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Efficacy and Safety of Idelalisib in Combination With Obinutuzumab Compared to Chlorambucil in Combination With Obinutuzumab for Previously Untreated Chronic Lymphocytic Leukemia

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ClinicalTrials.gov Identifier: NCT01980875
Recruitment Status : Terminated
First Posted : November 11, 2013
Results First Posted : June 28, 2017
Last Update Posted : November 19, 2018
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Chronic Lymphocytic Leukemia
Interventions Drug: Idelalisib
Drug: Chlorambucil
Drug: Obinutuzumab
Enrollment 57
Recruitment Details Participants were enrolled at study sites in Australia, Europe, and North America. The first participant was screened on 21 April 2015. The last study visit occurred on 13 May 2016.
Pre-assignment Details 80 participants were screened.
Arm/Group Title Safety Run-In: Idelalisib+Obinutuzumab Randomized: Idelalisib+Obinutuzumab Randomized: Obinutuzumab+Chlorambucil
Hide Arm/Group Description Idelalisib (Zydelig®) 150 mg tablet twice daily + obinutuzumab 1000 mg/40 mL intravenously for a total of 8 doses over 21 weeks Idelalisib 150 mg tablet twice daily + obinutuzumab 1000 mg/40 mL intravenously for a total of 8 doses over 21 weeks Chlorambucil 0.5 mg/kg, as 2 mg tablets every other week for a total of 12 doses + obinutuzumab 1000 mg/40 mL intravenously for a total of 8 doses over 21 weeks
Period Title: Overall Study
Started 8 25 24
Completed 0 0 0
Not Completed 8 25 24
Reason Not Completed
Withdrew Consent             1             1             1
Study Terminated by Sponsor             7             24             22
Lost to Follow-up             0             0             1
Arm/Group Title Safety Run-In: Idelalisib+Obinutuzumab Randomized: Idelalisib+Obinutuzumab Randomized: Obinutuzumab+Chlorambucil Total
Hide Arm/Group Description Idelalisib 150 mg tablet twice daily + obinutuzumab 1000 mg/40 mL intravenously for a total of 8 doses over 21 weeks Idelalisib 150 mg tablet twice daily + obinutuzumab 1000 mg/40 mL intravenously for a total of 8 doses over 21 weeks Chlorambucil 0.5 mg/kg, as 2 mg tablets every other week for a total of 12 doses + obinutuzumab 1000 mg/40 mL intravenously for a total of 8 doses over 21 weeks Total of all reporting groups
Overall Number of Baseline Participants 8 25 24 57
Hide Baseline Analysis Population Description
Intent-to-Treat Analysis Set: participants who were randomized regardless of whether participants received any study drug(s), or received a different regimen from the regimen to which they were randomized.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 8 participants 25 participants 24 participants 57 participants
67.1  (8.10) 72.2  (8.23) 71.1  (6.84) 71.1  (7.70)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 25 participants 24 participants 57 participants
Female
3
  37.5%
8
  32.0%
9
  37.5%
20
  35.1%
Male
5
  62.5%
17
  68.0%
15
  62.5%
37
  64.9%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 25 participants 24 participants 57 participants
Black or African American
1
  12.5%
0
   0.0%
0
   0.0%
1
   1.8%
White
7
  87.5%
22
  88.0%
21
  87.5%
50
  87.7%
Other
0
   0.0%
1
   4.0%
0
   0.0%
1
   1.8%
Not Permitted
0
   0.0%
2
   8.0%
3
  12.5%
5
   8.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 8 participants 25 participants 24 participants 57 participants
Canada 1 1 0 2
Belgium 0 1 1 2
United States 5 3 4 12
Poland 2 14 12 28
United Kingdom 0 1 2 3
France 0 3 2 5
Australia 0 1 3 4
Spain 0 1 0 1
Rai Stage   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 25 participants 24 participants 57 participants
Stage I-II
3
  37.5%
11
  44.0%
9
  37.5%
23
  40.4%
Stage III-IV
5
  62.5%
14
  56.0%
15
  62.5%
34
  59.6%
[1]
Measure Description:

Rai staging is a way to categorize the disease progression of chronic lymphocytic leukemia (CLL) with higher stages reflecting increasing severity.

