An Extension Study to Evaluate the Long-Term Safety of Lampalizumab in Participants With Geographic Atrophy
Sponsor
Genentech, Inc. (Industry)
Overall Status
Terminated
CT.gov ID
NCT01602120
Collaborator
(none)
159
46
4
68.4
3.5
0.1
Study Details
Study Description
Brief Summary
This is a multicenter, open-label extension study of safety and tolerability of lampalizumab administered by intravitreal (ITV) injection to participants with geographic atrophy (GA) who have completed the 18-month treatment in Study CFD4870g (GX01456) (NCT01229215) or 24-week treatment in Study GX29455 (NCT02288559).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
159 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Multicenter, Open-Label Extension Study to Evaluate the Long-Term Safety and Tolerability of Lampalizumab (FCFD4514S) in Patients With Geographic Atrophy Who Have Completed Genentech-Sponsored Lampalizumab Studies
Actual Study Start Date
:
May 29, 2012
Actual Primary Completion Date
:
Nov 8, 2017
Actual Study Completion Date
:
Feb 9, 2018
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: CFD4870g Sham Participants who were administered sham comparator in Study NCT01229215 (CFD4870g), will receive lampalizumab 10 milligrams (mg), intravitreally (ITV), either once in every 4 weeks (Q4W) or once in every 8 weeks (Q8W) in accordance with their previously assigned treatment frequency assignment in Study CFD4870g followed by Q4W administration for the remainder of the extension study up to approximately 96 months. |
Drug: Lampalizumab
Lampalizumab 10 mg ITV injections as per the schedule specified in respective arms.
Other Names:
|
| Experimental: CFD4870g Lampalizumab Participants will receive lampalizumab 10 mg, ITV, Q4W or Q8W in accordance with their previously assigned treatment frequency assignment in Study NCT01229215 (CFD4870g) followed by Q4W administration for the remainder of the extension study up to approximately 96 months. |
Drug: Lampalizumab
Lampalizumab 10 mg ITV injections as per the schedule specified in respective arms.
Other Names:
|
| Experimental: GX29455 Sham Participants who were administered sham comparator in Study NCT02288559 (GX29455), will receive lampalizumab 10 mg, ITV, Q4W throughout the extension study up to approximately 54 months. |
Drug: Lampalizumab
Lampalizumab 10 mg ITV injections as per the schedule specified in respective arms.
Other Names:
|
| Experimental: GX29455 Lampalizumab Participants who were administered lampalizumab in Study NCT02288559 (GX29455), will receive lampalizumab 10 mg, ITV, Q4W throughout the extension study up to approximately 54 months. |
Drug: Lampalizumab
Lampalizumab 10 mg ITV injections as per the schedule specified in respective arms.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Percentage of Participants With Ocular and Non-ocular Adverse Events (AEs) [From Day 1 up to the last study visit (up to approximately 62 months)]
An AE was defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether considered related to the medicinal product, any new disease or exacerbation of an existing disease, recurrence of an intermittent medical condition, or any deterioration in a laboratory value or other clinical test. Ocular AEs are events localized to the eye. Non-ocular events include all other events.
Eligibility Criteria
Criteria
Ages Eligible for Study:
60 Years
to 89 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
For CFD4870g participants: Previous enrollment and completion (Month 18 visit) of Study CFD4870g without early treatment discontinuation (lampalizumab or sham)
-
For GX29455 participants: Previous enrollment and completion (Week 24 visit) of Study GX29455 without early treatment discontinuation (lampalizumab or sham)
-
Sufficiently clear ocular media, adequate pupillary dilation, and fixation to permit quality fundus imaging
Exclusion Criteria:
-
Early treatment and/or study discontinuation prior to completion of study CFD4870g (GX01456) and GX29455
-
Vitrectomy surgery, submacular surgery, or other surgical intervention for age-related macular degeneration (AMD) in the study eye
-
Subfoveal focal laser photocoagulation in the study eye
-
Treatment with Visodyne, external-beam radiation therapy, or transpupillary thermotherapy in the study eye
-
Intravitreally (ITV) drug delivery (e.g., ITV corticosteroid injection, anti-angiogenic drugs, anticomplement drugs, or device implantation) in the study eye. Lampalizumab in study eye and ranibizumab in either eye are permitted
-
Any concurrent ocular or intraocular condition in the study eye that contraindicates the use of an investigational drug or may affect interpretation of the study results or may render the participant at high risk for treatment complications
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Retina Centers P.C. | Tucson | Arizona | United States | 85704 |
| 2 | Retina-Vitreous Assoc Med Grp | Beverly Hills | California | United States | 90211 |
| 3 | Retinal Diagnostic Center | Campbell | California | United States | 95008 |
| 4 | The Retina Partners | Encino | California | United States | 91436 |
| 5 | Loma Linda University | Loma Linda | California | United States | 92354 |
| 6 | San Diego Retina Associates | Oceanside | California | United States | 92056 |
| 7 | W Coast Retina Med Group Inc | San Francisco | California | United States | 94107 |
| 8 | West Coast Retina | San Francisco | California | United States | 94107 |
| 9 | California Retina Consultants | Santa Barbara | California | United States | 93103 |
| 10 | Retina Macula Institute | Torrance | California | United States | 90503 |
| 11 | Colorado Retina Associates, PC | Golden | Colorado | United States | 80401 |
| 12 | Retina Group of Florida | Boca Raton | Florida | United States | 33431 |
| 13 | National Ophthalmic Research Institute | Fort Myers | Florida | United States | 33912 |
| 14 | Florida Eye Associates | Melbourne | Florida | United States | 32901 |
| 15 | Retina Care Specialists | Palm Beach Gardens | Florida | United States | 33410 |
| 16 | Retina Specialty Institute | Pensacola | Florida | United States | 32503 |
| 17 | Ctr for Retina & Macular Dis | Winter Haven | Florida | United States | 33880 |
| 18 | Southeast Retina Center | Augusta | Georgia | United States | 30909 |
| 19 | Wolfe Eye Clinic | West Des Moines | Iowa | United States | 50266 |
| 20 | Elman Retina Group | Baltimore | Maryland | United States | 21237 |
| 21 | Ophthalmic Consultants of Boston | Boston | Massachusetts | United States | 02114 |
| 22 | Vitreoretinal Surgery | Edina | Minnesota | United States | 55435 |
| 23 | The Retina Institute | Saint Louis | Missouri | United States | 63128 |
| 24 | Sierra Eye Associates | Reno | Nevada | United States | 89502 |
| 25 | Eye Associates of New Mexico | Albuquerque | New Mexico | United States | 87102 |
| 26 | Opthalmic Consultants of LI | Lynbrook | New York | United States | 11563 |
| 27 | Western Carolina Retinal Associate PA | Asheville | North Carolina | United States | 28803 |
| 28 | Char Eye Ear &Throat Assoc | Charlotte | North Carolina | United States | 28210 |
| 29 | Retina Assoc of Cleveland Inc | Beachwood | Ohio | United States | 44122 |
| 30 | Cincinnati Eye Institute | Cincinnati | Ohio | United States | 45242 |
| 31 | Dean McGee Eye Institute | Oklahoma City | Oklahoma | United States | 73099 |
| 32 | Retina Northwest | Portland | Oregon | United States | 97221 |
| 33 | Mid Atlantic Retina | Philadelphia | Pennsylvania | United States | 19107 |
| 34 | Charleston Neuroscience Institute | Ladson | South Carolina | United States | 29456 |
| 35 | Southeastern Retina Associates | Knoxville | Tennessee | United States | 37923 |
| 36 | Tennessee Retina PC | Nashville | Tennessee | United States | 37203 |
| 37 | W Texas Retina Consultants PA | Abilene | Texas | United States | 79606 |
| 38 | Retina Research Center | Austin | Texas | United States | 78705 |
| 39 | Texas Retina Associates | Dallas | Texas | United States | 75231 |
| 40 | Wagner Macula & Retina Center | Norfolk | Virginia | United States | 23451 |
| 41 | Medical College of Wisconsin | Milwaukee | Wisconsin | United States | 53226 |
| 42 | Universitatsklinikum Bonn; Medizinische Klinik und Poliklinik III | Bonn | Germany | 53127 | |
| 43 | Universitätsklinikum Freiburg | Freiburg | Germany | 79106 | |
| 44 | Universitatsklinikum Leipzig | Leipzig | Germany | 04103 | |
| 45 | St. Franziskus Hospital | Munster | Germany | 48145 | |
| 46 | Universitätsklinikum Tübingen | Tuebingen | Germany | 72076 |
Sponsors and Collaborators
- Genentech, Inc.
