We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Long-Term Safety Extension of Studies ABE4869g and ABE4955g in Participants With Mild to Moderate Alzheimer's Disease Treated With Crenezumab

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01723826
Recruitment Status : Completed
First Posted : November 8, 2012
Results First Posted : February 12, 2020
Last Update Posted : February 20, 2020
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Alzheimer's Disease
Intervention Drug: Crenezumab
Enrollment 360
Recruitment Details A total of 360 participants were enrolled at 83 sites across 6 countries.
Pre-assignment Details 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.
Arm/Group Title PCP PL - OLE CREN SC - OLE CREN IV PCP PL - OLE CREN IV PCP CREN SC - OLE CREN SC - OLE CREN IV PCP CREN IV - OLE CREN IV
Hide Arm/Group Description 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). Participants who on their PCP/parent study received placebo and who on this OLE study received 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. Participants who on their PCP/parent study received CREN IV and who on this OLE study received CREN IV.
Period Title: Overall Study
Started 47 63 101 149
Completed 20 27 44 59
Not Completed 27 36 57 90
Reason Not Completed
Adverse Event             4             1             4             5
Death according to AE eCRF             2             3             3             7
Lost to Follow-up             1             3             1             1
Non-compliance             0             1             3             3
Non-compliance With Study Drug             0             1             0             0
Other Reason             8             6             12             14
Physician Decision             1             3             4             11
Protocol Violation             1             1             3             1
Withdrawal by Subject             10             17             27             48
Arm/Group Title PCP PL - OLE CREN SC - OLE CREN IV PCP PL - OLE CREN IV PCP CREN SC - OLE CREN SC - OLE CREN IV PCP CREN IV - OLE CREN IV Total
Hide Arm/Group Description 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). Participants who on their PCP/parent study received placebo and who on this OLE study received 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. Participants who on their PCP/parent study received CREN IV and who on this OLE study received CREN IV. Total of all reporting groups
Overall Number of Baseline Participants 47 63 101 149 360
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 47 participants 63 participants 101 participants 149 participants 360 participants
70.9  (7.4) 71.9  (7.4) 72.3  (7.2) 72.2  (6.7) 72.0  (7.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 47 participants 63 participants 101 participants 149 participants 360 participants
Female
26
  55.3%
36
  57.1%
58
  57.4%
79
  53.0%
199
  55.3%
Male
21
  44.7%
27
  42.9%
43
  42.6%
70
  47.0%
161
  44.7%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 47 participants 63 participants 101 participants 149 participants 360 participants
Hispanic or Latino
2
   4.3%
2
   3.2%
2
   2.0%
4
   2.7%
10
   2.8%
Not Hispanic or Latino
45
  95.7%
61
  96.8%
98
  97.0%
145
  97.3%
349
  96.9%
Not Stated
0
   0.0%
0
   0.0%
1
   1.0%
0
   0.0%
1
   0.3%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 47 participants 63 participants 101 participants 149 participants 360 participants
Asian
0
   0.0%
0
   0.0%
0
   0.0%
4
   2.7%
4
   1.1%
Black or African American
0
   0.0%
0
   0.0%
4
   4.0%
1
   0.7%
5
   1.4%
White
47
 100.0%
63
 100.0%
97
  96.0%
144
  96.6%
351
  97.5%
1.Primary Outcome
Title Percentage of Participants With Adverse Events (AEs)
Hide Description 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.
Time Frame Up to 50 months
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis population included all participants who received at least one dose of study drug.
Arm/Group Title PCP PL - OLE CREN SC - OLE CREN IV PCP PL - OLE CREN IV PCP CREN - OLE CREN SC -OLE CREN IV PCP CREN - OLE CREN IV
Hide Arm/Group Description:
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).
Participants who on their PCP/parent study received placebo and who on this OLE study received 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.
Participants who on their PCP/parent study received CREN IV and who on this OLE study received CREN IV.
Overall Number of Participants Analyzed 47 63 101 149
Measure Type: Number
Unit of Measure: percentage of participants
89.4 90.5 96.0 87.9
2.Primary Outcome
Title Percentage of Participants by Nature of AEs
Hide Description 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.
Time Frame Up to 50 months
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis population included all participants who received at least one dose of study drug.
