Trial Outcomes & Findings for AZD1656 in Diabetic Patients Hospitalised With Suspected or Confirmed COVID-19 (NCT NCT04516759)
NCT ID: NCT04516759
Last Updated: 2022-04-25
Results Overview
The World Health Organization (WHO) 8-point Ordinal Scale for Clinical Improvement (OSCI) was used to measure Clinical Improvement at Day 14 versus baseline, comparing AZD1656 treatment with placebo. The WHO OSCI score ranges from 0-8 (0 = no symptoms, 8 = death). The higher the score the worse the condition of the patient. Results are presented as number of responders. Patients who were assigned a WHO score of 1, 2 or 3 at Day 14 were considered a treatment responder. A patient who was discharged before Day 14 was also considered a responder. All other patients (WHO scores 4-8 at Day 14) were considered treatment failures.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
170 participants
Primary outcome timeframe
Day 1 to Day 14
Results posted on
2022-04-25
Participant Flow
170 subjects were screened for participation. 13 subjects were screening failures. 156 subjects were randomized of which 3 subjects withdrew consent prior to start of study medication. 153 subjects started with study treatment.
Participant milestones
| Measure |
AZD1656 (Plus Usual Hospital Care)
50mg film-coated tablets at a dose of 100mg BID
AZD1656: 50mg film-coated tablets (at daily dose of 100mg BID)
|
Matched Placebo (Plus Usual Hospital Care)
Matched placebo tablets
Placebo: Matched placebo tablets
|
|---|---|---|
|
Overall Study
STARTED
|
80
|
73
|
|
Overall Study
COMPLETED
|
79
|
71
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
| Measure |
AZD1656 (Plus Usual Hospital Care)
50mg film-coated tablets at a dose of 100mg BID
AZD1656: 50mg film-coated tablets (at daily dose of 100mg BID)
|
Matched Placebo (Plus Usual Hospital Care)
Matched placebo tablets
Placebo: Matched placebo tablets
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
|
Overall Study
Other
|
0
|
1
|
Baseline Characteristics
AZD1656 in Diabetic Patients Hospitalised With Suspected or Confirmed COVID-19
Baseline characteristics by cohort
| Measure |
AZD1656 (Plus Usual Hospital Care)
n=80 Participants
50mg film-coated tablets at a dose of 100mg BID
AZD1656: 50mg film-coated tablets (at daily dose of 100mg BID)
|
Matched Placebo (Plus Usual Hospital Care)
n=73 Participants
Matched placebo tablets
Placebo: Matched placebo tablets
|
Total
n=153 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
38 Participants
n=99 Participants
|
31 Participants
n=107 Participants
|
69 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
42 Participants
n=99 Participants
|
42 Participants
n=107 Participants
|
84 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=99 Participants
|
26 Participants
n=107 Participants
|
56 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
50 Participants
n=99 Participants
|
47 Participants
n=107 Participants
|
97 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
77 Participants
n=99 Participants
|
70 Participants
n=107 Participants
|
147 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Region of Enrollment
Romania
|
19 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
33 Participants
n=206 Participants
|
|
Region of Enrollment
Czechia
|
27 Participants
n=99 Participants
|
22 Participants
n=107 Participants
|
49 Participants
n=206 Participants
|
|
Region of Enrollment
United Kingdom
|
34 Participants
n=99 Participants
|
37 Participants
n=107 Participants
|
71 Participants
n=206 Participants
|
|
WHO OSCI rating
3 - Hospitalised, no oxygen
|
19 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
32 Participants
n=206 Participants
|
|
WHO OSCI rating
4 - Hospitalised, oxygen
|
52 Participants
n=99 Participants
|
42 Participants
n=107 Participants
|
94 Participants
n=206 Participants
|
|
WHO OSCI rating
5 - Non-invasive ventilation or high flow oxygen
|
9 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
27 Participants
n=206 Participants
|
|
Diabetes Type
Type 1
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Diabetes Type
Type 2
|
79 Participants
n=99 Participants
|
71 Participants
n=107 Participants
|
150 Participants
n=206 Participants
|
|
Vitamin D group
< 25 nmol/l
|
31 Participants
n=99 Participants
|
27 Participants
n=107 Participants
|
58 Participants
n=206 Participants
|
|
Vitamin D group
>= 25 nmol/l
|
46 Participants
n=99 Participants
|
45 Participants
n=107 Participants
|
91 Participants
n=206 Participants
|
|
Vitamin D group
missing
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Day 1 to Day 14Population: Full Analysis Set: all participants who received at least one dose of treatment
The World Health Organization (WHO) 8-point Ordinal Scale for Clinical Improvement (OSCI) was used to measure Clinical Improvement at Day 14 versus baseline, comparing AZD1656 treatment with placebo. The WHO OSCI score ranges from 0-8 (0 = no symptoms, 8 = death). The higher the score the worse the condition of the patient. Results are presented as number of responders. Patients who were assigned a WHO score of 1, 2 or 3 at Day 14 were considered a treatment responder. A patient who was discharged before Day 14 was also considered a responder. All other patients (WHO scores 4-8 at Day 14) were considered treatment failures.
Outcome measures
| Measure |
AZD1656 (Plus Usual Hospital Care)
n=80 Participants
50mg film-coated tablets at a dose of 100mg BID
AZD1656: 50mg film-coated tablets (at daily dose of 100mg BID)
|
Matched Placebo (Plus Usual Hospital Care)
n=73 Participants
Matched placebo tablets
Placebo: Matched placebo tablets
|
|---|---|---|
|
Clinical Improvement by Day 14
Treatment responder
|
61 Participants
|
51 Participants
|
|
Clinical Improvement by Day 14
Treatment failure
|
18 Participants
|
21 Participants
|
|
Clinical Improvement by Day 14
Missing
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Day 1 to Day 21Population: Full Analysis Set: all participants who received at least one dose of treatment
The World Health Organization (WHO) 8-point Ordinal Scale for Clinical Improvement (OSCI) was used to measure Clinical Improvement at Day 7, Day 14 and Day 21 versus baseline, comparing AZD1656 treatment with placebo. Results are presented as the percentage of patients categorised at each severity rating at each timepoint on the WHO 8-point OSCI scale. The WHO OSCI score ranges from 0-8 (0 = no symptoms, 8 = death). The higher the score the worse the condition of the patient. Study Drug Discontinuation was the date on which a patient discontinued treatment. Treatment was given for a maximum of 21 days, or until date of hospital discharge (WHO score 1 or 2), or date mechanical ventilation was required (WHO score 6 or 7) or until date of death (WHO score 8).
Outcome measures
| Measure |
AZD1656 (Plus Usual Hospital Care)
n=80 Participants
50mg film-coated tablets at a dose of 100mg BID
AZD1656: 50mg film-coated tablets (at daily dose of 100mg BID)
|
Matched Placebo (Plus Usual Hospital Care)
n=73 Participants
Matched placebo tablets
Placebo: Matched placebo tablets
|
|---|---|---|
|
Clinical Improvement at Day 7, 14 and 21
Day 7 · Score 2: Ambulatory - limitation of activities
|
22 Participants
|
10 Participants
|
|
Clinical Improvement at Day 7, 14 and 21
Day 21 · Score 7: Hospitalized, ventilation + additional organ support - pressors, RTT, ECMO
|
0 Participants
|
0 Participants
|
|
Clinical Improvement at Day 7, 14 and 21
Day 21 · Score 3: Hospitalized, no oxygen therapy
|
4 Participants
|
0 Participants
|
|
Clinical Improvement at Day 7, 14 and 21
Day 21 · Score 4: Hospitalized, oxygen by mask or nasal prongs
|
2 Participants
|
5 Participants
|
|
Clinical Improvement at Day 7, 14 and 21
Day 21 · Score 5: Hospitalized, non-invasive ventilation or high-flow oxygen
|
4 Participants
|
2 Participants
|
|
Clinical Improvement at Day 7, 14 and 21
Day 21 · Score 6: Hospitalized, intubation or mechanical ventilation
|
4 Participants
|
3 Participants
|
|
Clinical Improvement at Day 7, 14 and 21
Day 14 · Score 1: Ambulatory - no limitation of activities
|
16 Participants
|
14 Participants
|
|
Clinical Improvement at Day 7, 14 and 21
Day 14 · Score 2: Ambulatory - limitation of activities
|
37 Participants
|
30 Participants
|
|
Clinical Improvement at Day 7, 14 and 21
Day 14 · Score 3: Hospitalized, no oxygen therapy
|
8 Participants
|
7 Participants
|
|
Clinical Improvement at Day 7, 14 and 21
Day 14 · Score 4: Hospitalized, oxygen by mask or nasal prongs
|
9 Participants
|
10 Participants
|
|
Clinical Improvement at Day 7, 14 and 21
Day 14 · Score 5: Hospitalized, non-invasive ventilation or high-flow oxygen
|
4 Participants
|
2 Participants
|
|
Clinical Improvement at Day 7, 14 and 21
Day 14 · Score 6: Hospitalized, intubation or mechanical ventilation
|
4 Participants
|
3 Participants
|
|
Clinical Improvement at Day 7, 14 and 21
Day 14 · Score 7: Hospitalized, ventilation + additional organ support - pressors, RTT, ECMO
|
0 Participants
|
0 Participants
|
|
Clinical Improvement at Day 7, 14 and 21
Day 14 · Score 8: Death
