Trial Outcomes & Findings for Study to Compare Ferric Carboxymaltose With Placebo in Patients With Acute Heart Failure and Iron Deficiency (NCT NCT02937454)
NCT ID: NCT02937454
Last Updated: 2021-06-18
Results Overview
HF = Heart Failure, CV = Cardiovascular. The composite of recurrent HF hospitalizations and CV death up to 52 weeks after randomization Total hospitalisations included first and recurrent events. If a participant was hospitalised for heart failure and died within 24 h from any cardiovascular event, this was counted as one event.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
1132 participants
Primary outcome timeframe
up to 52 weeks after randomization
Results posted on
2021-06-18
Participant Flow
Participant milestones
| Measure |
FCM (Ferric Carboxymaltose)
Ferric carboxymaltose (FCM), administered by bolus intravenous (IV) injection at a dose of 10 ml or 20 ml of undiluted solution (containing 500 mg or 1,000 mg of iron respectively) depending on the participant's body weight and haemoglobin (Hb) level.
From a single dose given at Visit 2 (Week 0) up to 4 doses given over 24 weeks (at Visit 2 (Week 0), Visit 3 (Week 6), Visit 4 (Week 12) and Visit 5 (Week 24), depending on the participant's Hb levels measured prior to planned dosing dates.
|
Placebo (Normal Saline (NaCl 0.9%))
Normal saline (NaCl 0.9%), administered by bolus intravenous (IV) injection at a volume corresponding to the FCM dose determined by the participant's body weight and haemoglobin (Hb) level (i.e., 10 ml or 20 ml per administration).
From a single dose given at Visit 2 (Week 0) up to 4 doses given over 24 weeks (at Visit 2 (Week 0), Visit 3 (Week 6), Visit 4 (Week 12) and Visit 5 (Week 24)), depending on the participant's Hb levels measured prior to planned dosing dates.
|
|---|---|---|
|
Overall Study
STARTED
|
567
|
565
|
|
Overall Study
Started Treatment
|
559
|
551
|
|
Overall Study
COMPLETED
|
427
|
437
|
|
Overall Study
NOT COMPLETED
|
140
|
128
|
Reasons for withdrawal
| Measure |
FCM (Ferric Carboxymaltose)
Ferric carboxymaltose (FCM), administered by bolus intravenous (IV) injection at a dose of 10 ml or 20 ml of undiluted solution (containing 500 mg or 1,000 mg of iron respectively) depending on the participant's body weight and haemoglobin (Hb) level.
From a single dose given at Visit 2 (Week 0) up to 4 doses given over 24 weeks (at Visit 2 (Week 0), Visit 3 (Week 6), Visit 4 (Week 12) and Visit 5 (Week 24), depending on the participant's Hb levels measured prior to planned dosing dates.
|
Placebo (Normal Saline (NaCl 0.9%))
Normal saline (NaCl 0.9%), administered by bolus intravenous (IV) injection at a volume corresponding to the FCM dose determined by the participant's body weight and haemoglobin (Hb) level (i.e., 10 ml or 20 ml per administration).
From a single dose given at Visit 2 (Week 0) up to 4 doses given over 24 weeks (at Visit 2 (Week 0), Visit 3 (Week 6), Visit 4 (Week 12) and Visit 5 (Week 24)), depending on the participant's Hb levels measured prior to planned dosing dates.
|
|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
|
Overall Study
Death
|
98
|
95
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
|
Overall Study
Physician Decision
|
0
|
1
|
|
Overall Study
Protocol Violation
|
6
|
10
|
|
Overall Study
Withdrawal by Subject
|
27
|
15
|
|
Overall Study
Other
|
8
|
5
|
Baseline Characteristics
Study to Compare Ferric Carboxymaltose With Placebo in Patients With Acute Heart Failure and Iron Deficiency
Baseline characteristics by cohort
| Measure |
FCM (Ferric Carboxymaltose)
n=559 Participants
Ferric carboxymaltose (FCM), administered by bolus intravenous (IV) injection at a dose of 10 ml or 20 ml of undiluted solution (containing 500 mg or 1,000 mg of iron respectively) depending on the participant's body weight and haemoglobin (Hb) level.
From a single dose given at Visit 2 (Week 0) up to 4 doses given over 24 weeks (at Visit 2 (Week 0), Visit 3 (Week 6), Visit 4 (Week 12) and Visit 5 (Week 24), depending on the participant's Hb levels measured prior to planned dosing dates.
|
Placebo (Normal Saline (NaCl 0.9%))
n=551 Participants
Normal saline (NaCl 0.9%), administered by bolus intravenous (IV) injection at a volume corresponding to the FCM dose determined by the participant's body weight and haemoglobin (Hb) level (i.e., 10 ml or 20 ml per administration).
From a single dose given at Visit 2 (Week 0) up to 4 doses given over 24 weeks (at Visit 2 (Week 0), Visit 3 (Week 6), Visit 4 (Week 12) and Visit 5 (Week 24)), depending on the participant's Hb levels measured prior to planned dosing dates.
|
Total
n=1110 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
<18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Customized
Between 18 and 64 years
|
139 Participants
n=99 Participants
|
142 Participants
n=107 Participants
|
281 Participants
n=206 Participants
|
|
Age, Customized
Between 65 and 84 years
|
369 Participants
n=99 Participants
|
370 Participants
n=107 Participants
|
739 Participants
n=206 Participants
|
|
Age, Customized
≥ 85 years
|
51 Participants
n=99 Participants
|
39 Participants
n=107 Participants
|
90 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
244 Participants
n=99 Participants
|
250 Participants
n=107 Participants
|
494 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
315 Participants
n=99 Participants
|
301 Participants
n=107 Participants
|
616 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
51 Participants
n=99 Participants
|
50 Participants
n=107 Participants
|
101 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
498 Participants
n=99 Participants
|
489 Participants
n=107 Participants
|
987 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
10 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
|
Region of Enrollment
Argentina
|
24 Participants
n=99 Participants
|
24 Participants
n=107 Participants
|
48 Participants
n=206 Participants
|
|
Region of Enrollment
Brazil
|
14 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
28 Participants
n=206 Participants
|
|
Region of Enrollment
Croatia
|
39 Participants
n=99 Participants
|
43 Participants
n=107 Participants
|
82 Participants
n=206 Participants
|
|
Region of Enrollment
Georgia
|
98 Participants
n=99 Participants
|
95 Participants
n=107 Participants
|
193 Participants
n=206 Participants
|
|
Region of Enrollment
Israel
|
41 Participants
n=99 Participants
|
38 Participants
n=107 Participants
|
79 Participants
n=206 Participants
|
|
Region of Enrollment
Italy
|
55 Participants
n=99 Participants
|
58 Participants
n=107 Participants
|
113 Participants
n=206 Participants
|
|
Region of Enrollment
Lebanon
|
16 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
32 Participants
n=206 Participants
|
|
Region of Enrollment
Netherlands
|
38 Participants
n=99 Participants
|
31 Participants
n=107 Participants
|
69 Participants
n=206 Participants
|
|
Region of Enrollment
Poland
|
90 Participants
n=99 Participants
|
90 Participants
n=107 Participants
|
180 Participants
n=206 Participants
|
|
Region of Enrollment
Romania
|
76 Participants
n=99 Participants
|
78 Participants
n=107 Participants
|
154 Participants
n=206 Participants
|
|
Region of Enrollment
Singapore
|
23 Participants
n=99 Participants
|
22 Participants
n=107 Participants
|
45 Participants
n=206 Participants
|
|
Region of Enrollment
Spain
|
12 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
|
Region of Enrollment
Sweden
|
4 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Region of Enrollment
Ukraine
|
23 Participants
n=99 Participants
|
23 Participants
n=107 Participants
|
46 Participants
n=206 Participants
|
|
Region of Enrollment
United Kingdom
|
6 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: up to 52 weeks after randomizationPopulation: Full Analysis Set (FAS): All randomised participants for whom administration of study treatment was started and who had at least one post-baseline visit (including calls), death or hospitalisation or who withdrew from the study after but not on the randomisation date. The management and follow-up of patients was affected by the COVID-19 pandemic. Participants were censored in each country on the date when the first patient with COVID-19 was reported in the respective country.
HF = Heart Failure, CV = Cardiovascular. The composite of recurrent HF hospitalizations and CV death up to 52 weeks after randomization Total hospitalisations included first and recurrent events. If a participant was hospitalised for heart failure and died within 24 h from any cardiovascular event, this was counted as one event.
Outcome measures
| Measure |
FCM (Ferric Carboxymaltose)
n=558 Participants
Ferric carboxymaltose (FCM), administered by bolus intravenous (IV) injection at a dose of 10 ml or 20 ml of undiluted solution (containing 500 mg or 1,000 mg of iron respectively) depending on the participant's body weight and haemoglobin (Hb) level.
From a single dose given at Visit 2 (Week 0) up to 4 doses given over 24 weeks (at Visit 2 (Week 0), Visit 3 (Week 6), Visit 4 (Week 12) and Visit 5 (Week 24), depending on the participant's Hb levels measured prior to planned dosing dates.
|
Placebo (Normal Saline (NaCl 0.9%))
n=550 Participants
Normal saline (NaCl 0.9%), administered by bolus intravenous (IV) injection at a volume corresponding to the FCM dose determined by the participant's body weight and haemoglobin (Hb) level (i.e., 10 ml or 20 ml per administration).
From a single dose given at Visit 2 (Week 0) up to 4 doses given over 24 weeks (at Visit 2 (Week 0), Visit 3 (Week 6), Visit 4 (Week 12) and Visit 5 (Week 24)), depending on the participant's Hb levels measured prior to planned dosing dates.
|
|---|---|---|
|
HF Hospitalizations and CV Death
Full Analysis Set (FAS)
|
293 Events
|
372 Events
|
|
HF Hospitalizations and CV Death
Covid-19 Sensitivity Analysis
|
274 Events
|
363 Events
|
SECONDARY outcome
Timeframe: up to 52 weeks after randomizationPopulation: Full Analysis Set (FAS): All randomised participants for whom administration of study treatment was started and who had at least one post-baseline visit (including calls), death or hospitalisation or who withdrew from the study after but not on the randomisation date. The management and follow-up of patients was affected by the COVID-19 pandemic. Participants were censored in each country on the date when the first patient with COVID-19 was reported in the respective country.
CV = Cardiovascular The composite of recurrent CV hospitalisations and CV death at 52 weeks after randomisation Total hospitalisations included first and recurrent events. If a participant was hospitalised for a cardiovascular reason and died within 24 h of admission from any cardiovascular event, this was counted as one event.
Outcome measures
| Measure |
FCM (Ferric Carboxymaltose)
n=558 Participants
Ferric carboxymaltose (FCM), administered by bolus intravenous (IV) injection at a dose of 10 ml or 20 ml of undiluted solution (containing 500 mg or 1,000 mg of iron respectively) depending on the participant's body weight and haemoglobin (Hb) level.
From a single dose given at Visit 2 (Week 0) up to 4 doses given over 24 weeks (at Visit 2 (Week 0), Visit 3 (Week 6), Visit 4 (Week 12) and Visit 5 (Week 24), depending on the participant's Hb levels measured prior to planned dosing dates.
|
Placebo (Normal Saline (NaCl 0.9%))
n=550 Participants
Normal saline (NaCl 0.9%), administered by bolus intravenous (IV) injection at a volume corresponding to the FCM dose determined by the participant's body weight and haemoglobin (Hb) level (i.e., 10 ml or 20 ml per administration).
