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A Study of Idelalisib and Rituximab in Elderly Patients With Untreated CLL or SLL

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ClinicalTrials.gov Identifier: NCT01203930
Recruitment Status : Terminated
First Posted : September 17, 2010
Results First Posted : May 22, 2017
Last Update Posted : November 16, 2018
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Chronic Lymphocytic Leukemia (CLL)
Small Lymphocytic Lymphoma (SLL)
Interventions Drug: Idelalisib
Drug: Rituximab
Enrollment 105
Recruitment Details Participants were enrolled at study sites in the United States. The first participant was screened on 28 September 2010. The last study visit occurred on 07 June 2016.
Pre-assignment Details 113 participants were screened.
Arm/Group Title Idelalisib+Rituximab (Cohort 1) Idelalisib (Cohort 2)
Hide Arm/Group Description Idelalisib 150 mg capsules or tablets administered orally twice daily of each 28-day cycle for 12 cycles + rituximab 375 mg/m^2 administered intravenously weekly for 8 doses Idelalisib 150 mg capsules or tablets administered orally twice daily of each 28-day cycle until disease progression or unacceptable toxicity
Period Title: Overall Study
Started 64 41
Completed 43 [1] 0
Not Completed 21 41
Reason Not Completed
Disease Progression             0             4
Death             3             1
Withdrew Consent             1             10
Investigator Request             0             8
Study Terminated by Sponsor             0             12
Poor tolerance of study drug             0             1
Adverse Event             17             5
[1]
43 participants completed 12 cycles and were then eligible to enroll in the extension study (101-99)
Arm/Group Title Idelalisib+Rituximab (Cohort 1) Idelalisib (Cohort 2) Total
Hide Arm/Group Description Idelalisib 150 mg capsules or tablets administered orally twice daily of each 28-day cycle for 12 cycles + rituximab 375 mg/m^2 administered intravenously weekly for 8 doses. Participants who completed 12 cycles of idelalisib were eligible to continue treatment on an extension study (101-99). Idelalisib 150 mg capsules or tablets administered orally twice daily of each 28-day cycle until disease progression or unacceptable toxicity Total of all reporting groups
Overall Number of Baseline Participants 64 41 105
Hide Baseline Analysis Population Description
Intent-to-treat (ITT) Analysis Set: participants who received at least 1 dose of idelalisib.
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 64 participants 41 participants 105 participants
< 70 Years 29 14 43
≥ 70 Years 35 27 62
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 64 participants 41 participants 105 participants
Female
24
  37.5%
9
  22.0%
33
  31.4%
Male
40
  62.5%
32
  78.0%
72
  68.6%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 64 participants 41 participants 105 participants
Hispanic or Latino
0
   0.0%
1
   2.4%
1
   1.0%
Not Hispanic or Latino
64
 100.0%
40
  97.6%
104
  99.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 64 participants 41 participants 105 participants
White/Caucasian 61 40 101
Black or African American 1 1 2
Asian 1 0 1
Other 1 0 1
1.Primary Outcome
Title Overall Response Rate (ORR)
Hide Description

ORR was assessed based on standardized International Workshop on Chronic Lymphocytic Leukemia (IWCLL) criteria as specifically modified for this study to reflect current recommendations which consider the mechanism of action of idelalisib and similar drugs, and was defined as the proportion of participants achieving a complete response (CR) or partial response (PR) as assessed by the investigator. Based on the CLL response definition in the protocol (modified Hallek 2008), the parameters of lymphadenopathy, liver and/or spleen size, constitutional symptoms, polymorphonuclear leukocytes, circulating clonal B-lymphocytes, platelet count, hemoglobin, and marrow were assessed.

  • CR: meeting all defined criteria
  • PR: meeting at least 2 of the criteria of circulating lymphocytes, lymphadenopathy, liver, spleen, or bone marrow (or only lymphadenopathy if liver and spleen normal at baseline) and at least 1 of the criteria for polymorphonuclear leukocytes, platelet count, or hemoglobin.
Time Frame Up to 28 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) Analysis Set: participants who received at least 1 dose of idelalisib.
