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A Study of Lampalizumab Intravitreal Injections Administered Every Two Weeks or Every Four Weeks to Participants With Geographic Atrophy

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: NCT02288559
Recruitment Status : Completed
First Posted : November 11, 2014
Results First Posted : February 19, 2019
Last Update Posted : September 25, 2019
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Condition Geographic Atrophy
Interventions Other: Sham
Drug: Lampalizumab
Enrollment 96
Recruitment Details  
Pre-assignment Details

A total of 332 participants were screened and 92 participants were randomized out of which 3 participants from one site were removed from the randomized population due to serious good clinical practice (GCP) noncompliance. Out of 89, 4 participants were excluded from the randomized population as they did not have any post-baseline measurement.

.

Arm/Group Title Sham Q2W Sham Q4W Lampalizumab Q2W Lampalizumab Q4W
Hide Arm/Group Description Participants received sham comparator Q2W (once every 2 weeks) for 24 weeks. Participants received sham comparator Q4W (once every 4 weeks) for 24 weeks. Participants received 10 milligrams (mg) dose of lampalizumab administered by intravitreal injections Q2W for 24 weeks. Participants received 10 mg dose of lampalizumab administered by intravitreal injections Q4W for 24 weeks.
Period Title: Overall Study
Started 10 11 46 22
Completed 9 10 35 20
Not Completed 1 1 11 2
Reason Not Completed
Adverse Event             1             1             5             0
Death             0             0             1             0
Lost to Follow-up             0             0             0             1
Withdrawal by Subject             0             0             2             1
Reason Not Specified             0             0             3             0
Arm/Group Title Sham Q2W Sham Q4W Lampalizumab Q2W Lampalizumab Q4W Total
Hide Arm/Group Description Participants received sham comparator Q2W (once every 2 weeks) for 24 weeks. Participants received sham comparator Q4W (once every 4 weeks) for 24 weeks. Participants received 10 milligrams (mg) dose of lampalizumab administered by intravitreal injections Q2W for 24 weeks. Participants received 10 mg dose of lampalizumab administered by intravitreal injections Q4W for 24 weeks. Total of all reporting groups
Overall Number of Baseline Participants 10 10 43 22 85
Hide Baseline Analysis Population Description
Modified intent-to-treat (mITT) population included participants who were randomly assigned to study treatment and had at least one post-baseline geographic atrophy (GA) area measurement.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 10 participants 10 participants 43 participants 22 participants 85 participants
73.4  (4.4) 78.2  (7.7) 78.3  (8.0) 80.1  (7.7) 78.2  (7.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 10 participants 43 participants 22 participants 85 participants
Female
7
  70.0%
8
  80.0%
25
  58.1%
9
  40.9%
49
  57.6%
Male
3
  30.0%
2
  20.0%
18
  41.9%
13
  59.1%
36
  42.4%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 10 participants 43 participants 22 participants 85 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
1
   2.3%
0
   0.0%
1
   1.2%
Not Hispanic or Latino
10
 100.0%
10
 100.0%
42
  97.7%
22
 100.0%
84
  98.8%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 10 participants 43 participants 22 participants 85 participants
American Indian or Alaska Native
0
   0.0%
1
  10.0%
0
   0.0%
0
   0.0%
1
   1.2%
Asian
1
  10.0%
0
   0.0%
1
   2.3%
0
   0.0%
2
   2.4%
White
9
  90.0%
9
  90.0%
42
  97.7%
22
 100.0%
82
  96.5%
Geographic Atrophy Area, as Assessed by Fundus Autofluorescence (FAF)   [1] 
Mean (Standard Deviation)
Unit of measure:  Millimeter square (mm^2)
Number Analyzed 10 participants 10 participants 43 participants 22 participants 85 participants
7.034  (2.747) 6.891  (3.050) 8.755  (4.059) 7.172  (4.192) 7.923  (3.894)
[1]
Measure Description: GA or the death of photoreceptors and surrounding cells in the retina, is a common condition in participants with age-related macular degeneration (AMD). The death of these photoreceptors results in lesions that cause vision loss. The change in GA lesion area was measured by FAF and analysis of FAF images was performed by the central reading center.
1.Primary Outcome
Title Change From Baseline in Geographic Atrophy (GA) Area, as Assessed by Fundus Autofluorescence (FAF) at Week 24
Hide Description GA or the death of photoreceptors and surrounding cells in the retina, is a common condition in participants with age-related macular degeneration (AMD). The death of these photoreceptors results in lesions that cause vision loss. The change in GA lesion area was measured by FAF and analysis of FAF images was performed by the central reading center. A positive change from baseline indicates an increase in size of geographic atrophy lesion area (worsening; disease progression). BCVA=best corrected visual acuity; ETDRS=Early Treatment Diabetic Retinopathy Scale.