From a single dose given at Visit 2 (Week 0) up to 4 doses given over 24 weeks (at Visit 2 (Week 0), Visit 3 (Week 6), Visit 4 (Week 12) and Visit 5 (Week 24)), depending on the participant's Hb levels measured prior to planned dosing dates.
|
|---|---|---|
|
Recurrent CV Hospitalisations and CV Death
Full Analysis Set (FAS)
|
370 Events
|
451 Events
|
|
Recurrent CV Hospitalisations and CV Death
COVID-19 sensitivity analyses
|
350 Events
|
440 Events
|
SECONDARY outcome
Timeframe: up to 52 weeks after randomisationPopulation: Full Analysis Set (FAS): All randomised participants for whom administration of study treatment was started and who had at least one post-baseline visit (including calls), death or hospitalisation or who withdrew from the study after but not on the randomisation date. The management and follow-up of patients was affected by the COVID-19 pandemic. Participants were censored in each country on the date when the first patient with COVID-19 was reported in the respective country.
HF = Heart Failure HF hospitalisations up to 52 weeks after randomisation analysed as recurrent event.
Outcome measures
| Measure |
FCM (Ferric Carboxymaltose)
n=558 Participants
Ferric carboxymaltose (FCM), administered by bolus intravenous (IV) injection at a dose of 10 ml or 20 ml of undiluted solution (containing 500 mg or 1,000 mg of iron respectively) depending on the participant's body weight and haemoglobin (Hb) level.
From a single dose given at Visit 2 (Week 0) up to 4 doses given over 24 weeks (at Visit 2 (Week 0), Visit 3 (Week 6), Visit 4 (Week 12) and Visit 5 (Week 24), depending on the participant's Hb levels measured prior to planned dosing dates.
|
Placebo (Normal Saline (NaCl 0.9%))
n=550 Participants
Normal saline (NaCl 0.9%), administered by bolus intravenous (IV) injection at a volume corresponding to the FCM dose determined by the participant's body weight and haemoglobin (Hb) level (i.e., 10 ml or 20 ml per administration).
From a single dose given at Visit 2 (Week 0) up to 4 doses given over 24 weeks (at Visit 2 (Week 0), Visit 3 (Week 6), Visit 4 (Week 12) and Visit 5 (Week 24)), depending on the participant's Hb levels measured prior to planned dosing dates.
|
|---|---|---|
|
HF Hospitalisations
Full Analysis Set (FAS)
|
217 Events
|
294 Events
|
|
HF Hospitalisations
COVID-19 sensitivity analyses
|
202 Events
|
287 Events
|
SECONDARY outcome
Timeframe: at 52 weeks after randomisation.Population: Full Analysis Set (FAS): All randomised participants for whom administration of study treatment was started and who had at least one post-baseline visit (including calls), death or hospitalisation or who withdrew from the study after but not on the randomisation date. The management and follow-up of patients was affected by the COVID-19 pandemic. Participants were censored in each country on the date when the first patient with COVID-19 was reported in the respective country.
CV = Cardiovascular CV mortality analysed as time to first event at 52 weeks after randomisation.
Outcome measures
| Measure |
FCM (Ferric Carboxymaltose)
n=558 Participants
Ferric carboxymaltose (FCM), administered by bolus intravenous (IV) injection at a dose of 10 ml or 20 ml of undiluted solution (containing 500 mg or 1,000 mg of iron respectively) depending on the participant's body weight and haemoglobin (Hb) level.
From a single dose given at Visit 2 (Week 0) up to 4 doses given over 24 weeks (at Visit 2 (Week 0), Visit 3 (Week 6), Visit 4 (Week 12) and Visit 5 (Week 24), depending on the participant's Hb levels measured prior to planned dosing dates.
|
Placebo (Normal Saline (NaCl 0.9%))
n=550 Participants
Normal saline (NaCl 0.9%), administered by bolus intravenous (IV) injection at a volume corresponding to the FCM dose determined by the participant's body weight and haemoglobin (Hb) level (i.e., 10 ml or 20 ml per administration).
From a single dose given at Visit 2 (Week 0) up to 4 doses given over 24 weeks (at Visit 2 (Week 0), Visit 3 (Week 6), Visit 4 (Week 12) and Visit 5 (Week 24)), depending on the participant's Hb levels measured prior to planned dosing dates.
|
|---|---|---|
|
CV Mortality
Full Analysis Set (FAS)
|
77 Participants
|
78 Participants
|
|
CV Mortality
COVID-19 sensitivity analyses
|
73 Participants
|
76 Participants
|
SECONDARY outcome
Timeframe: at 52 weeks after randomisationPopulation: Full Analysis Set (FAS): All randomised participants for whom administration of study treatment was started and who had at least one post-baseline visit (including calls), death or hospitalisation or who withdrew from the study after but not on the randomisation date. The management and follow-up of patients was affected by the COVID-19 pandemic. Participants were censored in each country on the date when the first patient with COVID-19 was reported in the respective country.
HF = Heart Failure, CV = Cardiovascular Analysed as time to first event at 52 weeks after randomisation. The number of participants with at least one HF Hospitalisation or CV Death is presented below.
Outcome measures
| Measure |
FCM (Ferric Carboxymaltose)
n=558 Participants
Ferric carboxymaltose (FCM), administered by bolus intravenous (IV) injection at a dose of 10 ml or 20 ml of undiluted solution (containing 500 mg or 1,000 mg of iron respectively) depending on the participant's body weight and haemoglobin (Hb) level.
From a single dose given at Visit 2 (Week 0) up to 4 doses given over 24 weeks (at Visit 2 (Week 0), Visit 3 (Week 6), Visit 4 (Week 12) and Visit 5 (Week 24), depending on the participant's Hb levels measured prior to planned dosing dates.
|
Placebo (Normal Saline (NaCl 0.9%))
n=550 Participants
Normal saline (NaCl 0.9%), administered by bolus intravenous (IV) injection at a volume corresponding to the FCM dose determined by the participant's body weight and haemoglobin (Hb) level (i.e., 10 ml or 20 ml per administration).
From a single dose given at Visit 2 (Week 0) up to 4 doses given over 24 weeks (at Visit 2 (Week 0), Visit 3 (Week 6), Visit 4 (Week 12) and Visit 5 (Week 24)), depending on the participant's Hb levels measured prior to planned dosing dates.
|
|---|---|---|
|
Composite of HF Hospitalisations or CV Death
Full Analysis Set (FAS)
|
181 Participants
|
209 Participants
|
|
Composite of HF Hospitalisations or CV Death
COVID-19 sensitivity analyses
|
175 Participants
|
205 Participants
|
SECONDARY outcome
Timeframe: at 52 weeks after randomisationPopulation: Full Analysis Set (FAS): All randomised participants for whom administration of study treatment was started and who had at least one post-baseline visit (including calls), death or hospitalisation or who withdrew from the study after but not on the randomisation date. The management and follow-up of patients was affected by the COVID-19 pandemic. Participants were censored in each country on the date when the first patient with COVID-19 was reported in the respective country.
HF = Heart Failure, CV = Cardiovascular Number of days lost due to heart failure hospitalisations or cardiovascular death corresponds to the total number of days in hospital for heart failure from randomisation to last known date. Days lost due to cardiovascular death are added to the number of days lost due to heart failure hospitalisation.
Outcome measures
| Measure |
FCM (Ferric Carboxymaltose)
n=558 Participants
Ferric carboxymaltose (FCM), administered by bolus intravenous (IV) injection at a dose of 10 ml or 20 ml of undiluted solution (containing 500 mg or 1,000 mg of iron respectively) depending on the participant's body weight and haemoglobin (Hb) level.
From a single dose given at Visit 2 (Week 0) up to 4 doses given over 24 weeks (at Visit 2 (Week 0), Visit 3 (Week 6), Visit 4 (Week 12) and Visit 5 (Week 24), depending on the participant's Hb levels measured prior to planned dosing dates.
|
Placebo (Normal Saline (NaCl 0.9%))
n=550 Participants
Normal saline (NaCl 0.9%), administered by bolus intravenous (IV) injection at a volume corresponding to the FCM dose determined by the participant's body weight and haemoglobin (Hb) level (i.e., 10 ml or 20 ml per administration).
From a single dose given at Visit 2 (Week 0) up to 4 doses given over 24 weeks (at Visit 2 (Week 0), Visit 3 (Week 6), Visit 4 (Week 12) and Visit 5 (Week 24)), depending on the participant's Hb levels measured prior to planned dosing dates.
|
|---|---|---|
|
Days Lost Due to HF Hospitalisation or CV Death
Full Analysis Set (FAS)
|
3.8 days
Standard Deviation 9.06
|
6.2 days
Standard Deviation 14.48
|
|
Days Lost Due to HF Hospitalisation or CV Death
COVID-19 sensitivity analyses
|
3.5 days
Standard Deviation 8.18
|
6.1 days
Standard Deviation 14.42
|
OTHER_PRE_SPECIFIED outcome
Timeframe: up to 52 weeks after randomisationPopulation: Full Analysis Set (FAS): All randomised participants for whom administration of study treatment was started and who had at least one post-baseline visit (including calls), death or hospitalisation or who withdrew from the study after but not on the randomisation date.
HF = Heart Failure Number of participants with at least one HF Hospitalisation up to 52 weeks after randomisation
Outcome measures
| Measure |
FCM (Ferric Carboxymaltose)
n=558 Participants
Ferric carboxymaltose (FCM), administered by bolus intravenous (IV) injection at a dose of 10 ml or 20 ml of undiluted solution (containing 500 mg or 1,000 mg of iron respectively) depending on the participant's body weight and haemoglobin (Hb) level.
From a single dose given at Visit 2 (Week 0) up to 4 doses given over 24 weeks (at Visit 2 (Week 0), Visit 3 (Week 6), Visit 4 (Week 12) and Visit 5 (Week 24), depending on the participant's Hb levels measured prior to planned dosing dates.
|
Placebo (Normal Saline (NaCl 0.9%))
n=550 Participants
Normal saline (NaCl 0.9%), administered by bolus intravenous (IV) injection at a volume corresponding to the FCM dose determined by the participant's body weight and haemoglobin (Hb) level (i.e., 10 ml or 20 ml per administration).
From a single dose given at Visit 2 (Week 0) up to 4 doses given over 24 weeks (at Visit 2 (Week 0), Visit 3 (Week 6), Visit 4 (Week 12) and Visit 5 (Week 24)), depending on the participant's Hb levels measured prior to planned dosing dates.
|
|---|---|---|
|
HF Hospitalisations
|
142 Participants
|
178 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: up to 52 weeks after randomisationPopulation: Full Analysis Set (FAS): All randomised participants for whom administration of study treatment was started and who had at least one post-baseline visit (including calls), death or hospitalisation or who withdrew from the study after but not on the randomisation date.
CV = Cardiovascular Number of participants with at least one CV Hospitalisation up to 52 weeks after randomisation
Outcome measures
| Measure |
FCM (Ferric Carboxymaltose)
n=558 Participants
Ferric carboxymaltose (FCM), administered by bolus intravenous (IV) injection at a dose of 10 ml or 20 ml of undiluted solution (containing 500 mg or 1,000 mg of iron respectively) depending on the participant's body weight and haemoglobin (Hb) level.
From a single dose given at Visit 2 (Week 0) up to 4 doses given over 24 weeks (at Visit 2 (Week 0), Visit 3 (Week 6), Visit 4 (Week 12) and Visit 5 (Week 24), depending on the participant's Hb levels measured prior to planned dosing dates.
|
Placebo (Normal Saline (NaCl 0.9%))
n=550 Participants
Normal saline (NaCl 0.9%), administered by bolus intravenous (IV) injection at a volume corresponding to the FCM dose determined by the participant's body weight and haemoglobin (Hb) level (i.e., 10 ml or 20 ml per administration).