Arm/Group Title Idelalisib+Rituximab (Cohort 1) Idelalisib (Cohort 2)
Hide Arm/Group Description:
Idelalisib 150 mg capsules or tablets administered orally twice daily of each 28-day cycle for 12 cycles + rituximab 375 mg/m^2 administered intravenously weekly for 8 doses
Idelalisib 150 mg capsules or tablets administered orally twice daily of each 28-day cycle until disease progression or unacceptable toxicity
Overall Number of Participants Analyzed 64 41
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
96.9
(89.2 to 99.6)
87.8
(73.8 to 95.9)
2.Secondary Outcome
Title Overall Safety of Idelalisib
Hide Description The overall safety of idelalisib was assessed as the percentage of participants experiencing treatment-emergent adverse events (AEs; Serious AEs, Grade ≥ 3 AEs, AEs related to idelalisib, and AEs leading to discontinuation of idelalisib).
Time Frame Up to 28 Months
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Analysis Set
Arm/Group Title Idelalisib+Rituximab (Cohort 1) Idelalisib (Cohort 2)
Hide Arm/Group Description:
Idelalisib 150 mg capsules or tablets administered orally twice daily of each 28-day cycle for 12 cycles + rituximab 375 mg/m^2 administered intravenously weekly for 8 doses
Idelalisib 150 mg capsules or tablets administered orally twice daily of each 28-day cycle until disease progression or unacceptable toxicity
Overall Number of Participants Analyzed 64 41
Measure Type: Number
Unit of Measure: percentage of participants
Any AE 100.0 100.0
Serious AE 48.4 68.3
Grade ≥ 3 AE 76.6 85.4
AE related to idelalisib 81.3 97.6
AE leading to permanent drug discontinuation 28.1 56.1
3.Secondary Outcome
Title Lymphadenopathy Response Rate
Hide Description Lymphadenopathy response rate was defined as the percentage of participants with a ≥ 50% reduction from baseline in the sum of the perpendicular diameters of all measurable lesions while receiving study therapy.
Time Frame Baseline and up to 28 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the ITT Analysis Set with baseline measurable lymph nodes were analyzed.
Arm/Group Title Idelalisib+Rituximab (Cohort 1) Idelalisib (Cohort 2)
Hide Arm/Group Description:
Idelalisib 150 mg capsules or tablets administered orally twice daily of each 28-day cycle for 12 cycles + rituximab 375 mg/m^2 administered intravenously weekly for 8 doses
Idelalisib 150 mg capsules or tablets administered orally twice daily of each 28-day cycle until disease progression or unacceptable toxicity
Overall Number of Participants Analyzed 50 38
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
98.0
(89.4 to 99.9)
86.8
(71.9 to 95.6)
4.Secondary Outcome
Title Percent Change From Baseline in the Sum of the Product of the Greatest Perpendicular Diameters (SPD) of All Measurable Lesions
Hide Description [Not Specified]
Time Frame Baseline; Weeks 8, 16, 24, 36, 48, 60, 72, 84, 96, 108, and 120
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the ITT Analysis Set with available data were analyzed.
Arm/Group Title Idelalisib+Rituximab (Cohort 1) Idelalisib (Cohort 2)
Hide Arm/Group Description:
Idelalisib 150 mg capsules or tablets administered orally twice daily of each 28-day cycle for 12 cycles + rituximab 375 mg/m^2 administered intravenously weekly for 8 doses
Idelalisib 150 mg capsules or tablets administered orally twice daily of each 28-day cycle until disease progression or unacceptable toxicity
Overall Number of Participants Analyzed 50 38
Median (Full Range)
Unit of Measure: percent change
% Change at Wk 8 Number Analyzed 47 participants 20 participants
-100.0
(-100.0 to -8.3)
-69.8
(-100.0 to 0.0)
% Change at Wk 16 Number Analyzed 40 participants 16 participants
-100.0
(-100.0 to -69.2)
-74.5
(-100.0 to 0.0)
% Change at Wk 24 Number Analyzed 43 participants 26 participants
-100.0
(-100.0 to -50.0)
-76.0
(-100.0 to 0.0)
% Change at Wk 36 Number Analyzed 30 participants 10 participants
-100.0
(-100.0 to -66.7)
-77.5
(-100.0 to 0.0)
% Change at Wk 48 Number Analyzed 33 participants 18 participants
-100.0
(-100.0 to -50.0)
-73.9
(-98.3 to 44.4)
% Change at Wk 60 Number Analyzed 0 participants 9 participants
-69.7
(-93.3 to -56.7)
% Change at Wk 72 Number Analyzed 0 participants 5 participants
-78.0
(-85.5 to -68.8)
% Change at Wk 84 Number Analyzed 0 participants 3 participants
-80.0
(-91.2 to -68.1)
% Change at Wk 96 Number Analyzed 0 participants 2 participants
-81.3
(-100.0 to -62.5)
% Change at Wk 108 Number Analyzed 0 participants 1 participants
-78.1
(-78.1 to -78.1)
% Change at Wk 120 Number Analyzed 0 participants 1 participants
-71.9
(-71.9 to -71.9)
Best % Change Number Analyzed 50 participants 38 participants
-100.0
(-100.0 to -40.0)
-81.1
(-100.0 to 0.0)
5.Secondary Outcome
Title Duration of Response
Hide Description Duration of response (DOR) was defined as the interval from the first documentation of CR or PR to the earlier of the first documentation of disease progression or death from any cause.