Investigators
- Study Director: Clinical Trials, Genentech, Inc.
Study Documents (Full-Text)
More Information
Publications
None provided.Responsible Party:
Genentech, Inc.
ClinicalTrials.gov Identifier:
NCT01602120
Other Study ID Numbers:
- GX28198
- 2012-000578-41
First Posted:
May 18, 2012
Last Update Posted:
Sep 11, 2019
Last Verified:
Sep 1, 2019
Study Results
Participant Flow
| Recruitment Details | This study enrolled eligible patients who had completed the 18-month treatment period of Study NCT01229215 (CFD4870g) or the 24-week treatment period of Study NCT02288559 (GX29455). The study was terminated early by the Sponsor due to lack of efficacy. |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | CFD4870g Sham | CFD4870g Lampalizumab | GX29455 Sham | GX29455 Lampalizumab |
|---|---|---|---|---|
| Arm/Group Description | Participants who were administered sham comparator in Study NCT01229215 (CFD4870g), received lampalizumab 10 milligrams (mg), intravitreally (ITV), either once in every 4 weeks (Q4W) or once in every 8 weeks (Q8W) in accordance with their previously assigned treatment frequency assignment in Study CFD4870g followed by Q4W administration for the remainder of the extension study. | Participants received lampalizumab 10 mg, ITV, Q4W or Q8W in accordance with their previously assigned treatment frequency assignment in Study NCT01229215 (CFD4870g) followed by Q4W administration for the remainder of the extension study. | Participants who were administered sham comparator in Study NCT02288559 (GX29455), received lampalizumab 10 mg, ITV, Q4W throughout the extension study. | Participants who were administered lampalizumab in Study NCT02288559 (GX29455), received lampalizumab 10 mg, ITV, Q4W throughout the extension study. |
| Period Title: Overall Study | ||||
| STARTED | 29 | 60 | 17 | 53 |
| COMPLETED | 0 | 0 | 0 | 0 |
| NOT COMPLETED | 29 | 60 | 17 | 53 |
Baseline Characteristics
| Arm/Group Title | CFD4870g Sham | CFD4870g Lampalizumab | GX29455 Sham | GX29455 Lampalizumab | Total |
|---|---|---|---|---|---|
| Arm/Group Description | Participants who were administered sham comparator in Study NCT01229215 (CFD4870g), received lampalizumab 10 milligrams (mg), intravitreally (ITV), either once in every 4 weeks (Q4W) or once in every 8 weeks (Q8W) in accordance with their previously assigned treatment frequency assignment in Study CFD4870g followed by Q4W administration for the remainder of the extension study. | Participants received lampalizumab 10 mg, ITV, Q4W or Q8W in accordance with their previously assigned treatment frequency assignment in Study NCT01229215 (CFD4870g) followed by Q4W administration for the remainder of the extension study. | Participants who were administered sham comparator in Study NCT02288559 (GX29455), received lampalizumab 10 mg, ITV, Q4W throughout the extension study. | Participants who were administered lampalizumab in Study NCT02288559 (GX29455), received lampalizumab 10 mg, ITV, Q4W throughout the extension study. | Total of all reporting groups |
| Overall Participants | 29 | 60 | 17 | 53 | 159 |
| Age (years) [Mean (Standard Deviation) ] | |||||
| Mean (Standard Deviation) [years] |
79.4
(6.6)
|
79.4
(6.8)
|
76.7
(6.6)
|
79.5
(7.6)
|
79.1
(7.0)
|
| Sex: Female, Male (Count of Participants) | |||||
| Female |
17
58.6%
|
33
55%
|
12
70.6%
|
27
50.9%
|
89
56%
|
| Male |
12
41.4%
|
27
45%
|
5
29.4%
|
26
49.1%
|
70
44%
|
| Race/Ethnicity, Customized (Count of Participants) | |||||
| Hispanic or Latino |
0
0%
|
1
1.7%
|
0
0%
|
1
1.9%
|
2
1.3%
|
| Not Hispanic or Latino |
29
100%
|
59
98.3%
|
17
100%
|
52
98.1%
|
157
98.7%
|
| Race/Ethnicity, Customized (Count of Participants) | |||||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
1
5.9%
|
0
0%
|
1
0.6%
|
| Asian |
0
0%
|
0
0%
|
1
5.9%
|
0
0%
|
1
0.6%
|
| Black or African American |
0
0%
|
1
1.7%
|
0
0%
|
0
0%
|
1
0.6%
|
| White |
29
100%
|
59
98.3%
|
15
88.2%
|
53
100%
|
156
98.1%
|
Outcome Measures
| Title | Percentage of Participants With Ocular and Non-ocular Adverse Events (AEs) |
|---|---|
| Description | An AE was defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether considered related to the medicinal product, any new disease or exacerbation of an existing disease, recurrence of an intermittent medical condition, or any deterioration in a laboratory value or other clinical test. Ocular AEs are events localized to the eye. Non-ocular events include all other events. |
| Time Frame | From Day 1 up to the last study visit (up to approximately 62 months) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety population included all participants who were enrolled and received at least one lampalizumab injection in the extension study. |
