Trial Outcomes & Findings for Changes in NT-proBNP, Safety, and Tolerability in HFpEF Patients With a WHF Event (HFpEF Decompensation) Who Have Been Stabilized and Initiated at the Time of or Within 30 Days Post-decompensation (PARAGLIDE-HF) (NCT NCT03988634)
NCT ID: NCT03988634
Last Updated: 2025-03-06
Results Overview
To demonstrate the effect of sacubitril/valsartan vs. valsartan on time-averaged proportional change in N-terminal pro-brain natriuretic peptide (NT-proBNP) from baseline to weeks 4 and 8 in heart failure with preserved ejection fraction (HFpEF) patients with a worsening heart failure event (HFpEF decompensation) who have been stabilized for and initiated at the time of or within 30 days post-decompensation. Plasma NT-proBNP (pg/mL) values were averaged from Week 4 and Week 8 visits. The change from baseline to average of Week 4 and Week 8 was expressed as the geometric mean of the ratio: Week - 8/Baseline. NT-proBNP is a protein produced in large amounts by the heart when it is not working properly, as in heart failure. Baseline value was the last non-missing assessment of plasma NT-proBNP before the first administration of study drug.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
467 participants
Primary outcome timeframe
Baseline, Average of Week 4 and Week 8
Results posted on
2025-03-06
Participant Flow
Of 586 patients screened for the study, 467 patients were randomized to receive treatment, and 466 randomized patients were treated. The study had 90 sites in the US and 10 sites in Canada
Patients were randomized 1:1 to sacubitril/valsartan or valsartan. Randomized patients were deemed hemodynamically stabilized and needed to meet all inclusion and none of the exclusion criteria. At the randomization visit, all eligible patients were randomized via interactive response technology to one of the treatment arms.
Participant milestones
| Measure |
Double-blind Phase Sacubitril+ Valsartan (LCZ696)
Study treatment was titrated to the target dose of sacubitril/valsartan (LCZ696) 97/103 mg twice daily (Dose Level 3).
|
Double-blind Phase Valsartan
Study treatment was titrated to the target dose of valsartan 160 mg twice daily (Dose Level 3).
|
Open-label Phase Sacubitril+ Valsartan
Participants recruited under Protocol Version 00 (Original Protocol) and who had completed the double-blind phase before protocol amendment 01 was released. Participants were in the open-label phase from Week 8 to Week 12.
|
|---|---|---|---|
|
Double-Blind
STARTED
|
234
|
233
|
0
|
|
Double-Blind
Treated Patients
|
233
|
233
|
0
|
|
Double-Blind
COMPLETED
|
173
|
182
|
0
|
|
Double-Blind
NOT COMPLETED
|
61
|
51
|
0
|
|
Open-Label
STARTED
|
0
|
0
|
50
|
|
Open-Label
COMPLETED
|
0
|
0
|
41
|
|
Open-Label
NOT COMPLETED
|
0
|
0
|
9
|
Reasons for withdrawal
| Measure |
Double-blind Phase Sacubitril+ Valsartan (LCZ696)
Study treatment was titrated to the target dose of sacubitril/valsartan (LCZ696) 97/103 mg twice daily (Dose Level 3).
|
Double-blind Phase Valsartan
Study treatment was titrated to the target dose of valsartan 160 mg twice daily (Dose Level 3).
|
Open-label Phase Sacubitril+ Valsartan
Participants recruited under Protocol Version 00 (Original Protocol) and who had completed the double-blind phase before protocol amendment 01 was released. Participants were in the open-label phase from Week 8 to Week 12.
|
|---|---|---|---|
|
Double-Blind
Adverse Event
|
4
|
0
|
0
|
|
Double-Blind
Death
|
18
|
26
|
0
|
|
Double-Blind
Lost to Follow-up
|
6
|
7
|
0
|
|
Double-Blind
Physician Decision
|
9
|
5
|
0
|
|
Double-Blind
Subject decision
|
24
|
13
|
0
|
|
Open-Label
Adverse Event
|
0
|
0
|
7
|
|
Open-Label
Physician Decision
|
0
|
0
|
1
|
|
Open-Label
Technical problems
|
0
|
0
|
1
|
Baseline Characteristics
Changes in NT-proBNP, Safety, and Tolerability in HFpEF Patients With a WHF Event (HFpEF Decompensation) Who Have Been Stabilized and Initiated at the Time of or Within 30 Days Post-decompensation (PARAGLIDE-HF)
Baseline characteristics by cohort
| Measure |
Sacubitril/Valsartan (LCZ696)
n=233 Participants
Study treatment was titrated to the target dose of sacubitril/valsartan (LCZ696) 97/103 mg twice daily (Dose Level 3).
|
Valsartan
n=233 Participants
Study treatment was titrated to the target dose of valsartan 160 mg twice daily (Dose Level 3).
|
Total
n=466 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
69.2 years
STANDARD_DEVIATION 11.95 • n=5 Participants
|
70.5 years
STANDARD_DEVIATION 11.56 • n=7 Participants
|
69.8 years
STANDARD_DEVIATION 11.76 • n=5 Participants
|
|
Sex: Female, Male
Female
|
121 Participants
n=5 Participants
|
121 Participants
n=7 Participants
|
242 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
112 Participants
n=5 Participants
|
112 Participants
n=7 Participants
|
224 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
176 Participants
n=5 Participants
|
176 Participants
n=7 Participants
|
352 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
50 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
102 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Average of Week 4 and Week 8Population: Full analysis set: All patients to whom study treatment was assigned by randomization and at least 1 dose of study treatment was received. Patients with missing baseline NT-proBNP and/or missing data from both Weeks 4 and 8 were not included in the primary analysis.