Time Frame Up to 28 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the ITT Analysis Set who achieved complete or partial response.
Arm/Group Title Idelalisib+Rituximab (Cohort 1) Idelalisib (Cohort 2)
Hide Arm/Group Description:
Idelalisib 150 mg capsules or tablets administered orally twice daily of each 28-day cycle for 12 cycles + rituximab 375 mg/m^2 administered intravenously weekly for 8 doses
Idelalisib 150 mg capsules or tablets administered orally twice daily of each 28-day cycle until disease progression or unacceptable toxicity
Overall Number of Participants Analyzed 62 35
Median (95% Confidence Interval)
Unit of Measure: months
NA [1] 
(NA to NA)
14.8 [1] 
(10.0 to NA)
[1]
NA: Not reached
6.Secondary Outcome
Title Progression-Free Survival
Hide Description

Progression-free survival (PFS) was defined as the interval from the first dose date of drug to the earlier of the first documentation of definitive disease progression or death from any cause.

Progression was defined using the Standardized IWCLL criteria as specifically modified for this study to consider the mechanism of action of idelalisib and similar drugs. The occurrence of any of the following events indicated progression:

  1. Evidence of any new disease
  2. Evidence of worsening of index lesions, spleen or liver, or non-index disease
  3. Decrease in platelet count or hemoglobin that is attributable to CLL and is confirmed by bone marrow biopsy
Time Frame Up to 28 Months
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Analysis Set
Arm/Group Title Idelalisib+Rituximab (Cohort 1) Idelalisib (Cohort 2)
Hide Arm/Group Description:
Idelalisib 150 mg capsules or tablets administered orally twice daily of each 28-day cycle for 12 cycles + rituximab 375 mg/m^2 administered intravenously weekly for 8 doses
Idelalisib 150 mg capsules or tablets administered orally twice daily of each 28-day cycle until disease progression or unacceptable toxicity
Overall Number of Participants Analyzed 64 41
Median (95% Confidence Interval)
Unit of Measure: months
NA [1] 
(NA to NA)
26.2 [1] 
(14.0 to NA)
[1]
Not reached
7.Secondary Outcome
Title Idelalisib Plasma Concentrations (Cohort 1)
Hide Description [Not Specified]
Time Frame Predose and 1.5 hours postdose at Weeks 0, 4, and 24
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic (PK) Analysis Set: participants in the ITT Analysis Set from Cohort 1 who had the necessary baseline and on-study measurements to provide interpretable results for the specific parameters of interest.
