ELOQUENT - 1: Phase III Study of Lenalidomide and Dexamethasone With or Without Elotuzumab to Treat Newly Diagnosed, Previously Untreated Multiple Myeloma
Study Details
Study Description
Brief Summary
The purpose of the study is to determine whether the addition of Elotuzumab to Lenalidomide/low-dose Dexamethasone will increase the progression free survival (PFS)
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Active Comparator: Lenalidomide + Dexamethasone
|
Drug: Lenalidomide
Capsules, Oral, 25 mg, once daily, on Days 1-21, Repeat every 28 days until subject meets criteria for discontinuation of study drug
Other Names:
Drug: Dexamethasone
Tablets, Oral, 40 mg, weekly, on Days 1, 8, 15, 22, Repeat every 28 days until subject meets criteria for discontinuation of study drug
Other Names:
|
Experimental: Lenalidomide + Dexamethasone + Elotuzumab
|
Drug: Lenalidomide
Capsules, Oral, 25 mg, once daily, on Days 1-21, Repeat every 28 days until subject meets criteria for discontinuation of study drug
Other Names:
Drug: Dexamethasone
Tablets, Oral, 28 mg, once daily, on Days 1, 8, 15, 22 (cycles 1&2) ; Days 1 &15 (cycles 3-18); Day 1 (cycle 19 and beyond), Repeat every 28 days until subject meets criteria for discontinuation of study drug
Other Names:
Drug: Dexamethasone
Tablets, Oral, 40 mg, once daily, on Days 8 & 22 (cycles 3-18); Days 8, 15, 22 (cycle 19 and beyond), Repeat every 28 days until subject meets criteria for discontinuation of study drug
Other Names:
Drug: Dexamethasone
Solution, Intravenous (IV), 8 mg, Once daily, on Days 1, 8, 15, 22 (cycles 1&2) ; Days 1 &15 (cycles 3-18); Day 1 (cycle 19 and beyond), Repeat every 28 days until subject meets criteria for discontinuation of study drug
Other Names:
Biological: Elotuzumab (BMS-901608; HuLuc63)
Solution, Intravenous (IV), 10 mg/kg, weekly, on Days 1, 8, 15, 22 (cycles 1&2); Days 1 and 15 (cycles 3-18), Repeat every 28 days until subject meets criteria for discontinuation of study drug
Biological: Elotuzumab (BMS-901608; HuLuc63)
Solution, Intravenous (IV), 20 mg/kg, Day 1 (cycle 19 and beyond), Repeat every 28 days until subject meets criteria for discontinuation of study drug
|
Outcome Measures
Primary Outcome Measures
- Progression-Free Survival (PFS) [From randomization to date of first documented tumor progression or death due to any cause (up to 8 years)]
PFS is defined as the time from randomization to the date of the first documented tumor progression (as determined by the Independent Review Committee (IRC)) or death due to any cause. The IRC conducted a blinded, independent review of the tumor assessments based on the European Group for Blood and Bone Marrow Transplant (EBMT) criteria. Censoring rules applied: Participants receiving subsequent systemic anti-myeloma therapy prior to documented progression were censored at the date of the last adequate tumor assessment prior to new therapy. Participants who had an event (progression or death) > 10 weeks after their last tumor assessment were censored at their last adequate tumor assessment prior to the event. Participants without progression or death (and not receiving subsequent therapy prior to progression) were censored at their last adequate tumor assessment. Participants without any post-baseline tumor assessments were censored on the date of randomization
Secondary Outcome Measures
- Objective Response Rate (ORR) [From randomization to primary completion date (approximately 8 years)]
ORR is defined as the percentage of participants with objective response among all randomized subjects. Participants with an objective response are those participants experiencing a partial response (PR) or better, based on Indipendent Review Committee (IRC) assessment, as per EBMT criteria.
- Overall Survival (OS) [From randomization to the date of death (up to 8 years)]
Survival is defined as the time from randomization to the date of death. A participant who did not die had his or her survival duration censored at the date of last contact ('last known date alive").
- Mean Change From Baseline of Pain Severity Score and Pain Interference Score [From Baseline to End of Treatment (approximately 8 years)]
Pain severity (sensory dimension) and pain interference (reactive dimension, assessing the degree to which pain interferes with function) are measured using the Brief Pain Inventory- Short Form (BPI-SF). BPI-SF numeric rating scale goes from 0 (No pain) to 10 (Pain as bad as you can imagine).
- Progression Free Survival (PFS) Rate at Specific Time-points [From randomization to the specified time-point (up to 5 years)]
PFS rate is defined as the proportion of participants experiencing PFS at the defined time-points.
Eligibility Criteria
Criteria
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.
Inclusion Criteria:
-
Subjects who are newly diagnosed with symptomatic Multiple Myeloma (MM) and who:
-
have not received any prior systemic anti-myeloma therapy AND
-
have measurable disease AND
-
are not candidates for high-dose therapy plus stem-cell transplantation (SCT) because of age (≥ 65 years) or coexisting conditions. Refusal to undergo high dose therapy with SCT is NOT sufficient for entry onto CA204006 for a subject < 65 years old. There must be a comorbidity that prevents SCT for a subject < 65 years old
Exclusion Criteria:
-
Subjects with non-secretory or oligo-secretory or free light-chain only myeloma
-
Smoldering MM, defined as asymptomatic MM with absence of lytic bone lesions
-
Monoclonal Gammopathy of Undetermined Significance (MGUS)
-
Active plasma cell leukemia
-
Known Human Immunodeficiency Virus (HIV) infection or active hepatitis A, B, or C
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Alabama Oncology | Birmingham | Alabama | United States | 35243 |
2 | University Of South Alabama / Mitchell Cancer Institute | Mobile | Alabama | United States | 36604 |
3 | Southern Cancer Center, Inc. | Mobile | Alabama | United States | 36608 |
4 | Ironwood Cancer And Research Centers, Pc | Chandler | Arizona | United States | 85224 |
5 | Acrc/Arizona Clinical Research Center, Inc. | Tucson | Arizona | United States | 85715 |
6 | Comprehensive Blood And Cancer Center | Bakersfield | California | United States | 93309 |
7 | Alta Bates Summit Comprehensive Cancer Center | Berkeley | California | United States | 94704 |
8 | Compassionate Cancer Care Medical Group, Inc. | Corona | California | United States | 92879 |
9 | Compassionate Cancer Res Grp | Corona | California | United States | 92879 |
10 | Marin Cancer Care, Inc | Greenbrae | California | United States | 94904 |
11 | Pacific Shores Medical Group | Long Beach | California | United States | 90813 |
12 | Ucla-Division Of Hematology/Oncology | Los Angeles | California | United States | 90095 |
13 | Medical Oncology Care Associates | Orange | California | United States | 92868 |
14 | Sharp Clinical Oncology Research | San Diego | California | United States | 92123 |
15 | Yale University School Of Medicine | New Haven | Connecticut | United States | 06520 |
16 | Washington Cancer Inst at MedStar Washington Hospital Ctr | Washington | District of Columbia | United States | 20010 |
17 | Lynn Cancer Institute Center For Hematology-Oncology | Boca Raton | Florida | United States | 33486 |
18 | Local Institution | Brooksville | Florida | United States | 34613 |
19 | Florida Cancer Specialists S. | Fort Myers | Florida | United States | 33916 |
20 | Memorial Cancer Institute | Hollywood | Florida | United States | 33021 |
21 | Cancer Specialists, LLC | Jacksonville | Florida | United States | 32256 |
22 | Local Institution | New Port Richey | Florida | United States | 34652 |
23 | Florida Cancer Specialists | Saint Petersburg | Florida | United States | 33705 |
24 | Palm Beach Cancer Institute | West Palm Beach | Florida | United States | 33401 |