Arm/Group Title PCP PL - OLE CREN SC - OLE CREN IV PCP PL - OLE CREN IV PCP CREN - OLE CREN SC -OLE CREN IV PCP CREN - OLE CREN IV
Hide Arm/Group Description:
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).
Participants who on their PCP/parent study received placebo and who on this OLE study received 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.
Participants who on their PCP/parent study received CREN IV and who on this OLE study received CREN IV.
Overall Number of Participants Analyzed 47 63 101 149
Measure Type: Number
Unit of Measure: percentage of participants
SAE 19.1 22.2 21.8 23.5
Non-SAE 87.2 88.9 94.1 87.2
3.Primary Outcome
Title Percentage of Participants by Severity of AEs
Hide Description 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.
Time Frame Up to 50 months
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis population included all participants who received at least one dose of study drug.
Arm/Group Title PCP PL - OLE CREN SC - OLE CREN IV PCP PL - OLE CREN IV PCP CREN - OLE CREN SC -OLE CREN IV PCP CREN - OLE CREN IV
Hide Arm/Group Description:
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).
Participants who on their PCP/parent study received placebo and who on this OLE study received 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.
Participants who on their PCP/parent study received CREN IV and who on this OLE study received CREN IV.
Overall Number of Participants Analyzed 47 63 101 149
Measure Type: Number
Unit of Measure: percentage of participants
Grade 1 19.1 34.9 29.7 22.1
Grade 2 44.7 31.7 43.6 40.3
Grade 3 12.8 17.5 16.8 19.5
Grade 4 8.5 1.6 3.0 1.3
Grade 5 4.3 4.8 3.0 4.7
4.Primary Outcome
Title Percentage of Participants With Human Anti-Therapeutic Antibody (ATA) Formation
Hide Description 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.
Time Frame Pre-dose (Day-14), predose at Week 25, 49, 97, Follow-up Week 8 (Week 153) and 12 (Week 157)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis population included all participants who received at least one dose of study drug.
Arm/Group Title PCP PL - OLE CREN SC - OLE CREN IV PCP PL - OLE CREN IV PCP CREN - OLE CREN SC -OLE CREN IV PCP CREN - OLE CREN IV
Hide Arm/Group Description:
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).
Participants who on their PCP/parent study received placebo and who on this OLE study received 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.
Participants who on their PCP/parent study received CREN IV and who on this OLE study received CREN IV.
Overall Number of Participants Analyzed 47 63 101 149
Measure Type: Number
Unit of Measure: percentage of participants
9.1 3.4 9.1 0.7
5.Primary Outcome
Title Percentage of Participants With Amyloid-Related Imaging Abnormalities Edema/Effusions (ARIA-E)
Hide Description 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.
Time Frame Baseline, Weeks 23, 47, 71, 97, 121 and 153
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis population included all participants who received at least one dose of study drug.
Arm/Group Title PCP PL - OLE CREN SC - OLE CREN IV PCP PL - OLE CREN IV PCP CREN - OLE CREN SC -OLE CREN IV PCP CREN - OLE CREN IV
Hide Arm/Group Description:
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).
Participants who on their PCP/parent study received placebo and who on this OLE study received 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.
Participants who on their PCP/parent study received CREN IV and who on this OLE study received CREN IV.
Overall Number of Participants Analyzed 47 63 101 149
Measure Type: Number
Unit of Measure: percentage of participants
Symptomatic 0 0 0 0
Asymptomatic 0 0 0 0.7
6.Primary Outcome
Title Percentage of Participants With Amyloid-Related Imaging Abnormalities-Hemorrhage (ARIA-H)
Hide Description 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.
Time Frame Baseline, Weeks 23, 47, 71, 97, 121 and 153
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis population included all participants who received at least one dose of study drug.
Arm/Group Title PCP PL - OLE CREN SC - OLE CREN IV PCP PL - OLE CREN IV PCP CREN - OLE CREN SC -OLE CREN IV PCP CREN - OLE CREN IV
Hide Arm/Group Description:
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).
Participants who on their PCP/parent study received placebo and who on this OLE study received 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.
Participants who on their PCP/parent study received CREN IV and who on this OLE study received CREN IV.