Arm/Group Title Idelalisib+Rituximab (Cohort 1)
Hide Arm/Group Description:
Idelalisib 150 mg capsules or tablets administered orally twice daily of each 28-day cycle for 12 cycles + rituximab 375 mg/m^2 administered intravenously weekly for 8 doses
Overall Number of Participants Analyzed 64
Median (Inter-Quartile Range)
Unit of Measure: ng/mL
Week 0 predose Number Analyzed 64 participants
0.0
(0.0 to 0.0)
Week 0 postdose Number Analyzed 63 participants
1710.0
(1060.0 to 2660.0)
Week 4 predose Number Analyzed 57 participants
305.0
(189.0 to 606.0)
Week 4 postdose Number Analyzed 52 participants
1720.0
(1090.0 to 2500.0)
Week 24 predose Number Analyzed 44 participants
256.5
(173.5 to 625.5)
Week 24 postdose Number Analyzed 45 participants
1460.0
(925.0 to 2010.0)
8.Secondary Outcome
Title Idelalisib Plasma Concentrations (Cohort 2)
Hide Description [Not Specified]
Time Frame Predose and 1.5 hours postdose at Weeks 0 and 4 and predose at Weeks 8 and 20
Hide Outcome Measure Data
Hide Analysis Population Description
PK Analysis Set: participants in the ITT Analysis Set from Cohort 2 who had the necessary baseline and on-study measurements to provide interpretable results for the specific parameters of interest.
Arm/Group Title Idelalisib (Cohort 2)
Hide Arm/Group Description:
Idelalisib 150 mg capsules or tablets administered orally twice daily of each 28-day cycle until disease progression or unacceptable toxicity
Overall Number of Participants Analyzed 40
Median (Inter-Quartile Range)
Unit of Measure: ng/mL
Week 0 predose Number Analyzed 38 participants
0.0
(0.0 to 0.0)
Week 0 postdose Number Analyzed 40 participants
2190.0
(1575.0 to 2920.0)
Week 4 predose Number Analyzed 30 participants
293.0
(228.0 to 549.0)
Week 4 postdose Number Analyzed 31 participants
2120.0
(1850.0 to 2590.0)
Week 8 predose Number Analyzed 27 participants
453.0
(207.0 to 904.0)
Week 20 predose Number Analyzed 20 participants
590.0
(317.0 to 971.5)
9.Secondary Outcome
Title Changes in Potential Pharmacodynamic Markers of Drug Activity in Plasma and Whole Blood
Hide Description

Changes in potential pharmacodynamic markers of drug activity will include assessments of chemokine and cytokine concentrations, effects on the activity of PI3K and related pathways, and effect on cell migration and other functional outcomes. This endpoint will be assessed at the following time points:

  • Idelalisib+Rituximab (Cohort 1): Predose and 1.5 hour postdose on Day 1 and predose on Days 15, 29, 57, 113, and 169
  • Idelalisib (Cohort 2): Predose on Days 1, 29, 57, 141
Time Frame Up to 169 days
Hide Outcome Measure Data
Hide Analysis Population Description
The collection of plasma samples for pharmacodynamic (PD) analysis in this study was planned prior to the availability of results from an identical PD analysis in another idelalisib study with a larger sample size (n = 176 unique subjects with 2085 longitudinal plasma samples). Therefore, PD analysis was not performed in this study (n = 41).
Arm/Group Title Idelalisib+Rituximab (Cohort 1) Idelalisib (Cohort 2)
Hide Arm/Group Description:
Idelalisib 150 mg capsules or tablets administered orally twice daily of each 28-day cycle for 12 cycles + rituximab 375 mg/m^2 administered intravenously weekly for 8 doses. Participants who completed 12 cycles of idelalisib were eligible to continue treatment on an extension study (101-99).
Idelalisib 150 mg capsules or tablets administered orally twice daily of each 28-day cycle until disease progression or unacceptable toxicity
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
10.Secondary Outcome
Title Overall Survival
Hide Description Overall survival (OS) is defined as the interval from the start of study treatment to death from any cause.
Time Frame Up to 28 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Overall survival analysis was not performed because the follow-up period was insufficient to capture enough events.
Arm/Group Title Idelalisib+Rituximab (Cohort 1) Idelalisib (Cohort 2)
Hide Arm/Group Description:
Idelalisib 150 mg capsules or tablets administered orally twice daily of each 28-day cycle for 12 cycles + rituximab 375 mg/m^2 administered intravenously weekly for 8 doses. Participants who completed 12 cycles of idelalisib were eligible to continue treatment on an extension study (101-99).
Idelalisib 150 mg capsules or tablets administered orally twice daily of each 28-day cycle until disease progression or unacceptable toxicity
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Up to 28 Months
Adverse Event Reporting Description Adverse events were coded according to MedDRA Version 15.1 for Cohort 1 and MedDRA Version 19.0 for Cohort 2.
