Trial Outcomes & Findings for Comparison of the Safety and Efficacy of HOE901-U300 With Lantus in Older Patients With Type2 Diabetes Insufficiently Controlled on Their Current Antidiabetic Medications (NCT NCT02320721)
NCT ID: NCT02320721
Last Updated: 2020-04-21
Results Overview
Adjusted least square (LS) means were obtained from analysis of covariance (ANCOVA) after multiple imputation of missing data including post baseline HbA1c data during the 26-week randomized period.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1014 participants
Primary outcome timeframe
Baseline, Week 26
Results posted on
2020-04-21
Participant Flow
The study was conducted at 162 study centers across 18 countries. A total of 1515 participants were screened between 16 January 2015 and 14 October 2015, of whom 501 were screen failures.
A total of 1014 participants were randomized in 1:1 ratio to either HOE901-U300 or Lantus, stratified by screening hemoglobin A1c (HbA1c) values (\<8% or ≥8%); previous use of insulin (insulin-naïve versus pre-treated); and use of sulfonylurea or meglitinides at screening ('yes' versus 'no').
Participant milestones
| Measure |
HOE901-U300
HOE901-U300 (Insulin glargine, 300 U/mL) subcutaneous (SC) injection once daily up to Week 26 on top of stable non-insulin antihyperglycemic therapy.
|
Lantus
Lantus (Insulin glargine, 100 U/mL) SC injection once daily up to Week 26 on top of stable non-insulin antihyperglycemic therapy.
|
|---|---|---|
|
Overall Study
STARTED
|
508
|
506
|
|
Overall Study
Treated (Safety Population)
|
508
|
505
|
|
Overall Study
COMPLETED
|
481
|
472
|
|
Overall Study
NOT COMPLETED
|
27
|
34
|
Reasons for withdrawal
| Measure |
HOE901-U300
HOE901-U300 (Insulin glargine, 300 U/mL) subcutaneous (SC) injection once daily up to Week 26 on top of stable non-insulin antihyperglycemic therapy.
|
Lantus
Lantus (Insulin glargine, 100 U/mL) SC injection once daily up to Week 26 on top of stable non-insulin antihyperglycemic therapy.
|
|---|---|---|
|
Overall Study
Adverse Event
|
6
|
6
|
|
Overall Study
Lack of Efficacy
|
2
|
0
|
|
Overall Study
Poor compliance to protocol
|
3
|
7
|
|
Overall Study
Randomized but not treated
|
0
|
1
|
|
Overall Study
Hypoglycemia
|
1
|
0
|
|
Overall Study
Other than specified above
|
15
|
20
|
Baseline Characteristics
Number of participants analyzed = participants with available data for this baseline measure.
Baseline characteristics by cohort
| Measure |
HOE901-U300
n=508 Participants
HOE901-U300 (Insulin glargine, 300 U/mL) SC injection once daily up to Week 26 on top of stable non-insulin antihyperglycemic therapy.
|
Lantus
n=506 Participants
Lantus (Insulin glargine, 100 U/mL) SC injection once daily up to Week 26 on top of stable non-insulin antihyperglycemic therapy.
|
Total
n=1014 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
71.1 years
STANDARD_DEVIATION 4.9 • n=508 Participants
|
70.8 years
STANDARD_DEVIATION 4.8 • n=506 Participants
|
71.0 years
STANDARD_DEVIATION 4.9 • n=1014 Participants
|
|
Sex: Female, Male
Female
|
258 Participants
n=508 Participants
|
229 Participants
n=506 Participants
|
487 Participants
n=1014 Participants
|
|
Sex: Female, Male
Male
|
250 Participants
n=508 Participants
|
277 Participants
n=506 Participants
|
527 Participants
n=1014 Participants
|
|
Body Mass Index (BMI)
|
30.9 kg/m^2
STANDARD_DEVIATION 5.5 • n=508 Participants • Number of participants analyzed = participants with available data for this baseline measure.
|
31.2 kg/m^2
STANDARD_DEVIATION 5.7 • n=505 Participants • Number of participants analyzed = participants with available data for this baseline measure.
|
31.1 kg/m^2
STANDARD_DEVIATION 5.6 • n=1013 Participants • Number of participants analyzed = participants with available data for this baseline measure.
|
|
Duration of Type 2 Diabetes
|
15.29 years
STANDARD_DEVIATION 8.17 • n=508 Participants
|
15.35 years
STANDARD_DEVIATION 7.70 • n=506 Participants
|
15.32 years
STANDARD_DEVIATION 7.93 • n=1014 Participants
|
|
Baseline Glycated Hemoglobin A1c (HbA1c)
|
8.20 percentage of HbA1c
STANDARD_DEVIATION 0.91 • n=508 Participants
|
8.22 percentage of HbA1c
STANDARD_DEVIATION 0.92 • n=506 Participants
|
8.21 percentage of HbA1c
STANDARD_DEVIATION 0.91 • n=1014 Participants
|
|
Randomization strata of insulin
Insulin-naive
|
166 Participants
n=508 Participants
|
165 Participants
n=506 Participants
|
331 Participants
n=1014 Participants
|
|
Randomization strata of insulin
Insulin pre-treated
|
342 Participants
n=508 Participants
|
341 Participants
n=506 Participants
|
683 Participants
n=1014 Participants
|
|
Age Group
<75 years of age
|
373 Participants
n=508 Participants
|
400 Participants
n=506 Participants
|
773 Participants
n=1014 Participants
|
|
Age Group
≥75 years of age
|
135 Participants
n=508 Participants
|
106 Participants
n=506 Participants
|
241 Participants
n=1014 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 26Population: Intent-to-treat (ITT) population included all randomized participants regardless of whether the treatment kit was used, and analyzed according to the treatment group allocated by randomization.
Adjusted least square (LS) means were obtained from analysis of covariance (ANCOVA) after multiple imputation of missing data including post baseline HbA1c data during the 26-week randomized period.
Outcome measures
| Measure |
HOE901-U300
n=508 Participants
HOE901-U300 (Insulin glargine, 300 U/mL) SC injection once daily up to Week 26 on top of stable non-insulin antihyperglycemic therapy.
|
Lantus
n=506 Participants
Lantus (Insulin glargine, 100 U/mL) SC injection once daily up to Week 26 on top of stable non-insulin antihyperglycemic therapy.
|
|---|---|---|
|
Change in HbA1c From Baseline to Week 26
|
-0.89 percentage of hemoglobin
Standard Error 0.038
|
-0.91 percentage of hemoglobin
Standard Error 0.042
|
SECONDARY outcome
Timeframe: Baseline up to Week 26Population: ITT population.
Estimated percentages from multiple imputation approach including data from the 26-week randomized period. Severe hypoglycemia was an event that required assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Confirmed hypoglycemia was an event associated with plasma glucose ≤3.9 mmol/L (70 mg/dL).
Outcome measures
| Measure |
HOE901-U300
n=508 Participants
HOE901-U300 (Insulin glargine, 300 U/mL) SC injection once daily up to Week 26 on top of stable non-insulin antihyperglycemic therapy.
|
Lantus
n=506 Participants
Lantus (Insulin glargine, 100 U/mL) SC injection once daily up to Week 26 on top of stable non-insulin antihyperglycemic therapy.
|
|---|---|---|
|
Percentage of Participants With At Least One Severe and/ or Confirmed (≤3.9 mmol/L [70 mg/dL]) Nocturnal Hypoglycemia (22:00 to 08:59 Hours Next Morning) During 26-Week Randomized Period
|
48.3 percentage of participants
|
47.7 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline up to Week 26Population: ITT population.
Estimated percentages from multiple imputation approach including data from the 26-week randomized period. Severe hypoglycemia was an event that required assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Confirmed hypoglycemia was an event associated with plasma glucose ≤3.9 mmol/L (70 mg/dL).
Outcome measures
| Measure |
HOE901-U300
n=508 Participants
HOE901-U300 (Insulin glargine, 300 U/mL) SC injection once daily up to Week 26 on top of stable non-insulin antihyperglycemic therapy.
|
Lantus
n=506 Participants
Lantus (Insulin glargine, 100 U/mL) SC injection once daily up to Week 26 on top of stable non-insulin antihyperglycemic therapy.
|
|---|---|---|
|
Percentage of Participants With At Least One Severe and/ or Confirmed (≤3.9 mmol/L [70 mg/dL]) Nocturnal Hypoglycemia (00:00 to 05:59 Hours) During 26-Week Randomized Period
|
20.2 percentage of participants
|
22.5 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline up to Week 26Population: ITT population.
Estimated percentages from multiple imputation approach including data from the 26-week randomized period. Severe hypoglycemia was an event that required assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Confirmed hypoglycemia was an event associated with plasma glucose ≤3.9 mmol/L (70 mg/dL).
Outcome measures
| Measure |
HOE901-U300
n=508 Participants
HOE901-U300 (Insulin glargine, 300 U/mL) SC injection once daily up to Week 26 on top of stable non-insulin antihyperglycemic therapy.
|
Lantus
n=506 Participants
Lantus (Insulin glargine, 100 U/mL) SC injection once daily up to Week 26 on top of stable non-insulin antihyperglycemic therapy.
|
|---|---|---|
|
Percentage of Participants With At Least One Severe and/ or Confirmed (≤3.9 mmol/L [70 mg/dL]) Hypoglycemia Occurring at Any Time of the Day During 26-Week Randomized Period
|
59.4 percentage of participants
|
62.7 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline up to Week 26Population: ITT population.
Participants without any available HbA1c assessment at Week 26 were considered as non-responders in the analyses.
Outcome measures
| Measure |
HOE901-U300
n=508 Participants
HOE901-U300 (Insulin glargine, 300 U/mL) SC injection once daily up to Week 26 on top of stable non-insulin antihyperglycemic therapy.
|
Lantus
n=506 Participants
Lantus (Insulin glargine, 100 U/mL) SC injection once daily up to Week 26 on top of stable non-insulin antihyperglycemic therapy.
|
|---|---|---|
|
Percentage of Participants With HbA1c <7.5% or HbA1c <7% During 26-Week Randomized Period
HbA1c <7.5%
|
60.6 percentage of participants
|
58.9 percentage of participants
|
|
Percentage of Participants With HbA1c <7.5% or HbA1c <7% During 26-Week Randomized Period
HbA1c <7.0%
|
33.3 percentage of participants
|
35.2 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline up to Week 26Population: ITT population.