Overall Number of Participants Analyzed 47 63 101 149
Measure Type: Number
Unit of Measure: percentage of participants
Superficial Siderosis 2.1 0 3.0 0.7
New Micro-hemorrhage 6.4 9.5 4.0 6.0
Time Frame Up to 50 months
Adverse Event Reporting Description Safety Analysis population included all participants who received at least one dose of study drug.
 
Arm/Group Title PCP PL - OLE CREN SC - OLE CREN IV PCP PL - OLE CREN IV PCP CREN SC - OLE CREN SC - OLE CREN IV PCP CREN IV - OLE CREN IV
Hide Arm/Group Description 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). Participants who on their PCP/parent study received placebo and who on this OLE study received 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. Participants who on their PCP/parent study received CREN IV and who on this OLE study received CREN IV.
All-Cause Mortality
PCP PL - OLE CREN SC - OLE CREN IV PCP PL - OLE CREN IV PCP CREN SC - OLE CREN SC - OLE CREN IV PCP CREN IV - OLE CREN IV
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   2/47 (4.26%)      3/63 (4.76%)      3/101 (2.97%)      7/149 (4.70%)    
Hide Serious Adverse Events
PCP PL - OLE CREN SC - OLE CREN IV PCP PL - OLE CREN IV PCP CREN SC - OLE CREN SC - OLE CREN IV PCP CREN IV - OLE CREN IV
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   9/47 (19.15%)      14/63 (22.22%)      22/101 (21.78%)      35/149 (23.49%)    
Blood and lymphatic system disorders         
ANAEMIA  1  0/47 (0.00%)  0 0/63 (0.00%)  0 1/101 (0.99%)  1 0/149 (0.00%)  0
NEUTROPENIA  1  0/47 (0.00%)  0 0/63 (0.00%)  0 0/101 (0.00%)  0 1/149 (0.67%)  1
Cardiac disorders         
ACUTE MYOCARDIAL INFARCTION  1  0/47 (0.00%)  0 0/63 (0.00%)  0 0/101 (0.00%)  0 1/149 (0.67%)  1
ATRIAL FIBRILLATION  1  0/47 (0.00%)  0 0/63 (0.00%)  0 1/101 (0.99%)  1 1/149 (0.67%)  1
ATRIAL FLUTTER  1  1/47 (2.13%)  1 0/63 (0.00%)  0 0/101 (0.00%)  0 0/149 (0.00%)  0
CARDIO-RESPIRATORY ARREST  1  0/47 (0.00%)  0 0/63 (0.00%)  0 0/101 (0.00%)  0 1/149 (0.67%)  1
MYOCARDIAL INFARCTION  1  0/47 (0.00%)  0 0/63 (0.00%)  0 1/101 (0.99%)  1 2/149 (1.34%)  2
SINUS TACHYCARDIA  1  0/47 (0.00%)  0 0/63 (0.00%)  0 1/101 (0.99%)  1 0/149 (0.00%)  0
Ear and labyrinth disorders         
VERTIGO  1  0/47 (0.00%)  0 1/63 (1.59%)  1 0/101 (0.00%)  0 0/149 (0.00%)  0
Gastrointestinal disorders         
ABDOMINAL PAIN  1  0/47 (0.00%)  0 0/63 (0.00%)  0 1/101 (0.99%)  1 1/149 (0.67%)  1
INGUINAL HERNIA  1  0/47 (0.00%)  0 0/63 (0.00%)  0 0/101 (0.00%)  0 1/149 (0.67%)  1