Rai Stage 0: Lymphocytosis only, Rai Stage I: Lymphocytosis with lymphadenopathy, Rai Stage II: Lymphocytosis with hepatomegaly or splenomegaly, Rai Stage III: Lymphocytosis with anemia, Rai Stage IV: Lymphocytosis with thrombocytopenia.

IgHV Mutation   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 25 participants 24 participants 57 participants
Unmutated
5
  62.5%
16
  64.0%
17
  70.8%
38
  66.7%
Mutated
3
  37.5%
9
  36.0%
7
  29.2%
19
  33.3%
[1]
Measure Description: The mutation status of the unique immunoglobulin gene (IgHV) rearrangement in the monoclonal proliferation of B-cells in CLL can be used to predict aggressiveness of the disease. Participants with a mutated IgHV gene usually have a less aggressive and more indolent disease, with longer overall survival. Participants with an unmutated IgHV gene usually have a more aggressive disease and shorter overall survival.
17p Deletion in CLL Cells   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 25 participants 24 participants 57 participants
Present
0
   0.0%
3
  12.0%
3
  12.5%
6
  10.5%
Absent
8
 100.0%
22
  88.0%
21
  87.5%
51
  89.5%
[1]
Measure Description: Participants with CLL who have deletion of 17p, a portion of the chromosome that acts to suppress cancer growth and is a recognized negative prognostic risk factor.
1.Primary Outcome
Title Progression-Free Survival
Hide Description Progression-free survival (PFS) is defined as the interval from randomization to the first documentation of definitive disease progression or death from any cause. Definitive disease progression is CLL progression based on standard criteria, excluding lymphocytosis alone. PFS was to be assessed by an independent review committee (IRC).
Time Frame Up to 11 months
Hide Outcome Measure Data
Hide Analysis Population Description
The study was terminated in agreement with the FDA due to urgent safety measures. Complete data were not collected for any participant.
Arm/Group Title Safety Run-In: Idelalisib+Obinutuzumab Randomized: Idelalisib+Obinutuzumab Randomized: Obinutuzumab+Chlorambucil
Hide Arm/Group Description:
Idelalisib 150 mg tablet twice daily + obinutuzumab 1000 mg/40 mL intravenously for a total of 8 doses over 21 weeks
Idelalisib 150 mg tablet twice daily + obinutuzumab 1000 mg/40 mL intravenously for a total of 8 doses over 21 weeks
Chlorambucil 0.5 mg/kg, as 2 mg tablets every other week for a total of 12 doses + obinutuzumab 1000 mg/40 mL intravenously for a total of 8 doses over 21 weeks
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Overall Response Rate
Hide Description Overall response rate (ORR) is defined as the proportion of participants who achieve a confirmed complete or partial response. ORR was to be assessed by an IRC.
Time Frame Up to 11 months
Hide Outcome Measure Data
Hide Analysis Population Description
The study was terminated in agreement with the FDA due to urgent safety measures. Complete data were not collected for any participant.
Arm/Group Title Safety Run-In: Idelalisib+Obinutuzumab Randomized: Idelalisib+Obinutuzumab Randomized: Obinutuzumab+Chlorambucil
Hide Arm/Group Description:
Idelalisib 150 mg tablet twice daily + obinutuzumab 1000 mg/40 mL intravenously for a total of 8 doses over 21 weeks
Idelalisib 150 mg tablet twice daily + obinutuzumab 1000 mg/40 mL intravenously for a total of 8 doses over 21 weeks
Chlorambucil 0.5 mg/kg, as 2 mg tablets every other week for a total of 12 doses + obinutuzumab 1000 mg/40 mL intravenously for a total of 8 doses over 21 weeks
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Nodal Response Rate
Hide Description Nodal response rate is defined as the proportion of participants who achieve a 50% decrease from baseline in the sum of the products of the greatest perpendicular diameters of index lesions. Nodal response rate was to be assessed by an IRC.
Time Frame Up to 11 months
Hide Outcome Measure Data
Hide Analysis Population Description
The study was terminated in agreement with the FDA due to urgent safety measures. Complete data were not collected for any participant.