|
1 Participants
|
6 Participants
|
|
Clinical Improvement at Day 7, 14 and 21
Day 14 · Missing
|
1 Participants
|
1 Participants
|
|
Clinical Improvement at Day 7, 14 and 21
Day 21 · Score 1: Ambulatory - no limitation of activities
|
20 Participants
|
15 Participants
|
|
Clinical Improvement at Day 7, 14 and 21
Day 21 · Score 2: Ambulatory - limitation of activities
|
44 Participants
|
41 Participants
|
|
Clinical Improvement at Day 7, 14 and 21
Day 21 · Score 8: Death
|
1 Participants
|
6 Participants
|
|
Clinical Improvement at Day 7, 14 and 21
Day 21 · Missing
|
1 Participants
|
1 Participants
|
|
Clinical Improvement at Day 7, 14 and 21
Study Drug Discontinuation (SDD) · Score 1: Ambulatory - no limitation of activities
|
20 Participants
|
15 Participants
|
|
Clinical Improvement at Day 7, 14 and 21
Study Drug Discontinuation (SDD) · Score 2: Ambulatory - limitation of activities
|
44 Participants
|
40 Participants
|
|
Clinical Improvement at Day 7, 14 and 21
Study Drug Discontinuation (SDD) · Score 3: Hospitalized, no oxygen therapy
|
3 Participants
|
0 Participants
|
|
Clinical Improvement at Day 7, 14 and 21
Study Drug Discontinuation (SDD) · Score 4: Hospitalized, oxygen by mask or nasal prongs
|
3 Participants
|
5 Participants
|
|
Clinical Improvement at Day 7, 14 and 21
Study Drug Discontinuation (SDD) · Score 5: Hospitalized, non-invasive ventilation or high-flow oxygen
|
4 Participants
|
1 Participants
|
|
Clinical Improvement at Day 7, 14 and 21
Study Drug Discontinuation (SDD) · Score 6: Hospitalized, intubation or mechanical ventilation
|
4 Participants
|
3 Participants
|
|
Clinical Improvement at Day 7, 14 and 21
Study Drug Discontinuation (SDD) · Score 7: Hospitalized, ventilation + additional organ support - pressors, RTT, ECMO
|
0 Participants
|
0 Participants
|
|
Clinical Improvement at Day 7, 14 and 21
Study Drug Discontinuation (SDD) · Score 8: Death
|
1 Participants
|
6 Participants
|
|
Clinical Improvement at Day 7, 14 and 21
Study Drug Discontinuation (SDD) · Missing
|
1 Participants
|
3 Participants
|
|
Clinical Improvement at Day 7, 14 and 21
Baseline · Score 1: Ambulatory - no limitation of activities
|
0 Participants
|
0 Participants
|
|
Clinical Improvement at Day 7, 14 and 21
Baseline · Score 2: Ambulatory - limitation of activities
|
0 Participants
|
0 Participants
|
|
Clinical Improvement at Day 7, 14 and 21
Baseline · Score 3: Hospitalized, no oxygen therapy
|
19 Participants
|
13 Participants
|
|
Clinical Improvement at Day 7, 14 and 21
Baseline · Score 4: Hospitalized, oxygen by mask or nasal prongs
|
52 Participants
|
42 Participants
|
|
Clinical Improvement at Day 7, 14 and 21
Baseline · Score 5: Hospitalized, non-invasive ventilation or high-flow oxygen
|
9 Participants
|
18 Participants
|
|
Clinical Improvement at Day 7, 14 and 21
Baseline · Score 6: Hospitalized, intubation or mechanical ventilation
|
0 Participants
|
0 Participants
|
|
Clinical Improvement at Day 7, 14 and 21
Baseline · Score 7: Hospitalized, ventilation + additional organ support - pressors, RTT, ECMO
|
0 Participants
|
0 Participants
|
|
Clinical Improvement at Day 7, 14 and 21
Baseline · Score 8: Death
|
0 Participants
|
0 Participants
|
|
Clinical Improvement at Day 7, 14 and 21
Baseline · Missing
|
0 Participants
|
0 Participants
|
|
Clinical Improvement at Day 7, 14 and 21
Day 7 · Score 1: Ambulatory - no limitation of activities
|
7 Participants
|
7 Participants
|
|
Clinical Improvement at Day 7, 14 and 21
Day 7 · Score 3: Hospitalized, no oxygen therapy
|
15 Participants
|
17 Participants
|
|
Clinical Improvement at Day 7, 14 and 21
Day 7 · Score 4: Hospitalized, oxygen by mask or nasal prongs
|
23 Participants
|
26 Participants
|
|
Clinical Improvement at Day 7, 14 and 21
Day 7 · Score 5: Hospitalized, non-invasive ventilation or high-flow oxygen
|
10 Participants
|
5 Participants
|
|
Clinical Improvement at Day 7, 14 and 21
Day 7 · Score 6: Hospitalized, intubation or mechanical ventilation
|
2 Participants
|
3 Participants
|
|
Clinical Improvement at Day 7, 14 and 21
Day 7 · Score 7: Hospitalized, ventilation + additional organ support - pressors, RTT, ECMO
|
0 Participants
|
0 Participants
|
|
Clinical Improvement at Day 7, 14 and 21
Day 7 · Score 8: Death
|
0 Participants
|
5 Participants
|
|
Clinical Improvement at Day 7, 14 and 21
Day 7 · Missing
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 1 to Day 21Population: Full Analysis Set: all participants who at least received one dose of treatment
Degree of glycaemic control as measured by the need to increase baseline medication requirements or the need to add additional diabetic medications to maintain appropriate blood glucose levels in patients receiving AZD1656 compared with placebo
Outcome measures
| Measure |
AZD1656 (Plus Usual Hospital Care)
n=80 Participants
50mg film-coated tablets at a dose of 100mg BID
AZD1656: 50mg film-coated tablets (at daily dose of 100mg BID)
|
Matched Placebo (Plus Usual Hospital Care)
n=73 Participants
Matched placebo tablets
Placebo: Matched placebo tablets
|
|---|---|---|
|
Glycaemic Control
Increase in Diabetic Medication Needed equal or More Than 3 Days · True
|
12 Participants
|
13 Participants
|
|
Glycaemic Control
Increase in Diabetic Medication Needed equal or More Than 3 Days · False
|
68 Participants
|
60 Participants
|
|
Glycaemic Control
Diabetic Medication is Stable/Reduced Equal or More Than 3 days · True
|
61 Participants
|
58 Participants
|
|
Glycaemic Control
Diabetic Medication is Stable/Reduced Equal or More Than 3 days · False
|
19 Participants
|
15 Participants
|
|
Glycaemic Control
Increase in Diabetic Medication Needed at Any Time During the Study · True
|
25 Participants
|
21 Participants
|
|
Glycaemic Control
Increase in Diabetic Medication Needed at Any Time During the Study · False
|
55 Participants
|
52 Participants
|
|
Glycaemic Control
Diabetic Medication is Stable/Reduced at Any Time During the Study · True
|
74 Participants
|
67 Participants
|
|
Glycaemic Control
Diabetic Medication is Stable/Reduced at Any Time During the Study · False
|
6 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Day 1 to Day 28Population: This analysis includes all participants who received at least one dose of treatment and had at least one post-baseline safety assessment (where the statement that a patient had no AE on the AE eCRF constitutes a safety assessment). 4 patients from the placebo arm are moved to the AZD1656 arm due to having drug in their PK samples. The assignment of patients to the treatment groups are as actually treated.
Proportion of Treatment Emergent Adverse Events (TEAEs) leading to study drug discontinuation in patients receiving AZD1656 compared with placebo
Outcome measures
| Measure |
AZD1656 (Plus Usual Hospital Care)
n=84 Participants
50mg film-coated tablets at a dose of 100mg BID
AZD1656: 50mg film-coated tablets (at daily dose of 100mg BID)
|
Matched Placebo (Plus Usual Hospital Care)
n=69 Participants
Matched placebo tablets
Placebo: Matched placebo tablets
|
|---|---|---|
|
Occurrence of Adverse Events
TEAEs leading to study drug discontinuation
|
2 Events
|
2 Events
|
|
Occurrence of Adverse Events
Other TEAEs
|
28 Events
|
21 Events
|
SECONDARY outcome
Timeframe: Day 1 to Day 28Population: This analysis includes all patients who received at least one dose of IMP and had at least one post-baseline safety assessment (where the statement that a patient had no AE on the AE eCRF constitutes a safety assessment). 4 patients from the placebo arm are moved to the AZD1656 arm due to having drug in their PK samples. The assignment of patients to the treatment groups are as actually treated.
Proportion of Serious Adverse Events (SAEs) in patients receiving AZD1656 compared with placebo
Outcome measures
| Measure |
AZD1656 (Plus Usual Hospital Care)
n=84 Participants
50mg film-coated tablets at a dose of 100mg BID
AZD1656: 50mg film-coated tablets (at daily dose of 100mg BID)
|
Matched Placebo (Plus Usual Hospital Care)
n=69 Participants
Matched placebo tablets
Placebo: Matched placebo tablets
|
|---|---|---|
|
Occurrence of Serious Adverse Events
Other AEs
|
28 Events
|
17 Events
|
|
Occurrence of Serious Adverse Events
Serious Adverse Events
|
4 Events
|
7 Events
|
SECONDARY outcome
Timeframe: Day 1 to Day 21Population: Full Analysis Set: all participant who at least received on dose of treatment
Time from hospital admission to hospital discharge (in hours) in patients receiving AZD1656 compared with placebo
Outcome measures
| Measure |
AZD1656 (Plus Usual Hospital Care)
n=80 Participants
50mg film-coated tablets at a dose of 100mg BID
AZD1656: 50mg film-coated tablets (at daily dose of 100mg BID)
|
Matched Placebo (Plus Usual Hospital Care)
n=73 Participants
Matched placebo tablets
Placebo: Matched placebo tablets
|
|---|---|---|
|
Duration of Hospitalisation
|
264.3 hours
Interval 215.5 to 299.7
|
288.7 hours
Interval 260.1 to 307.1
|
SECONDARY outcome
Timeframe: Day 1 to Day 28Mortality rate in patients receiving AZD1656 compared with placebo.