INTESTINAL OBSTRUCTION  1  0/47 (0.00%)  0 0/63 (0.00%)  0 0/101 (0.00%)  0 1/149 (0.67%)  1
NAUSEA  1  0/47 (0.00%)  0 0/63 (0.00%)  0 1/101 (0.99%)  1 0/149 (0.00%)  0
SMALL INTESTINAL OBSTRUCTION  1  0/47 (0.00%)  0 0/63 (0.00%)  0 1/101 (0.99%)  1 0/149 (0.00%)  0
VOMITING  1  0/47 (0.00%)  0 0/63 (0.00%)  0 1/101 (0.99%)  1 0/149 (0.00%)  0
General disorders         
ASTHENIA  1  0/47 (0.00%)  0 0/63 (0.00%)  0 1/101 (0.99%)  1 0/149 (0.00%)  0
CHEST PAIN  1  0/47 (0.00%)  0 0/63 (0.00%)  0 1/101 (0.99%)  1 2/149 (1.34%)  2
DEATH  1  0/47 (0.00%)  0 0/63 (0.00%)  0 0/101 (0.00%)  0 1/149 (0.67%)  1
GAIT DISTURBANCE  1  0/47 (0.00%)  0 0/63 (0.00%)  0 1/101 (0.99%)  1 1/149 (0.67%)  1
INCARCERATED HERNIA  1  0/47 (0.00%)  0 0/63 (0.00%)  0 1/101 (0.99%)  1 0/149 (0.00%)  0
Hepatobiliary disorders         
BILIARY COLIC  1  1/47 (2.13%)  1 0/63 (0.00%)  0 0/101 (0.00%)  0 0/149 (0.00%)  0
CHOLELITHIASIS  1  0/47 (0.00%)  0 0/63 (0.00%)  0 0/101 (0.00%)  0 1/149 (0.67%)  1
Infections and infestations         
BACTERAEMIA  1  1/47 (2.13%)  1 0/63 (0.00%)  0 0/101 (0.00%)  0 0/149 (0.00%)  0
DIVERTICULITIS  1  0/47 (0.00%)  0 0/63 (0.00%)  0 0/101 (0.00%)  0 1/149 (0.67%)  1
ESCHERICHIA URINARY TRACT INFECTION  1  0/47 (0.00%)  0 0/63 (0.00%)  0 2/101 (1.98%)  2 0/149 (0.00%)  0
GASTROENTERITIS  1  0/47 (0.00%)  0 0/63 (0.00%)  0 0/101 (0.00%)  0 1/149 (0.67%)  1
INFLUENZA  1  0/47 (0.00%)  0 0/63 (0.00%)  0 0/101 (0.00%)  0 1/149 (0.67%)  1
OSTEOMYELITIS  1  0/47 (0.00%)  0 0/63 (0.00%)  0 0/101 (0.00%)  0 1/149 (0.67%)  1
PNEUMONIA  1  0/47 (0.00%)  0 1/63 (1.59%)  1 1/101 (0.99%)  1 3/149 (2.01%)  5
PNEUMONIA BACTERIAL  1  0/47 (0.00%)  0 0/63 (0.00%)  0 0/101 (0.00%)  0 1/149 (0.67%)  1
PNEUMONIA ESCHERICHIA  1  0/47 (0.00%)  0 0/63 (0.00%)  0 1/101 (0.99%)  1 0/149 (0.00%)  0
PNEUMONIA VIRAL  1  0/47 (0.00%)  0 0/63 (0.00%)  0 1/101 (0.99%)  1 0/149 (0.00%)  0
POST PROCEDURAL INFECTION  1  0/47 (0.00%)  0 0/63 (0.00%)  0 1/101 (0.99%)  1 0/149 (0.00%)  0
SEPSIS  1  0/47 (0.00%)  0 0/63 (0.00%)  0 0/101 (0.00%)  0 1/149 (0.67%)  1
SEPTIC SHOCK  1  0/47 (0.00%)  0 0/63 (0.00%)  0 0/101 (0.00%)  0 1/149 (0.67%)  1
UPPER RESPIRATORY TRACT INFECTION  1  0/47 (0.00%)  0 0/63 (0.00%)  0 1/101 (0.99%)  1 0/149 (0.00%)  0
URINARY TRACT INFECTION  1  0/47 (0.00%)  0 0/63 (0.00%)  0 2/101 (1.98%)  2 1/149 (0.67%)  1
UROSEPSIS  1  0/47 (0.00%)  0 1/63 (1.59%)  1 0/101 (0.00%)  0 0/149 (0.00%)  0
Injury, poisoning and procedural complications         
ANKLE FRACTURE  1  0/47 (0.00%)  0 0/63 (0.00%)  0 0/101 (0.00%)  0 1/149 (0.67%)  1