Arm/Group Title Safety Run-In: Idelalisib+Obinutuzumab Randomized: Idelalisib+Obinutuzumab Randomized: Obinutuzumab+Chlorambucil
Hide Arm/Group Description:
Idelalisib 150 mg tablet twice daily + obinutuzumab 1000 mg/40 mL intravenously for a total of 8 doses over 21 weeks
Idelalisib 150 mg tablet twice daily + obinutuzumab 1000 mg/40 mL intravenously for a total of 8 doses over 21 weeks
Chlorambucil 0.5 mg/kg, as 2 mg tablets every other week for a total of 12 doses + obinutuzumab 1000 mg/40 mL intravenously for a total of 8 doses over 21 weeks
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Complete Response Rate
Hide Description Complete response rate is defined as the proportion of participants who achieve a confirmed complete response. Complete response rate was to be assessed by an IRC.
Time Frame Up to 11 months
Hide Outcome Measure Data
Hide Analysis Population Description
The study was terminated in agreement with the FDA due to urgent safety measures. Complete data were not collected for any participant.
Arm/Group Title Safety Run-In: Idelalisib+Obinutuzumab Randomized: Idelalisib+Obinutuzumab Randomized: Obinutuzumab+Chlorambucil
Hide Arm/Group Description:
Idelalisib 150 mg tablet twice daily + obinutuzumab 1000 mg/40 mL intravenously for a total of 8 doses over 21 weeks
Idelalisib 150 mg tablet twice daily + obinutuzumab 1000 mg/40 mL intravenously for a total of 8 doses over 21 weeks
Chlorambucil 0.5 mg/kg, as 2 mg tablets every other week for a total of 12 doses + obinutuzumab 1000 mg/40 mL intravenously for a total of 8 doses over 21 weeks
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Overall Survival
Hide Description Overall survival is defined as the interval from randomization to death from any cause. Overall survival was to be assessed by an IRC.
Time Frame Up to 11 months
Hide Outcome Measure Data
Hide Analysis Population Description
The study was terminated in agreement with the FDA due to urgent safety measures. Complete data were not collected for any participant.
Arm/Group Title Safety Run-In: Idelalisib+Obinutuzumab Randomized: Idelalisib+Obinutuzumab Randomized: Obinutuzumab+Chlorambucil
Hide Arm/Group Description:
Idelalisib 150 mg tablet twice daily + obinutuzumab 1000 mg/40 mL intravenously for a total of 8 doses over 21 weeks
Idelalisib 150 mg tablet twice daily + obinutuzumab 1000 mg/40 mL intravenously for a total of 8 doses over 21 weeks
Chlorambucil 0.5 mg/kg, as 2 mg tablets every other week for a total of 12 doses + obinutuzumab 1000 mg/40 mL intravenously for a total of 8 doses over 21 weeks
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title Minimal Residual Disease Negativity Rate at Week 36
Hide Description Minimal residual disease (MRD) negativity rate is defined as the proportion of participants with MRD < 10^-4 assessed by flow cytometry in bone marrow at Week 36 after therapy initiation. For participants receiving the final dose of obinutuzumab after the original scheduled date, the MRD assessment was performed no less than 12 weeks after the last dose of obinutuzumab. MRD negativity rate was to be assessed by an IRC.
Time Frame Up to 11 months
Hide Outcome Measure Data
Hide Analysis Population Description
The study was terminated in agreement with the FDA due to urgent safety measures. Complete data were not collected for any participant.
