Trial Outcomes & Findings for Phase III Study of Florbetaben (BAY94-9172) PET Imaging for Detection/Exclusion of Cerebral β-amyloid Compared to Histopathology (NCT NCT01020838)
NCT ID: NCT01020838
Last Updated: 2016-05-27
Results Overview
The sensitivity/specificity of the visual assessment were calculated based on the majority read assessment of regional tracer uptake. This result was derived from assessments by 3 independent readers for brain regions of a subject where a Standard of Truth (SOT) was available. The SOT for this analysis was a centralized histopathological determination of β-amyloid presence/absence based on both Bielschowsky silver and immunohistochemical staining. Based on the PET images, a brain region was classified as "normal" or "abnormal" depending on the presence or absence of regional tracer uptake in the respective region. "Normal" therefore meant absence of β-amyloid and "abnormal" presence of β-amyloid. Sensitivity was defined as the percentage of abnormal brain regions from all regions where an SOT was available and the SOT was "β-amyloid present". Specificity was defined as the percentage of normal brain regions from all regions where an SOT was available and was "β-amyloid not present".
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
218 participants
Primary outcome timeframe
90-110 minutes post injection (PET image acquisition)
Results posted on
2016-05-27
Participant Flow
Subjects were screened at 15 study centers in Australia, Germany, France, Japan, and the U.S.
Participant milestones
| Measure |
All Study Participants
All patients enrolling into the study
|
|---|---|
|
Overall Study
STARTED
|
218
|
|
Overall Study
Safety Analysis Set
|
216
|
|
Overall Study
Interim Analysis Set (Primary Efficacy)
|
41
|
|
Overall Study
Final Analysis Set (Whole Brain)
|
97
|
|
Overall Study
First Annual Repeat Injection
|
91
|
|
Overall Study
Second Annual Repeat Injection
|
34
|
|
Overall Study
COMPLETED
|
35
|
|
Overall Study
NOT COMPLETED
|
183
|
Reasons for withdrawal
| Measure |
All Study Participants
All patients enrolling into the study
|
|---|---|
|
Overall Study
Death
|
90
|
|
Overall Study
Adverse Event
|
1
|
|
Overall Study
Withdrawal by Subject
|
9
|
|
Overall Study
Lost to Follow-up
|
6
|
|
Overall Study
Most common: Study ended by sponsor
|
77
|
Baseline Characteristics
Phase III Study of Florbetaben (BAY94-9172) PET Imaging for Detection/Exclusion of Cerebral β-amyloid Compared to Histopathology
Baseline characteristics by cohort
| Measure |
Safety Analysis Set
n=216 Participants
All study participants who received any amount of florbetaben were included in the safety analysis set.
|
|---|---|
|
Age, Continuous
|
74.4 years
STANDARD_DEVIATION 15.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
104 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
112 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
213 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
55 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
159 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
BMI (kg/m^2)
|
23.617 kg/m^2
STANDARD_DEVIATION 5.213 • n=5 Participants
|
|
Body weight
|
64.95 kg
STANDARD_DEVIATION 18.44 • n=5 Participants
|
|
Height
|
164.70 cm
STANDARD_DEVIATION 12.34 • n=5 Participants
|
|
Baseline clinical diagnosis
Alzheimer's Disease
|
137 participants
n=5 Participants
|
|
Baseline clinical diagnosis
Dementia with Lewy bodies
|
5 participants
n=5 Participants
|
|
Baseline clinical diagnosis
Other dementia subject
|
31 participants
n=5 Participants
|
|
Baseline clinical diagnosis
Healthy volunteers
|
32 participants
n=5 Participants
|
|
Baseline clinical diagnosis
Healthy negative control
|
11 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 90-110 minutes post injection (PET image acquisition)Population: All participants included in the Interim Analysis Set were included in this analysis.
The sensitivity/specificity of the visual assessment were calculated based on the majority read assessment of regional tracer uptake. This result was derived from assessments by 3 independent readers for brain regions of a subject where a Standard of Truth (SOT) was available. The SOT for this analysis was a centralized histopathological determination of β-amyloid presence/absence based on both Bielschowsky silver and immunohistochemical staining. Based on the PET images, a brain region was classified as "normal" or "abnormal" depending on the presence or absence of regional tracer uptake in the respective region. "Normal" therefore meant absence of β-amyloid and "abnormal" presence of β-amyloid. Sensitivity was defined as the percentage of abnormal brain regions from all regions where an SOT was available and the SOT was "β-amyloid present". Specificity was defined as the percentage of normal brain regions from all regions where an SOT was available and was "β-amyloid not present".
Outcome measures
| Measure |
Sensitivity (Interim Analysis Set)
n=41 Participants
The full analysis set consisted of 31 subjects for whom both brain specimen with a valid Standard of Truth (SOT) in at least one brain region and a florbetaben PET scan were available and 10 healthy controls for whom a florbetaben PET scan was available and whose SOT was considered β-amyloid negative by definition.
|
Specificity (Interim Analysis Set)
n=41 Participants
The full analysis set consisted of 31 subjects for whom both brain specimen with a valid Standard of Truth (SOT) in at least one brain region and a florbetaben PET scan were available and 10 healthy controls for whom a florbetaben PET scan was available and whose SOT was considered β-amyloid negative by definition.
|
2nd Repeat Drug Administration
The analysis set consisted of data from 3 subjects with brain specimens available.
|
|---|---|---|---|
|
Sensitivity and Specificity of the Majority Read of Visual Assessment of Tracer Uptake Compared to Histological Verification of the Presence or Absence of Cerebral Beta-amyloid in Postmortem Specimens
Cerebellar Cortex
|
0.00 percentage of regions
|
100.00 percentage of regions
|
—
|
|
Sensitivity and Specificity of the Majority Read of Visual Assessment of Tracer Uptake Compared to Histological Verification of the Presence or Absence of Cerebral Beta-amyloid in Postmortem Specimens
Total
|
77.36 percentage of regions
|
94.20 percentage of regions
|
—
|
|
Sensitivity and Specificity of the Majority Read of Visual Assessment of Tracer Uptake Compared to Histological Verification of the Presence or Absence of Cerebral Beta-amyloid in Postmortem Specimens
Frontal Cortex
|
85.71 percentage of regions
|
95.00 percentage of regions
|
—
|
|
Sensitivity and Specificity of the Majority Read of Visual Assessment of Tracer Uptake Compared to Histological Verification of the Presence or Absence of Cerebral Beta-amyloid in Postmortem Specimens
Occipital Cortex
|
88.89 percentage of regions
|
86.36 percentage of regions
|
—
|
|
Sensitivity and Specificity of the Majority Read of Visual Assessment of Tracer Uptake Compared to Histological Verification of the Presence or Absence of Cerebral Beta-amyloid in Postmortem Specimens
Hippocampus
|
57.14 percentage of regions
|
100.00 percentage of regions
|
—
|
|
Sensitivity and Specificity of the Majority Read of Visual Assessment of Tracer Uptake Compared to Histological Verification of the Presence or Absence of Cerebral Beta-amyloid in Postmortem Specimens
Anterior Cingulate Cortex
|
90.00 percentage of regions
|
85.71 percentage of regions
|
—
|
|
Sensitivity and Specificity of the Majority Read of Visual Assessment of Tracer Uptake Compared to Histological Verification of the Presence or Absence of Cerebral Beta-amyloid in Postmortem Specimens
Posterior Cingulate Cortex
|
81.82 percentage of regions
|
94.44 percentage of regions
|
—
|
SECONDARY outcome
Timeframe: 90-110 minutes post injection (PET image acquisition)Population: Sensitivity and Specificity of the Majority Read "Whole Brain" Visual Assessment in Detecting/Excluding Cerebral β-amyloid Plaques Compared with the Histopathological Verification with Bielschowsky silver staining (SOT 1).