Severe hypoglycemia was an event that required assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Confirmed hypoglycemia was an event associated with plasma glucose ≤3.9 mmol/L (70 mg/dL).
Outcome measures
| Measure |
HOE901-U300
n=508 Participants
HOE901-U300 (Insulin glargine, 300 U/mL) SC injection once daily up to Week 26 on top of stable non-insulin antihyperglycemic therapy.
|
Lantus
n=506 Participants
Lantus (Insulin glargine, 100 U/mL) SC injection once daily up to Week 26 on top of stable non-insulin antihyperglycemic therapy.
|
|---|---|---|
|
Percentage of Participants With HbA1c <7.5% or <7.0% at Week 26 and No Severe and/or Confirmed (≤3.9 mmol/L [70 mg/dL]) Hypoglycemia During 26-Week Randomized Period
HbA1c <7.5%
|
26.4 percentage of participants
|
21.5 percentage of participants
|
|
Percentage of Participants With HbA1c <7.5% or <7.0% at Week 26 and No Severe and/or Confirmed (≤3.9 mmol/L [70 mg/dL]) Hypoglycemia During 26-Week Randomized Period
HbA1c <7.0%
|
14.0 percentage of participants
|
12.3 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 26Population: ITT population. Here 'Overall number of participants analyzed' signifies participants with available data for this outcome measure.
Adjusted LS means from multiple imputation approach including post baseline values during the 26-week randomized period.
Outcome measures
| Measure |
HOE901-U300
n=484 Participants
HOE901-U300 (Insulin glargine, 300 U/mL) SC injection once daily up to Week 26 on top of stable non-insulin antihyperglycemic therapy.
|
Lantus
n=482 Participants
Lantus (Insulin glargine, 100 U/mL) SC injection once daily up to Week 26 on top of stable non-insulin antihyperglycemic therapy.
|
|---|---|---|
|
Change in Fasting Plasma Glucose (FPG) From Baseline to Week 26
|
-1.68 mmol/L
Standard Error 0.122
|
-1.77 mmol/L
Standard Error 0.135
|
SECONDARY outcome
Timeframe: Baseline, Week 26Population: ITT population. Here 'Overall number of participants analyzed' signifies participants with available data for this outcome measure.
WHO-5 well-being index evaluates positive psychological well-being during the past 2 weeks and consists of 5 questions, each rated on a 6-point Likert scale from 0 (not present) to 5 (constantly present). Total raw score was transformed into a percentage score ranging from 0 (worst possible quality of life) to 100 (best possible quality of life).
Outcome measures
| Measure |
HOE901-U300
n=484 Participants
HOE901-U300 (Insulin glargine, 300 U/mL) SC injection once daily up to Week 26 on top of stable non-insulin antihyperglycemic therapy.
|
Lantus
n=476 Participants
Lantus (Insulin glargine, 100 U/mL) SC injection once daily up to Week 26 on top of stable non-insulin antihyperglycemic therapy.
|
|---|---|---|
|
Change in World Health Organization-5 (WHO-5) Well-Being Questionnaire Percentage Score From Baseline to Week 26
|
-1.16 scores on a scale
Standard Error 0.751
|
0.22 scores on a scale
Standard Error 0.758
|
SECONDARY outcome
Timeframe: Baseline up to Week 26Population: ITT population.
Routine fasting self-monitored plasma glucose (SMPG) and central laboratory FPG (and HbA1c after Week 14) values were used to determine the requirement of rescue medication. Threshold values at Week 14: FPG \>200 mg/dL (11 mmol/L), or HbA1c \>8.5%.
Outcome measures
| Measure |
HOE901-U300
n=508 Participants
HOE901-U300 (Insulin glargine, 300 U/mL) SC injection once daily up to Week 26 on top of stable non-insulin antihyperglycemic therapy.
|
Lantus
n=506 Participants
Lantus (Insulin glargine, 100 U/mL) SC injection once daily up to Week 26 on top of stable non-insulin antihyperglycemic therapy.
|
|---|---|---|
|
Percentage of Participants Requiring Rescue Therapy Over the 26 Weeks of Treatment
|
3.7 percentage of participants
|
2.6 percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline up to Week 26Population: Safety population included all randomized participants who actually received at least 1 dose or part of a dose of investigational medicinal product (IMP) and analyzed according to the treatment actually received.
Hypoglycemia events were hypoglycemia of any category, severe hypoglycemia (an event that required assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions); documented symptomatic hypoglycemia (symptoms of hypoglycemia with plasma glucose ≤3.9 mmol/L \[70 mg/dL\]); confirmed hypoglycemia (with or without symptoms of hypoglycemia and plasma glucose ≤3.9 mmol/L).
Outcome measures
| Measure |
HOE901-U300
n=508 Participants
HOE901-U300 (Insulin glargine, 300 U/mL) SC injection once daily up to Week 26 on top of stable non-insulin antihyperglycemic therapy.
|
Lantus
n=505 Participants
Lantus (Insulin glargine, 100 U/mL) SC injection once daily up to Week 26 on top of stable non-insulin antihyperglycemic therapy.
|
|---|---|---|
|
Percentage of Participants With Hypoglycemia (Any Hypoglycemia, Documented Symptomatic Hypoglycemia, Severe and/or Confirmed Hypoglycemia) During the 26 Weeks of Treatment
Documented symptomatic hypoglycemia
|
32.9 percentage of participants
|
34.7 percentage of participants
|
|
Percentage of Participants With Hypoglycemia (Any Hypoglycemia, Documented Symptomatic Hypoglycemia, Severe and/or Confirmed Hypoglycemia) During the 26 Weeks of Treatment
Any hypoglycemia
|
62.6 percentage of participants
|
66.5 percentage of participants
|
|
Percentage of Participants With Hypoglycemia (Any Hypoglycemia, Documented Symptomatic Hypoglycemia, Severe and/or Confirmed Hypoglycemia) During the 26 Weeks of Treatment
Severe and/or confirmed hypoglycemia
|
58.1 percentage of participants
|
60.6 percentage of participants
|
|
Percentage of Participants With Hypoglycemia (Any Hypoglycemia, Documented Symptomatic Hypoglycemia, Severe and/or Confirmed Hypoglycemia) During the 26 Weeks of Treatment
Severe and/or confirmed hypoglycemia:<75 years age
|
59.2 percentage of participants
|
60.9 percentage of participants
|
|
Percentage of Participants With Hypoglycemia (Any Hypoglycemia, Documented Symptomatic Hypoglycemia, Severe and/or Confirmed Hypoglycemia) During the 26 Weeks of Treatment
Severe and/or confirmed hypoglycemia:≥75 years age
|
54.8 percentage of participants
|
59.4 percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline up to Week 26Population: Safety population.
Hypoglycemia events were hypoglycemia of any category, severe hypoglycemia (an event that required assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions); documented symptomatic hypoglycemia (symptoms of hypoglycemia with plasma glucose ≤3.9 mmol/L \[70 mg/dL\]); confirmed hypoglycemia (with or without symptoms of hypoglycemia and plasma glucose ≤3.9 mmol/L).
Outcome measures
| Measure |
HOE901-U300
n=508 Participants
HOE901-U300 (Insulin glargine, 300 U/mL) SC injection once daily up to Week 26 on top of stable non-insulin antihyperglycemic therapy.
|
Lantus
n=505 Participants
Lantus (Insulin glargine, 100 U/mL) SC injection once daily up to Week 26 on top of stable non-insulin antihyperglycemic therapy.
|
|---|---|---|
|
Hypoglycemia (Any Hypoglycemia, Documented Symptomatic Hypoglycemia, Severe and/or Confirmed Hypoglycemia) Event Rate Per Participant Year During the 26 Weeks of Treatment
Any hypoglycemia
|
6.06 events per participant year
|
7.74 events per participant year
|
|
Hypoglycemia (Any Hypoglycemia, Documented Symptomatic Hypoglycemia, Severe and/or Confirmed Hypoglycemia) Event Rate Per Participant Year During the 26 Weeks of Treatment
Documented symptomatic hypoglycemia
|
1.85 events per participant year
|
2.56 events per participant year
|
|
Hypoglycemia (Any Hypoglycemia, Documented Symptomatic Hypoglycemia, Severe and/or Confirmed Hypoglycemia) Event Rate Per Participant Year During the 26 Weeks of Treatment
Severe and/or confirmed hypoglycemia
|
5.17 events per participant year
|
6.36 events per participant year
|
POST_HOC outcome
Timeframe: Baseline up to Week 26Population: Safety population.
Hypoglycemia events were hypoglycemia of any category, severe hypoglycemia (an event that required assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions); documented symptomatic hypoglycemia (symptoms of hypoglycemia with plasma glucose ≤3.9 mmol/L \[70 mg/dL\]); confirmed hypoglycemia (with or without symptoms of hypoglycemia and plasma glucose ≤3.9 mmol/L).