To demonstrate the effect of sacubitril/valsartan vs. valsartan on time-averaged proportional change in N-terminal pro-brain natriuretic peptide (NT-proBNP) from baseline to weeks 4 and 8 in heart failure with preserved ejection fraction (HFpEF) patients with a worsening heart failure event (HFpEF decompensation) who have been stabilized for and initiated at the time of or within 30 days post-decompensation. Plasma NT-proBNP (pg/mL) values were averaged from Week 4 and Week 8 visits. The change from baseline to average of Week 4 and Week 8 was expressed as the geometric mean of the ratio: Week - 8/Baseline. NT-proBNP is a protein produced in large amounts by the heart when it is not working properly, as in heart failure. Baseline value was the last non-missing assessment of plasma NT-proBNP before the first administration of study drug.
Outcome measures
| Measure |
Sacubitril/Valsartan (LCZ696)
n=180 Participants
Study treatment was titrated to the target dose of sacubitril/valsartan (LCZ696) 97/103 mg twice daily (Dose Level 3).
|
Valsartan
n=197 Participants
Study treatment was titrated to the target dose of valsartan 160 mg twice daily (Dose Level 3).
|
Open-label Phase Sacubitril+ Valsartan
Participants recruited under Protocol Version 00 (Original Protocol) and who had completed the double-blind phase before protocol amendment 01 was released. Participants were in the open-label phase from Week 8 to Week 12.
|
|---|---|---|---|
|
Time-averaged Proportional Change in NT proBNP From Baseline to Weeks 4 and 8
|
0.7200 Geometric Mean Ratio
Interval 0.643 to 0.8062
|
0.8425 Geometric Mean Ratio
Interval 0.7561 to 0.9387
|
—
|
SECONDARY outcome
Timeframe: Up to 84 weeksPopulation: Full analysis set: All patients included in the double-blind phase to whom study treatment was assigned by randomization and at least 1 dose of study treatment was received.
This hierarchical composite endpoint consists of 4 ordered components: 1. Time to CV death, 2. Number and times of HF hospitalizations during follow-up, 3. Number and times of urgent HF visits during follow-up, 4. Time averaged proportional change in NT-proBNP from baseline to Weeks 4 and 8. This endpoint was analyzed estimating the unmatched win ratio by comparing every participant in the sacubitril/valsartan arm to every participant in the valsartan arm to determine a winner (unmatched pairing method). For every pair, a patient is labelled a 'winner' (i.e. achieve a better clinical outcome) or a 'loser'. Otherwise they are considered tied. The reported unit is the total "wins" or "ties" for each treatment group from performing such a hierarchical comparison.
Outcome measures
| Measure |
Sacubitril/Valsartan (LCZ696)
n=54289 Pairwise comparison
Study treatment was titrated to the target dose of sacubitril/valsartan (LCZ696) 97/103 mg twice daily (Dose Level 3).
|
Valsartan
n=54289 Pairwise comparison
Study treatment was titrated to the target dose of valsartan 160 mg twice daily (Dose Level 3).
|
Open-label Phase Sacubitril+ Valsartan
Participants recruited under Protocol Version 00 (Original Protocol) and who had completed the double-blind phase before protocol amendment 01 was released. Participants were in the open-label phase from Week 8 to Week 12.
|
|---|---|---|---|
|
Number of Pairwise Comparisons With Wins or Ties in the Endpoint Adjudication Committee (EAC)-Adjudicated Composite Hierarchical Outcome
Time to CV death wins
|
2170 Pairwise comparisons
|
1536 Pairwise comparisons
|
—
|
|
Number of Pairwise Comparisons With Wins or Ties in the Endpoint Adjudication Committee (EAC)-Adjudicated Composite Hierarchical Outcome
Time to CV death ties
|
50583 Pairwise comparisons
|
50583 Pairwise comparisons
|
—
|
|
Number of Pairwise Comparisons With Wins or Ties in the Endpoint Adjudication Committee (EAC)-Adjudicated Composite Hierarchical Outcome
Number and times of HF hospitalizations during follow-up wins
|
6963 Pairwise comparisons
|
6357 Pairwise comparisons
|
—
|
|
Number of Pairwise Comparisons With Wins or Ties in the Endpoint Adjudication Committee (EAC)-Adjudicated Composite Hierarchical Outcome
Number and times of HF hospitalizations during follow-up ties
|
37263 Pairwise comparisons
|
37263 Pairwise comparisons
|
—
|
|
Number of Pairwise Comparisons With Wins or Ties in the Endpoint Adjudication Committee (EAC)-Adjudicated Composite Hierarchical Outcome
Number and times of urgent HF visits during follow-up wins
|
930 Pairwise comparisons
|
572 Pairwise comparisons
|
—
|
|
Number of Pairwise Comparisons With Wins or Ties in the Endpoint Adjudication Committee (EAC)-Adjudicated Composite Hierarchical Outcome
Number and times of urgent HF visits during follow-up ties
|
35761 Pairwise comparisons
|
35761 Pairwise comparisons
|
—
|
|
Number of Pairwise Comparisons With Wins or Ties in the Endpoint Adjudication Committee (EAC)-Adjudicated Composite Hierarchical Outcome
Time-averaged proportional change in NT-proBNP wins
|
9987 Pairwise comparisons
|
8343 Pairwise comparisons
|
—
|
|
Number of Pairwise Comparisons With Wins or Ties in the Endpoint Adjudication Committee (EAC)-Adjudicated Composite Hierarchical Outcome
Time-averaged proportional change in NT-proBNP ties
|
17431 Pairwise comparisons
|
17431 Pairwise comparisons
|
—
|
|
Number of Pairwise Comparisons With Wins or Ties in the Endpoint Adjudication Committee (EAC)-Adjudicated Composite Hierarchical Outcome
Overall wins
|
20050 Pairwise comparisons
|
16808 Pairwise comparisons
|
—
|
|
Number of Pairwise Comparisons With Wins or Ties in the Endpoint Adjudication Committee (EAC)-Adjudicated Composite Hierarchical Outcome
Overall ties
|
17431 Pairwise comparisons
|
17431 Pairwise comparisons
|
—
|
SECONDARY outcome
Timeframe: Up to Week 84Population: Full analysis set: All patients included in the double-blind phase to whom study treatment was assigned by randomization and at least 1 dose of study treatment was received.