25 | Winship Cancer Institute. | Atlanta | Georgia | United States | 30322 |
26 | Kaiser Permanente Hawaii | Honolulu | Hawaii | United States | 96819 |
27 | The University Of Chicago | Chicago | Illinois | United States | 19123 |
28 | Rush University Medical Center | Chicago | Illinois | United States | 60612 |
29 | Loyola University Chicago | Maywood | Illinois | United States | 60153 |
30 | Illinois Cancercare, PC | Peoria | Illinois | United States | 61615 |
31 | Orchard Healthcare Research Inc. | Skokie | Illinois | United States | 60077 |
32 | Carle Cancer Center | Urbana | Illinois | United States | 61801 |
33 | Premier Healthcare, Llc | Bloomington | Indiana | United States | 47403 |
34 | Franciscan St. Francis Health | Indianapolis | Indiana | United States | 46237 |
35 | Investigative Clinical Research Of Indiana, Llc | Indianapolis | Indiana | United States | 46260 |
36 | Local Institution | Mishawaka | Indiana | United States | 46545 |
37 | University Of Iowa Hospitals And Clinics | Iowa City | Iowa | United States | 52242 |
38 | Baptist Health Lexington | Lexington | Kentucky | United States | 40503 |
39 | Norton Cancer Institute | Louisville | Kentucky | United States | 40207 |
40 | Cancer Center Of Acadiana At Lafayette General | Lafayette | Louisiana | United States | 70503 |
41 | Crescent City Research Consortium, LLC | Marrero | Louisiana | United States | 70072 |
42 | Ochsner Clinic Foundation | New Orleans | Louisiana | United States | 70121 |
43 | Willis Knighton Cancer Center | Shreveport | Louisiana | United States | 71103 |
44 | Greater Baltimore Medical Center | Baltimore | Maryland | United States | 21204 |
45 | Harry & Jeanette Weinberg Cancer Institute | Baltimore | Maryland | United States | 21237 |
46 | Dana Farber Cancer Institute. | Boston | Massachusetts | United States | 02215 |
47 | Dana-Farber Cancer Institute | Boston | Massachusetts | United States | 02215 |
48 | Henry Ford Health System | Detroit | Michigan | United States | 48202 |
49 | Columbia Comprehensive Cancer Care Clinic | Jefferson City | Missouri | United States | 65101 |
50 | Washington University School Of Medicine | Saint Louis | Missouri | United States | 63110 |
51 | Mercy Medical Research Institute | Springfield | Missouri | United States | 65804 |
52 | University Of Nebraska Medical Center | Omaha | Nebraska | United States | 68198-7680 |
53 | Winthrop University Hospital | Mineola | New York | United States | 11501 |
54 | Local Institution | New York | New York | United States | 10019 |
55 | Stony Brook University Medical Center | Stony Brook | New York | United States | 11794-8183 |
56 | Southeastern Medical Oncology Center | Goldsboro | North Carolina | United States | 27534 |
57 | Novant Health Oncology Specialists | Winston-Salem | North Carolina | United States | 27103 |
58 | Cleveland Clinic | Cleveland | Ohio | United States | 44195 |
59 | Benson, Md, Don | Columbus | Ohio | United States | 43210 |
60 | Mid Ohio Onc/Hema, Inc., Dba | Columbus | Ohio | United States | 43219 |
61 | Signal Point Clinical Research Center, Llc | Middletown | Ohio | United States | 45042 |
62 | Oklahoma Cancer Specialists and Research Institute, LLC-Clinical Research | Tulsa | Oklahoma | United States | 74146 |
63 | Alliance Cancer Specialists | Langhorne | Pennsylvania | United States | 19047 |
64 | Western Pennsylvania Hospital | Pittsburgh | Pennsylvania | United States | 15224 |
65 | Va Pittsburgh Healthcare System | Pittsburgh | Pennsylvania | United States | 15240 |
66 | Donald Guthrie Foundation | Sayre | Pennsylvania | United States | 18840 |
67 | Charleston Hematology Oncology Associates, Pa | Charleston | South Carolina | United States | 29414 |
68 | Local Institution - 7615 | Charleston | South Carolina | United States | 29425 |
69 | GHS Cancer Institute | Greenville | South Carolina | United States | 29615 |
70 | Avera Cancer Institute | Sioux Falls | South Dakota | United States | 57105 |
71 | Tennessee Cancer Specialists | Knoxville | Tennessee | United States | 37909 |
72 | Baptist Cancer Center | Memphis | Tennessee | United States | 38120 |
73 | Tennessee Oncology, Pc | Nashville | Tennessee | United States | 37203 |
74 | Vanderbilt University Medical Center | Nashville | Tennessee | United States | 37232-5505 |
75 | Cancer Specialists Of South Texas, Pa | Corpus Christi | Texas | United States | 78412 |
76 | Baylor Charles A. Sammons Cancer Center | Dallas | Texas | United States | 75246 |
77 | Baylor College Of Medicine | Houston | Texas | United States | 77030 |
78 | Michael E Debakey VA Medical Center | Houston | Texas | United States | 77030 |
79 | Northwest Cancer Center | Houston | Texas | United States | 77090 |
80 | Community Cancer Trials of Utah | Ogden | Utah | United States | 84405 |
81 | Hematology-Oncology Associates Of Fredricksburg, Inc | Fredericksburg | Virginia | United States | 22408 |
82 | Va Puget Sound Health Care System | Seattle | Washington | United States | 98108 |
83 | Fred Hutchinson Cancer Research Ctr | Seattle | Washington | United States | 98109 |
84 | Edwards Comprehensive Cancer Center | Huntington | West Virginia | United States | 25701 |
85 | Gundersen Clinic, Ltd | La Crosse | Wisconsin | United States | 54601 |
86 | Dean Clinic-Hematology And Oncology | Madison | Wisconsin | United States | 53717 |
87 | University Of Wisconsin Hospital And Clinics | Madison | Wisconsin | United States | 53792 |
88 | Local Institution | Garran | Australian Capital Territory | Australia | 2605 |
89 | Local Institution | Waratah | New South Wales | Australia | 2298 |
90 | Local Institution | Westmead | New South Wales | Australia | 2145 |
91 | Local Institution | Herston | Queensland | Australia | 4029 |
92 | Local Institution | Milton | Queensland | Australia | 4064 |
93 | Local Institution | Adelaide | South Australia | Australia | 5000 |
94 | Local Institution - 3606 | Woodville South | South Australia | Australia | 5001 |
95 | Local Institution | Fitzroy | Victoria | Australia | 3065 |
96 | Local Institution | Frankston | Victoria | Australia | 3199 |
97 | Local Institution | Heidelberg Melbourne | Victoria | Australia | 3084 |
98 | Local Institution | Wodonga | Victoria | Australia | 3690 |
99 | Local Institution | Murdoch | Australia | 6150 | |
100 | Local Institution | Nedlands | Australia | 6009 | |
101 | Local Institution | Fadingerstraße 1 | Austria | 4020 | |
102 | Local Institution | Innsbruck | Austria | 6020 | |
103 | Local Institution | Rankweil | Austria | 6830 | |
104 | Local Institution | Wels | Austria | 4600 | |
105 | Local Institution | Brussels | Belgium | 1020 | |
106 | Local Institution | Brussels | Belgium | 1090 | |
107 | Local Institution | Brussles | Belgium | 1200 | |
108 | Local Institution | Charleroi | Belgium | 6000 | |
109 | Local Institution | Haine St Paul | Belgium | 7100 | |
110 | Local Institution | Leuven | Belgium | 3000 | |
111 | Local Institution | Liege | Belgium | 4000 | |
112 | Local Institution | Roeselare | Belgium | 8800 | |
113 | Local Institution | Yvoir | Belgium | 5530 | |
114 | Local Institution | Calgary | Alberta | Canada | T2N 4N2 |
115 | Local Institution | Edmonton | Alberta | Canada | T6G 1Z2 |
116 | Local Institution | Winnipeg | Manitoba | Canada | R3E 0V9 |
117 | Local Institution | Saint John | New Brunswick | Canada | E2L 4L2 |
118 | Local Institution | Halifax | Nova Scotia | Canada | B3H 2Y9 |
119 | Local Institution | London | Ontario | Canada | N6A 5W9 |
120 | Local Institution | Toronto | Ontario | Canada | M5G 2M9 |
121 | Local Institution | Greenfield Park | Quebec | Canada | J4V 2H1 |
122 | Local Institution | Montreal | Quebec | Canada | H1T 2M4 |
123 | Local Institution | Montreal | Quebec | Canada | H3A 1A1 |
124 | Local Institution | Hradec Kralove | Czechia | 500 05 | |
125 | Local Institution | Praha 10 | Czechia | 100 34 | |
126 | Local Institution | Praha 2 | Czechia | 128 08 | |
