An Extension Study for Subjects Who Are Deriving Benefit With Idelalisib (GS-1101; CAL-101) Following Completion of a Prior Idelalisib Study
Study Details
Study Description
Brief Summary
This is a long-term safety extension study of idelalisib (GS-1101; CAL-101) in patients with hematologic malignancies who complete other idelalisib studies. It provides the opportunity for patients to continue treatment as long as the patient is deriving clinical benefit. Patients will be followed according to the standard of care as appropriate for their type of cancer. The dose of idelalisib will generally be the same as the dose that was administered at the end of the prior study, but may be titrated up to improve clinical response or down for toxicity. Patients will be withdrawn from the study if they develop progressive disease, unacceptable toxicity related to idelalisib, or if they no longer derive clinical benefit in the opinion of the investigator.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
Phase 1/Phase 2 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Idelalisib Participants will receive up to 350 mg of idelalisib twice daily until disease progression or unacceptable toxicity. |
Drug: Idelalisib
Idelalisib tablets or capsules administered orally
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Overall Response Rate [Parent study baseline to end of study 101-99 (maximum: up to 91.2 months)]
Overall response rate (ORR) was defined as the percentage of participants who achieve complete response (CR), partial response (PR), or minor response (MR; for lymphoplasmacytic lymphoma/Waldenström's macroglobulinemia (LPL/WM) only).
- Percentage of Participants Who Experienced Any Treatment-Emergent Adverse Events [Parent study baseline to end of study 101-99 (maximum: up to 91.2 months) plus 30 days]
Secondary Outcome Measures
- Duration of Response [Parent study baseline to end of study 101-99 (maximum: up to 91.2 months)]
Duration of response (DOR) was defined as the interval from the first documentation of CR, PR, or MR (for LPL/WM) to the earlier of the first documentation of disease progression or death from any cause. DOR was analyzed using Kaplan-Meier (KM) estimates.
- Progression-Free Survival [Parent study baseline to end of study 101-99 (maximum: up to 91.2 months)]
Progression-free survival (PFS) was defined as the interval from start of idelalisib treatment in the parent study to the earlier of the first documentation of disease progression or death from any cause. PFS was analyzed using KM estimates.
- Overall Survival [Parent study baseline to end of study 101-99 (maximum: up to 91.2 months)]
Overall survival (OS) was defined as the interval from the start of study treatment in the parent study to death from any cause. OS was analyzed using KM estimates.
- Time to Response [Parent study baseline to end of study 101-99 (maximum: up to 91.2 months)]
Time to response (TTR) was defined as the interval from start of study treatment to the first documentation of CR, PR, or MR (for LPL/WM). Analysis only includes participants who achieved complete or partial response (or minor response for LPL/WM participants). No participants in the 101-02 (AML and MM) groups achieved a complete or partial response.
Eligibility Criteria
Criteria
Key Inclusion Criteria:
-
Patients with hematologic malignancies completing a prior idelalisib study with a clinical benefit are eligible
-
Women of childbearing potential must have a negative pregnancy test to be eligible
-
Male patients, and female patients of childbearing potential, must agree to use method(s) of contraception specified in the protocol
Key Exclusion Criteria:
- Patients who are unwilling or unable to comply with the protocol are not eligible
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Clearview Cancer Institute | Huntsville | Alabama | United States | 35805 |
2 | UCLA | Los Angeles | California | United States | 90095-1678 |
3 | Stanford Cancer Center | Palo Alto | California | United States | 94304-5548 |
4 | Center for Cancer & Blood Disorders, PC | Bethesda | Maryland | United States | 20817 |
5 | Dana-Farber Cancer Institute | Boston | Massachusetts | United States | 02115 |
6 | Washington University School of Medicine | Saint Louis | Missouri | United States | 63110 |
7 | Long Island Jewish medical Center | New Hyde Park | New York | United States | 11042 |
8 | Memorial Sloan-Kettering Cancer Center | New York | New York | United States | 10021 |
9 | Weill Medical College of Cornell | New York | New York | United States | 10021 |
10 | Mount Sinai School of Medicine | New York | New York | United States | 10029 |
11 | The Ohio State University Medical Center | Columbus | Ohio | United States | 43210 |
12 | Oregon Health & Science University | Portland | Oregon | United States | 97239 |
13 | Willamette Valley Cancer Institute and Research Center | Springfield | Oregon | United States | 97477 |
14 | Sarah Cannon Research Institute | Nashville | Tennessee | United States | 37203 |
15 | MD Anderson Cancer and Research Center | Houston | Texas | United States | 77030 |
16 | MD Anderson Cancer Center | Houston | Texas | United States | 77030 |
17 | Yakima Regional Cancer Care | Yakima | Washington | United States | 98902 |
18 | University of Wisconsin | Madison | Wisconsin | United States | 53792-5156 |
Sponsors and Collaborators
- Gilead Sciences
Investigators
- Study Director: Gilead Study Director, Gilead Sciences
Study Documents (Full-Text)
- Study Protocol: Original - Jan 22, 2010
- Study Protocol: Amendment 1 - Apr 12, 2010
- Study Protocol: Amendment 2 - Oct 28, 2013
- Study Protocol: Amendment 3 - Nov 25, 2014
- Study Protocol: Amendment 4 - Mar 25, 2016
- Study Protocol: Amendment 5 - Nov 7, 2016
- Study Protocol: Amendment 6 - Aug 28, 2017
- Statistical Analysis Plan - Apr 1, 2013
More Information
Publications
None provided.- 101-99
Study Results
Participant Flow
Recruitment Details | Participants were enrolled at study sites in the United States. The first participant was screened on 22 March 2010. The last study visit occurred on 18 June 2018. |
---|---|
Pre-assignment Detail | Participants must have been enrolled in a previous Gilead-sponsored study. |
Arm/Group Title | 101-02 | 101-07 | 101-08 | 101-10 |
---|---|---|---|---|
Arm/Group Description | Participants with chronic lymphocytic leukemia (CLL), indolent non-Hodgkin lymphoma (iNHL), mantle cell lymphoma (MCL), diffuse large B-cell lymphoma (DLBCL), acute myeloid leukemia (AML), or multiple myeloma (MM) received idelalisib 50 mg, 100 mg, 150 mg, 200 mg, 300 mg, or 350 mg capsules twice daily during parent study 101-02 (NCT00710528, results reported within this record) and may have entered long-term safety extension study 101-99 to receive the same treatment. | Participants with CLL, iNHL, or MCL received idelalisib 100 mg or 150 mg tablets twice daily with or without rituximab, bendamustine, ofatumumab, fludarabine, everolimus, bortezomib, chlorambucil, and/or lenalidomide during parent study 101-07 (NCT01088048, results reported within this record) and may have entered long-term safety extension study 101-99 to receive the same treatment. | Participants with CLL or iNHL (specifically, small lymphocytic lymphoma (SLL)) received idelalisib 150 mg tablets twice daily with rituximab during parent study 101-08 (NCT01203930) and may have entered long-term safety extension study 101-99 to receive the same treatment. Note: Only participants from Cohort 1 were eligible to enter this Study 101-99, so Cohort 2 participants are not presented at all in this record. | Participants with iNHL received idelalisib 150 mg tablets twice daily during parent study 101-10 (NCT01306643) and may have entered long-term safety extension study 101-99 to receive the same treatment. |
Period Title: Parent Studies | ||||
STARTED | 191 | 241 | 64 | 18 |
COMPLETED | 50 | 114 | 43 | 5 |
NOT COMPLETED | 141 | 127 | 21 | 13 |
Period Title: Parent Studies | ||||
STARTED | 48 | 108 | 41 | 5 |
COMPLETED | 0 | 0 | 0 | 0 |
NOT COMPLETED | 48 | 108 | 41 | 5 |
Baseline Characteristics
Arm/Group Title | 101-02 | 101-07 | 101-08 | 101-10 | Total |
---|---|---|---|---|---|
Arm/Group Description | Participants with CLL, iNHL, MCL, DLBCL, AML, or MM received idelalisib 50 mg, 100 mg, 150 mg, 200 mg, 300 mg, or 350 mg capsules twice daily during parent study 101-02 (NCT00710528, results reported within this record) and may have entered long-term safety extension study 101-99 to receive the same treatment. | Participants with CLL, iNHL, or MCL received idelalisib 100 mg or 150 mg tablets twice daily with or without rituximab, bendamustine, ofatumumab, fludarabine, everolimus, bortezomib, chlorambucil, and/or lenalidomide during parent study 101-07 (NCT01088048, results reported within this record) and may have entered long-term safety extension study 101-99 to receive the same treatment. | Participants with CLL or iNHL (specifically, small lymphocytic lymphoma (SLL)) received idelalisib 150 mg tablets twice daily with rituximab during parent study 101-08 (NCT01203930) and may have entered long-term safety extension study 101-99 to receive the same treatment. | Participants with iNHL received idelalisib 150 mg tablets twice daily during parent study 101-10 (NCT01306643) and may have entered long-term safety extension study 101-99 to receive the same treatment. | Total of all reporting groups |