Outcome measures
| Measure |
HOE901-U300
n=508 Participants
HOE901-U300 (Insulin glargine, 300 U/mL) SC injection once daily up to Week 26 on top of stable non-insulin antihyperglycemic therapy.
|
Lantus
n=505 Participants
Lantus (Insulin glargine, 100 U/mL) SC injection once daily up to Week 26 on top of stable non-insulin antihyperglycemic therapy.
|
|---|---|---|
|
Hypoglycemia (Any Hypoglycemia, Documented Symptomatic Hypoglycemia, Severe and/or Confirmed Hypoglycemia) Event Rate Per Participant Year: By Age Categorical Data During the 26 Weeks of Treatment
Any hypoglycemia:<75 years age
|
6.44 events per participant year
|
7.85 events per participant year
|
|
Hypoglycemia (Any Hypoglycemia, Documented Symptomatic Hypoglycemia, Severe and/or Confirmed Hypoglycemia) Event Rate Per Participant Year: By Age Categorical Data During the 26 Weeks of Treatment
Any hypoglycemia:≥75 years age
|
5.01 events per participant year
|
7.32 events per participant year
|
|
Hypoglycemia (Any Hypoglycemia, Documented Symptomatic Hypoglycemia, Severe and/or Confirmed Hypoglycemia) Event Rate Per Participant Year: By Age Categorical Data During the 26 Weeks of Treatment
Documented symptomatic hypoglycemia:<75 years age
|
2.11 events per participant year
|
2.52 events per participant year
|
|
Hypoglycemia (Any Hypoglycemia, Documented Symptomatic Hypoglycemia, Severe and/or Confirmed Hypoglycemia) Event Rate Per Participant Year: By Age Categorical Data During the 26 Weeks of Treatment
Documented symptomatic hypoglycemia:≥75 years age
|
1.12 events per participant year
|
2.71 events per participant year
|
|
Hypoglycemia (Any Hypoglycemia, Documented Symptomatic Hypoglycemia, Severe and/or Confirmed Hypoglycemia) Event Rate Per Participant Year: By Age Categorical Data During the 26 Weeks of Treatment
Severe and/or confirmed hypoglycemia:<75 years age
|
5.43 events per participant year
|
6.37 events per participant year
|
|
Hypoglycemia (Any Hypoglycemia, Documented Symptomatic Hypoglycemia, Severe and/or Confirmed Hypoglycemia) Event Rate Per Participant Year: By Age Categorical Data During the 26 Weeks of Treatment
Severe and/or confirmed hypoglycemia:≥75 years age
|
4.46 events per participant year
|
6.28 events per participant year
|
Adverse Events
HOE901-U300
Serious events: 41 serious events
Other events: 62 other events
Deaths: 1 deaths
Lantus
Serious events: 34 serious events
Other events: 64 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
HOE901-U300
n=508 participants at risk
HOE901-U300 (Insulin glargine, 300 U/mL) SC injection once daily up to Week 26 on top of stable non-insulin antihyperglycemic therapy.
|
Lantus
n=505 participants at risk
Lantus (Insulin glargine, 100 U/mL) SC injection once daily up to Week 26 on top of stable non-insulin antihyperglycemic therapy.
|
|---|---|---|
|
Cardiac disorders
Acute left ventricular failure
|
0.00%
0/508 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 184) regardless of seriousness or relationship to IMP.
Reported AEs and deaths were treatment emergent that is AEs that developed/worsened and deaths that occurred during 'on treatment period' (from first dose of IMP injection up to 2 days after the last injection of IMP, regardless of introduction of rescue therapy). Analysis was performed using safety population which included all the treated participants.
|
0.20%
1/505 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 184) regardless of seriousness or relationship to IMP.
Reported AEs and deaths were treatment emergent that is AEs that developed/worsened and deaths that occurred during 'on treatment period' (from first dose of IMP injection up to 2 days after the last injection of IMP, regardless of introduction of rescue therapy). Analysis was performed using safety population which included all the treated participants.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.39%
2/508 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 184) regardless of seriousness or relationship to IMP.
Reported AEs and deaths were treatment emergent that is AEs that developed/worsened and deaths that occurred during 'on treatment period' (from first dose of IMP injection up to 2 days after the last injection of IMP, regardless of introduction of rescue therapy). Analysis was performed using safety population which included all the treated participants.
|
0.20%
1/505 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 184) regardless of seriousness or relationship to IMP.
Reported AEs and deaths were treatment emergent that is AEs that developed/worsened and deaths that occurred during 'on treatment period' (from first dose of IMP injection up to 2 days after the last injection of IMP, regardless of introduction of rescue therapy). Analysis was performed using safety population which included all the treated participants.
|
|
Cardiac disorders
Angina unstable
|
0.39%
2/508 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 184) regardless of seriousness or relationship to IMP.
Reported AEs and deaths were treatment emergent that is AEs that developed/worsened and deaths that occurred during 'on treatment period' (from first dose of IMP injection up to 2 days after the last injection of IMP, regardless of introduction of rescue therapy). Analysis was performed using safety population which included all the treated participants.
|
0.00%
0/505 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 184) regardless of seriousness or relationship to IMP.
Reported AEs and deaths were treatment emergent that is AEs that developed/worsened and deaths that occurred during 'on treatment period' (from first dose of IMP injection up to 2 days after the last injection of IMP, regardless of introduction of rescue therapy). Analysis was performed using safety population which included all the treated participants.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/508 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 184) regardless of seriousness or relationship to IMP.
Reported AEs and deaths were treatment emergent that is AEs that developed/worsened and deaths that occurred during 'on treatment period' (from first dose of IMP injection up to 2 days after the last injection of IMP, regardless of introduction of rescue therapy). Analysis was performed using safety population which included all the treated participants.
|
0.40%
2/505 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 184) regardless of seriousness or relationship to IMP.
Reported AEs and deaths were treatment emergent that is AEs that developed/worsened and deaths that occurred during 'on treatment period' (from first dose of IMP injection up to 2 days after the last injection of IMP, regardless of introduction of rescue therapy). Analysis was performed using safety population which included all the treated participants.
|
|
Cardiac disorders
Atrioventricular block
|
0.20%
1/508 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 184) regardless of seriousness or relationship to IMP.
Reported AEs and deaths were treatment emergent that is AEs that developed/worsened and deaths that occurred during 'on treatment period' (from first dose of IMP injection up to 2 days after the last injection of IMP, regardless of introduction of rescue therapy). Analysis was performed using safety population which included all the treated participants.
|
0.00%
0/505 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 184) regardless of seriousness or relationship to IMP.
Reported AEs and deaths were treatment emergent that is AEs that developed/worsened and deaths that occurred during 'on treatment period' (from first dose of IMP injection up to 2 days after the last injection of IMP, regardless of introduction of rescue therapy). Analysis was performed using safety population which included all the treated participants.
|
|
Cardiac disorders
Cardiac failure chronic
|
0.00%
0/508 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 184) regardless of seriousness or relationship to IMP.
Reported AEs and deaths were treatment emergent that is AEs that developed/worsened and deaths that occurred during 'on treatment period' (from first dose of IMP injection up to 2 days after the last injection of IMP, regardless of introduction of rescue therapy). Analysis was performed using safety population which included all the treated participants.
|
0.20%
1/505 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 184) regardless of seriousness or relationship to IMP.
Reported AEs and deaths were treatment emergent that is AEs that developed/worsened and deaths that occurred during 'on treatment period' (from first dose of IMP injection up to 2 days after the last injection of IMP, regardless of introduction of rescue therapy). Analysis was performed using safety population which included all the treated participants.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.20%
1/508 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 184) regardless of seriousness or relationship to IMP.
Reported AEs and deaths were treatment emergent that is AEs that developed/worsened and deaths that occurred during 'on treatment period' (from first dose of IMP injection up to 2 days after the last injection of IMP, regardless of introduction of rescue therapy). Analysis was performed using safety population which included all the treated participants.
|
0.00%
0/505 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 184) regardless of seriousness or relationship to IMP.
Reported AEs and deaths were treatment emergent that is AEs that developed/worsened and deaths that occurred during 'on treatment period' (from first dose of IMP injection up to 2 days after the last injection of IMP, regardless of introduction of rescue therapy). Analysis was performed using safety population which included all the treated participants.
|
|
Cardiac disorders
Coronary artery disease
|
0.39%
2/508 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 184) regardless of seriousness or relationship to IMP.
Reported AEs and deaths were treatment emergent that is AEs that developed/worsened and deaths that occurred during 'on treatment period' (from first dose of IMP injection up to 2 days after the last injection of IMP, regardless of introduction of rescue therapy). Analysis was performed using safety population which included all the treated participants.
|
0.40%
2/505 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 184) regardless of seriousness or relationship to IMP.
Reported AEs and deaths were treatment emergent that is AEs that developed/worsened and deaths that occurred during 'on treatment period' (from first dose of IMP injection up to 2 days after the last injection of IMP, regardless of introduction of rescue therapy). Analysis was performed using safety population which included all the treated participants.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.00%
0/508 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 184) regardless of seriousness or relationship to IMP.
Reported AEs and deaths were treatment emergent that is AEs that developed/worsened and deaths that occurred during 'on treatment period' (from first dose of IMP injection up to 2 days after the last injection of IMP, regardless of introduction of rescue therapy). Analysis was performed using safety population which included all the treated participants.
|
0.20%
1/505 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 184) regardless of seriousness or relationship to IMP.
Reported AEs and deaths were treatment emergent that is AEs that developed/worsened and deaths that occurred during 'on treatment period' (from first dose of IMP injection up to 2 days after the last injection of IMP, regardless of introduction of rescue therapy). Analysis was performed using safety population which included all the treated participants.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/508 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 184) regardless of seriousness or relationship to IMP.
Reported AEs and deaths were treatment emergent that is AEs that developed/worsened and deaths that occurred during 'on treatment period' (from first dose of IMP injection up to 2 days after the last injection of IMP, regardless of introduction of rescue therapy). Analysis was performed using safety population which included all the treated participants.
|
0.20%
1/505 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 184) regardless of seriousness or relationship to IMP.
Reported AEs and deaths were treatment emergent that is AEs that developed/worsened and deaths that occurred during 'on treatment period' (from first dose of IMP injection up to 2 days after the last injection of IMP, regardless of introduction of rescue therapy). Analysis was performed using safety population which included all the treated participants.
|
|
Cardiac disorders
Sinus node dysfunction
|
0.20%
1/508 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 184) regardless of seriousness or relationship to IMP.
Reported AEs and deaths were treatment emergent that is AEs that developed/worsened and deaths that occurred during 'on treatment period' (from first dose of IMP injection up to 2 days after the last injection of IMP, regardless of introduction of rescue therapy). Analysis was performed using safety population which included all the treated participants.
|
0.00%
0/505 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 184) regardless of seriousness or relationship to IMP.