This endpoint calculated the cumulative number of the following composite events over time: * CV death * recurrent HF hospitalizations * recurrent urgent HF visits The time to these recurrent events was analyzed using the semi-parametric proportional rates model (abbreviated as LWYY model). The exposure-adjusted rate per 100 subject years (EAR) was calculated diving the total number of events by 100 subject years (total exposure up to event/censoring). The role of the Endpoint Adjudication Committee (EAC) was to ensure that all treatment outcomes were judged uniformly, using standard criteria and processes. Events that occurred in the double-blind treatment phase are included in the analysis.
Outcome measures
| Measure |
Sacubitril/Valsartan (LCZ696)
n=233 Participants
Study treatment was titrated to the target dose of sacubitril/valsartan (LCZ696) 97/103 mg twice daily (Dose Level 3).
|
Valsartan
n=233 Participants
Study treatment was titrated to the target dose of valsartan 160 mg twice daily (Dose Level 3).
|
Open-label Phase Sacubitril+ Valsartan
Participants recruited under Protocol Version 00 (Original Protocol) and who had completed the double-blind phase before protocol amendment 01 was released. Participants were in the open-label phase from Week 8 to Week 12.
|
|---|---|---|---|
|
EAC Adjudicated Recurrent Composite Events
|
63.519 events per 100 subject years
Interval 51.33 to 77.732
|
76.189 events per 100 subject years
Interval 63.01 to 91.31
|
—
|
SECONDARY outcome
Timeframe: Up to Week 84Population: Full analysis set: All patients included in the double-blind phase to whom study treatment was assigned by randomization and at least 1 dose of study treatment was received.
This endpoint calculated the incidences of a composite endpoint of worsening renal function defined as: * renal death (from adverse events data) * reaching end-stage renal disease (ESRD) (Sustained eGFR \<15mL/min/m2, chronic dialysis, or renal transplant) * ≥ 50% decline in estimated glomerular filtration rate (eGFR) relative to baseline \[using central laboratory measurements (scheduled or unscheduled visits)\] The Investigator-reported AE and central laboratory data was used to identified event of interest in this secondary endpoint. Events that occurred in the randomized double-blind treatment phase were included in the analysis.
Outcome measures
| Measure |
Sacubitril/Valsartan (LCZ696)
n=233 Participants
Study treatment was titrated to the target dose of sacubitril/valsartan (LCZ696) 97/103 mg twice daily (Dose Level 3).
|
Valsartan
n=233 Participants
Study treatment was titrated to the target dose of valsartan 160 mg twice daily (Dose Level 3).
|
Open-label Phase Sacubitril+ Valsartan
Participants recruited under Protocol Version 00 (Original Protocol) and who had completed the double-blind phase before protocol amendment 01 was released. Participants were in the open-label phase from Week 8 to Week 12.
|
|---|---|---|---|
|
Total Number of Confirmed Incidences of a Composite Endpoint of Worsening Renal Function
|
34 events of worsening renal function
|
46 events of worsening renal function
|
—
|
SECONDARY outcome
Timeframe: Baseline and Week 8Population: Full analysis set: All patients to whom study treatment was assigned by randomization and at least 1 dose of study treatment was received. Patients with missing baseline NT-proBNP and/or missing data from Week 8 were not included in the this analysis
This endpoint intended to assess the effect of sacubitril/valsartan vs. valsartan on change in N-terminal pro-brain natriuretic peptide (NT-proBNP) from baseline to Week 8. NT-proBNP is a protein produced in large amounts by the heart when it is not working properly, as in heart failure. The change from baseline to Week 8 was expressed as the geometric mean of the ratio: Week 8/Baseline.
Outcome measures
| Measure |
Sacubitril/Valsartan (LCZ696)
n=155 Participants
Study treatment was titrated to the target dose of sacubitril/valsartan (LCZ696) 97/103 mg twice daily (Dose Level 3).
|
Valsartan
n=172 Participants
Study treatment was titrated to the target dose of valsartan 160 mg twice daily (Dose Level 3).
|
Open-label Phase Sacubitril+ Valsartan
Participants recruited under Protocol Version 00 (Original Protocol) and who had completed the double-blind phase before protocol amendment 01 was released. Participants were in the open-label phase from Week 8 to Week 12.
|
|---|---|---|---|
|
Proportional Change in NT-proBNP From Baseline to Week 8
|
0.6778 Geometric mean ratio
Interval 0.5882 to 0.781
|
0.7275 Geometric mean ratio
Interval 0.6359 to 0.8323
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 4 and Week 8Population: Full analysis set: All patients to whom study treatment was assigned by randomization and at least 1 dose of study treatment was received. Patients with missing baseline hs-Troponin and/or missing data from both Weeks 4 and 8 were not included in the this analysis
This endpoint intended to assess the effect of sacubitril/valsartan vs. valsartan on change from baseline in high sensitivity (hs)-Troponin at Weeks 4 and 8. Analysis was repeated for both the visits, Week 4 and Week 8 separately. Hs-Troponin-T is a biomarker that is released from the heart under stress or injury conditions. The change from baseline to Week 4 and Week 8 was expressed as the geometric mean of the ratio: Week 4 or Week 8/Baseline.
