Safety and Efficacy of Idelalisib in Relapsed or Refractory Hodgkin Lymphoma
Study Details
Study Description
Brief Summary
This study will evaluate the efficacy and safety of idelalisib in participants with relapsed of refractory Hodgkin Lymphoma (HL). The primary objective will be to assess the overall response rate.
Eligible participants will initiate oral therapy with idelalisib at a starting dose of 150 mg twice daily. Treatment with idelalisib will continue until tumor progression or unacceptable toxicity.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
Phase 2 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Idelalisib Participants will receive up to 300 mg of idelalisib twice daily. |
Drug: Idelalisib
Idelalisib tablets administered orally
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Overall Response Rate [Up to Week 110]
Overall response rate (ORR) was assessed based on the International Working Group Revised Response Criteria for Malignant Lymphoma (Cheson, 2007), and was defined as the proportion of participants achieving a complete response (CR) or partial response (PR) as assessed by the investigator. CR was defined as the complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease. PR was defined as a ≥ 50% reduction in the sum of the products of the longest perpendicular diameters of all index lesions, with no new lesions.
Secondary Outcome Measures
- Duration of Response [Up to Week 110]
Duration of response (DOR) was defined as the interval from the first documentation of PR or CR to the earlier of the first documentation of disease progression or death from any cause.
- Percent Change From Baseline in the Sum of the Product of the Greatest Perpendicular Diameters (SPD) of Target Lymph Nodes as Documented Radiographically [Baseline, Week 8, Week 48, and up to Week 110]
- Change From Baseline in Fluorodeoxyglucose (FDG) Uptake in Lymph Nodes as Assessed by Positron-emission Tomography (PET) [Up to Week 110]
- Time to Response [Up to Week 110]
Time to response (TTR) was defined as the interval from the start of idelalisib treatment to the first documentation of CR or PR.
- Overall Survival [Up to Week 110]
Overall survival was defined as the time from start of idelalisib treatment to death from any cause.
- Progression Free Survival [Up to Week 110]
Progression free survival (PFS) was defined as the interval from the start of idelalisib treatment to the earlier of the first documentation of disease progression or death from any cause.
- Time to Treatment Failure [Up to Week 110]
Time to treatment failure (TTF) was defined as the interval from the start of idelalisib treatment to the earlier of the first documentation of disease progression, the permanent cessation of idelalisib therapy due to an adverse event, or death from any cause.
- Changes in Health-related Quality of Life as Reported Using the Functional Assessment of Cancer Therapy: Lymphoma (FACT-Lym) Questionnaire [Baseline and up to Week 110]
Change in health-related quality of life was reported by participants using the FACT-Lym questionnaire assessment tool. Results are presented as the mean (SD) best change from baseline in FACT-Lym total score, which was defined as the highest change score (improvement) after baseline. The FACT-Lym total score is on a scale from 0-168, with higher scores associated with a better quality of life.
- Changes in Performance Status as Documented Using the Karnofsky Performance Criteria for Participants ≥ 16 Years of Age and the Lansky Performance Criteria for Participants < 16 Years of Age [Baseline and up to Week 110]
Changes in performance status were assessed using the Karnofsky performance criteria for participants ≥ 16 years of age and the Lansky performance criteria for participants < 16 years of age. Since there were no participants < 16 years of age, only the Karnofsky performance criteria were used. The change in Karnofsky performance status was reported as the best (highest change score) and worst (lowest change score) change from baseline using the Karnofsky performance criteria. The Karnofsky score classifies patients according to their functional impairment. Scores are on a scale from 0-100, the lower the score, the worse the survival for most serious illnesses.
- Changes in the Plasma Concentrations of Disease-associated Chemokines and Cytokines [Up to Week 110]
- Overall Safety Profile of Idelalisib [Up to Week 110]
The overall safety of idelalisib was assessed as the percentage of participants experiencing adverse events (AEs; Serious AEs, Grade ≥ 3 AEs, AEs related to idelalisib, and AEs leading to discontinuation of idelalisib), clinically significant abnormal electrocardiograms (ECG), and laboratory abnormalities. "Clinically significant" abnormalities in ECG were as determined by the investigator.