Overall Participants | 191 | 241 | 64 | 18 | 514 |
Age, Customized (Count of Participants) | |||||
< 65 years |
86
45%
|
116
48.1%
|
0
0%
|
13
72.2%
|
215
41.8%
|
≥ 65 years |
105
55%
|
125
51.9%
|
64
100%
|
5
27.8%
|
299
58.2%
|
Sex: Female, Male (Count of Participants) | |||||
Female |
52
27.2%
|
76
31.5%
|
24
37.5%
|
8
44.4%
|
160
31.1%
|
Male |
139
72.8%
|
165
68.5%
|
40
62.5%
|
10
55.6%
|
354
68.9%
|
Ethnicity (NIH/OMB) (Count of Participants) | |||||
Hispanic or Latino |
2
1%
|
4
1.7%
|
0
0%
|
1
5.6%
|
7
1.4%
|
Not Hispanic or Latino |
167
87.4%
|
234
97.1%
|
64
100%
|
17
94.4%
|
482
93.8%
|
Unknown or Not Reported |
22
11.5%
|
3
1.2%
|
0
0%
|
0
0%
|
25
4.9%
|
Race/Ethnicity, Customized (Count of Participants) | |||||
White |
160
83.8%
|
209
86.7%
|
61
95.3%
|
12
66.7%
|
442
86%
|
Black or African American |
6
3.1%
|
9
3.7%
|
1
1.6%
|
5
27.8%
|
21
4.1%
|
Asian |
1
0.5%
|
11
4.6%
|
1
1.6%
|
1
5.6%
|
14
2.7%
|
Other |
2
1%
|
1
0.4%
|
1
1.6%
|
0
0%
|
4
0.8%
|
Not Reported |
22
11.5%
|
11
4.6%
|
0
0%
|
0
0%
|
33
6.4%
|
Diagnosis Status (Count of Participants) | |||||
Chronic lymphocytic leukemia (CLL) |
54
28.3%
|
115
47.7%
|
59
92.2%
|
0
0%
|
228
44.4%
|
Indolent non-Hodgkin lymphoma (iNHL) |
64
33.5%
|
86
35.7%
|
5
7.8%
|
17
94.4%
|
172
33.5%
|
Mantle cell lymphoma (MCL) |
40
20.9%
|
40
16.6%
|
0
0%
|
0
0%
|
80
15.6%
|
Diffuse large B-cell lymphoma (DLBCL) |
9
4.7%
|
0
0%
|
0
0%
|
0
0%
|
9
1.8%
|
Acute myeloid leukemia (AML) |
12
6.3%
|
0
0%
|
0
0%
|
0
0%
|
12
2.3%
|
Multiple myeloma (MM) |
12
6.3%
|
0
0%
|
0
0%
|
0
0%
|
12
2.3%
|
Missing |
0
0%
|
0
0%
|
0
0%
|
1
5.6%
|
1
0.2%
|
Outcome Measures
Title | Overall Response Rate |
---|---|
Description | Overall response rate (ORR) was defined as the percentage of participants who achieve complete response (CR), partial response (PR), or minor response (MR; for lymphoplasmacytic lymphoma/Waldenström's macroglobulinemia (LPL/WM) only). |
Time Frame | Parent study baseline to end of study 101-99 (maximum: up to 91.2 months) |
Outcome Measure Data
Analysis Population Description |
---|
Data presented includes available data from both the parent studies and this Study 101-99. It was prespecified that data for Study 101-08 be combined for CLL and SLL participants. |
Arm/Group Title | 101-02 (AML) | 101-02 (CLL) | 101-02 (DLBCL) | 101-02 (iNHL) | 101-02 (MCL) | 101-02 (MM) | 101-07 (CLL) | 101-07 (iNHL) | 101-07 (MCL) | 101-08 (CLL or SLL) | 101-10 (iNHL) |
---|---|---|---|---|---|---|---|---|---|---|---|
Arm/Group Description | Participants with AML received idelalisib 50 mg, 100 mg, 150 mg, 200 mg, 300 mg, or 350 mg capsules twice daily during parent study 101-02 (NCT00710528, results reported within this record) and may have entered long-term safety extension study 101-99 to receive the same treatment. | Participants with CLL received idelalisib 50 mg, 100 mg, 150 mg, 200 mg, 300 mg, or 350 mg capsules twice daily during parent study 101-02 (NCT00710528, results reported within this record) and may have entered long-term safety extension study 101-99 to receive the same treatment. | Participants with DLBCL received idelalisib 50 mg, 100 mg, 150 mg, 200 mg, 300 mg, or 350 mg capsules twice daily during parent study 101-02 (NCT00710528, results reported within this record) and may have entered long-term safety extension study 101-99 to receive the same treatment. | Participants with iNHL received idelalisib 50 mg, 100 mg, 150 mg, 200 mg, 300 mg, or 350 mg capsules twice daily during parent study 101-02 (NCT00710528, results reported within this record) and may have entered long-term safety extension study 101-99 to receive the same treatment. | Participants with MCL received idelalisib 50 mg, 100 mg, 150 mg, 200 mg, 300 mg, or 350 mg capsules twice daily during parent study 101-02 (NCT00710528, results reported within this record) and may have entered long-term safety extension study 101-99 to receive the same treatment. | Participants with MM received idelalisib 50 mg, 100 mg, 150 mg, 200 mg, 300 mg, or 350 mg capsules twice daily during parent study 101-02 (NCT00710528, results reported within this record) and may have entered long-term safety extension study 101-99 to receive the same treatment. | Participants with CLL received idelalisib 100 mg or 150 mg tablets twice daily with or without rituximab, bendamustine, ofatumumab, fludarabine, chlorambucil, and/or lenalidomide during parent study 101-07 (NCT01088048, results reported within this record) and may have entered long-term safety extension study 101-99 to receive the same treatment. | Participants with iNHL received idelalisib 100 mg or 150 mg tablets twice daily with or without rituximab, bendamustine, and/or lenalidomide during parent study 101-07 (NCT01088048, results reported within this record) and may have entered long-term safety extension study 101-99 to receive the same treatment. | Participants with MCL received idelalisib 100 mg or 150 mg tablets twice daily with or without rituximab, bendamustine, everolimus, bortezomib, and/or lenalidomide during parent study 101-07 (NCT01088048, results reported within this record) and may have entered long-term safety extension study 101-99 to receive the same treatment. | Participants with CLL or SLL received idelalisib 150 mg tablets twice daily with rituximab during parent study 101-08 (NCT01203930) and may have entered long-term safety extension study 101-99 to receive the same treatment. | Participants with iNHL received idelalisib 150 mg tablets twice daily during parent study 101-10 (NCT01306643) and may have entered long-term safety extension study 101-99 to receive the same treatment. |
Measure Participants | 12 | 54 | 9 | 64 | 40 | 12 | 115 | 86 | 40 | 64 | 18 |
Number (95% Confidence Interval) [percentage of participants] |
0
0%
|
57.4
23.8%
|
11.1
17.3%
|
48.4
268.9%
|
40.0
7.8%
|
0
NaN
|
81.7
NaN
|
82.6
NaN
|
57.5
NaN
|
96.9
NaN
|
44.4
NaN
|
Title | Percentage of Participants Who Experienced Any Treatment-Emergent Adverse Events |
---|---|
Description | |
Time Frame | Parent study baseline to end of study 101-99 (maximum: up to 91.2 months) plus 30 days |
Outcome Measure Data
Analysis Population Description |
---|
Data presented includes data from both the parent studies and this Study 101-99. For this safety endpoint, data was prespecified to be combined. |
Arm/Group Title | 101-02 | 101-07 | 101-08 | 101-10 |
---|---|---|---|---|
Arm/Group Description | Participants with CLL or iNHL received idelalisib 50 mg, 100 mg, 150 mg, 200 mg, 300 mg, or 350 mg capsules twice daily during parent study 101-02 (NCT00710528, results reported within this record) and entered long-term safety extension study 101-99 to receive the same treatment. | Participants with CLL, iNHL, or MCL received idelalisib 100 mg or 150 mg tablets twice daily with or without rituximab, bendamustine, ofatumumab, fludarabine, everolimus, bortezomib, chlorambucil, and/or lenalidomide during parent study 101-07 (NCT01088048, results reported within this record) and entered long-term safety extension study 101-99 to receive the same treatment. | Participants with CLL or SLL received idelalisib 150 mg tablets twice daily with rituximab during parent study 101-08 (NCT01203930) and entered long-term safety extension study 101-99 to receive the same treatment. | Participants with iNHL received idelalisib 150 mg tablets twice daily during parent study 101-10 (NCT01306643) and entered long-term safety extension study 101-99 to receive the same treatment. |
Measure Participants | 191 | 241 | 64 | 18 |
Number [percentage of participants] |
98.4
51.5%
|
98.8
41%
|
100.0
156.3%
|
94.4
524.4%
|
Title | Duration of Response |
---|---|
Description | Duration of response (DOR) was defined as the interval from the first documentation of CR, PR, or MR (for LPL/WM) to the earlier of the first documentation of disease progression or death from any cause. DOR was analyzed using Kaplan-Meier (KM) estimates. |
Time Frame | Parent study baseline to end of study 101-99 (maximum: up to 91.2 months) |
Outcome Measure Data
Analysis Population Description |
---|
Data presented includes available data from both the parent studies and this Study 101-99. It was prespecified that data for Study 101-08 be combined for CLL and SLL participants. |