Outcome measures
| Measure |
Sacubitril/Valsartan (LCZ696)
n=171 Participants
Study treatment was titrated to the target dose of sacubitril/valsartan (LCZ696) 97/103 mg twice daily (Dose Level 3).
|
Valsartan
n=187 Participants
Study treatment was titrated to the target dose of valsartan 160 mg twice daily (Dose Level 3).
|
Open-label Phase Sacubitril+ Valsartan
Participants recruited under Protocol Version 00 (Original Protocol) and who had completed the double-blind phase before protocol amendment 01 was released. Participants were in the open-label phase from Week 8 to Week 12.
|
|---|---|---|---|
|
Proportional Change From Baseline in Hs-Troponin at Weeks 4 and 8
Week 4
|
0.8124 Geometric mean ratio
Interval 0.76 to 0.87
|
0.9826 Geometric mean ratio
Interval 0.92 to 1.05
|
—
|
|
Proportional Change From Baseline in Hs-Troponin at Weeks 4 and 8
Week 8
|
0.7545 Geometric mean ratio
Interval 0.7 to 0.81
|
0.9310 Geometric mean ratio
Interval 0.87 to 1.0
|
—
|
SECONDARY outcome
Timeframe: Randomization, Week 8, Week 24Population: Full analysis set: All patients included in the double-blind phase to whom study treatment was assigned by randomization and at least 1 dose of study treatment was received
The dosing level has been summarized by treatment group and in-/out-of-hospital randomization status. The dose levels used were: Dose Level 1: 40 mg valsartan or 24/26 mg \[50 mg\] LCZ696, BID; Dose Level 2: 80 mg valsartan or 49/51 mg \[100 mg\] LCZ696, BID; Dose Level 3: 160 mg valsartan or 97/103 mg \[200 mg\] LCZ696, BID Patients counted as "Off Treatment" are those who prematurely permanently discontinued study treatment but continued with visits. Patients counted as "No Treatment" are those who permanently discontinued with both study treatment and study visits
Outcome measures
| Measure |
Sacubitril/Valsartan (LCZ696)
n=233 Participants
Study treatment was titrated to the target dose of sacubitril/valsartan (LCZ696) 97/103 mg twice daily (Dose Level 3).
|
Valsartan
n=233 Participants
Study treatment was titrated to the target dose of valsartan 160 mg twice daily (Dose Level 3).
|
Open-label Phase Sacubitril+ Valsartan
Participants recruited under Protocol Version 00 (Original Protocol) and who had completed the double-blind phase before protocol amendment 01 was released. Participants were in the open-label phase from Week 8 to Week 12.
|
|---|---|---|---|
|
Dosing Levels and Discontinuations
Participants Randomized Out-of-hospital; Timepoint: Week 24 · No Treatment
|
3 Participants
|
9 Participants
|
—
|
|
Dosing Levels and Discontinuations
Participants Randomized In-Hospital ; Timepoint: Randomization (initial dose) · Dose Level 1
|
133 Participants
|
130 Participants
|
—
|
|
Dosing Levels and Discontinuations
Participants Randomized In-Hospital ; Timepoint: Randomization (initial dose) · Dose Level 2
|
29 Participants
|
32 Participants
|
—
|
|
Dosing Levels and Discontinuations
Participants Randomized In-Hospital ; Timepoint: Randomization (initial dose) · Dose Level 3
|
0 Participants
|
0 Participants
|
—
|
|
Dosing Levels and Discontinuations
Participants Randomized In-Hospital ; Timepoint: Randomization (initial dose) · No Treatment
|
0 Participants
|
0 Participants
|
—
|
|
Dosing Levels and Discontinuations
Participants Randomized In-Hospital ; Timepoint: Randomization (initial dose) · Off Treatment
|
0 Participants
|
0 Participants
|
—
|
|
Dosing Levels and Discontinuations
Participants Randomized In-Hospital ; Timepoint: Week 8 · Dose Level 1
|
29 Participants
|
40 Participants
|
—
|
|
Dosing Levels and Discontinuations
Participants Randomized In-Hospital ; Timepoint: Week 8 · Dose Level 2
|
22 Participants
|
23 Participants
|
—
|
|
Dosing Levels and Discontinuations
Participants Randomized In-Hospital ; Timepoint: Week 8 · Dose Level 3
|
48 Participants
|
48 Participants
|
—
|
|
Dosing Levels and Discontinuations
Participants Randomized In-Hospital ; Timepoint: Week 8 · No Treatment
|
27 Participants
|
18 Participants
|
—
|
|
Dosing Levels and Discontinuations
Participants Randomized In-Hospital ; Timepoint: Week 8 · Off Treatment
|
10 Participants
|
5 Participants
|
—
|
|
Dosing Levels and Discontinuations
Participants Randomized In-Hospital ; Timepoint: Week 24 · Dose Level 1
|
12 Participants
|
18 Participants
|
—
|
|
Dosing Levels and Discontinuations
Participants Randomized In-Hospital ; Timepoint: Week 24 · Dose Level 2
|
5 Participants
|
16 Participants
|
—
|
|
Dosing Levels and Discontinuations
Participants Randomized In-Hospital ; Timepoint: Week 24 · Dose Level 3
|
32 Participants
|
32 Participants
|
—
|
|
Dosing Levels and Discontinuations
Participants Randomized In-Hospital ; Timepoint: Week 24 · No Treatment
|
19 Participants
|
11 Participants
|
—
|
|
Dosing Levels and Discontinuations