CERVICAL VERTEBRAL FRACTURE  1  0/47 (0.00%)  0 0/63 (0.00%)  0 0/101 (0.00%)  0 1/149 (0.67%)  1
FACIAL BONES FRACTURE  1  0/47 (0.00%)  0 0/63 (0.00%)  0 0/101 (0.00%)  0 1/149 (0.67%)  1
FALL  1  0/47 (0.00%)  0 1/63 (1.59%)  1 0/101 (0.00%)  0 1/149 (0.67%)  1
FEMORAL NECK FRACTURE  1  0/47 (0.00%)  0 1/63 (1.59%)  1 0/101 (0.00%)  0 0/149 (0.00%)  0
FEMUR FRACTURE  1  0/47 (0.00%)  0 1/63 (1.59%)  1 0/101 (0.00%)  0 0/149 (0.00%)  0
FRACTURE DISPLACEMENT  1  0/47 (0.00%)  0 0/63 (0.00%)  0 0/101 (0.00%)  0 1/149 (0.67%)  1
FRACTURED SACRUM  1  0/47 (0.00%)  0 0/63 (0.00%)  0 0/101 (0.00%)  0 1/149 (0.67%)  1
HIP FRACTURE  1  1/47 (2.13%)  1 1/63 (1.59%)  1 1/101 (0.99%)  1 1/149 (0.67%)  1
HUMERUS FRACTURE  1  0/47 (0.00%)  0 0/63 (0.00%)  0 1/101 (0.99%)  1 1/149 (0.67%)  1
LACERATION  1  0/47 (0.00%)  0 0/63 (0.00%)  0 1/101 (0.99%)  1 0/149 (0.00%)  0
LIMB INJURY  1  0/47 (0.00%)  0 0/63 (0.00%)  0 0/101 (0.00%)  0 1/149 (0.67%)  1
PELVIC FRACTURE  1  0/47 (0.00%)  0 0/63 (0.00%)  0 0/101 (0.00%)  0 1/149 (0.67%)  1
SUBARACHNOID HAEMORRHAGE  1  0/47 (0.00%)  0 1/63 (1.59%)  1 1/101 (0.99%)  1 0/149 (0.00%)  0
SUBDURAL HAEMATOMA  1  2/47 (4.26%)  2 0/63 (0.00%)  0 0/101 (0.00%)  0 0/149 (0.00%)  0
THORACIC VERTEBRAL FRACTURE  1  0/47 (0.00%)  0 1/63 (1.59%)  1 0/101 (0.00%)  0 0/149 (0.00%)  0
WRIST FRACTURE  1  0/47 (0.00%)  0 0/63 (0.00%)  0 0/101 (0.00%)  0 1/149 (0.67%)  1
Metabolism and nutrition disorders         
ADULT FAILURE TO THRIVE  1  0/47 (0.00%)  0 0/63 (0.00%)  0 0/101 (0.00%)  0 1/149 (0.67%)  1
DEHYDRATION  1  0/47 (0.00%)  0 0/63 (0.00%)  0 0/101 (0.00%)  0 3/149 (2.01%)  3
Musculoskeletal and connective tissue disorders         
BACK PAIN  1  0/47 (0.00%)  0 1/63 (1.59%)  1 0/101 (0.00%)  0 0/149 (0.00%)  0
OSTEOARTHRITIS  1  0/47 (0.00%)  0 0/63 (0.00%)  0 0/101 (0.00%)  0 1/149 (0.67%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
BASAL CELL CARCINOMA  1  0/47 (0.00%)  0 1/63 (1.59%)  1 0/101 (0.00%)  0 0/149 (0.00%)  0
COLON CANCER  1  0/47 (0.00%)  0 0/63 (0.00%)  0 0/101 (0.00%)  0 1/149 (0.67%)  1
INTESTINAL ADENOCARCINOMA  1  0/47 (0.00%)  0 0/63 (0.00%)  0 1/101 (0.99%)  1 0/149 (0.00%)  0
METASTATIC NEOPLASM  1  0/47 (0.00%)  0 1/63 (1.59%)  1 0/101 (0.00%)  0 0/149 (0.00%)  0
PROSTATE CANCER  1  0/47 (0.00%)  0 1/63 (1.59%)  1 0/101 (0.00%)  0 0/149 (0.00%)  0
Nervous system disorders         
BASILAR ARTERY STENOSIS  1  0/47 (0.00%)  0 0/63 (0.00%)  0 0/101 (0.00%)  0 1/149 (0.67%)  1
CEREBROVASCULAR ACCIDENT  1  0/47 (0.00%)  0 0/63 (0.00%)  0 1/101 (0.99%)  1 0/149 (0.00%)  0