From a single dose given at Visit 2 (Week 0) up to 4 doses given over 24 weeks (at Visit 2 (Week 0), Visit 3 (Week 6), Visit 4 (Week 12) and Visit 5 (Week 24)), depending on the participant's Hb levels measured prior to planned dosing dates.
|
|---|---|---|
|
CV Hospitalisations
|
181 Participants
|
220 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: up to 52 weeks after randomisationPopulation: Full Analysis Set (FAS): All randomised participants for whom administration of study treatment was started and who had at least one post-baseline visit (including calls), death or hospitalisation or who withdrew from the study after but not on the randomisation date.
Number of participants who died up to 52 weeks after randomisation
Outcome measures
| Measure |
FCM (Ferric Carboxymaltose)
n=558 Participants
Ferric carboxymaltose (FCM), administered by bolus intravenous (IV) injection at a dose of 10 ml or 20 ml of undiluted solution (containing 500 mg or 1,000 mg of iron respectively) depending on the participant's body weight and haemoglobin (Hb) level.
From a single dose given at Visit 2 (Week 0) up to 4 doses given over 24 weeks (at Visit 2 (Week 0), Visit 3 (Week 6), Visit 4 (Week 12) and Visit 5 (Week 24), depending on the participant's Hb levels measured prior to planned dosing dates.
|
Placebo (Normal Saline (NaCl 0.9%))
n=550 Participants
Normal saline (NaCl 0.9%), administered by bolus intravenous (IV) injection at a volume corresponding to the FCM dose determined by the participant's body weight and haemoglobin (Hb) level (i.e., 10 ml or 20 ml per administration).
From a single dose given at Visit 2 (Week 0) up to 4 doses given over 24 weeks (at Visit 2 (Week 0), Visit 3 (Week 6), Visit 4 (Week 12) and Visit 5 (Week 24)), depending on the participant's Hb levels measured prior to planned dosing dates.
|
|---|---|---|
|
All-cause Mortality
|
98 Participants
|
96 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: at 6, 12, 24 and 52 weeks after randomisationPopulation: Full Analysis Set (FAS): All randomised participants for whom administration of study treatment was started and who had at least one post-baseline visit (including calls), death or hospitalisation or who withdrew from the study after but not on the randomisation date.
NYHA = New York Heart Association NYHA functional class was assessed as Class I, II, III, IV or V: Class I - No symptoms and no limitation in ordinary physical activity, e.g. shortness of breath when walking, climbing stairs etc. Class II - Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity. Class III - Marked limitation in activity due to symptoms, even during less-than-ordinary activity, e.g. walking short distances (20-100 m). Comfortable only at rest. Class IV - Severe limitations. Experiences symptoms even while at rest. Mostly bedbound patients. If a participant was hospitalised at any point during any post-baseline visit and did not have any NYHA assessment for this visit, then Class IV was to be imputed for the visit. Class V - Imputed for participants who died. Lower response categories are better for score NYHA.
Outcome measures
| Measure |
FCM (Ferric Carboxymaltose)
n=558 Participants
Ferric carboxymaltose (FCM), administered by bolus intravenous (IV) injection at a dose of 10 ml or 20 ml of undiluted solution (containing 500 mg or 1,000 mg of iron respectively) depending on the participant's body weight and haemoglobin (Hb) level.
From a single dose given at Visit 2 (Week 0) up to 4 doses given over 24 weeks (at Visit 2 (Week 0), Visit 3 (Week 6), Visit 4 (Week 12) and Visit 5 (Week 24), depending on the participant's Hb levels measured prior to planned dosing dates.
|
Placebo (Normal Saline (NaCl 0.9%))
n=550 Participants
Normal saline (NaCl 0.9%), administered by bolus intravenous (IV) injection at a volume corresponding to the FCM dose determined by the participant's body weight and haemoglobin (Hb) level (i.e., 10 ml or 20 ml per administration).
From a single dose given at Visit 2 (Week 0) up to 4 doses given over 24 weeks (at Visit 2 (Week 0), Visit 3 (Week 6), Visit 4 (Week 12) and Visit 5 (Week 24)), depending on the participant's Hb levels measured prior to planned dosing dates.
|
|---|---|---|
|
Change From Baseline in NYHA Functional Class
Baseline · Class I
|
14 Participants
|
8 Participants
|
|
Change From Baseline in NYHA Functional Class
Baseline · Class II
|
255 Participants
|
240 Participants
|
|
Change From Baseline in NYHA Functional Class
Baseline · Class III
|
272 Participants
|
277 Participants
|
|
Change From Baseline in NYHA Functional Class
Baseline · Class IV
|
16 Participants
|
22 Participants
|
|
Change From Baseline in NYHA Functional Class
Baseline · Class V
|
0 Participants
|
0 Participants
|
|
Change From Baseline in NYHA Functional Class
Week 6 · Class I
|
38 Participants
|
38 Participants
|
|
Change From Baseline in NYHA Functional Class
Week 6 · Class II
|
296 Participants
|
271 Participants
|
|
Change From Baseline in NYHA Functional Class
Week 6 · Class III
|
151 Participants
|
151 Participants
|
|
Change From Baseline in NYHA Functional Class
Week 6 · Class IV
|
13 Participants
|
31 Participants
|
|
Change From Baseline in NYHA Functional Class
Week 6 · Class V
|
18 Participants
|
23 Participants
|
|
Change From Baseline in NYHA Functional Class
Week 12 · Class I
|
39 Participants
|
40 Participants
|
|
Change From Baseline in NYHA Functional Class
Week 12 · Class II
|
296 Participants
|
267 Participants
|
|
Change From Baseline in NYHA Functional Class
Week 12 · Class III
|
107 Participants
|
131 Participants
|
|
Change From Baseline in NYHA Functional Class
Week 12 · Class IV
|
14 Participants
|
18 Participants
|
|
Change From Baseline in NYHA Functional Class
Week 12 · Class V
|
36 Participants
|
32 Participants
|
|
Change From Baseline in NYHA Functional Class
Week 24 · Class I
|
47 Participants
|
47 Participants
|
|
Change From Baseline in NYHA Functional Class
Week 24 · Class II
|
288 Participants
|
265 Participants
|
|
Change From Baseline in NYHA Functional Class
Week 24 · Class III
|
88 Participants
|
100 Participants
|
|
Change From Baseline in NYHA Functional Class
Week 24 · Class IV
|
13 Participants
|
20 Participants
|
|
Change From Baseline in NYHA Functional Class
Week 24 · Class V
|
56 Participants
|
63 Participants
|
|
Change From Baseline in NYHA Functional Class
Week 52 · Class I
|
48 Participants
|
53 Participants
|
|
Change From Baseline in NYHA Functional Class
Week 52 · Class II
|
234 Participants
|
223 Participants
|
|
Change From Baseline in NYHA Functional Class
Week 52 · Class III
|
61 Participants
|
75 Participants
|
|
Change From Baseline in NYHA Functional Class
Week 52 · Class IV
|
7 Participants
|
17 Participants
|
|
Change From Baseline in NYHA Functional Class
Week 52 · Class V
|
99 Participants
|
95 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: at 6, 24 and 52 weeks after randomisationPopulation: Full Analysis Set (FAS): All randomised participants for whom administration of study treatment was started and who had at least one post-baseline visit (including calls), death or hospitalisation or who withdrew from the study after but not on the randomisation date.
EQ-5D-5L: European Quality of Life-5 Dimensions-5 Levels The EQ 5D questionnaire consists of a health descriptive system for participants to self-classify and rate their health status on the day of administration. The descriptive system includes 5 items/dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression, which are coded from 1 (best state) to 5 (worst state).
Outcome measures
| Measure |
FCM (Ferric Carboxymaltose)
n=558 Participants
Ferric carboxymaltose (FCM), administered by bolus intravenous (IV) injection at a dose of 10 ml or 20 ml of undiluted solution (containing 500 mg or 1,000 mg of iron respectively) depending on the participant's body weight and haemoglobin (Hb) level.
From a single dose given at Visit 2 (Week 0) up to 4 doses given over 24 weeks (at Visit 2 (Week 0), Visit 3 (Week 6), Visit 4 (Week 12) and Visit 5 (Week 24), depending on the participant's Hb levels measured prior to planned dosing dates.
|
Placebo (Normal Saline (NaCl 0.9%))
n=550 Participants
Normal saline (NaCl 0.9%), administered by bolus intravenous (IV) injection at a volume corresponding to the FCM dose determined by the participant's body weight and haemoglobin (Hb) level (i.e., 10 ml or 20 ml per administration).
From a single dose given at Visit 2 (Week 0) up to 4 doses given over 24 weeks (at Visit 2 (Week 0), Visit 3 (Week 6), Visit 4 (Week 12) and Visit 5 (Week 24)), depending on the participant's Hb levels measured prior to planned dosing dates.
|
|---|---|---|
|
Change From Baseline in the EQ-5D-5L Questionnaire Indexed Value
Week 6
|
0.05 Change from baseline in EQ-5D-5L
Standard Error 0.01
|
0.03 Change from baseline in EQ-5D-5L
Standard Error 0.01
|
|
Change From Baseline in the EQ-5D-5L Questionnaire Indexed Value
Week 24
|
0.06 Change from baseline in EQ-5D-5L
Standard Error 0.01
|
0.05 Change from baseline in EQ-5D-5L
Standard Error 0.01
|
|
Change From Baseline in the EQ-5D-5L Questionnaire Indexed Value
Week 52
|
0.06 Change from baseline in EQ-5D-5L
Standard Error 0.01
|
0.06 Change from baseline in EQ-5D-5L
Standard Error 0.01
|
OTHER_PRE_SPECIFIED outcome
Timeframe: up to 52 weeks after randomisationPopulation: Full Analysis Set (FAS): All randomised participants for whom administration of study treatment was started and who had at least one post-baseline visit (including calls), death or hospitalisation or who withdrew from the study after but not on the randomisation date.
KCCQ = Kansas City Cardiomyopathy Questionnaire The KCCQ 12 is a health-related quality of life questionnaire for Heart Failure. It is a 12 item questionnaire that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge and Quality of life. Scores are generated for each domain and scaled from 0 to 100, with 0 denoting the lowest reportable health status and 100 the highest reportable health status.
Outcome measures
| Measure |
FCM (Ferric Carboxymaltose)
n=558 Participants
Ferric carboxymaltose (FCM), administered by bolus intravenous (IV) injection at a dose of 10 ml or 20 ml of undiluted solution (containing 500 mg or 1,000 mg of iron respectively) depending on the participant's body weight and haemoglobin (Hb) level.
From a single dose given at Visit 2 (Week 0) up to 4 doses given over 24 weeks (at Visit 2 (Week 0), Visit 3 (Week 6), Visit 4 (Week 12) and Visit 5 (Week 24), depending on the participant's Hb levels measured prior to planned dosing dates.
|
Placebo (Normal Saline (NaCl 0.9%))
n=550 Participants
Normal saline (NaCl 0.9%), administered by bolus intravenous (IV) injection at a volume corresponding to the FCM dose determined by the participant's body weight and haemoglobin (Hb) level (i.e., 10 ml or 20 ml per administration).