Sensitivity and specificity of the whole brain visual assessment were calculated. Any brain with a region classified as abnormal from PET imaging was to be classified as abnormal for the "whole brain" assessment. This result was derived from assessments by 3 independent readers for a subject where a Standard of Truth (SOT) was available. The SOT for this analysis was based on a centralized histopathological assessment of the presence/absence of β-amyloid based on Bielschowsky silver staining (SOT 1). The sensitivity was defined as the proportion of brains classified as abnormal from all brains where this SOT was available and was "β-amyloid present". The specificity was defined as the proportion of brains classified as normal from all brains where this SOT was available and was "β-amyloid not present".
Outcome measures
| Measure |
Sensitivity (Interim Analysis Set)
n=97 Participants
The full analysis set consisted of 31 subjects for whom both brain specimen with a valid Standard of Truth (SOT) in at least one brain region and a florbetaben PET scan were available and 10 healthy controls for whom a florbetaben PET scan was available and whose SOT was considered β-amyloid negative by definition.
|
Specificity (Interim Analysis Set)
The full analysis set consisted of 31 subjects for whom both brain specimen with a valid Standard of Truth (SOT) in at least one brain region and a florbetaben PET scan were available and 10 healthy controls for whom a florbetaben PET scan was available and whose SOT was considered β-amyloid negative by definition.
|
2nd Repeat Drug Administration
The analysis set consisted of data from 3 subjects with brain specimens available.
|
|---|---|---|---|
|
Sensitivity and Specificity of the Majority Read "Whole Brain" Visual Assessment in Detecting/Excluding Cerebral Neuritic β-amyloid Plaques Compared With the Histopathological Verification With Bielschowsky Silver Staining (SOT 1).
Sensitivity
|
96.49 percentage of subjects
Interval 91.71 to 100.0
|
—
|
—
|
|
Sensitivity and Specificity of the Majority Read "Whole Brain" Visual Assessment in Detecting/Excluding Cerebral Neuritic β-amyloid Plaques Compared With the Histopathological Verification With Bielschowsky Silver Staining (SOT 1).
Specificity
|
85.00 percentage of subjects
Interval 73.93 to 96.07
|
—
|
—
|
SECONDARY outcome
Timeframe: 90-110 minutes post injection (PET image acquisition)Population: Sensitivity and Specificity of the Majority Read "Whole Brain" Visual Assessment in Detecting/Excluding Cerebral neuritic β-amyloid Plaques Compared with the Histopathological Verification with Bielschowsky silver staining and immunohistochemistry (SOT 2).
Sensitivity and specificity of the whole brain visual assessment were calculated. Any brain with a region classified as abnormal from PET imaging was to be classified as abnormal for the "whole brain" assessment. This result was derived from assessments by 3 independent readers for a subject where a Standard of Truth (SOT) was available. The SOT for this analysis was based on a centralized histopathological assessment of the presence/absence of β-amyloid based on Bielschowsky silver staining and immunohistochemistry (SOT 2). The sensitivity was defined as the proportion of brains classified as abnormal from all brains where this SOT was available and was "β-amyloid present". The specificity was defined as the proportion of brains classified as normal from all brains where this SOT was available and was "β-amyloid not present".
Outcome measures
| Measure |
Sensitivity (Interim Analysis Set)
n=97 Participants
The full analysis set consisted of 31 subjects for whom both brain specimen with a valid Standard of Truth (SOT) in at least one brain region and a florbetaben PET scan were available and 10 healthy controls for whom a florbetaben PET scan was available and whose SOT was considered β-amyloid negative by definition.
|
Specificity (Interim Analysis Set)
The full analysis set consisted of 31 subjects for whom both brain specimen with a valid Standard of Truth (SOT) in at least one brain region and a florbetaben PET scan were available and 10 healthy controls for whom a florbetaben PET scan was available and whose SOT was considered β-amyloid negative by definition.
|
2nd Repeat Drug Administration
The analysis set consisted of data from 3 subjects with brain specimens available.
|
|---|---|---|---|
|
Sensitivity and Specificity of the Majority Read "Whole Brain" Visual Assessment in Detecting/Excluding Cerebral Neuritic β-amyloid Plaques Compared With Histopathological Verification With Bielschowsky Silver Staining and Immunohistochemistry (SOT 2).
Sensitivity
|
96.72 percentage of subjects
Interval 92.25 to 100.0
|
—
|
—
|
|
Sensitivity and Specificity of the Majority Read "Whole Brain" Visual Assessment in Detecting/Excluding Cerebral Neuritic β-amyloid Plaques Compared With Histopathological Verification With Bielschowsky Silver Staining and Immunohistochemistry (SOT 2).
Specificity
|
94.44 percentage of subjects
Interval 86.96 to 100.0
|
—
|
—
|
SECONDARY outcome
Timeframe: 90-110 minutes post injection (PET image acquisition)Population: Sensitivity and Specificity of the Majority Read "Whole Brain" Visual Assessment in Detecting/Excluding Cerebral β-amyloid Plaques Compared with the Histopathological Verification according to CERAD Criteria (SOT 3).
Sensitivity and specificity of the whole brain visual assessment were calculated. Any brain with a region classified as abnormal from PET imaging was to be classified as abnormal for the "whole brain" assessment. This result was derived from assessments by 3 independent readers for a subject where a Standard of Truth (SOT) was available. The SOT for this analysis was based on a histopathological assessment of the presence/absence of β-amyloid according to CERAD Criteria (SOT 3). The sensitivity was defined as the proportion of brains classified as abnormal from all brains where this SOT was available and was "β-amyloid present". The specificity was defined as the proportion of brains classified as normal from all brains where this SOT was available and was "β-amyloid not present".
Outcome measures
| Measure |
Sensitivity (Interim Analysis Set)
n=97 Participants
The full analysis set consisted of 31 subjects for whom both brain specimen with a valid Standard of Truth (SOT) in at least one brain region and a florbetaben PET scan were available and 10 healthy controls for whom a florbetaben PET scan was available and whose SOT was considered β-amyloid negative by definition.
|
Specificity (Interim Analysis Set)
The full analysis set consisted of 31 subjects for whom both brain specimen with a valid Standard of Truth (SOT) in at least one brain region and a florbetaben PET scan were available and 10 healthy controls for whom a florbetaben PET scan was available and whose SOT was considered β-amyloid negative by definition.
|
2nd Repeat Drug Administration
The analysis set consisted of data from 3 subjects with brain specimens available.
|
|---|---|---|---|
|
Sensitivity and Specificity of the Majority Read "Whole Brain" Visual Assessment in Detecting/Excluding Cerebral Neuritic β-amyloid Plaques Compared With the Histopathological Verification According to CERAD Criteria (SOT 3).
Sensitivity
|
96.49 percentage of subjects
Interval 91.71 to 100.0
|
—
|
—
|
|
Sensitivity and Specificity of the Majority Read "Whole Brain" Visual Assessment in Detecting/Excluding Cerebral Neuritic β-amyloid Plaques Compared With the Histopathological Verification According to CERAD Criteria (SOT 3).
Specificity
|
85.00 percentage of subjects
Interval 73.93 to 96.07
|
—
|
—
|
SECONDARY outcome
Timeframe: 90-110 minutes post injection (PET image acquisition)Population: Sensitivity and Specificity of the subject level Composite SUVR with three different SOTs.