| Arm/Group Title | CFD4870g Sham | CFD4870g Lampalizumab | GX29455 Sham | GX29455 Lampalizumab | All Participants |
|---|---|---|---|---|---|
| Arm/Group Description | Participants who were administered sham comparator in Study NCT01229215 (CFD4870g), received lampalizumab 10 milligrams (mg), intravitreally (ITV), either once in every 4 weeks (Q4W) or once in every 8 weeks (Q8W) in accordance with their previously assigned treatment frequency assignment in Study CFD4870g followed by Q4W administration for the remainder of the extension study. | Participants received lampalizumab 10 mg, ITV, Q4W or Q8W in accordance with their previously assigned treatment frequency assignment in Study NCT01229215 (CFD4870g) followed by Q4W administration for the remainder of the extension study. | Participants who were administered sham comparator in Study NCT02288559 (GX29455), received lampalizumab 10 mg, ITV, Q4W throughout the extension study. | Participants who were administered lampalizumab in Study NCT02288559 (GX29455), received lampalizumab 10 mg, ITV, Q4W throughout the extension study. | All participants in the study received lampalizumab 10 mg, ITV, Q4W. |
| Measure Participants | 29 | 60 | 17 | 53 | 159 |
| Ocular AEs in Study Eye |
62.1
214.1%
|
78.3
130.5%
|
52.9
311.2%
|
50.9
96%
|
63.5
39.9%
|
| Ocular AEs in Fellow Eye |
62.1
214.1%
|
68.3
113.8%
|
29.4
172.9%
|
60.4
114%
|
60.4
38%
|
| Non-Ocular AEs |
79.3
273.4%
|
90.0
150%
|
82.4
484.7%
|
67.9
128.1%
|
79.9
50.3%
|
Adverse Events
| Time Frame | From Day 1 up to the last study visit (up to approximately 62 months) | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | At the time of study enrollment, if the participant had any ongoing adverse events from Study NCT01229215 (CFD4870g) or NCT02288559 (GX29455) these events were counted in this study. Safety population included all participants who were enrolled and received at least one lampalizumab injection in the extension study. The arm All Participants reports all adverse events that occurred in the four arms in the study. | |||||||||
| Arm/Group Title | CFD4870g Sham | CFD4870g Lampalizumab | GX29455 Sham | GX29455 Lampalizumab | All Participants | |||||
| Arm/Group Description | Participants who were administered sham comparator in Study NCT01229215 (CFD4870g), received lampalizumab 10 milligrams (mg), intravitreally (ITV), either once in every 4 weeks (Q4W) or once in every 8 weeks (Q8W) in accordance with their previously assigned treatment frequency assignment in Study CFD4870g followed by Q4W administration for the remainder of the extension study. | Participants received lampalizumab 10 mg, ITV, Q4W or Q8W in accordance with their previously assigned treatment frequency assignment in Study NCT01229215 (CFD4870g) followed by Q4W administration for the remainder of the extension study. | Participants who were administered sham comparator in Study NCT02288559 (GX29455), received lampalizumab 10 mg, ITV, Q4W throughout the extension study. | Participants who were administered lampalizumab in Study NCT02288559 (GX29455), received lampalizumab 10 mg, ITV, Q4W throughout the extension study. | All participants in the study received lampalizumab 10 mg, ITV, Q4W. | |||||
All Cause Mortality |
||||||||||
| CFD4870g Sham | CFD4870g Lampalizumab | GX29455 Sham | GX29455 Lampalizumab | All Participants | ||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 1/29 (3.4%) | 6/60 (10%) | 0/17 (0%) | 1/53 (1.9%) | 8/159 (5%) | |||||
Serious Adverse Events |
||||||||||
| CFD4870g Sham | CFD4870g Lampalizumab | GX29455 Sham | GX29455 Lampalizumab | All Participants | ||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 16/29 (55.2%) | 40/60 (66.7%) | 5/17 (29.4%) | 9/53 (17%) | 70/159 (44%) | |||||
| Blood and lymphatic system disorders | ||||||||||
| Anaemia | 0/29 (0%) | 2/60 (3.3%) | 0/17 (0%) | 0/53 (0%) | 2/159 (1.3%) | |||||
| Cardiac disorders | ||||||||||
| Acute coronary syndrome | 0/29 (0%) | 1/60 (1.7%) | 1/17 (5.9%) | 0/53 (0%) | 2/159 (1.3%) | |||||
| Angina pectoris | 0/29 (0%) | 1/60 (1.7%) | 0/17 (0%) | 0/53 (0%) | 1/159 (0.6%) | |||||
| Atrial fibrillation | 0/29 (0%) | 5/60 (8.3%) | 0/17 (0%) | 0/53 (0%) | 5/159 (3.1%) | |||||
| Atrioventricular block second degree | 1/29 (3.4%) | 0/60 (0%) | 0/17 (0%) | 0/53 (0%) | 1/159 (0.6%) | |||||
| Cardiac failure congestive | 0/29 (0%) | 4/60 (6.7%) | 0/17 (0%) | 0/53 (0%) | 4/159 (2.5%) | |||||
| Cardiac perforation | 0/29 (0%) | 1/60 (1.7%) | 0/17 (0%) | 0/53 (0%) | 1/159 (0.6%) | |||||