Reported AEs and deaths were treatment emergent that is AEs that developed/worsened and deaths that occurred during 'on treatment period' (from first dose of IMP injection up to 2 days after the last injection of IMP, regardless of introduction of rescue therapy). Analysis was performed using safety population which included all the treated participants.
|
|
Cardiac disorders
Tachycardia
|
0.20%
1/508 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 184) regardless of seriousness or relationship to IMP.
Reported AEs and deaths were treatment emergent that is AEs that developed/worsened and deaths that occurred during 'on treatment period' (from first dose of IMP injection up to 2 days after the last injection of IMP, regardless of introduction of rescue therapy). Analysis was performed using safety population which included all the treated participants.
|
0.00%
0/505 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 184) regardless of seriousness or relationship to IMP.
Reported AEs and deaths were treatment emergent that is AEs that developed/worsened and deaths that occurred during 'on treatment period' (from first dose of IMP injection up to 2 days after the last injection of IMP, regardless of introduction of rescue therapy). Analysis was performed using safety population which included all the treated participants.
|
|
Endocrine disorders
Adrenal mass
|
0.20%
1/508 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 184) regardless of seriousness or relationship to IMP.
Reported AEs and deaths were treatment emergent that is AEs that developed/worsened and deaths that occurred during 'on treatment period' (from first dose of IMP injection up to 2 days after the last injection of IMP, regardless of introduction of rescue therapy). Analysis was performed using safety population which included all the treated participants.
|
0.00%
0/505 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 184) regardless of seriousness or relationship to IMP.
Reported AEs and deaths were treatment emergent that is AEs that developed/worsened and deaths that occurred during 'on treatment period' (from first dose of IMP injection up to 2 days after the last injection of IMP, regardless of introduction of rescue therapy). Analysis was performed using safety population which included all the treated participants.
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
0.20%
1/508 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 184) regardless of seriousness or relationship to IMP.
Reported AEs and deaths were treatment emergent that is AEs that developed/worsened and deaths that occurred during 'on treatment period' (from first dose of IMP injection up to 2 days after the last injection of IMP, regardless of introduction of rescue therapy). Analysis was performed using safety population which included all the treated participants.
|
0.00%
0/505 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 184) regardless of seriousness or relationship to IMP.
Reported AEs and deaths were treatment emergent that is AEs that developed/worsened and deaths that occurred during 'on treatment period' (from first dose of IMP injection up to 2 days after the last injection of IMP, regardless of introduction of rescue therapy). Analysis was performed using safety population which included all the treated participants.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/508 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 184) regardless of seriousness or relationship to IMP.
Reported AEs and deaths were treatment emergent that is AEs that developed/worsened and deaths that occurred during 'on treatment period' (from first dose of IMP injection up to 2 days after the last injection of IMP, regardless of introduction of rescue therapy). Analysis was performed using safety population which included all the treated participants.
|
0.20%
1/505 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 184) regardless of seriousness or relationship to IMP.
Reported AEs and deaths were treatment emergent that is AEs that developed/worsened and deaths that occurred during 'on treatment period' (from first dose of IMP injection up to 2 days after the last injection of IMP, regardless of introduction of rescue therapy). Analysis was performed using safety population which included all the treated participants.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.20%
1/508 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 184) regardless of seriousness or relationship to IMP.
Reported AEs and deaths were treatment emergent that is AEs that developed/worsened and deaths that occurred during 'on treatment period' (from first dose of IMP injection up to 2 days after the last injection of IMP, regardless of introduction of rescue therapy). Analysis was performed using safety population which included all the treated participants.
|
0.00%
0/505 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 184) regardless of seriousness or relationship to IMP.
Reported AEs and deaths were treatment emergent that is AEs that developed/worsened and deaths that occurred during 'on treatment period' (from first dose of IMP injection up to 2 days after the last injection of IMP, regardless of introduction of rescue therapy). Analysis was performed using safety population which included all the treated participants.
|
|
General disorders
Death
|
0.20%
1/508 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 184) regardless of seriousness or relationship to IMP.
Reported AEs and deaths were treatment emergent that is AEs that developed/worsened and deaths that occurred during 'on treatment period' (from first dose of IMP injection up to 2 days after the last injection of IMP, regardless of introduction of rescue therapy). Analysis was performed using safety population which included all the treated participants.
|
0.00%
0/505 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 184) regardless of seriousness or relationship to IMP.
Reported AEs and deaths were treatment emergent that is AEs that developed/worsened and deaths that occurred during 'on treatment period' (from first dose of IMP injection up to 2 days after the last injection of IMP, regardless of introduction of rescue therapy). Analysis was performed using safety population which included all the treated participants.
|
|
Hepatobiliary disorders
Bile duct stone
|
0.20%
1/508 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 184) regardless of seriousness or relationship to IMP.
Reported AEs and deaths were treatment emergent that is AEs that developed/worsened and deaths that occurred during 'on treatment period' (from first dose of IMP injection up to 2 days after the last injection of IMP, regardless of introduction of rescue therapy). Analysis was performed using safety population which included all the treated participants.
|
0.00%
0/505 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 184) regardless of seriousness or relationship to IMP.
Reported AEs and deaths were treatment emergent that is AEs that developed/worsened and deaths that occurred during 'on treatment period' (from first dose of IMP injection up to 2 days after the last injection of IMP, regardless of introduction of rescue therapy). Analysis was performed using safety population which included all the treated participants.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.20%
1/508 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 184) regardless of seriousness or relationship to IMP.
Reported AEs and deaths were treatment emergent that is AEs that developed/worsened and deaths that occurred during 'on treatment period' (from first dose of IMP injection up to 2 days after the last injection of IMP, regardless of introduction of rescue therapy). Analysis was performed using safety population which included all the treated participants.
|
0.00%
0/505 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 184) regardless of seriousness or relationship to IMP.
Reported AEs and deaths were treatment emergent that is AEs that developed/worsened and deaths that occurred during 'on treatment period' (from first dose of IMP injection up to 2 days after the last injection of IMP, regardless of introduction of rescue therapy). Analysis was performed using safety population which included all the treated participants.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.20%
1/508 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 184) regardless of seriousness or relationship to IMP.
Reported AEs and deaths were treatment emergent that is AEs that developed/worsened and deaths that occurred during 'on treatment period' (from first dose of IMP injection up to 2 days after the last injection of IMP, regardless of introduction of rescue therapy). Analysis was performed using safety population which included all the treated participants.
|
0.00%
0/505 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 184) regardless of seriousness or relationship to IMP.
Reported AEs and deaths were treatment emergent that is AEs that developed/worsened and deaths that occurred during 'on treatment period' (from first dose of IMP injection up to 2 days after the last injection of IMP, regardless of introduction of rescue therapy). Analysis was performed using safety population which included all the treated participants.
|
|
Infections and infestations
Arthritis infective
|
0.20%
1/508 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 184) regardless of seriousness or relationship to IMP.
Reported AEs and deaths were treatment emergent that is AEs that developed/worsened and deaths that occurred during 'on treatment period' (from first dose of IMP injection up to 2 days after the last injection of IMP, regardless of introduction of rescue therapy). Analysis was performed using safety population which included all the treated participants.
|
0.00%
0/505 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 184) regardless of seriousness or relationship to IMP.
Reported AEs and deaths were treatment emergent that is AEs that developed/worsened and deaths that occurred during 'on treatment period' (from first dose of IMP injection up to 2 days after the last injection of IMP, regardless of introduction of rescue therapy). Analysis was performed using safety population which included all the treated participants.
|
|
Infections and infestations
Bacterial pyelonephritis
|
0.00%
0/508 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 184) regardless of seriousness or relationship to IMP.
Reported AEs and deaths were treatment emergent that is AEs that developed/worsened and deaths that occurred during 'on treatment period' (from first dose of IMP injection up to 2 days after the last injection of IMP, regardless of introduction of rescue therapy). Analysis was performed using safety population which included all the treated participants.
|
0.20%
1/505 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 184) regardless of seriousness or relationship to IMP.
Reported AEs and deaths were treatment emergent that is AEs that developed/worsened and deaths that occurred during 'on treatment period' (from first dose of IMP injection up to 2 days after the last injection of IMP, regardless of introduction of rescue therapy). Analysis was performed using safety population which included all the treated participants.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/508 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 184) regardless of seriousness or relationship to IMP.
Reported AEs and deaths were treatment emergent that is AEs that developed/worsened and deaths that occurred during 'on treatment period' (from first dose of IMP injection up to 2 days after the last injection of IMP, regardless of introduction of rescue therapy). Analysis was performed using safety population which included all the treated participants.
|
0.20%
1/505 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 184) regardless of seriousness or relationship to IMP.
Reported AEs and deaths were treatment emergent that is AEs that developed/worsened and deaths that occurred during 'on treatment period' (from first dose of IMP injection up to 2 days after the last injection of IMP, regardless of introduction of rescue therapy). Analysis was performed using safety population which included all the treated participants.
|
|
Infections and infestations
Empyema
|
0.00%
0/508 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 184) regardless of seriousness or relationship to IMP.
Reported AEs and deaths were treatment emergent that is AEs that developed/worsened and deaths that occurred during 'on treatment period' (from first dose of IMP injection up to 2 days after the last injection of IMP, regardless of introduction of rescue therapy). Analysis was performed using safety population which included all the treated participants.
|
0.20%
1/505 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 184) regardless of seriousness or relationship to IMP.
Reported AEs and deaths were treatment emergent that is AEs that developed/worsened and deaths that occurred during 'on treatment period' (from first dose of IMP injection up to 2 days after the last injection of IMP, regardless of introduction of rescue therapy). Analysis was performed using safety population which included all the treated participants.
|
|
Infections and infestations
Endocarditis bacterial
|
0.20%
1/508 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 184) regardless of seriousness or relationship to IMP.
Reported AEs and deaths were treatment emergent that is AEs that developed/worsened and deaths that occurred during 'on treatment period' (from first dose of IMP injection up to 2 days after the last injection of IMP, regardless of introduction of rescue therapy). Analysis was performed using safety population which included all the treated participants.
|
0.00%
0/505 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 184) regardless of seriousness or relationship to IMP.
