acute-illness severity in the NHS, NEWS includes Blood Pressure (BP), Heart Rate (HR), Respiratory Rate (RR), body temperature, level of consciousness (A, V, P, U), peripheral arterial oxygen saturation (SpO2) and supplemental oxygen. Time to discharge or to a NEWS of \<= 2 (for 24 hours) = Min(Date of discharge, Date of NEWS of \<= 2 (for 24 hours)) - Day 1 date + 1. Date of NEWS of \<= 2 (for 24 hours): Given two consecutive days with NEWS of \<= 2, the date of the first assessment has been considered.
Outcome measures
| Measure |
Reparixin + Standard of Care
n=201 Participants
Reparixin was administered orally at the dose of 1200 mg (2 x 600 mg tablets) TID (6 tablets daily) for up to 21 days.
The three daily doses were administered maintaining an interval between doses of about 8 hours.
Reparixin: Reparixin 600 mg tablets, administered orally at the dose of 1200 mg TID (2 tablets TID) as add-on therapy to standard of care up to 21 days. IMP was taken with a glass of water (about 250 mL) and a light meal or snack, as it was preferable that reparixin was taken with food. However, If the patient was unwilling or unable to administer oral tablets, investigator could decide a nasogastric tube as an alternative route.
|
Placebo + Standard of Care
n=193 Participants
Placebo tablets are identical in appearance to the active formulation. Placebo was administered with the same treatment schedule.
Placebo: Administered orally three times a day (TID) as add-on therapy to standard of care up to 21 days.
Placebo was taken with a glass of water (about 250 mL) and a light meal or snack, as it was preferable that placebo was taken with food. However, If the patient was unwilling or unable to administer oral tablets, investigator could decide a nasogastric tube as an alternative route.
|
|---|---|---|
|
Time to Discharge or to a NEWS (National Early Warning Score) of ≤ 2 (for 24 Hours), Whichever Occurs First
|
5 days
Interval 4.0 to 6.0
|
5 days
Interval 5.0 to 6.0
|
SECONDARY outcome
Timeframe: Days 90±7 and 180±14Population: FAS: All randomized patients who received at least one dose of the investigational product. FAS population was analyzed according to ITT principle, by treatment allocation regardless of happening of intercurrent events.The FAS population was used to analyze results on efficacy data. n=120, n=108 for mobility \& self care at Day 90 n=71, n= 81 for mobility, self care \& usual activities at Day 180 n=120, n=108 for mobility and self care at Day 90 n=120, n=107 for usual activities at Day 90
The EQ-5D-5L asks patients to indicate whether they have no, slight, moderate, severe, extreme problems on each of 5 dimensions of health: mobility; self-care; usual activities; pain/discomfort; anxiety/depression.The count of patients of each level (1 - no problems, 2 - slight problems, 3 - moderate problems, 4 - severe problems, 5 - extreme problems) for each of the 5 dimensions were reported. The higher the score for each dimension (range 1-5), the worse the outcome.
Outcome measures
| Measure |
Reparixin + Standard of Care
n=120 Participants
Reparixin was administered orally at the dose of 1200 mg (2 x 600 mg tablets) TID (6 tablets daily) for up to 21 days.
The three daily doses were administered maintaining an interval between doses of about 8 hours.
Reparixin: Reparixin 600 mg tablets, administered orally at the dose of 1200 mg TID (2 tablets TID) as add-on therapy to standard of care up to 21 days. IMP was taken with a glass of water (about 250 mL) and a light meal or snack, as it was preferable that reparixin was taken with food. However, If the patient was unwilling or unable to administer oral tablets, investigator could decide a nasogastric tube as an alternative route.
|
Placebo + Standard of Care
n=108 Participants
Placebo tablets are identical in appearance to the active formulation. Placebo was administered with the same treatment schedule.
Placebo: Administered orally three times a day (TID) as add-on therapy to standard of care up to 21 days.
Placebo was taken with a glass of water (about 250 mL) and a light meal or snack, as it was preferable that placebo was taken with food. However, If the patient was unwilling or unable to administer oral tablets, investigator could decide a nasogastric tube as an alternative route.
|
|---|---|---|
|
Change in Quality of Life Using EuroQol-5-dimensions-5 Levels (EQ-5D-5L) Questionnaire From Hospital Discharge to Day 90 and Day 180
Mobility - Day 90 · 1 - no problem
|
61 Participants
|
54 Participants
|
|
Change in Quality of Life Using EuroQol-5-dimensions-5 Levels (EQ-5D-5L) Questionnaire From Hospital Discharge to Day 90 and Day 180
Mobility - Day 90 · 2 - slight problems
|
41 Participants
|
29 Participants
|
|
Change in Quality of Life Using EuroQol-5-dimensions-5 Levels (EQ-5D-5L) Questionnaire From Hospital Discharge to Day 90 and Day 180
Mobility - Day 90 · 3 - moderate problems
|
10 Participants
|
16 Participants
|
|
Change in Quality of Life Using EuroQol-5-dimensions-5 Levels (EQ-5D-5L) Questionnaire From Hospital Discharge to Day 90 and Day 180
Mobility - Day 90 · 4 - severe problems
|
5 Participants
|
5 Participants
|
|
Change in Quality of Life Using EuroQol-5-dimensions-5 Levels (EQ-5D-5L) Questionnaire From Hospital Discharge to Day 90 and Day 180
Mobility - Day 90 · 5 - extreme problems
|
3 Participants
|
4 Participants
|
|
Change in Quality of Life Using EuroQol-5-dimensions-5 Levels (EQ-5D-5L) Questionnaire From Hospital Discharge to Day 90 and Day 180
Mobility - Day 180 · 1 - no problem
|
31 Participants
|
45 Participants
|
|
Change in Quality of Life Using EuroQol-5-dimensions-5 Levels (EQ-5D-5L) Questionnaire From Hospital Discharge to Day 90 and Day 180
Mobility - Day 180 · 2 - slight problems
|
26 Participants
|
20 Participants
|
|
Change in Quality of Life Using EuroQol-5-dimensions-5 Levels (EQ-5D-5L) Questionnaire From Hospital Discharge to Day 90 and Day 180
Mobility - Day 180 · 3 - moderate problems
|
9 Participants
|
10 Participants
|
|
Change in Quality of Life Using EuroQol-5-dimensions-5 Levels (EQ-5D-5L) Questionnaire From Hospital Discharge to Day 90 and Day 180
Mobility - Day 180 · 4 - severe problems
|
2 Participants
|
3 Participants
|
|
Change in Quality of Life Using EuroQol-5-dimensions-5 Levels (EQ-5D-5L) Questionnaire From Hospital Discharge to Day 90 and Day 180
Mobility - Day 180 · 5 - extreme problems
|
3 Participants
|
3 Participants
|
|
Change in Quality of Life Using EuroQol-5-dimensions-5 Levels (EQ-5D-5L) Questionnaire From Hospital Discharge to Day 90 and Day 180
Self-care - Day 90 · 1 - no problem
|
83 Participants
|
73 Participants
|
|
Change in Quality of Life Using EuroQol-5-dimensions-5 Levels (EQ-5D-5L) Questionnaire From Hospital Discharge to Day 90 and Day 180
Self-care - Day 90 · 2 - slight problems
|
21 Participants
|
20 Participants
|
|
Change in Quality of Life Using EuroQol-5-dimensions-5 Levels (EQ-5D-5L) Questionnaire From Hospital Discharge to Day 90 and Day 180
Self-care - Day 90 · 3 - moderate problems
|
9 Participants
|
6 Participants
|
|
Change in Quality of Life Using EuroQol-5-dimensions-5 Levels (EQ-5D-5L) Questionnaire From Hospital Discharge to Day 90 and Day 180
Self-care - Day 90 · 4 - severe problems
|
4 Participants
|
5 Participants
|
|
Change in Quality of Life Using EuroQol-5-dimensions-5 Levels (EQ-5D-5L) Questionnaire From Hospital Discharge to Day 90 and Day 180
Self-care - Day 90 · 5 - extreme problems
|
3 Participants
|
4 Participants
|
|
Change in Quality of Life Using EuroQol-5-dimensions-5 Levels (EQ-5D-5L) Questionnaire From Hospital Discharge to Day 90 and Day 180
Self-care - Day 180 · 1 - no problem
|
46 Participants
|
57 Participants
|
|
Change in Quality of Life Using EuroQol-5-dimensions-5 Levels (EQ-5D-5L) Questionnaire From Hospital Discharge to Day 90 and Day 180
Self-care - Day 180 · 2 - slight problems
|
15 Participants
|
14 Participants
|
|
Change in Quality of Life Using EuroQol-5-dimensions-5 Levels (EQ-5D-5L) Questionnaire From Hospital Discharge to Day 90 and Day 180