Participants Randomized In-Hospital ; Timepoint: Week 24 · Off Treatment
|
3 Participants
|
1 Participants
|
—
|
|
Dosing Levels and Discontinuations
Participants Randomized Out-of-hospital; Timepoint: Randomization (Initial Dose) · Dose Level 1
|
62 Participants
|
60 Participants
|
—
|
|
Dosing Levels and Discontinuations
Participants Randomized Out-of-hospital; Timepoint: Randomization (Initial Dose) · Dose Level 2
|
9 Participants
|
11 Participants
|
—
|
|
Dosing Levels and Discontinuations
Participants Randomized Out-of-hospital; Timepoint: Randomization (Initial Dose) · Dose Level 3
|
0 Participants
|
0 Participants
|
—
|
|
Dosing Levels and Discontinuations
Participants Randomized Out-of-hospital; Timepoint: Randomization (Initial Dose) · No Treatment
|
0 Participants
|
0 Participants
|
—
|
|
Dosing Levels and Discontinuations
Participants Randomized Out-of-hospital; Timepoint: Randomization (Initial Dose) · Off Treatment
|
0 Participants
|
0 Participants
|
—
|
|
Dosing Levels and Discontinuations
Participants Randomized Out-of-hospital; Timepoint: Week 8 · Dose Level 1
|
18 Participants
|
21 Participants
|
—
|
|
Dosing Levels and Discontinuations
Participants Randomized Out-of-hospital; Timepoint: Week 8 · Dose Level 2
|
15 Participants
|
12 Participants
|
—
|
|
Dosing Levels and Discontinuations
Participants Randomized Out-of-hospital; Timepoint: Week 8 · Dose Level 3
|
22 Participants
|
20 Participants
|
—
|
|
Dosing Levels and Discontinuations
Participants Randomized Out-of-hospital; Timepoint: Week 8 · No Treatment
|
3 Participants
|
5 Participants
|
—
|
|
Dosing Levels and Discontinuations
Participants Randomized Out-of-hospital; Timepoint: Week 8 · Off Treatment
|
2 Participants
|
1 Participants
|
—
|
|
Dosing Levels and Discontinuations
Participants Randomized Out-of-hospital; Timepoint: Week 24 · Dose Level 1
|
10 Participants
|
11 Participants
|
—
|
|
Dosing Levels and Discontinuations
Participants Randomized Out-of-hospital; Timepoint: Week 24 · Dose Level 2
|
8 Participants
|
10 Participants
|
—
|
|
Dosing Levels and Discontinuations
Participants Randomized Out-of-hospital; Timepoint: Week 24 · Dose Level 3
|
16 Participants
|
15 Participants
|
—
|
|
Dosing Levels and Discontinuations
Participants Randomized Out-of-hospital; Timepoint: Week 24 · Off Treatment
|
1 Participants
|
4 Participants
|
—
|
SECONDARY outcome
Timeframe: Up to week 84Population: Full analysis set: All patients included in the double-blind phase to whom study treatment was assigned by randomization and at least 1 dose of study treatment was received.
This endpoint intended to calculate the incidence of the following adverse events of special interest (AESI) during treatment: Symptomatic hypotension, Hyperkalemia (potassium \> 5.5 mEq/L), Angioedema and worsening renal function (defined as an increase in serum creatinine of ≥ 0.5 mg/dL and worsening of the eGFR by at least 25%)
Outcome measures
| Measure |
Sacubitril/Valsartan (LCZ696)
n=233 Participants
Study treatment was titrated to the target dose of sacubitril/valsartan (LCZ696) 97/103 mg twice daily (Dose Level 3).
|
Valsartan
n=233 Participants
Study treatment was titrated to the target dose of valsartan 160 mg twice daily (Dose Level 3).
|
Open-label Phase Sacubitril+ Valsartan
Participants recruited under Protocol Version 00 (Original Protocol) and who had completed the double-blind phase before protocol amendment 01 was released. Participants were in the open-label phase from Week 8 to Week 12.
|
|---|---|---|---|
|
Incidence of Adverse Events of Special Interest (AESI) During Treatment
Symptomatic hypotension
|
56 Participants
|
36 Participants
|
—
|
|
Incidence of Adverse Events of Special Interest (AESI) During Treatment
Hyperkalemia
|
45 Participants
|
43 Participants
|
—
|
|
Incidence of Adverse Events of Special Interest (AESI) During Treatment
Angioedema
|
0 Participants
|
1 Participants
|
—
|
|
Incidence of Adverse Events of Special Interest (AESI) During Treatment
Worsening renal function
|
50 Participants
|
72 Participants
|
—
|
Adverse Events
Double-blind Phase Sacubitril+ Valsartan (LCZ696)
Serious events: 119 serious events
Other events: 161 other events
Deaths: 18 deaths
Double-blind Phase Valsartan
Serious events: 117 serious events
Other events: 165 other events
Deaths: 26 deaths
Open-label Phase Sacubitril+ Valsartan
Serious events: 3 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Double-blind Phase Sacubitril+ Valsartan (LCZ696)
n=233 participants at risk
Study treatment was titrated to the target dose of sacubitril/valsartan (LCZ696) 97/103 mg twice daily (Dose Level 3)
|
Double-blind Phase Valsartan
n=233 participants at risk
Study treatment was titrated to the target dose of valsartan 160 mg twice daily (Dose Level 3).