Arm/Group Title Safety Run-In: Idelalisib+Obinutuzumab Randomized: Idelalisib+Obinutuzumab Randomized: Obinutuzumab+Chlorambucil
Hide Arm/Group Description:
Idelalisib 150 mg tablet twice daily + obinutuzumab 1000 mg/40 mL intravenously for a total of 8 doses over 21 weeks
Idelalisib 150 mg tablet twice daily + obinutuzumab 1000 mg/40 mL intravenously for a total of 8 doses over 21 weeks
Chlorambucil 0.5 mg/kg, as 2 mg tablets every other week for a total of 12 doses + obinutuzumab 1000 mg/40 mL intravenously for a total of 8 doses over 21 weeks
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Baseline up to the last dose date plus 30 days (maximum: 12 months)
Adverse Event Reporting Description Safety Analysis Set: participants who received at least 1 dose of study drug, with treatment group designated according to actual treatment received
 
Arm/Group Title Safety Run-In: Idelalisib+Obinutuzumab Randomized: Idelalisib+Obinutuzumab Randomized: Obinutuzumab+Chlorambucil
Hide Arm/Group Description Idelalisib 150 mg tablet twice daily + obinutuzumab 1000 mg/40 mL intravenously for a total of 8 doses over 21 weeks Idelalisib 150 mg tablet twice daily + obinutuzumab 1000 mg/40 mL intravenously for a total of 8 doses over 21 weeks Chlorambucil 0.5 mg/kg, as 2 mg tablets every other week for a total of 12 doses + obinutuzumab 1000 mg/40 mL intravenously for a total of 8 doses over 21 weeks
All-Cause Mortality
Safety Run-In: Idelalisib+Obinutuzumab Randomized: Idelalisib+Obinutuzumab Randomized: Obinutuzumab+Chlorambucil
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/8 (0.00%)   0/24 (0.00%)   0/23 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Safety Run-In: Idelalisib+Obinutuzumab Randomized: Idelalisib+Obinutuzumab Randomized: Obinutuzumab+Chlorambucil
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   2/8 (25.00%)   12/24 (50.00%)   8/23 (34.78%) 
Blood and lymphatic system disorders       
Anaemia  1  0/8 (0.00%)  2/24 (8.33%)  1/23 (4.35%) 
Febrile neutropenia  1  0/8 (0.00%)  1/24 (4.17%)  1/23 (4.35%) 
Gastrointestinal disorders       
Diarrhoea  1  1/8 (12.50%)  0/24 (0.00%)  0/23 (0.00%) 
Enteritis  1  0/8 (0.00%)  1/24 (4.17%)  0/23 (0.00%) 
General disorders       
Chills  1  0/8 (0.00%)  1/24 (4.17%)  0/23 (0.00%) 
Pyrexia  1  0/8 (0.00%)  1/24 (4.17%)  0/23 (0.00%) 
Immune system disorders       
Hypersensitivity  1  0/8 (0.00%)  0/24 (0.00%)  1/23 (4.35%) 
Secondary immunodeficiency  1  0/8 (0.00%)  0/24 (0.00%)  1/23 (4.35%) 
Infections and infestations       
Bronchitis  1  0/8 (0.00%)  1/24 (4.17%)  0/23 (0.00%) 
Gastroenteritis  1  0/8 (0.00%)  0/24 (0.00%)  1/23 (4.35%) 
Herpes zoster  1  0/8 (0.00%)  0/24 (0.00%)  1/23 (4.35%) 
Lung infection  1  0/8 (0.00%)  1/24 (4.17%)  0/23 (0.00%) 
Pneumonia  1  0/8 (0.00%)  0/24 (0.00%)  1/23 (4.35%) 
Pyelonephritis  1  0/8 (0.00%)  0/24 (0.00%)  1/23 (4.35%) 
Sepsis  1  0/8 (0.00%)  1/24 (4.17%)  1/23 (4.35%) 
Upper respiratory tract infection  1  0/8 (0.00%)  1/24 (4.17%)  0/23 (0.00%) 
Injury, poisoning and procedural complications       
Infusion related reaction  1  0/8 (0.00%)  1/24 (4.17%)  0/23 (0.00%) 
Metabolism and nutrition disorders       