From a single dose given at Visit 2 (Week 0) up to 4 doses given over 24 weeks (at Visit 2 (Week 0), Visit 3 (Week 6), Visit 4 (Week 12) and Visit 5 (Week 24)), depending on the participant's Hb levels measured prior to planned dosing dates.
|
|---|---|---|
|
KCCQ-12 Repeated-Measures Model for Analysis of Treatment Difference
Week 6
|
23.49 KCCQ-12 score
Standard Error 1.20
|
19.88 KCCQ-12 score
Standard Error 1.23
|
|
KCCQ-12 Repeated-Measures Model for Analysis of Treatment Difference
Week 12
|
25.57 KCCQ-12 score
Standard Error 1.24
|
21.88 KCCQ-12 score
Standard Error 1.26
|
|
KCCQ-12 Repeated-Measures Model for Analysis of Treatment Difference
Week 2
|
18.53 KCCQ-12 score
Standard Error 1.16
|
17.24 KCCQ-12 score
Standard Error 1.19
|
|
KCCQ-12 Repeated-Measures Model for Analysis of Treatment Difference
Week 4
|
21.26 KCCQ-12 score
Standard Error 1.18
|
18.36 KCCQ-12 score
Standard Error 1.21
|
|
KCCQ-12 Repeated-Measures Model for Analysis of Treatment Difference
Week 24
|
26.30 KCCQ-12 score
Standard Error 1.26
|
23.32 KCCQ-12 score
Standard Error 1.27
|
|
KCCQ-12 Repeated-Measures Model for Analysis of Treatment Difference
Week 36
|
25.78 KCCQ-12 score
Standard Error 1.28
|
23.70 KCCQ-12 score
Standard Error 1.30
|
|
KCCQ-12 Repeated-Measures Model for Analysis of Treatment Difference
Week 52
|
25.75 KCCQ-12 score
Standard Error 1.33
|
24.31 KCCQ-12 score
Standard Error 1.34
|
Adverse Events
Group 1 - FCM (Ferric Carboxymaltose)
Serious events: 250 serious events
Other events: 51 other events
Deaths: 99 deaths
Group 2 - Placebo (Normal Saline (NaCl 0.9%))
Serious events: 282 serious events
Other events: 45 other events
Deaths: 96 deaths
Serious adverse events
| Measure |
Group 1 - FCM (Ferric Carboxymaltose)
n=559 participants at risk
Ferric carboxymaltose (FCM), administered by bolus IV injection at a dose of 10 ml or 20 ml of undiluted solution (containing 500 mg or 1,000 mg of iron respectively) depending on the subject's body weight and Hb level.
From a single dose given at Visit 2 (Week 0) up to 4 doses given over 24 weeks (at Visit 2 (Week 0), Visit 3 (Week 6), Visit 4 (Week 12) and Visit 5 (Week 24)), depending on the subject's Hb levels measured prior to planned dosing dates.
|
Group 2 - Placebo (Normal Saline (NaCl 0.9%))
n=551 participants at risk
Normal saline (NaCl 0.9%), administered by bolus IV injection at a volume corresponding to the FCM dose determined by the subject's body weight and Hb level (i.e., 10 ml or 20 ml per administration).
|
|---|---|---|
|
Cardiac disorders
Cardiac failure
|
20.8%
116/559 • Number of events 163 • During treatment period up to 52 weeks after randomization
|
23.0%
127/551 • Number of events 215 • During treatment period up to 52 weeks after randomization
|
|
Cardiac disorders
Cardiac failure acute
|
3.8%
21/559 • Number of events 25 • During treatment period up to 52 weeks after randomization
|
3.1%
17/551 • Number of events 23 • During treatment period up to 52 weeks after randomization
|
|
Cardiac disorders
Cardiac failure congestive
|
3.6%
20/559 • Number of events 32 • During treatment period up to 52 weeks after randomization
|
4.2%
23/551 • Number of events 35 • During treatment period up to 52 weeks after randomization
|
|
Cardiac disorders
Atrial fibrillation
|
1.8%
10/559 • Number of events 11 • During treatment period up to 52 weeks after randomization
|
0.73%
4/551 • Number of events 4 • During treatment period up to 52 weeks after randomization
|
|
Cardiac disorders
Cardiac arrest
|
1.4%
8/559 • Number of events 8 • During treatment period up to 52 weeks after randomization
|
2.0%
11/551 • Number of events 12 • During treatment period up to 52 weeks after randomization
|
|
Cardiac disorders
Angina unstable
|
0.89%
5/559 • Number of events 5 • During treatment period up to 52 weeks after randomization
|
0.91%
5/551 • Number of events 6 • During treatment period up to 52 weeks after randomization
|
|
Cardiac disorders
Myocardial infarction
|
0.89%
5/559 • Number of events 5 • During treatment period up to 52 weeks after randomization
|
0.18%
1/551 • Number of events 2 • During treatment period up to 52 weeks after randomization
|
|
Cardiac disorders
Ventricular arrhythmia
|
0.89%
5/559 • Number of events 6 • During treatment period up to 52 weeks after randomization
|
0.18%
1/551 • Number of events 1 • During treatment period up to 52 weeks after randomization
|
|
Cardiac disorders
Cardiac failure chronic
|
0.72%
4/559 • Number of events 4 • During treatment period up to 52 weeks after randomization
|
1.3%
7/551 • Number of events 7 • During treatment period up to 52 weeks after randomization
|
|
Cardiac disorders
Ventricular tachycardia
|
0.72%
4/559 • Number of events 6 • During treatment period up to 52 weeks after randomization
|
0.54%
3/551 • Number of events 3 • During treatment period up to 52 weeks after randomization
|
|
Cardiac disorders
Angina pectoris
|
0.54%
3/559 • Number of events 3 • During treatment period up to 52 weeks after randomization
|
0.18%
1/551 • Number of events 1 • During treatment period up to 52 weeks after randomization
|
|
Cardiac disorders
Acute myocardial infarction
|
0.36%
2/559 • Number of events 2 • During treatment period up to 52 weeks after randomization
|
1.5%
8/551 • Number of events 8 • During treatment period up to 52 weeks after randomization
|
|
Cardiac disorders
Bradyarrhythmia
|
0.36%
2/559 • Number of events 2 • During treatment period up to 52 weeks after randomization
|
0.00%
0/551 • During treatment period up to 52 weeks after randomization
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.36%
2/559 • Number of events 2 • During treatment period up to 52 weeks after randomization
|
0.54%
3/551 • Number of events 3 • During treatment period up to 52 weeks after randomization
|
|
Cardiac disorders
Ventricular fibrillation
|
0.36%
2/559 • Number of events 2 • During treatment period up to 52 weeks after randomization
|
0.54%
3/551 • Number of events 3 • During treatment period up to 52 weeks after randomization
|
|
Cardiac disorders
Acute left ventricular failure
|
0.18%
1/559 • Number of events 1 • During treatment period up to 52 weeks after randomization
|
0.18%
1/551 • Number of events 1 • During treatment period up to 52 weeks after randomization
|
|
Cardiac disorders
Atrioventricular block complete
|
0.18%
1/559 • Number of events 1 • During treatment period up to 52 weeks after randomization
|
0.18%
1/551 • Number of events 1 • During treatment period up to 52 weeks after randomization
|
|
Cardiac disorders
Bradycardia
|
0.18%
1/559 • Number of events 1 • During treatment period up to 52 weeks after randomization
|
0.36%
2/551 • Number of events 2 • During treatment period up to 52 weeks after randomization
|
|
Cardiac disorders
Cardiogenic shock
|
0.18%
1/559 • Number of events 1 • During treatment period up to 52 weeks after randomization
|
0.54%
3/551 • Number of events 3 • During treatment period up to 52 weeks after randomization
|
|
Cardiac disorders
Cardiomyopathy
|
0.18%
1/559 • Number of events 1 • During treatment period up to 52 weeks after randomization
|
0.00%
0/551 • During treatment period up to 52 weeks after randomization
|
|
Cardiac disorders
Cardiopulmonary failure
|
0.18%
1/559 • Number of events 1 • During treatment period up to 52 weeks after randomization
|
0.18%
1/551 • Number of events 1 • During treatment period up to 52 weeks after randomization
|
|
Cardiac disorders
Congestive cardiomyopathy
|
0.18%
1/559 • Number of events 1 • During treatment period up to 52 weeks after randomization
|
0.18%
1/551 • Number of events 2 • During treatment period up to 52 weeks after randomization
|
|
Cardiac disorders
Coronary artery disease
|
0.18%
1/559 • Number of events 1 • During treatment period up to 52 weeks after randomization
|
0.18%
1/551 • Number of events 1 • During treatment period up to 52 weeks after randomization
|
|
Cardiac disorders
Left ventricular failure
|
0.18%
1/559 • Number of events 1 • During treatment period up to 52 weeks after randomization
|
0.91%
5/551 • Number of events 6 • During treatment period up to 52 weeks after randomization
|
|
Cardiac disorders
Mitral valve incompetence
|
0.18%
1/559 • Number of events 1 • During treatment period up to 52 weeks after randomization
|
0.00%
0/551 • During treatment period up to 52 weeks after randomization
|
|
Cardiac disorders
Myocardial ischaemia
|
0.18%
1/559 • Number of events 1 • During treatment period up to 52 weeks after randomization
|
0.73%
4/551 • Number of events 4 • During treatment period up to 52 weeks after randomization
|
|
Cardiac disorders
Sinus node dysfunction
|
0.18%
1/559 • Number of events 1 • During treatment period up to 52 weeks after randomization
|
0.00%
0/551 • During treatment period up to 52 weeks after randomization
|
|
Cardiac disorders
Tachyarrhythmia
|
0.18%
1/559 • Number of events 1 • During treatment period up to 52 weeks after randomization
|
0.00%
0/551 • During treatment period up to 52 weeks after randomization
|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/559 • During treatment period up to 52 weeks after randomization
|
0.18%
1/551 • Number of events 1 • During treatment period up to 52 weeks after randomization
|
|
Cardiac disorders
Aortic valve disease mixed
|
0.00%
0/559 • During treatment period up to 52 weeks after randomization
|
0.18%
1/551 • Number of events 1 • During treatment period up to 52 weeks after randomization
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/559 • During treatment period up to 52 weeks after randomization
|
0.54%
3/551 • Number of events 3 • During treatment period up to 52 weeks after randomization
|
|
Cardiac disorders
Atrioventricular block second degree
|
0.00%
0/559 • During treatment period up to 52 weeks after randomization
|
0.18%
1/551 • Number of events 1 • During treatment period up to 52 weeks after randomization
|
|
Cardiac disorders
Cardiac amyloidosis
|
0.00%
0/559 • During treatment period up to 52 weeks after randomization
|
0.18%
1/551 • Number of events 1 • During treatment period up to 52 weeks after randomization
|
|
Cardiac disorders
Cardiorenal syndrome
|
0.00%
0/559 • During treatment period up to 52 weeks after randomization
|
0.18%
1/551 • Number of events 1 • During treatment period up to 52 weeks after randomization
|
|
Cardiac disorders
Coronary artery stenosis
|
0.00%
0/559 • During treatment period up to 52 weeks after randomization
|
0.18%
1/551 • Number of events 1 • During treatment period up to 52 weeks after randomization
|
|
Cardiac disorders
Left ventricular dysfunction
|
0.00%
0/559 • During treatment period up to 52 weeks after randomization
|
0.36%
2/551 • Number of events 2 • During treatment period up to 52 weeks after randomization
|
|
Cardiac disorders
Nodal arrhythmia
|
0.00%
0/559 • During treatment period up to 52 weeks after randomization
|
0.18%
1/551 • Number of events 1 • During treatment period up to 52 weeks after randomization
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/559 • During treatment period up to 52 weeks after randomization
|
0.18%
1/551 • Number of events 1 • During treatment period up to 52 weeks after randomization
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/559 • During treatment period up to 52 weeks after randomization
|
0.18%
1/551 • Number of events 1 • During treatment period up to 52 weeks after randomization
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/559 • During treatment period up to 52 weeks after randomization
|
0.18%
1/551 • Number of events 1 • During treatment period up to 52 weeks after randomization
|
|
Cardiac disorders
Ventricular dyssynchrony
|
0.00%
0/559 • During treatment period up to 52 weeks after randomization
|
0.18%
1/551 • Number of events 1 • During treatment period up to 52 weeks after randomization
|
|
Infections and infestations
Pneumonia
|
2.0%
11/559 • Number of events 11 • During treatment period up to 52 weeks after randomization
|
2.7%
15/551 • Number of events 16 • During treatment period up to 52 weeks after randomization
|
|
Infections and infestations
Sepsis
|
1.3%
7/559 • Number of events 7 • During treatment period up to 52 weeks after randomization
|
1.6%
9/551 • Number of events 9 • During treatment period up to 52 weeks after randomization
|
|
Infections and infestations
Bronchitis
|
0.89%
5/559 • Number of events 5 • During treatment period up to 52 weeks after randomization
|
0.36%