Self-care - Day 180 · 3 - moderate problems
|
7 Participants
|
4 Participants
|
|
Change in Quality of Life Using EuroQol-5-dimensions-5 Levels (EQ-5D-5L) Questionnaire From Hospital Discharge to Day 90 and Day 180
Self-care - Day 180 · 4 - severe problems
|
2 Participants
|
4 Participants
|
|
Change in Quality of Life Using EuroQol-5-dimensions-5 Levels (EQ-5D-5L) Questionnaire From Hospital Discharge to Day 90 and Day 180
Self-care - Day 180 · 5 - extreme problems
|
1 Participants
|
2 Participants
|
|
Change in Quality of Life Using EuroQol-5-dimensions-5 Levels (EQ-5D-5L) Questionnaire From Hospital Discharge to Day 90 and Day 180
Usual activities - Day 90 · 1 - no problem
|
52 Participants
|
50 Participants
|
|
Change in Quality of Life Using EuroQol-5-dimensions-5 Levels (EQ-5D-5L) Questionnaire From Hospital Discharge to Day 90 and Day 180
Usual activities - Day 90 · 2 - slight problems
|
36 Participants
|
33 Participants
|
|
Change in Quality of Life Using EuroQol-5-dimensions-5 Levels (EQ-5D-5L) Questionnaire From Hospital Discharge to Day 90 and Day 180
Usual activities - Day 90 · 3 - moderate problems
|
20 Participants
|
14 Participants
|
|
Change in Quality of Life Using EuroQol-5-dimensions-5 Levels (EQ-5D-5L) Questionnaire From Hospital Discharge to Day 90 and Day 180
Usual activities - Day 90 · 4 - severe problems
|
7 Participants
|
5 Participants
|
|
Change in Quality of Life Using EuroQol-5-dimensions-5 Levels (EQ-5D-5L) Questionnaire From Hospital Discharge to Day 90 and Day 180
Usual activities - Day 90 · 5 - extreme problems
|
5 Participants
|
5 Participants
|
|
Change in Quality of Life Using EuroQol-5-dimensions-5 Levels (EQ-5D-5L) Questionnaire From Hospital Discharge to Day 90 and Day 180
Usual activities - Day 180 · 1 - no problem
|
31 Participants
|
38 Participants
|
|
Change in Quality of Life Using EuroQol-5-dimensions-5 Levels (EQ-5D-5L) Questionnaire From Hospital Discharge to Day 90 and Day 180
Usual activities - Day 180 · 2 - slight problems
|
17 Participants
|
24 Participants
|
|
Change in Quality of Life Using EuroQol-5-dimensions-5 Levels (EQ-5D-5L) Questionnaire From Hospital Discharge to Day 90 and Day 180
Usual activities - Day 180 · 3 - moderate problems
|
15 Participants
|
11 Participants
|
|
Change in Quality of Life Using EuroQol-5-dimensions-5 Levels (EQ-5D-5L) Questionnaire From Hospital Discharge to Day 90 and Day 180
Usual activities - Day 180 · 4 - severe problems
|
5 Participants
|
4 Participants
|
|
Change in Quality of Life Using EuroQol-5-dimensions-5 Levels (EQ-5D-5L) Questionnaire From Hospital Discharge to Day 90 and Day 180
Usual activities - Day 180 · 5 - extreme problems
|
3 Participants
|
3 Participants
|
|
Change in Quality of Life Using EuroQol-5-dimensions-5 Levels (EQ-5D-5L) Questionnaire From Hospital Discharge to Day 90 and Day 180
Pain/discomfort - Day 90 · 1 - no problem
|
66 Participants
|
58 Participants
|
|
Change in Quality of Life Using EuroQol-5-dimensions-5 Levels (EQ-5D-5L) Questionnaire From Hospital Discharge to Day 90 and Day 180
Pain/discomfort - Day 90 · 2 - slight problems
|
33 Participants
|
38 Participants
|
|
Change in Quality of Life Using EuroQol-5-dimensions-5 Levels (EQ-5D-5L) Questionnaire From Hospital Discharge to Day 90 and Day 180
Pain/discomfort - Day 90 · 3 - moderate problems
|
16 Participants
|
11 Participants
|
|
Change in Quality of Life Using EuroQol-5-dimensions-5 Levels (EQ-5D-5L) Questionnaire From Hospital Discharge to Day 90 and Day 180
Pain/discomfort - Day 90 · 4 - severe problems
|
3 Participants
|
1 Participants
|
|
Change in Quality of Life Using EuroQol-5-dimensions-5 Levels (EQ-5D-5L) Questionnaire From Hospital Discharge to Day 90 and Day 180
Pain/discomfort - Day 90 · 5 - extreme problems
|
1 Participants
|
0 Participants
|
|
Change in Quality of Life Using EuroQol-5-dimensions-5 Levels (EQ-5D-5L) Questionnaire From Hospital Discharge to Day 90 and Day 180
Pain/discomfort - Day 180 · 1 - no problem
|
36 Participants
|
45 Participants
|
|
Change in Quality of Life Using EuroQol-5-dimensions-5 Levels (EQ-5D-5L) Questionnaire From Hospital Discharge to Day 90 and Day 180
Pain/discomfort - Day 180 · 2 - slight problems
|
21 Participants
|
25 Participants
|
|
Change in Quality of Life Using EuroQol-5-dimensions-5 Levels (EQ-5D-5L) Questionnaire From Hospital Discharge to Day 90 and Day 180
Pain/discomfort - Day 180 · 3 - moderate problems
|
9 Participants
|
11 Participants
|
|
Change in Quality of Life Using EuroQol-5-dimensions-5 Levels (EQ-5D-5L) Questionnaire From Hospital Discharge to Day 90 and Day 180
Pain/discomfort - Day 180 · 4 - severe problems
|
4 Participants
|
0 Participants
|
|
Change in Quality of Life Using EuroQol-5-dimensions-5 Levels (EQ-5D-5L) Questionnaire From Hospital Discharge to Day 90 and Day 180
Pain/discomfort - Day 180 · 5 - extreme problems
|
0 Participants
|
0 Participants
|
|
Change in Quality of Life Using EuroQol-5-dimensions-5 Levels (EQ-5D-5L) Questionnaire From Hospital Discharge to Day 90 and Day 180
Anxiety/Depression - Day 90 · 1 - no problem
|
62 Participants
|
69 Participants
|
|
Change in Quality of Life Using EuroQol-5-dimensions-5 Levels (EQ-5D-5L) Questionnaire From Hospital Discharge to Day 90 and Day 180
Anxiety/Depression - Day 90 · 2 - slight problems
|
33 Participants
|
32 Participants
|
|
Change in Quality of Life Using EuroQol-5-dimensions-5 Levels (EQ-5D-5L) Questionnaire From Hospital Discharge to Day 90 and Day 180
Anxiety/Depression - Day 90 · 3 - moderate problems
|
21 Participants
|
6 Participants
|
|
Change in Quality of Life Using EuroQol-5-dimensions-5 Levels (EQ-5D-5L) Questionnaire From Hospital Discharge to Day 90 and Day 180
Anxiety/Depression - Day 90 · 4 - severe problems
|
2 Participants
|
1 Participants
|
|
Change in Quality of Life Using EuroQol-5-dimensions-5 Levels (EQ-5D-5L) Questionnaire From Hospital Discharge to Day 90 and Day 180
Anxiety/Depression - Day 90 · 5 - extreme problems
|
2 Participants
|
0 Participants
|
|
Change in Quality of Life Using EuroQol-5-dimensions-5 Levels (EQ-5D-5L) Questionnaire From Hospital Discharge to Day 90 and Day 180
Anxiety/Depression - Day 180 · 1 - no problem
|
38 Participants
|
51 Participants
|
|
Change in Quality of Life Using EuroQol-5-dimensions-5 Levels (EQ-5D-5L) Questionnaire From Hospital Discharge to Day 90 and Day 180
Anxiety/Depression - Day 180 · 2 - slight problems
|
20 Participants
|
24 Participants
|
|
Change in Quality of Life Using EuroQol-5-dimensions-5 Levels (EQ-5D-5L) Questionnaire From Hospital Discharge to Day 90 and Day 180
Anxiety/Depression - Day 180 · 3 - moderate problems
|
11 Participants
|
4 Participants
|
|
Change in Quality of Life Using EuroQol-5-dimensions-5 Levels (EQ-5D-5L) Questionnaire From Hospital Discharge to Day 90 and Day 180
Anxiety/Depression - Day 180 · 4 - severe problems
|
1 Participants
|
1 Participants
|
|
Change in Quality of Life Using EuroQol-5-dimensions-5 Levels (EQ-5D-5L) Questionnaire From Hospital Discharge to Day 90 and Day 180
Anxiety/Depression - Day 180 · 5 - extreme problems
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Days 90 and 180Population: FAS: All randomized patients who received at least one dose of the investigational product. FAS population was analyzed according to intention-to-treat principle, ie, by treatment allocation regardless of happening of intercurrent events.The FAS population was used to analyze results on efficacy data.
The summary of IMV/ECMO duration by day 90 and day 180 for the FAS is presented. The duration of IMV/ECMO use by day 90 was calculated as the total number of days between day 1 and the last available assessment day (≥ day 83) during which the participant was either receiving IMV/ECMO or had a NIAID-OS score of 7. Participants with less than 83 days of follow-up were considered non-evaluable for this endpoint. Similarly, the duration of IMV/ECMO by day 180 was calculated using the same methodology.