- Compliance With Study Drug Dosing as Assessed by Accounting for Used and Unused Drug [Up to Week 110]
- Idelalisib Trough and Peak Plasma Concentration at Week 4 [Predose and 1.5 hours postdose at Week 4]
Plasma samples were collected predose (trough) and 1.5 hours postdose (peak). The minimum and maximum value among participants sampled at each time point are presented. Results of less than the lower limit of quantitation (ie, 5 ng/mL) were treated as zero prior to the achievement of the first quantifiable concentration and as missing otherwise.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Age ≥ 12 years
-
Karnofsky performance score of ≥ 60 (Eastern Cooperative Oncology Group (ECOG) performance score of 0, 1, or 2)
-
Histologically confirmed diagnosis of classic HL (ie, nodular sclerosis, mixed cellularity, lymphocyte depleted, and or lymphocyte rich types)
-
Nodal HL that shows fluorodeoxyglucose (FDG) avidity (defined as focal or diffuse FDG uptake above background in a location incompatible with normal anatomy or physiology), and is measurable (defined as the presence of ≥ 1 nodal lesion that measures ≥ 2 cm in a single dimension as assessed by CT, PET/CT, or magnetic resonance imaging (MRI))
-
Relapsed or refractory HL after prior myeloablative therapy with autologous stem cell transplantation (ASCT) or after ≥ 2 prior chemotherapy-containing regimens and no curative option with conventional therapy
-
Discontinuation of all radiotherapy or chemotherapy for the treatment of HL greater than or equal to 3 weeks before initiation of study treatment and discontinuation of all radioimmunotherapy for HL (Visit 2)
-
All acute toxic effects (excluding alopecia, neurotoxicity, or anemia) of any prior antitumor therapy resolved to Grade ≤ 2 before initiation of study treatment (Visit 2)
-
For men and women of childbearing potential willingness to abstain from sexual intercourse or employ an effective method of contraception during the study drug administration and follow-up periods
-
Willingness and ability to provide written informed consent and to comply with protocol requirements
Exclusion Criteria:
-
Known active central nervous system or leptomeningeal lymphoma
-
History of a non-lymphoma malignancy except for the following: adequately treated local basal cell or squamous cell carcinoma of the skin, cervical carcinoma in situ, superficial bladder cancer, localized prostate cancer, other adequately treated Stage 1 or 2 cancer currently in complete remission, or any other cancer that has been in complete remission for ≥ 5 years
-
Evidence of ongoing systemic bacterial, fungal, or viral infection (excluding viral upper respiratory tract infections) at the time of initiation of study treatment (Visit 2)
-
Pregnancy or breastfeeding
-
Ongoing alcohol or drug addiction
-
Known history of drug-induced liver injury, chronic active hepatitis C virus (HCV), chronic active hepatitis B virus (HBV), alcoholic liver disease, non-alcoholic steatohepatitis, primary biliary cirrhosis, ongoing extrahepatic obstruction caused by stones, cirrhosis of the liver or portal hypertension
-
History of prior allogeneic bone marrow progenitor cell or solid organ transplantation
-
Ongoing immunosuppressive therapy, including systemic corticosteroids.
-
Prior therapy with idelalisib
-
Exposure to another investigational drug within 3 weeks prior to start of study treatment
-
Concurrent participation in another therapeutic treatment trial
-
Prior or ongoing clinically significant illness, medical condition, surgical history, physical finding, ECG finding, or laboratory abnormality that, in the investigator's opinion, could affect the safety of the patient; alter the absorption, distribution, metabolism or excretion of the study drug; or impair the assessment of study results
-
Prior therapy with any drug that inhibits Akt, Bruton tyrosine kinase (BTK), Janus kinase (JAK), mammalian target of rapamycin (mTOR), phosphatidylinositol 3 kinase (PI3K) (including idelalisib), or spleen tyrosine kinase (SYK)
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Memorial Sloan Kettering Cancer Center | New York | New York | United States | 10065 |