127 | Local Institution | Aschaffenburg | Germany | 63739 | |
128 | Local Institution - 4550 | Berlin | Germany | 12200 | |
129 | Local Institution | Chemnitz | Germany | 09113 | |
130 | Local Institution | Dresden | Germany | 01307 | |
131 | Local Institution | Hamm | Germany | 59063 | |
132 | Local Institution | Heidelberg | Germany | 69120 | |
133 | Local Institution - 4560 | Jena | Germany | 07747 | |
134 | Local Institution - 4563 | Koln | Germany | 50937 | |
135 | Local Institution | Mainz | Germany | 55101 | |
136 | Local Institution | Munchen | Germany | 81377 | |
137 | Local Institution | Munster | Germany | 48149 | |
138 | Local Institution | Offenbach | Germany | 63069 | |
139 | Local Institution | Stuttgart | Germany | 70376 | |
140 | Local Institution | Tuebingen | Germany | 72076 | |
141 | Local Institution | Ulm | Germany | 89081 | |
142 | Local Institution | Athens | Greece | 11527 | |
143 | Local Institution | Athens | Greece | 11528 | |
144 | Local Institution | Ioannina | Greece | 45500 | |
145 | Local Institution | Larissa | Greece | 41110 | |
146 | Local Institution | Patras | Greece | 26504 | |
147 | Local Institution | Budapest | Hungary | 1097 | |
148 | Local Institution | Budapest | Hungary | 1122 | |
149 | Local Institution - 4750 | Debrecen | Hungary | 4012 | |
150 | Local Institution | Gyor | Hungary | 9024 | |
151 | Local Institution - 4752 | Szeged | Hungary | 6720 | |
152 | Local Institution | Dublin | Ireland | 7 | |
153 | Local Institution | Dublin | Ireland | 8 | |
154 | Local Institution | Galway | Ireland | ||
155 | Local Institution | Afula | Israel | 1834111 | |
156 | Local Institution | Ashkelon | Israel | 7830604 | |
157 | Local Institution - 4960 | Haifa | Israel | 3109601 | |
158 | Local Institution | Jerusalem | Israel | 91031 | |
159 | Local Institution | Jerusalem | Israel | 91120 | |
160 | Local Institution | Kfar Saba | Israel | 4428164 | |
161 | Local Institution | Nahariya | Israel | 2210001 | |
162 | Local Institution | Petah Tikva | Israel | 4941492 | |
163 | Local Institution | Tel Aviv | Israel | 64239 | |
164 | Local Institution | Zerifin | Israel | 70300 | |
165 | Local Institution | Ancona | Italy | 60126 | |
166 | Local Institution | Bari | Italy | 70124 | |
167 | Local Institution | Bergamo | Italy | 24127 | |
168 | Local Institution | Bologna | Italy | 40138 | |
169 | Local Institution | Firenze | Italy | 50134 | |
170 | Local Institution | Genova | Italy | 16132 | |
171 | Local Institution | Meldola | Italy | 47014 | |
172 | Local Institution | Milano | Italy | 20122 | |
173 | Local Institution | Milan | Italy | 20132 | |
174 | Local Institution | Monza | Italy | 20052 | |
175 | Local Institution | Napoli | Italy | 80131 | |
176 | Local Institution | Palermo | Italy | 90146 | |
177 | Local Institution | Ravenna | Italy | 48100 | |
178 | Local Institution | Reggio Nell Emilia (RE) | Italy | 42100 | |
179 | Local Institution | Rimini | Italy | 47923 | |
180 | Local Institution | Roma | Italy | 00144 | |
181 | Local Institution | Roma | Italy | 00168 | |
182 | Local Institution | Rome | Italy | 00161 | |
183 | Local Institution | Terni | Italy | 05100 | |
184 | Local Institution | Torino | Italy | 10126 | |
185 | Local Institution | Bialystok | Poland | 15-276 | |
186 | Local Institution | Chorzow | Poland | 41-500 | |
187 | Local Institution | Gdansk | Poland | 80-952 | |
188 | Local Institution | Krakow | Poland | 31-531 | |
189 | Local Institution | Lodz | Poland | 93-510 | |
190 | Local Institution | Lublin | Poland | 20-081 | |
191 | Local Institution | Poznan | Poland | 60-569 | |
192 | Local Institution | Szczecin | Poland | 70-111 | |
193 | Local Institution | Warszawa | Poland | 02-106 | |
194 | Local Institution | Warszawa | Poland | 02-507 | |
195 | Local Institution | Warszawa | Poland | 02-776 | |
196 | Local Institution | Wroclaw | Poland | 50-367 | |
197 | Local Institution | Ponce | Puerto Rico | 00716 | |
198 | Local Institution | San Juan | Puerto Rico | 00918 | |
199 | Local Institution | Brasov | Romania | 500152 | |
200 | Local Institution | Bucaresti | Romania | 030171 | |
201 | Local Institution | Bucuresti | Romania | 020125 | |
202 | Local Institution | Bucuresti | Romania | 050098 | |
203 | Local Institution | Bucuresti | Romania | 22328 | |
204 | Local Institution | Lasi | Romania | 700483 | |
205 | Local Institution | Samara | Russian Federation | 443095 | |
206 | Local Institution | St. Petersburg | Russian Federation | 197022 | |
207 | Local Institution - 5552 | Badalona-barcelona | Spain | 08916 | |
208 | Local Institution | Barcelona | Spain | 08036 | |
209 | Local Institution | Barcelona | Spain | 08041 | |
210 | Local Institution | La Laguna- Tenerife | Spain | 38320 | |
211 | Local Institution | Madrid | Spain | 28006 | |
212 | Local Institution | Madrid | Spain | 28007 | |
213 | Local Institution | Madrid | Spain | 28034 | |
214 | Local Institution | Madrid | Spain | 28041 | |
215 | Local Institution | Pamplona | Spain | 31008 | |
216 | Local Institution | Salamanca | Spain | 37007 | |
217 | Local Institution | San Sebastian | Spain | 20014 | |
218 | Local Institution | Toledo | Spain | 45004 | |
219 | Local Institution | Bern | Switzerland | 3010 | |
220 | Local Institution | St Gallen | Switzerland | 9007 | |
221 | Local Institution | Zurich | Switzerland | 8028 | |
222 | Local Institution | Zurich | Switzerland | 8091 | |
223 | Local Institution - 5853 | Izmir | Bornova | Turkey | 35100 |
224 | Local Institution - 5851 | Ankara | Dikimevi | Turkey | 06620 |
225 | Local Institution | Izmir | Inciralti | Turkey | 35340 |
226 | Local Institution | Gaziantep | Turkey | 27310 | |
227 | Local Institution | Belfast | Antrim | United Kingdom | BT9 7AB |
228 | Local Institution | London | Greater London | United Kingdom | SE5 9RS |
229 | Local Institution | London | United Kingdom | EC1A 7BE | |
230 | Local Institution | London | United Kingdom | HA1 3UJ | |
231 | Local Institution | London | United Kingdom | NW1 2PG | |
232 | Local Institution | London | United Kingdom | NW3 2QG |
Sponsors and Collaborators
- Bristol-Myers Squibb
- AbbVie
Investigators
- Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb
Study Documents (Full-Text)
More Information
Additional Information:
- BMS Clinical Trial Information
- BMS Clinical Trial Patient Recruiting
- Investigator Inquiry Form
- FDA Safety Alerts and Recalls
Publications
None provided.- CA204-006
- 2010-022445-20
Study Results
Participant Flow
Recruitment Details | |
---|---|
Pre-assignment Detail | E-Ld cohort: 374 participants were randomized. 371 participants entered the treatment period. Ld cohort: 374 participants were randomized. 371 participants entered the treatment period. |
Arm/Group Title | E-Ld Cohort | Ld Cohort |
---|---|---|
Arm/Group Description | Participants receiving a combination of Elotuzumab (E) Lenalidomide (L) Dexamethasone (d) in a 28 day cycle | Participants receiving a combination of Lenalidomide (L) Dexamethasone (d) in a 28 day cycle |
Period Title: Pre-treatment Period | ||
STARTED | 374 | 374 |
COMPLETED | 371 | 371 |
NOT COMPLETED | 3 | 3 |
Period Title: Pre-treatment Period | ||
STARTED | 371 | 371 |
COMPLETED | 38 | 32 |
NOT COMPLETED | 333 | 339 |
Baseline Characteristics
Arm/Group Title | E-Ld Cohort | Ld Cohort | Total |
---|---|---|---|
Arm/Group Description | Participants receiving a combination of Elotuzumab (E) Lenalidomide (L) Dexamethasone (d) in a 28 day cycle | Participants receiving a combination of Lenalidomide (L) Dexamethasone (d) in a 28 day cycle | Total of all reporting groups |
Overall Participants | 374 | 374 | 748 |
Age (Years) [Mean (Standard Deviation) ] | |||
Mean (Standard Deviation) [Years] |
72.9
(6.58)
|
73.1
(6.70)
|
73.0
(6.63)
|
Sex: Female, Male (Count of Participants) | |||
Female |
163
43.6%
|
173
46.3%
|
336
44.9%
|