Tumour lysis syndrome  1  0/8 (0.00%)  0/24 (0.00%)  1/23 (4.35%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Richter's syndrome  1  0/8 (0.00%)  0/24 (0.00%)  1/23 (4.35%) 
Nervous system disorders       
Leukoencephalopathy  1  1/8 (12.50%)  0/24 (0.00%)  0/23 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Acute respiratory failure  1  0/8 (0.00%)  1/24 (4.17%)  0/23 (0.00%) 
Pneumonitis  1  0/8 (0.00%)  2/24 (8.33%)  0/23 (0.00%) 
Skin and subcutaneous tissue disorders       
Rash  1  0/8 (0.00%)  1/24 (4.17%)  0/23 (0.00%) 
Vascular disorders       
Hypertension  1  0/8 (0.00%)  0/24 (0.00%)  1/23 (4.35%) 
1
Term from vocabulary, MedDRA 19.0
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Safety Run-In: Idelalisib+Obinutuzumab Randomized: Idelalisib+Obinutuzumab Randomized: Obinutuzumab+Chlorambucil
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   8/8 (100.00%)   19/24 (79.17%)   17/23 (73.91%) 
Blood and lymphatic system disorders       
Anaemia  1  2/8 (25.00%)  6/24 (25.00%)  2/23 (8.70%) 
Neutropenia  1  4/8 (50.00%)  6/24 (25.00%)  9/23 (39.13%) 
Thrombocytopenia  1  3/8 (37.50%)  2/24 (8.33%)  1/23 (4.35%) 
Eye disorders       
Dry eye  1  1/8 (12.50%)  0/24 (0.00%)  0/23 (0.00%) 
Eye swelling  1  1/8 (12.50%)  0/24 (0.00%)  0/23 (0.00%) 
Gastrointestinal disorders       
Abdominal pain  1  1/8 (12.50%)  1/24 (4.17%)  1/23 (4.35%) 
Autoimmune colitis  1  1/8 (12.50%)  0/24 (0.00%)  0/23 (0.00%) 
Constipation  1  2/8 (25.00%)  2/24 (8.33%)  1/23 (4.35%) 
Diarrhoea  1  4/8 (50.00%)  4/24 (16.67%)  1/23 (4.35%) 
Flatulence  1  1/8 (12.50%)  0/24 (0.00%)  0/23 (0.00%) 
Nausea  1  2/8 (25.00%)  2/24 (8.33%)  4/23 (17.39%) 
Stomatitis  1  1/8 (12.50%)  0/24 (0.00%)  0/23 (0.00%) 
General disorders       
Chills  1  1/8 (12.50%)  2/24 (8.33%)  0/23 (0.00%) 
Face oedema  1  1/8 (12.50%)  0/24 (0.00%)  0/23 (0.00%) 
Fatigue  1  1/8 (12.50%)  3/24 (12.50%)  2/23 (8.70%) 
Influenza like illness  1  2/8 (25.00%)  0/24 (0.00%)  0/23 (0.00%) 
Oedema peripheral  1  1/8 (12.50%)  3/24 (12.50%)  1/23 (4.35%) 
Pyrexia  1  1/8 (12.50%)  1/24 (4.17%)  4/23 (17.39%) 
Infections and infestations       
Acute sinusitis  1  1/8 (12.50%)  0/24 (0.00%)  0/23 (0.00%) 
Clostridium difficile colitis  1  1/8 (12.50%)  0/24 (0.00%)  0/23 (0.00%) 
Lower respiratory tract infection  1  0/8 (0.00%)  0/24 (0.00%)  2/23 (8.70%) 
Pneumonia  1  0/8 (0.00%)  2/24 (8.33%)  1/23 (4.35%) 
Upper respiratory tract infection  1  1/8 (12.50%)  2/24 (8.33%)  2/23 (8.70%) 
Urinary tract infection  1  1/8 (12.50%)  1/24 (4.17%)  0/23 (0.00%) 
Injury, poisoning and procedural complications       
Infusion related reaction  1  2/8 (25.00%)  3/24 (12.50%)  14/23 (60.87%) 
Muscle strain  1  1/8 (12.50%)  0/24 (0.00%)  0/23 (0.00%) 
Investigations       
Alanine aminotransferase increased  1  7/8 (87.50%)  5/24 (20.83%)  1/23 (4.35%) 
Aspartate aminotransferase increased  1  7/8 (87.50%)  5/24 (20.83%)  1/23 (4.35%) 
Blood creatinine increased  1  0/8 (0.00%)  2/24 (8.33%)  0/23 (0.00%) 
Heart rate increased  1  1/8 (12.50%)  0/24 (0.00%)  0/23 (0.00%) 
Metabolism and nutrition disorders       
Diabetes mellitus  1  1/8 (12.50%)  0/24 (0.00%)  1/23 (4.35%) 
Hyperglycaemia  1  1/8 (12.50%)  1/24 (4.17%)  0/23 (0.00%) 