2 | MD Anderson Cancer Center | Houston | Texas | United States | 77030 |
3 | Fred Hutchinson Cancer Research Center | Seattle | Washington | United States | 98109 |
Sponsors and Collaborators
- Gilead Sciences
Investigators
- Study Director: Lyndah Dreiling, MD, Gilead Sciences
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 101-11
Study Results
Participant Flow
Recruitment Details | Participants were enrolled at study sites in the United States. The first participant was screened on 15 September 2011. The last study visit occurred on 28 August 2014. |
---|---|
Pre-assignment Detail | 32 participants were screened. |
Arm/Group Title | Idelalisib |
---|---|
Arm/Group Description | Idelalisib up to 300 mg (75, 100, or 150 mg tablets) administered orally twice daily until tumor progression or development of unacceptable toxicity. |
Period Title: Overall Study | |
STARTED | 25 |
COMPLETED | 20 |
NOT COMPLETED | 5 |
Baseline Characteristics
Arm/Group Title | Idelalisib |
---|---|
Arm/Group Description | Idelalisib up to 300 mg (75, 100, or 150 mg tablets) administered orally twice daily until tumor progression or development of unacceptable toxicity. |
Overall Participants | 25 |
Age (years) [Mean (Standard Deviation) ] | |
Mean (Standard Deviation) [years] |
43
(16.1)
|
Sex: Female, Male (Count of Participants) | |
Female |
14
56%
|
Male |
11
44%
|
Race/Ethnicity, Customized (participants) [Number] | |
Asian |
1
4%
|
Black or African American |
2
8%
|
White |
19
76%
|
Other |
3
12%
|
Race/Ethnicity, Customized (participants) [Number] | |
Hispanic or Latino |
3
12%
|
Not Hispanic or Latino |
22
88%
|
Time Since Diagnosis (years) (years) [Mean (Standard Deviation) ] | |
Mean (Standard Deviation) [years] |
3.9
(4.26)
|
Classical Hodgkin Lymphoma Pathologic Subtype (participants) [Number] | |
Nodular Sclerosis |
23
92%
|
Lymphocyte Rich |
2
8%
|
Disease Stage at Screening (participants) [Number] | |
Stage I |
1
4%
|
Stage II |
8
32%
|
Stage III |
6
24%
|
Stage IV |
10
40%
|
Karnofsky Performance Status (units on a scale) [Mean (Standard Deviation) ] | |
Mean (Standard Deviation) [units on a scale] |
83
(7.1)
|
Outcome Measures
Title | Overall Response Rate |
---|---|
Description | Overall response rate (ORR) was assessed based on the International Working Group Revised Response Criteria for Malignant Lymphoma (Cheson, 2007), and was defined as the proportion of participants achieving a complete response (CR) or partial response (PR) as assessed by the investigator. CR was defined as the complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease. PR was defined as a ≥ 50% reduction in the sum of the products of the longest perpendicular diameters of all index lesions, with no new lesions. |
Time Frame | Up to Week 110 |
Outcome Measure Data
Analysis Population Description |
---|
Intent-to-treat (ITT) Analysis Set: participants who received at least one dose of study drug. |
Arm/Group Title | Idelalisib |
---|---|
Arm/Group Description | Idelalisib up to 300 mg (75, 100, or 150 mg tablets) administered orally twice daily until tumor progression or development of unacceptable toxicity. |
Measure Participants | 25 |
Number (95% Confidence Interval) [percentage of participants] |
20.0
80%
|
Title | Duration of Response |
---|---|
Description | Duration of response (DOR) was defined as the interval from the first documentation of PR or CR to the earlier of the first documentation of disease progression or death from any cause. |
Time Frame | Up to Week 110 |
Outcome Measure Data
Analysis Population Description |
---|
Responding Analysis Set: participants who achieved a best response of CR or PR. |
Arm/Group Title | Idelalisib |
---|---|
Arm/Group Description | Idelalisib up to 300 mg (75, 100, or 150 mg tablets) administered orally twice daily until tumor progression or development of unacceptable toxicity. |
Measure Participants | 5 |
Median (95% Confidence Interval) [months] |
8.4
|
Title | Percent Change From Baseline in the Sum of the Product of the Greatest Perpendicular Diameters (SPD) of Target Lymph Nodes as Documented Radiographically |
---|---|
Description | |
Time Frame | Baseline, Week 8, Week 48, and up to Week 110 |
Outcome Measure Data