Outcome measures
| Measure |
Reparixin + Standard of Care
n=201 Participants
Reparixin was administered orally at the dose of 1200 mg (2 x 600 mg tablets) TID (6 tablets daily) for up to 21 days.
The three daily doses were administered maintaining an interval between doses of about 8 hours.
Reparixin: Reparixin 600 mg tablets, administered orally at the dose of 1200 mg TID (2 tablets TID) as add-on therapy to standard of care up to 21 days. IMP was taken with a glass of water (about 250 mL) and a light meal or snack, as it was preferable that reparixin was taken with food. However, If the patient was unwilling or unable to administer oral tablets, investigator could decide a nasogastric tube as an alternative route.
|
Placebo + Standard of Care
n=193 Participants
Placebo tablets are identical in appearance to the active formulation. Placebo was administered with the same treatment schedule.
Placebo: Administered orally three times a day (TID) as add-on therapy to standard of care up to 21 days.
Placebo was taken with a glass of water (about 250 mL) and a light meal or snack, as it was preferable that placebo was taken with food. However, If the patient was unwilling or unable to administer oral tablets, investigator could decide a nasogastric tube as an alternative route.
|
|---|---|---|
|
Duration of IMV and/or ECMO by Days 90 and 180
Day 180
|
0.0 Days
Standard Deviation 0.0
|
0.1 Days
Standard Deviation 0.7
|
|
Duration of IMV and/or ECMO by Days 90 and 180
Day 90
|
0.0 Days
Standard Deviation 0.0
|
0.3 Days
Standard Deviation 2.6
|
SECONDARY outcome
Timeframe: Days 90 and 180Population: FAS: All randomized patients who received at least one dose of the investigational product. FAS set was analyzed according to ITT principle, ie, by treatment allocation regardless of happening of intercurrent events.The FAS population was used to analyze results on efficacy data. Of 394 participants in the FAS, 302 had available data for this outcome by day 90 (n=157 in the reparixin arm and n=145 in the placebo arm) and 206 (n=106 in the reparixin arm and n=100 in the placebo arm) by day 180.
Unadjusted proportion of ICU admission is reported as number and percentage of participants requiring ICU admission by day 90 and day 180.
Outcome measures
| Measure |
Reparixin + Standard of Care
n=157 Participants
Reparixin was administered orally at the dose of 1200 mg (2 x 600 mg tablets) TID (6 tablets daily) for up to 21 days.
The three daily doses were administered maintaining an interval between doses of about 8 hours.
Reparixin: Reparixin 600 mg tablets, administered orally at the dose of 1200 mg TID (2 tablets TID) as add-on therapy to standard of care up to 21 days. IMP was taken with a glass of water (about 250 mL) and a light meal or snack, as it was preferable that reparixin was taken with food. However, If the patient was unwilling or unable to administer oral tablets, investigator could decide a nasogastric tube as an alternative route.
|
Placebo + Standard of Care
n=145 Participants
Placebo tablets are identical in appearance to the active formulation. Placebo was administered with the same treatment schedule.
Placebo: Administered orally three times a day (TID) as add-on therapy to standard of care up to 21 days.
Placebo was taken with a glass of water (about 250 mL) and a light meal or snack, as it was preferable that placebo was taken with food. However, If the patient was unwilling or unable to administer oral tablets, investigator could decide a nasogastric tube as an alternative route.
|
|---|---|---|
|
Proportion of Participants Requiring ICU Admission by Days 90 and 180
Day 90
|
25 Participants
|
20 Participants
|
|
Proportion of Participants Requiring ICU Admission by Days 90 and 180
Day 180
|
26 Participants
|
20 Participants
|
SECONDARY outcome
Timeframe: Days 90 and 180Population: FAS: All randomized patients who received at least one dose of the investigational product. FAS population was analyzed according to intention-to-treat principle, ie, by treatment allocation regardless of happening of intercurrent events.The FAS population was used to analyze results on efficacy data. Of 394 participants in the FAS: 287 (n=147 in the rep arm and n=140 in the placebo arm) had available data for this outcome by day 90 and 180 (n=89 in the rep arm and n=91 for placebo) by day 180.
Results for the Intensive Care Unit length of stay (days) by day 90 and day 180 in the FAS are reported.
Outcome measures
| Measure |
Reparixin + Standard of Care
n=147 Participants
Reparixin was administered orally at the dose of 1200 mg (2 x 600 mg tablets) TID (6 tablets daily) for up to 21 days.
The three daily doses were administered maintaining an interval between doses of about 8 hours.
Reparixin: Reparixin 600 mg tablets, administered orally at the dose of 1200 mg TID (2 tablets TID) as add-on therapy to standard of care up to 21 days. IMP was taken with a glass of water (about 250 mL) and a light meal or snack, as it was preferable that reparixin was taken with food. However, If the patient was unwilling or unable to administer oral tablets, investigator could decide a nasogastric tube as an alternative route.
|
Placebo + Standard of Care
n=140 Participants
Placebo tablets are identical in appearance to the active formulation. Placebo was administered with the same treatment schedule.
Placebo: Administered orally three times a day (TID) as add-on therapy to standard of care up to 21 days.
Placebo was taken with a glass of water (about 250 mL) and a light meal or snack, as it was preferable that placebo was taken with food. However, If the patient was unwilling or unable to administer oral tablets, investigator could decide a nasogastric tube as an alternative route.
|
|---|---|---|
|
ICU Length of Stay by Days 90 and 180
Day 90
|
0.9 Days
Standard Deviation 2.5
|
1.0 Days
Standard Deviation 3.9
|
|
ICU Length of Stay by Days 90 and 180
Day 180
|
0.7 Days
Standard Deviation 2.4
|
0.8 Days
Standard Deviation 2.2
|
SECONDARY outcome
Timeframe: Days 90 and 180Population: FAS: All randomized patients who received at least one dose of the investigational product. FAS population was analyzed according to intention-to-treat principle, ie, by treatment allocation regardless of happening of intercurrent events.The FAS population was used to analyze results on efficacy data. Of 394 participants in the FAS: 287 (147 R + 140 P) had available data for this outcome by day 90 and 180 (89 R + 91 P) by day 180.
Results for hospital length of stay (days) by day 90 and 180 in the FAS are reported.
Outcome measures
| Measure |
Reparixin + Standard of Care
n=147 Participants
Reparixin was administered orally at the dose of 1200 mg (2 x 600 mg tablets) TID (6 tablets daily) for up to 21 days.
The three daily doses were administered maintaining an interval between doses of about 8 hours.
Reparixin: Reparixin 600 mg tablets, administered orally at the dose of 1200 mg TID (2 tablets TID) as add-on therapy to standard of care up to 21 days. IMP was taken with a glass of water (about 250 mL) and a light meal or snack, as it was preferable that reparixin was taken with food. However, If the patient was unwilling or unable to administer oral tablets, investigator could decide a nasogastric tube as an alternative route.
|
Placebo + Standard of Care
n=140 Participants
Placebo tablets are identical in appearance to the active formulation. Placebo was administered with the same treatment schedule.
Placebo: Administered orally three times a day (TID) as add-on therapy to standard of care up to 21 days.
Placebo was taken with a glass of water (about 250 mL) and a light meal or snack, as it was preferable that placebo was taken with food. However, If the patient was unwilling or unable to administer oral tablets, investigator could decide a nasogastric tube as an alternative route.
|
|---|---|---|
|
Hospital Length of Stay by Days 90 and 180
Day 90
|
9.8 Days
Standard Deviation 8.4
|
9.9 Days
Standard Deviation 10
|
|
Hospital Length of Stay by Days 90 and 180
Day 180
|
12.0 Days
Standard Deviation 12.7
|
10.5 Days
Standard Deviation 8.5
|
SECONDARY outcome
Timeframe: Days 90 and 180Population: FAS: All randomized patients who received at least one dose of the investigational product. FAS population was analyzed according to intention-to-treat principle, ie, by treatment allocation regardless of happening of intercurrent events.The FAS population was used to analyze results on efficacy data. Of 394 participants in the FAS: 299 (154 R + 145 P) had available data for this outcome by day 90 and 204 (101 R + 103 P) by day 180.
Occurrence of infections was expressed as the unadjusted proportion of participants with at least one infection by days 90 and 180 in the FAS.
Outcome measures
| Measure |
Reparixin + Standard of Care
n=154 Participants
Reparixin was administered orally at the dose of 1200 mg (2 x 600 mg tablets) TID (6 tablets daily) for up to 21 days.
The three daily doses were administered maintaining an interval between doses of about 8 hours.
Reparixin: Reparixin 600 mg tablets, administered orally at the dose of 1200 mg TID (2 tablets TID) as add-on therapy to standard of care up to 21 days. IMP was taken with a glass of water (about 250 mL) and a light meal or snack, as it was preferable that reparixin was taken with food. However, If the patient was unwilling or unable to administer oral tablets, investigator could decide a nasogastric tube as an alternative route.
|
Placebo + Standard of Care
n=145 Participants
Placebo tablets are identical in appearance to the active formulation. Placebo was administered with the same treatment schedule.