| Coronary artery disease | 0/29 (0%) | 2/60 (3.3%) | 0/17 (0%) | 0/53 (0%) | 2/159 (1.3%) | |||||
| Ischaemic cardiomyopathy | 0/29 (0%) | 1/60 (1.7%) | 0/17 (0%) | 0/53 (0%) | 1/159 (0.6%) | |||||
| Myocardial infarction | 1/29 (3.4%) | 0/60 (0%) | 0/17 (0%) | 0/53 (0%) | 1/159 (0.6%) | |||||
| Sinus node dysfunction | 0/29 (0%) | 2/60 (3.3%) | 0/17 (0%) | 0/53 (0%) | 2/159 (1.3%) | |||||
| Supraventricular tachycardia | 0/29 (0%) | 1/60 (1.7%) | 0/17 (0%) | 0/53 (0%) | 1/159 (0.6%) | |||||
| Ventricle rupture | 0/29 (0%) | 1/60 (1.7%) | 0/17 (0%) | 0/53 (0%) | 1/159 (0.6%) | |||||
| Ventricular tachycardia | 0/29 (0%) | 1/60 (1.7%) | 0/17 (0%) | 0/53 (0%) | 1/159 (0.6%) | |||||
| Endocrine disorders | ||||||||||
| Thyroid mass | 0/29 (0%) | 1/60 (1.7%) | 0/17 (0%) | 0/53 (0%) | 1/159 (0.6%) | |||||
| Eye disorders | ||||||||||
| Blindness transient | 0/29 (0%) | 1/60 (1.7%) | 0/17 (0%) | 0/53 (0%) | 1/159 (0.6%) | |||||
| Cataract | 0/29 (0%) | 1/60 (1.7%) | 0/17 (0%) | 0/53 (0%) | 1/159 (0.6%) | |||||
| Eye haemorrhage | 1/29 (3.4%) | 0/60 (0%) | 0/17 (0%) | 0/53 (0%) | 1/159 (0.6%) | |||||
| Retinal detachment | 0/29 (0%) | 1/60 (1.7%) | 0/17 (0%) | 0/53 (0%) | 1/159 (0.6%) | |||||
| Visual acuity reduced | 2/29 (6.9%) | 2/60 (3.3%) | 1/17 (5.9%) | 0/53 (0%) | 5/159 (3.1%) | |||||
| Visual impairment | 0/29 (0%) | 2/60 (3.3%) | 0/17 (0%) | 0/53 (0%) | 2/159 (1.3%) | |||||
| Vitritis | 1/29 (3.4%) | 0/60 (0%) | 0/17 (0%) | 0/53 (0%) | 1/159 (0.6%) | |||||
| Gastrointestinal disorders | ||||||||||
| Dysphagia | 0/29 (0%) | 1/60 (1.7%) | 0/17 (0%) | 0/53 (0%) | 1/159 (0.6%) | |||||
| Gastric ulcer haemorrhage | 0/29 (0%) | 1/60 (1.7%) | 0/17 (0%) | 0/53 (0%) | 1/159 (0.6%) | |||||
| Impaired gastric emptying | 0/29 (0%) | 1/60 (1.7%) | 0/17 (0%) | 0/53 (0%) | 1/159 (0.6%) | |||||
| General disorders | ||||||||||
| Asthenia | 0/29 (0%) | 0/60 (0%) | 1/17 (5.9%) | 0/53 (0%) | 1/159 (0.6%) | |||||
| Catheter site haemorrhage | 0/29 (0%) | 0/60 (0%) | 0/17 (0%) | 1/53 (1.9%) | 1/159 (0.6%) | |||||
| Chest pain | 0/29 (0%) | 1/60 (1.7%) | 0/17 (0%) | 0/53 (0%) | 1/159 (0.6%) | |||||
| Death | 0/29 (0%) | 1/60 (1.7%) | 0/17 (0%) | 0/53 (0%) | 1/159 (0.6%) | |||||
| Fatigue | 0/29 (0%) | 0/60 (0%) | 1/17 (5.9%) | 0/53 (0%) | 1/159 (0.6%) | |||||
| Peripheral swelling | 0/29 (0%) | 1/60 (1.7%) | 0/17 (0%) | 0/53 (0%) | 1/159 (0.6%) | |||||
| Pyrexia | 0/29 (0%) | 1/60 (1.7%) | 0/17 (0%) | 0/53 (0%) | 1/159 (0.6%) | |||||
| Hepatobiliary disorders | ||||||||||
| Bile duct stone | 0/29 (0%) | 1/60 (1.7%) | 0/17 (0%) | 0/53 (0%) | 1/159 (0.6%) | |||||
| Cholecystitis acute | 0/29 (0%) | 1/60 (1.7%) | 0/17 (0%) | 0/53 (0%) | 1/159 (0.6%) | |||||
| Infections and infestations | ||||||||||
| Cellulitis | 2/29 (6.9%) | 2/60 (3.3%) | 0/17 (0%) | 0/53 (0%) | 4/159 (2.5%) | |||||
| Diverticulitis | 1/29 (3.4%) | 0/60 (0%) | 0/17 (0%) | 0/53 (0%) | 1/159 (0.6%) | |||||
| Endophthalmitis | 0/29 (0%) | 1/60 (1.7%) | 0/17 (0%) | 0/53 (0%) | 1/159 (0.6%) | |||||
| Escherichia sepsis | 0/29 (0%) | 1/60 (1.7%) | 0/17 (0%) | 0/53 (0%) | 1/159 (0.6%) | |||||
| Infected lymphocele | 0/29 (0%) | 1/60 (1.7%) | 0/17 (0%) | 0/53 (0%) | 1/159 (0.6%) | |||||
| Pneumonia | 1/29 (3.4%) | 4/60 (6.7%) | 0/17 (0%) | 1/53 (1.9%) | 6/159 (3.8%) | |||||
| Pneumonia bacterial | 0/29 (0%) | 1/60 (1.7%) | 0/17 (0%) | 0/53 (0%) | 1/159 (0.6%) | |||||
| Sepsis | 0/29 (0%) | 1/60 (1.7%) | 0/17 (0%) | 0/53 (0%) | 1/159 (0.6%) | |||||
| Septic shock | 0/29 (0%) | 1/60 (1.7%) | 0/17 (0%) | 0/53 (0%) | 1/159 (0.6%) | |||||
| Urinary tract infection | 1/29 (3.4%) | 0/60 (0%) | 0/17 (0%) | 1/53 (1.9%) | 2/159 (1.3%) | |||||
| Urosepsis | 1/29 (3.4%) | 0/60 (0%) | 0/17 (0%) | 0/53 (0%) | 1/159 (0.6%) | |||||
| Injury, poisoning and procedural complications | ||||||||||
| Ankle fracture | 0/29 (0%) | 0/60 (0%) | 1/17 (5.9%) | 0/53 (0%) | 1/159 (0.6%) | |||||
| Corneal abrasion | 0/29 (0%) | 1/60 (1.7%) | 0/17 (0%) | 0/53 (0%) | 1/159 (0.6%) | |||||
| Craniocerebral injury | 0/29 (0%) | 0/60 (0%) | 0/17 (0%) | 1/53 (1.9%) | 1/159 (0.6%) | |||||
| Fall | 0/29 (0%) | 1/60 (1.7%) | 0/17 (0%) | 1/53 (1.9%) | 2/159 (1.3%) | |||||
| Foot fracture | 0/29 (0%) | 1/60 (1.7%) | 0/17 (0%) | 0/53 (0%) | 1/159 (0.6%) | |||||
| Foreign body aspiration | 0/29 (0%) | 1/60 (1.7%) | 0/17 (0%) | 0/53 (0%) | 1/159 (0.6%) | |||||
| Genital injury | 0/29 (0%) | 1/60 (1.7%) | 0/17 (0%) | 0/53 (0%) | 1/159 (0.6%) | |||||
| Hip fracture | 0/29 (0%) | 2/60 (3.3%) | 0/17 (0%) | 0/53 (0%) | 2/159 (1.3%) | |||||
| Limb injury | 0/29 (0%) | 0/60 (0%) | 0/17 (0%) | 1/53 (1.9%) | 1/159 (0.6%) | |||||