Reported AEs and deaths were treatment emergent that is AEs that developed/worsened and deaths that occurred during 'on treatment period' (from first dose of IMP injection up to 2 days after the last injection of IMP, regardless of introduction of rescue therapy). Analysis was performed using safety population which included all the treated participants.
|
|
Infections and infestations
Lung infection
|
0.00%
0/508 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 184) regardless of seriousness or relationship to IMP.
Reported AEs and deaths were treatment emergent that is AEs that developed/worsened and deaths that occurred during 'on treatment period' (from first dose of IMP injection up to 2 days after the last injection of IMP, regardless of introduction of rescue therapy). Analysis was performed using safety population which included all the treated participants.
|
0.20%
1/505 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 184) regardless of seriousness or relationship to IMP.
Reported AEs and deaths were treatment emergent that is AEs that developed/worsened and deaths that occurred during 'on treatment period' (from first dose of IMP injection up to 2 days after the last injection of IMP, regardless of introduction of rescue therapy). Analysis was performed using safety population which included all the treated participants.
|
|
Infections and infestations
Osteomyelitis
|
0.20%
1/508 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 184) regardless of seriousness or relationship to IMP.
Reported AEs and deaths were treatment emergent that is AEs that developed/worsened and deaths that occurred during 'on treatment period' (from first dose of IMP injection up to 2 days after the last injection of IMP, regardless of introduction of rescue therapy). Analysis was performed using safety population which included all the treated participants.
|
0.00%
0/505 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 184) regardless of seriousness or relationship to IMP.
Reported AEs and deaths were treatment emergent that is AEs that developed/worsened and deaths that occurred during 'on treatment period' (from first dose of IMP injection up to 2 days after the last injection of IMP, regardless of introduction of rescue therapy). Analysis was performed using safety population which included all the treated participants.
|
|
Infections and infestations
Perirectal abscess
|
0.20%
1/508 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 184) regardless of seriousness or relationship to IMP.
Reported AEs and deaths were treatment emergent that is AEs that developed/worsened and deaths that occurred during 'on treatment period' (from first dose of IMP injection up to 2 days after the last injection of IMP, regardless of introduction of rescue therapy). Analysis was performed using safety population which included all the treated participants.
|
0.00%
0/505 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 184) regardless of seriousness or relationship to IMP.
Reported AEs and deaths were treatment emergent that is AEs that developed/worsened and deaths that occurred during 'on treatment period' (from first dose of IMP injection up to 2 days after the last injection of IMP, regardless of introduction of rescue therapy). Analysis was performed using safety population which included all the treated participants.
|
|
Infections and infestations
Pneumonia
|
0.20%
1/508 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 184) regardless of seriousness or relationship to IMP.
Reported AEs and deaths were treatment emergent that is AEs that developed/worsened and deaths that occurred during 'on treatment period' (from first dose of IMP injection up to 2 days after the last injection of IMP, regardless of introduction of rescue therapy). Analysis was performed using safety population which included all the treated participants.
|
0.59%
3/505 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 184) regardless of seriousness or relationship to IMP.
Reported AEs and deaths were treatment emergent that is AEs that developed/worsened and deaths that occurred during 'on treatment period' (from first dose of IMP injection up to 2 days after the last injection of IMP, regardless of introduction of rescue therapy). Analysis was performed using safety population which included all the treated participants.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/508 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 184) regardless of seriousness or relationship to IMP.
Reported AEs and deaths were treatment emergent that is AEs that developed/worsened and deaths that occurred during 'on treatment period' (from first dose of IMP injection up to 2 days after the last injection of IMP, regardless of introduction of rescue therapy). Analysis was performed using safety population which included all the treated participants.
|
0.40%
2/505 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 184) regardless of seriousness or relationship to IMP.
Reported AEs and deaths were treatment emergent that is AEs that developed/worsened and deaths that occurred during 'on treatment period' (from first dose of IMP injection up to 2 days after the last injection of IMP, regardless of introduction of rescue therapy). Analysis was performed using safety population which included all the treated participants.
|
|
Infections and infestations
Urosepsis
|
0.20%
1/508 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 184) regardless of seriousness or relationship to IMP.
Reported AEs and deaths were treatment emergent that is AEs that developed/worsened and deaths that occurred during 'on treatment period' (from first dose of IMP injection up to 2 days after the last injection of IMP, regardless of introduction of rescue therapy). Analysis was performed using safety population which included all the treated participants.
|
0.00%
0/505 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 184) regardless of seriousness or relationship to IMP.
Reported AEs and deaths were treatment emergent that is AEs that developed/worsened and deaths that occurred during 'on treatment period' (from first dose of IMP injection up to 2 days after the last injection of IMP, regardless of introduction of rescue therapy). Analysis was performed using safety population which included all the treated participants.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/508 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 184) regardless of seriousness or relationship to IMP.
Reported AEs and deaths were treatment emergent that is AEs that developed/worsened and deaths that occurred during 'on treatment period' (from first dose of IMP injection up to 2 days after the last injection of IMP, regardless of introduction of rescue therapy). Analysis was performed using safety population which included all the treated participants.
|
0.20%
1/505 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 184) regardless of seriousness or relationship to IMP.
Reported AEs and deaths were treatment emergent that is AEs that developed/worsened and deaths that occurred during 'on treatment period' (from first dose of IMP injection up to 2 days after the last injection of IMP, regardless of introduction of rescue therapy). Analysis was performed using safety population which included all the treated participants.
|
|
Injury, poisoning and procedural complications
Fall
|
0.20%
1/508 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 184) regardless of seriousness or relationship to IMP.
Reported AEs and deaths were treatment emergent that is AEs that developed/worsened and deaths that occurred during 'on treatment period' (from first dose of IMP injection up to 2 days after the last injection of IMP, regardless of introduction of rescue therapy). Analysis was performed using safety population which included all the treated participants.
|
0.00%
0/505 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 184) regardless of seriousness or relationship to IMP.
Reported AEs and deaths were treatment emergent that is AEs that developed/worsened and deaths that occurred during 'on treatment period' (from first dose of IMP injection up to 2 days after the last injection of IMP, regardless of introduction of rescue therapy). Analysis was performed using safety population which included all the treated participants.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/508 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 184) regardless of seriousness or relationship to IMP.
Reported AEs and deaths were treatment emergent that is AEs that developed/worsened and deaths that occurred during 'on treatment period' (from first dose of IMP injection up to 2 days after the last injection of IMP, regardless of introduction of rescue therapy). Analysis was performed using safety population which included all the treated participants.
|
0.20%
1/505 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 184) regardless of seriousness or relationship to IMP.
Reported AEs and deaths were treatment emergent that is AEs that developed/worsened and deaths that occurred during 'on treatment period' (from first dose of IMP injection up to 2 days after the last injection of IMP, regardless of introduction of rescue therapy). Analysis was performed using safety population which included all the treated participants.
|
|
Injury, poisoning and procedural complications
Heart injury
|
0.00%
0/508 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 184) regardless of seriousness or relationship to IMP.
Reported AEs and deaths were treatment emergent that is AEs that developed/worsened and deaths that occurred during 'on treatment period' (from first dose of IMP injection up to 2 days after the last injection of IMP, regardless of introduction of rescue therapy). Analysis was performed using safety population which included all the treated participants.
|
0.20%
1/505 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 184) regardless of seriousness or relationship to IMP.
Reported AEs and deaths were treatment emergent that is AEs that developed/worsened and deaths that occurred during 'on treatment period' (from first dose of IMP injection up to 2 days after the last injection of IMP, regardless of introduction of rescue therapy). Analysis was performed using safety population which included all the treated participants.
|
|
Investigations
Hepatic enzyme increased
|
0.20%
1/508 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 184) regardless of seriousness or relationship to IMP.
Reported AEs and deaths were treatment emergent that is AEs that developed/worsened and deaths that occurred during 'on treatment period' (from first dose of IMP injection up to 2 days after the last injection of IMP, regardless of introduction of rescue therapy). Analysis was performed using safety population which included all the treated participants.
|
0.00%
0/505 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 184) regardless of seriousness or relationship to IMP.
Reported AEs and deaths were treatment emergent that is AEs that developed/worsened and deaths that occurred during 'on treatment period' (from first dose of IMP injection up to 2 days after the last injection of IMP, regardless of introduction of rescue therapy). Analysis was performed using safety population which included all the treated participants.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.20%
1/508 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 184) regardless of seriousness or relationship to IMP.
Reported AEs and deaths were treatment emergent that is AEs that developed/worsened and deaths that occurred during 'on treatment period' (from first dose of IMP injection up to 2 days after the last injection of IMP, regardless of introduction of rescue therapy). Analysis was performed using safety population which included all the treated participants.
|
0.00%
0/505 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 184) regardless of seriousness or relationship to IMP.
Reported AEs and deaths were treatment emergent that is AEs that developed/worsened and deaths that occurred during 'on treatment period' (from first dose of IMP injection up to 2 days after the last injection of IMP, regardless of introduction of rescue therapy). Analysis was performed using safety population which included all the treated participants.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.20%
1/508 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 184) regardless of seriousness or relationship to IMP.
Reported AEs and deaths were treatment emergent that is AEs that developed/worsened and deaths that occurred during 'on treatment period' (from first dose of IMP injection up to 2 days after the last injection of IMP, regardless of introduction of rescue therapy). Analysis was performed using safety population which included all the treated participants.
|
0.20%
1/505 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 184) regardless of seriousness or relationship to IMP.
Reported AEs and deaths were treatment emergent that is AEs that developed/worsened and deaths that occurred during 'on treatment period' (from first dose of IMP injection up to 2 days after the last injection of IMP, regardless of introduction of rescue therapy). Analysis was performed using safety population which included all the treated participants.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.20%
1/508 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 184) regardless of seriousness or relationship to IMP.