Placebo: Administered orally three times a day (TID) as add-on therapy to standard of care up to 21 days.
Placebo was taken with a glass of water (about 250 mL) and a light meal or snack, as it was preferable that placebo was taken with food. However, If the patient was unwilling or unable to administer oral tablets, investigator could decide a nasogastric tube as an alternative route.
|
|---|---|---|
|
Occurrence of Infections by Days 90 and 180
Day 180
|
23 Participants
|
19 Participants
|
|
Occurrence of Infections by Days 90 and 180
Day 90
|
21 Participants
|
19 Participants
|
SECONDARY outcome
Timeframe: Throughout the study till Day 180 (± 14) or end of treatmentPopulation: SAF: All randomized patients who received at least one dose of the investigational product. Please note that participants were summarized NOT according to their planned (randomized) treatment group, as reported in the Participant Flow subsection, BUT according to the actual treatment received. Hence n=200 for REP and n=194 for placebo.
A TEAE is defined as any adverse event reported in the study having a possible, probable, or highly probable relationship to investigational product. A serious AE is defined as any untoward medical occurrence that at any dose: * results in death. * is life-threatening (i.e. the patient was at risk of death at the time of the event. It does not refer to an event which hypothetically might have caused death if it were more severe), * requires inpatient hospitalization or prolongation of existing hospitalization, * results in persistent or significant disability/incapacity, * is a congenital anomaly/birth defect * is a medically significant or important medical condition, i.e. an important medical event that based upon appropriate medical judgment, may jeopardize the patient and may require medical or surgical intervention to prevent one of the outcomes listed above.
Outcome measures
| Measure |
Reparixin + Standard of Care
n=200 Participants
Reparixin was administered orally at the dose of 1200 mg (2 x 600 mg tablets) TID (6 tablets daily) for up to 21 days.
The three daily doses were administered maintaining an interval between doses of about 8 hours.
Reparixin: Reparixin 600 mg tablets, administered orally at the dose of 1200 mg TID (2 tablets TID) as add-on therapy to standard of care up to 21 days. IMP was taken with a glass of water (about 250 mL) and a light meal or snack, as it was preferable that reparixin was taken with food. However, If the patient was unwilling or unable to administer oral tablets, investigator could decide a nasogastric tube as an alternative route.
|
Placebo + Standard of Care
n=194 Participants
Placebo tablets are identical in appearance to the active formulation. Placebo was administered with the same treatment schedule.
Placebo: Administered orally three times a day (TID) as add-on therapy to standard of care up to 21 days.
Placebo was taken with a glass of water (about 250 mL) and a light meal or snack, as it was preferable that placebo was taken with food. However, If the patient was unwilling or unable to administer oral tablets, investigator could decide a nasogastric tube as an alternative route.
|
|---|---|---|
|
Number of Patients With at Least One Treatment-emergent Adverse Event (TEAE)
Number of Subjects with at least one TEAE (n (%))
|
129 Participants
|
127 Participants
|
|
Number of Patients With at Least One Treatment-emergent Adverse Event (TEAE)
Number of Subjects with at least one serious TEAE (n (%))
|
46 Participants
|
56 Participants
|
|
Number of Patients With at Least One Treatment-emergent Adverse Event (TEAE)
Number of Subjects with at least one non-Serious TEAE (n (%))
|
115 Participants
|
106 Participants
|
|
Number of Patients With at Least One Treatment-emergent Adverse Event (TEAE)
Number of Subjects with at least one severe TEAE (n (%))
|
32 Participants
|
33 Participants
|
|
Number of Patients With at Least One Treatment-emergent Adverse Event (TEAE)
Number of Subjects with at least one TEAE Leading to Discontinuation of IMP (n (%))
|
23 Participants
|
24 Participants
|
|
Number of Patients With at Least One Treatment-emergent Adverse Event (TEAE)
Number of Subjects with at least one TEAE Leading to Discontinuation of study (n (%))
|
1 Participants
|
1 Participants
|
|
Number of Patients With at Least One Treatment-emergent Adverse Event (TEAE)
Number of Subjects with at least one TEAE Leading to Death (n (%))
|
16 Participants
|
18 Participants
|
Adverse Events
Reparixin + Standard of Care
Serious events: 46 serious events
Other events: 129 other events
Deaths: 16 deaths
Placebo + Standard of Care
Serious events: 56 serious events
Other events: 127 other events
Deaths: 19 deaths
Serious adverse events
| Measure |
Reparixin + Standard of Care
n=200 participants at risk
Reparixin was administered orally at the dose of 1200 mg (2 x 600 mg tablets) TID (6 tablets daily) for up to 21 days.
The three daily doses were administered maintaining an interval between doses of about 8 hours.
Reparixin: Reparixin 600 mg tablets, administered orally at the dose of 1200 mg TID (2 tablets TID) as add-on therapy to standard of care up to 21 days. IMP was taken with a glass of water (about 250 mL) and a light meal or snack, as it was preferable that reparixin was taken with food. However, if the patient was unable to eat, the study drug might be administered without concomitant food ingestion.
|
Placebo + Standard of Care
n=194 participants at risk
Placebo tablets are identical in appearance to the active formulation. Placebo was administered with the same treatment schedule.
Placebo: Administered orally three times a day (TID) as add-on therapy to standard of care up to 21 days.
Placebo was taken with a glass of water (about 250 mL) and a light meal or snack, as it was preferable that placebo was taken with food. However, if the patient was unable to eat, the placebo might still be administered without concomitant food ingestion.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
5.0%
10/200 • Number of events 11 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
5.7%
11/194 • Number of events 11 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
3.0%
6/200 • Number of events 6 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
4.6%
9/194 • Number of events 10 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
4.0%
8/200 • Number of events 8 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
2.6%
5/194 • Number of events 5 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
3.0%
6/200 • Number of events 8 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
2.1%
4/194 • Number of events 5 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/200 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
2.1%
4/194 • Number of events 4 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.50%
1/200 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
1.0%
2/194 • Number of events 2 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Influenza
|
1.0%
2/200 • Number of events 2 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.00%
0/194 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.50%
1/200 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.52%
1/194 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.50%
1/200 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.52%
1/194 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.50%
1/200 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.00%
0/194 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.50%
1/200 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.00%
0/194 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/200 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.52%
1/194 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
COVID-19
|
0.00%
0/200 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.52%
1/194 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Hypercapnia
|
0.50%
1/200 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.00%
0/194 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Lung infiltration
|
0.50%
1/200 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.00%
0/194 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumocystis jirovecii pneumonia
|
0.00%
0/200 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.52%
1/194 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.50%
1/200 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.00%
0/194 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia streptococcal
|
0.50%
1/200 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.00%
0/194 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia viral
|
0.50%
1/200 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.00%
0/194 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/200 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.52%
1/194 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary cavitation
|
0.50%
1/200 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.00%
0/194 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.50%
1/200 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.00%
0/194 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Cardiac disorders
Atrial fibrillation
|
0.50%
1/200 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
1.0%
2/194 • Number of events 2 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Cardiac disorders
Myocarditis
|
0.00%
0/200 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
1.0%
2/194 • Number of events 2 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/200 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.52%
1/194 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Cardiac disorders
Atrial flutter
|
0.50%
1/200 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.00%
0/194 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/200 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.52%
1/194 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Cardiac disorders
Cardiac failure
|
0.50%
1/200 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.00%
0/194 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Cardiac disorders
Cardiac failure acute
|
0.50%
1/200 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.00%
0/194 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.50%
1/200 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.00%
0/194 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Cardiac disorders
Cardiogenic shock
|
0.00%
0/200 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.52%
1/194 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Cardiac disorders
Cardiorenal syndrome
|
0.50%
1/200 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.00%
0/194 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Cardiac disorders
Chronic left ventricular failure
|
0.00%
0/200 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.52%
1/194 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Cardiac disorders
Cor pulmonale
|
0.50%
1/200 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.00%
0/194 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/200 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.52%
1/194 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.50%
1/200 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.00%
0/194 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Cardiac disorders
Ventricular dysfunction
|
0.00%
0/200 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.52%
1/194 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.00%
0/200 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.52%
1/194 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Cardiac disorders
Ventricular hypokinesia
|
0.00%
0/200 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.52%
1/194 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/200 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.52%
1/194 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Infections and infestations
Urinary tract infection
|
0.50%
1/200 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
1.0%
2/194 • Number of events 2 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Infections and infestations
Osteomyelitis
|
1.0%
2/200 • Number of events 2 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.00%
0/194 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Infections and infestations
Sepsis
|
0.50%
1/200 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.52%
1/194 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Infections and infestations
Septic shock
|
0.00%
0/200 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
1.0%
2/194 • Number of events 2 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Infections and infestations
Bacteraemia
|
0.50%
1/200 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.00%
0/194 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Infections and infestations
Cellulitis
|
0.50%
1/200 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.00%
0/194 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Infections and infestations
Dengue fever
|
0.00%
0/200 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.52%
1/194 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.50%
1/200 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.00%
0/194 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Infections and infestations
Infection
|
0.00%
0/200 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.52%
1/194 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Infections and infestations
Infectious pleural effusion
|
0.00%
0/200 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.52%
1/194 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Infections and infestations
Metapneumovirus infection
|
0.00%
0/200 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.52%
1/194 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/200 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.52%
1/194 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Infections and infestations
Renal abscess
|
0.00%
0/200 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.52%
1/194 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Infections and infestations
Urosepsis
|
0.00%
0/200 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.52%
1/194 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/200 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
1.5%
3/194 • Number of events 3 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.50%
1/200 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.52%
1/194 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Gastrointestinal disorders
Nausea
|
0.50%
1/200 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.52%
1/194 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/200 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
1.0%
2/194 • Number of events 2 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/200 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.52%
1/194 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Gastrointestinal disorders
Gastritis erosive
|
0.00%
0/200 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.52%
1/194 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Gastrointestinal disorders
Ileus
|
0.50%
1/200 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.00%
0/194 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
General disorders
Chest pain
|
1.0%
2/200 • Number of events 2 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.52%
1/194 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
General disorders
Death
|
1.5%
3/200 • Number of events 3 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.00%
0/194 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.00%
0/200 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.52%
1/194 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
General disorders
Sudden death
|
0.00%
0/200 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.52%
1/194 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.50%
1/200 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.52%
1/194 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign lung neoplasm
|
0.50%
1/200 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.00%
0/194 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.50%
1/200 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.00%
0/194 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Glioblastoma
|
0.00%
0/200 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.52%
1/194 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haematological malignancy
