Trial Outcomes & Findings for Comparison of SAR342434 to Humalog as the Rapid Acting Insulin in Adult Patients With Type 2 Diabetes Mellitus Also Using Insulin Glargine (NCT NCT02294474)
NCT ID: NCT02294474
Last Updated: 2018-01-18
Results Overview
Change in HbA1c was calculated by subtracting baseline value from Week 26 value. Adjusted least square means and standard errors were obtained from a mixed-effect model with repeated measures (MMRM) to account for missing data, using all post-baseline HbA1c data available during the 6-month period and adequate contrasts at Week 26.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
505 participants
Primary outcome timeframe
Baseline, Week 26
Results posted on
2018-01-18
Participant Flow
The study was conducted at 103 centers in 12 countries. A total of 707 participants were screened between 14 January 2015 and 24 July 2015, of which 202 were screen failures. Screen failures were mainly due to glycated hemoglobin (HbA1c) level \<6.5% or \>10% at screening visit.
A total of 505 participants were randomized and treated in the study. Randomization was stratified by HbA1c at the screening visit (\<8%, \>=8%) and prior use of Humalog (Yes, No). Assignment to arms was done centrally using interactive voice/web response system in 1:1 ratio (SAR342434: Humalog).
Participant milestones
| Measure |
SAR342434
SAR342434 100 U/mL SC injection before meals intake on top of QD Insulin Glargine, up to Week 26.
|
Humalog
Humalog 100 U/mL SC injection before meals intake on top of QD Insulin Glargine, up to Week 26.
|
|---|---|---|
|
Overall Study
STARTED
|
253
|
252
|
|
Overall Study
COMPLETED
|
228
|
230
|
|
Overall Study
NOT COMPLETED
|
25
|
22
|
Reasons for withdrawal
| Measure |
SAR342434
SAR342434 100 U/mL SC injection before meals intake on top of QD Insulin Glargine, up to Week 26.
|
Humalog
Humalog 100 U/mL SC injection before meals intake on top of QD Insulin Glargine, up to Week 26.
|
|---|---|---|
|
Overall Study
Adverse Event
|
7
|
7
|
|
Overall Study
Lack of Efficacy
|
2
|
1
|
|
Overall Study
Protocol Violation
|
4
|
2
|
|
Overall Study
Other than specified above
|
12
|
12
|
Baseline Characteristics
Number of participants analyzed = participants with available data for specified measure.
Baseline characteristics by cohort
| Measure |
SAR342434
n=253 Participants
SAR342434 100 U/mL subcutaneous (SC) injection before meals intake on top of once daily (QD) Insulin Glargine, up to Week 26.
|
Humalog
n=252 Participants
Humalog 100 U/mL SC injection before meals intake on top of QD Insulin Glargine, up to Week 26.
|
Total
n=505 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.1 years
STANDARD_DEVIATION 9.4 • n=253 Participants
|
62.8 years
STANDARD_DEVIATION 8.9 • n=252 Participants
|
62.5 years
STANDARD_DEVIATION 9.1 • n=505 Participants
|
|
Sex: Female, Male
Female
|
117 Participants
n=253 Participants
|
120 Participants
n=252 Participants
|
237 Participants
n=505 Participants
|
|
Sex: Female, Male
Male
|
136 Participants
n=253 Participants
|
132 Participants
n=252 Participants
|
268 Participants
n=505 Participants
|
|
Previous meal time insulin
Humalog/Liprolog
|
133 Participants
n=253 Participants
|
126 Participants
n=252 Participants
|
259 Participants
n=505 Participants
|
|
Previous meal time insulin
NovoLog/NovoRapid
|
119 Participants
n=253 Participants
|
124 Participants
n=252 Participants
|
243 Participants
n=505 Participants
|
|
Previous meal time insulin
Both Humalog/Liprolog and NovoLog/NovoRapid
|
1 Participants
n=253 Participants
|
1 Participants
n=252 Participants
|
2 Participants
n=505 Participants
|
|
Previous meal time insulin
None of the above
|
0 Participants
n=253 Participants
|
1 Participants
n=252 Participants
|
1 Participants
n=505 Participants
|
|
Randomization Strata of Screening HbA1c
<8 %
|
105 Participants
n=253 Participants
|
104 Participants
n=252 Participants
|
209 Participants
n=505 Participants
|
|
Randomization Strata of Screening HbA1c
>=8 %
|
148 Participants
n=253 Participants
|
148 Participants
n=252 Participants
|
296 Participants
n=505 Participants
|
|
Body mass index (BMI)
|
32.3 kg/m^2
STANDARD_DEVIATION 4.8 • n=253 Participants
|
32.1 kg/m^2
STANDARD_DEVIATION 4.8 • n=252 Participants
|
32.2 kg/m^2
STANDARD_DEVIATION 4.8 • n=505 Participants
|
|
Duration of type 2 diabetes mellitus (T2DM)
|
16.6 years
STANDARD_DEVIATION 7.93 • n=253 Participants
|
17.52 years
STANDARD_DEVIATION 8.67 • n=252 Participants
|
17.06 years
STANDARD_DEVIATION 8.31 • n=505 Participants
|
|
HbA1c %
|
8 percentage of hemoglobin
STANDARD_DEVIATION 0.86 • n=253 Participants
|
8.03 percentage of hemoglobin
STANDARD_DEVIATION 0.91 • n=252 Participants
|
8.01 percentage of hemoglobin
STANDARD_DEVIATION 0.89 • n=505 Participants
|
|
Average Daily Basal Insulin Dose
|
0.477 U/kg
STANDARD_DEVIATION 0.265 • n=232 Participants • Number of participants analyzed = participants with available data for specified measure.