Reported AEs and deaths were treatment emergent that is AEs that developed/worsened and deaths that occurred during 'on treatment period' (from first dose of IMP injection up to 2 days after the last injection of IMP, regardless of introduction of rescue therapy). Analysis was performed using safety population which included all the treated participants.
|
0.00%
0/505 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 184) regardless of seriousness or relationship to IMP.
Reported AEs and deaths were treatment emergent that is AEs that developed/worsened and deaths that occurred during 'on treatment period' (from first dose of IMP injection up to 2 days after the last injection of IMP, regardless of introduction of rescue therapy). Analysis was performed using safety population which included all the treated participants.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.20%
1/508 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 184) regardless of seriousness or relationship to IMP.
Reported AEs and deaths were treatment emergent that is AEs that developed/worsened and deaths that occurred during 'on treatment period' (from first dose of IMP injection up to 2 days after the last injection of IMP, regardless of introduction of rescue therapy). Analysis was performed using safety population which included all the treated participants.
|
0.00%
0/505 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 184) regardless of seriousness or relationship to IMP.
Reported AEs and deaths were treatment emergent that is AEs that developed/worsened and deaths that occurred during 'on treatment period' (from first dose of IMP injection up to 2 days after the last injection of IMP, regardless of introduction of rescue therapy). Analysis was performed using safety population which included all the treated participants.
|
|
Musculoskeletal and connective tissue disorders
Chondrocalcinosis pyrophosphate
|
0.20%
1/508 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 184) regardless of seriousness or relationship to IMP.
Reported AEs and deaths were treatment emergent that is AEs that developed/worsened and deaths that occurred during 'on treatment period' (from first dose of IMP injection up to 2 days after the last injection of IMP, regardless of introduction of rescue therapy). Analysis was performed using safety population which included all the treated participants.
|
0.00%
0/505 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 184) regardless of seriousness or relationship to IMP.
Reported AEs and deaths were treatment emergent that is AEs that developed/worsened and deaths that occurred during 'on treatment period' (from first dose of IMP injection up to 2 days after the last injection of IMP, regardless of introduction of rescue therapy). Analysis was performed using safety population which included all the treated participants.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/508 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 184) regardless of seriousness or relationship to IMP.
Reported AEs and deaths were treatment emergent that is AEs that developed/worsened and deaths that occurred during 'on treatment period' (from first dose of IMP injection up to 2 days after the last injection of IMP, regardless of introduction of rescue therapy). Analysis was performed using safety population which included all the treated participants.
|
0.20%
1/505 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 184) regardless of seriousness or relationship to IMP.
Reported AEs and deaths were treatment emergent that is AEs that developed/worsened and deaths that occurred during 'on treatment period' (from first dose of IMP injection up to 2 days after the last injection of IMP, regardless of introduction of rescue therapy). Analysis was performed using safety population which included all the treated participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon
|
0.20%
1/508 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 184) regardless of seriousness or relationship to IMP.
Reported AEs and deaths were treatment emergent that is AEs that developed/worsened and deaths that occurred during 'on treatment period' (from first dose of IMP injection up to 2 days after the last injection of IMP, regardless of introduction of rescue therapy). Analysis was performed using safety population which included all the treated participants.
|
0.00%
0/505 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 184) regardless of seriousness or relationship to IMP.
Reported AEs and deaths were treatment emergent that is AEs that developed/worsened and deaths that occurred during 'on treatment period' (from first dose of IMP injection up to 2 days after the last injection of IMP, regardless of introduction of rescue therapy). Analysis was performed using safety population which included all the treated participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.20%
1/508 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 184) regardless of seriousness or relationship to IMP.
Reported AEs and deaths were treatment emergent that is AEs that developed/worsened and deaths that occurred during 'on treatment period' (from first dose of IMP injection up to 2 days after the last injection of IMP, regardless of introduction of rescue therapy). Analysis was performed using safety population which included all the treated participants.
|
0.20%
1/505 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 184) regardless of seriousness or relationship to IMP.
Reported AEs and deaths were treatment emergent that is AEs that developed/worsened and deaths that occurred during 'on treatment period' (from first dose of IMP injection up to 2 days after the last injection of IMP, regardless of introduction of rescue therapy). Analysis was performed using safety population which included all the treated participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.00%
0/508 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 184) regardless of seriousness or relationship to IMP.
Reported AEs and deaths were treatment emergent that is AEs that developed/worsened and deaths that occurred during 'on treatment period' (from first dose of IMP injection up to 2 days after the last injection of IMP, regardless of introduction of rescue therapy). Analysis was performed using safety population which included all the treated participants.
|
0.20%
1/505 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 184) regardless of seriousness or relationship to IMP.
Reported AEs and deaths were treatment emergent that is AEs that developed/worsened and deaths that occurred during 'on treatment period' (from first dose of IMP injection up to 2 days after the last injection of IMP, regardless of introduction of rescue therapy). Analysis was performed using safety population which included all the treated participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bowen's disease
|
0.20%
1/508 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 184) regardless of seriousness or relationship to IMP.
Reported AEs and deaths were treatment emergent that is AEs that developed/worsened and deaths that occurred during 'on treatment period' (from first dose of IMP injection up to 2 days after the last injection of IMP, regardless of introduction of rescue therapy). Analysis was performed using safety population which included all the treated participants.
|
0.00%
0/505 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 184) regardless of seriousness or relationship to IMP.
Reported AEs and deaths were treatment emergent that is AEs that developed/worsened and deaths that occurred during 'on treatment period' (from first dose of IMP injection up to 2 days after the last injection of IMP, regardless of introduction of rescue therapy). Analysis was performed using safety population which included all the treated participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/508 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 184) regardless of seriousness or relationship to IMP.
Reported AEs and deaths were treatment emergent that is AEs that developed/worsened and deaths that occurred during 'on treatment period' (from first dose of IMP injection up to 2 days after the last injection of IMP, regardless of introduction of rescue therapy). Analysis was performed using safety population which included all the treated participants.
|
0.20%
1/505 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 184) regardless of seriousness or relationship to IMP.
Reported AEs and deaths were treatment emergent that is AEs that developed/worsened and deaths that occurred during 'on treatment period' (from first dose of IMP injection up to 2 days after the last injection of IMP, regardless of introduction of rescue therapy). Analysis was performed using safety population which included all the treated participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic lymphocytic leukaemia
|
0.20%
1/508 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 184) regardless of seriousness or relationship to IMP.
Reported AEs and deaths were treatment emergent that is AEs that developed/worsened and deaths that occurred during 'on treatment period' (from first dose of IMP injection up to 2 days after the last injection of IMP, regardless of introduction of rescue therapy). Analysis was performed using safety population which included all the treated participants.
|
0.00%
0/505 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 184) regardless of seriousness or relationship to IMP.
Reported AEs and deaths were treatment emergent that is AEs that developed/worsened and deaths that occurred during 'on treatment period' (from first dose of IMP injection up to 2 days after the last injection of IMP, regardless of introduction of rescue therapy). Analysis was performed using safety population which included all the treated participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial cancer metastatic
|
0.20%
1/508 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 184) regardless of seriousness or relationship to IMP.
Reported AEs and deaths were treatment emergent that is AEs that developed/worsened and deaths that occurred during 'on treatment period' (from first dose of IMP injection up to 2 days after the last injection of IMP, regardless of introduction of rescue therapy). Analysis was performed using safety population which included all the treated participants.
|
0.00%
0/505 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 184) regardless of seriousness or relationship to IMP.
Reported AEs and deaths were treatment emergent that is AEs that developed/worsened and deaths that occurred during 'on treatment period' (from first dose of IMP injection up to 2 days after the last injection of IMP, regardless of introduction of rescue therapy). Analysis was performed using safety population which included all the treated participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Glioblastoma
|
0.00%
0/508 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 184) regardless of seriousness or relationship to IMP.
Reported AEs and deaths were treatment emergent that is AEs that developed/worsened and deaths that occurred during 'on treatment period' (from first dose of IMP injection up to 2 days after the last injection of IMP, regardless of introduction of rescue therapy). Analysis was performed using safety population which included all the treated participants.
|
0.20%
1/505 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 184) regardless of seriousness or relationship to IMP.
Reported AEs and deaths were treatment emergent that is AEs that developed/worsened and deaths that occurred during 'on treatment period' (from first dose of IMP injection up to 2 days after the last injection of IMP, regardless of introduction of rescue therapy). Analysis was performed using safety population which included all the treated participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic neoplasm
|
0.00%
0/508 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 184) regardless of seriousness or relationship to IMP.
Reported AEs and deaths were treatment emergent that is AEs that developed/worsened and deaths that occurred during 'on treatment period' (from first dose of IMP injection up to 2 days after the last injection of IMP, regardless of introduction of rescue therapy). Analysis was performed using safety population which included all the treated participants.
|
0.20%
1/505 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 184) regardless of seriousness or relationship to IMP.
Reported AEs and deaths were treatment emergent that is AEs that developed/worsened and deaths that occurred during 'on treatment period' (from first dose of IMP injection up to 2 days after the last injection of IMP, regardless of introduction of rescue therapy). Analysis was performed using safety population which included all the treated participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.20%
1/508 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 184) regardless of seriousness or relationship to IMP.
Reported AEs and deaths were treatment emergent that is AEs that developed/worsened and deaths that occurred during 'on treatment period' (from first dose of IMP injection up to 2 days after the last injection of IMP, regardless of introduction of rescue therapy). Analysis was performed using safety population which included all the treated participants.
|
0.00%
0/505 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 184) regardless of seriousness or relationship to IMP.
Reported AEs and deaths were treatment emergent that is AEs that developed/worsened and deaths that occurred during 'on treatment period' (from first dose of IMP injection up to 2 days after the last injection of IMP, regardless of introduction of rescue therapy). Analysis was performed using safety population which included all the treated participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm
|
0.00%
0/508 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 184) regardless of seriousness or relationship to IMP.
Reported AEs and deaths were treatment emergent that is AEs that developed/worsened and deaths that occurred during 'on treatment period' (from first dose of IMP injection up to 2 days after the last injection of IMP, regardless of introduction of rescue therapy). Analysis was performed using safety population which included all the treated participants.
|
0.20%
1/505 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 184) regardless of seriousness or relationship to IMP.