Time Frame Baseline, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Modified intent-to-treat (mITT) population included participants who were randomly assigned to study treatment and had at least one post-baseline GA area measurement. Number analyzed is the number of participants with data available for analysis at the given time-point.
Arm/Group Title Sham Q2W Sham Q4W Lampalizumab Q2W Lampalizumab Q4W
Hide Arm/Group Description:
Participants received sham comparator Q2W (once every 2 weeks) for 24 weeks.
Participants received sham comparator Q4W (once every 4 weeks) for 24 weeks.
Participants received 10 milligrams (mg) dose of lampalizumab administered by intravitreal injections Q2W for 24 weeks.
Participants received 10 mg dose of lampalizumab administered by intravitreal injections Q4W for 24 weeks.
Overall Number of Participants Analyzed 10 10 43 22
Mean (Standard Error)
Unit of Measure: mm^2
0.614  (0.188) 1.121  (0.179) 1.049  (0.094) 0.911  (0.123)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sham Q2W, Lampalizumab Q2W
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0428
Comments [Not Specified]
Method Mixed-Effect Model Repeated Measures
Comments MMRM analysis variables: treatment group, visit, treatment-by-visit interaction, baseline GA area, and BCVA ETDRS chart Snellen equivalent category.
Method of Estimation Estimation Parameter Difference in Adjusted Means
Estimated Value 0.435
Confidence Interval (2-Sided) 80%
0.162 to 0.707
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Sham Q4W, Lampalizumab Q4W
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3361
Comments [Not Specified]
Method MMRM
Comments MMRM analysis variables: treatment group, visit, treatment-by-visit interaction, baseline GA area, and BCVA ETDRS chart Snellen equivalent category.
Method of Estimation Estimation Parameter Difference in Adjusted Means
Estimated Value -0.210
Confidence Interval (2-Sided) 80%
-0.491 to 0.071
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Serum Concentrations of Lampalizumab (Q2W)
Hide Description Lower than reportable (LTR) results on pre-dose sample were set to 0, and LTR results on post-dose sample were set to half of lower limit of quantification (LLOQ) (0.5 nanograms per milliliter (ng/mL)).
Time Frame Baseline (Day 1, predose and postdose), Weeks 2,4,8,16 and 24, early termination, unscheduled predose and postdose
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetics (PK) population included participants randomized to lampalizumab treatment who received at least one dose of study drug and provided at least one serum sample for determination of lampalizumab. Number analyzed is the number of participants with data available for analysis at the given time-point.
Arm/Group Title Lampalizumab Q2W
Hide Arm/Group Description:
Participants received 10 milligrams (mg) dose of lampalizumab administered by intravitreal injections Q2W for 24 weeks.
Overall Number of Participants Analyzed 46
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng/mL
Day 1 (Predose) Number Analyzed 43 participants
NA [1] 
(NA%)
Day 1 (Postdose) Number Analyzed 44 participants
1.31 [2] 
(NA%)
Week 2 Number Analyzed 45 participants
55.5
(89.1%)
Week 4 Number Analyzed 42 participants
63.6
(69.4%)
Week 8 Number Analyzed 43 participants
64.4
(83.7%)
Week 16 Number Analyzed 33 participants
78.2
(68.0%)
Week 24 Number Analyzed 32 participants
62.7
(141.4%)
Early Termination Number Analyzed 6 participants
4.92
(1070.9%)
Unscheduled predose Number Analyzed 2 participants
0.500 [2] 
(NA%)
Unscheduled postdose Number Analyzed 1 participants
0.500 [2] 
(NA%)
[1]
Geometric mean and geometric coefficient of variation were not calculable as more than one-third of the values were LTR.
[2]
Geometric coefficient of variation was not calculable as more than one-third of the values were LTR.
3.Secondary Outcome
Title Serum Concentrations of Lampalizumab (Q4W)
Hide Description LTR results on pre-dose sample were set to 0, and LTR results on post-dose sample were set to half of LLOQ (0.5 ng/mL).
Time Frame Baseline (Day 1, predose and postdose), Weeks 4,8,16 and 24, early termination
Hide Outcome Measure Data
Hide Analysis Population Description
PK population included participants randomized to lampalizumab treatment who received at least one dose of study drug and provided at least one serum sample for determination of lampalizumab. Number analyzed is the number of participants with data available for analysis at the given time-point.