2/551 • Number of events 2 • During treatment period up to 52 weeks after randomization
|
|
Infections and infestations
Cellulitis
|
0.72%
4/559 • Number of events 5 • During treatment period up to 52 weeks after randomization
|
0.54%
3/551 • Number of events 3 • During treatment period up to 52 weeks after randomization
|
|
Infections and infestations
Urinary tract infection
|
0.72%
4/559 • Number of events 4 • During treatment period up to 52 weeks after randomization
|
0.91%
5/551 • Number of events 5 • During treatment period up to 52 weeks after randomization
|
|
Infections and infestations
Septic shock
|
0.54%
3/559 • Number of events 3 • During treatment period up to 52 weeks after randomization
|
0.54%
3/551 • Number of events 3 • During treatment period up to 52 weeks after randomization
|
|
Infections and infestations
Bacteraemia
|
0.36%
2/559 • Number of events 2 • During treatment period up to 52 weeks after randomization
|
0.18%
1/551 • Number of events 1 • During treatment period up to 52 weeks after randomization
|
|
Infections and infestations
Erysipelas
|
0.36%
2/559 • Number of events 2 • During treatment period up to 52 weeks after randomization
|
0.00%
0/551 • During treatment period up to 52 weeks after randomization
|
|
Infections and infestations
Gastroenteritis
|
0.36%
2/559 • Number of events 2 • During treatment period up to 52 weeks after randomization
|
0.18%
1/551 • Number of events 1 • During treatment period up to 52 weeks after randomization
|
|
Infections and infestations
Lower respiratory tract infection
|
0.36%
2/559 • Number of events 2 • During treatment period up to 52 weeks after randomization
|
0.18%
1/551 • Number of events 1 • During treatment period up to 52 weeks after randomization
|
|
Infections and infestations
Pyelonephritis acute
|
0.36%
2/559 • Number of events 2 • During treatment period up to 52 weeks after randomization
|
0.00%
0/551 • During treatment period up to 52 weeks after randomization
|
|
Infections and infestations
Dengue fever
|
0.18%
1/559 • Number of events 1 • During treatment period up to 52 weeks after randomization
|
0.00%
0/551 • During treatment period up to 52 weeks after randomization
|
|
Infections and infestations
Osteomyelitis chronic
|
0.18%
1/559 • Number of events 1 • During treatment period up to 52 weeks after randomization
|
0.00%
0/551 • During treatment period up to 52 weeks after randomization
|
|
Infections and infestations
Skin infection
|
0.18%
1/559 • Number of events 1 • During treatment period up to 52 weeks after randomization
|
0.00%
0/551 • During treatment period up to 52 weeks after randomization
|
|
Infections and infestations
Staphylococcal infection
|
0.18%
1/559 • Number of events 1 • During treatment period up to 52 weeks after randomization
|
0.00%
0/551 • During treatment period up to 52 weeks after randomization
|
|
Infections and infestations
Suspected COVID-19
|
0.18%
1/559 • Number of events 1 • During treatment period up to 52 weeks after randomization
|
0.00%
0/551 • During treatment period up to 52 weeks after randomization
|
|
Infections and infestations
Upper respiratory tract infection
|
0.18%
1/559 • Number of events 1 • During treatment period up to 52 weeks after randomization
|
0.18%
1/551 • Number of events 1 • During treatment period up to 52 weeks after randomization
|
|
Infections and infestations
Urosepsis
|
0.18%
1/559 • Number of events 1 • During treatment period up to 52 weeks after randomization
|
0.18%
1/551 • Number of events 1 • During treatment period up to 52 weeks after randomization
|
|
Infections and infestations
Abdominal abscess
|
0.00%
0/559 • During treatment period up to 52 weeks after randomization
|
0.18%
1/551 • Number of events 1 • During treatment period up to 52 weeks after randomization
|
|
Infections and infestations
Arthritis bacterial
|
0.00%
0/559 • During treatment period up to 52 weeks after randomization
|
0.18%
1/551 • Number of events 1 • During treatment period up to 52 weeks after randomization
|
|
Infections and infestations
Carbuncle
|
0.00%
0/559 • During treatment period up to 52 weeks after randomization
|
0.18%
1/551 • Number of events 1 • During treatment period up to 52 weeks after randomization
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/559 • During treatment period up to 52 weeks after randomization
|
0.18%
1/551 • Number of events 1 • During treatment period up to 52 weeks after randomization
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/559 • During treatment period up to 52 weeks after randomization
|
0.18%
1/551 • Number of events 1 • During treatment period up to 52 weeks after randomization
|
|
Infections and infestations
Enterococcal bacteraemia
|
0.00%
0/559 • During treatment period up to 52 weeks after randomization
|
0.18%
1/551 • Number of events 1 • During treatment period up to 52 weeks after randomization
|
|
Infections and infestations
Gangrene
|
0.00%
0/559 • During treatment period up to 52 weeks after randomization
|
0.18%
1/551 • Number of events 1 • During treatment period up to 52 weeks after randomization
|
|
Infections and infestations
Infected skin ulcer
|
0.00%
0/559 • During treatment period up to 52 weeks after randomization
|
0.18%
1/551 • Number of events 1 • During treatment period up to 52 weeks after randomization
|
|
Infections and infestations
Influenza
|
0.00%
0/559 • During treatment period up to 52 weeks after randomization
|
0.18%
1/551 • Number of events 1 • During treatment period up to 52 weeks after randomization
|
|
Infections and infestations
Intervertebral discitis
|
0.00%
0/559 • During treatment period up to 52 weeks after randomization
|
0.18%
1/551 • Number of events 1 • During treatment period up to 52 weeks after randomization
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/559 • During treatment period up to 52 weeks after randomization
|
0.18%
1/551 • Number of events 1 • During treatment period up to 52 weeks after randomization
|
|
Infections and infestations
Pneumonia klebsiella
|
0.00%
0/559 • During treatment period up to 52 weeks after randomization
|
0.36%
2/551 • Number of events 2 • During treatment period up to 52 weeks after randomization
|
|
Infections and infestations
Postoperative wound infection
|
0.00%
0/559 • During treatment period up to 52 weeks after randomization
|
0.18%
1/551 • Number of events 1 • During treatment period up to 52 weeks after randomization
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/559 • During treatment period up to 52 weeks after randomization
|
0.36%
2/551 • Number of events 2 • During treatment period up to 52 weeks after randomization
|
|
Infections and infestations
Shewanella algae bacteraemia
|
0.00%
0/559 • During treatment period up to 52 weeks after randomization
|
0.18%
1/551 • Number of events 1 • During treatment period up to 52 weeks after randomization
|
|
Infections and infestations
Tracheobronchitis
|
0.00%
0/559 • During treatment period up to 52 weeks after randomization
|
0.18%
1/551 • Number of events 1 • During treatment period up to 52 weeks after randomization
|
|
Infections and infestations
Viral infection
|
0.00%
0/559 • During treatment period up to 52 weeks after randomization
|
0.36%
2/551 • Number of events 3 • During treatment period up to 52 weeks after randomization
|
|
Infections and infestations
Wound infection
|
0.00%
0/559 • During treatment period up to 52 weeks after randomization
|
0.18%
1/551 • Number of events 1 • During treatment period up to 52 weeks after randomization
|
|
General disorders
Death
|
1.4%
8/559 • Number of events 8 • During treatment period up to 52 weeks after randomization
|
2.4%
13/551 • Number of events 13 • During treatment period up to 52 weeks after randomization
|
|
General disorders
Sudden cardiac death
|
0.89%
5/559 • Number of events 5 • During treatment period up to 52 weeks after randomization
|
0.91%
5/551 • Number of events 5 • During treatment period up to 52 weeks after randomization
|
|
General disorders
Sudden death
|
0.89%
5/559 • Number of events 5 • During treatment period up to 52 weeks after randomization
|
1.3%
7/551 • Number of events 7 • During treatment period up to 52 weeks after randomization
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.54%
3/559 • Number of events 4 • During treatment period up to 52 weeks after randomization
|
0.36%
2/551 • Number of events 2 • During treatment period up to 52 weeks after randomization
|
|
General disorders
Chest pain
|
0.36%
2/559 • Number of events 2 • During treatment period up to 52 weeks after randomization
|
0.00%
0/551 • During treatment period up to 52 weeks after randomization
|
|
General disorders
Oedema peripheral
|
0.36%
2/559 • Number of events 2 • During treatment period up to 52 weeks after randomization
|
0.36%
2/551 • Number of events 2 • During treatment period up to 52 weeks after randomization
|
|
General disorders
Pyrexia
|
0.36%
2/559 • Number of events 2 • During treatment period up to 52 weeks after randomization
|
0.00%
0/551 • During treatment period up to 52 weeks after randomization
|
|
General disorders
Chest discomfort
|
0.18%
1/559 • Number of events 1 • During treatment period up to 52 weeks after randomization
|
0.18%
1/551 • Number of events 1 • During treatment period up to 52 weeks after randomization
|
|
General disorders
Malaise
|
0.18%
1/559 • Number of events 1 • During treatment period up to 52 weeks after randomization
|
0.18%
1/551 • Number of events 1 • During treatment period up to 52 weeks after randomization
|
|
General disorders
Non-cardiac chest pain
|
0.18%
1/559 • Number of events 3 • During treatment period up to 52 weeks after randomization
|
0.73%
4/551 • Number of events 6 • During treatment period up to 52 weeks after randomization
|
|
General disorders
Asthenia
|
0.00%
0/559 • During treatment period up to 52 weeks after randomization
|
0.18%
1/551 • Number of events 1 • During treatment period up to 52 weeks after randomization
|
|
General disorders
Generalised oedema
|
0.00%
0/559 • During treatment period up to 52 weeks after randomization
|
0.18%
1/551 • Number of events 1 • During treatment period up to 52 weeks after randomization
|
|
General disorders
Influenza like illness
|
0.00%
0/559 • During treatment period up to 52 weeks after randomization
|
0.18%
1/551 • Number of events 1 • During treatment period up to 52 weeks after randomization
|
|
Nervous system disorders
Cerebrovascular accident
|
1.3%
7/559 • Number of events 7 • During treatment period up to 52 weeks after randomization
|
0.54%
3/551 • Number of events 3 • During treatment period up to 52 weeks after randomization
|
|
Nervous system disorders
Epilepsy
|
0.54%
3/559 • Number of events 4 • During treatment period up to 52 weeks after randomization
|
0.00%
0/551 • During treatment period up to 52 weeks after randomization
|
|
Nervous system disorders
Syncope
|
0.54%
3/559 • Number of events 3 • During treatment period up to 52 weeks after randomization
|
0.73%
4/551 • Number of events 4 • During treatment period up to 52 weeks after randomization
|
|
Nervous system disorders
Cerebrovascular disorder
|
0.36%
2/559 • Number of events 2 • During treatment period up to 52 weeks after randomization
|
0.00%
0/551 • During treatment period up to 52 weeks after randomization
|
|
Nervous system disorders
Altered state of consciousness
|
0.18%
1/559 • Number of events 1 • During treatment period up to 52 weeks after randomization
|
0.00%
0/551 • During treatment period up to 52 weeks after randomization
|
|
Nervous system disorders
Carotid artery stenosis
|
0.18%
1/559 • Number of events 1 • During treatment period up to 52 weeks after randomization
|
0.00%
0/551 • During treatment period up to 52 weeks after randomization
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.18%
1/559 • Number of events 1 • During treatment period up to 52 weeks after randomization
|
0.00%
0/551 • During treatment period up to 52 weeks after randomization
|
|
Nervous system disorders
Cerebral ischaemia
|
0.18%
1/559 • Number of events 1 • During treatment period up to 52 weeks after randomization
|
0.18%
1/551 • Number of events 1 • During treatment period up to 52 weeks after randomization
|
|
Nervous system disorders
Cerebrovascular insufficiency
|
0.18%
1/559 • Number of events 1 • During treatment period up to 52 weeks after randomization
|
0.00%
0/551 • During treatment period up to 52 weeks after randomization
|
|
Nervous system disorders