Analysis Population Description |
---|
ITT Analysis Set |
Arm/Group Title | Idelalisib |
---|---|
Arm/Group Description | Idelalisib up to 300 mg (75, 100, or 150 mg tablets) administered orally twice daily until tumor progression or development of unacceptable toxicity. |
Measure Participants | 25 |
Percent Change at Week 8 (n = 24) |
-14.1
|
Percent Change at Week 48 (n = 5) |
-45.9
|
Best Percent Change from Baseline (n = 24) |
-24.1
|
Title | Change From Baseline in Fluorodeoxyglucose (FDG) Uptake in Lymph Nodes as Assessed by Positron-emission Tomography (PET) |
---|---|
Description | |
Time Frame | Up to Week 110 |
Outcome Measure Data
Analysis Population Description |
---|
An analysis of changes in FDG uptake by the tumor was not conducted due to unavailability of lymph node biopsy samples. |
Arm/Group Title | Idelalisib |
---|---|
Arm/Group Description | Idelalisib up to 300 mg (75, 100, or 150 mg tablets) administered orally twice daily until tumor progression or development of unacceptable toxicity. |
Measure Participants | 0 |
Title | Time to Response |
---|---|
Description | Time to response (TTR) was defined as the interval from the start of idelalisib treatment to the first documentation of CR or PR. |
Time Frame | Up to Week 110 |
Outcome Measure Data
Analysis Population Description |
---|
Responding Analysis Set |
Arm/Group Title | Idelalisib |
---|---|
Arm/Group Description | Idelalisib up to 300 mg (75, 100, or 150 mg tablets) administered orally twice daily until tumor progression or development of unacceptable toxicity. |
Measure Participants | 5 |
Median (Full Range) [months] |
2.0
|
Title | Overall Survival |
---|---|
Description | Overall survival was defined as the time from start of idelalisib treatment to death from any cause. |
Time Frame | Up to Week 110 |
Outcome Measure Data
Analysis Population Description |
---|
ITT Analysis Set |
Arm/Group Title | Idelalisib |
---|---|
Arm/Group Description | Idelalisib up to 300 mg (75, 100, or 150 mg tablets) administered orally twice daily until tumor progression or development of unacceptable toxicity. |
Measure Participants | 25 |
Median (95% Confidence Interval) [months] |
19.8
|
Title | Progression Free Survival |
---|---|
Description | Progression free survival (PFS) was defined as the interval from the start of idelalisib treatment to the earlier of the first documentation of disease progression or death from any cause. |
Time Frame | Up to Week 110 |
Outcome Measure Data
Analysis Population Description |
---|
ITT Analysis Set |
Arm/Group Title | Idelalisib |
---|---|
Arm/Group Description | Idelalisib up to 300 mg (75, 100, or 150 mg tablets) administered orally twice daily until tumor progression or development of unacceptable toxicity. |
Measure Participants | 25 |
Median (95% Confidence Interval) [months] |
2.3
|
Title | Time to Treatment Failure |
---|---|
Description | Time to treatment failure (TTF) was defined as the interval from the start of idelalisib treatment to the earlier of the first documentation of disease progression, the permanent cessation of idelalisib therapy due to an adverse event, or death from any cause. |
Time Frame | Up to Week 110 |
Outcome Measure Data
Analysis Population Description |
---|
No data are presented because time to treatment failure data were not collected. |
Arm/Group Title | Idelalisib |
---|---|
Arm/Group Description | Idelalisib up to 300 mg (75, 100, or 150 mg tablets) administered orally twice daily until tumor progression or development of unacceptable toxicity. |
Measure Participants | 0 |
Title | Changes in Health-related Quality of Life as Reported Using the Functional Assessment of Cancer Therapy: Lymphoma (FACT-Lym) Questionnaire |
---|---|
Description | Change in health-related quality of life was reported by participants using the FACT-Lym questionnaire assessment tool. Results are presented as the mean (SD) best change from baseline in FACT-Lym total score, which was defined as the highest change score (improvement) after baseline. The FACT-Lym total score is on a scale from 0-168, with higher scores associated with a better quality of life. |
Time Frame | Baseline and up to Week 110 |
Outcome Measure Data