Sensitivity and specificity of subject level composite Standard Uptake Value Ratios (SUVR) by SOT for subjects with available brain tissue and 10 healthy volunteers. The SUVR were determined as a quantitative measure of tracer uptake. The SUV is defined as the ratio of the tissue radioactivity concentration c (in MBq/kg) at time point t, and the injected activity (in MBq), extrapolated to the same time (t) divided by the body weight (in kg). SUV numbers were then used to derive SUV ratios (SUVR) using the SUV from the cerebellar cortex as reference. SOTs comprised Bielschowsky silver staining (SOT 1), Bielschowsky silver staining with immunohistochemistry (SOT 2) and neuropathology assessment according to CERAD (SOT 3). SUVR analysis was performed for baseline and available follow-up scans. The optimal threshold for the distinction between β-amyloid present yes/no according to the respective SOT was derived based on ROC curve analyses and used to calculate sensitivity and specificity.
Outcome measures
| Measure |
Sensitivity (Interim Analysis Set)
n=96 Participants
The full analysis set consisted of 31 subjects for whom both brain specimen with a valid Standard of Truth (SOT) in at least one brain region and a florbetaben PET scan were available and 10 healthy controls for whom a florbetaben PET scan was available and whose SOT was considered β-amyloid negative by definition.
|
Specificity (Interim Analysis Set)
n=96 Participants
The full analysis set consisted of 31 subjects for whom both brain specimen with a valid Standard of Truth (SOT) in at least one brain region and a florbetaben PET scan were available and 10 healthy controls for whom a florbetaben PET scan was available and whose SOT was considered β-amyloid negative by definition.
|
2nd Repeat Drug Administration
The analysis set consisted of data from 3 subjects with brain specimens available.
|
|---|---|---|---|
|
Sensitivity and Specificity of the Subject Level Composite SUVR Calculated Based on Pathology Results.
SOT 1 (initial period)
|
89 percentage of subjects
|
82 percentage of subjects
|
—
|
|
Sensitivity and Specificity of the Subject Level Composite SUVR Calculated Based on Pathology Results.
SOT 2 (initial period)
|
90 percentage of subjects
|
91 percentage of subjects
|
—
|
|
Sensitivity and Specificity of the Subject Level Composite SUVR Calculated Based on Pathology Results.
SOT 3 (initial period)
|
89 percentage of subjects
|
90 percentage of subjects
|
—
|
|
Sensitivity and Specificity of the Subject Level Composite SUVR Calculated Based on Pathology Results.
SOT 1 (last available scan)
|
88 percentage of subjects
|
85 percentage of subjects
|
—
|
|
Sensitivity and Specificity of the Subject Level Composite SUVR Calculated Based on Pathology Results.
SOT 2 (last available scan)
|
89 percentage of subjects
|
94 percentage of subjects
|
—
|
|
Sensitivity and Specificity of the Subject Level Composite SUVR Calculated Based on Pathology Results.
SOT 3 (last available scan)
|
95 percentage of subjects
|
87 percentage of subjects
|
—
|
SECONDARY outcome
Timeframe: 90-110 minutes post injection (PET image acquisition)Subject level composite SUVRs (calculated as mean of SUVRs from the frontal, parietal, lateral temporal, anterior and posterior cingulate, and occipital cortices) by SOT are reported for subjects with available brain tissue. The initial drug administration group includes additionally 10 healthy controls who were considered as ß-amyloid negative. The SOTs for deceased subjects were based on Bielschowsky silver staining (SOT 1), Bielschowsky silver staining in combination with immunohistochemistry (SOT 2) and neuropathology assessment according to CERAD (SOT 3). SUVR analysis was performed for baseline and available follow-up scans.
Outcome measures
| Measure |
Sensitivity (Interim Analysis Set)
n=96 Participants
The full analysis set consisted of 31 subjects for whom both brain specimen with a valid Standard of Truth (SOT) in at least one brain region and a florbetaben PET scan were available and 10 healthy controls for whom a florbetaben PET scan was available and whose SOT was considered β-amyloid negative by definition.
|
Specificity (Interim Analysis Set)
n=20 Participants
The full analysis set consisted of 31 subjects for whom both brain specimen with a valid Standard of Truth (SOT) in at least one brain region and a florbetaben PET scan were available and 10 healthy controls for whom a florbetaben PET scan was available and whose SOT was considered β-amyloid negative by definition.
|
2nd Repeat Drug Administration
n=3 Participants
The analysis set consisted of data from 3 subjects with brain specimens available.
|
|---|---|---|---|
|
Subject Level Composite SUVRs by SOT for Baseline and Available Follow-Up Scans
SOT 1 (abeta absent)
|
1.296 Standardized Uptake Value Ratio (SUVR)
Standard Deviation 0.232
|
1.319 Standardized Uptake Value Ratio (SUVR)
Standard Deviation 0.414
|
1.537 Standardized Uptake Value Ratio (SUVR)
Standard Deviation NA
Sample size too low
|
|
Subject Level Composite SUVRs by SOT for Baseline and Available Follow-Up Scans
SOT 1 (abeta present)
|
1.707 Standardized Uptake Value Ratio (SUVR)
Standard Deviation 0.276
|
1.625 Standardized Uptake Value Ratio (SUVR)
Standard Deviation 0.250
|
1.699 Standardized Uptake Value Ratio (SUVR)
Standard Deviation 0.046
|
|
Subject Level Composite SUVRs by SOT for Baseline and Available Follow-Up Scans
SOT 2 (abeta absent)
|
1.237 Standardized Uptake Value Ratio (SUVR)
Standard Deviation 0.140
|
1.175 Standardized Uptake Value Ratio (SUVR)
Standard Deviation 0.364
|
1.537 Standardized Uptake Value Ratio (SUVR)
Standard Deviation NA
Sample size too low
|
|
Subject Level Composite SUVRs by SOT for Baseline and Available Follow-Up Scans
SOT 2 (abeta present)
|
1.714 Standardized Uptake Value Ratio (SUVR)
Standard Deviation 0.273
|
1.632 Standardized Uptake Value Ratio (SUVR)
Standard Deviation 0.244
|
1.699 Standardized Uptake Value Ratio (SUVR)
Standard Deviation 0.046
|
|
Subject Level Composite SUVRs by SOT for Baseline and Available Follow-Up Scans
SOT 3 (abeta absent)
|
1.263 Standardized Uptake Value Ratio (SUVR)
Standard Deviation 0.170
|
1.260 Standardized Uptake Value Ratio (SUVR)
Standard Deviation 0.390
|
NA Standardized Uptake Value Ratio (SUVR)
Standard Deviation NA
Sample size too low
|
|
Subject Level Composite SUVRs by SOT for Baseline and Available Follow-Up Scans
SOT 3 (abeta present)
|
1.729 Standardized Uptake Value Ratio (SUVR)
Standard Deviation 0.270
|
1.639 Standardized Uptake Value Ratio (SUVR)
Standard Deviation 0.236
|
1.645 Standardized Uptake Value Ratio (SUVR)
Standard Deviation 0.099
|
Adverse Events
Initial Drug Administration
Serious events: 12 serious events
Other events: 48 other events
Deaths: 0 deaths
1st Repeat Drug Administration
Serious events: 0 serious events
Other events: 22 other events
Deaths: 0 deaths
2nd Repeat Drug Administration
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Initial Drug Administration
n=216 participants at risk
Subjects with TEAEs within 7 days of the initial administration of florbetaben.
|
1st Repeat Drug Administration
n=91 participants at risk
Subjects with TEAEs within 7 days of the 1st repeat drug administration.
|
2nd Repeat Drug Administration
n=34 participants at risk
Subjects with TEAEs within 7 days of the 2nd repeat drug administration.
|
|---|---|---|---|
|
Nervous system disorders
Frontotemporal dementia
|
0.46%
1/216 • Number of events 1 • All treatment emergent adverse events were recorded within 7 days of the application or follow-up application of study drug.