Haemorrhagic stroke
|
0.18%
1/559 • Number of events 1 • During treatment period up to 52 weeks after randomization
|
0.18%
1/551 • Number of events 1 • During treatment period up to 52 weeks after randomization
|
|
Nervous system disorders
Headache
|
0.18%
1/559 • Number of events 1 • During treatment period up to 52 weeks after randomization
|
0.00%
0/551 • During treatment period up to 52 weeks after randomization
|
|
Nervous system disorders
Ischaemic stroke
|
0.18%
1/559 • Number of events 1 • During treatment period up to 52 weeks after randomization
|
0.73%
4/551 • Number of events 4 • During treatment period up to 52 weeks after randomization
|
|
Nervous system disorders
Presyncope
|
0.18%
1/559 • Number of events 1 • During treatment period up to 52 weeks after randomization
|
0.00%
0/551 • During treatment period up to 52 weeks after randomization
|
|
Nervous system disorders
Coma
|
0.00%
0/559 • During treatment period up to 52 weeks after randomization
|
0.18%
1/551 • Number of events 1 • During treatment period up to 52 weeks after randomization
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.00%
0/559 • During treatment period up to 52 weeks after randomization
|
0.18%
1/551 • Number of events 1 • During treatment period up to 52 weeks after randomization
|
|
Nervous system disorders
Thrombotic cerebral infarction
|
0.00%
0/559 • During treatment period up to 52 weeks after randomization
|
0.18%
1/551 • Number of events 1 • During treatment period up to 52 weeks after randomization
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/559 • During treatment period up to 52 weeks after randomization
|
0.18%
1/551 • Number of events 1 • During treatment period up to 52 weeks after randomization
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.72%
4/559 • Number of events 5 • During treatment period up to 52 weeks after randomization
|
1.1%
6/551 • Number of events 6 • During treatment period up to 52 weeks after randomization
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.72%
4/559 • Number of events 4 • During treatment period up to 52 weeks after randomization
|
0.91%
5/551 • Number of events 5 • During treatment period up to 52 weeks after randomization
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.54%
3/559 • Number of events 3 • During treatment period up to 52 weeks after randomization
|
0.36%
2/551 • Number of events 2 • During treatment period up to 52 weeks after randomization
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.36%
2/559 • Number of events 3 • During treatment period up to 52 weeks after randomization
|
0.54%
3/551 • Number of events 4 • During treatment period up to 52 weeks after randomization
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.36%
2/559 • Number of events 2 • During treatment period up to 52 weeks after randomization
|
0.18%
1/551 • Number of events 1 • During treatment period up to 52 weeks after randomization
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.18%
1/559 • Number of events 1 • During treatment period up to 52 weeks after randomization
|
0.54%
3/551 • Number of events 3 • During treatment period up to 52 weeks after randomization
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.18%
1/559 • Number of events 1 • During treatment period up to 52 weeks after randomization
|
0.00%
0/551 • During treatment period up to 52 weeks after randomization
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea at rest
|
0.18%
1/559 • Number of events 1 • During treatment period up to 52 weeks after randomization
|
0.00%
0/551 • During treatment period up to 52 weeks after randomization
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.18%
1/559 • Number of events 1 • During treatment period up to 52 weeks after randomization
|
0.00%
0/551 • During treatment period up to 52 weeks after randomization
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.18%
1/559 • Number of events 1 • During treatment period up to 52 weeks after randomization
|
0.00%
0/551 • During treatment period up to 52 weeks after randomization
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary congestion
|
0.18%
1/559 • Number of events 1 • During treatment period up to 52 weeks after randomization
|
1.5%
8/551 • Number of events 8 • During treatment period up to 52 weeks after randomization
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.18%
1/559 • Number of events 1 • During treatment period up to 52 weeks after randomization
|
0.18%
1/551 • Number of events 1 • During treatment period up to 52 weeks after randomization
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.18%
1/559 • Number of events 1 • During treatment period up to 52 weeks after randomization
|
0.00%
0/551 • During treatment period up to 52 weeks after randomization
|
|
Respiratory, thoracic and mediastinal disorders
Apnoea
|
0.00%
0/559 • During treatment period up to 52 weeks after randomization
|
0.18%
1/551 • Number of events 1 • During treatment period up to 52 weeks after randomization
|
|
Respiratory, thoracic and mediastinal disorders
Choking
|
0.00%
0/559 • During treatment period up to 52 weeks after randomization
|
0.18%
1/551 • Number of events 1 • During treatment period up to 52 weeks after randomization
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/559 • During treatment period up to 52 weeks after randomization
|
0.18%
1/551 • Number of events 1 • During treatment period up to 52 weeks after randomization
|
|
Respiratory, thoracic and mediastinal disorders
Hydrothorax
|
0.00%
0/559 • During treatment period up to 52 weeks after randomization
|
0.18%
1/551 • Number of events 1 • During treatment period up to 52 weeks after randomization
|
|
Respiratory, thoracic and mediastinal disorders
Orthopnoea
|
0.00%
0/559 • During treatment period up to 52 weeks after randomization
|
0.18%
1/551 • Number of events 1 • During treatment period up to 52 weeks after randomization
|
|
Renal and urinary disorders
Acute kidney injury
|
1.4%
8/559 • Number of events 8 • During treatment period up to 52 weeks after randomization
|
1.1%
6/551 • Number of events 6 • During treatment period up to 52 weeks after randomization
|
|
Renal and urinary disorders
Renal failure
|
0.89%
5/559 • Number of events 5 • During treatment period up to 52 weeks after randomization
|
0.91%
5/551 • Number of events 5 • During treatment period up to 52 weeks after randomization
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.36%
2/559 • Number of events 2 • During treatment period up to 52 weeks after randomization
|
0.36%
2/551 • Number of events 2 • During treatment period up to 52 weeks after randomization
|
|
Renal and urinary disorders
Renal impairment
|
0.36%
2/559 • Number of events 2 • During treatment period up to 52 weeks after randomization
|
0.00%
0/551 • During treatment period up to 52 weeks after randomization
|
|
Renal and urinary disorders
End stage renal disease
|
0.18%
1/559 • Number of events 1 • During treatment period up to 52 weeks after randomization
|
0.00%
0/551 • During treatment period up to 52 weeks after randomization
|
|
Renal and urinary disorders
Haematuria
|
0.18%
1/559 • Number of events 1 • During treatment period up to 52 weeks after randomization
|
0.00%
0/551 • During treatment period up to 52 weeks after randomization
|
|
Renal and urinary disorders
Diabetic nephropathy
|
0.00%
0/559 • During treatment period up to 52 weeks after randomization
|
0.18%
1/551 • Number of events 1 • During treatment period up to 52 weeks after randomization
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/559 • During treatment period up to 52 weeks after randomization
|
0.18%
1/551 • Number of events 1 • During treatment period up to 52 weeks after randomization
|
|
Renal and urinary disorders
Urinary tract inflammation
|
0.00%
0/559 • During treatment period up to 52 weeks after randomization
|
0.18%
1/551 • Number of events 1 • During treatment period up to 52 weeks after randomization
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.36%
2/559 • Number of events 2 • During treatment period up to 52 weeks after randomization
|
0.00%
0/551 • During treatment period up to 52 weeks after randomization
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.36%
2/559 • Number of events 2 • During treatment period up to 52 weeks after randomization
|
0.18%
1/551 • Number of events 1 • During treatment period up to 52 weeks after randomization
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.36%
2/559 • Number of events 2 • During treatment period up to 52 weeks after randomization
|
0.00%
0/551 • During treatment period up to 52 weeks after randomization
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.36%
2/559 • Number of events 2 • During treatment period up to 52 weeks after randomization
|
0.18%
1/551 • Number of events 1 • During treatment period up to 52 weeks after randomization
|
|
Injury, poisoning and procedural complications
Alcohol poisoning
|
0.18%
1/559 • Number of events 1 • During treatment period up to 52 weeks after randomization
|
0.00%
0/551 • During treatment period up to 52 weeks after randomization
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.18%
1/559 • Number of events 1 • During treatment period up to 52 weeks after randomization
|
0.00%
0/551 • During treatment period up to 52 weeks after randomization
|
|
Injury, poisoning and procedural complications
Fall
|
0.18%
1/559 • Number of events 1 • During treatment period up to 52 weeks after randomization
|
0.18%
1/551 • Number of events 1 • During treatment period up to 52 weeks after randomization
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.18%
1/559 • Number of events 1 • During treatment period up to 52 weeks after randomization
|
0.18%
1/551 • Number of events 1 • During treatment period up to 52 weeks after randomization
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.18%
1/559 • Number of events 2 • During treatment period up to 52 weeks after randomization
|
0.00%
0/551 • During treatment period up to 52 weeks after randomization
|
|
Injury, poisoning and procedural complications
Multiple fractures
|
0.18%
1/559 • Number of events 1 • During treatment period up to 52 weeks after randomization
|
0.00%
0/551 • During treatment period up to 52 weeks after randomization
|
|
Injury, poisoning and procedural complications
Pharyngeal injury
|
0.18%
1/559 • Number of events 1 • During treatment period up to 52 weeks after randomization
|
0.00%
0/551 • During treatment period up to 52 weeks after randomization
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.18%
1/559 • Number of events 1 • During treatment period up to 52 weeks after randomization
|
0.00%
0/551 • During treatment period up to 52 weeks after randomization
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.18%
1/559 • Number of events 1 • During treatment period up to 52 weeks after randomization
|
0.00%
0/551 • During treatment period up to 52 weeks after randomization
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.18%
1/559 • Number of events 1 • During treatment period up to 52 weeks after randomization
|
0.00%
0/551 • During treatment period up to 52 weeks after randomization
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
|
0.18%
1/559 • Number of events 1 • During treatment period up to 52 weeks after randomization
|
0.00%
0/551 • During treatment period up to 52 weeks after randomization
|
|
Injury, poisoning and procedural complications
Postoperative thoracic procedure complication
|
0.00%
0/559 • During treatment period up to 52 weeks after randomization
|
0.18%
1/551 • Number of events 1 • During treatment period up to 52 weeks after randomization
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/559 • During treatment period up to 52 weeks after randomization
|
0.18%
1/551 • Number of events 1 • During treatment period up to 52 weeks after randomization
|
|
Injury, poisoning and procedural complications
Traumatic haemothorax
|
0.00%
0/559 • During treatment period up to 52 weeks after randomization
|
0.18%
1/551 • Number of events 1 • During treatment period up to 52 weeks after randomization
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.54%
3/559 • Number of events 3 • During treatment period up to 52 weeks after randomization
|
0.54%
3/551 • Number of events 3 • During treatment period up to 52 weeks after randomization
|
|
Vascular disorders
Peripheral vascular disorder