 
Arm/Group Title Idelalisib+Rituximab (Cohort 1) Idelalisib (Cohort 2)
Hide Arm/Group Description Idelalisib 150 mg capsules or tablets administered orally twice daily of each 28-day cycle for 12 cycles + rituximab 375 mg/m^2 administered intravenously weekly for 8 doses Idelalisib 150 mg capsules or tablets administered orally twice daily of each 28-day cycle until disease progression or unacceptable toxicity
All-Cause Mortality
Idelalisib+Rituximab (Cohort 1) Idelalisib (Cohort 2)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Idelalisib+Rituximab (Cohort 1) Idelalisib (Cohort 2)
Affected / at Risk (%) Affected / at Risk (%)
Total   31/64 (48.44%)   28/41 (68.29%) 
Blood and lymphatic system disorders     
Anaemia  1  1/64 (1.56%)  1/41 (2.44%) 
Aplasia pure red cell  1  1/64 (1.56%)  0/41 (0.00%) 
Febrile neutropenia  1  2/64 (3.13%)  2/41 (4.88%) 
Neutropenia  1  0/64 (0.00%)  1/41 (2.44%) 
Thrombocytopenia  1  0/64 (0.00%)  1/41 (2.44%) 
Cardiac disorders     
Sinus node dysfunction  1  0/64 (0.00%)  1/41 (2.44%) 
Gastrointestinal disorders     
Abdominal distension  1  0/64 (0.00%)  1/41 (2.44%) 
Colitis  1  6/64 (9.38%)  4/41 (9.76%) 
Diarrhoea  1  6/64 (9.38%)  7/41 (17.07%) 
Intestinal obstruction  1  1/64 (1.56%)  0/41 (0.00%) 
Small intestinal obstruction  1  1/64 (1.56%)  0/41 (0.00%) 
General disorders     
Asthenia  1  1/64 (1.56%)  0/41 (0.00%) 
Chest pain  1  1/64 (1.56%)  0/41 (0.00%) 
Face oedema  1  0/64 (0.00%)  1/41 (2.44%) 
Fatigue  1  0/64 (0.00%)  1/41 (2.44%) 
Impaired healing  1  1/64 (1.56%)  0/41 (0.00%) 
Pyrexia  1  2/64 (3.13%)  3/41 (7.32%) 
Infections and infestations     
Cellulitis  1  1/64 (1.56%)  2/41 (4.88%) 
Clostridial infection  1  1/64 (1.56%)  0/41 (0.00%) 
Cytomegalovirus oesophagitis  1  0/64 (0.00%)  1/41 (2.44%) 
Oesophageal candidiasis  1  1/64 (1.56%)  1/41 (2.44%) 
Oral candidiasis  1  1/64 (1.56%)  0/41 (0.00%) 
Pneumocystis jiroveci pneumonia  1  1/64 (1.56%)  0/41 (0.00%) 
Pneumocystis jirovecii pneumonia  1  0/64 (0.00%)  1/41 (2.44%) 
Pneumonia  1  8/64 (12.50%)  5/41 (12.20%) 
Sepsis  1  0/64 (0.00%)  1/41 (2.44%) 
Urinary tract infection  1  1/64 (1.56%)  0/41 (0.00%) 
Urosepsis  1  1/64 (1.56%)  0/41 (0.00%) 
Injury, poisoning and procedural complications     
Arterial injury  1  1/64 (1.56%)  0/41 (0.00%) 
Infusion related reaction  1  1/64 (1.56%)  0/41 (0.00%) 
Metabolism and nutrition disorders     
Decreased appetite  1  0/64 (0.00%)  1/41 (2.44%) 
Dehydration  1  1/64 (1.56%)  2/41 (4.88%) 
Hypercalcaemia  1  1/64 (1.56%)  0/41 (0.00%) 
Hypoglycaemia  1  0/64 (0.00%)  1/41 (2.44%) 
Hypokalaemia  1  0/64 (0.00%)  1/41 (2.44%) 
Musculoskeletal and connective tissue disorders     
Back pain  1  0/64 (0.00%)  1/41 (2.44%) 
Muscular weakness  1  0/64 (0.00%)  1/41 (2.44%) 
Musculoskeletal pain  1  1/64 (1.56%)  0/41 (0.00%) 