|
Open-label Phase Sacubitril+ Valsartan
n=50 participants at risk
Participants recruited under Protocol Version 00 (Original Protocol) and who had completed the double-blind phase before protocol amendment 01 was released. Participants were in the open-label phase from Week 8 to Week 12.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
1.3%
3/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
2.1%
5/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Blood and lymphatic system disorders
Blood loss anaemia
|
0.43%
1/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.43%
1/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.43%
1/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Cardiac disorders
Acute left ventricular failure
|
2.1%
5/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
1.7%
4/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.86%
2/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
3.4%
8/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.86%
2/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Cardiac disorders
Arrhythmia supraventricular
|
0.43%
1/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Cardiac disorders
Atrial fibrillation
|
4.3%
10/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
5.6%
13/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Cardiac disorders
Atrial flutter
|
0.43%
1/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.86%
2/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Cardiac disorders
Atrial tachycardia
|
0.86%
2/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Cardiac disorders
Atrioventricular block
|
0.43%
1/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Cardiac disorders
BRASH syndrome
|
0.00%
0/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.43%
1/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Cardiac disorders
Bradycardia
|
0.86%
2/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.43%
1/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Cardiac disorders
Cardiac amyloidosis
|
0.00%
0/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.86%
2/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Cardiac disorders
Cardiac arrest
|
1.7%
4/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
1.3%
3/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Cardiac disorders
Cardiac failure
|
9.4%
22/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
8.6%
20/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Cardiac disorders
Cardiac failure acute
|
4.7%
11/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
6.0%
14/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Cardiac disorders
Cardiac failure chronic
|
0.43%
1/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.43%
1/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Cardiac disorders
Cardiac failure congestive
|
6.0%
14/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
8.2%
19/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.00%
0/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.43%
1/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Cardiac disorders
Cardiogenic shock
|
0.43%
1/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.86%
2/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Cardiac disorders
Chronic left ventricular failure
|
0.00%
0/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
1.7%
4/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
2.0%
1/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Cardiac disorders
Coronary artery disease
|
1.3%
3/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
1.7%
4/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Cardiac disorders
Left ventricular dysfunction
|
0.00%
0/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.43%
1/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Cardiac disorders
Mitral valve incompetence
|
0.43%
1/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Cardiac disorders
Myocarditis
|
0.00%
0/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.43%
1/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Cardiac disorders
Nodal arrhythmia
|
0.00%
0/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.43%
1/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.43%
1/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.43%
1/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.86%
2/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Cardiac disorders
Pulseless electrical activity
|
0.00%
0/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
2.0%
1/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Cardiac disorders
Right ventricular failure
|
0.00%
0/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.43%
1/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Cardiac disorders
Sinus node dysfunction
|
0.86%
2/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.43%
1/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Cardiac disorders
Supraventricular extrasystoles
|
0.43%
1/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.43%
1/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Cardiac disorders
Tricuspid valve incompetence
|
0.00%
0/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.43%
1/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.43%
1/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.43%
1/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Ear and labyrinth disorders
Vertigo
|
0.43%
1/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.43%
1/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Eye disorders
Cataract nuclear
|
0.43%
1/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Eye disorders
Retinal detachment
|
0.00%
0/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.43%
1/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Eye disorders
Visual impairment
|
0.43%
1/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.43%
1/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.43%
1/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.43%
1/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.43%
1/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Gastrointestinal disorders
Constipation
|
0.86%
2/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.43%
1/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.43%
1/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
1.3%
3/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
1.3%
3/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.43%
1/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.43%
1/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.43%
1/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.43%
1/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.43%
1/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Gastrointestinal disorders
Melaena
|
0.43%
1/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.86%
2/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Gastrointestinal disorders
Obstructive pancreatitis
|
0.00%
0/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.43%
1/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.86%
2/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Gastrointestinal disorders
Peptic ulcer
|
0.00%
0/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.43%
1/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.43%
1/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.86%
2/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.43%
1/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.43%
1/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Gastrointestinal disorders
Subileus
|
0.00%
0/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.43%
1/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.43%
1/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Gastrointestinal disorders
Vomiting
|
0.43%
1/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
General disorders
Asthenia
|
0.86%
2/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
General disorders
Chest pain
|
0.43%
1/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
2.1%
5/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
General disorders
Death
|
2.6%
6/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
3.0%
7/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
General disorders
Generalised oedema
|
0.43%
1/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
General disorders
Hypothermia
|
0.00%
0/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.43%
1/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.00%
0/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.43%
1/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.43%
1/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
2.0%
1/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
General disorders
Peripheral swelling
|
0.00%
0/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.43%
1/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.43%
1/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.43%
1/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Hepatobiliary disorders
Cholestasis
|
0.00%
0/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.43%
1/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Hepatobiliary disorders
Congestive hepatopathy
|
0.00%
0/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.43%
1/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Hepatobiliary disorders
Hepatic cyst ruptured
|
0.00%
0/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.43%
1/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
0.00%
0/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.43%
1/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Hepatobiliary disorders
Liver injury
|
0.00%
0/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.43%
1/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Immune system disorders
Primary amyloidosis
|
0.00%
0/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.43%
1/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Infections and infestations
Appendicitis
|
0.86%
2/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Infections and infestations
Bacteraemia
|
0.86%
2/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.43%
1/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Infections and infestations
Bacterial sepsis
|
0.43%
1/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Infections and infestations
Bacteriuria
|
0.43%
1/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Infections and infestations
Bronchitis
|
0.43%
1/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.43%
1/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Infections and infestations
COVID-19
|
2.6%
6/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
2.1%
5/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Infections and infestations
COVID-19 pneumonia
|
1.3%
3/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
1.7%
4/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Infections and infestations
Cellulitis
|
0.43%
1/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
2.6%