|
0.36%
2/559 • Number of events 2 • During treatment period up to 52 weeks after randomization
|
0.18%
1/551 • Number of events 1 • During treatment period up to 52 weeks after randomization
|
|
Vascular disorders
Aortic dissection
|
0.18%
1/559 • Number of events 1 • During treatment period up to 52 weeks after randomization
|
0.00%
0/551 • During treatment period up to 52 weeks after randomization
|
|
Vascular disorders
Circulatory collapse
|
0.18%
1/559 • Number of events 1 • During treatment period up to 52 weeks after randomization
|
0.00%
0/551 • During treatment period up to 52 weeks after randomization
|
|
Vascular disorders
Diabetic vascular disorder
|
0.18%
1/559 • Number of events 1 • During treatment period up to 52 weeks after randomization
|
0.00%
0/551 • During treatment period up to 52 weeks after randomization
|
|
Vascular disorders
Hypertension
|
0.18%
1/559 • Number of events 1 • During treatment period up to 52 weeks after randomization
|
0.00%
0/551 • During treatment period up to 52 weeks after randomization
|
|
Vascular disorders
Hypertensive crisis
|
0.18%
1/559 • Number of events 1 • During treatment period up to 52 weeks after randomization
|
0.00%
0/551 • During treatment period up to 52 weeks after randomization
|
|
Vascular disorders
Hypotension
|
0.18%
1/559 • Number of events 1 • During treatment period up to 52 weeks after randomization
|
0.00%
0/551 • During treatment period up to 52 weeks after randomization
|
|
Vascular disorders
Peripheral artery occlusion
|
0.18%
1/559 • Number of events 1 • During treatment period up to 52 weeks after randomization
|
0.36%
2/551 • Number of events 2 • During treatment period up to 52 weeks after randomization
|
|
Vascular disorders
Peripheral artery thrombosis
|
0.18%
1/559 • Number of events 1 • During treatment period up to 52 weeks after randomization
|
0.18%
1/551 • Number of events 1 • During treatment period up to 52 weeks after randomization
|
|
Vascular disorders
Peripheral ischaemia
|
0.18%
1/559 • Number of events 1 • During treatment period up to 52 weeks after randomization
|
0.18%
1/551 • Number of events 1 • During treatment period up to 52 weeks after randomization
|
|
Vascular disorders
Shock
|
0.18%
1/559 • Number of events 1 • During treatment period up to 52 weeks after randomization
|
0.00%
0/551 • During treatment period up to 52 weeks after randomization
|
|
Vascular disorders
Varicose ulceration
|
0.18%
1/559 • Number of events 1 • During treatment period up to 52 weeks after randomization
|
0.00%
0/551 • During treatment period up to 52 weeks after randomization
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/559 • During treatment period up to 52 weeks after randomization
|
0.36%
2/551 • Number of events 2 • During treatment period up to 52 weeks after randomization
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.36%
2/559 • Number of events 2 • During treatment period up to 52 weeks after randomization
|
0.18%
1/551 • Number of events 1 • During treatment period up to 52 weeks after randomization
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.36%
2/559 • Number of events 2 • During treatment period up to 52 weeks after randomization
|
0.00%
0/551 • During treatment period up to 52 weeks after randomization
|
|
Gastrointestinal disorders
Diarrhoea
|
0.18%
1/559 • Number of events 1 • During treatment period up to 52 weeks after randomization
|
0.00%
0/551 • During treatment period up to 52 weeks after randomization
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.18%
1/559 • Number of events 2 • During treatment period up to 52 weeks after randomization
|
0.18%
1/551 • Number of events 1 • During treatment period up to 52 weeks after randomization
|
|
Gastrointestinal disorders
Gastritis
|
0.18%
1/559 • Number of events 1 • During treatment period up to 52 weeks after randomization
|
0.00%
0/551 • During treatment period up to 52 weeks after randomization
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.18%
1/559 • Number of events 1 • During treatment period up to 52 weeks after randomization
|
0.00%
0/551 • During treatment period up to 52 weeks after randomization
|
|
Gastrointestinal disorders
Ileus
|
0.18%
1/559 • Number of events 3 • During treatment period up to 52 weeks after randomization
|
0.00%
0/551 • During treatment period up to 52 weeks after randomization
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.18%
1/559 • Number of events 1 • During treatment period up to 52 weeks after randomization
|
0.18%
1/551 • Number of events 1 • During treatment period up to 52 weeks after randomization
|
|
Gastrointestinal disorders
Large intestinal ulcer
|
0.18%
1/559 • Number of events 1 • During treatment period up to 52 weeks after randomization
|
0.00%
0/551 • During treatment period up to 52 weeks after randomization
|
|
Gastrointestinal disorders
Presbyoesophagus
|
0.18%
1/559 • Number of events 1 • During treatment period up to 52 weeks after randomization
|
0.00%
0/551 • During treatment period up to 52 weeks after randomization
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.18%
1/559 • Number of events 1 • During treatment period up to 52 weeks after randomization
|
0.18%
1/551 • Number of events 1 • During treatment period up to 52 weeks after randomization
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/559 • During treatment period up to 52 weeks after randomization
|
0.54%
3/551 • Number of events 3 • During treatment period up to 52 weeks after randomization
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/559 • During treatment period up to 52 weeks after randomization
|
0.18%
1/551 • Number of events 3 • During treatment period up to 52 weeks after randomization
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/559 • During treatment period up to 52 weeks after randomization
|
0.18%
1/551 • Number of events 1 • During treatment period up to 52 weeks after randomization
|
|
Gastrointestinal disorders
Gastric disorder
|
0.00%
0/559 • During treatment period up to 52 weeks after randomization
|
0.18%
1/551 • Number of events 1 • During treatment period up to 52 weeks after randomization
|
|
Gastrointestinal disorders
Gastric perforation
|
0.00%
0/559 • During treatment period up to 52 weeks after randomization
|
0.18%
1/551 • Number of events 1 • During treatment period up to 52 weeks after randomization
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
0.00%
0/559 • During treatment period up to 52 weeks after randomization
|
0.18%
1/551 • Number of events 1 • During treatment period up to 52 weeks after randomization
|
|
Gastrointestinal disorders
Gastrointestinal perforation
|
0.00%
0/559 • During treatment period up to 52 weeks after randomization
|
0.18%
1/551 • Number of events 1 • During treatment period up to 52 weeks after randomization
|
|
Gastrointestinal disorders
Intestinal infarction
|
0.00%
0/559 • During treatment period up to 52 weeks after randomization
|
0.18%
1/551 • Number of events 1 • During treatment period up to 52 weeks after randomization
|
|
Gastrointestinal disorders
Intestinal ischaemia
|
0.00%
0/559 • During treatment period up to 52 weeks after randomization
|
0.18%
1/551 • Number of events 1 • During treatment period up to 52 weeks after randomization
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/559 • During treatment period up to 52 weeks after randomization
|
0.18%
1/551 • Number of events 1 • During treatment period up to 52 weeks after randomization
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/559 • During treatment period up to 52 weeks after randomization
|
0.18%
1/551 • Number of events 1 • During treatment period up to 52 weeks after randomization
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/559 • During treatment period up to 52 weeks after randomization
|
0.18%
1/551 • Number of events 1 • During treatment period up to 52 weeks after randomization
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.00%
0/559 • During treatment period up to 52 weeks after randomization
|
0.18%
1/551 • Number of events 1 • During treatment period up to 52 weeks after randomization
|
|
Metabolism and nutrition disorders
Gout
|
0.54%
3/559 • Number of events 7 • During treatment period up to 52 weeks after randomization
|
0.00%
0/551 • During treatment period up to 52 weeks after randomization
|
|
Metabolism and nutrition disorders
Dehydration
|
0.36%
2/559 • Number of events 2 • During treatment period up to 52 weeks after randomization
|
0.36%
2/551 • Number of events 2 • During treatment period up to 52 weeks after randomization
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.36%
2/559 • Number of events 2 • During treatment period up to 52 weeks after randomization
|
0.18%
1/551 • Number of events 1 • During treatment period up to 52 weeks after randomization
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.18%
1/559 • Number of events 1 • During treatment period up to 52 weeks after randomization
|
0.00%
0/551 • During treatment period up to 52 weeks after randomization
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.18%
1/559 • Number of events 1 • During treatment period up to 52 weeks after randomization
|
0.36%
2/551 • Number of events 3 • During treatment period up to 52 weeks after randomization
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.18%
1/559 • Number of events 1 • During treatment period up to 52 weeks after randomization
|
0.18%
1/551 • Number of events 1 • During treatment period up to 52 weeks after randomization
|
|
Metabolism and nutrition disorders
Hyperglycaemic hyperosmolar nonketotic syndrome
|
0.18%
1/559 • Number of events 1 • During treatment period up to 52 weeks after randomization
|
0.00%
0/551 • During treatment period up to 52 weeks after randomization
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.18%
1/559 • Number of events 1 • During treatment period up to 52 weeks after randomization
|
0.36%
2/551 • Number of events 2 • During treatment period up to 52 weeks after randomization
|
|
Metabolism and nutrition disorders
Cachexia
|
0.00%
0/559 • During treatment period up to 52 weeks after randomization
|
0.36%
2/551 • Number of events 2 • During treatment period up to 52 weeks after randomization
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/559 • During treatment period up to 52 weeks after randomization
|
0.18%
1/551 • Number of events 1 • During treatment period up to 52 weeks after randomization
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
0.00%
0/559 • During treatment period up to 52 weeks after randomization
|
0.18%
1/551 • Number of events 1 • During treatment period up to 52 weeks after randomization
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/559 • During treatment period up to 52 weeks after randomization
|
0.36%
2/551 • Number of events 2 • During treatment period up to 52 weeks after randomization
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/559 • During treatment period up to 52 weeks after randomization
|
0.18%
1/551 • Number of events 1 • During treatment period up to 52 weeks after randomization
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
|
0.54%
3/559 • Number of events 3 • During treatment period up to 52 weeks after randomization
|
0.00%
0/551 • During treatment period up to 52 weeks after randomization
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.18%
1/559 • Number of events 1 • During treatment period up to 52 weeks after randomization
|
0.00%
0/551 • During treatment period up to 52 weeks after randomization
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.18%
1/559 • Number of events 2 • During treatment period up to 52 weeks after randomization
|
0.18%
1/551 • Number of events 1 • During treatment period up to 52 weeks after randomization
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic neoplasm
|
0.18%
1/559 • Number of events 1 • During treatment period up to 52 weeks after randomization
|
0.00%
0/551 • During treatment period up to 52 weeks after randomization
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.18%
1/559 • Number of events 1 • During treatment period up to 52 weeks after randomization
|
0.18%
1/551 • Number of events 1 • During treatment period up to 52 weeks after randomization
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
0.18%
1/559 • Number of events 1 • During treatment period up to 52 weeks after randomization
|
0.00%