Male |
211
56.4%
|
201
53.7%
|
412
55.1%
|
Ethnicity (NIH/OMB) (Count of Participants) | |||
Hispanic or Latino |
9
2.4%
|
8
2.1%
|
17
2.3%
|
Not Hispanic or Latino |
70
18.7%
|
87
23.3%
|
157
21%
|
Unknown or Not Reported |
295
78.9%
|
279
74.6%
|
574
76.7%
|
Race (NIH/OMB) (Count of Participants) | |||
American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
Asian |
1
0.3%
|
4
1.1%
|
5
0.7%
|
Native Hawaiian or Other Pacific Islander |
0
0%
|
1
0.3%
|
1
0.1%
|
Black or African American |
13
3.5%
|
16
4.3%
|
29
3.9%
|
White |
360
96.3%
|
351
93.9%
|
711
95.1%
|
More than one race |
0
0%
|
0
0%
|
0
0%
|
Unknown or Not Reported |
0
0%
|
2
0.5%
|
2
0.3%
|
Outcome Measures
Title | Progression-Free Survival (PFS) |
---|---|
Description | PFS is defined as the time from randomization to the date of the first documented tumor progression (as determined by the Independent Review Committee (IRC)) or death due to any cause. The IRC conducted a blinded, independent review of the tumor assessments based on the European Group for Blood and Bone Marrow Transplant (EBMT) criteria. Censoring rules applied: Participants receiving subsequent systemic anti-myeloma therapy prior to documented progression were censored at the date of the last adequate tumor assessment prior to new therapy. Participants who had an event (progression or death) > 10 weeks after their last tumor assessment were censored at their last adequate tumor assessment prior to the event. Participants without progression or death (and not receiving subsequent therapy prior to progression) were censored at their last adequate tumor assessment. Participants without any post-baseline tumor assessments were censored on the date of randomization |
Time Frame | From randomization to date of first documented tumor progression or death due to any cause (up to 8 years) |
Outcome Measure Data
Analysis Population Description |
---|
All randomized participants |
Arm/Group Title | E-Ld Cohort | Ld Cohort |
---|---|---|
Arm/Group Description | Participants receiving a combination of Elotuzumab (E) Lenalidomide (L) Dexamethasone (d) in a 28 day cycle | Participants receiving a combination of Lenalidomide (L) Dexamethasone (d) in a 28 day cycle |
Measure Participants | 374 | 374 |
Median (95% Confidence Interval) [Months] |
31.38
|
29.47
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | E-Ld Cohort, Ld Cohort |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.4358 |
Comments | ||
Method | Stratified Log Rank | |
Comments |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | E-Ld Cohort, Ld Cohort |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
Estimated Value | 0.93 | |
Confidence Interval |
(2-Sided) 95.71% 0.77 to 1.12 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | E-Ld/Ld. Calculated using Cox proportional hazards modeling |
Title | Objective Response Rate (ORR) |
---|---|
Description | ORR is defined as the percentage of participants with objective response among all randomized subjects. Participants with an objective response are those participants experiencing a partial response (PR) or better, based on Indipendent Review Committee (IRC) assessment, as per EBMT criteria. |
Time Frame | From randomization to primary completion date (approximately 8 years) |
Outcome Measure Data
Analysis Population Description |
---|
All randomized participants |
Arm/Group Title | E-Ld Cohort | Ld Cohort |
---|---|---|
Arm/Group Description | Participants receiving a combination of Elotuzumab (E) Lenalidomide (L) Dexamethasone (d) in a 28 day cycle | Participants receiving a combination of Lenalidomide (L) Dexamethasone (d) in a 28 day cycle |
Measure Participants | 374 | 374 |
Number (95% Confidence Interval) [Percent of Participants] |
82.9
22.2%
|
79.4
21.2%
|
Title | Overall Survival (OS) |
---|---|
Description | Survival is defined as the time from randomization to the date of death. A participant who did not die had his or her survival duration censored at the date of last contact ('last known date alive"). |
Time Frame | From randomization to the date of death (up to 8 years) |
Outcome Measure Data
Analysis Population Description |
---|
All randomized participants |
Arm/Group Title | E-Ld Cohort | Ld Cohort |
---|---|---|
Arm/Group Description | Participants receiving a combination of Elotuzumab (E) Lenalidomide (L) Dexamethasone (d) in a 28 day cycle | Participants receiving a combination of Lenalidomide (L) Dexamethasone (d) in a 28 day cycle |
Measure Participants | 374 | 374 |
Median (95% Confidence Interval) [Months] |
60.42
|
57.56
|
Title | Mean Change From Baseline of Pain Severity Score and Pain Interference Score |
---|---|
Description | Pain severity (sensory dimension) and pain interference (reactive dimension, assessing the degree to which pain interferes with function) are measured using the Brief Pain Inventory- Short Form (BPI-SF). BPI-SF numeric rating scale goes from 0 (No pain) to 10 (Pain as bad as you can imagine). |
Time Frame | From Baseline to End of Treatment (approximately 8 years) |
Outcome Measure Data
Analysis Population Description |
---|
All randomized participants |
Arm/Group Title | E-Ld Cohort | Ld Cohort |
---|---|---|
Arm/Group Description | Participants receiving a combination of Elotuzumab (E) Lenalidomide (L) Dexamethasone (d) in a 28 day cycle | Participants receiving a combination of Lenalidomide (L) Dexamethasone (d) in a 28 day cycle |
Measure Participants | 374 | 374 |
Pain Severity |
0.02
(2.645)
|
-0.25
(2.721)
|
Pain Interference |
0.33
(3.077)
|
-0.18
(3.082)
|
Title | Progression Free Survival (PFS) Rate at Specific Time-points |
---|---|
Description | PFS rate is defined as the proportion of participants experiencing PFS at the defined time-points. |
Time Frame | From randomization to the specified time-point (up to 5 years) |
Outcome Measure Data
Analysis Population Description |
---|
All randomized participants |
Arm/Group Title | E-Ld Cohort | Ld Cohort |
---|---|---|
Arm/Group Description | Participants receiving a combination of Elotuzumab (E) Lenalidomide (L) Dexamethasone (d) in a 28 day cycle | Participants receiving a combination of Lenalidomide (L) Dexamethasone (d) in a 28 day cycle |
Measure Participants | 374 | 374 |
1 year |
0.77
0.2%
|
0.76
0.2%
|
2 year |
0.59
0.2%
|
0.55
0.1%
|
3 year |
0.46
0.1%
|
0.41
0.1%
|
4 year |
0.36
0.1%
|
0.33
0.1%
|
5 year |
0.26
0.1%
|
0.25
0.1%
|
Adverse Events
Time Frame | From first dose to 60 days after last dose | |||
---|---|---|---|---|
Adverse Event Reporting Description | ||||
Arm/Group Title | E-Ld Cohort | Ld Cohort | ||
Arm/Group Description | Participants receiving a combination of Elotuzumab (E) Lenalidomide (L) Dexamethasone (d) in a 28 day cycle | Participants receiving a combination of Lenalidomide (L) Dexamethasone (d) in a 28 day cycle | ||
All Cause Mortality |
||||
E-Ld Cohort | Ld Cohort | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 221/371 (59.6%) | 215/371 (58%) | ||
Serious Adverse Events |
||||
E-Ld Cohort | Ld Cohort | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 292/371 (78.7%) | 277/371 (74.7%) | ||
Blood and lymphatic system disorders | ||||
Agranulocytosis | 1/371 (0.3%) | 0/371 (0%) | ||
Anaemia | 12/371 (3.2%) | 12/371 (3.2%) | ||
Febrile neutropenia | 5/371 (1.3%) | 3/371 (0.8%) | ||
Haemolysis | 1/371 (0.3%) | 0/371 (0%) | ||
Haemolytic anaemia | 0/371 (0%) | 1/371 (0.3%) | ||
Neutropenia | 0/371 (0%) | 1/371 (0.3%) | ||
Pancytopenia | 4/371 (1.1%) | 0/371 (0%) | ||
Plasmacytosis | 0/371 (0%) | 1/371 (0.3%) | ||
Thrombocytopenia | 1/371 (0.3%) | 2/371 (0.5%) | ||
Cardiac disorders | ||||
Acute coronary syndrome | 2/371 (0.5%) | 2/371 (0.5%) | ||
Acute myocardial infarction | 7/371 (1.9%) | 0/371 (0%) | ||
Angina pectoris | 2/371 (0.5%) | 0/371 (0%) | ||
Aortic valve calcification | 0/371 (0%) | 1/371 (0.3%) | ||
Aortic valve incompetence | 1/371 (0.3%) | 0/371 (0%) | ||
Arrhythmia | 1/371 (0.3%) | 2/371 (0.5%) | ||
Atrial fibrillation | 22/371 (5.9%) | 12/371 (3.2%) | ||
Atrial flutter | 3/371 (0.8%) | 3/371 (0.8%) | ||
Atrial tachycardia | 0/371 (0%) | 2/371 (0.5%) | ||
Atrial thrombosis | 1/371 (0.3%) | 0/371 (0%) | ||
Atrioventricular block | 0/371 (0%) | 1/371 (0.3%) | ||
Bradycardia | 1/371 (0.3%) | 0/371 (0%) | ||
Cardiac arrest | 6/371 (1.6%) | 5/371 (1.3%) | ||
Cardiac failure | 12/371 (3.2%) | 7/371 (1.9%) | ||
Cardiac failure acute | 1/371 (0.3%) | 1/371 (0.3%) | ||
Cardiac failure chronic | 1/371 (0.3%) | 1/371 (0.3%) | ||
Cardiac failure congestive | 4/371 (1.1%) | 4/371 (1.1%) | ||
Cardiac septal hypertrophy | 1/371 (0.3%) | 0/371 (0%) | ||
Cardiac ventricular thrombosis | 0/371 (0%) | 1/371 (0.3%) | ||
Cardio-respiratory arrest | 1/371 (0.3%) | 1/371 (0.3%) | ||
Cardiogenic shock | 1/371 (0.3%) | 0/371 (0%) | ||
Cardiomyopathy | 0/371 (0%) | 1/371 (0.3%) | ||
Cardiopulmonary failure | 0/371 (0%) | 1/371 (0.3%) | ||
Cardiovascular disorder | 2/371 (0.5%) | 0/371 (0%) | ||
Congestive cardiomyopathy | 0/371 (0%) | 1/371 (0.3%) | ||
Coronary artery disease | 2/371 (0.5%) | 1/371 (0.3%) | ||
Left ventricular dysfunction | 0/371 (0%) | 2/371 (0.5%) | ||
Mitral valve incompetence | 2/371 (0.5%) | 0/371 (0%) | ||
Myocardial infarction | 6/371 (1.6%) | 5/371 (1.3%) | ||
Myocardial ischaemia | 2/371 (0.5%) | 1/371 (0.3%) | ||
Pericarditis | 0/371 (0%) | 1/371 (0.3%) | ||
Prinzmetal angina | 1/371 (0.3%) | 0/371 (0%) | ||
Sinus arrest | 1/371 (0.3%) | 0/371 (0%) | ||
Sinus node dysfunction | 3/371 (0.8%) | 1/371 (0.3%) | ||
Sinus tachycardia | 0/371 (0%) | 1/371 (0.3%) | ||
Supraventricular tachycardia | 1/371 (0.3%) | 0/371 (0%) | ||
Systolic dysfunction | 1/371 (0.3%) | 0/371 (0%) | ||
Tachycardia | 2/371 (0.5%) | 0/371 (0%) | ||
Torsade de pointes | 1/371 (0.3%) | 0/371 (0%) | ||
Ventricular arrhythmia | 1/371 (0.3%) | 1/371 (0.3%) | ||
Congenital, familial and genetic disorders | ||||
Corneal dystrophy | 1/371 (0.3%) | 0/371 (0%) | ||
Ear and labyrinth disorders | ||||
Sudden hearing loss | 0/371 (0%) | 1/371 (0.3%) | ||
Vertigo | 0/371 (0%) | 1/371 (0.3%) | ||
Eye disorders | ||||
Blindness transient | 1/371 (0.3%) | 0/371 (0%) | ||
Cataract | 10/371 (2.7%) | 9/371 (2.4%) | ||
Cataract cortical | 1/371 (0.3%) | 0/371 (0%) | ||
Macular fibrosis | 1/371 (0.3%) | 0/371 (0%) | ||
Optic ischaemic neuropathy | 1/371 (0.3%) | 0/371 (0%) | ||
Retinal detachment | 1/371 (0.3%) | 0/371 (0%) | ||
Gastrointestinal disorders | ||||
Abdominal pain | 1/371 (0.3%) | 2/371 (0.5%) | ||
Abdominal pain lower | 0/371 (0%) | 1/371 (0.3%) | ||
Abdominal pain upper | 1/371 (0.3%) | 1/371 (0.3%) | ||
Anal haemorrhage | 0/371 (0%) | 1/371 (0.3%) | ||
Anorectal varices haemorrhage | 1/371 (0.3%) | 0/371 (0%) | ||
Colitis | 1/371 (0.3%) | 1/371 (0.3%) | ||
Colitis ulcerative | 0/371 (0%) | 1/371 (0.3%) | ||
Constipation | 3/371 (0.8%) | 2/371 (0.5%) | ||
Diaphragmatic hernia | 1/371 (0.3%) | 0/371 (0%) | ||
Diarrhoea | 9/371 (2.4%) | 9/371 (2.4%) | ||
Diverticulum intestinal | 1/371 (0.3%) | 0/371 (0%) | ||
Duodenal ulcer | 0/371 (0%) | 1/371 (0.3%) | ||
Enteritis | 1/371 (0.3%) | 0/371 (0%) | ||
Enterovesical fistula | 1/371 (0.3%) | 0/371 (0%) | ||
Femoral hernia | 1/371 (0.3%) | 0/371 (0%) | ||
Gastritis | 4/371 (1.1%) | 0/371 (0%) | ||
Gastrointestinal haemorrhage | 2/371 (0.5%) | 1/371 (0.3%) | ||
Hiatus hernia | 0/371 (0%) | 1/371 (0.3%) | ||
Ileus | 1/371 (0.3%) | 2/371 (0.5%) | ||
Incarcerated inguinal hernia | 1/371 (0.3%) | 0/371 (0%) | ||
Incarcerated umbilical hernia | 1/371 (0.3%) | 0/371 (0%) | ||
Inguinal hernia | 3/371 (0.8%) | 2/371 (0.5%) | ||
Inguinal hernia strangulated | 1/371 (0.3%) | 0/371 (0%) | ||
Intestinal infarction | 0/371 (0%) | 1/371 (0.3%) | ||
Intestinal obstruction | 4/371 (1.1%) | 2/371 (0.5%) | ||
Intestinal perforation | 0/371 (0%) | 2/371 (0.5%) | ||
Large intestine polyp | 0/371 (0%) | 1/371 (0.3%) | ||
Lower gastrointestinal haemorrhage | 0/371 (0%) | 1/371 (0.3%) | ||
Melaena | 1/371 (0.3%) | 0/371 (0%) | ||
Nausea | 0/371 (0%) | 3/371 (0.8%) | ||
Odynophagia | 0/371 (0%) | 1/371 (0.3%) | ||
Oesophageal ulcer | 1/371 (0.3%) | 0/371 (0%) | ||
Oesophagitis | 0/371 (0%) | 1/371 (0.3%) | ||
Oroantral fistula | 1/371 (0.3%) | 0/371 (0%) | ||
Pancreatitis | 0/371 (0%) | 3/371 (0.8%) | ||
Pancreatitis acute | 0/371 (0%) | 1/371 (0.3%) | ||
Pneumatosis intestinalis | 0/371 (0%) | 1/371 (0.3%) | ||
Rectal haemorrhage | 0/371 (0%) | 2/371 (0.5%) | ||
Small intestinal obstruction | 1/371 (0.3%) | 1/371 (0.3%) | ||
Umbilical hernia | 0/371 (0%) | 1/371 (0.3%) | ||
Vomiting | 3/371 (0.8%) | 1/371 (0.3%) | ||
General disorders | ||||
Adverse drug reaction | 1/371 (0.3%) | 0/371 (0%) | ||
Asthenia | 3/371 (0.8%) | 5/371 (1.3%) | ||
Chest pain | 2/371 (0.5%) | 4/371 (1.1%) | ||
Death | 2/371 (0.5%) | 3/371 (0.8%) | ||
Disease progression | 8/371 (2.2%) | 5/371 (1.3%) | ||
Fat necrosis | 0/371 (0%) | 1/371 (0.3%) | ||
Fatigue | 2/371 (0.5%) | 2/371 (0.5%) | ||
General physical health deterioration | 3/371 (0.8%) | 5/371 (1.3%) | ||
Inflammation | 2/371 (0.5%) | 0/371 (0%) | ||
Malaise | 1/371 (0.3%) | 0/371 (0%) | ||
Multiple organ dysfunction syndrome | 1/371 (0.3%) | 1/371 (0.3%) | ||
Non-cardiac chest pain | 0/371 (0%) | 3/371 (0.8%) | ||
Oedema | 1/371 (0.3%) | 1/371 (0.3%) | ||
Oedema peripheral | 1/371 (0.3%) | 4/371 (1.1%) | ||
Pain | 1/371 (0.3%) | 3/371 (0.8%) | ||
Performance status decreased | 0/371 (0%) | 1/371 (0.3%) | ||
Pyrexia | 19/371 (5.1%) | 7/371 (1.9%) | ||
Sudden cardiac death | 1/371 (0.3%) | 1/371 (0.3%) | ||
Sudden death | 2/371 (0.5%) | 1/371 (0.3%) | ||
Systemic inflammatory response syndrome | 0/371 (0%) | 1/371 (0.3%) | ||
Hepatobiliary disorders | ||||
Bile duct obstruction | 0/371 (0%) | 1/371 (0.3%) | ||
Bile duct stone | 1/371 (0.3%) | 0/371 (0%) | ||
Cholecystitis | 2/371 (0.5%) | 1/371 (0.3%) | ||
Cholecystitis acute | 2/371 (0.5%) | 0/371 (0%) | ||
Cholecystitis chronic | 0/371 (0%) | 1/371 (0.3%) | ||
Cholelithiasis | 0/371 (0%) | 1/371 (0.3%) | ||
Gallbladder rupture | 1/371 (0.3%) | 0/371 (0%) | ||
Hydrocholecystis | 0/371 (0%) | 1/371 (0.3%) | ||
Jaundice | 1/371 (0.3%) | 0/371 (0%) | ||
Immune system disorders | ||||
Drug hypersensitivity | 0/371 (0%) | 1/371 (0.3%) | ||
Hypersensitivity | 2/371 (0.5%) | 0/371 (0%) | ||
Infections and infestations | ||||
Abdominal abscess | 0/371 (0%) | 1/371 (0.3%) | ||
Abscess | 0/371 (0%) | 1/371 (0.3%) | ||
Abscess limb | 1/371 (0.3%) | 0/371 (0%) | ||
Appendicitis | 1/371 (0.3%) | 0/371 (0%) | ||
Bacteraemia | 1/371 (0.3%) | 1/371 (0.3%) | ||
Bacterial prostatitis | 0/371 (0%) | 1/371 (0.3%) | ||
Biliary sepsis | 1/371 (0.3%) | 0/371 (0%) | ||
Bronchiolitis | 1/371 (0.3%) | 0/371 (0%) | ||
Bronchitis | 18/371 (4.9%) | 6/371 (1.6%) | ||
Bursitis infective | 1/371 (0.3%) | 0/371 (0%) | ||
Cellulitis | 9/371 (2.4%) | 8/371 (2.2%) | ||
Cellulitis orbital | 1/371 (0.3%) | 1/371 (0.3%) | ||
Central nervous system infection | 1/371 (0.3%) | 0/371 (0%) | ||
Clostridium colitis | 1/371 (0.3%) | 0/371 (0%) | ||
Clostridium difficile colitis | 2/371 (0.5%) | 1/371 (0.3%) | ||
Clostridium difficile infection | 1/371 (0.3%) | 1/371 (0.3%) | ||
Dacryocystitis | 1/371 (0.3%) | 0/371 (0%) | ||
Device related infection | 1/371 (0.3%) | 1/371 (0.3%) | ||
Diverticulitis | 5/371 (1.3%) | 3/371 (0.8%) | ||
Erysipelas | 2/371 (0.5%) | 1/371 (0.3%) | ||
Escherichia bacteraemia | 0/371 (0%) | 2/371 (0.5%) | ||
Escherichia infection | 1/371 (0.3%) | 0/371 (0%) | ||
Escherichia urinary tract infection | 1/371 (0.3%) | 1/371 (0.3%) | ||
Febrile infection | 2/371 (0.5%) | 0/371 (0%) | ||
Gastroenteritis | 8/371 (2.2%) | 2/371 (0.5%) | ||
Gastroenteritis clostridial | 1/371 (0.3%) | 0/371 (0%) | ||
Gastroenteritis salmonella | 1/371 (0.3%) | 0/371 (0%) | ||
Gastroenteritis viral | 0/371 (0%) | 1/371 (0.3%) | ||
Gastrointestinal infection | 1/371 (0.3%) | 0/371 (0%) | ||
H1N1 influenza | 0/371 (0%) | 1/371 (0.3%) | ||
Hepatitis E | 1/371 (0.3%) | 0/371 (0%) | ||
Herpes zoster | 0/371 (0%) | 2/371 (0.5%) | ||
Herpes zoster disseminated | 0/371 (0%) | 1/371 (0.3%) | ||
Infected cyst | 1/371 (0.3%) | 0/371 (0%) | ||
Infection | 4/371 (1.1%) | 1/371 (0.3%) | ||
Infectious pleural effusion | 1/371 (0.3%) | 0/371 (0%) | ||
Influenza | 7/371 (1.9%) | 6/371 (1.6%) | ||
Intervertebral discitis | 1/371 (0.3%) | 0/371 (0%) | ||
Large intestine infection | 0/371 (0%) | 1/371 (0.3%) | ||
Leishmaniasis | 1/371 (0.3%) | 0/371 (0%) | ||
Liver abscess | 1/371 (0.3%) | 0/371 (0%) | ||
Localised infection | 1/371 (0.3%) | 0/371 (0%) | ||
Lower respiratory tract infection | 8/371 (2.2%) | 7/371 (1.9%) | ||
Meningitis listeria | 1/371 (0.3%) | 1/371 (0.3%) | ||
Metapneumovirus infection | 1/371 (0.3%) | 1/371 (0.3%) | ||
Neutropenic sepsis | 1/371 (0.3%) | 0/371 (0%) | ||
Orchitis | 0/371 (0%) | 1/371 (0.3%) | ||
Perirectal abscess | 1/371 (0.3%) | 1/371 (0.3%) | ||
Peritonitis | 1/371 (0.3%) | 0/371 (0%) | ||
Pharyngitis | 1/371 (0.3%) | 0/371 (0%) | ||
Plague | 1/371 (0.3%) | 0/371 (0%) | ||
Pleural infection | 0/371 (0%) | 1/371 (0.3%) | ||
Pneumococcal sepsis | 1/371 (0.3%) | 0/371 (0%) | ||
Pneumocystis jirovecii pneumonia | 2/371 (0.5%) | 0/371 (0%) | ||
Pneumonia | 60/371 (16.2%) | 48/371 (12.9%) | ||
Pneumonia bacterial | 1/371 (0.3%) | 1/371 (0.3%) | ||
Pneumonia cytomegaloviral | 1/371 (0.3%) | 0/371 (0%) | ||
Pneumonia fungal | 2/371 (0.5%) | 0/371 (0%) | ||
Pneumonia influenzal | 1/371 (0.3%) | 0/371 (0%) | ||
Pneumonia legionella | 0/371 (0%) | 1/371 (0.3%) | ||
Pneumonia staphylococcal | 1/371 (0.3%) | 0/371 (0%) | ||
Pneumonia streptococcal | 1/371 (0.3%) | 0/371 (0%) | ||
Pneumonia viral | 0/371 (0%) | 1/371 (0.3%) | ||
Progressive multifocal leukoencephalopathy | 0/371 (0%) | 1/371 (0.3%) | ||
Pseudomembranous colitis | 1/371 (0.3%) | 0/371 (0%) | ||
Pyelonephritis | 1/371 (0.3%) | 2/371 (0.5%) | ||
Pyoderma | 1/371 (0.3%) | 0/371 (0%) | ||
Respiratory syncytial virus infection | 0/371 (0%) | 1/371 (0.3%) | ||
Respiratory tract infection | 8/371 (2.2%) | 3/371 (0.8%) | ||
Sepsis | 15/371 (4%) | 6/371 (1.6%) | ||
Septic shock | 4/371 (1.1%) | 6/371 (1.6%) | ||
Staphylococcal infection | 2/371 (0.5%) | 0/371 (0%) | ||
Staphylococcal sepsis | 1/371 (0.3%) | 0/371 (0%) | ||
Subcutaneous abscess | 0/371 (0%) | 1/371 (0.3%) | ||
Upper respiratory tract infection | 5/371 (1.3%) | 4/371 (1.1%) | ||
Urinary tract infection | 15/371 (4%) | 11/371 (3%) | ||
Urinary tract infection bacterial | 0/371 (0%) | 1/371 (0.3%) | ||
Urinary tract infection enterococcal | 1/371 (0.3%) | 0/371 (0%) | ||
Urosepsis | 4/371 (1.1%) | 5/371 (1.3%) | ||
Varicella zoster virus infection | 1/371 (0.3%) | 0/371 (0%) | ||
Vascular device infection | 1/371 (0.3%) | 0/371 (0%) | ||
Viral infection | 1/371 (0.3%) | 1/371 (0.3%) | ||
Whipple's disease | 1/371 (0.3%) | 0/371 (0%) | ||
Wound infection staphylococcal | 1/371 (0.3%) | 0/371 (0%) | ||
Injury, poisoning and procedural complications | ||||
Accidental overdose | 0/371 (0%) | 1/371 (0.3%) | ||
Comminuted fracture | 0/371 (0%) | 1/371 (0.3%) | ||
Extradural haematoma | 0/371 (0%) | 1/371 (0.3%) | ||
Fall | 2/371 (0.5%) | 2/371 (0.5%) | ||
Femoral neck fracture | 0/371 (0%) | 2/371 (0.5%) | ||
Femur fracture | 4/371 (1.1%) | 8/371 (2.2%) | ||
Fibula fracture | 0/371 (0%) | 2/371 (0.5%) | ||
Fracture | 3/371 (0.8%) | 0/371 (0%) | ||
Hip fracture | 5/371 (1.3%) | 4/371 (1.1%) | ||
Humerus fracture | 1/371 (0.3%) | 1/371 (0.3%) | ||
Infusion related reaction | 1/371 (0.3%) | 0/371 (0%) | ||
Joint injury | 1/371 (0.3%) | 0/371 (0%) | ||
Lower limb fracture | 0/371 (0%) | 1/371 (0.3%) | ||
Lumbar vertebral fracture | 0/371 (0%) | 1/371 (0.3%) | ||
Medication error | 1/371 (0.3%) | 0/371 (0%) | ||
Overdose | 2/371 (0.5%) | 0/371 (0%) | ||
Pelvic fracture | 1/371 (0.3%) | 1/371 (0.3%) | ||
Post procedural complication | 1/371 (0.3%) | 0/371 (0%) | ||
Pubis fracture | 0/371 (0%) | 1/371 (0.3%) | ||
Rib fracture | 1/371 (0.3%) | 4/371 (1.1%) | ||
Shunt malfunction | 0/371 (0%) | 1/371 (0.3%) | ||
Skin laceration | 1/371 (0.3%) | 1/371 (0.3%) | ||
Spinal compression fracture | 2/371 (0.5%) | 4/371 (1.1%) | ||
Spinal fracture | 2/371 (0.5%) | 3/371 (0.8%) | ||
Stress fracture | 0/371 (0%) | 1/371 (0.3%) | ||
Subdural haematoma | 1/371 (0.3%) | 2/371 (0.5%) | ||
Thoracic vertebral fracture | 1/371 (0.3%) | 1/371 (0.3%) | ||
Tibia fracture | 0/371 (0%) | 2/371 (0.5%) | ||
Traumatic fracture | 0/371 (0%) | 2/371 (0.5%) | ||
Upper limb fracture | 0/371 (0%) | 1/371 (0.3%) | ||
Wrist fracture | 1/371 (0.3%) | 0/371 (0%) | ||
Investigations | ||||
Alanine aminotransferase increased | 1/371 (0.3%) | 0/371 (0%) | ||
Aspartate aminotransferase increased | 1/371 (0.3%) | 0/371 (0%) | ||
Bacterial test positive | 1/371 (0.3%) | 1/371 (0.3%) | ||
Blood creatinine increased | 2/371 (0.5%) | 2/371 (0.5%) | ||
Haemoglobin decreased | 1/371 (0.3%) | 0/371 (0%) | ||
Hepatic enzyme increased | 1/371 (0.3%) | 0/371 (0%) | ||
Influenza A virus test positive | 1/371 (0.3%) | 0/371 (0%) | ||
Influenza B virus test positive | 1/371 (0.3%) | 0/371 (0%) | ||
Liver function test abnormal | 1/371 (0.3%) | 0/371 (0%) | ||
Respiratory syncytial virus test positive | 1/371 (0.3%) | 0/371 (0%) | ||
Respirovirus test positive | 0/371 (0%) | 1/371 (0.3%) | ||
Transaminases increased | 0/371 (0%) | 2/371 (0.5%) | ||
Viral test positive | 1/371 (0.3%) | 0/371 (0%) | ||
Weight decreased | 1/371 (0.3%) | 1/371 (0.3%) | ||
Metabolism and nutrition disorders | ||||
Alcohol intolerance | 1/371 (0.3%) | 0/371 (0%) | ||
Decreased appetite | 1/371 (0.3%) | 0/371 (0%) | ||
Dehydration | 7/371 (1.9%) | 5/371 (1.3%) | ||
Diabetic complication | 0/371 (0%) | 1/371 (0.3%) | ||
Diabetic ketoacidosis | 0/371 (0%) | 1/371 (0.3%) | ||
Diabetic metabolic decompensation | 0/371 (0%) | 1/371 (0.3%) | ||
Electrolyte imbalance | 1/371 (0.3%) | 2/371 (0.5%) | ||
Failure to thrive | 1/371 (0.3%) | 2/371 (0.5%) | ||
Fluid overload | 0/371 (0%) | 1/371 (0.3%) | ||
Gout | 1/371 (0.3%) | 0/371 (0%) | ||
Hypercalcaemia | 2/371 (0.5%) | 5/371 (1.3%) | ||
Hyperglycaemia | 3/371 (0.8%) | 2/371 (0.5%) | ||
Hypoalbuminaemia | 1/371 (0.3%) | 1/371 (0.3%) | ||
Hypocalcaemia | 4/371 (1.1%) | 4/371 (1.1%) | ||
Hypoglycaemia | 5/371 (1.3%) | 1/371 (0.3%) | ||
Hypokalaemia | 4/371 (1.1%) | 1/371 (0.3%) | ||
Hypomagnesaemia | 4/371 (1.1%) | 0/371 (0%) | ||
Hyponatraemia | 2/371 (0.5%) | 1/371 (0.3%) | ||
Hypophosphataemia | 1/371 (0.3%) | 0/371 (0%) | ||
Malnutrition | 0/371 (0%) | 1/371 (0.3%) | ||
Tumour lysis syndrome | 1/371 (0.3%) | 1/371 (0.3%) | ||
Musculoskeletal and connective tissue disorders | ||||
Arthralgia | 1/371 (0.3%) | 2/371 (0.5%) | ||
Arthritis | 0/371 (0%) | 1/371 (0.3%) | ||
Arthritis reactive | 1/371 (0.3%) | 0/371 (0%) | ||
Back pain | 11/371 (3%) | 9/371 (2.4%) | ||
Bone pain | 3/371 (0.8%) | 4/371 (1.1%) | ||
Bursitis | 0/371 (0%) | 1/371 (0.3%) | ||
Chondrocalcinosis | 1/371 (0.3%) | 0/371 (0%) | ||
Chondrocalcinosis pyrophosphate | 1/371 (0.3%) | 0/371 (0%) | ||
Flank pain | 0/371 (0%) | 1/371 (0.3%) | ||
Intervertebral disc protrusion | 1/371 (0.3%) | 0/371 (0%) | ||
Joint hyperextension | 1/371 (0.3%) | 0/371 (0%) | ||
Muscle contracture | 0/371 (0%) | 1/371 (0.3%) | ||
Muscular weakness | 1/371 (0.3%) | 1/371 (0.3%) | ||
Musculoskeletal chest pain | 0/371 (0%) | 1/371 (0.3%) | ||
Musculoskeletal disorder | 1/371 (0.3%) | 0/371 (0%) | ||
Musculoskeletal pain | 1/371 (0.3%) | 1/371 (0.3%) | ||
Osteitis | 1/371 (0.3%) | 0/371 (0%) | ||
Osteoarthritis | 3/371 (0.8%) | 0/371 (0%) | ||
Osteonecrosis | 2/371 (0.5%) | 0/371 (0%) | ||
Osteonecrosis of jaw | 3/371 (0.8%) | 2/371 (0.5%) | ||
Pain in extremity | 1/371 (0.3%) | 2/371 (0.5%) | ||
Pathological fracture | 1/371 (0.3%) | 1/371 (0.3%) | ||
Spinal pain | 3/371 (0.8%) | 1/371 (0.3%) | ||
Spinal stenosis | 0/371 (0%) | 1/371 (0.3%) | ||
Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||
Acute lymphocytic leukaemia | 0/371 (0%) | 2/371 (0.5%) | ||
Adenocarcinoma | 1/371 (0.3%) | 0/371 (0%) | ||
Angiosarcoma | 1/371 (0.3%) | 0/371 (0%) | ||
Atypical fibroxanthoma | 1/371 (0.3%) | 0/371 (0%) | ||
Basal cell carcinoma | 10/371 (2.7%) | 8/371 (2.2%) | ||
Basosquamous carcinoma | 0/371 (0%) | 1/371 (0.3%) | ||
Bladder neoplasm | 0/371 (0%) | 1/371 (0.3%) | ||
Bowen's disease | 0/371 (0%) | 1/371 (0.3%) | ||
Cholangiocarcinoma | 1/371 (0.3%) | 1/371 (0.3%) | ||
Colon cancer | 1/371 (0.3%) | 0/371 (0%) | ||
Colon cancer metastatic | 0/371 (0%) | 1/371 (0.3%) | ||
Gastric cancer | 0/371 (0%) | 1/371 (0.3%) | ||
Hepatic cancer | 1/371 (0.3%) | 0/371 (0%) | ||
Hepatocellular carcinoma | 1/371 (0.3%) | 0/371 (0%) | ||
Intraductal proliferative breast lesion | 1/371 (0.3%) | 0/371 (0%) | ||
Keratoacanthoma | 1/371 (0.3%) | 1/371 (0.3%) | ||
Laryngeal cancer | 1/371 (0.3%) | 0/371 (0%) | ||
Laryngeal squamous cell carcinoma | 1/371 (0.3%) | 0/371 (0%) | ||
Lip squamous cell carcinoma | 0/371 (0%) | 1/371 (0.3%) | ||
Lung adenocarcinoma | 0/371 (0%) | 2/371 (0.5%) | ||
Malignant melanoma | 1/371 (0.3%) | 1/371 (0.3%) | ||
Malignant melanoma in situ | 0/371 (0%) | 2/371 (0.5%) | ||
Myelodysplastic syndrome | 1/371 (0.3%) | 0/371 (0%) | ||
Nasal cavity cancer | 0/371 (0%) | 1/371 (0.3%) | ||
Pancreatic carcinoma | 1/371 (0.3%) | 0/371 (0%) | ||
Papilloma | 1/371 (0.3%) | 0/371 (0%) | ||
Plasma cell leukaemia | 1/371 (0.3%) | 0/371 (0%) | ||
Plasma cell myeloma | 5/371 (1.3%) | 3/371 (0.8%) | ||
Plasmacytoma | 1/371 (0.3%) | 0/371 (0%) | ||
Prostate cancer | 5/371 (1.3%) | 0/371 (0%) | ||
Rectal cancer | 1/371 (0.3%) | 0/371 (0%) | ||
Rectosigmoid cancer | 1/371 (0.3%) | 0/371 (0%) | ||
Refractory anaemia with ringed sideroblasts | 1/371 (0.3%) | 0/371 (0%) | ||
Sebaceous carcinoma | 0/371 (0%) | 1/371 (0.3%) | ||
Spindle cell sarcoma | 1/371 (0.3%) | 0/371 (0%) | ||
Squamous cell carcinoma | 15/371 (4%) | 12/371 (3.2%) | ||
Squamous cell carcinoma of head and neck | 1/371 (0.3%) | 0/371 (0%) | ||
Squamous cell carcinoma of skin | 7/371 (1.9%) | 5/371 (1.3%) | ||
Squamous cell carcinoma of the oral cavity | 1/371 (0.3%) | 0/371 (0%) | ||
Transitional cell carcinoma | 1/371 (0.3%) | 0/371 (0%) | ||
Nervous system disorders | ||||
Ataxia | 1/371 (0.3%) | 0/371 (0%) | ||
Carotid artery stenosis | 1/371 (0.3%) | 1/371 (0.3%) | ||
Cerebellar haemorrhage | 1/371 (0.3%) | 0/371 (0%) | ||
Cerebral haemorrhage | 1/371 (0.3%) | 3/371 (0.8%) | ||
Cerebral infarction | 2/371 (0.5%) | 2/371 (0.5%) | ||
Cerebral ischaemia | 3/371 (0.8%) | 2/371 (0.5%) | ||
Cerebrovascular accident | 8/371 (2.2%) | 7/371 (1.9%) | ||
Cognitive disorder | 1/371 (0.3%) | 1/371 (0.3%) | ||
Coma | 1/371 (0.3%) | 0/371 (0%) | ||
Dementia | 1/371 (0.3%) | 0/371 (0%) | ||
Depressed level of consciousness | 1/371 (0.3%) | 0/371 (0%) | ||
Dizziness | 1/371 (0.3%) | 1/371 (0.3%) | ||
Dizziness postural | 0/371 (0%) | 1/371 (0.3%) | ||
Dysarthria | 2/371 (0.5%) | 0/371 (0%) | ||
Encephalopathy | 1/371 (0.3%) | 0/371 (0%) | ||
Generalised tonic-clonic seizure | 0/371 (0%) | 1/371 (0.3%) | ||
Guillain-Barre syndrome | 1/371 (0.3%) | 1/371 (0.3%) | ||
Haemorrhage intracranial | 1/371 (0.3%) | 0/371 (0%) | ||
Haemorrhagic cerebral infarction | 0/371 (0%) | 1/371 (0.3%) | ||
Haemorrhagic stroke | 0/371 (0%) | 1/371 (0.3%) | ||
Headache | 1/371 (0.3%) | 1/371 (0.3%) | ||
Intracranial aneurysm | 1/371 (0.3%) | 0/371 (0%) | ||
Intracranial haematoma | 0/371 (0%) | 1/371 (0.3%) | ||
Ischaemic cerebral infarction | 0/371 (0%) | 1/371 (0.3%) | ||
Ischaemic stroke | 3/371 (0.8%) | 1/371 (0.3%) | ||
Lethargy | 0/371 (0%) | 1/371 (0.3%) | ||
Loss of consciousness | 1/371 (0.3%) | 1/371 (0.3%) | ||
Memory impairment | 0/371 (0%) | 1/371 (0.3%) | ||
Metabolic encephalopathy | 0/371 (0%) | 1/371 (0.3%) | ||
Migraine | 1/371 (0.3%) | 0/371 (0%) | ||
Myelopathy | 1/371 (0.3%) | 0/371 (0%) | ||
Normal pressure hydrocephalus | 0/371 (0%) | 1/371 (0.3%) | ||
Presyncope | 2/371 (0.5%) | 0/371 (0%) | ||
Sciatica | 1/371 (0.3%) | 0/371 (0%) | ||
Somnolence | 1/371 (0.3%) | 0/371 (0%) | ||
Spinal cord compression | 0/371 (0%) | 1/371 (0.3%) | ||
Subarachnoid haemorrhage | 2/371 (0.5%) | 0/371 (0%) | ||
Syncope | 7/371 (1.9%) | 5/371 (1.3%) | ||
Transient aphasia | 1/371 (0.3%) | 0/371 (0%) | ||
Transient ischaemic attack | 6/371 (1.6%) | 4/371 (1.1%) | ||
Product Issues | ||||
Device dislocation | 2/371 (0.5%) | 0/371 (0%) | ||
Psychiatric disorders | ||||
Anxiety | 0/371 (0%) | 2/371 (0.5%) | ||
Completed suicide | 1/371 (0.3%) | 0/371 (0%) | ||
Confusional state | 5/371 (1.3%) | 5/371 (1.3%) | ||
Delirium | 2/371 (0.5%) | 0/371 (0%) | ||
Delusional disorder, unspecified type | 1/371 (0.3%) | 0/371 (0%) | ||
Depression | 2/371 (0.5%) | 0/371 (0%) | ||
Mental status changes | 1/371 (0.3%) | 1/371 (0.3%) | ||
Psychotic disorder | 1/371 (0.3%) | 1/371 (0.3%) | ||
Renal and urinary disorders | ||||
Acute kidney injury | 20/371 (5.4%) | 20/371 (5.4%) | ||
Calculus urinary | 0/371 (0%) | 1/371 (0.3%) | ||
Chronic kidney disease | 2/371 (0.5%) | 0/371 (0%) | ||
End stage renal disease | 1/371 (0.3%) | 0/371 (0%) | ||
Haematuria | 1/371 (0.3%) | 2/371 (0.5%) | ||
Myeloma cast nephropathy | 0/371 (0%) | 1/371 (0.3%) | ||
Nephrolithiasis | 1/371 (0.3%) | 2/371 (0.5%) | ||
Renal failure | 10/371 (2.7%) | 7/371 (1.9%) | ||
Renal impairment | 1/371 (0.3%) | 3/371 (0.8%) | ||
Renal injury | 1/371 (0.3%) | 0/371 (0%) | ||
Renal tubular necrosis | 1/371 (0.3%) | 0/371 (0%) | ||
Urinary retention | 2/371 (0.5%) | 0/371 (0%) | ||
Urinary tract disorder | 0/371 (0%) | 1/371 (0.3%) | ||
Reproductive system and breast disorders | ||||
Endometrial hyperplasia | 0/371 (0%) | 1/371 (0.3%) | ||
Uterine prolapse | 1/371 (0.3%) | 0/371 (0%) | ||
Respiratory, thoracic and mediastinal disorders | ||||
Acute pulmonary oedema | 2/371 (0.5%) | 0/371 (0%) | ||
Acute respiratory failure | 3/371 (0.8%) | 0/371 (0%) | ||
Bronchiectasis | 1/371 (0.3%) | 1/371 (0.3%) | ||
Bronchopneumopathy | 1/371 (0.3%) | 0/371 (0%) | ||
Bronchospasm | 1/371 (0.3%) | 0/371 (0%) | ||
Chronic obstructive pulmonary disease | 3/371 (0.8%) | 6/371 (1.6%) | ||
Cough | 1/371 (0.3%) | 0/371 (0%) | ||
Dyspnoea | 12/371 (3.2%) | 8/371 (2.2%) | ||
Epistaxis | 1/371 (0.3%) | 0/371 (0%) | ||
Hypoxia | 0/371 (0%) | 2/371 (0.5%) | ||
Interstitial lung disease | 3/371 (0.8%) | 3/371 (0.8%) | ||
Pleural effusion | 5/371 (1.3%) | 3/371 (0.8%) | ||
Pleuritic pain | 0/371 (0%) | 1/371 (0.3%) | ||
Pneumonia aspiration | 5/371 (1.3%) | 0/371 (0%) | ||
Pneumonitis | 1/371 (0.3%) | 4/371 (1.1%) | ||
Pneumothorax | 0/371 (0%) | 1/371 (0.3%) | ||
Pulmonary congestion | 0/371 (0%) | 1/371 (0.3%) | ||
Pulmonary embolism | 12/371 (3.2%) | 15/371 (4%) | ||
Pulmonary oedema | 3/371 (0.8%) | 4/371 (1.1%) | ||
Respiratory depression | 1/371 (0.3%) | 0/371 (0%) | ||
Respiratory disorder | 1/371 (0.3%) | 0/371 (0%) | ||
Respiratory distress | 2/371 (0.5%) | 1/371 (0.3%) | ||
Respiratory failure | 4/371 (1.1%) | 2/371 (0.5%) | ||
Restrictive pulmonary disease | 1/371 (0.3%) | 0/371 (0%) | ||
Sinus disorder | 1/371 (0.3%) | 0/371 (0%) | ||
Vocal cord disorder | 1/371 (0.3%) | 0/371 (0%) | ||
Skin and subcutaneous tissue disorders | ||||
Actinic keratosis | 1/371 (0.3%) | 0/371 (0%) | ||
Angioedema | 0/371 (0%) | 1/371 (0.3%) | ||
Cold sweat | 0/371 (0%) | 1/371 (0.3%) | ||
Cutaneous vasculitis | 1/371 (0.3%) | 0/371 (0%) | ||
Dermatitis bullous | 1/371 (0.3%) | 0/371 (0%) | ||
Dermatitis exfoliative generalised | 0/371 (0%) | 1/371 (0.3%) | ||
Diabetic foot | 0/371 (0%) | 1/371 (0.3%) | ||
Erythema | 0/371 (0%) | 1/371 (0.3%) | ||
Exfoliative rash | 0/371 (0%) | 2/371 (0.5%) | ||
Hypersensitivity vasculitis | 0/371 (0%) | 1/371 (0.3%) | ||
Purpura | 0/371 (0%) | 1/371 (0.3%) | ||
Rash | 1/371 (0.3%) | 1/371 (0.3%) | ||
Rash maculo-papular | 1/371 (0.3%) | 0/371 (0%) | ||
Skin ulcer | 0/371 (0%) | 1/371 (0.3%) | ||
Stasis dermatitis | 1/371 (0.3%) | 0/371 (0%) | ||
Stevens-Johnson syndrome | 1/371 (0.3%) | 0/371 (0%) | ||
Subcutaneous emphysema | 0/371 (0%) | 1/371 (0.3%) | ||
Vascular disorders | ||||
Aortic aneurysm | 1/371 (0.3%) | 2/371 (0.5%) | ||
Arteriosclerosis | 0/371 (0%) | 1/371 (0.3%) | ||
Circulatory collapse | 1/371 (0.3%) | 1/371 (0.3%) | ||
Deep vein thrombosis | 9/371 (2.4%) | 10/371 (2.7%) | ||
Embolism | 3/371 (0.8%) | 0/371 (0%) | ||
Embolism venous | 0/371 (0%) | 1/371 (0.3%) | ||
Haematoma | 0/371 (0%) | 1/371 (0.3%) | ||
Hypertension | 1/371 (0.3%) | 2/371 (0.5%) | ||
Hypotension | 6/371 (1.6%) | 2/371 (0.5%) | ||
Hypovolaemic shock | 1/371 (0.3%) | 0/371 (0%) | ||
Malignant hypertension | 1/371 (0.3%) | 0/371 (0%) | ||
Orthostatic hypotension | 1/371 (0.3%) | 0/371 (0%) | ||
Peripheral artery thrombosis | 0/371 (0%) | 1/371 (0.3%) | ||
Peripheral ischaemia | 0/371 (0%) | 1/371 (0.3%) | ||
Thrombophlebitis | 2/371 (0.5%) | 0/371 (0%) | ||
Thrombophlebitis superficial | 0/371 (0%) | 1/371 (0.3%) | ||
Thrombosis | 0/371 (0%) | 1/371 (0.3%) | ||
Venous thrombosis | 0/371 (0%) | 1/371 (0.3%) | ||
Other (Not Including Serious) Adverse Events |
||||
E-Ld Cohort | Ld Cohort | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 369/371 (99.5%) | 368/371 (99.2%) | ||
Blood and lymphatic system disorders | ||||
Anaemia | 151/371 (40.7%) | 159/371 (42.9%) | ||
Leukopenia | 23/371 (6.2%) | 37/371 (10%) | ||
Neutropenia | 94/371 (25.3%) | 117/371 (31.5%) | ||
Thrombocytopenia | 66/371 (17.8%) | 69/371 (18.6%) | ||
Cardiac disorders | ||||
Atrial fibrillation | 28/371 (7.5%) | 25/371 (6.7%) | ||
Eye disorders | ||||
Cataract | 61/371 (16.4%) | 56/371 (15.1%) | ||
Vision blurred | 28/371 (7.5%) | 28/371 (7.5%) | ||
Gastrointestinal disorders | ||||
Abdominal pain | 50/371 (13.5%) | 50/371 (13.5%) | ||
Abdominal pain upper | 33/371 (8.9%) | 29/371 (7.8%) | ||
Constipation | 141/371 (38%) | 144/371 (38.8%) | ||
Diarrhoea | 192/371 (51.8%) | 178/371 (48%) | ||
Dry mouth | 28/371 (7.5%) | 26/371 (7%) | ||
Dyspepsia | 43/371 (11.6%) | 30/371 (8.1%) | ||
Haemorrhoids | 9/371 (2.4%) | 19/371 (5.1%) | ||
Nausea | 117/371 (31.5%) | 107/371 (28.8%) | ||
Toothache | 24/371 (6.5%) | 15/371 (4%) | ||
Vomiting | 69/371 (18.6%) | 48/371 (12.9%) | ||
General disorders | ||||
Asthenia | 88/371 (23.7%) | 72/371 (19.4%) | ||
Chest pain | 24/371 (6.5%) | 32/371 (8.6%) | ||
Chills | 35/371 (9.4%) | 9/371 (2.4%) | ||
Fatigue | 182/371 (49.1%) | 186/371 (50.1%) | ||
Influenza like illness | 39/371 (10.5%) | 28/371 (7.5%) | ||
Mucosal inflammation | 21/371 (5.7%) | 7/371 (1.9%) | ||
Oedema | 17/371 (4.6%) | 20/371 (5.4%) | ||
Oedema peripheral | 162/371 (43.7%) | 181/371 (48.8%) | ||
Pain | 25/371 (6.7%) | 19/371 (5.1%) | ||
Peripheral swelling | 24/371 (6.5%) | 23/371 (6.2%) | ||
Pyrexia | 111/371 (29.9%) | 77/371 (20.8%) | ||
Infections and infestations | ||||
Bronchitis | 45/371 (12.1%) | 52/371 (14%) | ||
Cellulitis | 20/371 (5.4%) | 26/371 (7%) | ||
Cystitis | 13/371 (3.5%) | 19/371 (5.1%) | ||
Herpes zoster | 23/371 (6.2%) | 18/371 (4.9%) | ||
Influenza | 14/371 (3.8%) | 21/371 (5.7%) | ||
Nasopharyngitis | 60/371 (16.2%) | 62/371 (16.7%) | ||
Oral herpes | 23/371 (6.2%) | 11/371 (3%) | ||
Pneumonia | 33/371 (8.9%) | 23/371 (6.2%) | ||
Respiratory tract infection | 38/371 (10.2%) | 34/371 (9.2%) | ||
Sinusitis | 22/371 (5.9%) | 17/371 (4.6%) | ||
Upper respiratory tract infection | 81/371 (21.8%) | 83/371 (22.4%) | ||
Urinary tract infection | 58/371 (15.6%) | 56/371 (15.1%) | ||
Injury, poisoning and procedural complications | ||||
Contusion | 47/371 (12.7%) | 53/371 (14.3%) | ||
Fall | 30/371 (8.1%) | 32/371 (8.6%) | ||
Skin abrasion | 22/371 (5.9%) | 13/371 (3.5%) | ||
Skin laceration | 19/371 (5.1%) | 22/371 (5.9%) | ||
Investigations | ||||
Alanine aminotransferase increased | 18/371 (4.9%) | 27/371 (7.3%) | ||
Aspartate aminotransferase increased | 17/371 (4.6%) | 21/371 (5.7%) | ||
Blood creatinine increased | 54/371 (14.6%) | 72/371 (19.4%) | ||
Glomerular filtration rate decreased | 20/371 (5.4%) | 17/371 (4.6%) | ||
Neutrophil count decreased | 9/371 (2.4%) | 28/371 (7.5%) | ||
Platelet count decreased | 12/371 (3.2%) | 20/371 (5.4%) | ||
Weight decreased | 77/371 (20.8%) | 66/371 (17.8%) | ||
Metabolism and nutrition disorders | ||||
Decreased appetite | 100/371 (27%) | 85/371 (22.9%) | ||
Dehydration | 25/371 (6.7%) | 22/371 (5.9%) | ||
Hyperglycaemia | 120/371 (32.3%) | 69/371 (18.6%) | ||
Hypoalbuminaemia | 24/371 (6.5%) | 21/371 (5.7%) | ||
Hypocalcaemia | 73/371 (19.7%) | 75/371 (20.2%) | ||
Hypokalaemia | 84/371 (22.6%) | 90/371 (24.3%) | ||
Hypomagnesaemia | 40/371 (10.8%) | 23/371 (6.2%) | ||
Hyponatraemia | 27/371 (7.3%) | 17/371 (4.6%) | ||
Hypophosphataemia | 20/371 (5.4%) | 16/371 (4.3%) | ||
Musculoskeletal and connective tissue disorders | ||||
Arthralgia | 94/371 (25.3%) | 100/371 (27%) | ||
Back pain | 135/371 (36.4%) | 135/371 (36.4%) | ||
Bone pain | 58/371 (15.6%) | 56/371 (15.1%) | ||
Joint swelling | 19/371 (5.1%) | 16/371 (4.3%) | ||
Muscle spasms | 84/371 (22.6%) | 83/371 (22.4%) | ||
Muscular weakness | 45/371 (12.1%) | 52/371 (14%) | ||
Musculoskeletal chest pain | 49/371 (13.2%) | 48/371 (12.9%) | ||
Musculoskeletal pain | 70/371 (18.9%) | 65/371 (17.5%) | ||
Myalgia | 21/371 (5.7%) | 18/371 (4.9%) | ||
Neck pain | 30/371 (8.1%) | 38/371 (10.2%) | ||
Pain in extremity | 74/371 (19.9%) | 76/371 (20.5%) | ||
Pain in jaw | 19/371 (5.1%) | 12/371 (3.2%) | ||
Spinal pain | 14/371 (3.8%) | 21/371 (5.7%) | ||
Nervous system disorders | ||||
Dizziness | 83/371 (22.4%) | 66/371 (17.8%) | ||
Dysgeusia | 26/371 (7%) | 13/371 (3.5%) | ||
Headache | 61/371 (16.4%) | 49/371 (13.2%) | ||
Hypoaesthesia | 24/371 (6.5%) | 25/371 (6.7%) | ||
Memory impairment | 26/371 (7%) | 15/371 (4%) | ||
Neuropathy peripheral | 42/371 (11.3%) | 48/371 (12.9%) | ||
Paraesthesia | 39/371 (10.5%) | 45/371 (12.1%) | ||
Peripheral sensory neuropathy | 57/371 (15.4%) | 59/371 (15.9%) | ||
Syncope | 17/371 (4.6%) | 20/371 (5.4%) | ||
Taste disorder | 24/371 (6.5%) | 27/371 (7.3%) | ||
Tremor | 61/371 (16.4%) | 55/371 (14.8%) | ||
Psychiatric disorders | ||||
Agitation | 21/371 (5.7%) | 17/371 (4.6%) | ||
Anxiety | 44/371 (11.9%) | 28/371 (7.5%) | ||
Confusional state | 36/371 (9.7%) | 31/371 (8.4%) | ||
Depression | 41/371 (11.1%) | 31/371 (8.4%) | ||
Insomnia | 98/371 (26.4%) | 95/371 (25.6%) | ||
Mood altered | 25/371 (6.7%) | 17/371 (4.6%) | ||
Respiratory, thoracic and mediastinal disorders | ||||
Cough | 119/371 (32.1%) | 106/371 (28.6%) | ||
Dysphonia | 45/371 (12.1%) | 27/371 (7.3%) | ||
Dyspnoea | 87/371 (23.5%) | 93/371 (25.1%) | ||
Dyspnoea exertional | 24/371 (6.5%) | 18/371 (4.9%) | ||
Epistaxis | 27/371 (7.3%) | 18/371 (4.9%) | ||
Oropharyngeal pain | 25/371 (6.7%) | 26/371 (7%) | ||
Productive cough | 33/371 (8.9%) | 20/371 (5.4%) | ||
Skin and subcutaneous tissue disorders | ||||
Dry skin | 27/371 (7.3%) | 20/371 (5.4%) | ||
Erythema | 19/371 (5.1%) | 24/371 (6.5%) | ||
Hyperhidrosis | 35/371 (9.4%) | 26/371 (7%) | ||
Night sweats | 24/371 (6.5%) | 15/371 (4%) | ||
Pruritus | 40/371 (10.8%) | 44/371 (11.9%) | ||
Rash | 90/371 (24.3%) | 87/371 (23.5%) | ||
Skin lesion | 20/371 (5.4%) | 15/371 (4%) | ||
Vascular disorders | ||||
Deep vein thrombosis | 20/371 (5.4%) | 27/371 (7.3%) | ||
Flushing | 19/371 (5.1%) | 17/371 (4.6%) | ||
Hypertension | 53/371 (14.3%) | 44/371 (11.9%) | ||
Hypotension | 63/371 (17%) | 44/371 (11.9%) |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
Results Point of Contact
Name/Title | Bristol-Myers Squibb Study Director |
---|---|
Organization | Bristol-Myers Squibb |
Phone | Please email |
Clinical.Trials@bms.com |
- CA204-006
- 2010-022445-20