Analysis Population Description |
---|
FACT-Lym Evaluable Analysis Set: participants who had sufficient baseline and on-study measurements to provide interpretable results for this endpoint. |
Arm/Group Title | Idelalisib |
---|---|
Arm/Group Description | Idelalisib up to 300 mg (75, 100, or 150 mg tablets) administered orally twice daily until tumor progression or development of unacceptable toxicity. |
Measure Participants | 20 |
Mean (Standard Deviation) [units on a scale] |
5.1
(7.24)
|
Title | Changes in Performance Status as Documented Using the Karnofsky Performance Criteria for Participants ≥ 16 Years of Age and the Lansky Performance Criteria for Participants < 16 Years of Age |
---|---|
Description | Changes in performance status were assessed using the Karnofsky performance criteria for participants ≥ 16 years of age and the Lansky performance criteria for participants < 16 years of age. Since there were no participants < 16 years of age, only the Karnofsky performance criteria were used. The change in Karnofsky performance status was reported as the best (highest change score) and worst (lowest change score) change from baseline using the Karnofsky performance criteria. The Karnofsky score classifies patients according to their functional impairment. Scores are on a scale from 0-100, the lower the score, the worse the survival for most serious illnesses. |
Time Frame | Baseline and up to Week 110 |
Outcome Measure Data
Analysis Population Description |
---|
Participants in the ITT Analysis Set with available data were analyzed. |
Arm/Group Title | Idelalisib |
---|---|
Arm/Group Description | Idelalisib up to 300 mg (75, 100, or 150 mg tablets) administered orally twice daily until tumor progression or development of unacceptable toxicity. |
Measure Participants | 7 |
Best Change |
6
(5.3)
|
Worst Change |
-1
(6.9)
|
Title | Changes in the Plasma Concentrations of Disease-associated Chemokines and Cytokines |
---|---|
Description | |
Time Frame | Up to Week 110 |
Outcome Measure Data
Analysis Population Description |
---|
This analysis was not conducted due to discrepancies with the transfer of samples. |
Arm/Group Title | Idelalisib |
---|---|
Arm/Group Description | Idelalisib up to 300 mg (75, 100, or 150 mg tablets) administered orally twice daily until tumor progression or development of unacceptable toxicity. |
Measure Participants | 0 |
Title | Overall Safety Profile of Idelalisib |
---|---|
Description | The overall safety of idelalisib was assessed as the percentage of participants experiencing adverse events (AEs; Serious AEs, Grade ≥ 3 AEs, AEs related to idelalisib, and AEs leading to discontinuation of idelalisib), clinically significant abnormal electrocardiograms (ECG), and laboratory abnormalities. "Clinically significant" abnormalities in ECG were as determined by the investigator. |
Time Frame | Up to Week 110 |
Outcome Measure Data
Analysis Population Description |
---|
ITT Analysis Set |
Arm/Group Title | Idelalisib |
---|---|
Arm/Group Description | Idelalisib up to 300 mg (75, 100, or 150 mg tablets) administered orally twice daily until tumor progression or development of unacceptable toxicity. |
Measure Participants | 25 |
Any AE |
96.0
384%
|
Serious AE |
36.0
144%
|
Grade ≥ 3 AE |
48.0
192%
|
AE related to idelalisib |
76.0
304%
|
AE leading to permanent drug discontinuation |
8.0
32%
|
Clinically significant abnormal ECG at Week 16 |
0
0%
|
Grade 3 or 4 hemoglobin |
4.0
16%
|
Grade 3 or 4 neutrophils |
8.0
32%
|
Grade 3 or 4 platelets |
4.0
16%
|
Grade 3 or 4 alanine aminotransferase |
20.0
80%
|
Grade 3 or 4 aspartate aminotransferase |
16.0
64%
|
Title | Compliance With Study Drug Dosing as Assessed by Accounting for Used and Unused Drug |
---|---|
Description | |
Time Frame | Up to Week 110 |
Outcome Measure Data
Analysis Population Description |
---|
ITT Analysis Set |
Arm/Group Title | Idelalisib |
---|---|
Arm/Group Description | Idelalisib up to 300 mg (75, 100, or 150 mg tablets) administered orally twice daily until tumor progression or development of unacceptable toxicity. |
Measure Participants | 25 |
Number of doses dispensed |
463
(462.3)
|
Number of doses taken |
329
(321.1)