0/551 • During treatment period up to 52 weeks after randomization
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.18%
1/559 • Number of events 1 • During treatment period up to 52 weeks after randomization
|
0.00%
0/551 • During treatment period up to 52 weeks after randomization
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to liver
|
0.18%
1/559 • Number of events 1 • During treatment period up to 52 weeks after randomization
|
0.18%
1/551 • Number of events 1 • During treatment period up to 52 weeks after randomization
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.18%
1/559 • Number of events 1 • During treatment period up to 52 weeks after randomization
|
0.18%
1/551 • Number of events 1 • During treatment period up to 52 weeks after randomization
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bronchial carcinoma
|
0.00%
0/559 • During treatment period up to 52 weeks after randomization
|
0.18%
1/551 • Number of events 1 • During treatment period up to 52 weeks after randomization
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.00%
0/559 • During treatment period up to 52 weeks after randomization
|
0.18%
1/551 • Number of events 2 • During treatment period up to 52 weeks after randomization
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma metastatic
|
0.00%
0/559 • During treatment period up to 52 weeks after randomization
|
0.18%
1/551 • Number of events 1 • During treatment period up to 52 weeks after randomization
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasma cell myeloma
|
0.00%
0/559 • During treatment period up to 52 weeks after randomization
|
0.18%
1/551 • Number of events 1 • During treatment period up to 52 weeks after randomization
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.18%
1/559 • Number of events 1 • During treatment period up to 52 weeks after randomization
|
0.00%
0/551 • During treatment period up to 52 weeks after randomization
|
|
Musculoskeletal and connective tissue disorders
Fracture nonunion
|
0.18%
1/559 • Number of events 1 • During treatment period up to 52 weeks after randomization
|
0.00%
0/551 • During treatment period up to 52 weeks after randomization
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
0.18%
1/559 • Number of events 1 • During treatment period up to 52 weeks after randomization
|
0.00%
0/551 • During treatment period up to 52 weeks after randomization
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.18%
1/559 • Number of events 1 • During treatment period up to 52 weeks after randomization
|
0.00%
0/551 • During treatment period up to 52 weeks after randomization
|
|
Musculoskeletal and connective tissue disorders
Periarthritis
|
0.18%
1/559 • Number of events 1 • During treatment period up to 52 weeks after randomization
|
0.00%
0/551 • During treatment period up to 52 weeks after randomization
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/559 • During treatment period up to 52 weeks after randomization
|
0.18%
1/551 • Number of events 1 • During treatment period up to 52 weeks after randomization
|
|
Musculoskeletal and connective tissue disorders
Gouty arthritis
|
0.00%
0/559 • During treatment period up to 52 weeks after randomization
|
0.18%
1/551 • Number of events 1 • During treatment period up to 52 weeks after randomization
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/559 • During treatment period up to 52 weeks after randomization
|
0.18%
1/551 • Number of events 1 • During treatment period up to 52 weeks after randomization
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/559 • During treatment period up to 52 weeks after randomization
|
0.18%
1/551 • Number of events 1 • During treatment period up to 52 weeks after randomization
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/559 • During treatment period up to 52 weeks after randomization
|
0.18%
1/551 • Number of events 1 • During treatment period up to 52 weeks after randomization
|
|
Musculoskeletal and connective tissue disorders
Sarcopenia
|
0.00%
0/559 • During treatment period up to 52 weeks after randomization
|
0.18%
1/551 • Number of events 1 • During treatment period up to 52 weeks after randomization
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
0.00%
0/559 • During treatment period up to 52 weeks after randomization
|
0.18%
1/551 • Number of events 1 • During treatment period up to 52 weeks after randomization
|
|
Blood and lymphatic system disorders
Anaemia
|
0.72%
4/559 • Number of events 5 • During treatment period up to 52 weeks after randomization
|
0.73%
4/551 • Number of events 4 • During treatment period up to 52 weeks after randomization
|
|
Blood and lymphatic system disorders
Lymphadenopathy mediastinal
|
0.00%
0/559 • During treatment period up to 52 weeks after randomization
|
0.18%
1/551 • Number of events 2 • During treatment period up to 52 weeks after randomization
|
|
Blood and lymphatic system disorders
Microcytic anaemia
|
0.00%
0/559 • During treatment period up to 52 weeks after randomization
|
0.18%
1/551 • Number of events 1 • During treatment period up to 52 weeks after randomization
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/559 • During treatment period up to 52 weeks after randomization
|
0.18%
1/551 • Number of events 1 • During treatment period up to 52 weeks after randomization
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.18%
1/559 • Number of events 1 • During treatment period up to 52 weeks after randomization
|
0.18%
1/551 • Number of events 1 • During treatment period up to 52 weeks after randomization
|
|
Hepatobiliary disorders
Hepatic failure
|
0.18%
1/559 • Number of events 1 • During treatment period up to 52 weeks after randomization
|
0.00%
0/551 • During treatment period up to 52 weeks after randomization
|
|
Hepatobiliary disorders
Jaundice cholestatic
|
0.18%
1/559 • Number of events 1 • During treatment period up to 52 weeks after randomization
|
0.00%
0/551 • During treatment period up to 52 weeks after randomization
|
|
Hepatobiliary disorders
Bile duct stone
|
0.00%
0/559 • During treatment period up to 52 weeks after randomization
|
0.18%
1/551 • Number of events 1 • During treatment period up to 52 weeks after randomization
|
|
Hepatobiliary disorders
Cholangitis
|
0.00%
0/559 • During treatment period up to 52 weeks after randomization
|
0.18%
1/551 • Number of events 1 • During treatment period up to 52 weeks after randomization
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.00%
0/559 • During treatment period up to 52 weeks after randomization
|
0.18%
1/551 • Number of events 1 • During treatment period up to 52 weeks after randomization
|
|
Hepatobiliary disorders
Hepatic steatosis
|
0.00%
0/559 • During treatment period up to 52 weeks after randomization
|
0.18%
1/551 • Number of events 1 • During treatment period up to 52 weeks after randomization
|
|
Hepatobiliary disorders
Jaundice
|
0.00%
0/559 • During treatment period up to 52 weeks after randomization
|
0.36%
2/551 • Number of events 2 • During treatment period up to 52 weeks after randomization
|
|
Endocrine disorders
Diabetic foot
|
0.18%
1/559 • Number of events 1 • During treatment period up to 52 weeks after randomization
|
0.00%
0/551 • During treatment period up to 52 weeks after randomization
|
|
Endocrine disorders
Hyperthyroidism
|
0.18%
1/559 • Number of events 1 • During treatment period up to 52 weeks after randomization
|
0.00%
0/551 • During treatment period up to 52 weeks after randomization
|
|
Eye disorders
Corneal decompensation
|
0.18%
1/559 • Number of events 1 • During treatment period up to 52 weeks after randomization
|
0.00%
0/551 • During treatment period up to 52 weeks after randomization
|
|
Eye disorders
Ulcerative keratitis
|
0.18%
1/559 • Number of events 1 • During treatment period up to 52 weeks after randomization
|
0.00%
0/551 • During treatment period up to 52 weeks after randomization
|
|
Product Issues
Device malfunction
|
0.36%
2/559 • Number of events 2 • During treatment period up to 52 weeks after randomization
|
0.73%
4/551 • Number of events 4 • During treatment period up to 52 weeks after randomization
|
|
Psychiatric disorders
Anxiety
|
0.18%
1/559 • Number of events 1 • During treatment period up to 52 weeks after randomization
|
0.00%
0/551 • During treatment period up to 52 weeks after randomization
|
|
Psychiatric disorders
Delirium
|
0.18%
1/559 • Number of events 1 • During treatment period up to 52 weeks after randomization
|
0.18%
1/551 • Number of events 1 • During treatment period up to 52 weeks after randomization
|
|
Psychiatric disorders
Depression
|
0.00%
0/559 • During treatment period up to 52 weeks after randomization
|
0.18%
1/551 • Number of events 1 • During treatment period up to 52 weeks after randomization
|
|
Psychiatric disorders
Disorientation
|
0.00%
0/559 • During treatment period up to 52 weeks after randomization
|
0.18%
1/551 • Number of events 1 • During treatment period up to 52 weeks after randomization
|
|
Immune system disorders
Heart transplant rejection
|
0.18%
1/559 • Number of events 1 • During treatment period up to 52 weeks after randomization
|
0.00%
0/551 • During treatment period up to 52 weeks after randomization
|
|
Investigations
Heart rate abnormal
|
0.18%
1/559 • Number of events 1 • During treatment period up to 52 weeks after randomization
|
0.00%
0/551 • During treatment period up to 52 weeks after randomization
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/559 • During treatment period up to 52 weeks after randomization
|
0.18%
1/551 • Number of events 1 • During treatment period up to 52 weeks after randomization
|
|
Investigations
Ejection fraction decreased
|
0.00%
0/559 • During treatment period up to 52 weeks after randomization
|
0.18%
1/551 • Number of events 1 • During treatment period up to 52 weeks after randomization
|
|
Investigations
International normalised ratio decreased
|
0.00%
0/559 • During treatment period up to 52 weeks after randomization
|
0.18%
1/551 • Number of events 1 • During treatment period up to 52 weeks after randomization
|
|
Pregnancy, puerperium and perinatal conditions
Abortion incomplete
|
0.18%
1/559 • Number of events 1 • During treatment period up to 52 weeks after randomization
|
0.00%
0/551 • During treatment period up to 52 weeks after randomization
|
|
Ear and labyrinth disorders
Deafness unilateral
|
0.00%
0/559 • During treatment period up to 52 weeks after randomization
|
0.18%
1/551 • Number of events 1 • During treatment period up to 52 weeks after randomization
|
|
Ear and labyrinth disorders
Hypoacusis
|
0.00%
0/559 • During treatment period up to 52 weeks after randomization
|
0.18%
1/551 • Number of events 1 • During treatment period up to 52 weeks after randomization
|
|
Reproductive system and breast disorders
Prostatitis
|
0.00%
0/559 • During treatment period up to 52 weeks after randomization
|
0.18%
1/551 • Number of events 1 • During treatment period up to 52 weeks after randomization
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/559 • During treatment period up to 52 weeks after randomization
|
0.18%
1/551 • Number of events 1 • During treatment period up to 52 weeks after randomization
|
Other adverse events
| Measure |
Group 1 - FCM (Ferric Carboxymaltose)
n=559 participants at risk
Ferric carboxymaltose (FCM), administered by bolus IV injection at a dose of 10 ml or 20 ml of undiluted solution (containing 500 mg or 1,000 mg of iron respectively) depending on the subject's body weight and Hb level.
From a single dose given at Visit 2 (Week 0) up to 4 doses given over 24 weeks (at Visit 2 (Week 0), Visit 3 (Week 6), Visit 4 (Week 12) and Visit 5 (Week 24)), depending on the subject's Hb levels measured prior to planned dosing dates.
|
Group 2 - Placebo (Normal Saline (NaCl 0.9%))
n=551 participants at risk
Normal saline (NaCl 0.9%), administered by bolus IV injection at a volume corresponding to the FCM dose determined by the subject's body weight and Hb level (i.e., 10 ml or 20 ml per administration).
|
|---|---|---|
|
Cardiac disorders
Cardiac failure
|
9.1%
51/559 • Number of events 57 • During treatment period up to 52 weeks after randomization
|
8.2%
45/551 • Number of events 49 • During treatment period up to 52 weeks after randomization
|
Additional Information
FER-CARS-06 Clinical Study Team
Vifor (International) AG.
Phone: +41 588 518 000
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place