DEMENTIA  1  0/47 (0.00%)  0 2/63 (3.17%)  2 1/101 (0.99%)  1 0/149 (0.00%)  0
DEMENTIA ALZHEIMER'S TYPE  1  2/47 (4.26%)  2 2/63 (3.17%)  2 0/101 (0.00%)  0 1/149 (0.67%)  1
DEMENTIA WITH LEWY BODIES  1  0/47 (0.00%)  0 0/63 (0.00%)  0 0/101 (0.00%)  0 1/149 (0.67%)  1
DEPRESSED LEVEL OF CONSCIOUSNESS  1  0/47 (0.00%)  0 0/63 (0.00%)  0 0/101 (0.00%)  0 1/149 (0.67%)  1
DIZZINESS  1  0/47 (0.00%)  0 0/63 (0.00%)  0 0/101 (0.00%)  0 1/149 (0.67%)  1
ENCEPHALOPATHY  1  0/47 (0.00%)  0 0/63 (0.00%)  0 0/101 (0.00%)  0 1/149 (0.67%)  1
EPILEPSY  1  0/47 (0.00%)  0 0/63 (0.00%)  0 0/101 (0.00%)  0 1/149 (0.67%)  1
GENERALISED TONIC-CLONIC SEIZURE  1  0/47 (0.00%)  0 0/63 (0.00%)  0 0/101 (0.00%)  0 1/149 (0.67%)  1
HYDROCEPHALUS  1  0/47 (0.00%)  0 1/63 (1.59%)  1 0/101 (0.00%)  0 0/149 (0.00%)  0
ISCHAEMIC STROKE  1  0/47 (0.00%)  0 0/63 (0.00%)  0 0/101 (0.00%)  0 1/149 (0.67%)  1
METABOLIC ENCEPHALOPATHY  1  0/47 (0.00%)  0 0/63 (0.00%)  0 0/101 (0.00%)  0 1/149 (0.67%)  1
PARAESTHESIA  1  0/47 (0.00%)  0 0/63 (0.00%)  0 0/101 (0.00%)  0 1/149 (0.67%)  1
PRESYNCOPE  1  0/47 (0.00%)  0 0/63 (0.00%)  0 2/101 (1.98%)  2 0/149 (0.00%)  0
SEIZURE  1  0/47 (0.00%)  0 1/63 (1.59%)  1 0/101 (0.00%)  0 2/149 (1.34%)  3
SYNCOPE  1  0/47 (0.00%)  0 2/63 (3.17%)  2 3/101 (2.97%)  3 0/149 (0.00%)  0
TRANSIENT ISCHAEMIC ATTACK  1  1/47 (2.13%)  1 0/63 (0.00%)  0 0/101 (0.00%)  0 1/149 (0.67%)  1
Product Issues         
DEVICE DISLOCATION  1  1/47 (2.13%)  1 0/63 (0.00%)  0 0/101 (0.00%)  0 0/149 (0.00%)  0
DEVICE FAILURE  1  0/47 (0.00%)  0 1/63 (1.59%)  1 0/101 (0.00%)  0 0/149 (0.00%)  0
Psychiatric disorders         
ABNORMAL BEHAVIOUR  1  0/47 (0.00%)  0 1/63 (1.59%)  1 0/101 (0.00%)  0 0/149 (0.00%)  0
AGGRESSION  1  1/47 (2.13%)  1 0/63 (0.00%)  0 0/101 (0.00%)  0 1/149 (0.67%)  1
AGITATION  1  1/47 (2.13%)  2 1/63 (1.59%)  1 1/101 (0.99%)  1 0/149 (0.00%)  0
DELIRIUM  1  0/47 (0.00%)  0 1/63 (1.59%)  2 1/101 (0.99%)  1 1/149 (0.67%)  1
DISORIENTATION  1  0/47 (0.00%)  0 0/63 (0.00%)  0 1/101 (0.99%)  1 0/149 (0.00%)  0
MENTAL STATUS CHANGES  1  0/47 (0.00%)  0 0/63 (0.00%)  0 2/101 (1.98%)  2 0/149 (0.00%)  0
PSYCHOTIC DISORDER  1  0/47 (0.00%)  0 0/63 (0.00%)  0 0/101 (0.00%)  0 1/149 (0.67%)  1
Renal and urinary disorders         
ACUTE PRERENAL FAILURE  1  0/47 (0.00%)  0 0/63 (0.00%)  0 0/101 (0.00%)  0 1/149 (0.67%)  1
URINARY RETENTION  1  0/47 (0.00%)  0 0/63 (0.00%)  0 0/101 (0.00%)  0 1/149 (0.67%)  1
Respiratory, thoracic and mediastinal disorders         