| Pubis fracture | 0/29 (0%) | 1/60 (1.7%) | 0/17 (0%) | 0/53 (0%) | 1/159 (0.6%) | |||||
| Rib fracture | 2/29 (6.9%) | 0/60 (0%) | 0/17 (0%) | 0/53 (0%) | 2/159 (1.3%) | |||||
| Subdural haematoma | 0/29 (0%) | 1/60 (1.7%) | 0/17 (0%) | 0/53 (0%) | 1/159 (0.6%) | |||||
| Toxicity to various agents | 0/29 (0%) | 0/60 (0%) | 0/17 (0%) | 1/53 (1.9%) | 1/159 (0.6%) | |||||
| Upper limb fracture | 0/29 (0%) | 1/60 (1.7%) | 0/17 (0%) | 0/53 (0%) | 1/159 (0.6%) | |||||
| Vascular pseudoaneurysm | 0/29 (0%) | 1/60 (1.7%) | 0/17 (0%) | 0/53 (0%) | 1/159 (0.6%) | |||||
| Investigations | ||||||||||
| Intraocular pressure increased | 1/29 (3.4%) | 0/60 (0%) | 0/17 (0%) | 1/53 (1.9%) | 2/159 (1.3%) | |||||
| Metabolism and nutrition disorders | ||||||||||
| Dehydration | 0/29 (0%) | 1/60 (1.7%) | 0/17 (0%) | 1/53 (1.9%) | 2/159 (1.3%) | |||||
| Failure to thrive | 0/29 (0%) | 1/60 (1.7%) | 0/17 (0%) | 0/53 (0%) | 1/159 (0.6%) | |||||
| Hypernatraemia | 0/29 (0%) | 0/60 (0%) | 0/17 (0%) | 1/53 (1.9%) | 1/159 (0.6%) | |||||
| Hyponatraemia | 0/29 (0%) | 1/60 (1.7%) | 0/17 (0%) | 0/53 (0%) | 1/159 (0.6%) | |||||
| Musculoskeletal and connective tissue disorders | ||||||||||
| Arthralgia | 0/29 (0%) | 0/60 (0%) | 1/17 (5.9%) | 0/53 (0%) | 1/159 (0.6%) | |||||
| Back pain | 0/29 (0%) | 1/60 (1.7%) | 0/17 (0%) | 0/53 (0%) | 1/159 (0.6%) | |||||
| Bursitis | 0/29 (0%) | 0/60 (0%) | 1/17 (5.9%) | 0/53 (0%) | 1/159 (0.6%) | |||||
| Costochondritis | 0/29 (0%) | 1/60 (1.7%) | 0/17 (0%) | 0/53 (0%) | 1/159 (0.6%) | |||||
| Osteoarthritis | 0/29 (0%) | 1/60 (1.7%) | 1/17 (5.9%) | 0/53 (0%) | 2/159 (1.3%) | |||||
| Spinal osteoarthritis | 1/29 (3.4%) | 0/60 (0%) | 0/17 (0%) | 0/53 (0%) | 1/159 (0.6%) | |||||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||||||
| Adenocarcinoma pancreas | 0/29 (0%) | 1/60 (1.7%) | 0/17 (0%) | 0/53 (0%) | 1/159 (0.6%) | |||||
| Bladder cancer | 0/29 (0%) | 1/60 (1.7%) | 0/17 (0%) | 1/53 (1.9%) | 2/159 (1.3%) | |||||
| Bladder neoplasm | 1/29 (3.4%) | 0/60 (0%) | 0/17 (0%) | 0/53 (0%) | 1/159 (0.6%) | |||||
| Bladder transitional cell carcinoma | 0/29 (0%) | 0/60 (0%) | 0/17 (0%) | 1/53 (1.9%) | 1/159 (0.6%) | |||||
| Breast cancer | 0/29 (0%) | 1/60 (1.7%) | 0/17 (0%) | 0/53 (0%) | 1/159 (0.6%) | |||||
| Colon cancer | 1/29 (3.4%) | 0/60 (0%) | 0/17 (0%) | 0/53 (0%) | 1/159 (0.6%) | |||||
| Hepatic cancer | 0/29 (0%) | 1/60 (1.7%) | 0/17 (0%) | 0/53 (0%) | 1/159 (0.6%) | |||||
| Leukaemia | 0/29 (0%) | 1/60 (1.7%) | 0/17 (0%) | 0/53 (0%) | 1/159 (0.6%) | |||||
| Lung carcinoma cell type unspecified stage III | 0/29 (0%) | 0/60 (0%) | 1/17 (5.9%) | 0/53 (0%) | 1/159 (0.6%) | |||||
| Lymphoma | 0/29 (0%) | 1/60 (1.7%) | 0/17 (0%) | 0/53 (0%) | 1/159 (0.6%) | |||||
| Meningioma | 0/29 (0%) | 1/60 (1.7%) | 0/17 (0%) | 0/53 (0%) | 1/159 (0.6%) | |||||
| Myelodysplastic syndrome | 1/29 (3.4%) | 1/60 (1.7%) | 0/17 (0%) | 0/53 (0%) | 2/159 (1.3%) | |||||
| Prostate cancer | 0/29 (0%) | 1/60 (1.7%) | 0/17 (0%) | 0/53 (0%) | 1/159 (0.6%) | |||||
| Squamous cell carcinoma | 1/29 (3.4%) | 0/60 (0%) | 0/17 (0%) | 0/53 (0%) | 1/159 (0.6%) | |||||
| Squamous cell carcinoma of lung | 1/29 (3.4%) | 0/60 (0%) | 0/17 (0%) | 0/53 (0%) | 1/159 (0.6%) | |||||
| Transitional cell carcinoma | 1/29 (3.4%) | 0/60 (0%) | 0/17 (0%) | 0/53 (0%) | 1/159 (0.6%) | |||||
| Nervous system disorders | ||||||||||
| Carotid artery stenosis | 1/29 (3.4%) | 0/60 (0%) | 0/17 (0%) | 0/53 (0%) | 1/159 (0.6%) | |||||
| Cerebrovascular accident | 1/29 (3.4%) | 0/60 (0%) | 0/17 (0%) | 0/53 (0%) | 1/159 (0.6%) | |||||
| Epilepsy | 0/29 (0%) | 1/60 (1.7%) | 0/17 (0%) | 0/53 (0%) | 1/159 (0.6%) | |||||
| Hydrocephalus | 0/29 (0%) | 1/60 (1.7%) | 0/17 (0%) | 0/53 (0%) | 1/159 (0.6%) | |||||
| Hypoaesthesia | 1/29 (3.4%) | 0/60 (0%) | 0/17 (0%) | 0/53 (0%) | 1/159 (0.6%) | |||||
| Ischaemic stroke | 1/29 (3.4%) | 0/60 (0%) | 0/17 (0%) | 0/53 (0%) | 1/159 (0.6%) | |||||
| Syncope | 0/29 (0%) | 1/60 (1.7%) | 1/17 (5.9%) | 0/53 (0%) | 2/159 (1.3%) | |||||
| Transient ischaemic attack | 1/29 (3.4%) | 0/60 (0%) | 0/17 (0%) | 0/53 (0%) | 1/159 (0.6%) | |||||
| Psychiatric disorders | ||||||||||
| Mental status changes | 0/29 (0%) | 1/60 (1.7%) | 0/17 (0%) | 0/53 (0%) | 1/159 (0.6%) | |||||
| Renal and urinary disorders | ||||||||||
| Nephrolithiasis | 0/29 (0%) | 0/60 (0%) | 0/17 (0%) | 1/53 (1.9%) | 1/159 (0.6%) | |||||
| Reproductive system and breast disorders | ||||||||||
| Pelvic pain | 0/29 (0%) | 1/60 (1.7%) | 0/17 (0%) | 0/53 (0%) | 1/159 (0.6%) | |||||
| Respiratory, thoracic and mediastinal disorders | ||||||||||
| Asthma | 1/29 (3.4%) | 0/60 (0%) | 0/17 (0%) | 0/53 (0%) | 1/159 (0.6%) | |||||