Hyperuricaemia  1  0/8 (0.00%)  3/24 (12.50%)  0/23 (0.00%) 
Hypocalcaemia  1  1/8 (12.50%)  0/24 (0.00%)  0/23 (0.00%) 
Hypokalaemia  1  1/8 (12.50%)  2/24 (8.33%)  0/23 (0.00%) 
Hyponatraemia  1  1/8 (12.50%)  0/24 (0.00%)  0/23 (0.00%) 
Tetany  1  0/8 (0.00%)  0/24 (0.00%)  2/23 (8.70%) 
Tumour lysis syndrome  1  0/8 (0.00%)  0/24 (0.00%)  2/23 (8.70%) 
Musculoskeletal and connective tissue disorders       
Arthralgia  1  1/8 (12.50%)  2/24 (8.33%)  0/23 (0.00%) 
Back pain  1  0/8 (0.00%)  2/24 (8.33%)  1/23 (4.35%) 
Neck pain  1  1/8 (12.50%)  0/24 (0.00%)  0/23 (0.00%) 
Nervous system disorders       
Cerebellar syndrome  1  1/8 (12.50%)  0/24 (0.00%)  0/23 (0.00%) 
Circadian rhythm sleep disorder  1  1/8 (12.50%)  0/24 (0.00%)  0/23 (0.00%) 
Dementia  1  1/8 (12.50%)  0/24 (0.00%)  0/23 (0.00%) 
Dizziness  1  1/8 (12.50%)  2/24 (8.33%)  0/23 (0.00%) 
Dizziness postural  1  1/8 (12.50%)  0/24 (0.00%)  0/23 (0.00%) 
Headache  1  1/8 (12.50%)  2/24 (8.33%)  2/23 (8.70%) 
Psychomotor skills impaired  1  1/8 (12.50%)  0/24 (0.00%)  0/23 (0.00%) 
Somnolence  1  1/8 (12.50%)  0/24 (0.00%)  0/23 (0.00%) 
Tremor  1  1/8 (12.50%)  0/24 (0.00%)  0/23 (0.00%) 
Psychiatric disorders       
Anxiety  1  1/8 (12.50%)  0/24 (0.00%)  1/23 (4.35%) 
Insomnia  1  2/8 (25.00%)  2/24 (8.33%)  0/23 (0.00%) 
Restlessness  1  2/8 (25.00%)  0/24 (0.00%)  0/23 (0.00%) 
Renal and urinary disorders       
Renal failure  1  0/8 (0.00%)  0/24 (0.00%)  2/23 (8.70%) 
Urinary retention  1  1/8 (12.50%)  0/24 (0.00%)  0/23 (0.00%) 
Reproductive system and breast disorders       
Penile pain  1  0/8 (0.00%)  2/24 (8.33%)  0/23 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Cough  1  0/8 (0.00%)  2/24 (8.33%)  0/23 (0.00%) 
Dyspnoea  1  1/8 (12.50%)  0/24 (0.00%)  0/23 (0.00%) 
Hypoxia  1  1/8 (12.50%)  0/24 (0.00%)  0/23 (0.00%) 
Skin and subcutaneous tissue disorders       
Ecchymosis  1  1/8 (12.50%)  0/24 (0.00%)  0/23 (0.00%) 
Night sweats  1  2/8 (25.00%)  0/24 (0.00%)  0/23 (0.00%) 
Rash  1  1/8 (12.50%)  1/24 (4.17%)  0/23 (0.00%) 
Rash macular  1  1/8 (12.50%)  0/24 (0.00%)  0/23 (0.00%) 
Vascular disorders       
Flushing  1  1/8 (12.50%)  0/24 (0.00%)  1/23 (4.35%) 
Hypertension  1  0/8 (0.00%)  2/24 (8.33%)  1/23 (4.35%) 
Orthostatic hypotension  1  1/8 (12.50%)  0/24 (0.00%)  0/23 (0.00%) 
1
Term from vocabulary, MedDRA 19.0
Indicates events were collected by systematic assessment
The study was terminated in agreement with the FDA due to urgent safety measures. Complete data were not collected for any participant.
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.

After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met:

  • The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or
  • The study has been completed at all study sites for at least 2 years
Results Point of Contact
Name/Title: Clinical Trial Disclosures
Organization: Gilead Sciences
Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT01980875     History of Changes
Other Study ID Numbers: GS-US-312-0118
2013-004551-20 ( EudraCT Number )
First Submitted: November 5, 2013
First Posted: November 11, 2013
Results First Submitted: March 30, 2017
Results First Posted: June 28, 2017
Last Update Posted: November 19, 2018