|
0.00%
0/200 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.52%
1/194 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.00%
0/200 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.52%
1/194 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of lung
|
0.00%
0/200 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.52%
1/194 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Vascular disorders
Hypotension
|
0.50%
1/200 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.52%
1/194 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Vascular disorders
Cerebrovascular accident
|
0.50%
1/200 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.00%
0/194 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Injury, poisoning and procedural complications
Embolic stroke
|
0.50%
1/200 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.00%
0/194 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Vascular disorders
Haemorrhage
|
0.00%
0/200 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.52%
1/194 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.50%
1/200 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.00%
0/194 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Vascular disorders
Syncope
|
0.50%
1/200 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.00%
0/194 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.50%
1/200 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.52%
1/194 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Injury, poisoning and procedural complications
Alcohol poisoning
|
0.00%
0/200 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.52%
1/194 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.50%
1/200 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.00%
0/194 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Injury, poisoning and procedural complications
Postoperative respiratory failure
|
0.50%
1/200 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.00%
0/194 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.50%
1/200 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.52%
1/194 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.00%
0/200 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.52%
1/194 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Metabolism and nutrition disorders
Diabetic neuropathy
|
0.00%
0/200 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.52%
1/194 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
0.00%
0/200 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.52%
1/194 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/200 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.52%
1/194 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/200 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.52%
1/194 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/200 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.52%
1/194 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/200 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.52%
1/194 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.50%
1/200 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.00%
0/194 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/200 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.52%
1/194 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/200 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.52%
1/194 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Nervous system disorders
Myoclonus
|
0.50%
1/200 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.00%
0/194 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Nervous system disorders
Status migrainosus
|
0.50%
1/200 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.00%
0/194 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/200 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.52%
1/194 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Psychiatric disorders
Mania
|
0.50%
1/200 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.00%
0/194 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Psychiatric disorders
Mental status changes
|
0.50%
1/200 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.00%
0/194 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Renal and urinary disorders
Acute kidney injury
|
1.0%
2/200 • Number of events 2 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.00%
0/194 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.50%
1/200 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.00%
0/194 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Endocrine disorders
Adrenal haemorrhage
|
0.50%
1/200 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.00%
0/194 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Musculoskeletal and connective tissue disorders
Haematoma muscle
|
0.00%
0/200 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.52%
1/194 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Reproductive system and breast disorders
Pelvic haematoma
|
0.50%
1/200 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.00%
0/194 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Skin and subcutaneous tissue disorders
Diabetic foot
|
0.00%
0/200 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.52%
1/194 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Surgical and medical procedures
Diabetic foot
|
0.50%
1/200 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.00%
0/194 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
Other adverse events
| Measure |
Reparixin + Standard of Care
n=200 participants at risk
Reparixin was administered orally at the dose of 1200 mg (2 x 600 mg tablets) TID (6 tablets daily) for up to 21 days.
The three daily doses were administered maintaining an interval between doses of about 8 hours.
Reparixin: Reparixin 600 mg tablets, administered orally at the dose of 1200 mg TID (2 tablets TID) as add-on therapy to standard of care up to 21 days. IMP was taken with a glass of water (about 250 mL) and a light meal or snack, as it was preferable that reparixin was taken with food. However, if the patient was unable to eat, the study drug might be administered without concomitant food ingestion.
|
Placebo + Standard of Care
n=194 participants at risk
Placebo tablets are identical in appearance to the active formulation. Placebo was administered with the same treatment schedule.
Placebo: Administered orally three times a day (TID) as add-on therapy to standard of care up to 21 days.
Placebo was taken with a glass of water (about 250 mL) and a light meal or snack, as it was preferable that placebo was taken with food. However, if the patient was unable to eat, the placebo might still be administered without concomitant food ingestion.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
5.5%
11/200 • Number of events 13 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
7.2%
14/194 • Number of events 14 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
5.0%
10/200 • Number of events 10 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
3.1%
6/194 • Number of events 6 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
3.0%
6/200 • Number of events 6 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
4.6%
9/194 • Number of events 11 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
3.0%
6/200 • Number of events 8 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
2.6%
5/194 • Number of events 6 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.5%
3/200 • Number of events 3 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
3.6%
7/194 • Number of events 7 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
1.5%
3/200 • Number of events 3 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
2.6%
5/194 • Number of events 5 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.5%
5/200 • Number of events 5 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
1.0%
2/194 • Number of events 2 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.0%
2/200 • Number of events 2 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
2.1%
4/194 • Number of events 4 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.5%
3/200 • Number of events 3 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
1.5%
3/194 • Number of events 3 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
1.0%
2/200 • Number of events 2 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
1.0%
2/194 • Number of events 3 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
COVID-19
|
1.0%
2/200 • Number of events 2 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
1.0%
2/194 • Number of events 3 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract infection
|
1.0%
2/200 • Number of events 2 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
1.0%
2/194 • Number of events 2 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Influenza
|
1.5%
3/200 • Number of events 3 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.00%
0/194 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchiectasis
|
0.50%
1/200 • Number of events 4 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.52%
1/194 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Emphysema
|
0.50%
1/200 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.52%
1/194 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Hypercapnia
|
0.50%
1/200 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.52%
1/194 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.50%
1/200 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.52%
1/194 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia streptococcal
|
1.0%
2/200 • Number of events 2 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.00%
0/194 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
0.50%
1/200 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.52%
1/194 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.50%
1/200 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.00%
0/194 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.50%
1/200 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.00%
0/194 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.50%
1/200 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.00%
0/194 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.50%
1/200 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.00%
0/194 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.50%
1/200 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.00%
0/194 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/200 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.52%
1/194 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/200 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.52%
1/194 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/200 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.52%
1/194 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
0.00%
0/200 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.52%
1/194 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Hypocapnia
|
0.00%
0/200 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.52%
1/194 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Infectious pleural effusion
|
0.50%
1/200 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.00%
0/194 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Lung abscess
|
0.00%
0/200 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.52%
1/194 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Lung consolidation
|
0.50%
1/200 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.00%
0/194 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Lung infiltration
|
0.50%
1/200 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.00%
0/194 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Musculoskeletal chest pain
|
0.50%
1/200 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.00%
0/194 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngitis streptococcal
|
0.00%
0/200 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.52%
1/194 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumocystis jirovecii pneumonia
|
0.00%
0/200 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.52%
1/194 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.50%
1/200 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.00%
0/194 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia viral
|
0.50%
1/200 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.00%
0/194 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/200 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.52%
1/194 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary cavitation
|
0.50%
1/200 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.00%
0/194 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.50%
1/200 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.00%
0/194 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
0.50%
1/200 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.00%
0/194 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.50%
1/200 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.00%
0/194 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary pneumatocele
|
0.50%
1/200 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.00%
0/194 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Respiration abnormal
|
0.00%
0/200 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.52%
1/194 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract infection
|
0.00%
0/200 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.52%
1/194 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis atrophic
|
0.50%
1/200 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.00%
0/194 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.50%
1/200 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.00%
0/194 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Sinusitis
|
0.50%
1/200 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.00%
0/194 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Gastrointestinal disorders
Diarrhoea
|
7.5%
15/200 • Number of events 16 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
5.7%
11/194 • Number of events 12 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Gastrointestinal disorders
Nausea
|
5.5%
11/200 • Number of events 11 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
4.1%
8/194 • Number of events 8 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Gastrointestinal disorders
Vomiting
|
3.0%
6/200 • Number of events 6 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
3.6%
7/194 • Number of events 8 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Gastrointestinal disorders
Constipation
|
1.0%
2/200 • Number of events 2 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
4.1%
8/194 • Number of events 8 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
1.5%
3/200 • Number of events 3 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
1.0%
2/194 • Number of events 2 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Gastrointestinal disorders
Gastritis
|
0.50%
1/200 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
1.0%
2/194 • Number of events 2 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.50%
1/200 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.52%
1/194 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/200 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
1.0%
2/194 • Number of events 2 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Gastrointestinal disorders
Diverticulum
|
0.00%
0/200 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
1.0%
2/194 • Number of events 2 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.50%
1/200 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.52%
1/194 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
1.0%
2/200 • Number of events 2 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.00%
0/194 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/200 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.52%
1/194 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Gastrointestinal disorders
Aphthous ulcer
|
0.50%
1/200 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.00%
0/194 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Gastrointestinal disorders
Chapped lips
|
0.00%
0/200 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.52%
1/194 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Gastrointestinal disorders
Colitis
|
0.50%
1/200 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.00%