| Chronic obstructive pulmonary disease | 0/29 (0%) | 3/60 (5%) | 0/17 (0%) | 0/53 (0%) | 3/159 (1.9%) | |||||
| Dyspnoea | 0/29 (0%) | 2/60 (3.3%) | 0/17 (0%) | 0/53 (0%) | 2/159 (1.3%) | |||||
| Pneumothorax | 1/29 (3.4%) | 0/60 (0%) | 0/17 (0%) | 0/53 (0%) | 1/159 (0.6%) | |||||
| Pneumothorax spontaneous | 0/29 (0%) | 1/60 (1.7%) | 0/17 (0%) | 0/53 (0%) | 1/159 (0.6%) | |||||
| Respiratory failure | 0/29 (0%) | 1/60 (1.7%) | 0/17 (0%) | 0/53 (0%) | 1/159 (0.6%) | |||||
| Sleep apnoea syndrome | 0/29 (0%) | 1/60 (1.7%) | 0/17 (0%) | 0/53 (0%) | 1/159 (0.6%) | |||||
| Vascular disorders | ||||||||||
| Deep vein thrombosis | 1/29 (3.4%) | 1/60 (1.7%) | 0/17 (0%) | 0/53 (0%) | 2/159 (1.3%) | |||||
| Hypertension | 0/29 (0%) | 1/60 (1.7%) | 0/17 (0%) | 0/53 (0%) | 1/159 (0.6%) | |||||
| Varicose vein | 0/29 (0%) | 1/60 (1.7%) | 0/17 (0%) | 0/53 (0%) | 1/159 (0.6%) | |||||
Other (Not Including Serious) Adverse Events |
||||||||||
| CFD4870g Sham | CFD4870g Lampalizumab | GX29455 Sham | GX29455 Lampalizumab | All Participants | ||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 24/29 (82.8%) | 56/60 (93.3%) | 16/17 (94.1%) | 41/53 (77.4%) | 137/159 (86.2%) | |||||
| Blood and lymphatic system disorders | ||||||||||
| Anaemia | 2/29 (6.9%) | 1/60 (1.7%) | 1/17 (5.9%) | 2/53 (3.8%) | 6/159 (3.8%) | |||||
| Leukocytosis | 0/29 (0%) | 0/60 (0%) | 1/17 (5.9%) | 0/53 (0%) | 1/159 (0.6%) | |||||
| Cardiac disorders | ||||||||||
| Atrial fibrillation | 2/29 (6.9%) | 10/60 (16.7%) | 1/17 (5.9%) | 2/53 (3.8%) | 15/159 (9.4%) | |||||
| Coronary artery disease | 1/29 (3.4%) | 4/60 (6.7%) | 0/17 (0%) | 0/53 (0%) | 5/159 (3.1%) | |||||
| Cardiac failure congestive | 0/29 (0%) | 3/60 (5%) | 0/17 (0%) | 1/53 (1.9%) | 4/159 (2.5%) | |||||
| Ear and labyrinth disorders | ||||||||||
| Vertigo positional | 0/29 (0%) | 0/60 (0%) | 1/17 (5.9%) | 0/53 (0%) | 1/159 (0.6%) | |||||
| Eye disorders | ||||||||||
| Conjunctival haemorrhage | 4/29 (13.8%) | 18/60 (30%) | 3/17 (17.6%) | 3/53 (5.7%) | 28/159 (17.6%) | |||||
| Retinal haemorrhage | 4/29 (13.8%) | 13/60 (21.7%) | 2/17 (11.8%) | 3/53 (5.7%) | 22/159 (13.8%) | |||||
| Eye pain | 3/29 (10.3%) | 14/60 (23.3%) | 0/17 (0%) | 4/53 (7.5%) | 21/159 (13.2%) | |||||
| Cataract | 1/29 (3.4%) | 9/60 (15%) | 0/17 (0%) | 5/53 (9.4%) | 15/159 (9.4%) | |||||
| Posterior capsule opacification | 3/29 (10.3%) | 3/60 (5%) | 2/17 (11.8%) | 5/53 (9.4%) | 13/159 (8.2%) | |||||
| Vitreous detachment | 4/29 (13.8%) | 2/60 (3.3%) | 0/17 (0%) | 6/53 (11.3%) | 12/159 (7.5%) | |||||
| Vitreous floaters | 2/29 (6.9%) | 6/60 (10%) | 1/17 (5.9%) | 3/53 (5.7%) | 12/159 (7.5%) | |||||
| Dry eye | 1/29 (3.4%) | 6/60 (10%) | 0/17 (0%) | 4/53 (7.5%) | 11/159 (6.9%) | |||||
| Punctate keratitis | 1/29 (3.4%) | 7/60 (11.7%) | 2/17 (11.8%) | 1/53 (1.9%) | 11/159 (6.9%) | |||||
| Visual impairment | 0/29 (0%) | 5/60 (8.3%) | 1/17 (5.9%) | 3/53 (5.7%) | 9/159 (5.7%) | |||||
| Cataract nuclear | 1/29 (3.4%) | 3/60 (5%) | 0/17 (0%) | 4/53 (7.5%) | 8/159 (5%) | |||||
| Blepharitis | 1/29 (3.4%) | 4/60 (6.7%) | 0/17 (0%) | 2/53 (3.8%) | 7/159 (4.4%) | |||||
| Neovascular age-related macular degeneration | 2/29 (6.9%) | 3/60 (5%) | 1/17 (5.9%) | 1/53 (1.9%) | 7/159 (4.4%) | |||||
| Vision blurred | 3/29 (10.3%) | 4/60 (6.7%) | 0/17 (0%) | 0/53 (0%) | 7/159 (4.4%) | |||||
| Iritis | 1/29 (3.4%) | 4/60 (6.7%) | 1/17 (5.9%) | 0/53 (0%) | 6/159 (3.8%) | |||||
| Blindness transient | 1/29 (3.4%) | 4/60 (6.7%) | 0/17 (0%) | 0/53 (0%) | 5/159 (3.1%) | |||||
| Cataract subcapsular | 0/29 (0%) | 4/60 (6.7%) | 1/17 (5.9%) | 0/53 (0%) | 5/159 (3.1%) | |||||
| Dry age-related macular degeneration | 2/29 (6.9%) | 2/60 (3.3%) | 0/17 (0%) | 1/53 (1.9%) | 5/159 (3.1%) | |||||
| Eye pruritus | 1/29 (3.4%) | 3/60 (5%) | 1/17 (5.9%) | 0/53 (0%) | 5/159 (3.1%) | |||||
| Lacrimation increased | 2/29 (6.9%) | 1/60 (1.7%) | 0/17 (0%) | 2/53 (3.8%) | 5/159 (3.1%) | |||||
| Ocular hyperaemia | 1/29 (3.4%) | 3/60 (5%) | 0/17 (0%) | 1/53 (1.9%) | 5/159 (3.1%) | |||||
| Foreign body sensation in eyes | 1/29 (3.4%) | 3/60 (5%) | 0/17 (0%) | 0/53 (0%) | 4/159 (2.5%) | |||||
| Visual acuity reduced | 2/29 (6.9%) | 1/60 (1.7%) | 0/17 (0%) | 1/53 (1.9%) | 4/159 (2.5%) | |||||
| Blepharochalasis | 0/29 (0%) | 0/60 (0%) | 0/17 (0%) | 3/53 (5.7%) | 3/159 (1.9%) | |||||
| Conjunctival hyperaemia | 2/29 (6.9%) | 1/60 (1.7%) | 0/17 (0%) | 0/53 (0%) | 3/159 (1.9%) | |||||
| Ocular hypertension | 0/29 (0%) | 0/60 (0%) | 0/17 (0%) | 3/53 (5.7%) | 3/159 (1.9%) | |||||
| Open angle glaucoma | 1/29 (3.4%) | 0/60 (0%) | 1/17 (5.9%) | 1/53 (1.9%) | 3/159 (1.9%) | |||||