Rhabdomyolysis  1  0/64 (0.00%)  1/41 (2.44%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Metastatic malignant melanoma  1  1/64 (1.56%)  0/41 (0.00%) 
Nervous system disorders     
Balance disorder  1  1/64 (1.56%)  0/41 (0.00%) 
Syncope  1  0/64 (0.00%)  1/41 (2.44%) 
Psychiatric disorders     
Confusional state  1  1/64 (1.56%)  0/41 (0.00%) 
Renal and urinary disorders     
Acute kidney injury  1  0/64 (0.00%)  1/41 (2.44%) 
Renal failure acute  1  1/64 (1.56%)  0/41 (0.00%) 
Urinary retention  1  0/64 (0.00%)  1/41 (2.44%) 
Reproductive system and breast disorders     
Testicular pain  1  1/64 (1.56%)  0/41 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Chronic obstructive pulmonary disease  1  0/64 (0.00%)  1/41 (2.44%) 
Cough  1  0/64 (0.00%)  2/41 (4.88%) 
Dyspnoea  1  2/64 (3.13%)  1/41 (2.44%) 
Hypoxia  1  2/64 (3.13%)  0/41 (0.00%) 
Organising pneumonia  1  1/64 (1.56%)  0/41 (0.00%) 
Pneumonitis  1  2/64 (3.13%)  2/41 (4.88%) 
Pulmonary fibrosis  1  2/64 (3.13%)  0/41 (0.00%) 
Respiratory failure  1  2/64 (3.13%)  0/41 (0.00%) 
Skin and subcutaneous tissue disorders     
Rash maculo-papular  1  0/64 (0.00%)  1/41 (2.44%) 
Vascular disorders     
Embolism  1  0/64 (0.00%)  1/41 (2.44%) 
Hypertension  1  1/64 (1.56%)  0/41 (0.00%) 
Hypotension  1  0/64 (0.00%)  1/41 (2.44%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 15.1 and 19.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Idelalisib+Rituximab (Cohort 1) Idelalisib (Cohort 2)
Affected / at Risk (%) Affected / at Risk (%)
Total   63/64 (98.44%)   40/41 (97.56%) 
Blood and lymphatic system disorders     
Anaemia  1  5/64 (7.81%)  8/41 (19.51%) 
Neutropenia  1  3/64 (4.69%)  9/41 (21.95%) 
Thrombocytopenia  1  0/64 (0.00%)  10/41 (24.39%) 
Gastrointestinal disorders     
Abdominal pain  1  7/64 (10.94%)  1/41 (2.44%) 
Abdominal pain upper  1  5/64 (7.81%)  0/41 (0.00%) 
Colitis  1  2/64 (3.13%)  3/41 (7.32%) 
Constipation  1  11/64 (17.19%)  12/41 (29.27%) 
Diarrhoea  1  31/64 (48.44%)  27/41 (65.85%) 
Dry mouth  1  1/64 (1.56%)  4/41 (9.76%) 
Flatulence  1  4/64 (6.25%)  3/41 (7.32%) 
Mouth ulceration  1  0/64 (0.00%)  4/41 (9.76%) 
Nausea  1  24/64 (37.50%)  14/41 (34.15%) 
Stomatitis  1  7/64 (10.94%)  1/41 (2.44%) 
Vomiting  1  14/64 (21.88%)  7/41 (17.07%) 
General disorders     
Asthenia  1  7/64 (10.94%)  0/41 (0.00%) 
Chest discomfort  1  4/64 (6.25%)  0/41 (0.00%) 
Chills  1  23/64 (35.94%)  6/41 (14.63%) 
Fatigue  1  20/64 (31.25%)  13/41 (31.71%) 
Influenza like illness  1  8/64 (12.50%)  1/41 (2.44%) 
Malaise  1  6/64 (9.38%)  1/41 (2.44%) 
Oedema  1  4/64 (6.25%)  2/41 (4.88%) 
Oedema peripheral  1  8/64 (12.50%)  10/41 (24.39%) 
Peripheral swelling  1  0/64 (0.00%)  3/41 (7.32%) 
Pyrexia  1  26/64 (40.63%)  13/41 (31.71%) 
Infections and infestations     
Candida infection  1  0/64 (0.00%)  3/41 (7.32%) 