0/194 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/200 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.52%
1/194 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Gastrointestinal disorders
Duodenitis
|
0.00%
0/200 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.52%
1/194 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.50%
1/200 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.00%
0/194 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Gastrointestinal disorders
Dysphagia
|
0.50%
1/200 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.00%
0/194 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Gastrointestinal disorders
Gastritis erosive
|
0.00%
0/200 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.52%
1/194 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Gastrointestinal disorders
Glossodynia
|
0.50%
1/200 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.00%
0/194 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Gastrointestinal disorders
Haematemesis
|
0.50%
1/200 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.00%
0/194 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.50%
1/200 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.00%
0/194 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Gastrointestinal disorders
Ileus
|
0.50%
1/200 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.00%
0/194 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.00%
0/200 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.52%
1/194 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Gastrointestinal disorders
Oesophageal motility disorder
|
0.00%
0/200 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.52%
1/194 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Gastrointestinal disorders
Oral pain
|
0.50%
1/200 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.00%
0/194 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Gastrointestinal disorders
Oropharyngeal pain
|
0.00%
0/200 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.52%
1/194 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/200 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.52%
1/194 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Gastrointestinal disorders
Ulcerative duodenitis
|
0.00%
0/200 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.52%
1/194 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.50%
1/200 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.00%
0/194 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
7.5%
15/200 • Number of events 15 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
7.2%
14/194 • Number of events 14 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.50%
1/200 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
3.6%
7/194 • Number of events 8 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.50%
1/200 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
1.5%
3/194 • Number of events 3 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
1.0%
2/200 • Number of events 2 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
1.0%
2/194 • Number of events 2 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.50%
1/200 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
1.0%
2/194 • Number of events 2 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.50%
1/200 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
1.0%
2/194 • Number of events 2 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
1.0%
2/200 • Number of events 2 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.52%
1/194 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.50%
1/200 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.52%
1/194 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Metabolism and nutrition disorders
Folate deficiency
|
0.50%
1/200 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.52%
1/194 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.50%
1/200 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.52%
1/194 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.50%
1/200 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.52%
1/194 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
1.0%
2/200 • Number of events 2 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.00%
0/194 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Metabolism and nutrition disorders
Iron deficiency
|
0.50%
1/200 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.52%
1/194 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.50%
1/200 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.00%
0/194 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.00%
0/200 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.52%
1/194 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Metabolism and nutrition disorders
Diabetic neuropathy
|
0.00%
0/200 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.52%
1/194 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
0.00%
0/200 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.52%
1/194 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Metabolism and nutrition disorders
Hyperferritinaemia
|
0.50%
1/200 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.00%
0/194 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Metabolism and nutrition disorders
Hypophagia
|
0.00%
0/200 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.52%
1/194 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Metabolism and nutrition disorders
Hypoproteinaemia
|
0.50%
1/200 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.00%
0/194 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Metabolism and nutrition disorders
Hypouricaemia
|
0.00%
0/200 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.52%
1/194 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Metabolism and nutrition disorders
Magnesium deficiency
|
0.50%
1/200 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.00%
0/194 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.50%
1/200 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.00%
0/194 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.50%
1/200 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.00%
0/194 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Metabolism and nutrition disorders
Metabolic alkalosis
|
0.50%
1/200 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.00%
0/194 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.00%
0/200 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.52%
1/194 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Investigations
Hepatic enzyme increased
|
3.0%
6/200 • Number of events 6 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
2.1%
4/194 • Number of events 4 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Investigations
Transaminases increased
|
1.0%
2/200 • Number of events 2 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
3.1%
6/194 • Number of events 6 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Investigations
C-reactive protein increased
|
1.0%
2/200 • Number of events 2 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
2.6%
5/194 • Number of events 5 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Investigations
Fibrin D dimer increased
|
2.0%
4/200 • Number of events 4 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
1.5%
3/194 • Number of events 3 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Investigations
Serum ferritin increased
|
1.0%
2/200 • Number of events 2 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
1.5%
3/194 • Number of events 3 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Investigations
Procalcitonin increased
|
1.0%
2/200 • Number of events 2 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
1.0%
2/194 • Number of events 2 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/200 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
1.5%
3/194 • Number of events 3 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/200 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
1.5%
3/194 • Number of events 3 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Investigations
Liver function test increased
|
0.50%
1/200 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
1.0%
2/194 • Number of events 2 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Investigations
Neutrophil count increased
|
0.00%
0/200 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
1.5%
3/194 • Number of events 3 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Investigations
Platelet count increased
|
0.50%
1/200 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
1.0%
2/194 • Number of events 2 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Investigations
White blood cell count increased
|
1.0%
2/200 • Number of events 2 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.52%
1/194 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/200 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
1.0%
2/194 • Number of events 2 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Investigations
Blood creatinine increased
|
0.50%
1/200 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.52%
1/194 • Number of events 2 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Investigations
Haematocrit decreased
|
0.50%
1/200 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.52%
1/194 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Investigations
N-terminal prohormone brain natriuretic peptide increased
|
0.00%
0/200 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
1.0%
2/194 • Number of events 2 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Investigations
Amylase increased
|
0.50%
1/200 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.00%
0/194 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Investigations
Anion gap increased
|
0.00%
0/200 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.52%
1/194 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Investigations
Blood albumin decreased
|
0.00%
0/200 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.52%
1/194 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Investigations
Blood ketone body
|
0.00%
0/200 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.52%
1/194 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Investigations
Blood pressure systolic abnormal
|
0.00%
0/200 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.52%
1/194 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Investigations
Blood pressure systolic increased
|
0.50%
1/200 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.00%
0/194 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Investigations
Electrocardiogram T wave inversion
|
0.00%
0/200 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.52%
1/194 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Investigations
Electrocardiogram abnormal
|
0.50%
1/200 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.00%
0/194 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Investigations
Eosinophil count increased
|
0.00%
0/200 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.52%
1/194 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Investigations
Glomerular filtration rate decreased
|
0.50%
1/200 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.00%
0/194 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Investigations
Haematocrit increased
|
0.00%
0/200 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.52%
1/194 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/200 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.52%
1/194 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/200 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.52%
1/194 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Investigations
PaO2/FiO2 ratio
|
0.00%
0/200 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.52%
1/194 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Investigations
Red blood cell count decreased
|
0.50%
1/200 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.00%
0/194 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Investigations
Red blood cell count increased
|
0.00%
0/200 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.52%
1/194 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Investigations
Troponin T
|
0.00%
0/200 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.52%
1/194 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Investigations
Venous pressure jugular
|
0.50%
1/200 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.00%
0/194 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/200 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.52%
1/194 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Blood and lymphatic system disorders
Atrial fibrillation
|
3.0%
6/200 • Number of events 6 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
1.5%
3/194 • Number of events 3 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Cardiac disorders
Cardiac failure
|
1.0%
2/200 • Number of events 2 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
2.1%
4/194 • Number of events 4 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Cardiac disorders
Tachycardia
|
2.0%
4/200 • Number of events 4 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.52%
1/194 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Cardiac disorders
Cardiac failure congestive
|
1.5%
3/200 • Number of events 3 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.00%
0/194 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/200 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
1.0%
2/194 • Number of events 2 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Cardiac disorders
Atrial flutter
|
0.50%
1/200 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.52%
1/194 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Cardiac disorders
Cardiac failure acute
|
0.50%
1/200 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.52%
1/194 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Cardiac disorders
Coronary artery disease
|
0.50%
1/200 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.52%
1/194 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Cardiac disorders
Left ventricular hypertrophy
|
0.50%
1/200 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.52%
1/194 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Cardiac disorders
Myocarditis
|
0.00%
0/200 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
1.0%
2/194 • Number of events 2 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/200 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
1.0%
2/194 • Number of events 2 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Cardiac disorders
Aortic valve stenosis
|
0.00%
0/200 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.52%
1/194 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.00%
0/200 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.52%
1/194 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/200 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.52%
1/194 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Cardiac disorders
Bundle branch block left
|
0.00%
0/200 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.52%
1/194 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/200 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.52%
1/194 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Cardiac disorders
Cardiogenic shock
|
0.00%
0/200 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.52%
1/194 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Cardiac disorders
Cardiorenal syndrome
|
0.50%
1/200 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.00%
0/194 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Cardiac disorders
Chronic left ventricular failure
|
0.00%
0/200 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.52%
1/194 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Cardiac disorders
Cor pulmonale
|
0.50%
1/200 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.00%
0/194 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Cardiac disorders
Extrasystoles
|
0.00%
0/200 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.52%
1/194 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Cardiac disorders
Long QT syndrome
|
0.50%
1/200 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.00%
0/194 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.50%
1/200 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.00%
0/194 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/200 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.52%