Outcome measures
| Measure |
AZD1656 (Plus Usual Hospital Care)
n=80 Participants
50mg film-coated tablets at a dose of 100mg BID
AZD1656: 50mg film-coated tablets (at daily dose of 100mg BID)
|
Matched Placebo (Plus Usual Hospital Care)
n=73 Participants
Matched placebo tablets
Placebo: Matched placebo tablets
|
|---|---|---|
|
Mortality Rate
Died
|
4 Participants
|
9 Participants
|
|
Mortality Rate
Did not die
|
75 Participants
|
63 Participants
|
|
Mortality Rate
Missing
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Day 1 to Day 21Population: Full Analysis Set: all participants who at least received one dose of treatment
Number of Patients Receiving Intubation/Mechanical Ventilation
Outcome measures
| Measure |
AZD1656 (Plus Usual Hospital Care)
n=80 Participants
50mg film-coated tablets at a dose of 100mg BID
AZD1656: 50mg film-coated tablets (at daily dose of 100mg BID)
|
Matched Placebo (Plus Usual Hospital Care)
n=73 Participants
Matched placebo tablets
Placebo: Matched placebo tablets
|
|---|---|---|
|
Intubation/Mechanical Ventilation
Receiving Intubation/Mechanical Ventilation
|
3 Participants
|
3 Participants
|
|
Intubation/Mechanical Ventilation
Not Receiving Intubation/Mechanical Ventilation
|
76 Participants
|
69 Participants
|
|
Intubation/Mechanical Ventilation
Missing
|
1 Participants
|
1 Participants
|
POST_HOC outcome
Timeframe: Randomization to 168 hours post randomizationPopulation: Full Analysis Set: all participant who received at least one dose of treatment; patients who withdrew consent are categorised as missing
Mortality rate from randomization up to and including 168 hours post randomization
Outcome measures
| Measure |
AZD1656 (Plus Usual Hospital Care)
n=80 Participants
50mg film-coated tablets at a dose of 100mg BID
AZD1656: 50mg film-coated tablets (at daily dose of 100mg BID)
|
Matched Placebo (Plus Usual Hospital Care)
n=73 Participants
Matched placebo tablets
Placebo: Matched placebo tablets
|
|---|---|---|
|
Mortality Rate
Died
|
0 Participants
|
6 Participants
|
|
Mortality Rate
Did not die
|
79 Participants
|
66 Participants
|
|
Mortality Rate
Missing
|
1 Participants
|
1 Participants
|
POST_HOC outcome
Timeframe: Day 1 up to and including 168 hours post randomizationPopulation: Full Analysis Set: all participants who had at least one dose of treatment
Proportion of Patients Being Discharged From Hospital up to and Including 168 hrs Having WHO OSCI Rating of 1 or 2
Outcome measures
| Measure |
AZD1656 (Plus Usual Hospital Care)
n=80 Participants
50mg film-coated tablets at a dose of 100mg BID
AZD1656: 50mg film-coated tablets (at daily dose of 100mg BID)
|
Matched Placebo (Plus Usual Hospital Care)
n=73 Participants
Matched placebo tablets
Placebo: Matched placebo tablets
|
|---|---|---|
|
Proportion of Patients Discharged up to and Including 168 Hours Having a WHO OSCI Rating of 1 or 2
Discharged from hospital (within 168 hrs with WHO 1 or 2)
|
30 Participants
|
18 Participants
|
|
Proportion of Patients Discharged up to and Including 168 Hours Having a WHO OSCI Rating of 1 or 2
Not discharged from Hospital (within 168 hrs with WHO 1 or 2)
|
49 Participants
|
54 Participants
|
|
Proportion of Patients Discharged up to and Including 168 Hours Having a WHO OSCI Rating of 1 or 2
Missing
|
1 Participants
|
1 Participants
|
Adverse Events
AZD1656 (Plus Usual Hospital Care)
Serious events: 10 serious events
Other events: 43 other events
Deaths: 4 deaths
Matched Placebo (Plus Usual Hospital Care)
Serious events: 19 serious events
Other events: 17 other events
Deaths: 9 deaths
Serious adverse events
| Measure |
AZD1656 (Plus Usual Hospital Care)
n=84 participants at risk
50mg film-coated tablets at a dose of 100mg BID
AZD1656: 50mg film-coated tablets (at daily dose of 100mg BID)
|
Matched Placebo (Plus Usual Hospital Care)
n=69 participants at risk
Matched placebo tablets
Placebo: Matched placebo tablets
|
|---|---|---|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/84 • All AEs, including SAEs, were captured after signing the informed consent and until 7 days after treatment discontinuation (up to a maximum of 28 days).
Serious and other Adverse Events were assessed using the Safety Set (SAF) dataset. The SAF dataset included 84 patients in the AZD1656 arm and 69 patients in the placebo arm, All-Cause Mortality was assessed using the Full Analysis Set (FAS) dataset. The FAS dataset included 80 patients in the AZD1656 arm and 73 patients in the placebo arm.
|
2.9%
2/69 • Number of events 2 • All AEs, including SAEs, were captured after signing the informed consent and until 7 days after treatment discontinuation (up to a maximum of 28 days).
Serious and other Adverse Events were assessed using the Safety Set (SAF) dataset. The SAF dataset included 84 patients in the AZD1656 arm and 69 patients in the placebo arm, All-Cause Mortality was assessed using the Full Analysis Set (FAS) dataset. The FAS dataset included 80 patients in the AZD1656 arm and 73 patients in the placebo arm.
|
|
Vascular disorders
Circulatory collapse
|
1.2%
1/84 • Number of events 1 • All AEs, including SAEs, were captured after signing the informed consent and until 7 days after treatment discontinuation (up to a maximum of 28 days).
Serious and other Adverse Events were assessed using the Safety Set (SAF) dataset. The SAF dataset included 84 patients in the AZD1656 arm and 69 patients in the placebo arm, All-Cause Mortality was assessed using the Full Analysis Set (FAS) dataset. The FAS dataset included 80 patients in the AZD1656 arm and 73 patients in the placebo arm.
|
0.00%
0/69 • All AEs, including SAEs, were captured after signing the informed consent and until 7 days after treatment discontinuation (up to a maximum of 28 days).
Serious and other Adverse Events were assessed using the Safety Set (SAF) dataset. The SAF dataset included 84 patients in the AZD1656 arm and 69 patients in the placebo arm, All-Cause Mortality was assessed using the Full Analysis Set (FAS) dataset. The FAS dataset included 80 patients in the AZD1656 arm and 73 patients in the placebo arm.
|
|
Cardiac disorders
Angina unstable
|
1.2%
1/84 • Number of events 1 • All AEs, including SAEs, were captured after signing the informed consent and until 7 days after treatment discontinuation (up to a maximum of 28 days).
Serious and other Adverse Events were assessed using the Safety Set (SAF) dataset. The SAF dataset included 84 patients in the AZD1656 arm and 69 patients in the placebo arm, All-Cause Mortality was assessed using the Full Analysis Set (FAS) dataset. The FAS dataset included 80 patients in the AZD1656 arm and 73 patients in the placebo arm.
|
0.00%
0/69 • All AEs, including SAEs, were captured after signing the informed consent and until 7 days after treatment discontinuation (up to a maximum of 28 days).
Serious and other Adverse Events were assessed using the Safety Set (SAF) dataset. The SAF dataset included 84 patients in the AZD1656 arm and 69 patients in the placebo arm, All-Cause Mortality was assessed using the Full Analysis Set (FAS) dataset. The FAS dataset included 80 patients in the AZD1656 arm and 73 patients in the placebo arm.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.00%
0/84 • All AEs, including SAEs, were captured after signing the informed consent and until 7 days after treatment discontinuation (up to a maximum of 28 days).
Serious and other Adverse Events were assessed using the Safety Set (SAF) dataset. The SAF dataset included 84 patients in the AZD1656 arm and 69 patients in the placebo arm, All-Cause Mortality was assessed using the Full Analysis Set (FAS) dataset. The FAS dataset included 80 patients in the AZD1656 arm and 73 patients in the placebo arm.
|
1.4%
1/69 • Number of events 1 • All AEs, including SAEs, were captured after signing the informed consent and until 7 days after treatment discontinuation (up to a maximum of 28 days).
Serious and other Adverse Events were assessed using the Safety Set (SAF) dataset. The SAF dataset included 84 patients in the AZD1656 arm and 69 patients in the placebo arm, All-Cause Mortality was assessed using the Full Analysis Set (FAS) dataset. The FAS dataset included 80 patients in the AZD1656 arm and 73 patients in the placebo arm.
|
|
Cardiac disorders
Cardiogenic shock
|
0.00%
0/84 • All AEs, including SAEs, were captured after signing the informed consent and until 7 days after treatment discontinuation (up to a maximum of 28 days).
Serious and other Adverse Events were assessed using the Safety Set (SAF) dataset. The SAF dataset included 84 patients in the AZD1656 arm and 69 patients in the placebo arm, All-Cause Mortality was assessed using the Full Analysis Set (FAS) dataset. The FAS dataset included 80 patients in the AZD1656 arm and 73 patients in the placebo arm.
|
1.4%
1/69 • Number of events 1 • All AEs, including SAEs, were captured after signing the informed consent and until 7 days after treatment discontinuation (up to a maximum of 28 days).
Serious and other Adverse Events were assessed using the Safety Set (SAF) dataset. The SAF dataset included 84 patients in the AZD1656 arm and 69 patients in the placebo arm, All-Cause Mortality was assessed using the Full Analysis Set (FAS) dataset. The FAS dataset included 80 patients in the AZD1656 arm and 73 patients in the placebo arm.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/84 • All AEs, including SAEs, were captured after signing the informed consent and until 7 days after treatment discontinuation (up to a maximum of 28 days).
Serious and other Adverse Events were assessed using the Safety Set (SAF) dataset. The SAF dataset included 84 patients in the AZD1656 arm and 69 patients in the placebo arm, All-Cause Mortality was assessed using the Full Analysis Set (FAS) dataset. The FAS dataset included 80 patients in the AZD1656 arm and 73 patients in the placebo arm.
|
1.4%
1/69 • Number of events 1 • All AEs, including SAEs, were captured after signing the informed consent and until 7 days after treatment discontinuation (up to a maximum of 28 days).