ACUTE RESPIRATORY FAILURE  1  0/47 (0.00%)  0 0/63 (0.00%)  0 1/101 (0.99%)  1 1/149 (0.67%)  1
PULMONARY GRANULOMA  1  0/47 (0.00%)  0 0/63 (0.00%)  0 0/101 (0.00%)  0 1/149 (0.67%)  1
TACHYPNOEA  1  0/47 (0.00%)  0 0/63 (0.00%)  0 0/101 (0.00%)  0 1/149 (0.67%)  1
Vascular disorders         
AORTIC ANEURYSM  1  0/47 (0.00%)  0 0/63 (0.00%)  0 0/101 (0.00%)  0 1/149 (0.67%)  1
DEEP VEIN THROMBOSIS  1  0/47 (0.00%)  0 0/63 (0.00%)  0 1/101 (0.99%)  1 2/149 (1.34%)  2
EXSANGUINATION  1  0/47 (0.00%)  0 0/63 (0.00%)  0 0/101 (0.00%)  0 1/149 (0.67%)  1
HYPERTENSION  1  0/47 (0.00%)  0 1/63 (1.59%)  1 0/101 (0.00%)  0 0/149 (0.00%)  0
HYPOTENSION  1  0/47 (0.00%)  0 0/63 (0.00%)  0 2/101 (1.98%)  2 0/149 (0.00%)  0
PHLEBITIS  1  0/47 (0.00%)  0 0/63 (0.00%)  0 0/101 (0.00%)  0 1/149 (0.67%)  1
1
Term from vocabulary, MedDRA version 20.0
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
PCP PL - OLE CREN SC - OLE CREN IV PCP PL - OLE CREN IV PCP CREN SC - OLE CREN SC - OLE CREN IV PCP CREN IV - OLE CREN IV
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   37/47 (78.72%)      51/63 (80.95%)      80/101 (79.21%)      97/149 (65.10%)    
Gastrointestinal disorders         
CONSTIPATION  1  0/47 (0.00%)  0 4/63 (6.35%)  4 3/101 (2.97%)  3 5/149 (3.36%)  5
DIARRHOEA  1  6/47 (12.77%)  7 3/63 (4.76%)  3 11/101 (10.89%)  12 14/149 (9.40%)  23
VOMITING  1  0/47 (0.00%)  0 3/63 (4.76%)  5 5/101 (4.95%)  6 8/149 (5.37%)  11
General disorders         
FATIGUE  1  2/47 (4.26%)  2 0/63 (0.00%)  0 8/101 (7.92%)  8 4/149 (2.68%)  4
INJECTION SITE ERYTHEMA  1  2/47 (4.26%)  13 1/63 (1.59%)  1 8/101 (7.92%)  10 2/149 (1.34%)  2
INJECTION SITE EXTRAVASATION  1  3/47 (6.38%)  5 1/63 (1.59%)  1 3/101 (2.97%)  7 4/149 (2.68%)  16
Infections and infestations         
BRONCHITIS  1  2/47 (4.26%)  2 2/63 (3.17%)  2 4/101 (3.96%)  5 9/149 (6.04%)  9
UPPER RESPIRATORY TRACT INFECTION  1  6/47 (12.77%)  7 5/63 (7.94%)  5 15/101 (14.85%)  20 13/149 (8.72%)  15
URINARY TRACT INFECTION  1  7/47 (14.89%)  8 9/63 (14.29%)  13 16/101 (15.84%)  23 18/149 (12.08%)  34
VIRAL UPPER RESPIRATORY TRACT INFECTION  1  5/47 (10.64%)  7 11/63 (17.46%)  14 10/101 (9.90%)  11 13/149 (8.72%)  13
Injury, poisoning and procedural complications         
CONTUSION  1  2/47 (4.26%)  6 2/63 (3.17%)  2 6/101 (5.94%)  8 8/149 (5.37%)  10
FALL  1  7/47 (14.89%)  10 8/63 (12.70%)  11 26/101 (25.74%)  42 18/149 (12.08%)  28
LACERATION  1  3/47 (6.38%)  3 2/63 (3.17%)  3 10/101 (9.90%)  11 7/149 (4.70%)  7
SKIN ABRASION  1  0/47 (0.00%)  0 4/63 (6.35%)  4 5/101 (4.95%)  5 3/149 (2.01%)  5