Arm/Group Title | 101-02 (AML) | 101-02 (CLL) | 101-02 (DLBCL) | 101-02 (iNHL) | 101-02 (MCL) | 101-02 (MM) | 101-07 (CLL) | 101-07 (iNHL) | 101-07 (MCL) | 101-08 (CLL or SLL) | 101-10 (iNHL) |
---|---|---|---|---|---|---|---|---|---|---|---|
Arm/Group Description | Participants with AML received idelalisib 50 mg, 100 mg, 150 mg, 200 mg, 300 mg, or 350 mg capsules twice daily during parent study 101-02 (NCT00710528, results reported within this record) and may have entered long-term safety extension study 101-99 to receive the same treatment. | Participants with CLL received idelalisib 50 mg, 100 mg, 150 mg, 200 mg, 300 mg, or 350 mg capsules twice daily during parent study 101-02 (NCT00710528, results reported within this record) and may have entered long-term safety extension study 101-99 to receive the same treatment. | Participants with DLBCL received idelalisib 50 mg, 100 mg, 150 mg, 200 mg, 300 mg, or 350 mg capsules twice daily during parent study 101-02 (NCT00710528, results reported within this record) and may have entered long-term safety extension study 101-99 to receive the same treatment. | Participants with iNHL received idelalisib 50 mg, 100 mg, 150 mg, 200 mg, 300 mg, or 350 mg capsules twice daily during parent study 101-02 (NCT00710528, results reported within this record) and may have entered long-term safety extension study 101-99 to receive the same treatment. | Participants with MCL received idelalisib 50 mg, 100 mg, 150 mg, 200 mg, 300 mg, or 350 mg capsules twice daily during parent study 101-02 (NCT00710528, results reported within this record) and may have entered long-term safety extension study 101-99 to receive the same treatment. | Participants with MM received idelalisib 50 mg, 100 mg, 150 mg, 200 mg, 300 mg, or 350 mg capsules twice daily during parent study 101-02 (NCT00710528, results reported within this record) and may have entered long-term safety extension study 101-99 to receive the same treatment. | Participants with CLL received idelalisib 100 mg or 150 mg tablets twice daily with or without rituximab, bendamustine, ofatumumab, fludarabine, chlorambucil, and/or lenalidomide during parent study 101-07 (NCT01088048, results reported within this record) and may have entered long-term safety extension study 101-99 to receive the same treatment. | Participants with iNHL received idelalisib 100 mg or 150 mg tablets twice daily with or without rituximab, bendamustine, and/or lenalidomide during parent study 101-07 (NCT01088048, results reported within this record) and may have entered long-term safety extension study 101-99 to receive the same treatment. | Participants with MCL received idelalisib 100 mg or 150 mg tablets twice daily with or without rituximab, bendamustine, everolimus, bortezomib, and/or lenalidomide during parent study 101-07 (NCT01088048, results reported within this record) and may have entered long-term safety extension study 101-99 to receive the same treatment. | Participants with CLL or SLL received idelalisib 150 mg tablets twice daily with rituximab during parent study 101-08 (NCT01203930) and may have entered long-term safety extension study 101-99 to receive the same treatment. | Participants with iNHL received idelalisib 150 mg tablets twice daily during parent study 101-10 (NCT01306643) and may have entered long-term safety extension study 101-99 to receive the same treatment. |
Measure Participants | 12 | 54 | 9 | 64 | 40 | 12 | 115 | 86 | 40 | 64 | 18 |
Median (95% Confidence Interval) [Months] |
NA
|
21.2
|
NA
|
18.4
|
2.7
|
NA
|
26.6
|
42.9
|
9.3
|
63.8
|
14.4
|
Title | Progression-Free Survival |
---|---|
Description | Progression-free survival (PFS) was defined as the interval from start of idelalisib treatment in the parent study to the earlier of the first documentation of disease progression or death from any cause. PFS was analyzed using KM estimates. |
Time Frame | Parent study baseline to end of study 101-99 (maximum: up to 91.2 months) |
Outcome Measure Data
Analysis Population Description |
---|
Data presented includes available data from both the parent studies and this Study 101-99. It was prespecified that data for Study 101-08 be combined for CLL and SLL participants. |
Arm/Group Title | 101-02 (AML) | 101-02 (CLL) | 101-02 (DLBCL) | 101-02 (iNHL) | 101-02 (MCL) | 101-02 (MM) | 101-07 (CLL) | 101-07 (iNHL) | 101-07 (MCL) | 101-08 (CLL or SLL) | 101-10 (iNHL) |
---|---|---|---|---|---|---|---|---|---|---|---|
Arm/Group Description | Participants with AML received idelalisib 50 mg, 100 mg, 150 mg, 200 mg, 300 mg, or 350 mg capsules twice daily during parent study 101-02 (NCT00710528, results reported within this record) and may have entered long-term safety extension study 101-99 to receive the same treatment. | Participants with CLL received idelalisib 50 mg, 100 mg, 150 mg, 200 mg, 300 mg, or 350 mg capsules twice daily during parent study 101-02 (NCT00710528, results reported within this record) and may have entered long-term safety extension study 101-99 to receive the same treatment. | Participants with DLBCL received idelalisib 50 mg, 100 mg, 150 mg, 200 mg, 300 mg, or 350 mg capsules twice daily during parent study 101-02 (NCT00710528, results reported within this record) and may have entered long-term safety extension study 101-99 to receive the same treatment. | Participants with iNHL received idelalisib 50 mg, 100 mg, 150 mg, 200 mg, 300 mg, or 350 mg capsules twice daily during parent study 101-02 (NCT00710528, results reported within this record) and may have entered long-term safety extension study 101-99 to receive the same treatment. | Participants with MCL received idelalisib 50 mg, 100 mg, 150 mg, 200 mg, 300 mg, or 350 mg capsules twice daily during parent study 101-02 (NCT00710528, results reported within this record) and may have entered long-term safety extension study 101-99 to receive the same treatment. | Participants with MM received idelalisib 50 mg, 100 mg, 150 mg, 200 mg, 300 mg, or 350 mg capsules twice daily during parent study 101-02 (NCT00710528, results reported within this record) and may have entered long-term safety extension study 101-99 to receive the same treatment. | Participants with CLL received idelalisib 100 mg or 150 mg tablets twice daily with or without rituximab, bendamustine, ofatumumab, fludarabine, chlorambucil, and/or lenalidomide during parent study 101-07 (NCT01088048, results reported within this record) and may have entered long-term safety extension study 101-99 to receive the same treatment. | Participants with iNHL received idelalisib 100 mg or 150 mg tablets twice daily with or without rituximab, bendamustine, and/or lenalidomide during parent study 101-07 (NCT01088048, results reported within this record) and may have entered long-term safety extension study 101-99 to receive the same treatment. | Participants with MCL received idelalisib 100 mg or 150 mg tablets twice daily with or without rituximab, bendamustine, everolimus, bortezomib, and/or lenalidomide during parent study 101-07 (NCT01088048, results reported within this record) and may have entered long-term safety extension study 101-99 to receive the same treatment. | Participants with CLL or SLL received idelalisib 150 mg tablets twice daily with rituximab during parent study 101-08 (NCT01203930) and may have entered long-term safety extension study 101-99 to receive the same treatment. | Participants with iNHL received idelalisib 150 mg tablets twice daily during parent study 101-10 (NCT01306643) and may have entered long-term safety extension study 101-99 to receive the same treatment. |
Measure Participants | 12 | 54 | 9 | 64 | 40 | 12 | 115 | 86 | 40 | 64 | 18 |
Median (95% Confidence Interval) [Months] |
0.9
|
15.8
|
1.5
|
7.6
|
3.7
|
1
|
26.1
|
32.8
|
11.1
|
65.6
|
10.2
|
Title | Overall Survival |
---|---|
Description | Overall survival (OS) was defined as the interval from the start of study treatment in the parent study to death from any cause. OS was analyzed using KM estimates. |
Time Frame | Parent study baseline to end of study 101-99 (maximum: up to 91.2 months) |
Outcome Measure Data
Analysis Population Description |
---|
Data presented includes available data from both the parent studies and this Study 101-99. It was prespecified that data for Study 101-08 be combined for CLL and SLL participants. |
Arm/Group Title | 101-02 (AML) | 101-02 (CLL) | 101-02 (DLBCL) | 101-02 (iNHL) | 101-02 (MCL) | 101-02 (MM) | 101-07 (CLL) | 101-07 (iNHL) | 101-07 (MCL) | 101-08 (CLL or SLL) | 101-10 (iNHL) |
---|---|---|---|---|---|---|---|---|---|---|---|