Reported AEs and deaths were treatment emergent that is AEs that developed/worsened and deaths that occurred during 'on treatment period' (from first dose of IMP injection up to 2 days after the last injection of IMP, regardless of introduction of rescue therapy). Analysis was performed using safety population which included all the treated participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal adenocarcinoma
|
0.00%
0/508 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 184) regardless of seriousness or relationship to IMP.
Reported AEs and deaths were treatment emergent that is AEs that developed/worsened and deaths that occurred during 'on treatment period' (from first dose of IMP injection up to 2 days after the last injection of IMP, regardless of introduction of rescue therapy). Analysis was performed using safety population which included all the treated participants.
|
0.20%
1/505 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 184) regardless of seriousness or relationship to IMP.
Reported AEs and deaths were treatment emergent that is AEs that developed/worsened and deaths that occurred during 'on treatment period' (from first dose of IMP injection up to 2 days after the last injection of IMP, regardless of introduction of rescue therapy). Analysis was performed using safety population which included all the treated participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.39%
2/508 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 184) regardless of seriousness or relationship to IMP.
Reported AEs and deaths were treatment emergent that is AEs that developed/worsened and deaths that occurred during 'on treatment period' (from first dose of IMP injection up to 2 days after the last injection of IMP, regardless of introduction of rescue therapy). Analysis was performed using safety population which included all the treated participants.
|
0.00%
0/505 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 184) regardless of seriousness or relationship to IMP.
Reported AEs and deaths were treatment emergent that is AEs that developed/worsened and deaths that occurred during 'on treatment period' (from first dose of IMP injection up to 2 days after the last injection of IMP, regardless of introduction of rescue therapy). Analysis was performed using safety population which included all the treated participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.59%
3/508 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 184) regardless of seriousness or relationship to IMP.
Reported AEs and deaths were treatment emergent that is AEs that developed/worsened and deaths that occurred during 'on treatment period' (from first dose of IMP injection up to 2 days after the last injection of IMP, regardless of introduction of rescue therapy). Analysis was performed using safety population which included all the treated participants.
|
0.20%
1/505 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 184) regardless of seriousness or relationship to IMP.
Reported AEs and deaths were treatment emergent that is AEs that developed/worsened and deaths that occurred during 'on treatment period' (from first dose of IMP injection up to 2 days after the last injection of IMP, regardless of introduction of rescue therapy). Analysis was performed using safety population which included all the treated participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
|
0.00%
0/508 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 184) regardless of seriousness or relationship to IMP.
Reported AEs and deaths were treatment emergent that is AEs that developed/worsened and deaths that occurred during 'on treatment period' (from first dose of IMP injection up to 2 days after the last injection of IMP, regardless of introduction of rescue therapy). Analysis was performed using safety population which included all the treated participants.
|
0.20%
1/505 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 184) regardless of seriousness or relationship to IMP.
Reported AEs and deaths were treatment emergent that is AEs that developed/worsened and deaths that occurred during 'on treatment period' (from first dose of IMP injection up to 2 days after the last injection of IMP, regardless of introduction of rescue therapy). Analysis was performed using safety population which included all the treated participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.20%
1/508 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 184) regardless of seriousness or relationship to IMP.
Reported AEs and deaths were treatment emergent that is AEs that developed/worsened and deaths that occurred during 'on treatment period' (from first dose of IMP injection up to 2 days after the last injection of IMP, regardless of introduction of rescue therapy). Analysis was performed using safety population which included all the treated participants.
|
0.00%
0/505 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 184) regardless of seriousness or relationship to IMP.
Reported AEs and deaths were treatment emergent that is AEs that developed/worsened and deaths that occurred during 'on treatment period' (from first dose of IMP injection up to 2 days after the last injection of IMP, regardless of introduction of rescue therapy). Analysis was performed using safety population which included all the treated participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell carcinoma
|
0.00%
0/508 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 184) regardless of seriousness or relationship to IMP.
Reported AEs and deaths were treatment emergent that is AEs that developed/worsened and deaths that occurred during 'on treatment period' (from first dose of IMP injection up to 2 days after the last injection of IMP, regardless of introduction of rescue therapy). Analysis was performed using safety population which included all the treated participants.
|
0.20%
1/505 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 184) regardless of seriousness or relationship to IMP.
Reported AEs and deaths were treatment emergent that is AEs that developed/worsened and deaths that occurred during 'on treatment period' (from first dose of IMP injection up to 2 days after the last injection of IMP, regardless of introduction of rescue therapy). Analysis was performed using safety population which included all the treated participants.
|
|
Nervous system disorders
Embolic stroke
|
0.20%
1/508 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 184) regardless of seriousness or relationship to IMP.
Reported AEs and deaths were treatment emergent that is AEs that developed/worsened and deaths that occurred during 'on treatment period' (from first dose of IMP injection up to 2 days after the last injection of IMP, regardless of introduction of rescue therapy). Analysis was performed using safety population which included all the treated participants.
|
0.00%
0/505 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 184) regardless of seriousness or relationship to IMP.
Reported AEs and deaths were treatment emergent that is AEs that developed/worsened and deaths that occurred during 'on treatment period' (from first dose of IMP injection up to 2 days after the last injection of IMP, regardless of introduction of rescue therapy). Analysis was performed using safety population which included all the treated participants.
|
|
Nervous system disorders
Hypoglycaemic coma
|
0.20%
1/508 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 184) regardless of seriousness or relationship to IMP.
Reported AEs and deaths were treatment emergent that is AEs that developed/worsened and deaths that occurred during 'on treatment period' (from first dose of IMP injection up to 2 days after the last injection of IMP, regardless of introduction of rescue therapy). Analysis was performed using safety population which included all the treated participants.
|
0.00%
0/505 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 184) regardless of seriousness or relationship to IMP.
Reported AEs and deaths were treatment emergent that is AEs that developed/worsened and deaths that occurred during 'on treatment period' (from first dose of IMP injection up to 2 days after the last injection of IMP, regardless of introduction of rescue therapy). Analysis was performed using safety population which included all the treated participants.
|
|
Nervous system disorders
Hypoglycaemic unconsciousness
|
0.20%
1/508 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 184) regardless of seriousness or relationship to IMP.
Reported AEs and deaths were treatment emergent that is AEs that developed/worsened and deaths that occurred during 'on treatment period' (from first dose of IMP injection up to 2 days after the last injection of IMP, regardless of introduction of rescue therapy). Analysis was performed using safety population which included all the treated participants.
|
0.00%
0/505 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 184) regardless of seriousness or relationship to IMP.
Reported AEs and deaths were treatment emergent that is AEs that developed/worsened and deaths that occurred during 'on treatment period' (from first dose of IMP injection up to 2 days after the last injection of IMP, regardless of introduction of rescue therapy). Analysis was performed using safety population which included all the treated participants.
|
|
Nervous system disorders
IIIrd nerve paresis
|
0.20%
1/508 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 184) regardless of seriousness or relationship to IMP.
Reported AEs and deaths were treatment emergent that is AEs that developed/worsened and deaths that occurred during 'on treatment period' (from first dose of IMP injection up to 2 days after the last injection of IMP, regardless of introduction of rescue therapy). Analysis was performed using safety population which included all the treated participants.
|
0.00%
0/505 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 184) regardless of seriousness or relationship to IMP.
Reported AEs and deaths were treatment emergent that is AEs that developed/worsened and deaths that occurred during 'on treatment period' (from first dose of IMP injection up to 2 days after the last injection of IMP, regardless of introduction of rescue therapy). Analysis was performed using safety population which included all the treated participants.
|
|
Nervous system disorders
Ischaemic stroke
|
0.39%
2/508 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 184) regardless of seriousness or relationship to IMP.
Reported AEs and deaths were treatment emergent that is AEs that developed/worsened and deaths that occurred during 'on treatment period' (from first dose of IMP injection up to 2 days after the last injection of IMP, regardless of introduction of rescue therapy). Analysis was performed using safety population which included all the treated participants.
|
0.00%
0/505 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 184) regardless of seriousness or relationship to IMP.
Reported AEs and deaths were treatment emergent that is AEs that developed/worsened and deaths that occurred during 'on treatment period' (from first dose of IMP injection up to 2 days after the last injection of IMP, regardless of introduction of rescue therapy). Analysis was performed using safety population which included all the treated participants.
|
|
Nervous system disorders
Loss of consciousness
|
0.20%
1/508 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 184) regardless of seriousness or relationship to IMP.
Reported AEs and deaths were treatment emergent that is AEs that developed/worsened and deaths that occurred during 'on treatment period' (from first dose of IMP injection up to 2 days after the last injection of IMP, regardless of introduction of rescue therapy). Analysis was performed using safety population which included all the treated participants.
|
0.00%
0/505 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 184) regardless of seriousness or relationship to IMP.
Reported AEs and deaths were treatment emergent that is AEs that developed/worsened and deaths that occurred during 'on treatment period' (from first dose of IMP injection up to 2 days after the last injection of IMP, regardless of introduction of rescue therapy). Analysis was performed using safety population which included all the treated participants.
|
|
Nervous system disorders
Neuromyopathy
|
0.20%
1/508 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 184) regardless of seriousness or relationship to IMP.
Reported AEs and deaths were treatment emergent that is AEs that developed/worsened and deaths that occurred during 'on treatment period' (from first dose of IMP injection up to 2 days after the last injection of IMP, regardless of introduction of rescue therapy). Analysis was performed using safety population which included all the treated participants.
|
0.00%
0/505 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 184) regardless of seriousness or relationship to IMP.
Reported AEs and deaths were treatment emergent that is AEs that developed/worsened and deaths that occurred during 'on treatment period' (from first dose of IMP injection up to 2 days after the last injection of IMP, regardless of introduction of rescue therapy). Analysis was performed using safety population which included all the treated participants.
|
|
Nervous system disorders
Syncope
|
0.20%
1/508 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 184) regardless of seriousness or relationship to IMP.