Serious and other Adverse Events were assessed using the Safety Set (SAF) dataset. The SAF dataset included 84 patients in the AZD1656 arm and 69 patients in the placebo arm, All-Cause Mortality was assessed using the Full Analysis Set (FAS) dataset. The FAS dataset included 80 patients in the AZD1656 arm and 73 patients in the placebo arm.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/84 • All AEs, including SAEs, were captured after signing the informed consent and until 7 days after treatment discontinuation (up to a maximum of 28 days).
Serious and other Adverse Events were assessed using the Safety Set (SAF) dataset. The SAF dataset included 84 patients in the AZD1656 arm and 69 patients in the placebo arm, All-Cause Mortality was assessed using the Full Analysis Set (FAS) dataset. The FAS dataset included 80 patients in the AZD1656 arm and 73 patients in the placebo arm.
|
1.4%
1/69 • Number of events 1 • All AEs, including SAEs, were captured after signing the informed consent and until 7 days after treatment discontinuation (up to a maximum of 28 days).
Serious and other Adverse Events were assessed using the Safety Set (SAF) dataset. The SAF dataset included 84 patients in the AZD1656 arm and 69 patients in the placebo arm, All-Cause Mortality was assessed using the Full Analysis Set (FAS) dataset. The FAS dataset included 80 patients in the AZD1656 arm and 73 patients in the placebo arm.
|
|
Psychiatric disorders
Suicide attempt
|
1.2%
1/84 • Number of events 1 • All AEs, including SAEs, were captured after signing the informed consent and until 7 days after treatment discontinuation (up to a maximum of 28 days).
Serious and other Adverse Events were assessed using the Safety Set (SAF) dataset. The SAF dataset included 84 patients in the AZD1656 arm and 69 patients in the placebo arm, All-Cause Mortality was assessed using the Full Analysis Set (FAS) dataset. The FAS dataset included 80 patients in the AZD1656 arm and 73 patients in the placebo arm.
|
0.00%
0/69 • All AEs, including SAEs, were captured after signing the informed consent and until 7 days after treatment discontinuation (up to a maximum of 28 days).
Serious and other Adverse Events were assessed using the Safety Set (SAF) dataset. The SAF dataset included 84 patients in the AZD1656 arm and 69 patients in the placebo arm, All-Cause Mortality was assessed using the Full Analysis Set (FAS) dataset. The FAS dataset included 80 patients in the AZD1656 arm and 73 patients in the placebo arm.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/84 • All AEs, including SAEs, were captured after signing the informed consent and until 7 days after treatment discontinuation (up to a maximum of 28 days).
Serious and other Adverse Events were assessed using the Safety Set (SAF) dataset. The SAF dataset included 84 patients in the AZD1656 arm and 69 patients in the placebo arm, All-Cause Mortality was assessed using the Full Analysis Set (FAS) dataset. The FAS dataset included 80 patients in the AZD1656 arm and 73 patients in the placebo arm.
|
1.4%
1/69 • Number of events 1 • All AEs, including SAEs, were captured after signing the informed consent and until 7 days after treatment discontinuation (up to a maximum of 28 days).
Serious and other Adverse Events were assessed using the Safety Set (SAF) dataset. The SAF dataset included 84 patients in the AZD1656 arm and 69 patients in the placebo arm, All-Cause Mortality was assessed using the Full Analysis Set (FAS) dataset. The FAS dataset included 80 patients in the AZD1656 arm and 73 patients in the placebo arm.
|
|
Hepatobiliary disorders
Acute hepatic failure
|
1.2%
1/84 • Number of events 1 • All AEs, including SAEs, were captured after signing the informed consent and until 7 days after treatment discontinuation (up to a maximum of 28 days).
Serious and other Adverse Events were assessed using the Safety Set (SAF) dataset. The SAF dataset included 84 patients in the AZD1656 arm and 69 patients in the placebo arm, All-Cause Mortality was assessed using the Full Analysis Set (FAS) dataset. The FAS dataset included 80 patients in the AZD1656 arm and 73 patients in the placebo arm.
|
0.00%
0/69 • All AEs, including SAEs, were captured after signing the informed consent and until 7 days after treatment discontinuation (up to a maximum of 28 days).
Serious and other Adverse Events were assessed using the Safety Set (SAF) dataset. The SAF dataset included 84 patients in the AZD1656 arm and 69 patients in the placebo arm, All-Cause Mortality was assessed using the Full Analysis Set (FAS) dataset. The FAS dataset included 80 patients in the AZD1656 arm and 73 patients in the placebo arm.
|
|
Metabolism and nutrition disorders
Dehydration
|
1.2%
1/84 • Number of events 1 • All AEs, including SAEs, were captured after signing the informed consent and until 7 days after treatment discontinuation (up to a maximum of 28 days).
Serious and other Adverse Events were assessed using the Safety Set (SAF) dataset. The SAF dataset included 84 patients in the AZD1656 arm and 69 patients in the placebo arm, All-Cause Mortality was assessed using the Full Analysis Set (FAS) dataset. The FAS dataset included 80 patients in the AZD1656 arm and 73 patients in the placebo arm.
|
0.00%
0/69 • All AEs, including SAEs, were captured after signing the informed consent and until 7 days after treatment discontinuation (up to a maximum of 28 days).
Serious and other Adverse Events were assessed using the Safety Set (SAF) dataset. The SAF dataset included 84 patients in the AZD1656 arm and 69 patients in the placebo arm, All-Cause Mortality was assessed using the Full Analysis Set (FAS) dataset. The FAS dataset included 80 patients in the AZD1656 arm and 73 patients in the placebo arm.
|
|
Metabolism and nutrition disorders
Hypophagia
|
1.2%
1/84 • Number of events 1 • All AEs, including SAEs, were captured after signing the informed consent and until 7 days after treatment discontinuation (up to a maximum of 28 days).
Serious and other Adverse Events were assessed using the Safety Set (SAF) dataset. The SAF dataset included 84 patients in the AZD1656 arm and 69 patients in the placebo arm, All-Cause Mortality was assessed using the Full Analysis Set (FAS) dataset. The FAS dataset included 80 patients in the AZD1656 arm and 73 patients in the placebo arm.
|
0.00%
0/69 • All AEs, including SAEs, were captured after signing the informed consent and until 7 days after treatment discontinuation (up to a maximum of 28 days).
Serious and other Adverse Events were assessed using the Safety Set (SAF) dataset. The SAF dataset included 84 patients in the AZD1656 arm and 69 patients in the placebo arm, All-Cause Mortality was assessed using the Full Analysis Set (FAS) dataset. The FAS dataset included 80 patients in the AZD1656 arm and 73 patients in the placebo arm.
|
|
Infections and infestations
Abcess limb
|
0.00%
0/84 • All AEs, including SAEs, were captured after signing the informed consent and until 7 days after treatment discontinuation (up to a maximum of 28 days).
Serious and other Adverse Events were assessed using the Safety Set (SAF) dataset. The SAF dataset included 84 patients in the AZD1656 arm and 69 patients in the placebo arm, All-Cause Mortality was assessed using the Full Analysis Set (FAS) dataset. The FAS dataset included 80 patients in the AZD1656 arm and 73 patients in the placebo arm.
|
1.4%
1/69 • Number of events 1 • All AEs, including SAEs, were captured after signing the informed consent and until 7 days after treatment discontinuation (up to a maximum of 28 days).
Serious and other Adverse Events were assessed using the Safety Set (SAF) dataset. The SAF dataset included 84 patients in the AZD1656 arm and 69 patients in the placebo arm, All-Cause Mortality was assessed using the Full Analysis Set (FAS) dataset. The FAS dataset included 80 patients in the AZD1656 arm and 73 patients in the placebo arm.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/84 • All AEs, including SAEs, were captured after signing the informed consent and until 7 days after treatment discontinuation (up to a maximum of 28 days).
Serious and other Adverse Events were assessed using the Safety Set (SAF) dataset. The SAF dataset included 84 patients in the AZD1656 arm and 69 patients in the placebo arm, All-Cause Mortality was assessed using the Full Analysis Set (FAS) dataset. The FAS dataset included 80 patients in the AZD1656 arm and 73 patients in the placebo arm.
|
1.4%
1/69 • Number of events 1 • All AEs, including SAEs, were captured after signing the informed consent and until 7 days after treatment discontinuation (up to a maximum of 28 days).
Serious and other Adverse Events were assessed using the Safety Set (SAF) dataset. The SAF dataset included 84 patients in the AZD1656 arm and 69 patients in the placebo arm, All-Cause Mortality was assessed using the Full Analysis Set (FAS) dataset. The FAS dataset included 80 patients in the AZD1656 arm and 73 patients in the placebo arm.
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/84 • All AEs, including SAEs, were captured after signing the informed consent and until 7 days after treatment discontinuation (up to a maximum of 28 days).
Serious and other Adverse Events were assessed using the Safety Set (SAF) dataset. The SAF dataset included 84 patients in the AZD1656 arm and 69 patients in the placebo arm, All-Cause Mortality was assessed using the Full Analysis Set (FAS) dataset. The FAS dataset included 80 patients in the AZD1656 arm and 73 patients in the placebo arm.
|
1.4%
1/69 • Number of events 1 • All AEs, including SAEs, were captured after signing the informed consent and until 7 days after treatment discontinuation (up to a maximum of 28 days).
Serious and other Adverse Events were assessed using the Safety Set (SAF) dataset. The SAF dataset included 84 patients in the AZD1656 arm and 69 patients in the placebo arm, All-Cause Mortality was assessed using the Full Analysis Set (FAS) dataset. The FAS dataset included 80 patients in the AZD1656 arm and 73 patients in the placebo arm.
|
|
Infections and infestations
Septic shock
|
0.00%
0/84 • All AEs, including SAEs, were captured after signing the informed consent and until 7 days after treatment discontinuation (up to a maximum of 28 days).