Investigations         
WEIGHT DECREASED  1  4/47 (8.51%)  4 2/63 (3.17%)  2 8/101 (7.92%)  11 7/149 (4.70%)  7
Musculoskeletal and connective tissue disorders         
ARTHRALGIA  1  2/47 (4.26%)  4 5/63 (7.94%)  6 8/101 (7.92%)  10 8/149 (5.37%)  10
BACK PAIN  1  3/47 (6.38%)  3 4/63 (6.35%)  5 7/101 (6.93%)  7 8/149 (5.37%)  8
MUSCLE SPASMS  1  3/47 (6.38%)  3 0/63 (0.00%)  0 4/101 (3.96%)  6 1/149 (0.67%)  2
TENDONITIS  1  3/47 (6.38%)  3 2/63 (3.17%)  2 1/101 (0.99%)  1 0/149 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
SQUAMOUS CELL CARCINOMA  1  3/47 (6.38%)  8 1/63 (1.59%)  1 2/101 (1.98%)  2 0/149 (0.00%)  0
Nervous system disorders         
CEREBRAL MICROHAEMORRHAGE  1  3/47 (6.38%)  3 4/63 (6.35%)  5 3/101 (2.97%)  3 6/149 (4.03%)  7
DIZZINESS  1  2/47 (4.26%)  2 5/63 (7.94%)  5 11/101 (10.89%)  14 10/149 (6.71%)  11
HEADACHE  1  1/47 (2.13%)  1 2/63 (3.17%)  2 8/101 (7.92%)  10 3/149 (2.01%)  4
Psychiatric disorders         
AGITATION  1  9/47 (19.15%)  9 4/63 (6.35%)  4 13/101 (12.87%)  20 13/149 (8.72%)  14
ANXIETY  1  1/47 (2.13%)  1 4/63 (6.35%)  4 8/101 (7.92%)  9 15/149 (10.07%)  16
CONFUSIONAL STATE  1  3/47 (6.38%)  3 1/63 (1.59%)  1 3/101 (2.97%)  4 3/149 (2.01%)  4
DELUSION  1  3/47 (6.38%)  3 1/63 (1.59%)  1 7/101 (6.93%)  7 4/149 (2.68%)  6
DEPRESSION  1  3/47 (6.38%)  3 8/63 (12.70%)  9 5/101 (4.95%)  5 7/149 (4.70%)  7
INSOMNIA  1  3/47 (6.38%)  6 1/63 (1.59%)  1 8/101 (7.92%)  10 8/149 (5.37%)  9
Renal and urinary disorders         
URINARY INCONTINENCE  1  4/47 (8.51%)  4 0/63 (0.00%)  0 5/101 (4.95%)  6 8/149 (5.37%)  8
Respiratory, thoracic and mediastinal disorders         
COUGH  1  5/47 (10.64%)  11 3/63 (4.76%)  3 8/101 (7.92%)  9 11/149 (7.38%)  13
Skin and subcutaneous tissue disorders         
RASH  1  2/47 (4.26%)  7 5/63 (7.94%)  5 2/101 (1.98%)  2 6/149 (4.03%)  7
Vascular disorders         
HAEMATOMA  1  3/47 (6.38%)  3 2/63 (3.17%)  2 2/101 (1.98%)  2 3/149 (2.01%)  3
1
Term from vocabulary, MedDRA version 20.0
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Medical Communications
Organization: Hoffmann-La Roche
Phone: 800 821-8590
EMail: genentech@druginfo.com
Layout table for additonal information
Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT01723826    
Other Study ID Numbers: GN28525
2012-003242-33 ( EudraCT Number )
First Submitted: November 6, 2012
First Posted: November 8, 2012
Results First Submitted: January 24, 2020
Results First Posted: February 12, 2020
Last Update Posted: February 20, 2020