Arm/Group Description | Participants with AML received idelalisib 50 mg, 100 mg, 150 mg, 200 mg, 300 mg, or 350 mg capsules twice daily during parent study 101-02 (NCT00710528, results reported within this record) and may have entered long-term safety extension study 101-99 to receive the same treatment. | Participants with CLL received idelalisib 50 mg, 100 mg, 150 mg, 200 mg, 300 mg, or 350 mg capsules twice daily during parent study 101-02 (NCT00710528, results reported within this record) and may have entered long-term safety extension study 101-99 to receive the same treatment. | Participants with DLBCL received idelalisib 50 mg, 100 mg, 150 mg, 200 mg, 300 mg, or 350 mg capsules twice daily during parent study 101-02 (NCT00710528, results reported within this record) and may have entered long-term safety extension study 101-99 to receive the same treatment. | Participants with iNHL received idelalisib 50 mg, 100 mg, 150 mg, 200 mg, 300 mg, or 350 mg capsules twice daily during parent study 101-02 (NCT00710528, results reported within this record) and may have entered long-term safety extension study 101-99 to receive the same treatment. | Participants with MCL received idelalisib 50 mg, 100 mg, 150 mg, 200 mg, 300 mg, or 350 mg capsules twice daily during parent study 101-02 (NCT00710528, results reported within this record) and may have entered long-term safety extension study 101-99 to receive the same treatment. | Participants with MM received idelalisib 50 mg, 100 mg, 150 mg, 200 mg, 300 mg, or 350 mg capsules twice daily during parent study 101-02 (NCT00710528, results reported within this record) and may have entered long-term safety extension study 101-99 to receive the same treatment. | Participants with CLL received idelalisib 100 mg or 150 mg tablets twice daily with or without rituximab, bendamustine, ofatumumab, fludarabine, chlorambucil, and/or lenalidomide during parent study 101-07 (NCT01088048, results reported within this record) and may have entered long-term safety extension study 101-99 to receive the same treatment. | Participants with iNHL received idelalisib 100 mg or 150 mg tablets twice daily with or without rituximab, bendamustine, and/or lenalidomide during parent study 101-07 (NCT01088048, results reported within this record) and may have entered long-term safety extension study 101-99 to receive the same treatment. | Participants with MCL received idelalisib 100 mg or 150 mg tablets twice daily with or without rituximab, bendamustine, everolimus, bortezomib, and/or lenalidomide during parent study 101-07 (NCT01088048, results reported within this record) and may have entered long-term safety extension study 101-99 to receive the same treatment. | Participants with CLL or SLL received idelalisib 150 mg tablets twice daily with rituximab during parent study 101-08 (NCT01203930) and may have entered long-term safety extension study 101-99 to receive the same treatment. | Participants with iNHL received idelalisib 150 mg tablets twice daily during parent study 101-10 (NCT01306643) and may have entered long-term safety extension study 101-99 to receive the same treatment. |
Measure Participants | 12 | 54 | 9 | 64 | 40 | 12 | 115 | 86 | 40 | 64 | 18 |
Median (95% Confidence Interval) [Months] |
NA
|
NA
|
NA
|
NA
|
NA
|
5.2
|
NA
|
NA
|
NA
|
NA
|
NA
|
Title | Time to Response |
---|---|
Description | Time to response (TTR) was defined as the interval from start of study treatment to the first documentation of CR, PR, or MR (for LPL/WM). Analysis only includes participants who achieved complete or partial response (or minor response for LPL/WM participants). No participants in the 101-02 (AML and MM) groups achieved a complete or partial response. |
Time Frame | Parent study baseline to end of study 101-99 (maximum: up to 91.2 months) |
Outcome Measure Data
Analysis Population Description |
---|
Data presented includes available data from both the parent studies and this Study 101-99. It was prespecified that data for Study 101-08 be combined for CLL and SLL participants. |
Arm/Group Title | 101-02 (AML) | 101-02 (CLL) | 101-02 (DLBCL) | 101-02 (iNHL) | 101-02 (MCL) | 101-02 (MM) | 101-07 (CLL) | 101-07 (iNHL) | 101-07 (MCL) | 101-08 (CLL or SLL) | 101-10 (iNHL) |
---|---|---|---|---|---|---|---|---|---|---|---|
Arm/Group Description | Participants with AML received idelalisib 50 mg, 100 mg, 150 mg, 200 mg, 300 mg, or 350 mg capsules twice daily during parent study 101-02 (NCT00710528, results reported within this record) and may have entered long-term safety extension study 101-99 to receive the same treatment. | Participants with CLL received idelalisib 50 mg, 100 mg, 150 mg, 200 mg, 300 mg, or 350 mg capsules twice daily during parent study 101-02 (NCT00710528, results reported within this record) and may have entered long-term safety extension study 101-99 to receive the same treatment. | Participants with DLBCL received idelalisib 50 mg, 100 mg, 150 mg, 200 mg, 300 mg, or 350 mg capsules twice daily during parent study 101-02 (NCT00710528, results reported within this record) and may have entered long-term safety extension study 101-99 to receive the same treatment. | Participants with iNHL received idelalisib 50 mg, 100 mg, 150 mg, 200 mg, 300 mg, or 350 mg capsules twice daily during parent study 101-02 (NCT00710528, results reported within this record) and may have entered long-term safety extension study 101-99 to receive the same treatment. | Participants with MCL received idelalisib 50 mg, 100 mg, 150 mg, 200 mg, 300 mg, or 350 mg capsules twice daily during parent study 101-02 (NCT00710528, results reported within this record) and may have entered long-term safety extension study 101-99 to receive the same treatment. | Participants with MM received idelalisib 50 mg, 100 mg, 150 mg, 200 mg, 300 mg, or 350 mg capsules twice daily during parent study 101-02 (NCT00710528, results reported within this record) and may have entered long-term safety extension study 101-99 to receive the same treatment. | Participants with CLL received idelalisib 100 mg or 150 mg tablets twice daily with or without rituximab, bendamustine, ofatumumab, fludarabine, chlorambucil, and/or lenalidomide during parent study 101-07 (NCT01088048, results reported within this record) and may have entered long-term safety extension study 101-99 to receive the same treatment. | Participants with iNHL received idelalisib 100 mg or 150 mg tablets twice daily with or without rituximab, bendamustine, and/or lenalidomide during parent study 101-07 (NCT01088048, results reported within this record) and may have entered long-term safety extension study 101-99 to receive the same treatment. | Participants with MCL received idelalisib 100 mg or 150 mg tablets twice daily with or without rituximab, bendamustine, everolimus, bortezomib, and/or lenalidomide during parent study 101-07 (NCT01088048, results reported within this record) and may have entered long-term safety extension study 101-99 to receive the same treatment. | Participants with CLL or SLL received idelalisib 150 mg tablets twice daily with rituximab during parent study 101-08 (NCT01203930) and may have entered long-term safety extension study 101-99 to receive the same treatment. | Participants iNHL received idelalisib 150 mg tablets twice daily during parent study 101-10 (NCT01306643) and may have entered long-term safety extension study 101-99 to receive the same treatment. |
Measure Participants | 0 | 31 | 1 | 31 | 16 | 0 | 94 | 71 | 23 | 62 | 8 |
Median (Inter-Quartile Range) [Months] |
1.9
|
4.0
|
1.3
|
1.1
|
1.9
|
1.9
|
1.9
|
1.9
|
2.7
|
Adverse Events
Time Frame | First dose date in parent study to end of study 101-99 (maximum: up to 91.2 months) plus 30 days | |||||||
---|---|---|---|---|---|---|---|---|
Adverse Event Reporting Description | Adverse events presented occurred during either the parent studies or Study 101-99. Because Study 101-99 was a long-term extension study, the adverse event data was prespecified to be combined and reported based on the participation in the parent studies. | |||||||
Arm/Group Title | 101-02 | 101-07 | 101-08 | 101-10 | ||||
Arm/Group Description | Participants with CLL, iNHL, MCL, DLBCL, AML, or MM received idelalisib 50 mg, 100 mg, 150 mg, 200 mg, 300 mg, or 350 mg capsules twice daily during parent study 101-02 (NCT00710528, results reported within this record) and may have entered the long-term safety extension study 101-99 to receive the same treatment. | Participants with CLL, iNHL, or MCL received idelalisib 100 mg or 150 mg tablets twice daily with or without rituximab, bendamustine, ofatumumab, fludarabine, everolimus, bortezomib, chlorambucil, and/or lenalidomide during parent study 101-07 (NCT01088048, results reported within this record) and may have entered long-term safety extension study 101-99 to receive the same treatment. | Participants with CLL or SLL received idelalisib 150 mg tablets twice daily with rituximab during parent study 101-08 (NCT01203930) and may have entered long-term safety extension study 101-99 to receive the same treatment. | Participants with iNHL received idelalisib 150 mg tablets twice daily during parent study 101-10 (NCT01306643) and may have entered long-term safety extension study 101-99 to receive the same treatment. | ||||