Serious and other Adverse Events were assessed using the Safety Set (SAF) dataset. The SAF dataset included 84 patients in the AZD1656 arm and 69 patients in the placebo arm, All-Cause Mortality was assessed using the Full Analysis Set (FAS) dataset. The FAS dataset included 80 patients in the AZD1656 arm and 73 patients in the placebo arm.
|
1.4%
1/69 • Number of events 1 • All AEs, including SAEs, were captured after signing the informed consent and until 7 days after treatment discontinuation (up to a maximum of 28 days).
Serious and other Adverse Events were assessed using the Safety Set (SAF) dataset. The SAF dataset included 84 patients in the AZD1656 arm and 69 patients in the placebo arm, All-Cause Mortality was assessed using the Full Analysis Set (FAS) dataset. The FAS dataset included 80 patients in the AZD1656 arm and 73 patients in the placebo arm.
|
|
Infections and infestations
COVID-19
|
2.4%
2/84 • Number of events 2 • All AEs, including SAEs, were captured after signing the informed consent and until 7 days after treatment discontinuation (up to a maximum of 28 days).
Serious and other Adverse Events were assessed using the Safety Set (SAF) dataset. The SAF dataset included 84 patients in the AZD1656 arm and 69 patients in the placebo arm, All-Cause Mortality was assessed using the Full Analysis Set (FAS) dataset. The FAS dataset included 80 patients in the AZD1656 arm and 73 patients in the placebo arm.
|
7.2%
5/69 • Number of events 5 • All AEs, including SAEs, were captured after signing the informed consent and until 7 days after treatment discontinuation (up to a maximum of 28 days).
Serious and other Adverse Events were assessed using the Safety Set (SAF) dataset. The SAF dataset included 84 patients in the AZD1656 arm and 69 patients in the placebo arm, All-Cause Mortality was assessed using the Full Analysis Set (FAS) dataset. The FAS dataset included 80 patients in the AZD1656 arm and 73 patients in the placebo arm.
|
|
Infections and infestations
COVID-19 pneumonia
|
2.4%
2/84 • Number of events 2 • All AEs, including SAEs, were captured after signing the informed consent and until 7 days after treatment discontinuation (up to a maximum of 28 days).
Serious and other Adverse Events were assessed using the Safety Set (SAF) dataset. The SAF dataset included 84 patients in the AZD1656 arm and 69 patients in the placebo arm, All-Cause Mortality was assessed using the Full Analysis Set (FAS) dataset. The FAS dataset included 80 patients in the AZD1656 arm and 73 patients in the placebo arm.
|
2.9%
2/69 • Number of events 2 • All AEs, including SAEs, were captured after signing the informed consent and until 7 days after treatment discontinuation (up to a maximum of 28 days).
Serious and other Adverse Events were assessed using the Safety Set (SAF) dataset. The SAF dataset included 84 patients in the AZD1656 arm and 69 patients in the placebo arm, All-Cause Mortality was assessed using the Full Analysis Set (FAS) dataset. The FAS dataset included 80 patients in the AZD1656 arm and 73 patients in the placebo arm.
|
|
Infections and infestations
Sepsis
|
0.00%
0/84 • All AEs, including SAEs, were captured after signing the informed consent and until 7 days after treatment discontinuation (up to a maximum of 28 days).
Serious and other Adverse Events were assessed using the Safety Set (SAF) dataset. The SAF dataset included 84 patients in the AZD1656 arm and 69 patients in the placebo arm, All-Cause Mortality was assessed using the Full Analysis Set (FAS) dataset. The FAS dataset included 80 patients in the AZD1656 arm and 73 patients in the placebo arm.
|
1.4%
1/69 • Number of events 1 • All AEs, including SAEs, were captured after signing the informed consent and until 7 days after treatment discontinuation (up to a maximum of 28 days).
Serious and other Adverse Events were assessed using the Safety Set (SAF) dataset. The SAF dataset included 84 patients in the AZD1656 arm and 69 patients in the placebo arm, All-Cause Mortality was assessed using the Full Analysis Set (FAS) dataset. The FAS dataset included 80 patients in the AZD1656 arm and 73 patients in the placebo arm.
|
Other adverse events
| Measure |
AZD1656 (Plus Usual Hospital Care)
n=84 participants at risk
50mg film-coated tablets at a dose of 100mg BID
AZD1656: 50mg film-coated tablets (at daily dose of 100mg BID)
|
Matched Placebo (Plus Usual Hospital Care)
n=69 participants at risk
Matched placebo tablets
Placebo: Matched placebo tablets
|
|---|---|---|
|
Investigations
Aspartate aminotransferase increased
|
1.2%
1/84 • Number of events 1 • All AEs, including SAEs, were captured after signing the informed consent and until 7 days after treatment discontinuation (up to a maximum of 28 days).
Serious and other Adverse Events were assessed using the Safety Set (SAF) dataset. The SAF dataset included 84 patients in the AZD1656 arm and 69 patients in the placebo arm, All-Cause Mortality was assessed using the Full Analysis Set (FAS) dataset. The FAS dataset included 80 patients in the AZD1656 arm and 73 patients in the placebo arm.
|
0.00%
0/69 • All AEs, including SAEs, were captured after signing the informed consent and until 7 days after treatment discontinuation (up to a maximum of 28 days).
Serious and other Adverse Events were assessed using the Safety Set (SAF) dataset. The SAF dataset included 84 patients in the AZD1656 arm and 69 patients in the placebo arm, All-Cause Mortality was assessed using the Full Analysis Set (FAS) dataset. The FAS dataset included 80 patients in the AZD1656 arm and 73 patients in the placebo arm.
|
|
Investigations
Blood glucose decreased
|
1.2%
1/84 • Number of events 1 • All AEs, including SAEs, were captured after signing the informed consent and until 7 days after treatment discontinuation (up to a maximum of 28 days).
Serious and other Adverse Events were assessed using the Safety Set (SAF) dataset. The SAF dataset included 84 patients in the AZD1656 arm and 69 patients in the placebo arm, All-Cause Mortality was assessed using the Full Analysis Set (FAS) dataset. The FAS dataset included 80 patients in the AZD1656 arm and 73 patients in the placebo arm.
|
0.00%
0/69 • All AEs, including SAEs, were captured after signing the informed consent and until 7 days after treatment discontinuation (up to a maximum of 28 days).
Serious and other Adverse Events were assessed using the Safety Set (SAF) dataset. The SAF dataset included 84 patients in the AZD1656 arm and 69 patients in the placebo arm, All-Cause Mortality was assessed using the Full Analysis Set (FAS) dataset. The FAS dataset included 80 patients in the AZD1656 arm and 73 patients in the placebo arm.
|
|
Investigations
Gamma-glutamyltransferase increased
|
1.2%
1/84 • Number of events 1 • All AEs, including SAEs, were captured after signing the informed consent and until 7 days after treatment discontinuation (up to a maximum of 28 days).
Serious and other Adverse Events were assessed using the Safety Set (SAF) dataset. The SAF dataset included 84 patients in the AZD1656 arm and 69 patients in the placebo arm, All-Cause Mortality was assessed using the Full Analysis Set (FAS) dataset. The FAS dataset included 80 patients in the AZD1656 arm and 73 patients in the placebo arm.
|
0.00%
0/69 • All AEs, including SAEs, were captured after signing the informed consent and until 7 days after treatment discontinuation (up to a maximum of 28 days).
Serious and other Adverse Events were assessed using the Safety Set (SAF) dataset. The SAF dataset included 84 patients in the AZD1656 arm and 69 patients in the placebo arm, All-Cause Mortality was assessed using the Full Analysis Set (FAS) dataset. The FAS dataset included 80 patients in the AZD1656 arm and 73 patients in the placebo arm.
|
|
Investigations
Vitamin D decreased
|
1.2%
1/84 • Number of events 1 • All AEs, including SAEs, were captured after signing the informed consent and until 7 days after treatment discontinuation (up to a maximum of 28 days).
Serious and other Adverse Events were assessed using the Safety Set (SAF) dataset. The SAF dataset included 84 patients in the AZD1656 arm and 69 patients in the placebo arm, All-Cause Mortality was assessed using the Full Analysis Set (FAS) dataset. The FAS dataset included 80 patients in the AZD1656 arm and 73 patients in the placebo arm.
|
0.00%
0/69 • All AEs, including SAEs, were captured after signing the informed consent and until 7 days after treatment discontinuation (up to a maximum of 28 days).
Serious and other Adverse Events were assessed using the Safety Set (SAF) dataset. The SAF dataset included 84 patients in the AZD1656 arm and 69 patients in the placebo arm, All-Cause Mortality was assessed using the Full Analysis Set (FAS) dataset. The FAS dataset included 80 patients in the AZD1656 arm and 73 patients in the placebo arm.
|
|
Cardiac disorders
Atrial fibrillation
|
2.4%
2/84 • Number of events 2 • All AEs, including SAEs, were captured after signing the informed consent and until 7 days after treatment discontinuation (up to a maximum of 28 days).
Serious and other Adverse Events were assessed using the Safety Set (SAF) dataset. The SAF dataset included 84 patients in the AZD1656 arm and 69 patients in the placebo arm, All-Cause Mortality was assessed using the Full Analysis Set (FAS) dataset. The FAS dataset included 80 patients in the AZD1656 arm and 73 patients in the placebo arm.
|
0.00%
0/69 • All AEs, including SAEs, were captured after signing the informed consent and until 7 days after treatment discontinuation (up to a maximum of 28 days).
Serious and other Adverse Events were assessed using the Safety Set (SAF) dataset. The SAF dataset included 84 patients in the AZD1656 arm and 69 patients in the placebo arm, All-Cause Mortality was assessed using the Full Analysis Set (FAS) dataset. The FAS dataset included 80 patients in the AZD1656 arm and 73 patients in the placebo arm.
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/84 • All AEs, including SAEs, were captured after signing the informed consent and until 7 days after treatment discontinuation (up to a maximum of 28 days).
Serious and other Adverse Events were assessed using the Safety Set (SAF) dataset. The SAF dataset included 84 patients in the AZD1656 arm and 69 patients in the placebo arm, All-Cause Mortality was assessed using the Full Analysis Set (FAS) dataset. The FAS dataset included 80 patients in the AZD1656 arm and 73 patients in the placebo arm.
|
1.4%
1/69 • Number of events 1 • All AEs, including SAEs, were captured after signing the informed consent and until 7 days after treatment discontinuation (up to a maximum of 28 days).
Serious and other Adverse Events were assessed using the Safety Set (SAF) dataset. The SAF dataset included 84 patients in the AZD1656 arm and 69 patients in the placebo arm, All-Cause Mortality was assessed using the Full Analysis Set (FAS) dataset. The FAS dataset included 80 patients in the AZD1656 arm and 73 patients in the placebo arm.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/84 • All AEs, including SAEs, were captured after signing the informed consent and until 7 days after treatment discontinuation (up to a maximum of 28 days).
Serious and other Adverse Events were assessed using the Safety Set (SAF) dataset. The SAF dataset included 84 patients in the AZD1656 arm and 69 patients in the placebo arm, All-Cause Mortality was assessed using the Full Analysis Set (FAS) dataset. The FAS dataset included 80 patients in the AZD1656 arm and 73 patients in the placebo arm.
|
2.9%
2/69 • Number of events 2 • All AEs, including SAEs, were captured after signing the informed consent and until 7 days after treatment discontinuation (up to a maximum of 28 days).
Serious and other Adverse Events were assessed using the Safety Set (SAF) dataset. The SAF dataset included 84 patients in the AZD1656 arm and 69 patients in the placebo arm, All-Cause Mortality was assessed using the Full Analysis Set (FAS) dataset. The FAS dataset included 80 patients in the AZD1656 arm and 73 patients in the placebo arm.
|
|
Blood and lymphatic system disorders
Leucocytosis
|
1.2%
1/84 • Number of events 1 • All AEs, including SAEs, were captured after signing the informed consent and until 7 days after treatment discontinuation (up to a maximum of 28 days).
Serious and other Adverse Events were assessed using the Safety Set (SAF) dataset. The SAF dataset included 84 patients in the AZD1656 arm and 69 patients in the placebo arm, All-Cause Mortality was assessed using the Full Analysis Set (FAS) dataset. The FAS dataset included 80 patients in the AZD1656 arm and 73 patients in the placebo arm.
|
0.00%
0/69 • All AEs, including SAEs, were captured after signing the informed consent and until 7 days after treatment discontinuation (up to a maximum of 28 days).
Serious and other Adverse Events were assessed using the Safety Set (SAF) dataset. The SAF dataset included 84 patients in the AZD1656 arm and 69 patients in the placebo arm, All-Cause Mortality was assessed using the Full Analysis Set (FAS) dataset. The FAS dataset included 80 patients in the AZD1656 arm and 73 patients in the placebo arm.
|
|
Blood and lymphatic system disorders
Neutrophilia
|
1.2%
1/84 • Number of events 1 • All AEs, including SAEs, were captured after signing the informed consent and until 7 days after treatment discontinuation (up to a maximum of 28 days).
Serious and other Adverse Events were assessed using the Safety Set (SAF) dataset. The SAF dataset included 84 patients in the AZD1656 arm and 69 patients in the placebo arm, All-Cause Mortality was assessed using the Full Analysis Set (FAS) dataset. The FAS dataset included 80 patients in the AZD1656 arm and 73 patients in the placebo arm.
|
0.00%
0/69 • All AEs, including SAEs, were captured after signing the informed consent and until 7 days after treatment discontinuation (up to a maximum of 28 days).
Serious and other Adverse Events were assessed using the Safety Set (SAF) dataset. The SAF dataset included 84 patients in the AZD1656 arm and 69 patients in the placebo arm, All-Cause Mortality was assessed using the Full Analysis Set (FAS) dataset. The FAS dataset included 80 patients in the AZD1656 arm and 73 patients in the placebo arm.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/84 • All AEs, including SAEs, were captured after signing the informed consent and until 7 days after treatment discontinuation (up to a maximum of 28 days).
Serious and other Adverse Events were assessed using the Safety Set (SAF) dataset. The SAF dataset included 84 patients in the AZD1656 arm and 69 patients in the placebo arm, All-Cause Mortality was assessed using the Full Analysis Set (FAS) dataset. The FAS dataset included 80 patients in the AZD1656 arm and 73 patients in the placebo arm.
|
1.4%
1/69 • Number of events 1 • All AEs, including SAEs, were captured after signing the informed consent and until 7 days after treatment discontinuation (up to a maximum of 28 days).
Serious and other Adverse Events were assessed using the Safety Set (SAF) dataset. The SAF dataset included 84 patients in the AZD1656 arm and 69 patients in the placebo arm, All-Cause Mortality was assessed using the Full Analysis Set (FAS) dataset. The FAS dataset included 80 patients in the AZD1656 arm and 73 patients in the placebo arm.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
4.8%
4/84 • Number of events 4 • All AEs, including SAEs, were captured after signing the informed consent and until 7 days after treatment discontinuation (up to a maximum of 28 days).
Serious and other Adverse Events were assessed using the Safety Set (SAF) dataset. The SAF dataset included 84 patients in the AZD1656 arm and 69 patients in the placebo arm, All-Cause Mortality was assessed using the Full Analysis Set (FAS) dataset. The FAS dataset included 80 patients in the AZD1656 arm and 73 patients in the placebo arm.
|
4.3%
3/69 • Number of events 3 • All AEs, including SAEs, were captured after signing the informed consent and until 7 days after treatment discontinuation (up to a maximum of 28 days).
Serious and other Adverse Events were assessed using the Safety Set (SAF) dataset. The SAF dataset included 84 patients in the AZD1656 arm and 69 patients in the placebo arm, All-Cause Mortality was assessed using the Full Analysis Set (FAS) dataset. The FAS dataset included 80 patients in the AZD1656 arm and 73 patients in the placebo arm.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/84 • All AEs, including SAEs, were captured after signing the informed consent and until 7 days after treatment discontinuation (up to a maximum of 28 days).
Serious and other Adverse Events were assessed using the Safety Set (SAF) dataset. The SAF dataset included 84 patients in the AZD1656 arm and 69 patients in the placebo arm, All-Cause Mortality was assessed using the Full Analysis Set (FAS) dataset. The FAS dataset included 80 patients in the AZD1656 arm and 73 patients in the placebo arm.
|
1.4%
1/69 • Number of events 1 • All AEs, including SAEs, were captured after signing the informed consent and until 7 days after treatment discontinuation (up to a maximum of 28 days).
Serious and other Adverse Events were assessed using the Safety Set (SAF) dataset. The SAF dataset included 84 patients in the AZD1656 arm and 69 patients in the placebo arm, All-Cause Mortality was assessed using the Full Analysis Set (FAS) dataset. The FAS dataset included 80 patients in the AZD1656 arm and 73 patients in the placebo arm.
|
|
Nervous system disorders
Reversible ischaemic neurological deficit
|
1.2%
1/84 • Number of events 1 • All AEs, including SAEs, were captured after signing the informed consent and until 7 days after treatment discontinuation (up to a maximum of 28 days).
Serious and other Adverse Events were assessed using the Safety Set (SAF) dataset. The SAF dataset included 84 patients in the AZD1656 arm and 69 patients in the placebo arm, All-Cause Mortality was assessed using the Full Analysis Set (FAS) dataset. The FAS dataset included 80 patients in the AZD1656 arm and 73 patients in the placebo arm.
|
0.00%
0/69 • All AEs, including SAEs, were captured after signing the informed consent and until 7 days after treatment discontinuation (up to a maximum of 28 days).
Serious and other Adverse Events were assessed using the Safety Set (SAF) dataset. The SAF dataset included 84 patients in the AZD1656 arm and 69 patients in the placebo arm, All-Cause Mortality was assessed using the Full Analysis Set (FAS) dataset. The FAS dataset included 80 patients in the AZD1656 arm and 73 patients in the placebo arm.
|
|
Ear and labyrinth disorders
Ear pain
|
1.2%
1/84 • Number of events 1 • All AEs, including SAEs, were captured after signing the informed consent and until 7 days after treatment discontinuation (up to a maximum of 28 days).
Serious and other Adverse Events were assessed using the Safety Set (SAF) dataset. The SAF dataset included 84 patients in the AZD1656 arm and 69 patients in the placebo arm, All-Cause Mortality was assessed using the Full Analysis Set (FAS) dataset. The FAS dataset included 80 patients in the AZD1656 arm and 73 patients in the placebo arm.
|
0.00%
0/69 • All AEs, including SAEs, were captured after signing the informed consent and until 7 days after treatment discontinuation (up to a maximum of 28 days).
Serious and other Adverse Events were assessed using the Safety Set (SAF) dataset. The SAF dataset included 84 patients in the AZD1656 arm and 69 patients in the placebo arm, All-Cause Mortality was assessed using the Full Analysis Set (FAS) dataset. The FAS dataset included 80 patients in the AZD1656 arm and 73 patients in the placebo arm.
|
|
Psychiatric disorders
Restlessness
|
0.00%
0/84 • All AEs, including SAEs, were captured after signing the informed consent and until 7 days after treatment discontinuation (up to a maximum of 28 days).
Serious and other Adverse Events were assessed using the Safety Set (SAF) dataset. The SAF dataset included 84 patients in the AZD1656 arm and 69 patients in the placebo arm, All-Cause Mortality was assessed using the Full Analysis Set (FAS) dataset. The FAS dataset included 80 patients in the AZD1656 arm and 73 patients in the placebo arm.
|
1.4%
1/69 • Number of events 1 • All AEs, including SAEs, were captured after signing the informed consent and until 7 days after treatment discontinuation (up to a maximum of 28 days).
Serious and other Adverse Events were assessed using the Safety Set (SAF) dataset. The SAF dataset included 84 patients in the AZD1656 arm and 69 patients in the placebo arm, All-Cause Mortality was assessed using the Full Analysis Set (FAS) dataset. The FAS dataset included 80 patients in the AZD1656 arm and 73 patients in the placebo arm.
|
|
Gastrointestinal disorders
Diarrhoea
|
2.4%
2/84 • Number of events 2 • All AEs, including SAEs, were captured after signing the informed consent and until 7 days after treatment discontinuation (up to a maximum of 28 days).