Arm/Group Title Lampalizumab Q4W
Hide Arm/Group Description:
Participants received 10 mg dose of lampalizumab administered by intravitreal injections Q4W for 24 weeks.
Overall Number of Participants Analyzed 23
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng/mL
Day 1 (Predose) Number Analyzed 22 participants
NA [1] 
(NA%)
Day 1 (Postdose) Number Analyzed 21 participants
2.08 [2] 
(NA%)
Week 4 Number Analyzed 22 participants
8.52
(114.3%)
Week 8 Number Analyzed 22 participants
10.3
(84.1%)
Week 16 Number Analyzed 21 participants
8.66
(88.0%)
Week 24 Number Analyzed 18 participants
9.92
(102.0%)
Early Termination Number Analyzed 1 participants
14.1 [2] 
(NA%)
[1]
Geometric mean and geometric coefficient of variation were not calculable as more than one-third of the values were LTR.
[2]
Geometric coefficient of variation was not calculable as more than one-third of the values were LTR.
4.Secondary Outcome
Title Percentage of Participants With Ocular Adverse Events (AEs)
Hide 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 the events which are localized in the ocular region.
Time Frame Baseline up to approximately 30 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis population included all randomized participants who received at least one dose of study drug.
Arm/Group Title Sham Q2W Sham Q4W Lampalizumab Q2W Lampalizumab Q4W
Hide Arm/Group Description:
Participants received sham comparator Q2W (once every 2 weeks) for 24 weeks.
Participants received sham comparator Q4W (once every 4 weeks) for 24 weeks.
Participants received 10 milligrams (mg) dose of lampalizumab administered by intravitreal injections Q2W for 24 weeks.
Participants received 10 mg dose of lampalizumab administered by intravitreal injections Q4W for 24 weeks.
Overall Number of Participants Analyzed 10 11 46 22
Measure Type: Number
Unit of Measure: percentage of participants
60.0 9.1 63.0 63.6
5.Secondary Outcome
Title Percentage of Participants With Systemic (Non-ocular) Adverse Events
Hide 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. Non-ocular AEs were the systemic events.
Time Frame Baseline up to approximately 30 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis population included all randomized participants who received at least one dose of study drug.
Arm/Group Title Sham Q2W Sham Q4W Lampalizumab Q2W Lampalizumab Q4W
Hide Arm/Group Description:
Participants received sham comparator Q2W (once every 2 weeks) for 24 weeks.
Participants received sham comparator Q4W (once every 4 weeks) for 24 weeks.
Participants received 10 milligrams (mg) dose of lampalizumab administered by intravitreal injections Q2W for 24 weeks.
Participants received 10 mg dose of lampalizumab administered by intravitreal injections Q4W for 24 weeks.
Overall Number of Participants Analyzed 10 11 46 22
Measure Type: Number
Unit of Measure: percentage of participants
40.0 63.6 52.2 50.0
6.Secondary Outcome
Title Percentage of Participants With Anti-Lampalizumab Antibodies
Hide Description Having treatment-induced anti-drug antibodies (ADAs) was defined as being ADA-negative at baseline and ADA-positive at any post-baseline timepoint. Having treatment-enhanced ADAs was defined as being ADA-positive at baseline with titer values increased by 0.6 titer units at any post-baseline timepoint.
Time Frame Baseline up to approximately 30 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis population included all randomized participants who received at least one dose of study drug. Number analyzed is the number of participants with data available for analysis at the given time-point.
Arm/Group Title Sham Q2W Sham Q4W Lampalizumab Q2W Lampalizumab Q4W
Hide Arm/Group Description:
Participants received sham comparator Q2W (once every 2 weeks) for 24 weeks.
Participants received sham comparator Q4W (once every 4 weeks) for 24 weeks.
Participants received 10 milligrams (mg) dose of lampalizumab administered by intravitreal injections Q2W for 24 weeks.
Participants received 10 mg dose of lampalizumab administered by intravitreal injections Q4W for 24 weeks.
Overall Number of Participants Analyzed 10 11 46 22
Measure Type: Number
Unit of Measure: percentage of participants
Treatment-induced ADA Number Analyzed 10 participants 11 participants 45 participants 22 participants
0 0 1 1
Treatment-enhanced ADA Number Analyzed 10 participants 11 participants 45 participants 22 participants
0 0 0 0
Time Frame Baseline up to approximately 30 weeks
Adverse Event Reporting Description Safety analysis population included all randomized participants who received at least one dose of study drug.