6/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.43%
1/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Infections and infestations
Cystitis
|
0.00%
0/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.43%
1/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.43%
1/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Infections and infestations
Empyema
|
0.43%
1/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Infections and infestations
Escherichia bacteraemia
|
0.00%
0/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.43%
1/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Infections and infestations
Gangrene
|
0.43%
1/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Infections and infestations
Gastroenteritis
|
0.43%
1/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Infections and infestations
Histoplasmosis
|
0.00%
0/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.43%
1/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Infections and infestations
Influenza
|
0.86%
2/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Infections and infestations
Kidney infection
|
0.43%
1/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Infections and infestations
Osteomyelitis
|
0.43%
1/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.43%
1/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Infections and infestations
Pneumonia
|
3.0%
7/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
6.0%
14/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Infections and infestations
Pneumonia bacterial
|
0.43%
1/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Infections and infestations
Pneumonia legionella
|
0.43%
1/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Infections and infestations
Post procedural infection
|
0.00%
0/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.43%
1/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.43%
1/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Infections and infestations
Sepsis
|
2.1%
5/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
2.1%
5/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Infections and infestations
Septic shock
|
0.43%
1/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.86%
2/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.00%
0/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
2.0%
1/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Infections and infestations
Staphylococcal sepsis
|
0.00%
0/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.43%
1/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Infections and infestations
Urinary tract infection
|
1.3%
3/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
1.7%
4/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Infections and infestations
Urinary tract infection bacterial
|
0.00%
0/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.43%
1/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Infections and infestations
Urosepsis
|
0.43%
1/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Infections and infestations
Wound infection bacterial
|
0.00%
0/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.43%
1/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Injury, poisoning and procedural complications
Anastomotic stenosis
|
0.43%
1/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.43%
1/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Injury, poisoning and procedural complications
Burns third degree
|
0.43%
1/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Injury, poisoning and procedural complications
Fall
|
1.7%
4/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
1.7%
4/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.43%
1/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.43%
1/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Injury, poisoning and procedural complications
Fractured sacrum
|
0.43%
1/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.43%
1/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.43%
1/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.86%
2/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.43%
1/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.43%
1/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.43%
1/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.00%
0/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.86%
2/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
|
0.43%
1/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.43%
1/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm ruptured
|
0.00%
0/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.43%
1/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.43%
1/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Investigations
Blood creatinine increased
|
0.86%
2/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Investigations
International normalised ratio increased
|
0.00%
0/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.86%
2/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Investigations
Troponin increased
|
0.43%
1/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.43%
1/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.43%
1/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.43%
1/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.43%
1/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.86%
2/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.43%
1/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.43%
1/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.43%
1/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Metabolism and nutrition disorders
Hyperinsulinaemic hypoglycaemia
|
0.43%
1/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
3.4%
8/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
1.7%
4/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Metabolism and nutrition disorders
Hypervolaemia
|
0.86%
2/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.86%
2/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
1.3%
3/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
1.3%
3/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.43%
1/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
1.3%
3/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.43%
1/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.43%
1/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.43%
1/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.43%
1/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.43%
1/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.43%
1/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.43%
1/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.43%
1/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Musculoskeletal and connective tissue disorders
Osteoporotic fracture
|
0.43%
1/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.43%
1/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cholangiocarcinoma
|
0.43%
1/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Epithelioid mesothelioma
|
0.43%
1/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.86%
2/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to adrenals
|
0.43%
1/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to bone
|
0.43%
1/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to liver
|
0.43%
1/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lung
|
0.43%
1/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.00%
0/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.43%
1/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasma cell myeloma
|
0.43%
1/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer metastatic
|
0.43%
1/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Nervous system disorders
Autonomic nervous system imbalance
|
0.00%
0/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.43%
1/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Nervous system disorders
Balance disorder
|
0.00%
0/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.43%
1/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Nervous system disorders
Carotid artery stenosis
|
0.43%
1/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Nervous system disorders
Cauda equina syndrome
|
0.43%
1/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.43%
1/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Nervous system disorders
Cerebrovascular accident
|
1.3%
3/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.43%
1/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Nervous system disorders
Dizziness
|
1.3%
3/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.86%
2/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Nervous system disorders
Encephalopathy
|
0.43%
1/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.43%
1/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Nervous system disorders
Headache
|
0.43%
1/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.43%
1/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Nervous system disorders
Loss of consciousness
|
0.43%
1/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.43%
1/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Nervous system disorders
Metabolic encephalopathy
|
0.00%
0/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.86%
2/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Nervous system disorders
Presyncope
|
0.86%
2/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.86%
2/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Nervous system disorders
Seizure
|
0.00%
0/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.43%
1/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.43%
1/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Nervous system disorders
Syncope
|
4.3%
10/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
3.9%
9/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.43%
1/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Nervous system disorders
Unresponsive to stimuli
|
0.43%
1/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.86%
2/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Product Issues
Device malfunction
|
0.43%
1/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.43%
1/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Psychiatric disorders
Agitation
|
0.00%
0/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.43%
1/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Psychiatric disorders
Delirium
|
0.43%
1/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Psychiatric disorders
Intentional self-injury
|
0.00%
0/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.43%
1/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Psychiatric disorders
Major depression
|
0.00%
0/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.43%
1/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Psychiatric disorders
Mental status changes
|
0.86%
2/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Renal and urinary disorders
Acute kidney injury
|
9.0%
21/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
6.4%