All Cause Mortality |
||||||||
101-02 | 101-07 | 101-08 | 101-10 | |||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 25/191 (13.1%) | 36/241 (14.9%) | 7/45 (15.6%) | 2/6 (33.3%) | ||||
Serious Adverse Events |
||||||||
101-02 | 101-07 | 101-08 | 101-10 | |||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 100/191 (52.4%) | 165/241 (68.5%) | 45/64 (70.3%) | 6/18 (33.3%) | ||||
Blood and lymphatic system disorders | ||||||||
Anaemia | 3/191 (1.6%) | 5/241 (2.1%) | 1/64 (1.6%) | 0/18 (0%) | ||||
Aplasia pure red cell | 0/191 (0%) | 0/241 (0%) | 1/64 (1.6%) | 0/18 (0%) | ||||
Autoimmune haemolytic anaemia | 0/191 (0%) | 2/241 (0.8%) | 0/64 (0%) | 0/18 (0%) | ||||
Autoimmune neutropenia | 1/191 (0.5%) | 0/241 (0%) | 0/64 (0%) | 0/18 (0%) | ||||
Coombs positive haemolytic anaemia | 0/191 (0%) | 1/241 (0.4%) | 0/64 (0%) | 0/18 (0%) | ||||
Febrile neutropenia | 12/191 (6.3%) | 23/241 (9.5%) | 3/64 (4.7%) | 0/18 (0%) | ||||
Haemolytic anaemia | 1/191 (0.5%) | 0/241 (0%) | 0/64 (0%) | 0/18 (0%) | ||||
Immune thrombocytopenic purpura | 0/191 (0%) | 1/241 (0.4%) | 0/64 (0%) | 0/18 (0%) | ||||
Leukocytosis | 0/191 (0%) | 0/241 (0%) | 1/64 (1.6%) | 0/18 (0%) | ||||
Neutropenia | 2/191 (1%) | 4/241 (1.7%) | 1/64 (1.6%) | 0/18 (0%) | ||||
Pancytopenia | 1/191 (0.5%) | 1/241 (0.4%) | 0/64 (0%) | 0/18 (0%) | ||||
Thrombocytopenia | 3/191 (1.6%) | 6/241 (2.5%) | 0/64 (0%) | 0/18 (0%) | ||||
Cardiac disorders | ||||||||
Angina unstable | 1/191 (0.5%) | 1/241 (0.4%) | 0/64 (0%) | 0/18 (0%) | ||||
Atrial fibrillation | 0/191 (0%) | 3/241 (1.2%) | 0/64 (0%) | 1/18 (5.6%) | ||||
Atrioventricular block second degree | 0/191 (0%) | 1/241 (0.4%) | 0/64 (0%) | 0/18 (0%) | ||||
Cardiac arrest | 0/191 (0%) | 4/241 (1.7%) | 0/64 (0%) | 0/18 (0%) | ||||
Cardiac failure | 0/191 (0%) | 1/241 (0.4%) | 0/64 (0%) | 0/18 (0%) | ||||
Mitral valve incompetence | 0/191 (0%) | 1/241 (0.4%) | 0/64 (0%) | 0/18 (0%) | ||||
Myocardial infarction | 1/191 (0.5%) | 2/241 (0.8%) | 1/64 (1.6%) | 0/18 (0%) | ||||
Pulseless electrical activity | 1/191 (0.5%) | 0/241 (0%) | 0/64 (0%) | 0/18 (0%) | ||||
Supraventricular tachycardia | 1/191 (0.5%) | 1/241 (0.4%) | 0/64 (0%) | 0/18 (0%) | ||||
Tachycardia | 0/191 (0%) | 1/241 (0.4%) | 0/64 (0%) | 0/18 (0%) | ||||
Ventricular tachycardia | 0/191 (0%) | 1/241 (0.4%) | 0/64 (0%) | 0/18 (0%) | ||||
Ear and labyrinth disorders | ||||||||
Vertigo | 0/191 (0%) | 1/241 (0.4%) | 0/64 (0%) | 0/18 (0%) | ||||
Endocrine disorders | ||||||||
Endocrine disorder | 0/191 (0%) | 1/241 (0.4%) | 0/64 (0%) | 0/18 (0%) | ||||
Eye disorders | ||||||||
Retinal detachment | 0/191 (0%) | 1/241 (0.4%) | 0/64 (0%) | 0/18 (0%) | ||||
Uveitis | 0/191 (0%) | 1/241 (0.4%) | 0/64 (0%) | 0/18 (0%) | ||||
Gastrointestinal disorders | ||||||||
Abdominal pain | 2/191 (1%) | 3/241 (1.2%) | 0/64 (0%) | 0/18 (0%) | ||||
Colitis | 8/191 (4.2%) | 14/241 (5.8%) | 13/64 (20.3%) | 0/18 (0%) | ||||
Colitis ischaemic | 0/191 (0%) | 1/241 (0.4%) | 0/64 (0%) | 0/18 (0%) | ||||
Colitis microscopic | 0/191 (0%) | 1/241 (0.4%) | 0/64 (0%) | 0/18 (0%) | ||||
Crohn's disease | 0/191 (0%) | 1/241 (0.4%) | 0/64 (0%) | 0/18 (0%) | ||||
Diarrhoea | 9/191 (4.7%) | 14/241 (5.8%) | 13/64 (20.3%) | 0/18 (0%) | ||||
Diarrhoea haemorrhagic | 1/191 (0.5%) | 0/241 (0%) | 0/64 (0%) | 0/18 (0%) | ||||
Dysphagia | 0/191 (0%) | 1/241 (0.4%) | 0/64 (0%) | 0/18 (0%) | ||||
Gastrointestinal haemorrhage | 1/191 (0.5%) | 2/241 (0.8%) | 0/64 (0%) | 1/18 (5.6%) | ||||
Gastrointestinal obstruction | 0/191 (0%) | 1/241 (0.4%) | 0/64 (0%) | 0/18 (0%) | ||||
Gastrointestinal perforation | 1/191 (0.5%) | 0/241 (0%) | 0/64 (0%) | 0/18 (0%) | ||||
Gingival bleeding | 0/191 (0%) | 1/241 (0.4%) | 0/64 (0%) | 0/18 (0%) | ||||
Intestinal obstruction | 1/191 (0.5%) | 2/241 (0.8%) | 1/64 (1.6%) | 0/18 (0%) | ||||
Large intestinal ulcer | 0/191 (0%) | 1/241 (0.4%) | 0/64 (0%) | 0/18 (0%) | ||||
Mouth haemorrhage | 0/191 (0%) | 1/241 (0.4%) | 0/64 (0%) | 0/18 (0%) | ||||
Nausea | 1/191 (0.5%) | 1/241 (0.4%) | 0/64 (0%) | 0/18 (0%) | ||||
Neutropenic colitis | 0/191 (0%) | 1/241 (0.4%) | 0/64 (0%) | 0/18 (0%) | ||||
Odynophagia | 1/191 (0.5%) | 0/241 (0%) | 0/64 (0%) | 0/18 (0%) | ||||
Oesophagitis | 1/191 (0.5%) | 0/241 (0%) | 0/64 (0%) | 0/18 (0%) | ||||
Peptic ulcer | 0/191 (0%) | 1/241 (0.4%) | 0/64 (0%) | 0/18 (0%) | ||||
Rectal haemorrhage | 0/191 (0%) | 1/241 (0.4%) | 0/64 (0%) | 0/18 (0%) | ||||
Retroperitoneal haemorrhage | 0/191 (0%) | 0/241 (0%) | 1/64 (1.6%) | 0/18 (0%) | ||||
Small intestinal obstruction | 0/191 (0%) | 2/241 (0.8%) | 1/64 (1.6%) | 0/18 (0%) | ||||
Stomatitis | 1/191 (0.5%) | 1/241 (0.4%) | 0/64 (0%) | 0/18 (0%) | ||||
Umbilical hernia | 1/191 (0.5%) | 0/241 (0%) | 0/64 (0%) | 0/18 (0%) | ||||
Vomiting | 1/191 (0.5%) | 2/241 (0.8%) | 0/64 (0%) | 0/18 (0%) | ||||
General disorders | ||||||||
Asthenia | 1/191 (0.5%) | 1/241 (0.4%) | 1/64 (1.6%) | 0/18 (0%) | ||||
Chest pain | 0/191 (0%) | 2/241 (0.8%) | 1/64 (1.6%) | 0/18 (0%) | ||||
Chills | 1/191 (0.5%) | 0/241 (0%) | 0/64 (0%) | 0/18 (0%) | ||||
Fatigue | 0/191 (0%) | 3/241 (1.2%) | 0/64 (0%) | 0/18 (0%) | ||||
Generalised oedema | 0/191 (0%) | 1/241 (0.4%) | 0/64 (0%) | 0/18 (0%) | ||||
Impaired healing | 0/191 (0%) | 0/241 (0%) | 1/64 (1.6%) | 0/18 (0%) | ||||
Mucosal inflammation | 0/191 (0%) | 1/241 (0.4%) | 0/64 (0%) | 0/18 (0%) | ||||
Multiple organ dysfunction syndrome | 1/191 (0.5%) | 2/241 (0.8%) | 0/64 (0%) | 0/18 (0%) | ||||
Pyrexia | 6/191 (3.1%) | 31/241 (12.9%) | 3/64 (4.7%) | 0/18 (0%) | ||||
Hepatobiliary disorders | ||||||||
Cholecystitis | 1/191 (0.5%) | 1/241 (0.4%) | 0/64 (0%) | 0/18 (0%) | ||||
Cholecystitis acute | 0/191 (0%) | 1/241 (0.4%) | 0/64 (0%) | 0/18 (0%) | ||||
Cholecystitis chronic | 0/191 (0%) | 1/241 (0.4%) | 0/64 (0%) | 0/18 (0%) | ||||
Hepatic failure | 0/191 (0%) | 1/241 (0.4%) | 0/64 (0%) | 0/18 (0%) | ||||
Hepatitis | 0/191 (0%) | 1/241 (0.4%) | 0/64 (0%) | 0/18 (0%) | ||||
Immune system disorders | ||||||||
Hypersensitivity | 0/191 (0%) | 1/241 (0.4%) | 0/64 (0%) | 0/18 (0%) | ||||
Infections and infestations | ||||||||
Abdominal wall infection | 0/191 (0%) | 1/241 (0.4%) | 0/64 (0%) | 0/18 (0%) | ||||
Abscess neck | 0/191 (0%) | 1/241 (0.4%) | 0/64 (0%) | 0/18 (0%) | ||||
Appendicitis | 0/191 (0%) | 1/241 (0.4%) | 0/64 (0%) | 0/18 (0%) | ||||
Arthritis bacterial | 0/191 (0%) | 2/241 (0.8%) | 0/64 (0%) | 0/18 (0%) | ||||
Aspergillus infection | 0/191 (0%) | 2/241 (0.8%) | 0/64 (0%) | 0/18 (0%) | ||||
Atypical pneumonia | 0/191 (0%) | 1/241 (0.4%) | 0/64 (0%) | 0/18 (0%) | ||||
Bacteraemia | 1/191 (0.5%) | 1/241 (0.4%) | 0/64 (0%) | 0/18 (0%) | ||||
Bacterial infection | 0/191 (0%) | 1/241 (0.4%) | 0/64 (0%) | 0/18 (0%) | ||||
Bacterial sepsis | 1/191 (0.5%) | 0/241 (0%) | 0/64 (0%) | 0/18 (0%) | ||||
Bronchiolitis | 0/191 (0%) | 1/241 (0.4%) | 0/64 (0%) | 0/18 (0%) | ||||
Bronchitis | 3/191 (1.6%) | 2/241 (0.8%) | 0/64 (0%) | 0/18 (0%) | ||||
Bronchopulmonary aspergillosis | 0/191 (0%) | 1/241 (0.4%) | 0/64 (0%) | 0/18 (0%) | ||||
Candida infection | 0/191 (0%) | 1/241 (0.4%) | 0/64 (0%) | 0/18 (0%) | ||||
Cellulitis | 5/191 (2.6%) | 4/241 (1.7%) | 2/64 (3.1%) | 1/18 (5.6%) | ||||
Cellulitis staphylococcal | 1/191 (0.5%) | 0/241 (0%) | 0/64 (0%) | 0/18 (0%) | ||||
Cerebral aspergillosis | 1/191 (0.5%) | 0/241 (0%) | 0/64 (0%) | 0/18 (0%) | ||||
Clostridium difficile colitis | 2/191 (1%) | 1/241 (0.4%) | 1/64 (1.6%) | 0/18 (0%) | ||||
Clostridium difficile infection | 0/191 (0%) | 1/241 (0.4%) | 1/64 (1.6%) | 0/18 (0%) | ||||
Corynebacterium bacteraemia | 0/191 (0%) | 1/241 (0.4%) | 0/64 (0%) | 0/18 (0%) | ||||
Cytomegalovirus gastrointestinal infection | 0/191 (0%) | 1/241 (0.4%) | 0/64 (0%) | 0/18 (0%) | ||||
Cytomegalovirus infection | 1/191 (0.5%) | 1/241 (0.4%) | 0/64 (0%) | 0/18 (0%) | ||||
Cytomegalovirus viraemia | 0/191 (0%) | 2/241 (0.8%) | 0/64 (0%) | 0/18 (0%) | ||||
Diverticulitis | 1/191 (0.5%) | 2/241 (0.8%) | 0/64 (0%) | 0/18 (0%) | ||||
Encephalitis | 0/191 (0%) | 1/241 (0.4%) | 0/64 (0%) | 0/18 (0%) | ||||
Endophthalmitis | 1/191 (0.5%) | 0/241 (0%) | 0/64 (0%) | 0/18 (0%) | ||||
Enterococcal bacteraemia | 0/191 (0%) | 1/241 (0.4%) | 0/64 (0%) | 0/18 (0%) | ||||
Enterocolitis infectious | 0/191 (0%) | 0/241 (0%) | 1/64 (1.6%) | 0/18 (0%) | ||||
Escherichia bacteraemia | 1/191 (0.5%) | 2/241 (0.8%) | 0/64 (0%) | 0/18 (0%) | ||||
Escherichia sepsis | 0/191 (0%) | 1/241 (0.4%) | 0/64 (0%) | 0/18 (0%) | ||||
Folliculitis | 0/191 (0%) | 1/241 (0.4%) | 0/64 (0%) | 0/18 (0%) | ||||
Gangrene | 0/191 (0%) | 1/241 (0.4%) | 0/64 (0%) | 0/18 (0%) | ||||
Gastroenteritis | 1/191 (0.5%) | 1/241 (0.4%) | 0/64 (0%) | 0/18 (0%) | ||||
Gastroenteritis salmonella | 0/191 (0%) | 1/241 (0.4%) | 0/64 (0%) | 0/18 (0%) | ||||
Groin abscess | 0/191 (0%) | 1/241 (0.4%) | 0/64 (0%) | 0/18 (0%) | ||||
Herpes zoster | 0/191 (0%) | 4/241 (1.7%) | 0/64 (0%) | 0/18 (0%) | ||||
Herpes zoster disseminated | 0/191 (0%) | 1/241 (0.4%) | 0/64 (0%) | 0/18 (0%) | ||||
Herpes zoster pharyngitis | 0/191 (0%) | 1/241 (0.4%) | 0/64 (0%) | 0/18 (0%) | ||||
Histoplasmosis | 0/191 (0%) | 1/241 (0.4%) | 0/64 (0%) | 0/18 (0%) | ||||
Human herpesvirus 6 infection | 0/191 (0%) | 2/241 (0.8%) | 0/64 (0%) | 0/18 (0%) | ||||
Hydrocele male infected | 0/191 (0%) | 1/241 (0.4%) | 0/64 (0%) | 0/18 (0%) | ||||
Infection | 2/191 (1%) | 1/241 (0.4%) | 0/64 (0%) | 0/18 (0%) | ||||
Influenza | 1/191 (0.5%) | 2/241 (0.8%) | 1/64 (1.6%) | 0/18 (0%) | ||||
Listeria sepsis | 0/191 (0%) | 1/241 (0.4%) | 0/64 (0%) | 0/18 (0%) | ||||
Listeriosis | 0/191 (0%) | 1/241 (0.4%) | 0/64 (0%) | 0/18 (0%) | ||||
Lower respiratory tract infection bacterial | 1/191 (0.5%) | 0/241 (0%) | 0/64 (0%) | 0/18 (0%) | ||||
Lung infection | 0/191 (0%) | 2/241 (0.8%) | 1/64 (1.6%) | 0/18 (0%) | ||||
Meningitis | 0/191 (0%) | 1/241 (0.4%) | 0/64 (0%) | 0/18 (0%) | ||||
Meningitis aseptic | 1/191 (0.5%) | 0/241 (0%) | 0/64 (0%) | 0/18 (0%) | ||||
Meningitis enterococcal | 1/191 (0.5%) | 0/241 (0%) | 0/64 (0%) | 0/18 (0%) | ||||
Mycobacterium avium complex infection | 0/191 (0%) | 1/241 (0.4%) | 0/64 (0%) | 0/18 (0%) | ||||
Neutropenic infection | 2/191 (1%) | 0/241 (0%) | 0/64 (0%) | 0/18 (0%) | ||||
Neutropenic sepsis | 0/191 (0%) | 1/241 (0.4%) | 0/64 (0%) | 0/18 (0%) | ||||
Oesophageal candidiasis | 0/191 (0%) | 0/241 (0%) | 1/64 (1.6%) | 0/18 (0%) | ||||
Ophthalmic herpes zoster | 0/191 (0%) | 1/241 (0.4%) | 0/64 (0%) | 0/18 (0%) | ||||
Oral candidiasis | 0/191 (0%) | 0/241 (0%) | 1/64 (1.6%) | 0/18 (0%) | ||||
Otitis media | 1/191 (0.5%) | 0/241 (0%) | 0/64 (0%) | 0/18 (0%) | ||||
Perirectal abscess | 0/191 (0%) | 1/241 (0.4%) | 0/64 (0%) | 0/18 (0%) | ||||
Pneumococcal bacteraemia | 1/191 (0.5%) | 0/241 (0%) | 0/64 (0%) | 0/18 (0%) | ||||
Pneumococcal sepsis | 0/191 (0%) | 2/241 (0.8%) | 0/64 (0%) | 0/18 (0%) | ||||
Pneumocystis jirovecii infection | 0/191 (0%) | 1/241 (0.4%) | 0/64 (0%) | 0/18 (0%) | ||||
Pneumocystis jirovecii pneumonia | 2/191 (1%) | 8/241 (3.3%) | 1/64 (1.6%) | 0/18 (0%) | ||||
Pneumonia | 30/191 (15.7%) | 40/241 (16.6%) | 12/64 (18.8%) | 1/18 (5.6%) | ||||
Pneumonia bacterial | 0/191 (0%) | 1/241 (0.4%) | 0/64 (0%) | 0/18 (0%) | ||||
Pneumonia fungal | 3/191 (1.6%) | 3/241 (1.2%) | 0/64 (0%) | 0/18 (0%) | ||||
Pneumonia haemophilus | 0/191 (0%) | 1/241 (0.4%) | 0/64 (0%) | 0/18 (0%) | ||||
Pneumonia influenzal | 0/191 (0%) | 1/241 (0.4%) | 0/64 (0%) | 0/18 (0%) | ||||
Pneumonia pneumococcal | 1/191 (0.5%) | 0/241 (0%) | 0/64 (0%) | 0/18 (0%) | ||||
Pneumonia pseudomonal | 1/191 (0.5%) | 0/241 (0%) | 0/64 (0%) | 0/18 (0%) | ||||
Pseudomonal bacteraemia | 3/191 (1.6%) | 2/241 (0.8%) | 0/64 (0%) | 0/18 (0%) | ||||
Pseudomonas infection | 1/191 (0.5%) | 0/241 (0%) | 0/64 (0%) | 0/18 (0%) | ||||
Respiratory syncytial virus infection | 1/191 (0.5%) | 0/241 (0%) | 0/64 (0%) | 0/18 (0%) | ||||
Sepsis | 4/191 (2.1%) | 14/241 (5.8%) | 1/64 (1.6%) | 1/18 (5.6%) | ||||
Sepsis syndrome | 1/191 (0.5%) | 0/241 (0%) | 0/64 (0%) | 0/18 (0%) | ||||
Septic shock | 0/191 (0%) | 2/241 (0.8%) | 0/64 (0%) | 0/18 (0%) | ||||
Sinusitis | 0/191 (0%) | 1/241 (0.4%) | 0/64 (0%) | 0/18 (0%) | ||||
Sinusitis fungal | 1/191 (0.5%) | 0/241 (0%) | 0/64 (0%) | 0/18 (0%) | ||||
Staphylococcal bacteraemia | 0/191 (0%) | 1/241 (0.4%) | 0/64 (0%) | 0/18 (0%) | ||||
Staphylococcal infection | 2/191 (1%) | 0/241 (0%) | 0/64 (0%) | 0/18 (0%) | ||||
Streptococcal bacteraemia | 0/191 (0%) | 2/241 (0.8%) | 0/64 (0%) | 0/18 (0%) | ||||
Systemic candida | 1/191 (0.5%) | 0/241 (0%) | 0/64 (0%) | 0/18 (0%) | ||||
Tooth infection | 0/191 (0%) | 1/241 (0.4%) | 0/64 (0%) | 0/18 (0%) | ||||
Upper respiratory tract infection | 0/191 (0%) | 2/241 (0.8%) | 0/64 (0%) | 0/18 (0%) | ||||
Urinary tract infection | 2/191 (1%) | 3/241 (1.2%) | 3/64 (4.7%) | 0/18 (0%) | ||||
Urosepsis | 0/191 (0%) | 0/241 (0%) | 1/64 (1.6%) | 0/18 (0%) | ||||
Vaginal infection | 0/191 (0%) | 1/241 (0.4%) | 0/64 (0%) | 0/18 (0%) | ||||
Viral upper respiratory tract infection | 1/191 (0.5%) | 1/241 (0.4%) | 0/64 (0%) | 0/18 (0%) | ||||
Vulvovaginitis | 0/191 (0%) | 1/241 (0.4%) | 0/64 (0%) | 0/18 (0%) | ||||
Wound infection | 1/191 (0.5%) | 0/241 (0%) | 0/64 (0%) | 0/18 (0%) | ||||
Injury, poisoning and procedural complications | ||||||||
Arterial injury | 0/191 (0%) | 0/241 (0%) | 1/64 (1.6%) | 0/18 (0%) | ||||
Fall | 1/191 (0.5%) | 3/241 (1.2%) | 0/64 (0%) | 0/18 (0%) | ||||
Humerus fracture | 0/191 (0%) | 0/241 (0%) | 1/64 (1.6%) | 0/18 (0%) | ||||
Infusion related reaction | 1/191 (0.5%) | 0/241 (0%) | 1/64 (1.6%) | 0/18 (0%) | ||||
Pelvic fracture | 0/191 (0%) | 1/241 (0.4%) | 0/64 (0%) | 0/18 (0%) | ||||
Post procedural haemorrhage | 1/191 (0.5%) | 0/241 (0%) | 0/64 (0%) | 0/18 (0%) | ||||
Subarachnoid haemorrhage | 1/191 (0.5%) | 0/241 (0%) | 0/64 (0%) | 0/18 (0%) | ||||
Subdural haematoma | 0/191 (0%) | 3/241 (1.2%) | 0/64 (0%) | 0/18 (0%) | ||||
Investigations | ||||||||
Alanine aminotransferase increased | 2/191 (1%) | 4/241 (1.7%) | 0/64 (0%) | 1/18 (5.6%) | ||||
Aspartate aminotransferase increased | 2/191 (1%) | 3/241 (1.2%) | 0/64 (0%) | 1/18 (5.6%) | ||||
Blood bilirubin increased | 0/191 (0%) | 1/241 (0.4%) | 0/64 (0%) | 0/18 (0%) | ||||
Blood lactate dehydrogenase increased | 0/191 (0%) | 2/241 (0.8%) | 0/64 (0%) | 0/18 (0%) | ||||
Blood uric acid increased | 1/191 (0.5%) | 0/241 (0%) | 0/64 (0%) | 0/18 (0%) | ||||
Hepatic enzyme increased | 0/191 (0%) | 1/241 (0.4%) | 0/64 (0%) | 0/18 (0%) | ||||
International normalised ratio increased | 1/191 (0.5%) | 0/241 (0%) | 1/64 (1.6%) | 0/18 (0%) | ||||
Liver function test increased | 2/191 (1%) | 0/241 (0%) | 0/64 (0%) | 0/18 (0%) | ||||
Transaminases increased | 0/191 (0%) | 3/241 (1.2%) | 0/64 (0%) | 1/18 (5.6%) | ||||
Weight decreased | 0/191 (0%) | 1/241 (0.4%) | 0/64 (0%) | 0/18 (0%) | ||||
Metabolism and nutrition disorders | ||||||||
Decreased appetite | 0/191 (0%) | 1/241 (0.4%) | 0/64 (0%) | 0/18 (0%) | ||||
Dehydration | 0/191 (0%) | 1/241 (0.4%) | 2/64 (3.1%) | 0/18 (0%) | ||||
Failure to thrive | 1/191 (0.5%) | 1/241 (0.4%) | 0/64 (0%) | 0/18 (0%) | ||||
Fluid retention | 1/191 (0.5%) | 0/241 (0%) | 0/64 (0%) | 0/18 (0%) | ||||
Hypercalcaemia | 1/191 (0.5%) | 1/241 (0.4%) | 1/64 (1.6%) | 0/18 (0%) | ||||
Hyperglycaemia | 0/191 (0%) | 1/241 (0.4%) | 0/64 (0%) | 0/18 (0%) | ||||
Hyperkalaemia | 0/191 (0%) | 1/241 (0.4%) | 0/64 (0%) | 0/18 (0%) | ||||
Hyperuricaemia | 0/191 (0%) | 1/241 (0.4%) | 0/64 (0%) | 0/18 (0%) | ||||
Hypoglycaemia | 0/191 (0%) | 1/241 (0.4%) | 0/64 (0%) | 0/18 (0%) | ||||
Hypokalaemia | 0/191 (0%) | 4/241 (1.7%) | 0/64 (0%) | 0/18 (0%) | ||||
Hyponatraemia | 0/191 (0%) | 1/241 (0.4%) | 1/64 (1.6%) | 0/18 (0%) | ||||
Lactic acidosis | 0/191 (0%) | 2/241 (0.8%) | 0/64 (0%) | 0/18 (0%) | ||||
Malnutrition | 0/191 (0%) | 1/241 (0.4%) | 0/64 (0%) | 0/18 (0%) | ||||
Tumour lysis syndrome | 0/191 (0%) | 4/241 (1.7%) | 0/64 (0%) | 2/18 (11.1%) | ||||
Musculoskeletal and connective tissue disorders | ||||||||
Arthralgia | 1/191 (0.5%) | 1/241 (0.4%) | 1/64 (1.6%) | 0/18 (0%) | ||||
Back pain | 0/191 (0%) | 0/241 (0%) | 2/64 (3.1%) | 0/18 (0%) | ||||
Flank pain | 0/191 (0%) | 1/241 (0.4%) | 0/64 (0%) | 0/18 (0%) | ||||
Musculoskeletal pain | 0/191 (0%) | 0/241 (0%) | 1/64 (1.6%) | 0/18 (0%) | ||||
Myalgia | 0/191 (0%) | 1/241 (0.4%) | 0/64 (0%) | 0/18 (0%) | ||||
Neck pain | 1/191 (0.5%) | 0/241 (0%) | 0/64 (0%) | 0/18 (0%) | ||||
Polyarthritis | 0/191 (0%) | 1/241 (0.4%) | 0/64 (0%) | 0/18 (0%) | ||||
Rhabdomyolysis | 0/191 (0%) | 1/241 (0.4%) | 0/64 (0%) | 0/18 (0%) | ||||
Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||||
Acute myeloid leukaemia | 0/191 (0%) | 2/241 (0.8%) | 0/64 (0%) | 0/18 (0%) | ||||
Basal cell carcinoma | 0/191 (0%) | 0/241 (0%) | 1/64 (1.6%) | 0/18 (0%) | ||||
Breast cancer | 0/191 (0%) | 1/241 (0.4%) | 0/64 (0%) | 0/18 (0%) | ||||
Chronic myeloid leukaemia | 0/191 (0%) | 0/241 (0%) | 1/64 (1.6%) | 0/18 (0%) | ||||
Colon cancer | 0/191 (0%) | 1/241 (0.4%) | 0/64 (0%) | 0/18 (0%) | ||||
Endometrial adenocarcinoma | 0/191 (0%) | 1/241 (0.4%) | 0/64 (0%) | 0/18 (0%) | ||||
Malignant pleural effusion | 1/191 (0.5%) | 0/241 (0%) | 0/64 (0%) | 0/18 (0%) | ||||
Mantle cell lymphoma | 1/191 (0.5%) | 0/241 (0%) | 0/64 (0%) | 0/18 (0%) | ||||
Metastatic malignant melanoma | 0/191 (0%) | 0/241 (0%) | 1/64 (1.6%) | 0/18 (0%) | ||||
Myelodysplastic syndrome | 2/191 (1%) | 0/241 (0%) | 0/64 (0%) | 0/18 (0%) | ||||
Non-Hodgkin's lymphoma | 0/191 (0%) | 1/241 (0.4%) | 0/64 (0%) | 0/18 (0%) | ||||
Oesophageal squamous cell carcinoma | 0/191 (0%) | 1/241 (0.4%) | 0/64 (0%) | 0/18 (0%) | ||||
Prostate cancer | 0/191 (0%) | 0/241 (0%) | 1/64 (1.6%) | 0/18 (0%) | ||||
Rectal adenocarcinoma | 1/191 (0.5%) | 0/241 (0%) | 0/64 (0%) | 0/18 (0%) | ||||
Renal cell carcinoma | 0/191 (0%) | 1/241 (0.4%) | 0/64 (0%) | 0/18 (0%) | ||||
Richter's syndrome | 1/191 (0.5%) | 0/241 (0%) | 0/64 (0%) | 0/18 (0%) | ||||
Squamous cell carcinoma | 2/191 (1%) | 0/241 (0%) | 0/64 (0%) | 0/18 (0%) | ||||
Squamous cell carcinoma of lung | 0/191 (0%) | 1/241 (0.4%) | 0/64 (0%) | 0/18 (0%) | ||||
Nervous system disorders | ||||||||
Balance disorder | 0/191 (0%) | 0/241 (0%) | 1/64 (1.6%) | 0/18 (0%) | ||||
Cerebral ischaemia | 0/191 (0%) | 1/241 (0.4%) | 0/64 (0%) | 0/18 (0%) | ||||
Cerebrovascular accident | 0/191 (0%) | 2/241 (0.8%) | 0/64 (0%) | 0/18 (0%) | ||||
Dizziness | 0/191 (0%) | 1/241 (0.4%) | 1/64 (1.6%) | 0/18 (0%) | ||||
Embolic stroke | 0/191 (0%) | 1/241 (0.4%) | 0/64 (0%) | 0/18 (0%) | ||||
Haemorrhage intracranial | 0/191 (0%) | 1/241 (0.4%) | 0/64 (0%) | 0/18 (0%) | ||||
Lethargy | 0/191 (0%) | 1/241 (0.4%) | 0/64 (0%) | 0/18 (0%) | ||||
Normal pressure hydrocephalus | 0/191 (0%) | 1/241 (0.4%) | 0/64 (0%) | 0/18 (0%) | ||||
Seizure | 0/191 (0%) | 1/241 (0.4%) | 0/64 (0%) | 0/18 (0%) | ||||
Syncope | 1/191 (0.5%) | 2/241 (0.8%) | 0/64 (0%) | 0/18 (0%) | ||||
Psychiatric disorders | ||||||||
Confusional state | 0/191 (0%) | 0/241 (0%) | 1/64 (1.6%) | 0/18 (0%) | ||||
Depression | 1/191 (0.5%) | 1/241 (0.4%) | 0/64 (0%) | 0/18 (0%) | ||||
Mental status changes | 0/191 (0%) | 1/241 (0.4%) | 0/64 (0%) | 0/18 (0%) | ||||
Suicidal ideation | 0/191 (0%) | 2/241 (0.8%) | 0/64 (0%) | 0/18 (0%) | ||||
Renal and urinary disorders | ||||||||
Acute kidney injury | 7/191 (3.7%) | 9/241 (3.7%) | 1/64 (1.6%) | 0/18 (0%) | ||||
Haematuria | 2/191 (1%) | 0/241 (0%) | 0/64 (0%) | 0/18 (0%) | ||||
Hydronephrosis | 0/191 (0%) | 1/241 (0.4%) | 0/64 (0%) | 0/18 (0%) | ||||
Nephrolithiasis | 0/191 (0%) | 2/241 (0.8%) | 0/64 (0%) | 0/18 (0%) | ||||
Renal failure | 3/191 (1.6%) | 0/241 (0%) | 0/64 (0%) | 2/18 (11.1%) | ||||
Urethral obstruction | 0/191 (0%) | 1/241 (0.4%) | 0/64 (0%) | 0/18 (0%) | ||||
Urinary retention | 1/191 (0.5%) | 0/241 (0%) | 0/64 (0%) | 0/18 (0%) | ||||
Urinary tract obstruction | 0/191 (0%) | 2/241 (0.8%) | 1/64 (1.6%) | 0/18 (0%) | ||||
Reproductive system and breast disorders | ||||||||
Pelvic pain | 0/191 (0%) | 1/241 (0.4%) | 0/64 (0%) | 0/18 (0%) | ||||
Testicular pain | 0/191 (0%) | 0/241 (0%) | 1/64 (1.6%) | 0/18 (0%) | ||||
Vaginal haemorrhage | 0/191 (0%) | 1/241 (0.4%) | 0/64 (0%) | 0/18 (0%) | ||||
Respiratory, thoracic and mediastinal disorders | ||||||||
Acute lung injury | 1/191 (0.5%) | 0/241 (0%) | 0/64 (0%) | 0/18 (0%) | ||||
Acute respiratory failure | 1/191 (0.5%) | 4/241 (1.7%) | 0/64 (0%) | 0/18 (0%) | ||||
Atelectasis | 1/191 (0.5%) | 0/241 (0%) | 0/64 (0%) | 0/18 (0%) | ||||
Bronchial secretion retention | 0/191 (0%) | 1/241 (0.4%) | 0/64 (0%) | 0/18 (0%) | ||||
Bronchiectasis | 0/191 (0%) | 1/241 (0.4%) | 0/64 (0%) | 0/18 (0%) | ||||
Chronic obstructive pulmonary disease | 0/191 (0%) | 1/241 (0.4%) | 0/64 (0%) | 0/18 (0%) | ||||
Dyspnoea | 0/191 (0%) | 1/241 (0.4%) | 2/64 (3.1%) | 0/18 (0%) | ||||
Epistaxis | 0/191 (0%) | 1/241 (0.4%) | 0/64 (0%) | 0/18 (0%) | ||||
Hypoxia | 0/191 (0%) | 2/241 (0.8%) | 2/64 (3.1%) | 1/18 (5.6%) | ||||
Organising pneumonia | 2/191 (1%) | 1/241 (0.4%) | 1/64 (1.6%) | 0/18 (0%) | ||||
Pleural effusion | 1/191 (0.5%) | 4/241 (1.7%) | 1/64 (1.6%) | 0/18 (0%) | ||||
Pleuritic pain | 0/191 (0%) | 1/241 (0.4%) | 0/64 (0%) | 0/18 (0%) | ||||
Pneumonitis | 3/191 (1.6%) | 8/241 (3.3%) | 3/64 (4.7%) | 1/18 (5.6%) | ||||
Pneumothorax | 0/191 (0%) | 0/241 (0%) | 0/64 (0%) | 1/18 (5.6%) | ||||
Pulmonary embolism | 6/191 (3.1%) | 3/241 (1.2%) | 0/64 (0%) | 0/18 (0%) | ||||
Pulmonary fibrosis | 0/191 (0%) | 0/241 (0%) | 2/64 (3.1%) | 0/18 (0%) | ||||
Pulmonary haemorrhage | 0/191 (0%) | 1/241 (0.4%) | 0/64 (0%) | 0/18 (0%) | ||||
Respiratory distress | 0/191 (0%) | 1/241 (0.4%) | 0/64 (0%) | 0/18 (0%) | ||||
Respiratory failure | 1/191 (0.5%) | 2/241 (0.8%) | 3/64 (4.7%) | 0/18 (0%) | ||||
Upper airway obstruction | 1/191 (0.5%) | 0/241 (0%) | 0/64 (0%) | 0/18 (0%) | ||||
Skin and subcutaneous tissue disorders | ||||||||
Angioedema | 0/191 (0%) | 1/241 (0.4%) | 0/64 (0%) | 0/18 (0%) | ||||
Drug eruption | 0/191 (0%) | 2/241 (0.8%) | 0/64 (0%) | 0/18 (0%) | ||||
Erythema multiforme | 0/191 (0%) | 1/241 (0.4%) | 0/64 (0%) | 0/18 (0%) | ||||
Rash | 1/191 (0.5%) | 4/241 (1.7%) | 0/64 (0%) | 0/18 (0%) | ||||
Rash erythematous | 0/191 (0%) | 1/241 (0.4%) | 0/64 (0%) | 0/18 (0%) | ||||
Rash maculo-papular | 1/191 (0.5%) | 2/241 (0.8%) | 0/64 (0%) | 0/18 (0%) | ||||
Skin ulcer | 0/191 (0%) | 1/241 (0.4%) | 0/64 (0%) | 0/18 (0%) | ||||
Vascular disorders | ||||||||
Deep vein thrombosis | 1/191 (0.5%) | 2/241 (0.8%) | 0/64 (0%) | 0/18 (0%) | ||||
Embolism | 1/191 (0.5%) | 0/241 (0%) | 1/64 (1.6%) | 0/18 (0%) | ||||
Haematoma | 1/191 (0.5%) | 0/241 (0%) | 0/64 (0%) | 0/18 (0%) | ||||
Haemorrhage | 0/191 (0%) | 1/241 (0.4%) | 0/64 (0%) | 0/18 (0%) | ||||
Hypertension | 0/191 (0%) | 0/241 (0%) | 1/64 (1.6%) | 0/18 (0%) | ||||
Hypotension | 1/191 (0.5%) | 4/241 (1.7%) | 0/64 (0%) | 0/18 (0%) | ||||
Jugular vein thrombosis | 1/191 (0.5%) | 0/241 (0%) | 0/64 (0%) | 0/18 (0%) | ||||
Orthostatic hypotension | 0/191 (0%) | 1/241 (0.4%) | 0/64 (0%) | 0/18 (0%) | ||||
Peripheral vascular disorder | 0/191 (0%) | 1/241 (0.4%) | 0/64 (0%) | 0/18 (0%) | ||||
Subclavian vein thrombosis | 1/191 (0.5%) | 0/241 (0%) | 0/64 (0%) | 0/18 (0%) | ||||
Thrombosis | 0/191 (0%) | 1/241 (0.4%) | 0/64 (0%) | 0/18 (0%) | ||||
Vasculitis necrotising | 0/191 (0%) | 1/241 (0.4%) | 0/64 (0%) | 0/18 (0%) | ||||
Other (Not Including Serious) Adverse Events |
||||||||
101-02 | 101-07 | 101-08 | 101-10 | |||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 183/191 (95.8%) | 236/241 (97.9%) | 63/64 (98.4%) | 16/18 (88.9%) | ||||
Blood and lymphatic system disorders | ||||||||
Anaemia | 31/191 (16.2%) | 48/241 (19.9%) | 7/64 (10.9%) | 0/18 (0%) | ||||
Leukopenia | 7/191 (3.7%) | 21/241 (8.7%) | 0/64 (0%) | 0/18 (0%) | ||||
Neutropenia | 31/191 (16.2%) | 102/241 (42.3%) | 5/64 (7.8%) | 3/18 (16.7%) | ||||
Thrombocytopenia | 25/191 (13.1%) | 48/241 (19.9%) | 3/64 (4.7%) | 2/18 (11.1%) | ||||
Cardiac disorders | ||||||||
Atrial fibrillation | 1/191 (0.5%) | 8/241 (3.3%) | 1/64 (1.6%) | 1/18 (5.6%) | ||||
Atrial tachycardia | 0/191 (0%) | 0/241 (0%) | 0/64 (0%) | 1/18 (5.6%) | ||||
Palpitations | 0/191 (0%) | 6/241 (2.5%) | 1/64 (1.6%) | 1/18 (5.6%) | ||||
Ear and labyrinth disorders | ||||||||
Vertigo | 0/191 (0%) | 7/241 (2.9%) | 1/64 (1.6%) | 2/18 (11.1%) | ||||
Eye disorders | ||||||||
Blepharospasm | 1/191 (0.5%) | 0/241 (0%) | 0/64 (0%) | 1/18 (5.6%) | ||||
Chalazion | 0/191 (0%) | 0/241 (0%) | 0/64 (0%) | 1/18 (5.6%) | ||||
Conjunctival hyperaemia | 1/191 (0.5%) | 0/241 (0%) | 0/64 (0%) | 1/18 (5.6%) | ||||
Keratitis | 0/191 (0%) | 0/241 (0%) | 0/64 (0%) | 1/18 (5.6%) | ||||
Photopsia | 0/191 (0%) | 0/241 (0%) | 0/64 (0%) | 1/18 (5.6%) | ||||
Vision blurred | 5/191 (2.6%) | 7/241 (2.9%) | 2/64 (3.1%) | 1/18 (5.6%) | ||||
Gastrointestinal disorders | ||||||||
Abdominal discomfort | 2/191 (1%) | 5/241 (2.1%) | 4/64 (6.3%) | 1/18 (5.6%) | ||||
Abdominal pain | 14/191 (7.3%) | 31/241 (12.9%) | 8/64 (12.5%) | 2/18 (11.1%) | ||||
Abdominal pain upper | 6/191 (3.1%) | 7/241 (2.9%) | 5/64 (7.8%) | 0/18 (0%) | ||||
Colitis | 3/191 (1.6%) | 8/241 (3.3%) | 3/64 (4.7%) | 1/18 (5.6%) | ||||
Constipation | 23/191 (12%) | 49/241 (20.3%) | 11/64 (17.2%) | 3/18 (16.7%) | ||||
Diarrhoea | 58/191 (30.4%) | 106/241 (44%) | 36/64 (56.3%) | 8/18 (44.4%) | ||||
Dyschezia | 0/191 (0%) | 0/241 (0%) | 0/64 (0%) | 1/18 (5.6%) | ||||
Dyspepsia | 5/191 (2.6%) | 15/241 (6.2%) | 3/64 (4.7%) | 0/18 (0%) | ||||
Flatulence | 8/191 (4.2%) | 9/241 (3.7%) | 4/64 (6.3%) | 3/18 (16.7%) | ||||
Gastrointestinal pain | 0/191 (0%) | 0/241 (0%) | 0/64 (0%) | 1/18 (5.6%) | ||||
Gastrooesophageal reflux disease | 4/191 (2.1%) | 11/241 (4.6%) | 4/64 (6.3%) | 1/18 (5.6%) | ||||
Haemorrhoidal haemorrhage | 0/191 (0%) | 0/241 (0%) | 1/64 (1.6%) | 1/18 (5.6%) | ||||
Lip discolouration | 0/191 (0%) | 0/241 (0%) | 0/64 (0%) | 1/18 (5.6%) | ||||
Nausea | 44/191 (23%) | 81/241 (33.6%) | 24/64 (37.5%) | 7/18 (38.9%) | ||||
Oral pain | 2/191 (1%) | 3/241 (1.2%) | 1/64 (1.6%) | 1/18 (5.6%) | ||||
Paraesthesia oral | 0/191 (0%) | 1/241 (0.4%) | 0/64 (0%) | 1/18 (5.6%) | ||||
Stomatitis | 10/191 (5.2%) | 18/241 (7.5%) | 8/64 (12.5%) | 0/18 (0%) | ||||
Vomiting | 23/191 (12%) | 33/241 (13.7%) | 14/64 (21.9%) | 5/18 (27.8%) | ||||
General disorders | ||||||||
Asthenia | 16/191 (8.4%) | 21/241 (8.7%) | 7/64 (10.9%) | 2/18 (11.1%) | ||||
Chest discomfort | 1/191 (0.5%) | 5/241 (2.1%) | 4/64 (6.3%) | 0/18 (0%) | ||||
Chest pain | 1/191 (0.5%) | 9/241 (3.7%) | 0/64 (0%) | 1/18 (5.6%) | ||||
Chills | 31/191 (16.2%) | 40/241 (16.6%) | 23/64 (35.9%) | 2/18 (11.1%) | ||||
Fatigue | 63/191 (33%) | 85/241 (35.3%) | 21/64 (32.8%) | 8/18 (44.4%) | ||||
Influenza like illness | 0/191 (0%) | 2/241 (0.8%) | 9/64 (14.1%) | 2/18 (11.1%) | ||||
Malaise | 1/191 (0.5%) | 4/241 (1.7%) | 6/64 (9.4%) | 2/18 (11.1%) | ||||
Mucosal inflammation | 7/191 (3.7%) | 15/241 (6.2%) | 0/64 (0%) | 0/18 (0%) | ||||
Oedema | 3/191 (1.6%) | 8/241 (3.3%) | 4/64 (6.3%) | 0/18 (0%) | ||||
Oedema peripheral | 18/191 (9.4%) | 29/241 (12%) | 7/64 (10.9%) | 0/18 (0%) | ||||
Pain | 6/191 (3.1%) | 24/241 (10%) | 1/64 (1.6%) | 2/18 (11.1%) | ||||
Pyrexia | 49/191 (25.7%) | 92/241 (38.2%) | 26/64 (40.6%) | 5/18 (27.8%) | ||||
Hepatobiliary disorders | ||||||||
Hyperbilirubinaemia | 8/191 (4.2%) | 4/241 (1.7%) | 0/64 (0%) | 1/18 (5.6%) | ||||
Infections and infestations | ||||||||
Candida infection | 5/191 (2.6%) | 5/241 (2.1%) | 0/64 (0%) | 1/18 (5.6%) | ||||
Conjunctivitis | 2/191 (1%) | 4/241 (1.7%) | 1/64 (1.6%) | 1/18 (5.6%) | ||||
Herpes zoster | 4/191 (2.1%) | 13/241 (5.4%) | 2/64 (3.1%) | 0/18 (0%) | ||||
Hordeolum | 0/191 (0%) | 0/241 (0%) | 1/64 (1.6%) | 1/18 (5.6%) | ||||
Nasopharyngitis | 5/191 (2.6%) | 11/241 (4.6%) | 3/64 (4.7%) | 2/18 (11.1%) | ||||
Pneumonia | 6/191 (3.1%) | 18/241 (7.5%) | 7/64 (10.9%) | 0/18 (0%) | ||||
Pneumonia viral | 1/191 (0.5%) | 0/241 (0%) | 0/64 (0%) | 1/18 (5.6%) | ||||
Sinusitis | 10/191 (5.2%) | 22/241 (9.1%) | 6/64 (9.4%) | 0/18 (0%) | ||||
Upper respiratory tract infection | 32/191 (16.8%) | 38/241 (15.8%) | 8/64 (12.5%) | 4/18 (22.2%) | ||||
Urinary tract infection | 10/191 (5.2%) | 15/241 (6.2%) | 9/64 (14.1%) | 0/18 (0%) | ||||
Injury, poisoning and procedural complications | ||||||||
Contusion | 7/191 (3.7%) | 2/241 (0.8%) | 1/64 (1.6%) | 2/18 (11.1%) | ||||
Fall | 2/191 (1%) | 5/241 (2.1%) | 1/64 (1.6%) | 1/18 (5.6%) | ||||
Infusion related reaction | 0/191 (0%) | 14/241 (5.8%) | 7/64 (10.9%) | 0/18 (0%) | ||||
Investigations | ||||||||
Alanine aminotransferase increased | 33/191 (17.3%) | 52/241 (21.6%) | 18/64 (28.1%) | 8/18 (44.4%) | ||||
Aspartate aminotransferase increased | 35/191 (18.3%) | 47/241 (19.5%) | 18/64 (28.1%) | 8/18 (44.4%) | ||||
Blood alkaline phosphatase increased | 12/191 (6.3%) | 13/241 (5.4%) | 2/64 (3.1%) | 0/18 (0%) | ||||
Blood bilirubin increased | 2/191 (1%) | 6/241 (2.5%) | 1/64 (1.6%) | 2/18 (11.1%) | ||||
Blood creatinine increased | 11/191 (5.8%) | 9/241 (3.7%) | 3/64 (4.7%) | 1/18 (5.6%) | ||||
Blood lactate dehydrogenase increased | 4/191 (2.1%) | 14/241 (5.8%) | 0/64 (0%) | 0/18 (0%) | ||||
Blood phosphorus increased | 0/191 (0%) | 0/241 (0%) | 0/64 (0%) | 1/18 (5.6%) | ||||
Blood uric acid increased | 0/191 (0%) | 1/241 (0.4%) | 0/64 (0%) | 1/18 (5.6%) | ||||
Glomerular filtration rate decreased | 0/191 (0%) | 0/241 (0%) | 0/64 (0%) | 1/18 (5.6%) | ||||
Hepatic enzyme increased | 1/191 (0.5%) | 0/241 (0%) | 1/64 (1.6%) | 1/18 (5.6%) | ||||
Liver function test increased | 6/191 (3.1%) | 5/241 (2.1%) | 6/64 (9.4%) | 0/18 (0%) | ||||
Neutrophil count decreased | 8/191 (4.2%) | 9/241 (3.7%) | 5/64 (7.8%) | 1/18 (5.6%) | ||||
Transaminases increased | 6/191 (3.1%) | 5/241 (2.1%) | 9/64 (14.1%) | 4/18 (22.2%) | ||||
Weight decreased | 10/191 (5.2%) | 21/241 (8.7%) | 7/64 (10.9%) | 2/18 (11.1%) | ||||
Metabolism and nutrition disorders | ||||||||
Decreased appetite | 22/191 (11.5%) | 41/241 (17%) | 9/64 (14.1%) | 3/18 (16.7%) | ||||
Dehydration | 11/191 (5.8%) | 10/241 (4.1%) | 6/64 (9.4%) | 1/18 (5.6%) | ||||
Hyperglycaemia | 11/191 (5.8%) | 12/241 (5%) | 4/64 (6.3%) | 0/18 (0%) | ||||
Hyperuricaemia | 0/191 (0%) | 10/241 (4.1%) | 4/64 (6.3%) | 1/18 (5.6%) | ||||
Hypocalcaemia | 10/191 (5.2%) | 12/241 (5%) | 2/64 (3.1%) | 0/18 (0%) | ||||
Hypokalaemia | 8/191 (4.2%) | 35/241 (14.5%) | 6/64 (9.4%) | 1/18 (5.6%) | ||||
Hypomagnesaemia | 1/191 (0.5%) | 11/241 (4.6%) | 5/64 (7.8%) | 0/18 (0%) | ||||
Hyponatraemia | 16/191 (8.4%) | 7/241 (2.9%) | 1/64 (1.6%) | 0/18 (0%) | ||||
Hypophosphataemia | 12/191 (6.3%) | 9/241 (3.7%) | 1/64 (1.6%) | 0/18 (0%) | ||||
Musculoskeletal and connective tissue disorders | ||||||||
Arthralgia | 10/191 (5.2%) | 16/241 (6.6%) | 10/64 (15.6%) | 2/18 (11.1%) | ||||
Back pain | 23/191 (12%) | 24/241 (10%) | 9/64 (14.1%) | 2/18 (11.1%) | ||||
Flank pain | 1/191 (0.5%) | 3/241 (1.2%) | 0/64 (0%) | 1/18 (5.6%) | ||||
Haemarthrosis | 0/191 (0%) | 0/241 (0%) | 1/64 (1.6%) | 1/18 (5.6%) | ||||
Joint stiffness | 0/191 (0%) | 0/241 (0%) | 0/64 (0%) | 1/18 (5.6%) | ||||
Muscle spasms | 8/191 (4.2%) | 5/241 (2.1%) | 4/64 (6.3%) | 2/18 (11.1%) | ||||
Muscular weakness | 2/191 (1%) | 4/241 (1.7%) | 1/64 (1.6%) | 1/18 (5.6%) | ||||
Musculoskeletal pain | 6/191 (3.1%) | 5/241 (2.1%) | 4/64 (6.3%) | 1/18 (5.6%) | ||||
Myalgia | 5/191 (2.6%) | 10/241 (4.1%) | 4/64 (6.3%) | 0/18 (0%) | ||||
Pain in extremity | 13/191 (6.8%) | 13/241 (5.4%) | 6/64 (9.4%) | 3/18 (16.7%) | ||||
Nervous system disorders | ||||||||
Dizziness | 15/191 (7.9%) | 32/241 (13.3%) | 7/64 (10.9%) | 0/18 (0%) | ||||
Dysgeusia | 6/191 (3.1%) | 24/241 (10%) | 4/64 (6.3%) | 3/18 (16.7%) | ||||
Headache | 22/191 (11.5%) | 31/241 (12.9%) | 15/64 (23.4%) | 4/18 (22.2%) | ||||
Hypersomnia | 0/191 (0%) | 1/241 (0.4%) | 1/64 (1.6%) | 1/18 (5.6%) | ||||
Lethargy | 0/191 (0%) | 2/241 (0.8%) | 0/64 (0%) | 2/18 (11.1%) | ||||
Mental impairment | 0/191 (0%) | 2/241 (0.8%) | 0/64 (0%) | 1/18 (5.6%) | ||||
Neuropathy peripheral | 4/191 (2.1%) | 9/241 (3.7%) | 2/64 (3.1%) | 1/18 (5.6%) | ||||
Psychiatric disorders | ||||||||
Agitation | 0/191 (0%) | 2/241 (0.8%) | 1/64 (1.6%) | 2/18 (11.1%) | ||||
Anxiety | 5/191 (2.6%) | 16/241 (6.6%) | 4/64 (6.3%) | 0/18 (0%) | ||||
Confusional state | 4/191 (2.1%) | 3/241 (1.2%) | 1/64 (1.6%) | 1/18 (5.6%) | ||||
Emotional disorder | 0/191 (0%) | 0/241 (0%) | 0/64 (0%) | 1/18 (5.6%) | ||||
Insomnia | 17/191 (8.9%) | 36/241 (14.9%) | 13/64 (20.3%) | 5/18 (27.8%) | ||||
Renal and urinary disorders | ||||||||
Acute kidney injury | 4/191 (2.1%) | 7/241 (2.9%) | 4/64 (6.3%) | 0/18 (0%) | ||||
Chromaturia | 1/191 (0.5%) | 0/241 (0%) | 0/64 (0%) | 1/18 (5.6%) | ||||
Dysuria | 3/191 (1.6%) | 7/241 (2.9%) | 2/64 (3.1%) | 1/18 (5.6%) | ||||
Nocturia | 2/191 (1%) | 4/241 (1.7%) | 0/64 (0%) | 1/18 (5.6%) | ||||
Pollakiuria | 5/191 (2.6%) | 3/241 (1.2%) | 2/64 (3.1%) | 1/18 (5.6%) | ||||
Renal failure | 2/191 (1%) | 0/241 (0%) | 0/64 (0%) | 1/18 (5.6%) | ||||
Respiratory, thoracic and mediastinal disorders | ||||||||
Cough | 36/191 (18.8%) | 81/241 (33.6%) | 21/64 (32.8%) | 4/18 (22.2%) | ||||
Dysphonia | 5/191 (2.6%) | 10/241 (4.1%) | 1/64 (1.6%) | 1/18 (5.6%) | ||||
Dyspnoea | 17/191 (8.9%) | 42/241 (17.4%) | 14/64 (21.9%) | 2/18 (11.1%) | ||||
Hypopnoea | 0/191 (0%) | 0/241 (0%) | 0/64 (0%) | 1/18 (5.6%) | ||||
Nasal congestion | 3/191 (1.6%) | 12/241 (5%) | 2/64 (3.1%) | 1/18 (5.6%) | ||||
Oropharyngeal pain | 7/191 (3.7%) | 18/241 (7.5%) | 2/64 (3.1%) | 1/18 (5.6%) | ||||
Pneumonitis | 0/191 (0%) | 6/241 (2.5%) | 0/64 (0%) | 2/18 (11.1%) | ||||
Productive cough | 11/191 (5.8%) | 20/241 (8.3%) | 4/64 (6.3%) | 1/18 (5.6%) | ||||
Rhinorrhoea | 11/191 (5.8%) | 15/241 (6.2%) | 1/64 (1.6%) | 0/18 (0%) | ||||
Sinus pain | 1/191 (0.5%) | 0/241 (0%) | 0/64 (0%) | 1/18 (5.6%) | ||||
Skin and subcutaneous tissue disorders | ||||||||
Acne | 1/191 (0.5%) | 0/241 (0%) | 0/64 (0%) | 1/18 (5.6%) | ||||
Exfoliative rash | 0/191 (0%) | 0/241 (0%) | 1/64 (1.6%) | 3/18 (16.7%) | ||||
Hyperhidrosis | 5/191 (2.6%) | 1/241 (0.4%) | 4/64 (6.3%) | 2/18 (11.1%) | ||||
Hyperkeratosis | 0/191 (0%) | 0/241 (0%) | 1/64 (1.6%) | 1/18 (5.6%) | ||||
Night sweats | 23/191 (12%) | 23/241 (9.5%) | 10/64 (15.6%) | 0/18 (0%) | ||||
Pruritus | 5/191 (2.6%) | 29/241 (12%) | 11/64 (17.2%) | 3/18 (16.7%) | ||||
Rash | 39/191 (20.4%) | 65/241 (27%) | 24/64 (37.5%) | 5/18 (27.8%) | ||||
Skin fissures | 0/191 (0%) | 0/241 (0%) | 1/64 (1.6%) | 1/18 (5.6%) | ||||
Vascular disorders | ||||||||
Flushing | 4/191 (2.1%) | 10/241 (4.1%) | 4/64 (6.3%) | 0/18 (0%) | ||||
Hot flush | 1/191 (0.5%) | 2/241 (0.8%) | 2/64 (3.1%) | 1/18 (5.6%) | ||||
Hypertension | 6/191 (3.1%) | 11/241 (4.6%) | 4/64 (6.3%) | 0/18 (0%) | ||||
Hypotension | 8/191 (4.2%) | 7/241 (2.9%) | 7/64 (10.9%) | 1/18 (5.6%) | ||||
Thrombosis | 0/191 (0%) | 0/241 (0%) | 0/64 (0%) | 1/18 (5.6%) |
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 | Gilead Clinical Study Information Center |
---|---|
Organization | Gilead Sciences |
Phone | 1-833-445-3230 (GILEAD-0) |
GileadClinicalTrials@gilead.com |
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