 
Arm/Group Title Lampalizumab Q2W Lampalizumab Q4W Sham Q2W Sham Q4W
Hide Arm/Group Description Participants received 10 milligrams (mg) dose of lampalizumab administered by intravitreal injections Q2W for 24 weeks. Participants received 10 mg dose of lampalizumab administered by intravitreal injections Q4W for 24 weeks. Participants received sham comparator Q2W (once every 2 weeks) for 24 weeks. Participants received sham comparator Q4W (once every 4 weeks) for 24 weeks.
All-Cause Mortality
Lampalizumab Q2W Lampalizumab Q4W Sham Q2W Sham Q4W
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   2/46 (4.35%)   0/22 (0.00%)   0/10 (0.00%)   0/11 (0.00%) 
Hide Serious Adverse Events
Lampalizumab Q2W Lampalizumab Q4W Sham Q2W Sham Q4W
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   7/46 (15.22%)   3/22 (13.64%)   0/10 (0.00%)   1/11 (9.09%) 
Cardiac disorders         
Cardiac arrest  1  1/46 (2.17%)  0/22 (0.00%)  0/10 (0.00%)  0/11 (0.00%) 
Myocardial infarction  1  1/46 (2.17%)  0/22 (0.00%)  0/10 (0.00%)  0/11 (0.00%) 
Postural orthostatic tachycardia syndrome  1  0/46 (0.00%)  1/22 (4.55%)  0/10 (0.00%)  0/11 (0.00%) 
Eye disorders         
Scleritis  1  1/46 (2.17%)  0/22 (0.00%)  0/10 (0.00%)  0/11 (0.00%) 
Uveitis  1  1/46 (2.17%)  0/22 (0.00%)  0/10 (0.00%)  0/11 (0.00%) 
Gastrointestinal disorders         
Abdominal hernia  1  1/46 (2.17%)  0/22 (0.00%)  0/10 (0.00%)  0/11 (0.00%) 
Infections and infestations         
Influenza  1  0/46 (0.00%)  1/22 (4.55%)  0/10 (0.00%)  0/11 (0.00%) 
Injury, poisoning and procedural complications         
Fall  1  1/46 (2.17%)  1/22 (4.55%)  0/10 (0.00%)  0/11 (0.00%) 
Femoral neck fracture  1  1/46 (2.17%)  0/22 (0.00%)  0/10 (0.00%)  0/11 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Malignant melanoma in situ  1  1/46 (2.17%)  0/22 (0.00%)  0/10 (0.00%)  0/11 (0.00%) 
Non-hodgkins lymphoma recurrent  1  0/46 (0.00%)  0/22 (0.00%)  0/10 (0.00%)  1/11 (9.09%) 
Nervous system disorders         
Embolic stroke  1  0/46 (0.00%)  1/22 (4.55%)  0/10 (0.00%)  0/11 (0.00%) 
Presyncope  1  0/46 (0.00%)  0/22 (0.00%)  0/10 (0.00%)  1/11 (9.09%) 
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%
Lampalizumab Q2W Lampalizumab Q4W Sham Q2W Sham Q4W
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   21/46 (45.65%)   13/22 (59.09%)   7/10 (70.00%)   7/11 (63.64%) 
Cardiac disorders         
Atrial fibrillation  1  1/46 (2.17%)  0/22 (0.00%)  0/10 (0.00%)  1/11 (9.09%) 
Ear and labyrinth disorders         
Deafness unilateral  1  0/46 (0.00%)  0/22 (0.00%)  1/10 (10.00%)  0/11 (0.00%) 
Middle ear effusion  1  0/46 (0.00%)  0/22 (0.00%)  0/10 (0.00%)  1/11 (9.09%) 
Vertigo  1  0/46 (0.00%)  0/22 (0.00%)  0/10 (0.00%)  1/11 (9.09%) 
Eye disorders         
Conjunctival haemorrhage  1  12/46 (26.09%)  6/22 (27.27%)  3/10 (30.00%)  1/11 (9.09%) 
Eye pain  1  6/46 (13.04%)  3/22 (13.64%)  0/10 (0.00%)  0/11 (0.00%) 
Vitreous floaters  1  3/46 (6.52%)  2/22 (9.09%)  1/10 (10.00%)  0/11 (0.00%) 
Vitreous detachment  1  2/46 (4.35%)  3/22 (13.64%)  0/10 (0.00%)  0/11 (0.00%) 