Reported AEs and deaths were treatment emergent that is AEs that developed/worsened and deaths that occurred during 'on treatment period' (from first dose of IMP injection up to 2 days after the last injection of IMP, regardless of introduction of rescue therapy). Analysis was performed using safety population which included all the treated participants.
|
0.20%
1/505 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 184) regardless of seriousness or relationship to IMP.
Reported AEs and deaths were treatment emergent that is AEs that developed/worsened and deaths that occurred during 'on treatment period' (from first dose of IMP injection up to 2 days after the last injection of IMP, regardless of introduction of rescue therapy). Analysis was performed using safety population which included all the treated participants.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/508 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 184) regardless of seriousness or relationship to IMP.
Reported AEs and deaths were treatment emergent that is AEs that developed/worsened and deaths that occurred during 'on treatment period' (from first dose of IMP injection up to 2 days after the last injection of IMP, regardless of introduction of rescue therapy). Analysis was performed using safety population which included all the treated participants.
|
0.20%
1/505 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 184) regardless of seriousness or relationship to IMP.
Reported AEs and deaths were treatment emergent that is AEs that developed/worsened and deaths that occurred during 'on treatment period' (from first dose of IMP injection up to 2 days after the last injection of IMP, regardless of introduction of rescue therapy). Analysis was performed using safety population which included all the treated participants.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.20%
1/508 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 184) regardless of seriousness or relationship to IMP.
Reported AEs and deaths were treatment emergent that is AEs that developed/worsened and deaths that occurred during 'on treatment period' (from first dose of IMP injection up to 2 days after the last injection of IMP, regardless of introduction of rescue therapy). Analysis was performed using safety population which included all the treated participants.
|
0.20%
1/505 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 184) regardless of seriousness or relationship to IMP.
Reported AEs and deaths were treatment emergent that is AEs that developed/worsened and deaths that occurred during 'on treatment period' (from first dose of IMP injection up to 2 days after the last injection of IMP, regardless of introduction of rescue therapy). Analysis was performed using safety population which included all the treated participants.
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.20%
1/508 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 184) regardless of seriousness or relationship to IMP.
Reported AEs and deaths were treatment emergent that is AEs that developed/worsened and deaths that occurred during 'on treatment period' (from first dose of IMP injection up to 2 days after the last injection of IMP, regardless of introduction of rescue therapy). Analysis was performed using safety population which included all the treated participants.
|
0.00%
0/505 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 184) regardless of seriousness or relationship to IMP.
Reported AEs and deaths were treatment emergent that is AEs that developed/worsened and deaths that occurred during 'on treatment period' (from first dose of IMP injection up to 2 days after the last injection of IMP, regardless of introduction of rescue therapy). Analysis was performed using safety population which included all the treated participants.
|
|
Renal and urinary disorders
Renal colic
|
0.00%
0/508 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 184) regardless of seriousness or relationship to IMP.
Reported AEs and deaths were treatment emergent that is AEs that developed/worsened and deaths that occurred during 'on treatment period' (from first dose of IMP injection up to 2 days after the last injection of IMP, regardless of introduction of rescue therapy). Analysis was performed using safety population which included all the treated participants.
|
0.20%
1/505 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 184) regardless of seriousness or relationship to IMP.
Reported AEs and deaths were treatment emergent that is AEs that developed/worsened and deaths that occurred during 'on treatment period' (from first dose of IMP injection up to 2 days after the last injection of IMP, regardless of introduction of rescue therapy). Analysis was performed using safety population which included all the treated participants.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.20%
1/508 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 184) regardless of seriousness or relationship to IMP.
Reported AEs and deaths were treatment emergent that is AEs that developed/worsened and deaths that occurred during 'on treatment period' (from first dose of IMP injection up to 2 days after the last injection of IMP, regardless of introduction of rescue therapy). Analysis was performed using safety population which included all the treated participants.
|
0.00%
0/505 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 184) regardless of seriousness or relationship to IMP.
Reported AEs and deaths were treatment emergent that is AEs that developed/worsened and deaths that occurred during 'on treatment period' (from first dose of IMP injection up to 2 days after the last injection of IMP, regardless of introduction of rescue therapy). Analysis was performed using safety population which included all the treated participants.
|
|
Reproductive system and breast disorders
Breast mass
|
0.00%
0/508 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 184) regardless of seriousness or relationship to IMP.
Reported AEs and deaths were treatment emergent that is AEs that developed/worsened and deaths that occurred during 'on treatment period' (from first dose of IMP injection up to 2 days after the last injection of IMP, regardless of introduction of rescue therapy). Analysis was performed using safety population which included all the treated participants.
|
0.20%
1/505 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 184) regardless of seriousness or relationship to IMP.
Reported AEs and deaths were treatment emergent that is AEs that developed/worsened and deaths that occurred during 'on treatment period' (from first dose of IMP injection up to 2 days after the last injection of IMP, regardless of introduction of rescue therapy). Analysis was performed using safety population which included all the treated participants.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.20%
1/508 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 184) regardless of seriousness or relationship to IMP.
Reported AEs and deaths were treatment emergent that is AEs that developed/worsened and deaths that occurred during 'on treatment period' (from first dose of IMP injection up to 2 days after the last injection of IMP, regardless of introduction of rescue therapy). Analysis was performed using safety population which included all the treated participants.
|
0.00%
0/505 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 184) regardless of seriousness or relationship to IMP.
Reported AEs and deaths were treatment emergent that is AEs that developed/worsened and deaths that occurred during 'on treatment period' (from first dose of IMP injection up to 2 days after the last injection of IMP, regardless of introduction of rescue therapy). Analysis was performed using safety population which included all the treated participants.
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.20%
1/508 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 184) regardless of seriousness or relationship to IMP.
Reported AEs and deaths were treatment emergent that is AEs that developed/worsened and deaths that occurred during 'on treatment period' (from first dose of IMP injection up to 2 days after the last injection of IMP, regardless of introduction of rescue therapy). Analysis was performed using safety population which included all the treated participants.
|
0.00%
0/505 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 184) regardless of seriousness or relationship to IMP.
Reported AEs and deaths were treatment emergent that is AEs that developed/worsened and deaths that occurred during 'on treatment period' (from first dose of IMP injection up to 2 days after the last injection of IMP, regardless of introduction of rescue therapy). Analysis was performed using safety population which included all the treated participants.
|
|
Vascular disorders
Hypertensive crisis
|
0.20%
1/508 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 184) regardless of seriousness or relationship to IMP.
Reported AEs and deaths were treatment emergent that is AEs that developed/worsened and deaths that occurred during 'on treatment period' (from first dose of IMP injection up to 2 days after the last injection of IMP, regardless of introduction of rescue therapy). Analysis was performed using safety population which included all the treated participants.
|
0.40%
2/505 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 184) regardless of seriousness or relationship to IMP.
Reported AEs and deaths were treatment emergent that is AEs that developed/worsened and deaths that occurred during 'on treatment period' (from first dose of IMP injection up to 2 days after the last injection of IMP, regardless of introduction of rescue therapy). Analysis was performed using safety population which included all the treated participants.
|
|
Vascular disorders
Peripheral venous disease
|
0.20%
1/508 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 184) regardless of seriousness or relationship to IMP.
Reported AEs and deaths were treatment emergent that is AEs that developed/worsened and deaths that occurred during 'on treatment period' (from first dose of IMP injection up to 2 days after the last injection of IMP, regardless of introduction of rescue therapy). Analysis was performed using safety population which included all the treated participants.
|
0.00%
0/505 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 184) regardless of seriousness or relationship to IMP.
Reported AEs and deaths were treatment emergent that is AEs that developed/worsened and deaths that occurred during 'on treatment period' (from first dose of IMP injection up to 2 days after the last injection of IMP, regardless of introduction of rescue therapy). Analysis was performed using safety population which included all the treated participants.
|
Other adverse events
| Measure |
HOE901-U300
n=508 participants at risk
HOE901-U300 (Insulin glargine, 300 U/mL) SC injection once daily up to Week 26 on top of stable non-insulin antihyperglycemic therapy.
|
Lantus
n=505 participants at risk
Lantus (Insulin glargine, 100 U/mL) SC injection once daily up to Week 26 on top of stable non-insulin antihyperglycemic therapy.
|
|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
7.3%
37/508 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 184) regardless of seriousness or relationship to IMP.
Reported AEs and deaths were treatment emergent that is AEs that developed/worsened and deaths that occurred during 'on treatment period' (from first dose of IMP injection up to 2 days after the last injection of IMP, regardless of introduction of rescue therapy). Analysis was performed using safety population which included all the treated participants.
|
7.5%
38/505 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 184) regardless of seriousness or relationship to IMP.
Reported AEs and deaths were treatment emergent that is AEs that developed/worsened and deaths that occurred during 'on treatment period' (from first dose of IMP injection up to 2 days after the last injection of IMP, regardless of introduction of rescue therapy). Analysis was performed using safety population which included all the treated participants.
|
|
Infections and infestations
Upper respiratory tract infection
|
5.3%
27/508 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 184) regardless of seriousness or relationship to IMP.
Reported AEs and deaths were treatment emergent that is AEs that developed/worsened and deaths that occurred during 'on treatment period' (from first dose of IMP injection up to 2 days after the last injection of IMP, regardless of introduction of rescue therapy). Analysis was performed using safety population which included all the treated participants.
|
5.5%
28/505 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 184) regardless of seriousness or relationship to IMP.
Reported AEs and deaths were treatment emergent that is AEs that developed/worsened and deaths that occurred during 'on treatment period' (from first dose of IMP injection up to 2 days after the last injection of IMP, regardless of introduction of rescue therapy). Analysis was performed using safety population which included all the treated participants.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee If no publication has occurred within 12 months of the completion of the study, the Investigator shall have the right to publish/present independently the results of the study. The Investigator shall provide the Sponsor with a copy of any such presentation/publication for comment at least 30 days before any presentation/submission for publication. If requested by the Sponsor, any presentation/submission shall be delayed up to 90 days, to allow the Sponsor to preserve its proprietary rights.
- Publication restrictions are in place
Restriction type: OTHER