| Trichiasis | 2/29 (6.9%) | 1/60 (1.7%) | 0/17 (0%) | 0/53 (0%) | 3/159 (1.9%) | |||||
| Corneal erosion | 2/29 (6.9%) | 0/60 (0%) | 0/17 (0%) | 0/53 (0%) | 2/159 (1.3%) | |||||
| Corneal opacity | 0/29 (0%) | 1/60 (1.7%) | 1/17 (5.9%) | 0/53 (0%) | 2/159 (1.3%) | |||||
| Vitreous haemorrhage | 2/29 (6.9%) | 0/60 (0%) | 0/17 (0%) | 0/53 (0%) | 2/159 (1.3%) | |||||
| Corneal oedema | 0/29 (0%) | 0/60 (0%) | 1/17 (5.9%) | 0/53 (0%) | 1/159 (0.6%) | |||||
| Eyelid ptosis | 0/29 (0%) | 0/60 (0%) | 1/17 (5.9%) | 0/53 (0%) | 1/159 (0.6%) | |||||
| Macular oedema | 0/29 (0%) | 0/60 (0%) | 1/17 (5.9%) | 0/53 (0%) | 1/159 (0.6%) | |||||
| Gastrointestinal disorders | ||||||||||
| Constipation | 2/29 (6.9%) | 9/60 (15%) | 1/17 (5.9%) | 1/53 (1.9%) | 13/159 (8.2%) | |||||
| Diarrhoea | 1/29 (3.4%) | 7/60 (11.7%) | 0/17 (0%) | 2/53 (3.8%) | 10/159 (6.3%) | |||||
| Nausea | 1/29 (3.4%) | 5/60 (8.3%) | 0/17 (0%) | 2/53 (3.8%) | 8/159 (5%) | |||||
| Gastrooesophageal reflux disease | 2/29 (6.9%) | 5/60 (8.3%) | 0/17 (0%) | 0/53 (0%) | 7/159 (4.4%) | |||||
| Gastritis | 0/29 (0%) | 5/60 (8.3%) | 0/17 (0%) | 0/53 (0%) | 5/159 (3.1%) | |||||
| General disorders | ||||||||||
| Oedema peripheral | 2/29 (6.9%) | 3/60 (5%) | 1/17 (5.9%) | 2/53 (3.8%) | 8/159 (5%) | |||||
| Pain | 1/29 (3.4%) | 3/60 (5%) | 0/17 (0%) | 0/53 (0%) | 4/159 (2.5%) | |||||
| Asthenia | 0/29 (0%) | 3/60 (5%) | 0/17 (0%) | 0/53 (0%) | 3/159 (1.9%) | |||||
| Injection site pain | 0/29 (0%) | 0/60 (0%) | 1/17 (5.9%) | 0/53 (0%) | 1/159 (0.6%) | |||||
| Immune system disorders | ||||||||||
| Seasonal allergy | 1/29 (3.4%) | 3/60 (5%) | 0/17 (0%) | 0/53 (0%) | 4/159 (2.5%) | |||||
| Drug hypersensitivity | 0/29 (0%) | 3/60 (5%) | 0/17 (0%) | 0/53 (0%) | 3/159 (1.9%) | |||||
| Infections and infestations | ||||||||||
| Nasopharyngitis | 8/29 (27.6%) | 11/60 (18.3%) | 1/17 (5.9%) | 4/53 (7.5%) | 24/159 (15.1%) | |||||
| Urinary tract infection | 3/29 (10.3%) | 13/60 (21.7%) | 1/17 (5.9%) | 4/53 (7.5%) | 21/159 (13.2%) | |||||
| Upper respiratory tract infection | 4/29 (13.8%) | 9/60 (15%) | 3/17 (17.6%) | 4/53 (7.5%) | 20/159 (12.6%) | |||||
| Bronchitis | 5/29 (17.2%) | 7/60 (11.7%) | 0/17 (0%) | 2/53 (3.8%) | 14/159 (8.8%) | |||||
| Sinusitis | 4/29 (13.8%) | 5/60 (8.3%) | 1/17 (5.9%) | 1/53 (1.9%) | 11/159 (6.9%) | |||||
| Pneumonia | 0/29 (0%) | 6/60 (10%) | 1/17 (5.9%) | 2/53 (3.8%) | 9/159 (5.7%) | |||||
| Herpes zoster | 1/29 (3.4%) | 4/60 (6.7%) | 0/17 (0%) | 2/53 (3.8%) | 7/159 (4.4%) | |||||
| Influenza | 0/29 (0%) | 6/60 (10%) | 1/17 (5.9%) | 0/53 (0%) | 7/159 (4.4%) | |||||
| Cystitis | 1/29 (3.4%) | 3/60 (5%) | 0/17 (0%) | 1/53 (1.9%) | 5/159 (3.1%) | |||||
| Ear infection | 0/29 (0%) | 4/60 (6.7%) | 1/17 (5.9%) | 0/53 (0%) | 5/159 (3.1%) | |||||
| Conjunctivitis | 1/29 (3.4%) | 3/60 (5%) | 0/17 (0%) | 0/53 (0%) | 4/159 (2.5%) | |||||
| Tooth infection | 1/29 (3.4%) | 3/60 (5%) | 0/17 (0%) | 0/53 (0%) | 4/159 (2.5%) | |||||
| Cellulitis | 1/29 (3.4%) | 1/60 (1.7%) | 1/17 (5.9%) | 0/53 (0%) | 3/159 (1.9%) | |||||
| Diverticulitis | 0/29 (0%) | 3/60 (5%) | 0/17 (0%) | 0/53 (0%) | 3/159 (1.9%) | |||||
| Oral herpes | 0/29 (0%) | 1/60 (1.7%) | 1/17 (5.9%) | 0/53 (0%) | 2/159 (1.3%) | |||||
| Injury, poisoning and procedural complications | ||||||||||
| Fall | 7/29 (24.1%) | 13/60 (21.7%) | 3/17 (17.6%) | 2/53 (3.8%) | 25/159 (15.7%) | |||||
| Contusion | 0/29 (0%) | 5/60 (8.3%) | 0/17 (0%) | 1/53 (1.9%) | 6/159 (3.8%) | |||||
| Procedural pain | 1/29 (3.4%) | 5/60 (8.3%) | 0/17 (0%) | 0/53 (0%) | 6/159 (3.8%) | |||||
| Corneal abrasion | 1/29 (3.4%) | 4/60 (6.7%) | 0/17 (0%) | 0/53 (0%) | 5/159 (3.1%) | |||||
| Laceration | 0/29 (0%) | 3/60 (5%) | 1/17 (5.9%) | 0/53 (0%) | 4/159 (2.5%) | |||||
| Ligament sprain | 0/29 (0%) | 3/60 (5%) | 1/17 (5.9%) | 0/53 (0%) | 4/159 (2.5%) | |||||
| Rib fracture | 1/29 (3.4%) | 3/60 (5%) | 0/17 (0%) | 0/53 (0%) | 4/159 (2.5%) | |||||
| Muscle strain | 0/29 (0%) | 3/60 (5%) | 0/17 (0%) | 0/53 (0%) | 3/159 (1.9%) | |||||
| Skin abrasion | 2/29 (6.9%) | 0/60 (0%) | 0/17 (0%) | 1/53 (1.9%) | 3/159 (1.9%) | |||||
| Foot fracture | 0/29 (0%) | 0/60 (0%) | 1/17 (5.9%) | 0/53 (0%) | 1/159 (0.6%) | |||||
| Forearm fracture | 0/29 (0%) | 0/60 (0%) | 1/17 (5.9%) | 0/53 (0%) | 1/159 (0.6%) | |||||
| Investigations | ||||||||||
| Intraocular pressure increased | 3/29 (10.3%) | 6/60 (10%) | 0/17 (0%) | 3/53 (5.7%) | 12/159 (7.5%) | |||||
| Blood glucose increased | 0/29 (0%) | 0/60 (0%) | 1/17 (5.9%) | 0/53 (0%) | 1/159 (0.6%) | |||||
| Metabolism and nutrition disorders | ||||||||||
| Hypokalaemia | 0/29 (0%) | 5/60 (8.3%) | 0/17 (0%) | 1/53 (1.9%) | 6/159 (3.8%) | |||||