Cataract subcapsular  1  1/46 (2.17%)  0/22 (0.00%)  0/10 (0.00%)  1/11 (9.09%) 
Photopsia  1  1/46 (2.17%)  0/22 (0.00%)  1/10 (10.00%)  0/11 (0.00%) 
Posterior capsule opacification  1  1/46 (2.17%)  0/22 (0.00%)  1/10 (10.00%)  0/11 (0.00%) 
Retinal haemorrhage  1  1/46 (2.17%)  0/22 (0.00%)  1/10 (10.00%)  0/11 (0.00%) 
Borderline glaucoma  1  0/46 (0.00%)  0/22 (0.00%)  1/10 (10.00%)  0/11 (0.00%) 
Cataract nuclear  1  0/46 (0.00%)  0/22 (0.00%)  0/10 (0.00%)  1/11 (9.09%) 
Conjunctival oedema  1  0/46 (0.00%)  0/22 (0.00%)  1/10 (10.00%)  0/11 (0.00%) 
Eye pruritus  1  0/46 (0.00%)  0/22 (0.00%)  1/10 (10.00%)  0/11 (0.00%) 
Eyelid ptosis  1  0/46 (0.00%)  0/22 (0.00%)  1/10 (10.00%)  0/11 (0.00%) 
Neovascular age-related macular degeneration  1  0/46 (0.00%)  0/22 (0.00%)  1/10 (10.00%)  0/11 (0.00%) 
Gastrointestinal disorders         
Constipation  1  0/46 (0.00%)  0/22 (0.00%)  0/10 (0.00%)  1/11 (9.09%) 
Dental caries  1  0/46 (0.00%)  0/22 (0.00%)  1/10 (10.00%)  0/11 (0.00%) 
Immune system disorders         
Seasonal allergy  1  3/46 (6.52%)  1/22 (4.55%)  0/10 (0.00%)  0/11 (0.00%) 
Infections and infestations         
Viral upper respiratory tract infection  1  4/46 (8.70%)  3/22 (13.64%)  1/10 (10.00%)  0/11 (0.00%) 
Cystitis  1  0/46 (0.00%)  0/22 (0.00%)  0/10 (0.00%)  1/11 (9.09%) 
Sinusitis  1  0/46 (0.00%)  0/22 (0.00%)  0/10 (0.00%)  1/11 (9.09%) 
Tooth infection  1  0/46 (0.00%)  0/22 (0.00%)  1/10 (10.00%)  0/11 (0.00%) 
Injury, poisoning and procedural complications         
Fall  1  3/46 (6.52%)  0/22 (0.00%)  0/10 (0.00%)  0/11 (0.00%) 
Tooth fracture  1  0/46 (0.00%)  0/22 (0.00%)  1/10 (10.00%)  0/11 (0.00%) 
Investigations         
Blood glucose increased  1  0/46 (0.00%)  0/22 (0.00%)  0/10 (0.00%)  1/11 (9.09%) 
Neutrophil count increased  1  0/46 (0.00%)  0/22 (0.00%)  0/10 (0.00%)  1/11 (9.09%) 
Prothrombin time prolonged  1  0/46 (0.00%)  0/22 (0.00%)  0/10 (0.00%)  1/11 (9.09%) 
White blood cell count increased  1  0/46 (0.00%)  0/22 (0.00%)  0/10 (0.00%)  1/11 (9.09%) 
Musculoskeletal and connective tissue disorders         
Bursitis  1  0/46 (0.00%)  0/22 (0.00%)  0/10 (0.00%)  1/11 (9.09%) 
Osteoarthritis  1  0/46 (0.00%)  0/22 (0.00%)  0/10 (0.00%)  1/11 (9.09%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Squamous cell carcinoma  1  1/46 (2.17%)  2/22 (9.09%)  0/10 (0.00%)  0/11 (0.00%) 
Product Issues         
Device breakage  1  0/46 (0.00%)  0/22 (0.00%)  1/10 (10.00%)  0/11 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Pleural effusion  1  0/46 (0.00%)  0/22 (0.00%)  0/10 (0.00%)  1/11 (9.09%) 
Upper respiratory tract congestion  1  0/46 (0.00%)  0/22 (0.00%)  0/10 (0.00%)  1/11 (9.09%) 
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: (+41) 616878333
EMail: global.trial_information@roche.com
Layout table for additonal information
Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT02288559    
Other Study ID Numbers: GX29455
First Submitted: November 7, 2014
First Posted: November 11, 2014
Results First Submitted: January 24, 2019
Results First Posted: February 19, 2019
Last Update Posted: September 25, 2019