|
0.458 U/kg
STANDARD_DEVIATION 0.239 • n=244 Participants • Number of participants analyzed = participants with available data for specified measure.
|
0.467 U/kg
STANDARD_DEVIATION 0.252 • n=476 Participants • Number of participants analyzed = participants with available data for specified measure.
|
|
Average Daily Mealtime Insulin Dose
|
0.449 U/kg
STANDARD_DEVIATION 0.294 • n=231 Participants • Number of participants analyzed = participants with available data for specified measure.
|
0.433 U/kg
STANDARD_DEVIATION 0.315 • n=243 Participants • Number of participants analyzed = participants with available data for specified measure.
|
0.441 U/kg
STANDARD_DEVIATION 0.305 • n=474 Participants • Number of participants analyzed = participants with available data for specified measure.
|
|
Average Daily Total Insulin Dose
|
0.927 U/kg
STANDARD_DEVIATION 0.47 • n=230 Participants • Number of participants analyzed = participants with available data for specified measure.
|
0.888 U/kg
STANDARD_DEVIATION 0.449 • n=242 Participants • Number of participants analyzed = participants with available data for specified measure.
|
0.907 U/kg
STANDARD_DEVIATION 0.459 • n=472 Participants • Number of participants analyzed = participants with available data for specified measure.
|
PRIMARY outcome
Timeframe: Baseline, Week 26Population: Analysis was performed on intent-to-treat (ITT) population that included all randomized participants, irrespective of compliance with the study protocol and procedures. Here, number of participants analyzed = participants with at least one post-baseline HbA1c assessment during the 6-month study period.
Change in HbA1c was calculated by subtracting baseline value from Week 26 value. Adjusted least square means and standard errors were obtained from a mixed-effect model with repeated measures (MMRM) to account for missing data, using all post-baseline HbA1c data available during the 6-month period and adequate contrasts at Week 26.
Outcome measures
| Measure |
SAR342434
n=239 Participants
SAR342434 100 U/mL SC injection before meals intake on top of QD Insulin Glargine, up to Week 26.
|
Humalog
n=246 Participants
Humalog 100 U/mL SC injection before meals intake on top of QD Insulin Glargine, up to Week 26.
|
|---|---|---|
|
Change in HbA1c From Baseline to Week 26
|
-0.92 percentage of HbA1c
Standard Error 0.051
|
-0.85 percentage of HbA1c
Standard Error 0.051
|
SECONDARY outcome
Timeframe: Week 26Population: Analysis was performed on ITT population.
Participants who had no available assessment for HbA1c at Week 26 were considered as non-responders.
Outcome measures
| Measure |
SAR342434
n=253 Participants
SAR342434 100 U/mL SC injection before meals intake on top of QD Insulin Glargine, up to Week 26.
|
Humalog
n=252 Participants
Humalog 100 U/mL SC injection before meals intake on top of QD Insulin Glargine, up to Week 26.
|
|---|---|---|
|
Percentage of Participants With HbA1c <7.0% and <=6.5% at Week 26
HbA1c<=6.5%
|
27.3 percentage of participants
|
24.2 percentage of participants
|
|
Percentage of Participants With HbA1c <7.0% and <=6.5% at Week 26
HbA1c <7.0%
|
42.3 percentage of participants
|
40.5 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 26Population: Analysis was performed on ITT population. Here, number of participants analyzed = participants with at least one post-baseline FPG assessment during the 6-months study period.
Change in FPG was calculated by subtracting baseline value from Week 26 value. Adjusted least squares means and standard errors were obtained from a MMRM approach to account for missing data, using all post-baseline FPG data available during the 6-month period and adequate contrasts at Week 26.
Outcome measures
| Measure |
SAR342434
n=228 Participants
SAR342434 100 U/mL SC injection before meals intake on top of QD Insulin Glargine, up to Week 26.
|
Humalog
n=235 Participants
Humalog 100 U/mL SC injection before meals intake on top of QD Insulin Glargine, up to Week 26.
|
|---|---|---|
|
Change in Fasting Plasma Glucose (FPG) From Baseline to Week 26
|
-0.62 mmol/L
Standard Error 0.176
|
-0.67 mmol/L
Standard Error 0.176
|
SECONDARY outcome
Timeframe: Baseline, Week 26Population: Analysis was performed on ITT population. Here, number of participants analyzed = participants with at least one post-baseline mean 24-hour plasma glucose concentration assessment during 6-month study period.
The mean 24-hour plasma glucose concentration was calculated based on 7-point self-measured plasma glucose (SMPG) profiles with plasma glucose measurements before and 2-hours after each main meal and at bedtime. 7-point SMPGs were performed at least two times in a week before baseline, before visit Week 12 and before visit Week 26. Mean 24-hour plasma glucose concentration was calculated for each profile and then averaged across profiles performed in the week before a visit. Change in mean 24-hour plasma glucose concentration was calculated by subtracting baseline value from Week 26 value. Adjusted least squares means and standard errors were obtained from a MMRM to account for missing data, using all post-baseline data available during 6-month period and adequate contrasts at Week 26.
Outcome measures
| Measure |
SAR342434
n=201 Participants
SAR342434 100 U/mL SC injection before meals intake on top of QD Insulin Glargine, up to Week 26.
|
Humalog
n=210 Participants
Humalog 100 U/mL SC injection before meals intake on top of QD Insulin Glargine, up to Week 26.
|
|---|---|---|
|
Change in Mean 24-Hour Plasma Glucose Concentration From Baseline to Week 26
|
-1 mmol/L
Standard Error 0.137
|
-0.91 mmol/L
Standard Error 0.133
|
SECONDARY outcome
Timeframe: Baseline, Week 26Population: Analysis was performed on ITT population. Here, number analyzed in each row = participants with at least one post-baseline data during the 6-month period for specified categories.
Plasma glucose excursions were calculated at breakfast, lunch and dinner for each 7-point SMPG profile, as 2-hour postprandial glucose (PPG) minus plasma glucose value obtained 30 minutes prior to start of the meal. Values of plasma glucose excursions at each visit were then calculated as average across the profiles performed in the week before the visit. Change in PPG excursions was calculated by subtracting baseline value from Week 26 value. Adjusted least squares means and standard errors were obtained from a MMRM to account for missing data, using all post-baseline data available during the 6-month period and adequate contrasts at Week 26.
Outcome measures
| Measure |
SAR342434
n=253 Participants
SAR342434 100 U/mL SC injection before meals intake on top of QD Insulin Glargine, up to Week 26.
|
Humalog
n=252 Participants
Humalog 100 U/mL SC injection before meals intake on top of QD Insulin Glargine, up to Week 26.
|
|---|---|---|
|
Change in Post Prandial Glucose (PPG) Excursion From Baseline to Week 26
At breakfast
|
-0.72 mmol/L
Standard Error 0.236
|
-0.23 mmol/L
Standard Error 0.228
|
|
Change in Post Prandial Glucose (PPG) Excursion From Baseline to Week 26
At lunch
|
0.06 mmol/L
Standard Error 0.255
|
0.11 mmol/L
Standard Error 0.25
|
|
Change in Post Prandial Glucose (PPG) Excursion From Baseline to Week 26
At dinner
|
0.11 mmol/L
Standard Error 0.264
|
-0.1 mmol/L
Standard Error 0.264
|
SECONDARY outcome
Timeframe: First dose of study drug up to 1 day after the last dose administration (maximum treatment exposure: 210 days)Population: Analysis was performed on safety population that included all participants randomized and exposed to at least 1 dose of investigational medicinal product (IMP) (SAR342434 or Humalog), regardless of the amount of treatment administered.
Percentage of participants with at least one treatment emergent hypoglycemia reported at any time of the day were reported. Severe hypoglycemia was an event in which the participant required the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Documented symptomatic hypoglycemia was an event during which typical symptoms of hypoglycemia were accompanied by a measured plasma glucose concentration of \<=70 mg/dL (3.9 mmol/L). Hypoglycemic episodes with plasma glucose of 54 mg/dL (\<3.0 mmol/L) were also analyzed.
Outcome measures
| Measure |
SAR342434
n=253 Participants
SAR342434 100 U/mL SC injection before meals intake on top of QD Insulin Glargine, up to Week 26.
|
Humalog
n=252 Participants
Humalog 100 U/mL SC injection before meals intake on top of QD Insulin Glargine, up to Week 26.
|
|---|---|---|
|
Percentage of Participants With Hypoglycemia (Any Hypoglycemia, Documented Symptomatic Hypoglycemia and Severe Hypoglycemia)
Any hypoglycemia
|
68.4 percentage of participants
|
74.6 percentage of participants
|
|
Percentage of Participants With Hypoglycemia (Any Hypoglycemia, Documented Symptomatic Hypoglycemia and Severe Hypoglycemia)
Severe hypoglycemia
|
2.4 percentage of participants
|
1.6 percentage of participants
|
|
Percentage of Participants With Hypoglycemia (Any Hypoglycemia, Documented Symptomatic Hypoglycemia and Severe Hypoglycemia)
Documented Symptomatic Hypoglycemia (<=3.9mmol/L)
|
60.1 percentage of participants
|
66.3 percentage of participants
|
|
Percentage of Participants With Hypoglycemia (Any Hypoglycemia, Documented Symptomatic Hypoglycemia and Severe Hypoglycemia)
Documented Symptomatic Hypoglycemia (<3.0mmol/L)
|
28.9 percentage of participants
|
27.4 percentage of participants
|
SECONDARY outcome
Timeframe: First dose of study drug up to 1 day after the last dose administration (maximum treatment exposure: 210 days)Population: Analysis was performed on safety population.
Percentage of participants with hypersensitivity reactions and injection site reactions were reported.
Outcome measures
| Measure |
SAR342434
n=253 Participants
SAR342434 100 U/mL SC injection before meals intake on top of QD Insulin Glargine, up to Week 26.
|
Humalog
n=252 Participants
Humalog 100 U/mL SC injection before meals intake on top of QD Insulin Glargine, up to Week 26.
|
|---|---|---|
|
Percentage of Participants With Hypersensitivity Reactions and Injection Site Reactions
Any injection site reactions
|
0.4 percentage of participants
|
1.6 percentage of participants
|
|
Percentage of Participants With Hypersensitivity Reactions and Injection Site Reactions
Any hypersensitivity reactions
|
4 percentage of participants
|
3.6 percentage of participants
|
SECONDARY outcome
Timeframe: First dose of study drug up to 1 day after the last dose administration (maximum treatment exposure: 210 days)Population: Analysis was performed on anti-insulin antibody population that included all participants from the safety population with at least one AIA sample available for analysis during the 6-months on-treatment period.
Participants with treatment-emergent AIA (incidence) were reported (as participants with treatment-boosted or treatment-induced AIAs). Participants with treatment-induced AIAs were participants who developed AIA following IMP administration (participants with at least one positive AIA sample at any time during on-treatment period, in those participants without pre-existing AIA or with missing baseline sample). Participants with treatment-boosted AIAs were participants with pre-existing AIAs that were boosted to a significant higher titer following IMP administration (participants with at least one AIA sample with at least a 4-fold increase in titers compared to baseline value at any time during on-treatment period, in those participants with pre-existing AIA).
Outcome measures
| Measure |
SAR342434
n=245 Participants
SAR342434 100 U/mL SC injection before meals intake on top of QD Insulin Glargine, up to Week 26.
|
Humalog
n=248 Participants
Humalog 100 U/mL SC injection before meals intake on top of QD Insulin Glargine, up to Week 26.
|
|---|---|---|
|
Percentage of Participants With Treatment-Emergent Anti-insulin Antibodies (AIAs)
|
18.8 percentage of participants
|
14.5 percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Week 26Population: Analysis was performed on safety population. Here, number analyzed in each row = participants with available data for specified categories.
Change in daily insulin dose (basal, mealtime and total) was calculated by subtracting baseline value from Week 26 value.
Outcome measures
| Measure |
SAR342434
n=253 Participants
SAR342434 100 U/mL SC injection before meals intake on top of QD Insulin Glargine, up to Week 26.
|
Humalog
n=252 Participants
Humalog 100 U/mL SC injection before meals intake on top of QD Insulin Glargine, up to Week 26.
|
|---|---|---|
|
Change in Daily Insulin Dose From Baseline to Week 26
Basal insulin
|
0.082 U/kg
Standard Deviation 0.133
|
0.071 U/kg
Standard Deviation 0.122
|
|
Change in Daily Insulin Dose From Baseline to Week 26
Mealtime insulin
|
0.087 U/kg
Standard Deviation 0.209
|
0.08 U/kg
Standard Deviation 0.248
|
|
Change in Daily Insulin Dose From Baseline to Week 26
Total insulin
|
0.172 U/kg
Standard Deviation 0.296
|
0.151 U/kg
Standard Deviation 0.297
|
Adverse Events
SAR342434
Serious events: 14 serious events
Other events: 0 other events
Deaths: 1 deaths
Humalog
Serious events: 27 serious events
Other events: 0 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
SAR342434
n=253 participants at risk
SAR342434 100 U/mL SC injection before meals intake on top of QD Insulin Glargine, up to Week 26.
|
Humalog
n=252 participants at risk
Humalog 100 U/mL SC injection before meals intake on top of QD Insulin Glargine, up to Week 26.
|
|---|---|---|
|
Gastrointestinal disorders
Gastritis erosive
|
0.00%
0/253 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Day 183) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent adverse events that is AEs that developed, worsened or became serious during the 'on treatment period' (time from first injection of IMP up to 1 day after the last injection of IMP).
|
0.40%
1/252 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Day 183) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent adverse events that is AEs that developed, worsened or became serious during the 'on treatment period' (time from first injection of IMP up to 1 day after the last injection of IMP).
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.00%
0/253 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Day 183) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent adverse events that is AEs that developed, worsened or became serious during the 'on treatment period' (time from first injection of IMP up to 1 day after the last injection of IMP).
|
0.40%
1/252 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Day 183) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent adverse events that is AEs that developed, worsened or became serious during the 'on treatment period' (time from first injection of IMP up to 1 day after the last injection of IMP).
|
|
Gastrointestinal disorders
Pancreatitis
|
0.79%
2/253 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Day 183) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent adverse events that is AEs that developed, worsened or became serious during the 'on treatment period' (time from first injection of IMP up to 1 day after the last injection of IMP).
|
0.00%
0/252 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Day 183) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent adverse events that is AEs that developed, worsened or became serious during the 'on treatment period' (time from first injection of IMP up to 1 day after the last injection of IMP).
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/253 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Day 183) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent adverse events that is AEs that developed, worsened or became serious during the 'on treatment period' (time from first injection of IMP up to 1 day after the last injection of IMP).
|
1.2%
3/252 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Day 183) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent adverse events that is AEs that developed, worsened or became serious during the 'on treatment period' (time from first injection of IMP up to 1 day after the last injection of IMP).
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/253 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Day 183) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent adverse events that is AEs that developed, worsened or became serious during the 'on treatment period' (time from first injection of IMP up to 1 day after the last injection of IMP).
|
0.79%
2/252 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Day 183) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent adverse events that is AEs that developed, worsened or became serious during the 'on treatment period' (time from first injection of IMP up to 1 day after the last injection of IMP).
|
|
Cardiac disorders
Bundle branch block left
|
0.00%
0/253 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Day 183) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent adverse events that is AEs that developed, worsened or became serious during the 'on treatment period' (time from first injection of IMP up to 1 day after the last injection of IMP).
|
0.40%
1/252 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Day 183) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent adverse events that is AEs that developed, worsened or became serious during the 'on treatment period' (time from first injection of IMP up to 1 day after the last injection of IMP).
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/253 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Day 183) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent adverse events that is AEs that developed, worsened or became serious during the 'on treatment period' (time from first injection of IMP up to 1 day after the last injection of IMP).
|
0.40%
1/252 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Day 183) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent adverse events that is AEs that developed, worsened or became serious during the 'on treatment period' (time from first injection of IMP up to 1 day after the last injection of IMP).
|
|
Cardiac disorders
Cardiac failure chronic
|
0.40%
1/253 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Day 183) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent adverse events that is AEs that developed, worsened or became serious during the 'on treatment period' (time from first injection of IMP up to 1 day after the last injection of IMP).
|
0.00%
0/252 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Day 183) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent adverse events that is AEs that developed, worsened or became serious during the 'on treatment period' (time from first injection of IMP up to 1 day after the last injection of IMP).
|
|
Cardiac disorders
Cardiac failure congestive
|
0.40%
1/253 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Day 183) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent adverse events that is AEs that developed, worsened or became serious during the 'on treatment period' (time from first injection of IMP up to 1 day after the last injection of IMP).
|
0.79%
2/252 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Day 183) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent adverse events that is AEs that developed, worsened or became serious during the 'on treatment period' (time from first injection of IMP up to 1 day after the last injection of IMP).
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.40%
1/253 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Day 183) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent adverse events that is AEs that developed, worsened or became serious during the 'on treatment period' (time from first injection of IMP up to 1 day after the last injection of IMP).
|
0.00%
0/252 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Day 183) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent adverse events that is AEs that developed, worsened or became serious during the 'on treatment period' (time from first injection of IMP up to 1 day after the last injection of IMP).
|
|
Cardiac disorders
Cardiopulmonary failure
|
0.00%
0/253 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Day 183) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent adverse events that is AEs that developed, worsened or became serious during the 'on treatment period' (time from first injection of IMP up to 1 day after the last injection of IMP).
|
0.40%
1/252 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Day 183) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent adverse events that is AEs that developed, worsened or became serious during the 'on treatment period' (time from first injection of IMP up to 1 day after the last injection of IMP).
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/253 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Day 183) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent adverse events that is AEs that developed, worsened or became serious during the 'on treatment period' (time from first injection of IMP up to 1 day after the last injection of IMP).
|
0.40%
1/252 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Day 183) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent adverse events that is AEs that developed, worsened or became serious during the 'on treatment period' (time from first injection of IMP up to 1 day after the last injection of IMP).
|
|
Cardiac disorders
Ischaemic cardiomyopathy
|
0.40%
1/253 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Day 183) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent adverse events that is AEs that developed, worsened or became serious during the 'on treatment period' (time from first injection of IMP up to 1 day after the last injection of IMP).
|
0.00%
0/252 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Day 183) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent adverse events that is AEs that developed, worsened or became serious during the 'on treatment period' (time from first injection of IMP up to 1 day after the last injection of IMP).
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/253 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Day 183) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent adverse events that is AEs that developed, worsened or became serious during the 'on treatment period' (time from first injection of IMP up to 1 day after the last injection of IMP).
|
0.40%
1/252 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Day 183) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent adverse events that is AEs that developed, worsened or became serious during the 'on treatment period' (time from first injection of IMP up to 1 day after the last injection of IMP).
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/253 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Day 183) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent adverse events that is AEs that developed, worsened or became serious during the 'on treatment period' (time from first injection of IMP up to 1 day after the last injection of IMP).
|
0.40%
1/252 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Day 183) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent adverse events that is AEs that developed, worsened or became serious during the 'on treatment period' (time from first injection of IMP up to 1 day after the last injection of IMP).
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.40%
1/253 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Day 183) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent adverse events that is AEs that developed, worsened or became serious during the 'on treatment period' (time from first injection of IMP up to 1 day after the last injection of IMP).
|
0.00%
0/252 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Day 183) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent adverse events that is AEs that developed, worsened or became serious during the 'on treatment period' (time from first injection of IMP up to 1 day after the last injection of IMP).
|
|
Eye disorders
Cataract
|
0.40%
1/253 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Day 183) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent adverse events that is AEs that developed, worsened or became serious during the 'on treatment period' (time from first injection of IMP up to 1 day after the last injection of IMP).
|
0.00%
0/252 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Day 183) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent adverse events that is AEs that developed, worsened or became serious during the 'on treatment period' (time from first injection of IMP up to 1 day after the last injection of IMP).
|
|
Eye disorders
Vitreous haemorrhage
|
0.40%
1/253 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Day 183) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent adverse events that is AEs that developed, worsened or became serious during the 'on treatment period' (time from first injection of IMP up to 1 day after the last injection of IMP).
|
0.00%
0/252 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Day 183) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent adverse events that is AEs that developed, worsened or became serious during the 'on treatment period' (time from first injection of IMP up to 1 day after the last injection of IMP).
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/253 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Day 183) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent adverse events that is AEs that developed, worsened or became serious during the 'on treatment period' (time from first injection of IMP up to 1 day after the last injection of IMP).
|
0.40%
1/252 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Day 183) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent adverse events that is AEs that developed, worsened or became serious during the 'on treatment period' (time from first injection of IMP up to 1 day after the last injection of IMP).
|
|
Hepatobiliary disorders
Bile duct stone
|
0.00%
0/253 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Day 183) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent adverse events that is AEs that developed, worsened or became serious during the 'on treatment period' (time from first injection of IMP up to 1 day after the last injection of IMP).
|
0.40%
1/252 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Day 183) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent adverse events that is AEs that developed, worsened or became serious during the 'on treatment period' (time from first injection of IMP up to 1 day after the last injection of IMP).
|
|
Infections and infestations
Pneumonia
|
0.79%
2/253 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Day 183) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent adverse events that is AEs that developed, worsened or became serious during the 'on treatment period' (time from first injection of IMP up to 1 day after the last injection of IMP).
|
0.40%
1/252 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Day 183) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent adverse events that is AEs that developed, worsened or became serious during the 'on treatment period' (time from first injection of IMP up to 1 day after the last injection of IMP).
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/253 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Day 183) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent adverse events that is AEs that developed, worsened or became serious during the 'on treatment period' (time from first injection of IMP up to 1 day after the last injection of IMP).
|
0.40%
1/252 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Day 183) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent adverse events that is AEs that developed, worsened or became serious during the 'on treatment period' (time from first injection of IMP up to 1 day after the last injection of IMP).
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.00%
0/253 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Day 183) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent adverse events that is AEs that developed, worsened or became serious during the 'on treatment period' (time from first injection of IMP up to 1 day after the last injection of IMP).
|
0.40%
1/252 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Day 183) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent adverse events that is AEs that developed, worsened or became serious during the 'on treatment period' (time from first injection of IMP up to 1 day after the last injection of IMP).
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/253 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Day 183) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent adverse events that is AEs that developed, worsened or became serious during the 'on treatment period' (time from first injection of IMP up to 1 day after the last injection of IMP).
|
0.79%
2/252 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Day 183) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent adverse events that is AEs that developed, worsened or became serious during the 'on treatment period' (time from first injection of IMP up to 1 day after the last injection of IMP).
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/253 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Day 183) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent adverse events that is AEs that developed, worsened or became serious during the 'on treatment period' (time from first injection of IMP up to 1 day after the last injection of IMP).
|
0.40%
1/252 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Day 183) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent adverse events that is AEs that developed, worsened or became serious during the 'on treatment period' (time from first injection of IMP up to 1 day after the last injection of IMP).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/253 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Day 183) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent adverse events that is AEs that developed, worsened or became serious during the 'on treatment period' (time from first injection of IMP up to 1 day after the last injection of IMP).
|
0.40%
1/252 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Day 183) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent adverse events that is AEs that developed, worsened or became serious during the 'on treatment period' (time from first injection of IMP up to 1 day after the last injection of IMP).
|
|
Musculoskeletal and connective tissue disorders
Cervical spinal stenosis
|
0.00%
0/253 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Day 183) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent adverse events that is AEs that developed, worsened or became serious during the 'on treatment period' (time from first injection of IMP up to 1 day after the last injection of IMP).
|
0.40%
1/252 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Day 183) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent adverse events that is AEs that developed, worsened or became serious during the 'on treatment period' (time from first injection of IMP up to 1 day after the last injection of IMP).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon
|
0.00%
0/253 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Day 183) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent adverse events that is AEs that developed, worsened or became serious during the 'on treatment period' (time from first injection of IMP up to 1 day after the last injection of IMP).
|
0.40%
1/252 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Day 183) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent adverse events that is AEs that developed, worsened or became serious during the 'on treatment period' (time from first injection of IMP up to 1 day after the last injection of IMP).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder transitional cell carcinoma
|
0.40%
1/253 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Day 183) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent adverse events that is AEs that developed, worsened or became serious during the 'on treatment period' (time from first injection of IMP up to 1 day after the last injection of IMP).
|
0.00%
0/252 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Day 183) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent adverse events that is AEs that developed, worsened or became serious during the 'on treatment period' (time from first injection of IMP up to 1 day after the last injection of IMP).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic carcinoma of the bladder
|
0.00%
0/253 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Day 183) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent adverse events that is AEs that developed, worsened or became serious during the 'on treatment period' (time from first injection of IMP up to 1 day after the last injection of IMP).
|
0.40%
1/252 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Day 183) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent adverse events that is AEs that developed, worsened or became serious during the 'on treatment period' (time from first injection of IMP up to 1 day after the last injection of IMP).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.00%
0/253 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Day 183) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent adverse events that is AEs that developed, worsened or became serious during the 'on treatment period' (time from first injection of IMP up to 1 day after the last injection of IMP).
|
0.40%
1/252 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Day 183) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent adverse events that is AEs that developed, worsened or became serious during the 'on treatment period' (time from first injection of IMP up to 1 day after the last injection of IMP).
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.40%
1/253 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Day 183) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent adverse events that is AEs that developed, worsened or became serious during the 'on treatment period' (time from first injection of IMP up to 1 day after the last injection of IMP).
|
0.00%
0/252 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Day 183) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent adverse events that is AEs that developed, worsened or became serious during the 'on treatment period' (time from first injection of IMP up to 1 day after the last injection of IMP).
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/253 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Day 183) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent adverse events that is AEs that developed, worsened or became serious during the 'on treatment period' (time from first injection of IMP up to 1 day after the last injection of IMP).
|
0.40%
1/252 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Day 183) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent adverse events that is AEs that developed, worsened or became serious during the 'on treatment period' (time from first injection of IMP up to 1 day after the last injection of IMP).
|
|
Nervous system disorders
Gliosis
|
0.40%
1/253 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Day 183) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent adverse events that is AEs that developed, worsened or became serious during the 'on treatment period' (time from first injection of IMP up to 1 day after the last injection of IMP).
|
0.00%
0/252 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Day 183) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent adverse events that is AEs that developed, worsened or became serious during the 'on treatment period' (time from first injection of IMP up to 1 day after the last injection of IMP).
|
|
Nervous system disorders
Hypoglycaemic unconsciousness
|
0.79%
2/253 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Day 183) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent adverse events that is AEs that developed, worsened or became serious during the 'on treatment period' (time from first injection of IMP up to 1 day after the last injection of IMP).
|
0.00%
0/252 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Day 183) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent adverse events that is AEs that developed, worsened or became serious during the 'on treatment period' (time from first injection of IMP up to 1 day after the last injection of IMP).
|
|
Nervous system disorders
Syncope
|
0.00%
0/253 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Day 183) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent adverse events that is AEs that developed, worsened or became serious during the 'on treatment period' (time from first injection of IMP up to 1 day after the last injection of IMP).
|
0.40%
1/252 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Day 183) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent adverse events that is AEs that developed, worsened or became serious during the 'on treatment period' (time from first injection of IMP up to 1 day after the last injection of IMP).
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.40%
1/253 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Day 183) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent adverse events that is AEs that developed, worsened or became serious during the 'on treatment period' (time from first injection of IMP up to 1 day after the last injection of IMP).
|
0.00%
0/252 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Day 183) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent adverse events that is AEs that developed, worsened or became serious during the 'on treatment period' (time from first injection of IMP up to 1 day after the last injection of IMP).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/253 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Day 183) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent adverse events that is AEs that developed, worsened or became serious during the 'on treatment period' (time from first injection of IMP up to 1 day after the last injection of IMP).
|
0.40%
1/252 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Day 183) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent adverse events that is AEs that developed, worsened or became serious during the 'on treatment period' (time from first injection of IMP up to 1 day after the last injection of IMP).
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.40%
1/253 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Day 183) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent adverse events that is AEs that developed, worsened or became serious during the 'on treatment period' (time from first injection of IMP up to 1 day after the last injection of IMP).
|
0.00%
0/252 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Day 183) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent adverse events that is AEs that developed, worsened or became serious during the 'on treatment period' (time from first injection of IMP up to 1 day after the last injection of IMP).
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/253 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Day 183) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent adverse events that is AEs that developed, worsened or became serious during the 'on treatment period' (time from first injection of IMP up to 1 day after the last injection of IMP).
|
0.40%
1/252 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Day 183) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent adverse events that is AEs that developed, worsened or became serious during the 'on treatment period' (time from first injection of IMP up to 1 day after the last injection of IMP).
|
|
Vascular disorders
Hypotension
|
0.00%
0/253 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Day 183) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent adverse events that is AEs that developed, worsened or became serious during the 'on treatment period' (time from first injection of IMP up to 1 day after the last injection of IMP).
|
0.40%
1/252 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Day 183) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent adverse events that is AEs that developed, worsened or became serious during the 'on treatment period' (time from first injection of IMP up to 1 day after the last injection of IMP).
|
Other adverse events
Adverse event data not reported
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