Serious and other Adverse Events were assessed using the Safety Set (SAF) dataset. The SAF dataset included 84 patients in the AZD1656 arm and 69 patients in the placebo arm, All-Cause Mortality was assessed using the Full Analysis Set (FAS) dataset. The FAS dataset included 80 patients in the AZD1656 arm and 73 patients in the placebo arm.
|
0.00%
0/69 • All AEs, including SAEs, were captured after signing the informed consent and until 7 days after treatment discontinuation (up to a maximum of 28 days).
Serious and other Adverse Events were assessed using the Safety Set (SAF) dataset. The SAF dataset included 84 patients in the AZD1656 arm and 69 patients in the placebo arm, All-Cause Mortality was assessed using the Full Analysis Set (FAS) dataset. The FAS dataset included 80 patients in the AZD1656 arm and 73 patients in the placebo arm.
|
|
Gastrointestinal disorders
Abdominal tenderness
|
1.2%
1/84 • Number of events 1 • All AEs, including SAEs, were captured after signing the informed consent and until 7 days after treatment discontinuation (up to a maximum of 28 days).
Serious and other Adverse Events were assessed using the Safety Set (SAF) dataset. The SAF dataset included 84 patients in the AZD1656 arm and 69 patients in the placebo arm, All-Cause Mortality was assessed using the Full Analysis Set (FAS) dataset. The FAS dataset included 80 patients in the AZD1656 arm and 73 patients in the placebo arm.
|
0.00%
0/69 • All AEs, including SAEs, were captured after signing the informed consent and until 7 days after treatment discontinuation (up to a maximum of 28 days).
Serious and other Adverse Events were assessed using the Safety Set (SAF) dataset. The SAF dataset included 84 patients in the AZD1656 arm and 69 patients in the placebo arm, All-Cause Mortality was assessed using the Full Analysis Set (FAS) dataset. The FAS dataset included 80 patients in the AZD1656 arm and 73 patients in the placebo arm.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/84 • All AEs, including SAEs, were captured after signing the informed consent and until 7 days after treatment discontinuation (up to a maximum of 28 days).
Serious and other Adverse Events were assessed using the Safety Set (SAF) dataset. The SAF dataset included 84 patients in the AZD1656 arm and 69 patients in the placebo arm, All-Cause Mortality was assessed using the Full Analysis Set (FAS) dataset. The FAS dataset included 80 patients in the AZD1656 arm and 73 patients in the placebo arm.
|
1.4%
1/69 • Number of events 1 • All AEs, including SAEs, were captured after signing the informed consent and until 7 days after treatment discontinuation (up to a maximum of 28 days).
Serious and other Adverse Events were assessed using the Safety Set (SAF) dataset. The SAF dataset included 84 patients in the AZD1656 arm and 69 patients in the placebo arm, All-Cause Mortality was assessed using the Full Analysis Set (FAS) dataset. The FAS dataset included 80 patients in the AZD1656 arm and 73 patients in the placebo arm.
|
|
Renal and urinary disorders
Acute kidney injury
|
1.2%
1/84 • Number of events 1 • All AEs, including SAEs, were captured after signing the informed consent and until 7 days after treatment discontinuation (up to a maximum of 28 days).
Serious and other Adverse Events were assessed using the Safety Set (SAF) dataset. The SAF dataset included 84 patients in the AZD1656 arm and 69 patients in the placebo arm, All-Cause Mortality was assessed using the Full Analysis Set (FAS) dataset. The FAS dataset included 80 patients in the AZD1656 arm and 73 patients in the placebo arm.
|
0.00%
0/69 • All AEs, including SAEs, were captured after signing the informed consent and until 7 days after treatment discontinuation (up to a maximum of 28 days).
Serious and other Adverse Events were assessed using the Safety Set (SAF) dataset. The SAF dataset included 84 patients in the AZD1656 arm and 69 patients in the placebo arm, All-Cause Mortality was assessed using the Full Analysis Set (FAS) dataset. The FAS dataset included 80 patients in the AZD1656 arm and 73 patients in the placebo arm.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/84 • All AEs, including SAEs, were captured after signing the informed consent and until 7 days after treatment discontinuation (up to a maximum of 28 days).
Serious and other Adverse Events were assessed using the Safety Set (SAF) dataset. The SAF dataset included 84 patients in the AZD1656 arm and 69 patients in the placebo arm, All-Cause Mortality was assessed using the Full Analysis Set (FAS) dataset. The FAS dataset included 80 patients in the AZD1656 arm and 73 patients in the placebo arm.
|
1.4%
1/69 • Number of events 1 • All AEs, including SAEs, were captured after signing the informed consent and until 7 days after treatment discontinuation (up to a maximum of 28 days).
Serious and other Adverse Events were assessed using the Safety Set (SAF) dataset. The SAF dataset included 84 patients in the AZD1656 arm and 69 patients in the placebo arm, All-Cause Mortality was assessed using the Full Analysis Set (FAS) dataset. The FAS dataset included 80 patients in the AZD1656 arm and 73 patients in the placebo arm.
|
|
Renal and urinary disorders
Urinary retention
|
1.2%
1/84 • Number of events 1 • All AEs, including SAEs, were captured after signing the informed consent and until 7 days after treatment discontinuation (up to a maximum of 28 days).
Serious and other Adverse Events were assessed using the Safety Set (SAF) dataset. The SAF dataset included 84 patients in the AZD1656 arm and 69 patients in the placebo arm, All-Cause Mortality was assessed using the Full Analysis Set (FAS) dataset. The FAS dataset included 80 patients in the AZD1656 arm and 73 patients in the placebo arm.
|
0.00%
0/69 • All AEs, including SAEs, were captured after signing the informed consent and until 7 days after treatment discontinuation (up to a maximum of 28 days).
Serious and other Adverse Events were assessed using the Safety Set (SAF) dataset. The SAF dataset included 84 patients in the AZD1656 arm and 69 patients in the placebo arm, All-Cause Mortality was assessed using the Full Analysis Set (FAS) dataset. The FAS dataset included 80 patients in the AZD1656 arm and 73 patients in the placebo arm.
|
|
Hepatobiliary disorders
Hepatitis toxic
|
1.2%
1/84 • Number of events 1 • All AEs, including SAEs, were captured after signing the informed consent and until 7 days after treatment discontinuation (up to a maximum of 28 days).
Serious and other Adverse Events were assessed using the Safety Set (SAF) dataset. The SAF dataset included 84 patients in the AZD1656 arm and 69 patients in the placebo arm, All-Cause Mortality was assessed using the Full Analysis Set (FAS) dataset. The FAS dataset included 80 patients in the AZD1656 arm and 73 patients in the placebo arm.
|
0.00%
0/69 • All AEs, including SAEs, were captured after signing the informed consent and until 7 days after treatment discontinuation (up to a maximum of 28 days).
Serious and other Adverse Events were assessed using the Safety Set (SAF) dataset. The SAF dataset included 84 patients in the AZD1656 arm and 69 patients in the placebo arm, All-Cause Mortality was assessed using the Full Analysis Set (FAS) dataset. The FAS dataset included 80 patients in the AZD1656 arm and 73 patients in the placebo arm.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
9.5%
8/84 • Number of events 13 • All AEs, including SAEs, were captured after signing the informed consent and until 7 days after treatment discontinuation (up to a maximum of 28 days).
Serious and other Adverse Events were assessed using the Safety Set (SAF) dataset. The SAF dataset included 84 patients in the AZD1656 arm and 69 patients in the placebo arm, All-Cause Mortality was assessed using the Full Analysis Set (FAS) dataset. The FAS dataset included 80 patients in the AZD1656 arm and 73 patients in the placebo arm.
|
1.4%
1/69 • Number of events 1 • All AEs, including SAEs, were captured after signing the informed consent and until 7 days after treatment discontinuation (up to a maximum of 28 days).
Serious and other Adverse Events were assessed using the Safety Set (SAF) dataset. The SAF dataset included 84 patients in the AZD1656 arm and 69 patients in the placebo arm, All-Cause Mortality was assessed using the Full Analysis Set (FAS) dataset. The FAS dataset included 80 patients in the AZD1656 arm and 73 patients in the placebo arm.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
4.8%
4/84 • Number of events 4 • All AEs, including SAEs, were captured after signing the informed consent and until 7 days after treatment discontinuation (up to a maximum of 28 days).
Serious and other Adverse Events were assessed using the Safety Set (SAF) dataset. The SAF dataset included 84 patients in the AZD1656 arm and 69 patients in the placebo arm, All-Cause Mortality was assessed using the Full Analysis Set (FAS) dataset. The FAS dataset included 80 patients in the AZD1656 arm and 73 patients in the placebo arm.
|
1.4%
1/69 • Number of events 1 • All AEs, including SAEs, were captured after signing the informed consent and until 7 days after treatment discontinuation (up to a maximum of 28 days).
Serious and other Adverse Events were assessed using the Safety Set (SAF) dataset. The SAF dataset included 84 patients in the AZD1656 arm and 69 patients in the placebo arm, All-Cause Mortality was assessed using the Full Analysis Set (FAS) dataset. The FAS dataset included 80 patients in the AZD1656 arm and 73 patients in the placebo arm.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
4.8%
4/84 • Number of events 4 • All AEs, including SAEs, were captured after signing the informed consent and until 7 days after treatment discontinuation (up to a maximum of 28 days).
Serious and other Adverse Events were assessed using the Safety Set (SAF) dataset. The SAF dataset included 84 patients in the AZD1656 arm and 69 patients in the placebo arm, All-Cause Mortality was assessed using the Full Analysis Set (FAS) dataset. The FAS dataset included 80 patients in the AZD1656 arm and 73 patients in the placebo arm.
|
0.00%
0/69 • All AEs, including SAEs, were captured after signing the informed consent and until 7 days after treatment discontinuation (up to a maximum of 28 days).
Serious and other Adverse Events were assessed using the Safety Set (SAF) dataset. The SAF dataset included 84 patients in the AZD1656 arm and 69 patients in the placebo arm, All-Cause Mortality was assessed using the Full Analysis Set (FAS) dataset. The FAS dataset included 80 patients in the AZD1656 arm and 73 patients in the placebo arm.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
2.4%
2/84 • Number of events 2 • All AEs, including SAEs, were captured after signing the informed consent and until 7 days after treatment discontinuation (up to a maximum of 28 days).
Serious and other Adverse Events were assessed using the Safety Set (SAF) dataset. The SAF dataset included 84 patients in the AZD1656 arm and 69 patients in the placebo arm, All-Cause Mortality was assessed using the Full Analysis Set (FAS) dataset. The FAS dataset included 80 patients in the AZD1656 arm and 73 patients in the placebo arm.
|
0.00%
0/69 • All AEs, including SAEs, were captured after signing the informed consent and until 7 days after treatment discontinuation (up to a maximum of 28 days).
Serious and other Adverse Events were assessed using the Safety Set (SAF) dataset. The SAF dataset included 84 patients in the AZD1656 arm and 69 patients in the placebo arm, All-Cause Mortality was assessed using the Full Analysis Set (FAS) dataset. The FAS dataset included 80 patients in the AZD1656 arm and 73 patients in the placebo arm.
|
|
Infections and infestations
Oral candidiasis
|
1.2%
1/84 • Number of events 1 • All AEs, including SAEs, were captured after signing the informed consent and until 7 days after treatment discontinuation (up to a maximum of 28 days).
Serious and other Adverse Events were assessed using the Safety Set (SAF) dataset. The SAF dataset included 84 patients in the AZD1656 arm and 69 patients in the placebo arm, All-Cause Mortality was assessed using the Full Analysis Set (FAS) dataset. The FAS dataset included 80 patients in the AZD1656 arm and 73 patients in the placebo arm.
|
1.4%
1/69 • Number of events 1 • All AEs, including SAEs, were captured after signing the informed consent and until 7 days after treatment discontinuation (up to a maximum of 28 days).
Serious and other Adverse Events were assessed using the Safety Set (SAF) dataset. The SAF dataset included 84 patients in the AZD1656 arm and 69 patients in the placebo arm, All-Cause Mortality was assessed using the Full Analysis Set (FAS) dataset. The FAS dataset included 80 patients in the AZD1656 arm and 73 patients in the placebo arm.
|
|
Infections and infestations
Sepsis
|
1.2%
1/84 • Number of events 1 • All AEs, including SAEs, were captured after signing the informed consent and until 7 days after treatment discontinuation (up to a maximum of 28 days).
Serious and other Adverse Events were assessed using the Safety Set (SAF) dataset. The SAF dataset included 84 patients in the AZD1656 arm and 69 patients in the placebo arm, All-Cause Mortality was assessed using the Full Analysis Set (FAS) dataset. The FAS dataset included 80 patients in the AZD1656 arm and 73 patients in the placebo arm.
|
0.00%
0/69 • All AEs, including SAEs, were captured after signing the informed consent and until 7 days after treatment discontinuation (up to a maximum of 28 days).
Serious and other Adverse Events were assessed using the Safety Set (SAF) dataset. The SAF dataset included 84 patients in the AZD1656 arm and 69 patients in the placebo arm, All-Cause Mortality was assessed using the Full Analysis Set (FAS) dataset. The FAS dataset included 80 patients in the AZD1656 arm and 73 patients in the placebo arm.
|
|
Infections and infestations
Cystitis
|
0.00%
0/84 • All AEs, including SAEs, were captured after signing the informed consent and until 7 days after treatment discontinuation (up to a maximum of 28 days).
Serious and other Adverse Events were assessed using the Safety Set (SAF) dataset. The SAF dataset included 84 patients in the AZD1656 arm and 69 patients in the placebo arm, All-Cause Mortality was assessed using the Full Analysis Set (FAS) dataset. The FAS dataset included 80 patients in the AZD1656 arm and 73 patients in the placebo arm.
|
1.4%
1/69 • Number of events 1 • All AEs, including SAEs, were captured after signing the informed consent and until 7 days after treatment discontinuation (up to a maximum of 28 days).
Serious and other Adverse Events were assessed using the Safety Set (SAF) dataset. The SAF dataset included 84 patients in the AZD1656 arm and 69 patients in the placebo arm, All-Cause Mortality was assessed using the Full Analysis Set (FAS) dataset. The FAS dataset included 80 patients in the AZD1656 arm and 73 patients in the placebo arm.
|
|
Infections and infestations
Device related infection
|
1.2%
1/84 • Number of events 1 • All AEs, including SAEs, were captured after signing the informed consent and until 7 days after treatment discontinuation (up to a maximum of 28 days).
Serious and other Adverse Events were assessed using the Safety Set (SAF) dataset. The SAF dataset included 84 patients in the AZD1656 arm and 69 patients in the placebo arm, All-Cause Mortality was assessed using the Full Analysis Set (FAS) dataset. The FAS dataset included 80 patients in the AZD1656 arm and 73 patients in the placebo arm.
|
0.00%
0/69 • All AEs, including SAEs, were captured after signing the informed consent and until 7 days after treatment discontinuation (up to a maximum of 28 days).
Serious and other Adverse Events were assessed using the Safety Set (SAF) dataset. The SAF dataset included 84 patients in the AZD1656 arm and 69 patients in the placebo arm, All-Cause Mortality was assessed using the Full Analysis Set (FAS) dataset. The FAS dataset included 80 patients in the AZD1656 arm and 73 patients in the placebo arm.
|
|
Infections and infestations
Oral fungal infection
|
1.2%
1/84 • Number of events 1 • All AEs, including SAEs, were captured after signing the informed consent and until 7 days after treatment discontinuation (up to a maximum of 28 days).
Serious and other Adverse Events were assessed using the Safety Set (SAF) dataset. The SAF dataset included 84 patients in the AZD1656 arm and 69 patients in the placebo arm, All-Cause Mortality was assessed using the Full Analysis Set (FAS) dataset. The FAS dataset included 80 patients in the AZD1656 arm and 73 patients in the placebo arm.
|
0.00%
0/69 • All AEs, including SAEs, were captured after signing the informed consent and until 7 days after treatment discontinuation (up to a maximum of 28 days).
Serious and other Adverse Events were assessed using the Safety Set (SAF) dataset. The SAF dataset included 84 patients in the AZD1656 arm and 69 patients in the placebo arm, All-Cause Mortality was assessed using the Full Analysis Set (FAS) dataset. The FAS dataset included 80 patients in the AZD1656 arm and 73 patients in the placebo arm.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/84 • All AEs, including SAEs, were captured after signing the informed consent and until 7 days after treatment discontinuation (up to a maximum of 28 days).
Serious and other Adverse Events were assessed using the Safety Set (SAF) dataset. The SAF dataset included 84 patients in the AZD1656 arm and 69 patients in the placebo arm, All-Cause Mortality was assessed using the Full Analysis Set (FAS) dataset. The FAS dataset included 80 patients in the AZD1656 arm and 73 patients in the placebo arm.
|
1.4%
1/69 • Number of events 1 • All AEs, including SAEs, were captured after signing the informed consent and until 7 days after treatment discontinuation (up to a maximum of 28 days).
Serious and other Adverse Events were assessed using the Safety Set (SAF) dataset. The SAF dataset included 84 patients in the AZD1656 arm and 69 patients in the placebo arm, All-Cause Mortality was assessed using the Full Analysis Set (FAS) dataset. The FAS dataset included 80 patients in the AZD1656 arm and 73 patients in the placebo arm.
|
|
Infections and infestations
Urinary tract infection
|
1.2%
1/84 • Number of events 1 • All AEs, including SAEs, were captured after signing the informed consent and until 7 days after treatment discontinuation (up to a maximum of 28 days).
Serious and other Adverse Events were assessed using the Safety Set (SAF) dataset. The SAF dataset included 84 patients in the AZD1656 arm and 69 patients in the placebo arm, All-Cause Mortality was assessed using the Full Analysis Set (FAS) dataset. The FAS dataset included 80 patients in the AZD1656 arm and 73 patients in the placebo arm.
|
0.00%
0/69 • All AEs, including SAEs, were captured after signing the informed consent and until 7 days after treatment discontinuation (up to a maximum of 28 days).
Serious and other Adverse Events were assessed using the Safety Set (SAF) dataset. The SAF dataset included 84 patients in the AZD1656 arm and 69 patients in the placebo arm, All-Cause Mortality was assessed using the Full Analysis Set (FAS) dataset. The FAS dataset included 80 patients in the AZD1656 arm and 73 patients in the placebo arm.
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
0.00%
0/84 • All AEs, including SAEs, were captured after signing the informed consent and until 7 days after treatment discontinuation (up to a maximum of 28 days).
Serious and other Adverse Events were assessed using the Safety Set (SAF) dataset. The SAF dataset included 84 patients in the AZD1656 arm and 69 patients in the placebo arm, All-Cause Mortality was assessed using the Full Analysis Set (FAS) dataset. The FAS dataset included 80 patients in the AZD1656 arm and 73 patients in the placebo arm.
|
1.4%
1/69 • Number of events 1 • All AEs, including SAEs, were captured after signing the informed consent and until 7 days after treatment discontinuation (up to a maximum of 28 days).
Serious and other Adverse Events were assessed using the Safety Set (SAF) dataset. The SAF dataset included 84 patients in the AZD1656 arm and 69 patients in the placebo arm, All-Cause Mortality was assessed using the Full Analysis Set (FAS) dataset. The FAS dataset included 80 patients in the AZD1656 arm and 73 patients in the placebo arm.
|
Additional Information
Mike Johnson, Managing Director
St George Street Capital
Phone: +447768335460
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place