|
Title | Idelalisib Trough and Peak Plasma Concentration at Week 4 |
---|---|
Description | Plasma samples were collected predose (trough) and 1.5 hours postdose (peak). The minimum and maximum value among participants sampled at each time point are presented. Results of less than the lower limit of quantitation (ie, 5 ng/mL) were treated as zero prior to the achievement of the first quantifiable concentration and as missing otherwise. |
Time Frame | Predose and 1.5 hours postdose at Week 4 |
Outcome Measure Data
Analysis Population Description |
---|
Participants in the ITT Analysis Set with available data were analyzed. |
Arm/Group Title | Idelalisib |
---|---|
Arm/Group Description | Idelalisib up to 300 mg (75, 100, or 150 mg tablets) administered orally twice daily until tumor progression or development of unacceptable toxicity. |
Measure Participants | 25 |
Trough - minimum (n = 20) |
142
|
Trough - maximum (n = 20) |
2120.0
|
Peak - minimum (n = 22) |
90.2
|
Peak - maximum (n = 22) |
8570.0
|
Adverse Events
Time Frame | Up to Week 110 | |
---|---|---|
Adverse Event Reporting Description | ITT Analysis Set | |
Arm/Group Title | Idelalisib | |
Arm/Group Description | Idelalisib up to 300 mg (75, 100, or 150 mg tablets) administered orally twice daily until tumor progression or development of unacceptable toxicity. | |
All Cause Mortality |
||
Idelalisib | ||
Affected / at Risk (%) | # Events | |
Total | / (NaN) | |
Serious Adverse Events |
||
Idelalisib | ||
Affected / at Risk (%) | # Events | |
Total | 9/25 (36%) | |
Blood and lymphatic system disorders | ||
Febrile neutropenia | 1/25 (4%) | |
Gastrointestinal disorders | ||
Colitis | 1/25 (4%) | |
Vomiting | 1/25 (4%) | |
General disorders | ||
Pyrexia | 1/25 (4%) | |
Infections and infestations | ||
Herpes zoster | 1/25 (4%) | |
Lung infection | 1/25 (4%) | |
Pneumonia | 1/25 (4%) | |
Skin infection | 1/25 (4%) | |
Investigations | ||
Platelet count decreased | 1/25 (4%) | |
Metabolism and nutrition disorders | ||
Hypocalcaemia | 1/25 (4%) | |
Hypokalaemia | 1/25 (4%) | |
Hypomagnesaemia | 1/25 (4%) | |
Respiratory, thoracic and mediastinal disorders | ||
Hypoxia | 1/25 (4%) | |
Pneumonitis | 1/25 (4%) | |
Productive cough | 1/25 (4%) | |
Skin and subcutaneous tissue disorders | ||
Rash maculo-papular | 2/25 (8%) | |
Surgical and medical procedures | ||
Hospitalisation | 1/25 (4%) | |
Other (Not Including Serious) Adverse Events |
||
Idelalisib | ||
Affected / at Risk (%) | # Events | |
Total | 24/25 (96%) | |
Blood and lymphatic system disorders | ||
Anaemia | 3/25 (12%) | |
Leukopenia | 4/25 (16%) | |
Neutropenia | 4/25 (16%) | |
Thrombocytopenia | 4/25 (16%) | |
Cardiac disorders | ||
Tachycardia | 2/25 (8%) | |
Gastrointestinal disorders | ||
Abdominal pain | 2/25 (8%) | |
Abdominal pain upper | 2/25 (8%) | |
Constipation | 6/25 (24%) | |
Diarrhoea | 3/25 (12%) | |
Dyspepsia | 4/25 (16%) | |
Nausea | 4/25 (16%) | |
Vomiting | 6/25 (24%) | |
General disorders | ||
Chills | 5/25 (20%) | |
Fatigue | 8/25 (32%) | |
Pain | 2/25 (8%) | |
Pyrexia | 6/25 (24%) | |
Infections and infestations | ||
Upper respiratory tract infection | 2/25 (8%) | |
Injury, poisoning and procedural complications | ||
Fall | 2/25 (8%) | |
Investigations | ||
Alanine aminotransferase increased | 5/25 (20%) | |
Aspartate aminotransferase increased | 6/25 (24%) | |
Metabolism and nutrition disorders | ||
Hyperglycaemia | 4/25 (16%) | |
Hypoalbuminaemia | 2/25 (8%) | |
Hypocalcaemia | 2/25 (8%) | |
Hypokalaemia | 2/25 (8%) | |
Musculoskeletal and connective tissue disorders | ||
Back pain | 2/25 (8%) | |
Muscle spasms | 2/25 (8%) | |
Musculoskeletal pain | 2/25 (8%) | |
Myalgia | 2/25 (8%) | |
Nervous system disorders | ||
Memory impairment | 2/25 (8%) | |
Neuropathy peripheral | 3/25 (12%) | |
Respiratory, thoracic and mediastinal disorders | ||
Cough | 5/25 (20%) | |
Dyspnoea | 2/25 (8%) | |
Skin and subcutaneous tissue disorders | ||
Night sweats | 3/25 (12%) | |
Rash | 3/25 (12%) | |
Vascular disorders | ||
Hypertension | 2/25 (8%) |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
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 |
Phone | |
ClinicalTrialDisclosures@gilead.com |
- 101-11