1/194 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/200 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.52%
1/194 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Cardiac disorders
Sinus node dysfunction
|
0.00%
0/200 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.52%
1/194 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Cardiac disorders
Sinus tachycardia
|
0.50%
1/200 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.00%
0/194 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Cardiac disorders
Supraventricular extrasystoles
|
0.00%
0/200 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.52%
1/194 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.50%
1/200 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.00%
0/194 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Cardiac disorders
Ventricular dysfunction
|
0.00%
0/200 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.52%
1/194 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.00%
0/200 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.52%
1/194 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Cardiac disorders
Ventricular hypokinesia
|
0.00%
0/200 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.52%
1/194 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Infections and infestations
Urinary tract infection
|
2.0%
4/200 • Number of events 4 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
3.1%
6/194 • Number of events 6 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Infections and infestations
Cellulitis
|
2.0%
4/200 • Number of events 4 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.00%
0/194 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Infections and infestations
Oral candidiasis
|
1.5%
3/200 • Number of events 3 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.52%
1/194 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Infections and infestations
Sepsis
|
1.5%
3/200 • Number of events 3 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.52%
1/194 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Infections and infestations
Candida infection
|
1.0%
2/200 • Number of events 2 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.00%
0/194 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Infections and infestations
Dengue fever
|
0.50%
1/200 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.52%
1/194 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Infections and infestations
Osteomyelitis
|
1.0%
2/200 • Number of events 2 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.00%
0/194 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/200 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
1.0%
2/194 • Number of events 2 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Infections and infestations
Septic shock
|
0.00%
0/200 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
1.0%
2/194 • Number of events 2 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Infections and infestations
Aspergilloma
|
0.50%
1/200 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.00%
0/194 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Infections and infestations
Aspergillus infection
|
0.50%
1/200 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.00%
0/194 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Infections and infestations
Bacteraemia
|
0.50%
1/200 • Number of events 2 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.00%
0/194 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Infections and infestations
Clostridium difficile infection
|
0.50%
1/200 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.00%
0/194 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.50%
1/200 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.00%
0/194 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Infections and infestations
Herpes simplex
|
0.50%
1/200 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.00%
0/194 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Infections and infestations
Herpes zoster
|
0.50%
1/200 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.00%
0/194 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Infections and infestations
Infection
|
0.00%
0/200 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.52%
1/194 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Infections and infestations
Infectious pleural effusion
|
0.00%
0/200 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.52%
1/194 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Infections and infestations
Lice infestation
|
0.50%
1/200 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.00%
0/194 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Infections and infestations
Meningitis
|
0.00%
0/200 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.52%
1/194 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Infections and infestations
Metapneumovirus infection
|
0.00%
0/200 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.52%
1/194 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Infections and infestations
Oesophageal candidiasis
|
0.50%
1/200 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.00%
0/194 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/200 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.52%
1/194 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Infections and infestations
Oropharyngeal candidiasis
|
0.00%
0/200 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.52%
1/194 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Infections and infestations
Oropharyngitis fungal
|
0.00%
0/200 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.52%
1/194 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Infections and infestations
Pneumococcal bacteraemia
|
0.00%
0/200 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.52%
1/194 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Infections and infestations
Pyuria
|
0.50%
1/200 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.00%
0/194 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Infections and infestations
Renal abscess
|
0.00%
0/200 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.52%
1/194 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/200 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.52%
1/194 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Infections and infestations
Tinea pedis
|
0.50%
1/200 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.00%
0/194 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Infections and infestations
Urosepsis
|
0.00%
0/200 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.52%
1/194 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Infections and infestations
Vulvovaginal candidiasis
|
0.50%
1/200 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.00%
0/194 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Infections and infestations
Vulvovaginitis
|
0.00%
0/200 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.52%
1/194 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Vascular disorders
Hypertension
|
5.0%
10/200 • Number of events 10 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
3.6%
7/194 • Number of events 7 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Vascular disorders
Hypotension
|
5.5%
11/200 • Number of events 11 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
2.1%
4/194 • Number of events 4 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Vascular disorders
Syncope
|
1.0%
2/200 • Number of events 2 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
1.0%
2/194 • Number of events 2 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Vascular disorders
Phlebitis
|
1.0%
2/200 • Number of events 2 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.52%
1/194 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Vascular disorders
Aortic aneurysm
|
0.00%
0/200 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.52%
1/194 • Number of events 2 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Vascular disorders
Arteriosclerosis
|
0.00%
0/200 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.52%
1/194 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Vascular disorders
Carotid artery occlusion
|
0.00%
0/200 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.52%
1/194 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Vascular disorders
Cerebrovascular accident
|
0.50%
1/200 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.00%
0/194 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Vascular disorders
Embolic stroke
|
0.50%
1/200 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.00%
0/194 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Vascular disorders
Haemorrhage
|
0.00%
0/200 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.52%
1/194 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Vascular disorders
Haemorrhoids thrombosed
|
0.50%
1/200 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.00%
0/194 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Vascular disorders
Hypertensive urgency
|
0.00%
0/200 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.52%
1/194 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.50%
1/200 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.00%
0/194 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Vascular disorders
Peripheral venous disease
|
0.50%
1/200 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.00%
0/194 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Vascular disorders
Splenic infarction
|
0.00%
0/200 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.52%
1/194 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Vascular disorders
Carotid artery stenosis
|
0.00%
0/200 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.52%
1/194 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
General disorders
Chest pain
|
2.5%
5/200 • Number of events 5 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
2.6%
5/194 • Number of events 5 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
General disorders
Pyrexia
|
1.0%
2/200 • Number of events 2 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
1.5%
3/194 • Number of events 3 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
General disorders
Asthenia
|
1.0%
2/200 • Number of events 2 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
1.0%
2/194 • Number of events 3 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
General disorders
Death
|
1.5%
3/200 • Number of events 3 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.00%
0/194 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
General disorders
Oedema peripheral
|
1.0%
2/200 • Number of events 2 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.52%
1/194 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
General disorders
Chest discomfort
|
0.00%
0/200 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
1.0%
2/194 • Number of events 2 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
General disorders
Fatigue
|
0.50%
1/200 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.52%
1/194 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
General disorders
Oedema
|
0.50%
1/200 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.52%
1/194 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
General disorders
Drug withdrawal syndrome
|
0.00%
0/200 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.52%
1/194 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
General disorders
Inflammation
|
0.50%
1/200 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.00%
0/194 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
General disorders
Influenza like illness
|
0.50%
1/200 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.00%
0/194 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
General disorders
Infusion site swelling
|
0.00%
0/200 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.52%
1/194 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
General disorders
Malaise
|
0.50%
1/200 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.00%
0/194 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.00%
0/200 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.52%
1/194 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
General disorders
Pain
|
0.50%
1/200 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.00%
0/194 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
General disorders
Sudden death
|
0.00%
0/200 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.52%
1/194 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
General disorders
Systemic inflammatory response syndrome
|
0.00%
0/200 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.52%
1/194 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Nervous system disorders
Headache
|
3.5%
7/200 • Number of events 8 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
2.6%
5/194 • Number of events 5 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Nervous system disorders
Tremor
|
1.0%
2/200 • Number of events 2 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
1.0%
2/194 • Number of events 2 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Nervous system disorders
Toxic encephalopathy
|
1.0%
2/200 • Number of events 2 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.00%
0/194 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/200 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.52%
1/194 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Nervous system disorders
Disturbance in attention
|
0.50%
1/200 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.00%
0/194 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/200 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.52%
1/194 • Number of events 2 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Nervous system disorders
Encephalopathy
|
0.50%
1/200 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.00%
0/194 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Nervous system disorders
Hemiparesis
|
0.50%
1/200 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.00%
0/194 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Nervous system disorders
Migraine
|
0.50%
1/200 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.00%
0/194 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Nervous system disorders
Myoclonus
|
0.50%
1/200 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.00%
0/194 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Nervous system disorders
Neuralgia
|
0.50%
1/200 • Number of events 2 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.00%
0/194 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Nervous system disorders
Paraesthesia
|
0.50%
1/200 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.00%
0/194 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Nervous system disorders
Status migrainosus
|
0.50%
1/200 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.00%
0/194 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Psychiatric disorders
Insomnia
|
3.0%
6/200 • Number of events 6 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
1.0%
2/194 • Number of events 3 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Psychiatric disorders
Anxiety
|
2.0%
4/200 • Number of events 4 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.00%
0/194 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Psychiatric disorders
Delirium
|
1.5%
3/200 • Number of events 3 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.52%
1/194 • Number of events 2 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Psychiatric disorders
Sleep disorder
|
0.50%
1/200 • Number of events 2 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
1.0%
2/194 • Number of events 2 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Psychiatric disorders
Generalised anxiety disorder
|
1.0%
2/200 • Number of events 2 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.00%
0/194 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Psychiatric disorders
Mental status changes
|
1.0%
2/200 • Number of events 2 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.00%
0/194 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Psychiatric disorders
Confusional state
|
0.50%
1/200 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.00%
0/194 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Psychiatric disorders
Depression
|
0.00%
0/200 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.52%
1/194 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Psychiatric disorders