| Hypercholesterolaemia | 2/29 (6.9%) | 2/60 (3.3%) | 0/17 (0%) | 1/53 (1.9%) | 5/159 (3.1%) | |||||
| Hyperlipidaemia | 0/29 (0%) | 4/60 (6.7%) | 0/17 (0%) | 0/53 (0%) | 4/159 (2.5%) | |||||
| Diabetes mellitus | 1/29 (3.4%) | 1/60 (1.7%) | 1/17 (5.9%) | 0/53 (0%) | 3/159 (1.9%) | |||||
| Musculoskeletal and connective tissue disorders | ||||||||||
| Arthralgia | 1/29 (3.4%) | 5/60 (8.3%) | 1/17 (5.9%) | 2/53 (3.8%) | 9/159 (5.7%) | |||||
| Back pain | 2/29 (6.9%) | 4/60 (6.7%) | 0/17 (0%) | 2/53 (3.8%) | 8/159 (5%) | |||||
| Arthritis | 3/29 (10.3%) | 3/60 (5%) | 1/17 (5.9%) | 0/53 (0%) | 7/159 (4.4%) | |||||
| Pain in extremity | 2/29 (6.9%) | 4/60 (6.7%) | 1/17 (5.9%) | 0/53 (0%) | 7/159 (4.4%) | |||||
| Musculoskeletal pain | 3/29 (10.3%) | 2/60 (3.3%) | 0/17 (0%) | 1/53 (1.9%) | 6/159 (3.8%) | |||||
| Osteoporosis | 0/29 (0%) | 3/60 (5%) | 1/17 (5.9%) | 1/53 (1.9%) | 5/159 (3.1%) | |||||
| Sjogren's syndrome | 0/29 (0%) | 3/60 (5%) | 0/17 (0%) | 0/53 (0%) | 3/159 (1.9%) | |||||
| Foot deformity | 0/29 (0%) | 1/60 (1.7%) | 1/17 (5.9%) | 0/53 (0%) | 2/159 (1.3%) | |||||
| Bone swelling | 0/29 (0%) | 0/60 (0%) | 1/17 (5.9%) | 0/53 (0%) | 1/159 (0.6%) | |||||
| Metatarsalgia | 0/29 (0%) | 0/60 (0%) | 1/17 (5.9%) | 0/53 (0%) | 1/159 (0.6%) | |||||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||||||
| Basal cell carcinoma | 3/29 (10.3%) | 2/60 (3.3%) | 1/17 (5.9%) | 0/53 (0%) | 6/159 (3.8%) | |||||
| Benign neoplasm of skin | 2/29 (6.9%) | 1/60 (1.7%) | 0/17 (0%) | 0/53 (0%) | 3/159 (1.9%) | |||||
| Blepharal papilloma | 0/29 (0%) | 3/60 (5%) | 0/17 (0%) | 0/53 (0%) | 3/159 (1.9%) | |||||
| Nervous system disorders | ||||||||||
| Headache | 1/29 (3.4%) | 8/60 (13.3%) | 0/17 (0%) | 0/53 (0%) | 9/159 (5.7%) | |||||
| Dementia | 1/29 (3.4%) | 3/60 (5%) | 0/17 (0%) | 1/53 (1.9%) | 5/159 (3.1%) | |||||
| Dizziness | 0/29 (0%) | 2/60 (3.3%) | 1/17 (5.9%) | 1/53 (1.9%) | 4/159 (2.5%) | |||||
| Neuropathy peripheral | 1/29 (3.4%) | 2/60 (3.3%) | 1/17 (5.9%) | 0/53 (0%) | 4/159 (2.5%) | |||||
| Paraesthesia | 2/29 (6.9%) | 0/60 (0%) | 0/17 (0%) | 0/53 (0%) | 2/159 (1.3%) | |||||
| Migraine | 0/29 (0%) | 0/60 (0%) | 1/17 (5.9%) | 0/53 (0%) | 1/159 (0.6%) | |||||
| Psychiatric disorders | ||||||||||
| Depression | 1/29 (3.4%) | 4/60 (6.7%) | 0/17 (0%) | 1/53 (1.9%) | 6/159 (3.8%) | |||||
| Anxiety | 0/29 (0%) | 3/60 (5%) | 0/17 (0%) | 2/53 (3.8%) | 5/159 (3.1%) | |||||
| Hallucination, visual | 0/29 (0%) | 1/60 (1.7%) | 1/17 (5.9%) | 0/53 (0%) | 2/159 (1.3%) | |||||
| Renal and urinary disorders | ||||||||||
| Haematuria | 1/29 (3.4%) | 4/60 (6.7%) | 0/17 (0%) | 0/53 (0%) | 5/159 (3.1%) | |||||
| Respiratory, thoracic and mediastinal disorders | ||||||||||
| Cough | 2/29 (6.9%) | 5/60 (8.3%) | 0/17 (0%) | 1/53 (1.9%) | 8/159 (5%) | |||||
| Dyspnoea | 0/29 (0%) | 3/60 (5%) | 1/17 (5.9%) | 1/53 (1.9%) | 5/159 (3.1%) | |||||
| Chronic obstructive pulmonary disease | 1/29 (3.4%) | 2/60 (3.3%) | 1/17 (5.9%) | 0/53 (0%) | 4/159 (2.5%) | |||||
| Oropharyngeal pain | 2/29 (6.9%) | 0/60 (0%) | 0/17 (0%) | 1/53 (1.9%) | 3/159 (1.9%) | |||||
| Sinus congestion | 0/29 (0%) | 0/60 (0%) | 1/17 (5.9%) | 0/53 (0%) | 1/159 (0.6%) | |||||
| Skin and subcutaneous tissue disorders | ||||||||||
| Ingrowing nail | 2/29 (6.9%) | 1/60 (1.7%) | 0/17 (0%) | 0/53 (0%) | 3/159 (1.9%) | |||||
| Hyperkeratosis | 1/29 (3.4%) | 0/60 (0%) | 1/17 (5.9%) | 0/53 (0%) | 2/159 (1.3%) | |||||
| Skin ulcer | 1/29 (3.4%) | 0/60 (0%) | 1/17 (5.9%) | 0/53 (0%) | 2/159 (1.3%) | |||||
| Surgical and medical procedures | ||||||||||
| Cataract operation | 0/29 (0%) | 0/60 (0%) | 1/17 (5.9%) | 0/53 (0%) | 1/159 (0.6%) | |||||
| Vascular disorders | ||||||||||
| Hypertension | 2/29 (6.9%) | 7/60 (11.7%) | 1/17 (5.9%) | 1/53 (1.9%) | 11/159 (6.9%) | |||||
| Hypotension | 0/29 (0%) | 4/60 (6.7%) | 1/17 (5.9%) | 0/53 (0%) | 5/159 (3.1%) | |||||
| Peripheral vascular disorder | 0/29 (0%) | 0/60 (0%) | 1/17 (5.9%) | 0/53 (0%) | 1/159 (0.6%) | |||||
Limitations/Caveats
This study was terminated early by the Sponsor, because the compound had demonstrated lack of efficacy. Thus, no participant in this study completed the full duration of treatment.
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
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
| Name/Title | Medical Communications |
|---|---|
| Organization | Hoffmann-La Roche |
| Phone | 800 821 - 8590 |
| genentech@druginfo.com |
Responsible Party:
Genentech, Inc.
ClinicalTrials.gov Identifier:
NCT01602120
Other Study ID Numbers:
- GX28198
- 2012-000578-41
First Posted:
May 18, 2012
Last Update Posted:
Sep 11, 2019
Last Verified:
Sep 1, 2019