As this study was conducted in an end-of-life population, death occurring outside 7 day follow-up period after administration of the drug was not collected as part of the study SAE data unless investigator considered the event to be related to drug administration or study procedure.
|
0.00%
0/91 • All treatment emergent adverse events were recorded within 7 days of the application or follow-up application of study drug.
As this study was conducted in an end-of-life population, death occurring outside 7 day follow-up period after administration of the drug was not collected as part of the study SAE data unless investigator considered the event to be related to drug administration or study procedure.
|
0.00%
0/34 • All treatment emergent adverse events were recorded within 7 days of the application or follow-up application of study drug.
As this study was conducted in an end-of-life population, death occurring outside 7 day follow-up period after administration of the drug was not collected as part of the study SAE data unless investigator considered the event to be related to drug administration or study procedure.
|
|
Nervous system disorders
Dementia, Alzheimers' type
|
0.46%
1/216 • Number of events 1 • All treatment emergent adverse events were recorded within 7 days of the application or follow-up application of study drug.
As this study was conducted in an end-of-life population, death occurring outside 7 day follow-up period after administration of the drug was not collected as part of the study SAE data unless investigator considered the event to be related to drug administration or study procedure.
|
0.00%
0/91 • All treatment emergent adverse events were recorded within 7 days of the application or follow-up application of study drug.
As this study was conducted in an end-of-life population, death occurring outside 7 day follow-up period after administration of the drug was not collected as part of the study SAE data unless investigator considered the event to be related to drug administration or study procedure.
|
0.00%
0/34 • All treatment emergent adverse events were recorded within 7 days of the application or follow-up application of study drug.
As this study was conducted in an end-of-life population, death occurring outside 7 day follow-up period after administration of the drug was not collected as part of the study SAE data unless investigator considered the event to be related to drug administration or study procedure.
|
|
Gastrointestinal disorders
Colitis
|
0.46%
1/216 • Number of events 1 • All treatment emergent adverse events were recorded within 7 days of the application or follow-up application of study drug.
As this study was conducted in an end-of-life population, death occurring outside 7 day follow-up period after administration of the drug was not collected as part of the study SAE data unless investigator considered the event to be related to drug administration or study procedure.
|
0.00%
0/91 • All treatment emergent adverse events were recorded within 7 days of the application or follow-up application of study drug.
As this study was conducted in an end-of-life population, death occurring outside 7 day follow-up period after administration of the drug was not collected as part of the study SAE data unless investigator considered the event to be related to drug administration or study procedure.
|
0.00%
0/34 • All treatment emergent adverse events were recorded within 7 days of the application or follow-up application of study drug.
As this study was conducted in an end-of-life population, death occurring outside 7 day follow-up period after administration of the drug was not collected as part of the study SAE data unless investigator considered the event to be related to drug administration or study procedure.
|
|
Infections and infestations
Pneumonia
|
0.46%
1/216 • Number of events 1 • All treatment emergent adverse events were recorded within 7 days of the application or follow-up application of study drug.
As this study was conducted in an end-of-life population, death occurring outside 7 day follow-up period after administration of the drug was not collected as part of the study SAE data unless investigator considered the event to be related to drug administration or study procedure.
|
0.00%
0/91 • All treatment emergent adverse events were recorded within 7 days of the application or follow-up application of study drug.
As this study was conducted in an end-of-life population, death occurring outside 7 day follow-up period after administration of the drug was not collected as part of the study SAE data unless investigator considered the event to be related to drug administration or study procedure.
|
0.00%
0/34 • All treatment emergent adverse events were recorded within 7 days of the application or follow-up application of study drug.
As this study was conducted in an end-of-life population, death occurring outside 7 day follow-up period after administration of the drug was not collected as part of the study SAE data unless investigator considered the event to be related to drug administration or study procedure.
|
|
Musculoskeletal and connective tissue disorders
Spinal compression fracture
|
0.46%
1/216 • Number of events 1 • All treatment emergent adverse events were recorded within 7 days of the application or follow-up application of study drug.
As this study was conducted in an end-of-life population, death occurring outside 7 day follow-up period after administration of the drug was not collected as part of the study SAE data unless investigator considered the event to be related to drug administration or study procedure.
|
0.00%
0/91 • All treatment emergent adverse events were recorded within 7 days of the application or follow-up application of study drug.
As this study was conducted in an end-of-life population, death occurring outside 7 day follow-up period after administration of the drug was not collected as part of the study SAE data unless investigator considered the event to be related to drug administration or study procedure.
|
0.00%
0/34 • All treatment emergent adverse events were recorded within 7 days of the application or follow-up application of study drug.
As this study was conducted in an end-of-life population, death occurring outside 7 day follow-up period after administration of the drug was not collected as part of the study SAE data unless investigator considered the event to be related to drug administration or study procedure.
|
|
Infections and infestations
Pneumonia aspiration
|
0.46%
1/216 • Number of events 1 • All treatment emergent adverse events were recorded within 7 days of the application or follow-up application of study drug.
As this study was conducted in an end-of-life population, death occurring outside 7 day follow-up period after administration of the drug was not collected as part of the study SAE data unless investigator considered the event to be related to drug administration or study procedure.
|
0.00%
0/91 • All treatment emergent adverse events were recorded within 7 days of the application or follow-up application of study drug.
As this study was conducted in an end-of-life population, death occurring outside 7 day follow-up period after administration of the drug was not collected as part of the study SAE data unless investigator considered the event to be related to drug administration or study procedure.
|
0.00%
0/34 • All treatment emergent adverse events were recorded within 7 days of the application or follow-up application of study drug.
As this study was conducted in an end-of-life population, death occurring outside 7 day follow-up period after administration of the drug was not collected as part of the study SAE data unless investigator considered the event to be related to drug administration or study procedure.
|
|
Injury, poisoning and procedural complications
Pubis fracture
|
0.46%
1/216 • Number of events 1 • All treatment emergent adverse events were recorded within 7 days of the application or follow-up application of study drug.
As this study was conducted in an end-of-life population, death occurring outside 7 day follow-up period after administration of the drug was not collected as part of the study SAE data unless investigator considered the event to be related to drug administration or study procedure.
|
0.00%
0/91 • All treatment emergent adverse events were recorded within 7 days of the application or follow-up application of study drug.
As this study was conducted in an end-of-life population, death occurring outside 7 day follow-up period after administration of the drug was not collected as part of the study SAE data unless investigator considered the event to be related to drug administration or study procedure.
|
0.00%
0/34 • All treatment emergent adverse events were recorded within 7 days of the application or follow-up application of study drug.
As this study was conducted in an end-of-life population, death occurring outside 7 day follow-up period after administration of the drug was not collected as part of the study SAE data unless investigator considered the event to be related to drug administration or study procedure.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.46%
1/216 • Number of events 1 • All treatment emergent adverse events were recorded within 7 days of the application or follow-up application of study drug.
As this study was conducted in an end-of-life population, death occurring outside 7 day follow-up period after administration of the drug was not collected as part of the study SAE data unless investigator considered the event to be related to drug administration or study procedure.
|
0.00%
0/91 • All treatment emergent adverse events were recorded within 7 days of the application or follow-up application of study drug.
As this study was conducted in an end-of-life population, death occurring outside 7 day follow-up period after administration of the drug was not collected as part of the study SAE data unless investigator considered the event to be related to drug administration or study procedure.
|
0.00%
0/34 • All treatment emergent adverse events were recorded within 7 days of the application or follow-up application of study drug.
As this study was conducted in an end-of-life population, death occurring outside 7 day follow-up period after administration of the drug was not collected as part of the study SAE data unless investigator considered the event to be related to drug administration or study procedure.
|
|
Gastrointestinal disorders
Colon cancer
|
0.46%
1/216 • Number of events 1 • All treatment emergent adverse events were recorded within 7 days of the application or follow-up application of study drug.
As this study was conducted in an end-of-life population, death occurring outside 7 day follow-up period after administration of the drug was not collected as part of the study SAE data unless investigator considered the event to be related to drug administration or study procedure.
|
0.00%
0/91 • All treatment emergent adverse events were recorded within 7 days of the application or follow-up application of study drug.
As this study was conducted in an end-of-life population, death occurring outside 7 day follow-up period after administration of the drug was not collected as part of the study SAE data unless investigator considered the event to be related to drug administration or study procedure.
|
0.00%
0/34 • All treatment emergent adverse events were recorded within 7 days of the application or follow-up application of study drug.
As this study was conducted in an end-of-life population, death occurring outside 7 day follow-up period after administration of the drug was not collected as part of the study SAE data unless investigator considered the event to be related to drug administration or study procedure.
|
|
Hepatobiliary disorders
Hepatic cancer metastatic
|
0.46%
1/216 • Number of events 1 • All treatment emergent adverse events were recorded within 7 days of the application or follow-up application of study drug.
As this study was conducted in an end-of-life population, death occurring outside 7 day follow-up period after administration of the drug was not collected as part of the study SAE data unless investigator considered the event to be related to drug administration or study procedure.
|
0.00%
0/91 • All treatment emergent adverse events were recorded within 7 days of the application or follow-up application of study drug.
As this study was conducted in an end-of-life population, death occurring outside 7 day follow-up period after administration of the drug was not collected as part of the study SAE data unless investigator considered the event to be related to drug administration or study procedure.
|
0.00%
0/34 • All treatment emergent adverse events were recorded within 7 days of the application or follow-up application of study drug.
As this study was conducted in an end-of-life population, death occurring outside 7 day follow-up period after administration of the drug was not collected as part of the study SAE data unless investigator considered the event to be related to drug administration or study procedure.
|
|
General disorders
Heat stroke
|
0.46%
1/216 • Number of events 1 • All treatment emergent adverse events were recorded within 7 days of the application or follow-up application of study drug.
As this study was conducted in an end-of-life population, death occurring outside 7 day follow-up period after administration of the drug was not collected as part of the study SAE data unless investigator considered the event to be related to drug administration or study procedure.
|
0.00%
0/91 • All treatment emergent adverse events were recorded within 7 days of the application or follow-up application of study drug.
As this study was conducted in an end-of-life population, death occurring outside 7 day follow-up period after administration of the drug was not collected as part of the study SAE data unless investigator considered the event to be related to drug administration or study procedure.
|
0.00%
0/34 • All treatment emergent adverse events were recorded within 7 days of the application or follow-up application of study drug.
As this study was conducted in an end-of-life population, death occurring outside 7 day follow-up period after administration of the drug was not collected as part of the study SAE data unless investigator considered the event to be related to drug administration or study procedure.
|
|
Nervous system disorders
Convulsion
|
0.46%
1/216 • Number of events 1 • All treatment emergent adverse events were recorded within 7 days of the application or follow-up application of study drug.
As this study was conducted in an end-of-life population, death occurring outside 7 day follow-up period after administration of the drug was not collected as part of the study SAE data unless investigator considered the event to be related to drug administration or study procedure.
|
0.00%
0/91 • All treatment emergent adverse events were recorded within 7 days of the application or follow-up application of study drug.
As this study was conducted in an end-of-life population, death occurring outside 7 day follow-up period after administration of the drug was not collected as part of the study SAE data unless investigator considered the event to be related to drug administration or study procedure.
|
0.00%
0/34 • All treatment emergent adverse events were recorded within 7 days of the application or follow-up application of study drug.
As this study was conducted in an end-of-life population, death occurring outside 7 day follow-up period after administration of the drug was not collected as part of the study SAE data unless investigator considered the event to be related to drug administration or study procedure.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.46%
1/216 • Number of events 1 • All treatment emergent adverse events were recorded within 7 days of the application or follow-up application of study drug.
As this study was conducted in an end-of-life population, death occurring outside 7 day follow-up period after administration of the drug was not collected as part of the study SAE data unless investigator considered the event to be related to drug administration or study procedure.
|
0.00%
0/91 • All treatment emergent adverse events were recorded within 7 days of the application or follow-up application of study drug.
As this study was conducted in an end-of-life population, death occurring outside 7 day follow-up period after administration of the drug was not collected as part of the study SAE data unless investigator considered the event to be related to drug administration or study procedure.
|
0.00%
0/34 • All treatment emergent adverse events were recorded within 7 days of the application or follow-up application of study drug.
As this study was conducted in an end-of-life population, death occurring outside 7 day follow-up period after administration of the drug was not collected as part of the study SAE data unless investigator considered the event to be related to drug administration or study procedure.
|
|
General disorders
Oedema peripheral
|
0.46%
1/216 • Number of events 1 • All treatment emergent adverse events were recorded within 7 days of the application or follow-up application of study drug.
As this study was conducted in an end-of-life population, death occurring outside 7 day follow-up period after administration of the drug was not collected as part of the study SAE data unless investigator considered the event to be related to drug administration or study procedure.
|
0.00%
0/91 • All treatment emergent adverse events were recorded within 7 days of the application or follow-up application of study drug.
As this study was conducted in an end-of-life population, death occurring outside 7 day follow-up period after administration of the drug was not collected as part of the study SAE data unless investigator considered the event to be related to drug administration or study procedure.
|
0.00%
0/34 • All treatment emergent adverse events were recorded within 7 days of the application or follow-up application of study drug.
As this study was conducted in an end-of-life population, death occurring outside 7 day follow-up period after administration of the drug was not collected as part of the study SAE data unless investigator considered the event to be related to drug administration or study procedure.
|
|
Psychiatric disorders
Delirium
|
0.46%
1/216 • Number of events 1 • All treatment emergent adverse events were recorded within 7 days of the application or follow-up application of study drug.
As this study was conducted in an end-of-life population, death occurring outside 7 day follow-up period after administration of the drug was not collected as part of the study SAE data unless investigator considered the event to be related to drug administration or study procedure.
|
0.00%
0/91 • All treatment emergent adverse events were recorded within 7 days of the application or follow-up application of study drug.
As this study was conducted in an end-of-life population, death occurring outside 7 day follow-up period after administration of the drug was not collected as part of the study SAE data unless investigator considered the event to be related to drug administration or study procedure.
|
0.00%
0/34 • All treatment emergent adverse events were recorded within 7 days of the application or follow-up application of study drug.
As this study was conducted in an end-of-life population, death occurring outside 7 day follow-up period after administration of the drug was not collected as part of the study SAE data unless investigator considered the event to be related to drug administration or study procedure.
|
|
Cardiac disorders
Cardiac Failure
|
0.46%
1/216 • Number of events 1 • All treatment emergent adverse events were recorded within 7 days of the application or follow-up application of study drug.
As this study was conducted in an end-of-life population, death occurring outside 7 day follow-up period after administration of the drug was not collected as part of the study SAE data unless investigator considered the event to be related to drug administration or study procedure.
|
0.00%
0/91 • All treatment emergent adverse events were recorded within 7 days of the application or follow-up application of study drug.
As this study was conducted in an end-of-life population, death occurring outside 7 day follow-up period after administration of the drug was not collected as part of the study SAE data unless investigator considered the event to be related to drug administration or study procedure.
|
0.00%
0/34 • All treatment emergent adverse events were recorded within 7 days of the application or follow-up application of study drug.
As this study was conducted in an end-of-life population, death occurring outside 7 day follow-up period after administration of the drug was not collected as part of the study SAE data unless investigator considered the event to be related to drug administration or study procedure.
|
Other adverse events
| Measure |
Initial Drug Administration
n=216 participants at risk
Subjects with TEAEs within 7 days of the initial administration of florbetaben.
|
1st Repeat Drug Administration
n=91 participants at risk
Subjects with TEAEs within 7 days of the 1st repeat drug administration.
|
2nd Repeat Drug Administration
n=34 participants at risk
Subjects with TEAEs within 7 days of the 2nd repeat drug administration.
|
|---|---|---|---|
|
General disorders
Injection site erythema
|
1.9%
4/216 • Number of events 4 • All treatment emergent adverse events were recorded within 7 days of the application or follow-up application of study drug.
As this study was conducted in an end-of-life population, death occurring outside 7 day follow-up period after administration of the drug was not collected as part of the study SAE data unless investigator considered the event to be related to drug administration or study procedure.
|
0.00%
0/91 • All treatment emergent adverse events were recorded within 7 days of the application or follow-up application of study drug.
As this study was conducted in an end-of-life population, death occurring outside 7 day follow-up period after administration of the drug was not collected as part of the study SAE data unless investigator considered the event to be related to drug administration or study procedure.
|
2.9%
1/34 • Number of events 1 • All treatment emergent adverse events were recorded within 7 days of the application or follow-up application of study drug.
As this study was conducted in an end-of-life population, death occurring outside 7 day follow-up period after administration of the drug was not collected as part of the study SAE data unless investigator considered the event to be related to drug administration or study procedure.
|
|
General disorders
Injection site pain
|
1.9%
4/216 • Number of events 4 • All treatment emergent adverse events were recorded within 7 days of the application or follow-up application of study drug.
As this study was conducted in an end-of-life population, death occurring outside 7 day follow-up period after administration of the drug was not collected as part of the study SAE data unless investigator considered the event to be related to drug administration or study procedure.
|
0.00%
0/91 • All treatment emergent adverse events were recorded within 7 days of the application or follow-up application of study drug.
As this study was conducted in an end-of-life population, death occurring outside 7 day follow-up period after administration of the drug was not collected as part of the study SAE data unless investigator considered the event to be related to drug administration or study procedure.
|
0.00%
0/34 • All treatment emergent adverse events were recorded within 7 days of the application or follow-up application of study drug.
As this study was conducted in an end-of-life population, death occurring outside 7 day follow-up period after administration of the drug was not collected as part of the study SAE data unless investigator considered the event to be related to drug administration or study procedure.
|
|
General disorders
Puncture site reaction
|
3.2%
7/216 • Number of events 7 • All treatment emergent adverse events were recorded within 7 days of the application or follow-up application of study drug.
As this study was conducted in an end-of-life population, death occurring outside 7 day follow-up period after administration of the drug was not collected as part of the study SAE data unless investigator considered the event to be related to drug administration or study procedure.
|
4.4%
4/91 • Number of events 4 • All treatment emergent adverse events were recorded within 7 days of the application or follow-up application of study drug.
As this study was conducted in an end-of-life population, death occurring outside 7 day follow-up period after administration of the drug was not collected as part of the study SAE data unless investigator considered the event to be related to drug administration or study procedure.
|
0.00%
0/34 • All treatment emergent adverse events were recorded within 7 days of the application or follow-up application of study drug.
As this study was conducted in an end-of-life population, death occurring outside 7 day follow-up period after administration of the drug was not collected as part of the study SAE data unless investigator considered the event to be related to drug administration or study procedure.
|
|
General disorders
Pyrexia
|
3.2%
7/216 • Number of events 8 • All treatment emergent adverse events were recorded within 7 days of the application or follow-up application of study drug.
As this study was conducted in an end-of-life population, death occurring outside 7 day follow-up period after administration of the drug was not collected as part of the study SAE data unless investigator considered the event to be related to drug administration or study procedure.
|
2.2%
2/91 • Number of events 2 • All treatment emergent adverse events were recorded within 7 days of the application or follow-up application of study drug.
As this study was conducted in an end-of-life population, death occurring outside 7 day follow-up period after administration of the drug was not collected as part of the study SAE data unless investigator considered the event to be related to drug administration or study procedure.
|
0.00%
0/34 • All treatment emergent adverse events were recorded within 7 days of the application or follow-up application of study drug.
As this study was conducted in an end-of-life population, death occurring outside 7 day follow-up period after administration of the drug was not collected as part of the study SAE data unless investigator considered the event to be related to drug administration or study procedure.
|
|
Investigations
Blood pressure increased
|
1.4%
3/216 • Number of events 3 • All treatment emergent adverse events were recorded within 7 days of the application or follow-up application of study drug.
As this study was conducted in an end-of-life population, death occurring outside 7 day follow-up period after administration of the drug was not collected as part of the study SAE data unless investigator considered the event to be related to drug administration or study procedure.
|
1.1%
1/91 • Number of events 1 • All treatment emergent adverse events were recorded within 7 days of the application or follow-up application of study drug.
As this study was conducted in an end-of-life population, death occurring outside 7 day follow-up period after administration of the drug was not collected as part of the study SAE data unless investigator considered the event to be related to drug administration or study procedure.
|
0.00%
0/34 • All treatment emergent adverse events were recorded within 7 days of the application or follow-up application of study drug.
As this study was conducted in an end-of-life population, death occurring outside 7 day follow-up period after administration of the drug was not collected as part of the study SAE data unless investigator considered the event to be related to drug administration or study procedure.
|
|
Nervous system disorders
Headache
|
1.4%
3/216 • Number of events 3 • All treatment emergent adverse events were recorded within 7 days of the application or follow-up application of study drug.
As this study was conducted in an end-of-life population, death occurring outside 7 day follow-up period after administration of the drug was not collected as part of the study SAE data unless investigator considered the event to be related to drug administration or study procedure.
|
0.00%
0/91 • All treatment emergent adverse events were recorded within 7 days of the application or follow-up application of study drug.
As this study was conducted in an end-of-life population, death occurring outside 7 day follow-up period after administration of the drug was not collected as part of the study SAE data unless investigator considered the event to be related to drug administration or study procedure.
|
0.00%
0/34 • All treatment emergent adverse events were recorded within 7 days of the application or follow-up application of study drug.
As this study was conducted in an end-of-life population, death occurring outside 7 day follow-up period after administration of the drug was not collected as part of the study SAE data unless investigator considered the event to be related to drug administration or study procedure.
|
|
Vascular disorders
Hypertension
|
2.3%
5/216 • Number of events 5 • All treatment emergent adverse events were recorded within 7 days of the application or follow-up application of study drug.
As this study was conducted in an end-of-life population, death occurring outside 7 day follow-up period after administration of the drug was not collected as part of the study SAE data unless investigator considered the event to be related to drug administration or study procedure.
|
1.1%
1/91 • Number of events 1 • All treatment emergent adverse events were recorded within 7 days of the application or follow-up application of study drug.
As this study was conducted in an end-of-life population, death occurring outside 7 day follow-up period after administration of the drug was not collected as part of the study SAE data unless investigator considered the event to be related to drug administration or study procedure.
|
2.9%
1/34 • Number of events 1 • All treatment emergent adverse events were recorded within 7 days of the application or follow-up application of study drug.
As this study was conducted in an end-of-life population, death occurring outside 7 day follow-up period after administration of the drug was not collected as part of the study SAE data unless investigator considered the event to be related to drug administration or study procedure.
|
|
General disorders
Injection site hematoma
|
4.6%
10/216 • Number of events 10 • All treatment emergent adverse events were recorded within 7 days of the application or follow-up application of study drug.
As this study was conducted in an end-of-life population, death occurring outside 7 day follow-up period after administration of the drug was not collected as part of the study SAE data unless investigator considered the event to be related to drug administration or study procedure.
|
1.1%
1/91 • Number of events 1 • All treatment emergent adverse events were recorded within 7 days of the application or follow-up application of study drug.
As this study was conducted in an end-of-life population, death occurring outside 7 day follow-up period after administration of the drug was not collected as part of the study SAE data unless investigator considered the event to be related to drug administration or study procedure.
|
0.00%
0/34 • All treatment emergent adverse events were recorded within 7 days of the application or follow-up application of study drug.
As this study was conducted in an end-of-life population, death occurring outside 7 day follow-up period after administration of the drug was not collected as part of the study SAE data unless investigator considered the event to be related to drug administration or study procedure.
|
|
Skin and subcutaneous tissue disorders
Haemorrhage subcutaneous
|
0.46%
1/216 • Number of events 1 • All treatment emergent adverse events were recorded within 7 days of the application or follow-up application of study drug.
As this study was conducted in an end-of-life population, death occurring outside 7 day follow-up period after administration of the drug was not collected as part of the study SAE data unless investigator considered the event to be related to drug administration or study procedure.
|
3.3%
3/91 • Number of events 3 • All treatment emergent adverse events were recorded within 7 days of the application or follow-up application of study drug.
As this study was conducted in an end-of-life population, death occurring outside 7 day follow-up period after administration of the drug was not collected as part of the study SAE data unless investigator considered the event to be related to drug administration or study procedure.
|
2.9%
1/34 • Number of events 1 • All treatment emergent adverse events were recorded within 7 days of the application or follow-up application of study drug.
As this study was conducted in an end-of-life population, death occurring outside 7 day follow-up period after administration of the drug was not collected as part of the study SAE data unless investigator considered the event to be related to drug administration or study procedure.
|
|
Vascular disorders
Haematoma
|
0.46%
1/216 • Number of events 1 • All treatment emergent adverse events were recorded within 7 days of the application or follow-up application of study drug.
As this study was conducted in an end-of-life population, death occurring outside 7 day follow-up period after administration of the drug was not collected as part of the study SAE data unless investigator considered the event to be related to drug administration or study procedure.
|
5.5%
5/91 • Number of events 5 • All treatment emergent adverse events were recorded within 7 days of the application or follow-up application of study drug.
As this study was conducted in an end-of-life population, death occurring outside 7 day follow-up period after administration of the drug was not collected as part of the study SAE data unless investigator considered the event to be related to drug administration or study procedure.
|
17.6%
6/34 • Number of events 6 • All treatment emergent adverse events were recorded within 7 days of the application or follow-up application of study drug.
As this study was conducted in an end-of-life population, death occurring outside 7 day follow-up period after administration of the drug was not collected as part of the study SAE data unless investigator considered the event to be related to drug administration or study procedure.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.46%
1/216 • Number of events 1 • All treatment emergent adverse events were recorded within 7 days of the application or follow-up application of study drug.
As this study was conducted in an end-of-life population, death occurring outside 7 day follow-up period after administration of the drug was not collected as part of the study SAE data unless investigator considered the event to be related to drug administration or study procedure.
|
4.4%
4/91 • Number of events 5 • All treatment emergent adverse events were recorded within 7 days of the application or follow-up application of study drug.
As this study was conducted in an end-of-life population, death occurring outside 7 day follow-up period after administration of the drug was not collected as part of the study SAE data unless investigator considered the event to be related to drug administration or study procedure.
|
8.8%
3/34 • Number of events 3 • All treatment emergent adverse events were recorded within 7 days of the application or follow-up application of study drug.
As this study was conducted in an end-of-life population, death occurring outside 7 day follow-up period after administration of the drug was not collected as part of the study SAE data unless investigator considered the event to be related to drug administration or study procedure.
|
|
General disorders
Injection site hemorrhage
|
0.46%
1/216 • Number of events 1 • All treatment emergent adverse events were recorded within 7 days of the application or follow-up application of study drug.
As this study was conducted in an end-of-life population, death occurring outside 7 day follow-up period after administration of the drug was not collected as part of the study SAE data unless investigator considered the event to be related to drug administration or study procedure.
|
4.4%
4/91 • Number of events 4 • All treatment emergent adverse events were recorded within 7 days of the application or follow-up application of study drug.
As this study was conducted in an end-of-life population, death occurring outside 7 day follow-up period after administration of the drug was not collected as part of the study SAE data unless investigator considered the event to be related to drug administration or study procedure.
|
5.9%
2/34 • Number of events 2 • All treatment emergent adverse events were recorded within 7 days of the application or follow-up application of study drug.
As this study was conducted in an end-of-life population, death occurring outside 7 day follow-up period after administration of the drug was not collected as part of the study SAE data unless investigator considered the event to be related to drug administration or study procedure.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/216 • All treatment emergent adverse events were recorded within 7 days of the application or follow-up application of study drug.
As this study was conducted in an end-of-life population, death occurring outside 7 day follow-up period after administration of the drug was not collected as part of the study SAE data unless investigator considered the event to be related to drug administration or study procedure.
|
0.00%
0/91 • All treatment emergent adverse events were recorded within 7 days of the application or follow-up application of study drug.
As this study was conducted in an end-of-life population, death occurring outside 7 day follow-up period after administration of the drug was not collected as part of the study SAE data unless investigator considered the event to be related to drug administration or study procedure.
|
2.9%
1/34 • Number of events 1 • All treatment emergent adverse events were recorded within 7 days of the application or follow-up application of study drug.
As this study was conducted in an end-of-life population, death occurring outside 7 day follow-up period after administration of the drug was not collected as part of the study SAE data unless investigator considered the event to be related to drug administration or study procedure.
|
|
Respiratory, thoracic and mediastinal disorders
Emphysema
|
0.00%
0/216 • All treatment emergent adverse events were recorded within 7 days of the application or follow-up application of study drug.
As this study was conducted in an end-of-life population, death occurring outside 7 day follow-up period after administration of the drug was not collected as part of the study SAE data unless investigator considered the event to be related to drug administration or study procedure.
|
0.00%
0/91 • All treatment emergent adverse events were recorded within 7 days of the application or follow-up application of study drug.
As this study was conducted in an end-of-life population, death occurring outside 7 day follow-up period after administration of the drug was not collected as part of the study SAE data unless investigator considered the event to be related to drug administration or study procedure.
|
2.9%
1/34 • Number of events 1 • All treatment emergent adverse events were recorded within 7 days of the application or follow-up application of study drug.
As this study was conducted in an end-of-life population, death occurring outside 7 day follow-up period after administration of the drug was not collected as part of the study SAE data unless investigator considered the event to be related to drug administration or study procedure.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.93%
2/216 • Number of events 3 • All treatment emergent adverse events were recorded within 7 days of the application or follow-up application of study drug.
As this study was conducted in an end-of-life population, death occurring outside 7 day follow-up period after administration of the drug was not collected as part of the study SAE data unless investigator considered the event to be related to drug administration or study procedure.
|
1.1%
1/91 • Number of events 1 • All treatment emergent adverse events were recorded within 7 days of the application or follow-up application of study drug.
As this study was conducted in an end-of-life population, death occurring outside 7 day follow-up period after administration of the drug was not collected as part of the study SAE data unless investigator considered the event to be related to drug administration or study procedure.
|
0.00%
0/34 • All treatment emergent adverse events were recorded within 7 days of the application or follow-up application of study drug.
As this study was conducted in an end-of-life population, death occurring outside 7 day follow-up period after administration of the drug was not collected as part of the study SAE data unless investigator considered the event to be related to drug administration or study procedure.
|
|
General disorders
Injection site bruising
|
2.3%
5/216 • Number of events 5 • All treatment emergent adverse events were recorded within 7 days of the application or follow-up application of study drug.
As this study was conducted in an end-of-life population, death occurring outside 7 day follow-up period after administration of the drug was not collected as part of the study SAE data unless investigator considered the event to be related to drug administration or study procedure.
|
0.00%
0/91 • All treatment emergent adverse events were recorded within 7 days of the application or follow-up application of study drug.
As this study was conducted in an end-of-life population, death occurring outside 7 day follow-up period after administration of the drug was not collected as part of the study SAE data unless investigator considered the event to be related to drug administration or study procedure.
|
0.00%
0/34 • All treatment emergent adverse events were recorded within 7 days of the application or follow-up application of study drug.
As this study was conducted in an end-of-life population, death occurring outside 7 day follow-up period after administration of the drug was not collected as part of the study SAE data unless investigator considered the event to be related to drug administration or study procedure.
|
|
Vascular disorders
Hypotension
|
1.4%
3/216 • Number of events 3 • All treatment emergent adverse events were recorded within 7 days of the application or follow-up application of study drug.
As this study was conducted in an end-of-life population, death occurring outside 7 day follow-up period after administration of the drug was not collected as part of the study SAE data unless investigator considered the event to be related to drug administration or study procedure.
|
0.00%
0/91 • All treatment emergent adverse events were recorded within 7 days of the application or follow-up application of study drug.
As this study was conducted in an end-of-life population, death occurring outside 7 day follow-up period after administration of the drug was not collected as part of the study SAE data unless investigator considered the event to be related to drug administration or study procedure.
|
0.00%
0/34 • All treatment emergent adverse events were recorded within 7 days of the application or follow-up application of study drug.
As this study was conducted in an end-of-life population, death occurring outside 7 day follow-up period after administration of the drug was not collected as part of the study SAE data unless investigator considered the event to be related to drug administration or study procedure.
|
|
Gastrointestinal disorders
Frequent bowel movements
|
0.46%
1/216 • Number of events 1 • All treatment emergent adverse events were recorded within 7 days of the application or follow-up application of study drug.
As this study was conducted in an end-of-life population, death occurring outside 7 day follow-up period after administration of the drug was not collected as part of the study SAE data unless investigator considered the event to be related to drug administration or study procedure.
|
1.1%
1/91 • Number of events 1 • All treatment emergent adverse events were recorded within 7 days of the application or follow-up application of study drug.
As this study was conducted in an end-of-life population, death occurring outside 7 day follow-up period after administration of the drug was not collected as part of the study SAE data unless investigator considered the event to be related to drug administration or study procedure.
|
0.00%
0/34 • All treatment emergent adverse events were recorded within 7 days of the application or follow-up application of study drug.
As this study was conducted in an end-of-life population, death occurring outside 7 day follow-up period after administration of the drug was not collected as part of the study SAE data unless investigator considered the event to be related to drug administration or study procedure.
|
|
General disorders
Vessel puncture site swelling
|
0.46%
1/216 • Number of events 1 • All treatment emergent adverse events were recorded within 7 days of the application or follow-up application of study drug.
As this study was conducted in an end-of-life population, death occurring outside 7 day follow-up period after administration of the drug was not collected as part of the study SAE data unless investigator considered the event to be related to drug administration or study procedure.
|
1.1%
1/91 • Number of events 1 • All treatment emergent adverse events were recorded within 7 days of the application or follow-up application of study drug.
As this study was conducted in an end-of-life population, death occurring outside 7 day follow-up period after administration of the drug was not collected as part of the study SAE data unless investigator considered the event to be related to drug administration or study procedure.
|
2.9%
1/34 • Number of events 1 • All treatment emergent adverse events were recorded within 7 days of the application or follow-up application of study drug.
As this study was conducted in an end-of-life population, death occurring outside 7 day follow-up period after administration of the drug was not collected as part of the study SAE data unless investigator considered the event to be related to drug administration or study procedure.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/216 • All treatment emergent adverse events were recorded within 7 days of the application or follow-up application of study drug.
As this study was conducted in an end-of-life population, death occurring outside 7 day follow-up period after administration of the drug was not collected as part of the study SAE data unless investigator considered the event to be related to drug administration or study procedure.
|
1.1%
1/91 • Number of events 1 • All treatment emergent adverse events were recorded within 7 days of the application or follow-up application of study drug.
As this study was conducted in an end-of-life population, death occurring outside 7 day follow-up period after administration of the drug was not collected as part of the study SAE data unless investigator considered the event to be related to drug administration or study procedure.
|
0.00%
0/34 • All treatment emergent adverse events were recorded within 7 days of the application or follow-up application of study drug.
As this study was conducted in an end-of-life population, death occurring outside 7 day follow-up period after administration of the drug was not collected as part of the study SAE data unless investigator considered the event to be related to drug administration or study procedure.
|
|
Skin and subcutaneous tissue disorders
Papule
|
0.00%
0/216 • All treatment emergent adverse events were recorded within 7 days of the application or follow-up application of study drug.
As this study was conducted in an end-of-life population, death occurring outside 7 day follow-up period after administration of the drug was not collected as part of the study SAE data unless investigator considered the event to be related to drug administration or study procedure.
|
1.1%
1/91 • Number of events 1 • All treatment emergent adverse events were recorded within 7 days of the application or follow-up application of study drug.
As this study was conducted in an end-of-life population, death occurring outside 7 day follow-up period after administration of the drug was not collected as part of the study SAE data unless investigator considered the event to be related to drug administration or study procedure.
|
0.00%
0/34 • All treatment emergent adverse events were recorded within 7 days of the application or follow-up application of study drug.
As this study was conducted in an end-of-life population, death occurring outside 7 day follow-up period after administration of the drug was not collected as part of the study SAE data unless investigator considered the event to be related to drug administration or study procedure.
|
|
Infections and infestations
Cystitis
|
0.00%
0/216 • All treatment emergent adverse events were recorded within 7 days of the application or follow-up application of study drug.
As this study was conducted in an end-of-life population, death occurring outside 7 day follow-up period after administration of the drug was not collected as part of the study SAE data unless investigator considered the event to be related to drug administration or study procedure.
|
0.00%
0/91 • All treatment emergent adverse events were recorded within 7 days of the application or follow-up application of study drug.
As this study was conducted in an end-of-life population, death occurring outside 7 day follow-up period after administration of the drug was not collected as part of the study SAE data unless investigator considered the event to be related to drug administration or study procedure.
|
2.9%
1/34 • Number of events 1 • All treatment emergent adverse events were recorded within 7 days of the application or follow-up application of study drug.
As this study was conducted in an end-of-life population, death occurring outside 7 day follow-up period after administration of the drug was not collected as part of the study SAE data unless investigator considered the event to be related to drug administration or study procedure.
|
|
Injury, poisoning and procedural complications
Procedural hypertension
|
0.00%
0/216 • All treatment emergent adverse events were recorded within 7 days of the application or follow-up application of study drug.
As this study was conducted in an end-of-life population, death occurring outside 7 day follow-up period after administration of the drug was not collected as part of the study SAE data unless investigator considered the event to be related to drug administration or study procedure.
|
0.00%
0/91 • All treatment emergent adverse events were recorded within 7 days of the application or follow-up application of study drug.
As this study was conducted in an end-of-life population, death occurring outside 7 day follow-up period after administration of the drug was not collected as part of the study SAE data unless investigator considered the event to be related to drug administration or study procedure.
|
2.9%
1/34 • Number of events 1 • All treatment emergent adverse events were recorded within 7 days of the application or follow-up application of study drug.
As this study was conducted in an end-of-life population, death occurring outside 7 day follow-up period after administration of the drug was not collected as part of the study SAE data unless investigator considered the event to be related to drug administration or study procedure.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60