Pneumonia  1  7/64 (10.94%)  4/41 (9.76%) 
Sinusitis  1  6/64 (9.38%)  2/41 (4.88%) 
Upper respiratory tract infection  1  7/64 (10.94%)  11/41 (26.83%) 
Urinary tract infection  1  9/64 (14.06%)  2/41 (4.88%) 
Injury, poisoning and procedural complications     
Infusion related reaction  1  6/64 (9.38%)  0/41 (0.00%) 
Investigations     
Alanine aminotransferase increased  1  18/64 (28.13%)  11/41 (26.83%) 
Aspartate aminotransferase increased  1  17/64 (26.56%)  10/41 (24.39%) 
Blood alkaline phosphatase increased  1  2/64 (3.13%)  3/41 (7.32%) 
Liver function test abnormal  1  6/64 (9.38%)  0/41 (0.00%) 
Neutrophil count decreased  1  2/64 (3.13%)  3/41 (7.32%) 
Transaminases increased  1  9/64 (14.06%)  0/41 (0.00%) 
Weight decreased  1  6/64 (9.38%)  2/41 (4.88%) 
Metabolism and nutrition disorders     
Decreased appetite  1  9/64 (14.06%)  2/41 (4.88%) 
Dehydration  1  6/64 (9.38%)  2/41 (4.88%) 
Hypercalcaemia  1  1/64 (1.56%)  3/41 (7.32%) 
Hypocalcaemia  1  1/64 (1.56%)  4/41 (9.76%) 
Hypokalaemia  1  6/64 (9.38%)  6/41 (14.63%) 
Hypomagnesaemia  1  4/64 (6.25%)  8/41 (19.51%) 
Hypophosphataemia  1  1/64 (1.56%)  5/41 (12.20%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  10/64 (15.63%)  7/41 (17.07%) 
Back pain  1  9/64 (14.06%)  3/41 (7.32%) 
Muscle spasms  1  4/64 (6.25%)  5/41 (12.20%) 
Musculoskeletal pain  1  4/64 (6.25%)  2/41 (4.88%) 
Myalgia  1  4/64 (6.25%)  3/41 (7.32%) 
Pain in extremity  1  6/64 (9.38%)  4/41 (9.76%) 
Nervous system disorders     
Dizziness  1  7/64 (10.94%)  1/41 (2.44%) 
Dysgeusia  1  4/64 (6.25%)  0/41 (0.00%) 
Headache  1  15/64 (23.44%)  5/41 (12.20%) 
Psychiatric disorders     
Anxiety  1  4/64 (6.25%)  6/41 (14.63%) 
Insomnia  1  13/64 (20.31%)  2/41 (4.88%) 
Renal and urinary disorders     
Renal failure acute  1  4/64 (6.25%)  0/41 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  21/64 (32.81%)  11/41 (26.83%) 
Dyspnoea  1  13/64 (20.31%)  4/41 (9.76%) 
Rhinorrhoea  1  1/64 (1.56%)  4/41 (9.76%) 
Skin and subcutaneous tissue disorders     
Dry skin  1  1/64 (1.56%)  6/41 (14.63%) 
Erythema  1  0/64 (0.00%)  3/41 (7.32%) 
Night sweats  1  10/64 (15.63%)  5/41 (12.20%) 
Pruritus  1  10/64 (15.63%)  5/41 (12.20%) 
Rash  1  24/64 (37.50%)  14/41 (34.15%) 
Rash maculo-papular  1  1/64 (1.56%)  7/41 (17.07%) 
Vascular disorders     
Flushing  1  4/64 (6.25%)  1/41 (2.44%) 
Hypertension  1  3/64 (4.69%)  3/41 (7.32%) 
Hypotension  1  7/64 (10.94%)  4/41 (9.76%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 15.1 and 19.0
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: NCT01203930     History of Changes
Other Study ID Numbers: 101-08
First Submitted: September 15, 2010
First Posted: September 17, 2010
Results First Submitted: August 3, 2016
Results First Posted: May 22, 2017
Last Update Posted: November 16, 2018