Mania
|
0.50%
1/200 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.00%
0/194 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Psychiatric disorders
Post-traumatic stress disorder
|
0.00%
0/200 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.52%
1/194 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Psychiatric disorders
Restlessness
|
0.00%
0/200 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.52%
1/194 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Psychiatric disorders
Tobacco withdrawal symptoms
|
0.50%
1/200 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.00%
0/194 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Blood and lymphatic system disorders
Anaemia
|
1.0%
2/200 • Number of events 3 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
2.6%
5/194 • Number of events 5 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
1.5%
3/200 • Number of events 4 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
2.1%
4/194 • Number of events 4 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Blood and lymphatic system disorders
Thrombocytosis
|
2.0%
4/200 • Number of events 4 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.52%
1/194 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.50%
1/200 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.52%
1/194 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Blood and lymphatic system disorders
Hypochromic anaemia
|
0.00%
0/200 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.52%
1/194 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/200 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.52%
1/194 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.50%
1/200 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.00%
0/194 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/200 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.52%
1/194 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/200 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.52%
1/194 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Renal and urinary disorders
Acute kidney injury
|
4.5%
9/200 • Number of events 10 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.52%
1/194 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Renal and urinary disorders
Renal failure
|
1.5%
3/200 • Number of events 3 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.00%
0/194 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Renal and urinary disorders
Renal impairment
|
1.0%
2/200 • Number of events 2 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.00%
0/194 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Renal and urinary disorders
Bladder pain
|
0.00%
0/200 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.52%
1/194 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/200 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.52%
1/194 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.50%
1/200 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.00%
0/194 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/200 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.52%
1/194 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Renal and urinary disorders
Renal colic
|
0.50%
1/200 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.00%
0/194 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Renal and urinary disorders
Urinary retention
|
0.50%
1/200 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.00%
0/194 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.0%
4/200 • Number of events 4 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
1.0%
2/194 • Number of events 2 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
1.0%
2/200 • Number of events 2 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.00%
0/194 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.50%
1/200 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.52%
1/194 • Number of events 2 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
1.0%
2/200 • Number of events 2 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.00%
0/194 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Skin and subcutaneous tissue disorders
Actinic keratosis
|
0.00%
0/200 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.52%
1/194 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.50%
1/200 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.00%
0/194 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Skin and subcutaneous tissue disorders
Diabetic foot
|
0.00%
0/200 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.52%
1/194 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.00%
0/200 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.52%
1/194 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Skin and subcutaneous tissue disorders
Dyshidrotic eczema
|
0.50%
1/200 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.00%
0/194 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/200 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.52%
1/194 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Skin and subcutaneous tissue disorders
Ingrowing nail
|
0.50%
1/200 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.00%
0/194 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Skin and subcutaneous tissue disorders
Nail hypertrophy
|
0.00%
0/200 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.52%
1/194 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.00%
0/200 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.52%
1/194 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/200 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.52%
1/194 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.5%
3/200 • Number of events 4 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
2.1%
4/194 • Number of events 4 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.50%
1/200 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
1.5%
3/194 • Number of events 3 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
1.0%
2/200 • Number of events 2 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.00%
0/194 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/200 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
1.0%
2/194 • Number of events 2 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Musculoskeletal and connective tissue disorders
Haematoma muscle
|
0.00%
0/200 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.52%
1/194 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness
|
0.00%
0/200 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.52%
1/194 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/200 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.52%
1/194 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/200 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.52%
1/194 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.50%
1/200 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.00%
0/194 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.50%
1/200 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.00%
0/194 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Musculoskeletal and connective tissue disorders
Osteochondrosis
|
0.00%
0/200 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.52%
1/194 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.00%
0/200 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.52%
1/194 • Number of events 2 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
0.00%
0/200 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.52%
1/194 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.00%
0/200 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.52%
1/194 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Musculoskeletal and connective tissue disorders
Vertebral foraminal stenosis
|
0.00%
0/200 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.52%
1/194 • Number of events 2 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.50%
1/200 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
1.0%
2/194 • Number of events 2 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Injury, poisoning and procedural complications
Fall
|
0.50%
1/200 • Number of events 2 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.52%
1/194 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.50%
1/200 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.52%
1/194 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Injury, poisoning and procedural complications
Alcohol poisoning
|
0.00%
0/200 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.52%
1/194 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Injury, poisoning and procedural complications
Craniocerebral injury
|
0.50%
1/200 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.00%
0/194 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Injury, poisoning and procedural complications
Face injury
|
0.50%
1/200 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.00%
0/194 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.00%
0/200 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.52%
1/194 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.50%
1/200 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.00%
0/194 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Injury, poisoning and procedural complications
Penis injury
|
0.50%
1/200 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.00%
0/194 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Injury, poisoning and procedural complications
Postoperative respiratory failure
|
0.50%
1/200 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.00%
0/194 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.50%
1/200 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.00%
0/194 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Injury, poisoning and procedural complications
Product administration error
|
0.50%
1/200 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.00%
0/194 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.50%
1/200 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.00%
0/194 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.50%
1/200 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.00%
0/194 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Injury, poisoning and procedural complications
Traumatic haematoma
|
0.00%
0/200 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.52%
1/194 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.50%
1/200 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.52%
1/194 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.50%
1/200 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.00%
0/194 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign lung neoplasm
|
0.50%
1/200 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.00%
0/194 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.50%
1/200 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.00%
0/194 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Glioblastoma
|
0.00%
0/200 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.52%
1/194 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haematological malignancy
|
0.00%
0/200 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.52%
1/194 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma
|
0.50%
1/200 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.00%
0/194 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.00%
0/200 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.52%
1/194 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Melanocytic naevus
|
0.50%
1/200 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.00%
0/194 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.50%
1/200 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.00%
0/194 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of lung
|
0.00%
0/200 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.52%
1/194 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
0.50%
1/200 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
1.5%
3/194 • Number of events 3 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Hepatobiliary disorders
Hepatic failure
|
0.50%
1/200 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.00%
0/194 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Hepatobiliary disorders
Hepatic lesion
|
0.50%
1/200 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.00%
0/194 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Hepatobiliary disorders
Hepatic pain
|
0.00%
0/200 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.52%
1/194 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Hepatobiliary disorders
Hepatic steatosis
|
0.00%
0/200 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.52%
1/194 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/200 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.52%
1/194 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Ear and labyrinth disorders
Deafness
|
0.00%
0/200 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.52%
1/194 • Number of events 2 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Ear and labyrinth disorders
Ear discomfort
|
0.50%
1/200 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.00%
0/194 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Ear and labyrinth disorders
Middle ear effusion
|
0.50%
1/200 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.00%
0/194 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.50%
1/200 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.00%
0/194 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Surgical and medical procedures
Knee arthroplasty
|
0.50%
1/200 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.00%
0/194 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Surgical and medical procedures
Mitral valve repair
|
0.50%
1/200 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.00%
0/194 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Surgical and medical procedures
Renal stone removal
|
0.50%
1/200 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.00%
0/194 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Surgical and medical procedures
Therapy cessation
|
0.50%
1/200 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.00%
0/194 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Endocrine disorders
Adrenal haemorrhage
|
0.50%
1/200 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.00%
0/194 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Endocrine disorders
Hyperthyroidism
|
0.50%
1/200 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.00%
0/194 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Endocrine disorders
Hypothyroidism
|
0.50%
1/200 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.00%
0/194 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Eye disorders
Blindness
|
0.00%
0/200 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.52%
1/194 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Eye disorders
Cataract
|
0.00%
0/200 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.52%
1/194 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Eye disorders
Visual impairment
|
0.50%
1/200 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.00%
0/194 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Reproductive system and breast disorders
Adenomyosis
|
0.00%
0/200 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.52%
1/194 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Reproductive system and breast disorders
Balanoposthitis
|
0.00%
0/200 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.52%
1/194 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
|
Reproductive system and breast disorders
Pelvic haematoma
|
0.50%
1/200 • Number of events 1 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
0.00%
0/194 • Throughout the study, during the treatment period (up to 21 days) and during the follow-up period (till day 180 or EoT) considered together as an "overall period", up to 7 months. Please note: SAF set participants were summarized according to the actual treatment received. Hence n=200 for REP and n=194 for placebo, in serious AE and non-serious AE.
All-cause mortality was analyzed for the randomized set, consisting of all participants who were randomized to the study, regardless of whether they receive the IMP or not. The safety set was used for reporting serious adverse events.
|
Additional Information
Clinical Development & Operations
Dompé Farmaceutici S.p.A.
Phone: +39 02 583831
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place