15/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.00%
0/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.86%
2/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Renal and urinary disorders
Cystitis haemorrhagic
|
0.00%
0/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.43%
1/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Renal and urinary disorders
Dysuria
|
0.43%
1/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Renal and urinary disorders
End stage renal disease
|
0.43%
1/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.43%
1/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Renal and urinary disorders
Haematuria
|
0.43%
1/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.43%
1/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.43%
1/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.43%
1/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Renal and urinary disorders
Oliguria
|
0.00%
0/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.43%
1/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Renal and urinary disorders
Renal artery stenosis
|
0.00%
0/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.43%
1/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Renal and urinary disorders
Renal failure
|
0.43%
1/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.43%
1/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Renal and urinary disorders
Renal impairment
|
1.7%
4/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
1.3%
3/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Renal and urinary disorders
Renal infarct
|
0.00%
0/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.43%
1/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Renal and urinary disorders
Renal mass
|
0.43%
1/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.43%
1/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.43%
1/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.86%
2/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.43%
1/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
3.9%
9/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
3.4%
8/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.43%
1/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.43%
1/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.43%
1/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.86%
2/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.1%
5/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
2.1%
5/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.86%
2/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.43%
1/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
0.43%
1/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.86%
2/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.43%
1/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.86%
2/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.86%
2/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.43%
1/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.43%
1/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.7%
4/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.86%
2/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
0.43%
1/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.00%
0/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.86%
2/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
1.3%
3/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Skin and subcutaneous tissue disorders
Diabetic foot
|
0.00%
0/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.43%
1/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.43%
1/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Vascular disorders
Aortic stenosis
|
0.43%
1/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.43%
1/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Vascular disorders
Deep vein thrombosis
|
0.43%
1/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.43%
1/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Vascular disorders
Dialysis hypotension
|
0.43%
1/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Vascular disorders
Haematoma
|
0.00%
0/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.43%
1/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Vascular disorders
Hypertension
|
0.00%
0/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.86%
2/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Vascular disorders
Hypertensive emergency
|
0.00%
0/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
1.7%
4/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Vascular disorders
Hypertensive urgency
|
0.43%
1/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
1.3%
3/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Vascular disorders
Hypotension
|
6.4%
15/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
5.6%
13/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Vascular disorders
Hypovolaemic shock
|
0.86%
2/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Vascular disorders
Orthostatic hypotension
|
0.86%
2/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.00%
0/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.43%
1/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Vascular disorders
Peripheral artery occlusion
|
0.00%
0/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.43%
1/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Vascular disorders
Peripheral ischaemia
|
0.43%
1/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.43%
1/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Vascular disorders
Shock
|
0.00%
0/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.43%
1/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Vascular disorders
Superficial vein thrombosis
|
0.43%
1/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
Other adverse events
| Measure |
Double-blind Phase Sacubitril+ Valsartan (LCZ696)
n=233 participants at risk
Study treatment was titrated to the target dose of sacubitril/valsartan (LCZ696) 97/103 mg twice daily (Dose Level 3)
|
Double-blind Phase Valsartan
n=233 participants at risk
Study treatment was titrated to the target dose of valsartan 160 mg twice daily (Dose Level 3).
|
Open-label Phase Sacubitril+ Valsartan
n=50 participants at risk
Participants recruited under Protocol Version 00 (Original Protocol) and who had completed the double-blind phase before protocol amendment 01 was released. Participants were in the open-label phase from Week 8 to Week 12.
|
|---|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
3.9%
9/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
5.6%
13/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
2.0%
1/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Cardiac disorders
Cardiac failure
|
6.9%
16/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
6.9%
16/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
4.0%
2/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Gastrointestinal disorders
Constipation
|
2.6%
6/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
5.2%
12/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
General disorders
Fatigue
|
1.7%
4/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
5.2%
12/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Infections and infestations
COVID-19
|
7.7%
18/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
6.0%
14/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Infections and infestations
Urinary tract infection
|
8.2%
19/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
9.0%
21/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
4.0%
2/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Injury, poisoning and procedural complications
Fall
|
6.9%
16/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
6.0%
14/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Investigations
Blood creatinine increased
|
9.9%
23/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
11.6%
27/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
6.0%
3/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Investigations
Glomerular filtration rate decreased
|
1.7%
4/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
1.7%
4/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
6.0%
3/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Investigations
SARS-CoV-2 test negative
|
24.9%
58/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
31.3%
73/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Investigations
SARS-CoV-2 test positive
|
9.9%
23/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
7.7%
18/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
16.3%
38/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
18.5%
43/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
6.0%
3/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
8.2%
19/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
9.4%
22/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
2.0%
1/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Nervous system disorders
Dizziness
|
9.0%
21/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
7.7%
18/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
2.0%
1/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Renal and urinary disorders
Acute kidney injury
|
15.0%
35/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
20.2%
47/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Renal and urinary disorders
Chronic kidney disease
|
2.6%
6/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
6.4%
15/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
2.0%
1/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Renal and urinary disorders
Renal impairment
|
4.7%
11/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
8.6%
20/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
2.0%
1/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
3.4%
8/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
6.0%
14/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
2.0%
1/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Vascular disorders
Hypertension
|
3.4%
8/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
5.2%
12/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
0.00%
0/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
|
Vascular disorders
Hypotension
|
24.9%
58/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
17.2%
40/233 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
2.0%
1/50 • Adverse events of the double-blind phase were reported from first dose of study treatment until end of study treatment plus 1 month post treatment, up to a maximum duration of 21 months. For those patients enrolled during the original version (00) of the protocol, where the open-label phase existed, adverse events were reported during the 4 week Open-Label period, and 1 month post treatment, for a maximum of 2 months.
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Adverse events are provided by arm and not by dose as it was not planned in the analysis to provide AEs by dose.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER