Trial Outcomes & Findings for A Long-Term Safety Extension of Studies ABE4869g and ABE4955g in Participants With Mild to Moderate Alzheimer's Disease Treated With Crenezumab (NCT NCT01723826)
NCT ID: NCT01723826
Last Updated: 2020-02-20
Results Overview
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product which does not necessarily have a causal relationship with the treatment. . An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
360 participants
Primary outcome timeframe
Up to 50 months
Results posted on
2020-02-20
Participant Flow
A total of 360 participants were enrolled at 83 sites across 6 countries.
Participants who completed either Phase II Study NCT01343966 (ABE4869g) or NCT01397578 (ABE4955g) and had Mini-Mental State Examination (MMSE) score of 10 or more at the time of screening were included. Participant flow is represented based on the safety population by treatment received.
Participant milestones
| Measure |
PCP PL - OLE CREN SC - OLE CREN IV
Participants who on their placebo-controlled portion \[PCP\]/parent study received placebo (PL) and who on this open-label extension (OLE) study initially received crenezumab (CREN) subcutaneously (SC) and after the protocol amendment received CREN intravenously (IV).
|
PCP PL - OLE CREN IV
Participants who on their PCP/parent study received placebo and who on this OLE study received CREN IV.
|
PCP CREN SC - OLE CREN SC - OLE CREN IV
Participants who on their PCP/parent study received CREN and who on this OLE study initially received CREN SC and after the protocol amendment received CREN IV.
|
PCP CREN IV - OLE CREN IV
Participants who on their PCP/parent study received CREN IV and who on this OLE study received CREN IV.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
47
|
63
|
101
|
149
|
|
Overall Study
COMPLETED
|
20
|
27
|
44
|
59
|
|
Overall Study
NOT COMPLETED
|
27
|
36
|
57
|
90
|
Reasons for withdrawal
| Measure |
PCP PL - OLE CREN SC - OLE CREN IV
Participants who on their placebo-controlled portion \[PCP\]/parent study received placebo (PL) and who on this open-label extension (OLE) study initially received crenezumab (CREN) subcutaneously (SC) and after the protocol amendment received CREN intravenously (IV).
|
PCP PL - OLE CREN IV
Participants who on their PCP/parent study received placebo and who on this OLE study received CREN IV.
|
PCP CREN SC - OLE CREN SC - OLE CREN IV
Participants who on their PCP/parent study received CREN and who on this OLE study initially received CREN SC and after the protocol amendment received CREN IV.
|
PCP CREN IV - OLE CREN IV
Participants who on their PCP/parent study received CREN IV and who on this OLE study received CREN IV.
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
4
|
1
|
4
|
5
|
|
Overall Study
Death according to AE eCRF
|
2
|
3
|
3
|
7
|
|
Overall Study
Lost to Follow-up
|
1
|
3
|
1
|
1
|
|
Overall Study
Non-compliance
|
0
|
1
|
3
|
3
|
|
Overall Study
Non-compliance With Study Drug
|
0
|
1
|
0
|
0
|
|
Overall Study
Other Reason
|
8
|
6
|
12
|
14
|
|
Overall Study
Physician Decision
|
1
|
3
|
4
|
11
|
|
Overall Study
Protocol Violation
|
1
|
1
|
3
|
1
|
|
Overall Study
Withdrawal by Subject
|
10
|
17
|
27
|
48
|
Baseline Characteristics
A Long-Term Safety Extension of Studies ABE4869g and ABE4955g in Participants With Mild to Moderate Alzheimer's Disease Treated With Crenezumab
Baseline characteristics by cohort
| Measure |
PCP PL - OLE CREN SC - OLE CREN IV
n=47 Participants
Participants who on their placebo-controlled portion \[PCP\]/parent study received placebo (PL) and who on this open-label extension (OLE) study initially received crenezumab (CREN) subcutaneously (SC) and after the protocol amendment received CREN intravenously (IV).
|
PCP PL - OLE CREN IV
n=63 Participants
Participants who on their PCP/parent study received placebo and who on this OLE study received CREN IV.
|
PCP CREN SC - OLE CREN SC - OLE CREN IV
n=101 Participants
Participants who on their PCP/parent study received CREN and who on this OLE study initially received CREN SC and after the protocol amendment received CREN IV.
|
PCP CREN IV - OLE CREN IV
n=149 Participants
Participants who on their PCP/parent study received CREN IV and who on this OLE study received CREN IV.
|
Total
n=360 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
70.9 Years
STANDARD_DEVIATION 7.4 • n=5 Participants
|
71.9 Years
STANDARD_DEVIATION 7.4 • n=7 Participants
|
72.3 Years
STANDARD_DEVIATION 7.2 • n=5 Participants
|
72.2 Years
STANDARD_DEVIATION 6.7 • n=4 Participants
|
72.0 Years
STANDARD_DEVIATION 7.0 • n=21 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
79 Participants
n=4 Participants
|
199 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
70 Participants
n=4 Participants
|
161 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
45 Participants
n=5 Participants
|
61 Participants
n=7 Participants
|
98 Participants
n=5 Participants
|
145 Participants
n=4 Participants
|
349 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Not Stated
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
White
|
47 Participants
n=5 Participants
|
63 Participants
n=7 Participants
|
97 Participants
n=5 Participants
|
144 Participants
n=4 Participants
|
351 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Up to 50 monthsPopulation: Safety Analysis population included all participants who received at least one dose of study drug.
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product which does not necessarily have a causal relationship with the treatment. . An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.
Outcome measures
| Measure |
PCP PL - OLE CREN SC - OLE CREN IV
n=47 Participants
Participants who on their placebo-controlled portion \[PCP\]/parent study received placebo (PL) and who on this open-label extension (OLE) study initially received crenezumab (CREN) subcutaneously (SC) and after the protocol amendment received CREN intravenously (IV).
|
PCP PL - OLE CREN IV
n=63 Participants
Participants who on their PCP/parent study received placebo and who on this OLE study received CREN IV.
|
PCP CREN - OLE CREN SC -OLE CREN IV
n=101 Participants
Participants who on their PCP/parent study received CREN and who on this OLE study initially received CREN SC and after the protocol amendment received CREN IV.
|
PCP CREN - OLE CREN IV
n=149 Participants
Participants who on their PCP/parent study received CREN IV and who on this OLE study received CREN IV.
|
|---|---|---|---|---|
|
Percentage of Participants With Adverse Events (AEs)
|
89.4 percentage of participants
|
90.5 percentage of participants
|
96.0 percentage of participants
|
87.9 percentage of participants
|
PRIMARY outcome
Timeframe: Up to 50 monthsPopulation: Safety Analysis population included all participants who received at least one dose of study drug.
A serious adverse event (SAE) is any AE that meets any of the following criteria: fatal, life threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, congenital anomaly/birth defect in a neonate/infant. Non-SAE of special interest for this study include the following: cerebral vascular edema, Superficial siderosis of central nervous system, cerebral micro-hemorrhages or macro-hemorrhages, pneumonia, liver injury.
Outcome measures
| Measure |
PCP PL - OLE CREN SC - OLE CREN IV
n=47 Participants
Participants who on their placebo-controlled portion \[PCP\]/parent study received placebo (PL) and who on this open-label extension (OLE) study initially received crenezumab (CREN) subcutaneously (SC) and after the protocol amendment received CREN intravenously (IV).
|
PCP PL - OLE CREN IV
n=63 Participants
Participants who on their PCP/parent study received placebo and who on this OLE study received CREN IV.
|
PCP CREN - OLE CREN SC -OLE CREN IV
n=101 Participants
Participants who on their PCP/parent study received CREN and who on this OLE study initially received CREN SC and after the protocol amendment received CREN IV.
|
PCP CREN - OLE CREN IV
n=149 Participants
Participants who on their PCP/parent study received CREN IV and who on this OLE study received CREN IV.
|
|---|---|---|---|---|
|
Percentage of Participants by Nature of AEs
SAE
|
19.1 percentage of participants
|
22.2 percentage of participants
|
21.8 percentage of participants
|
23.5 percentage of participants
|
|
Percentage of Participants by Nature of AEs
Non-SAE
|
87.2 percentage of participants
|
88.9 percentage of participants
|
94.1 percentage of participants
|
87.2 percentage of participants
|
PRIMARY outcome
Timeframe: Up to 50 monthsPopulation: Safety Analysis population included all participants who received at least one dose of study drug.
AE severity grading scale for the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.0 was used for assessing adverse event severity. The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each AE based on the following general guideline: Grade 1) mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated, Grade 2) moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living (ADL), Grade 3) severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL, Grade 4) life-threatening consequences; urgent intervention indicated, Grade 5) death related to AE.
Outcome measures
| Measure |
PCP PL - OLE CREN SC - OLE CREN IV
n=47 Participants
Participants who on their placebo-controlled portion \[PCP\]/parent study received placebo (PL) and who on this open-label extension (OLE) study initially received crenezumab (CREN) subcutaneously (SC) and after the protocol amendment received CREN intravenously (IV).
|
PCP PL - OLE CREN IV
n=63 Participants
Participants who on their PCP/parent study received placebo and who on this OLE study received CREN IV.
|
PCP CREN - OLE CREN SC -OLE CREN IV
n=101 Participants
Participants who on their PCP/parent study received CREN and who on this OLE study initially received CREN SC and after the protocol amendment received CREN IV.
|
PCP CREN - OLE CREN IV
n=149 Participants
Participants who on their PCP/parent study received CREN IV and who on this OLE study received CREN IV.
|
|---|---|---|---|---|
|
Percentage of Participants by Severity of AEs
Grade 2
|
44.7 percentage of participants
|
31.7 percentage of participants
|
43.6 percentage of participants
|
40.3 percentage of participants
|
|
Percentage of Participants by Severity of AEs
Grade 3
|
12.8 percentage of participants
|
17.5 percentage of participants
|
16.8 percentage of participants
|
19.5 percentage of participants
|
|
Percentage of Participants by Severity of AEs
Grade 4
|
8.5 percentage of participants
|
1.6 percentage of participants
|
3.0 percentage of participants
|
1.3 percentage of participants
|
|
Percentage of Participants by Severity of AEs
Grade 5
|
4.3 percentage of participants
|
4.8 percentage of participants
|
3.0 percentage of participants
|
4.7 percentage of participants
|
|
Percentage of Participants by Severity of AEs
Grade 1
|
19.1 percentage of participants
|
34.9 percentage of participants
|
29.7 percentage of participants
|
22.1 percentage of participants
|
PRIMARY outcome
Timeframe: Pre-dose (Day-14), predose at Week 25, 49, 97, Follow-up Week 8 (Week 153) and 12 (Week 157)Population: Safety Analysis population included all participants who received at least one dose of study drug.
ATA is a measurement to explore the potential relationship of immunogenicity response with pharmacokinetics, safety and efficacy. Percentage of participants at post-baseline with positive results for ATA against crenezumab are reported.
Outcome measures
| Measure |
PCP PL - OLE CREN SC - OLE CREN IV
n=47 Participants
Participants who on their placebo-controlled portion \[PCP\]/parent study received placebo (PL) and who on this open-label extension (OLE) study initially received crenezumab (CREN) subcutaneously (SC) and after the protocol amendment received CREN intravenously (IV).
|
PCP PL - OLE CREN IV
n=63 Participants
Participants who on their PCP/parent study received placebo and who on this OLE study received CREN IV.
|
PCP CREN - OLE CREN SC -OLE CREN IV
n=101 Participants
Participants who on their PCP/parent study received CREN and who on this OLE study initially received CREN SC and after the protocol amendment received CREN IV.
|
PCP CREN - OLE CREN IV
n=149 Participants
Participants who on their PCP/parent study received CREN IV and who on this OLE study received CREN IV.
|
|---|---|---|---|---|
|
Percentage of Participants With Human Anti-Therapeutic Antibody (ATA) Formation
|
9.1 percentage of participants
|
3.4 percentage of participants
|
9.1 percentage of participants
|
0.7 percentage of participants
|
PRIMARY outcome
Timeframe: Baseline, Weeks 23, 47, 71, 97, 121 and 153Population: Safety Analysis population included all participants who received at least one dose of study drug.
Alzheimer's disease (AD) is associated with ARIA. The occurrence of imaging abnormalities believed to represent cerebral vasogenic edema, has been reported in association with the investigational use of compounds that are intended to treat Alzheimer's disease by reducing Abeta in the brain. Here, the percentage of participants with symptomatic and asymptomatic ARIA-E were reported.
Outcome measures
| Measure |
PCP PL - OLE CREN SC - OLE CREN IV
n=47 Participants
Participants who on their placebo-controlled portion \[PCP\]/parent study received placebo (PL) and who on this open-label extension (OLE) study initially received crenezumab (CREN) subcutaneously (SC) and after the protocol amendment received CREN intravenously (IV).
|
PCP PL - OLE CREN IV
n=63 Participants
Participants who on their PCP/parent study received placebo and who on this OLE study received CREN IV.
|
PCP CREN - OLE CREN SC -OLE CREN IV
n=101 Participants
Participants who on their PCP/parent study received CREN and who on this OLE study initially received CREN SC and after the protocol amendment received CREN IV.
|
PCP CREN - OLE CREN IV
n=149 Participants
Participants who on their PCP/parent study received CREN IV and who on this OLE study received CREN IV.
|
|---|---|---|---|---|
|
Percentage of Participants With Amyloid-Related Imaging Abnormalities Edema/Effusions (ARIA-E)
Symptomatic
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Amyloid-Related Imaging Abnormalities Edema/Effusions (ARIA-E)
Asymptomatic
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0.7 percentage of participants
|
PRIMARY outcome
Timeframe: Baseline, Weeks 23, 47, 71, 97, 121 and 153Population: Safety Analysis population included all participants who received at least one dose of study drug.
AD is associated with ARIA. Cerebral micro-hemorrhages (microbleeds \[MBs\]) are radiologically defined as small dot-like foci of signal loss observed on magnetic resonance imaging (MRI) sequences sensitive for paramagnetic tissue properties. The occurrence of MBs has also been identified as an adverse event in anti-amyloid vaccination trials, and together with superficial siderosis, they have been termed ARIA-H.
Outcome measures
| Measure |
PCP PL - OLE CREN SC - OLE CREN IV
n=47 Participants
Participants who on their placebo-controlled portion \[PCP\]/parent study received placebo (PL) and who on this open-label extension (OLE) study initially received crenezumab (CREN) subcutaneously (SC) and after the protocol amendment received CREN intravenously (IV).
|
PCP PL - OLE CREN IV
n=63 Participants
Participants who on their PCP/parent study received placebo and who on this OLE study received CREN IV.
|
PCP CREN - OLE CREN SC -OLE CREN IV
n=101 Participants
Participants who on their PCP/parent study received CREN and who on this OLE study initially received CREN SC and after the protocol amendment received CREN IV.
|
PCP CREN - OLE CREN IV
n=149 Participants
Participants who on their PCP/parent study received CREN IV and who on this OLE study received CREN IV.
|
|---|---|---|---|---|
|
Percentage of Participants With Amyloid-Related Imaging Abnormalities-Hemorrhage (ARIA-H)
Superficial Siderosis
|
2.1 percentage of participants
|
0 percentage of participants
|
3.0 percentage of participants
|
0.7 percentage of participants
|
|
Percentage of Participants With Amyloid-Related Imaging Abnormalities-Hemorrhage (ARIA-H)
New Micro-hemorrhage
|
6.4 percentage of participants
|
9.5 percentage of participants
|
4.0 percentage of participants
|
6.0 percentage of participants
|
Adverse Events
PCP PL - OLE CREN SC - OLE CREN IV
Serious events: 9 serious events
Other events: 37 other events
Deaths: 2 deaths
PCP PL - OLE CREN IV
Serious events: 14 serious events
Other events: 51 other events
Deaths: 3 deaths
PCP CREN SC - OLE CREN SC - OLE CREN IV
Serious events: 22 serious events
Other events: 80 other events
Deaths: 3 deaths
PCP CREN IV - OLE CREN IV
Serious events: 35 serious events
Other events: 97 other events
Deaths: 7 deaths
Serious adverse events
| Measure |
PCP PL - OLE CREN SC - OLE CREN IV
n=47 participants at risk
Participants who on their placebo-controlled portion \[PCP\]/parent study received placebo (PL) and who on this open-label extension (OLE) study initially received crenezumab (CREN) subcutaneously (SC) and after the protocol amendment received CREN intravenously (IV).
|
PCP PL - OLE CREN IV
n=63 participants at risk
Participants who on their PCP/parent study received placebo and who on this OLE study received CREN IV.
|
PCP CREN SC - OLE CREN SC - OLE CREN IV
n=101 participants at risk
Participants who on their PCP/parent study received CREN and who on this OLE study initially received CREN SC and after the protocol amendment received CREN IV.
|
PCP CREN IV - OLE CREN IV
n=149 participants at risk
Participants who on their PCP/parent study received CREN IV and who on this OLE study received CREN IV.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
0.00%
0/47 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.00%
0/63 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.99%
1/101 • Number of events 1 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.00%
0/149 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
0.00%
0/47 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.00%
0/63 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.00%
0/101 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.67%
1/149 • Number of events 1 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
|
Cardiac disorders
ACUTE MYOCARDIAL INFARCTION
|
0.00%
0/47 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.00%
0/63 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.00%
0/101 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.67%
1/149 • Number of events 1 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
|
Cardiac disorders
ATRIAL FIBRILLATION
|
0.00%
0/47 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.00%
0/63 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.99%
1/101 • Number of events 1 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.67%
1/149 • Number of events 1 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
|
Cardiac disorders
ATRIAL FLUTTER
|
2.1%
1/47 • Number of events 1 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.00%
0/63 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.00%
0/101 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.00%
0/149 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
|
Cardiac disorders
CARDIO-RESPIRATORY ARREST
|
0.00%
0/47 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.00%
0/63 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.00%
0/101 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.67%
1/149 • Number of events 1 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
|
Cardiac disorders
MYOCARDIAL INFARCTION
|
0.00%
0/47 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.00%
0/63 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.99%
1/101 • Number of events 1 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
1.3%
2/149 • Number of events 2 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
|
Cardiac disorders
SINUS TACHYCARDIA
|
0.00%
0/47 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.00%
0/63 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.99%
1/101 • Number of events 1 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.00%
0/149 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
|
Ear and labyrinth disorders
VERTIGO
|
0.00%
0/47 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
1.6%
1/63 • Number of events 1 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.00%
0/101 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.00%
0/149 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
0.00%
0/47 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.00%
0/63 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.99%
1/101 • Number of events 1 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.67%
1/149 • Number of events 1 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
INGUINAL HERNIA
|
0.00%
0/47 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.00%
0/63 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.00%
0/101 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.67%
1/149 • Number of events 1 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
INTESTINAL OBSTRUCTION
|
0.00%
0/47 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.00%
0/63 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.00%
0/101 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.67%
1/149 • Number of events 1 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
NAUSEA
|
0.00%
0/47 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.00%
0/63 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.99%
1/101 • Number of events 1 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.00%
0/149 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
SMALL INTESTINAL OBSTRUCTION
|
0.00%
0/47 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.00%
0/63 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.99%
1/101 • Number of events 1 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.00%
0/149 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
VOMITING
|
0.00%
0/47 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.00%
0/63 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.99%
1/101 • Number of events 1 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.00%
0/149 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
|
General disorders
ASTHENIA
|
0.00%
0/47 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.00%
0/63 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.99%
1/101 • Number of events 1 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.00%
0/149 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
|
General disorders
CHEST PAIN
|
0.00%
0/47 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.00%
0/63 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.99%
1/101 • Number of events 1 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
1.3%
2/149 • Number of events 2 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
|
General disorders
DEATH
|
0.00%
0/47 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.00%
0/63 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.00%
0/101 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.67%
1/149 • Number of events 1 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
|
General disorders
GAIT DISTURBANCE
|
0.00%
0/47 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.00%
0/63 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.99%
1/101 • Number of events 1 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.67%
1/149 • Number of events 1 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
|
General disorders
INCARCERATED HERNIA
|
0.00%
0/47 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.00%
0/63 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.99%
1/101 • Number of events 1 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.00%
0/149 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
|
Hepatobiliary disorders
BILIARY COLIC
|
2.1%
1/47 • Number of events 1 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.00%
0/63 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.00%
0/101 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.00%
0/149 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
|
Hepatobiliary disorders
CHOLELITHIASIS
|
0.00%
0/47 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.00%
0/63 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.00%
0/101 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.67%
1/149 • Number of events 1 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
|
Infections and infestations
BACTERAEMIA
|
2.1%
1/47 • Number of events 1 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.00%
0/63 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.00%
0/101 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.00%
0/149 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
|
Infections and infestations
DIVERTICULITIS
|
0.00%
0/47 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.00%
0/63 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.00%
0/101 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.67%
1/149 • Number of events 1 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
|
Infections and infestations
ESCHERICHIA URINARY TRACT INFECTION
|
0.00%
0/47 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.00%
0/63 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
2.0%
2/101 • Number of events 2 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.00%
0/149 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
|
Infections and infestations
GASTROENTERITIS
|
0.00%
0/47 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.00%
0/63 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.00%
0/101 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.67%
1/149 • Number of events 1 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
|
Infections and infestations
INFLUENZA
|
0.00%
0/47 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.00%
0/63 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.00%
0/101 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.67%
1/149 • Number of events 1 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
|
Infections and infestations
OSTEOMYELITIS
|
0.00%
0/47 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.00%
0/63 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.00%
0/101 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.67%
1/149 • Number of events 1 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
|
Infections and infestations
PNEUMONIA
|
0.00%
0/47 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
1.6%
1/63 • Number of events 1 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.99%
1/101 • Number of events 1 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
2.0%
3/149 • Number of events 5 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
|
Infections and infestations
PNEUMONIA BACTERIAL
|
0.00%
0/47 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.00%
0/63 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.00%
0/101 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.67%
1/149 • Number of events 1 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
|
Infections and infestations
PNEUMONIA ESCHERICHIA
|
0.00%
0/47 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.00%
0/63 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.99%
1/101 • Number of events 1 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.00%
0/149 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
|
Infections and infestations
PNEUMONIA VIRAL
|
0.00%
0/47 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.00%
0/63 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.99%
1/101 • Number of events 1 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.00%
0/149 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
|
Infections and infestations
POST PROCEDURAL INFECTION
|
0.00%
0/47 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.00%
0/63 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.99%
1/101 • Number of events 1 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.00%
0/149 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
|
Infections and infestations
SEPSIS
|
0.00%
0/47 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.00%
0/63 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.00%
0/101 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.67%
1/149 • Number of events 1 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
|
Infections and infestations
SEPTIC SHOCK
|
0.00%
0/47 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.00%
0/63 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.00%
0/101 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.67%
1/149 • Number of events 1 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
0.00%
0/47 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.00%
0/63 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.99%
1/101 • Number of events 1 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.00%
0/149 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
|
Infections and infestations
URINARY TRACT INFECTION
|
0.00%
0/47 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.00%
0/63 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
2.0%
2/101 • Number of events 2 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.67%
1/149 • Number of events 1 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
|
Infections and infestations
UROSEPSIS
|
0.00%
0/47 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
1.6%
1/63 • Number of events 1 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.00%
0/101 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.00%
0/149 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
ANKLE FRACTURE
|
0.00%
0/47 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.00%
0/63 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.00%
0/101 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.67%
1/149 • Number of events 1 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
CERVICAL VERTEBRAL FRACTURE
|
0.00%
0/47 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.00%
0/63 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.00%
0/101 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.67%
1/149 • Number of events 1 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
FACIAL BONES FRACTURE
|
0.00%
0/47 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.00%
0/63 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.00%
0/101 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.67%
1/149 • Number of events 1 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
FALL
|
0.00%
0/47 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
1.6%
1/63 • Number of events 1 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.00%
0/101 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.67%
1/149 • Number of events 1 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
FEMORAL NECK FRACTURE
|
0.00%
0/47 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
1.6%
1/63 • Number of events 1 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.00%
0/101 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.00%
0/149 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
FEMUR FRACTURE
|
0.00%
0/47 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
1.6%
1/63 • Number of events 1 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.00%
0/101 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.00%
0/149 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
FRACTURE DISPLACEMENT
|
0.00%
0/47 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.00%
0/63 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.00%
0/101 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.67%
1/149 • Number of events 1 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
FRACTURED SACRUM
|
0.00%
0/47 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.00%
0/63 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.00%
0/101 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.67%
1/149 • Number of events 1 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
HIP FRACTURE
|
2.1%
1/47 • Number of events 1 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
1.6%
1/63 • Number of events 1 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.99%
1/101 • Number of events 1 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.67%
1/149 • Number of events 1 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
HUMERUS FRACTURE
|
0.00%
0/47 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.00%
0/63 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.99%
1/101 • Number of events 1 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.67%
1/149 • Number of events 1 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
LACERATION
|
0.00%
0/47 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.00%
0/63 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.99%
1/101 • Number of events 1 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.00%
0/149 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
LIMB INJURY
|
0.00%
0/47 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.00%
0/63 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.00%
0/101 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.67%
1/149 • Number of events 1 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
PELVIC FRACTURE
|
0.00%
0/47 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.00%
0/63 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.00%
0/101 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.67%
1/149 • Number of events 1 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
SUBARACHNOID HAEMORRHAGE
|
0.00%
0/47 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
1.6%
1/63 • Number of events 1 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.99%
1/101 • Number of events 1 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.00%
0/149 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
SUBDURAL HAEMATOMA
|
4.3%
2/47 • Number of events 2 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.00%
0/63 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.00%
0/101 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.00%
0/149 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
THORACIC VERTEBRAL FRACTURE
|
0.00%
0/47 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
1.6%
1/63 • Number of events 1 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.00%
0/101 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.00%
0/149 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
WRIST FRACTURE
|
0.00%
0/47 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.00%
0/63 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.00%
0/101 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.67%
1/149 • Number of events 1 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
ADULT FAILURE TO THRIVE
|
0.00%
0/47 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.00%
0/63 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.00%
0/101 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.67%
1/149 • Number of events 1 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
0.00%
0/47 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.00%
0/63 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.00%
0/101 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
2.0%
3/149 • Number of events 3 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
0.00%
0/47 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
1.6%
1/63 • Number of events 1 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.00%
0/101 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.00%
0/149 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
OSTEOARTHRITIS
|
0.00%
0/47 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.00%
0/63 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.00%
0/101 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.67%
1/149 • Number of events 1 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BASAL CELL CARCINOMA
|
0.00%
0/47 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
1.6%
1/63 • Number of events 1 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.00%
0/101 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.00%
0/149 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
COLON CANCER
|
0.00%
0/47 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.00%
0/63 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.00%
0/101 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.67%
1/149 • Number of events 1 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
INTESTINAL ADENOCARCINOMA
|
0.00%
0/47 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.00%
0/63 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.99%
1/101 • Number of events 1 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.00%
0/149 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
METASTATIC NEOPLASM
|
0.00%
0/47 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
1.6%
1/63 • Number of events 1 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.00%
0/101 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.00%
0/149 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
PROSTATE CANCER
|
0.00%
0/47 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
1.6%
1/63 • Number of events 1 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.00%
0/101 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.00%
0/149 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
|
Nervous system disorders
BASILAR ARTERY STENOSIS
|
0.00%
0/47 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.00%
0/63 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.00%
0/101 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.67%
1/149 • Number of events 1 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
|
Nervous system disorders
CEREBROVASCULAR ACCIDENT
|
0.00%
0/47 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.00%
0/63 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.99%
1/101 • Number of events 1 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.00%
0/149 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
|
Nervous system disorders
DEMENTIA
|
0.00%
0/47 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
3.2%
2/63 • Number of events 2 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.99%
1/101 • Number of events 1 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.00%
0/149 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
|
Nervous system disorders
DEMENTIA ALZHEIMER'S TYPE
|
4.3%
2/47 • Number of events 2 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
3.2%
2/63 • Number of events 2 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.00%
0/101 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.67%
1/149 • Number of events 1 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
|
Nervous system disorders
DEMENTIA WITH LEWY BODIES
|
0.00%
0/47 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.00%
0/63 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.00%
0/101 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.67%
1/149 • Number of events 1 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
|
Nervous system disorders
DEPRESSED LEVEL OF CONSCIOUSNESS
|
0.00%
0/47 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.00%
0/63 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.00%
0/101 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.67%
1/149 • Number of events 1 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
|
Nervous system disorders
DIZZINESS
|
0.00%
0/47 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.00%
0/63 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.00%
0/101 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.67%
1/149 • Number of events 1 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
|
Nervous system disorders
ENCEPHALOPATHY
|
0.00%
0/47 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.00%
0/63 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.00%
0/101 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.67%
1/149 • Number of events 1 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
|
Nervous system disorders
EPILEPSY
|
0.00%
0/47 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.00%
0/63 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.00%
0/101 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.67%
1/149 • Number of events 1 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
|
Nervous system disorders
GENERALISED TONIC-CLONIC SEIZURE
|
0.00%
0/47 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.00%
0/63 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.00%
0/101 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.67%
1/149 • Number of events 1 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
|
Nervous system disorders
HYDROCEPHALUS
|
0.00%
0/47 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
1.6%
1/63 • Number of events 1 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.00%
0/101 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.00%
0/149 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
|
Nervous system disorders
ISCHAEMIC STROKE
|
0.00%
0/47 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.00%
0/63 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.00%
0/101 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.67%
1/149 • Number of events 1 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
|
Nervous system disorders
METABOLIC ENCEPHALOPATHY
|
0.00%
0/47 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.00%
0/63 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.00%
0/101 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.67%
1/149 • Number of events 1 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
|
Nervous system disorders
PARAESTHESIA
|
0.00%
0/47 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.00%
0/63 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.00%
0/101 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.67%
1/149 • Number of events 1 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
|
Nervous system disorders
PRESYNCOPE
|
0.00%
0/47 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.00%
0/63 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
2.0%
2/101 • Number of events 2 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.00%
0/149 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
|
Nervous system disorders
SEIZURE
|
0.00%
0/47 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
1.6%
1/63 • Number of events 1 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.00%
0/101 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
1.3%
2/149 • Number of events 3 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
|
Nervous system disorders
SYNCOPE
|
0.00%
0/47 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
3.2%
2/63 • Number of events 2 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
3.0%
3/101 • Number of events 3 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.00%
0/149 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
|
Nervous system disorders
TRANSIENT ISCHAEMIC ATTACK
|
2.1%
1/47 • Number of events 1 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.00%
0/63 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.00%
0/101 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.67%
1/149 • Number of events 1 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
|
Product Issues
DEVICE DISLOCATION
|
2.1%
1/47 • Number of events 1 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.00%
0/63 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.00%
0/101 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.00%
0/149 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
|
Product Issues
DEVICE FAILURE
|
0.00%
0/47 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
1.6%
1/63 • Number of events 1 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.00%
0/101 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.00%
0/149 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
|
Psychiatric disorders
ABNORMAL BEHAVIOUR
|
0.00%
0/47 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
1.6%
1/63 • Number of events 1 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.00%
0/101 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.00%
0/149 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
|
Psychiatric disorders
AGGRESSION
|
2.1%
1/47 • Number of events 1 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.00%
0/63 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.00%
0/101 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.67%
1/149 • Number of events 1 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
|
Psychiatric disorders
AGITATION
|
2.1%
1/47 • Number of events 2 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
1.6%
1/63 • Number of events 1 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.99%
1/101 • Number of events 1 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.00%
0/149 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
|
Psychiatric disorders
DELIRIUM
|
0.00%
0/47 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
1.6%
1/63 • Number of events 2 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.99%
1/101 • Number of events 1 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.67%
1/149 • Number of events 1 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
|
Psychiatric disorders
DISORIENTATION
|
0.00%
0/47 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.00%
0/63 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.99%
1/101 • Number of events 1 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.00%
0/149 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
|
Psychiatric disorders
MENTAL STATUS CHANGES
|
0.00%
0/47 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.00%
0/63 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
2.0%
2/101 • Number of events 2 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.00%
0/149 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
|
Psychiatric disorders
PSYCHOTIC DISORDER
|
0.00%
0/47 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.00%
0/63 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.00%
0/101 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.67%
1/149 • Number of events 1 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
ACUTE PRERENAL FAILURE
|
0.00%
0/47 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.00%
0/63 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.00%
0/101 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.67%
1/149 • Number of events 1 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
URINARY RETENTION
|
0.00%
0/47 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.00%
0/63 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.00%
0/101 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.67%
1/149 • Number of events 1 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
ACUTE RESPIRATORY FAILURE
|
0.00%
0/47 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.00%
0/63 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.99%
1/101 • Number of events 1 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.67%
1/149 • Number of events 1 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY GRANULOMA
|
0.00%
0/47 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.00%
0/63 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.00%
0/101 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.67%
1/149 • Number of events 1 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
TACHYPNOEA
|
0.00%
0/47 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.00%
0/63 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.00%
0/101 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.67%
1/149 • Number of events 1 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
|
Vascular disorders
AORTIC ANEURYSM
|
0.00%
0/47 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.00%
0/63 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.00%
0/101 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.67%
1/149 • Number of events 1 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
|
Vascular disorders
DEEP VEIN THROMBOSIS
|
0.00%
0/47 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.00%
0/63 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.99%
1/101 • Number of events 1 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
1.3%
2/149 • Number of events 2 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
|
Vascular disorders
EXSANGUINATION
|
0.00%
0/47 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.00%
0/63 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.00%
0/101 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.67%
1/149 • Number of events 1 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
|
Vascular disorders
HYPERTENSION
|
0.00%
0/47 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
1.6%
1/63 • Number of events 1 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.00%
0/101 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.00%
0/149 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
|
Vascular disorders
HYPOTENSION
|
0.00%
0/47 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.00%
0/63 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
2.0%
2/101 • Number of events 2 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.00%
0/149 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
|
Vascular disorders
PHLEBITIS
|
0.00%
0/47 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.00%
0/63 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.00%
0/101 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.67%
1/149 • Number of events 1 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
Other adverse events
| Measure |
PCP PL - OLE CREN SC - OLE CREN IV
n=47 participants at risk
Participants who on their placebo-controlled portion \[PCP\]/parent study received placebo (PL) and who on this open-label extension (OLE) study initially received crenezumab (CREN) subcutaneously (SC) and after the protocol amendment received CREN intravenously (IV).
|
PCP PL - OLE CREN IV
n=63 participants at risk
Participants who on their PCP/parent study received placebo and who on this OLE study received CREN IV.
|
PCP CREN SC - OLE CREN SC - OLE CREN IV
n=101 participants at risk
Participants who on their PCP/parent study received CREN and who on this OLE study initially received CREN SC and after the protocol amendment received CREN IV.
|
PCP CREN IV - OLE CREN IV
n=149 participants at risk
Participants who on their PCP/parent study received CREN IV and who on this OLE study received CREN IV.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
CONSTIPATION
|
0.00%
0/47 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
6.3%
4/63 • Number of events 4 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
3.0%
3/101 • Number of events 3 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
3.4%
5/149 • Number of events 5 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
DIARRHOEA
|
12.8%
6/47 • Number of events 7 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
4.8%
3/63 • Number of events 3 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
10.9%
11/101 • Number of events 12 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
9.4%
14/149 • Number of events 23 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
VOMITING
|
0.00%
0/47 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
4.8%
3/63 • Number of events 5 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
5.0%
5/101 • Number of events 6 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
5.4%
8/149 • Number of events 11 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
|
General disorders
FATIGUE
|
4.3%
2/47 • Number of events 2 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.00%
0/63 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
7.9%
8/101 • Number of events 8 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
2.7%
4/149 • Number of events 4 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
|
General disorders
INJECTION SITE ERYTHEMA
|
4.3%
2/47 • Number of events 13 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
1.6%
1/63 • Number of events 1 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
7.9%
8/101 • Number of events 10 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
1.3%
2/149 • Number of events 2 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
|
General disorders
INJECTION SITE EXTRAVASATION
|
6.4%
3/47 • Number of events 5 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
1.6%
1/63 • Number of events 1 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
3.0%
3/101 • Number of events 7 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
2.7%
4/149 • Number of events 16 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
|
Infections and infestations
BRONCHITIS
|
4.3%
2/47 • Number of events 2 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
3.2%
2/63 • Number of events 2 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
4.0%
4/101 • Number of events 5 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
6.0%
9/149 • Number of events 9 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
12.8%
6/47 • Number of events 7 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
7.9%
5/63 • Number of events 5 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
14.9%
15/101 • Number of events 20 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
8.7%
13/149 • Number of events 15 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
|
Infections and infestations
URINARY TRACT INFECTION
|
14.9%
7/47 • Number of events 8 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
14.3%
9/63 • Number of events 13 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
15.8%
16/101 • Number of events 23 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
12.1%
18/149 • Number of events 34 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
|
Infections and infestations
VIRAL UPPER RESPIRATORY TRACT INFECTION
|
10.6%
5/47 • Number of events 7 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
17.5%
11/63 • Number of events 14 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
9.9%
10/101 • Number of events 11 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
8.7%
13/149 • Number of events 13 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
CONTUSION
|
4.3%
2/47 • Number of events 6 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
3.2%
2/63 • Number of events 2 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
5.9%
6/101 • Number of events 8 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
5.4%
8/149 • Number of events 10 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
FALL
|
14.9%
7/47 • Number of events 10 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
12.7%
8/63 • Number of events 11 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
25.7%
26/101 • Number of events 42 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
12.1%
18/149 • Number of events 28 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
LACERATION
|
6.4%
3/47 • Number of events 3 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
3.2%
2/63 • Number of events 3 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
9.9%
10/101 • Number of events 11 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
4.7%
7/149 • Number of events 7 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
SKIN ABRASION
|
0.00%
0/47 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
6.3%
4/63 • Number of events 4 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
5.0%
5/101 • Number of events 5 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
2.0%
3/149 • Number of events 5 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
|
Investigations
WEIGHT DECREASED
|
8.5%
4/47 • Number of events 4 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
3.2%
2/63 • Number of events 2 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
7.9%
8/101 • Number of events 11 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
4.7%
7/149 • Number of events 7 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
4.3%
2/47 • Number of events 4 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
7.9%
5/63 • Number of events 6 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
7.9%
8/101 • Number of events 10 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
5.4%
8/149 • Number of events 10 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
6.4%
3/47 • Number of events 3 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
6.3%
4/63 • Number of events 5 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
6.9%
7/101 • Number of events 7 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
5.4%
8/149 • Number of events 8 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
MUSCLE SPASMS
|
6.4%
3/47 • Number of events 3 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.00%
0/63 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
4.0%
4/101 • Number of events 6 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.67%
1/149 • Number of events 2 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
TENDONITIS
|
6.4%
3/47 • Number of events 3 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
3.2%
2/63 • Number of events 2 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.99%
1/101 • Number of events 1 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.00%
0/149 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
SQUAMOUS CELL CARCINOMA
|
6.4%
3/47 • Number of events 8 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
1.6%
1/63 • Number of events 1 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
2.0%
2/101 • Number of events 2 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.00%
0/149 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
|
Nervous system disorders
CEREBRAL MICROHAEMORRHAGE
|
6.4%
3/47 • Number of events 3 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
6.3%
4/63 • Number of events 5 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
3.0%
3/101 • Number of events 3 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
4.0%
6/149 • Number of events 7 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
|
Nervous system disorders
DIZZINESS
|
4.3%
2/47 • Number of events 2 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
7.9%
5/63 • Number of events 5 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
10.9%
11/101 • Number of events 14 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
6.7%
10/149 • Number of events 11 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
|
Nervous system disorders
HEADACHE
|
2.1%
1/47 • Number of events 1 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
3.2%
2/63 • Number of events 2 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
7.9%
8/101 • Number of events 10 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
2.0%
3/149 • Number of events 4 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
|
Psychiatric disorders
AGITATION
|
19.1%
9/47 • Number of events 9 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
6.3%
4/63 • Number of events 4 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
12.9%
13/101 • Number of events 20 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
8.7%
13/149 • Number of events 14 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
|
Psychiatric disorders
ANXIETY
|
2.1%
1/47 • Number of events 1 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
6.3%
4/63 • Number of events 4 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
7.9%
8/101 • Number of events 9 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
10.1%
15/149 • Number of events 16 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
|
Psychiatric disorders
CONFUSIONAL STATE
|
6.4%
3/47 • Number of events 3 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
1.6%
1/63 • Number of events 1 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
3.0%
3/101 • Number of events 4 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
2.0%
3/149 • Number of events 4 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
|
Psychiatric disorders
DELUSION
|
6.4%
3/47 • Number of events 3 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
1.6%
1/63 • Number of events 1 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
6.9%
7/101 • Number of events 7 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
2.7%
4/149 • Number of events 6 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
|
Psychiatric disorders
DEPRESSION
|
6.4%
3/47 • Number of events 3 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
12.7%
8/63 • Number of events 9 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
5.0%
5/101 • Number of events 5 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
4.7%
7/149 • Number of events 7 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
|
Psychiatric disorders
INSOMNIA
|
6.4%
3/47 • Number of events 6 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
1.6%
1/63 • Number of events 1 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
7.9%
8/101 • Number of events 10 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
5.4%
8/149 • Number of events 9 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
URINARY INCONTINENCE
|
8.5%
4/47 • Number of events 4 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
0.00%
0/63 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
5.0%
5/101 • Number of events 6 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
5.4%
8/149 • Number of events 8 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
10.6%
5/47 • Number of events 11 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
4.8%
3/63 • Number of events 3 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
7.9%
8/101 • Number of events 9 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
7.4%
11/149 • Number of events 13 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
RASH
|
4.3%
2/47 • Number of events 7 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
7.9%
5/63 • Number of events 5 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
2.0%
2/101 • Number of events 2 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
4.0%
6/149 • Number of events 7 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
|
Vascular disorders
HAEMATOMA
|
6.4%
3/47 • Number of events 3 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
3.2%
2/63 • Number of events 2 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
2.0%
2/101 • Number of events 2 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
2.0%
3/149 • Number of events 3 • Up to 50 months
Safety Analysis population included all participants who received at least one dose of study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER