SOPRA: Selinexor (KPT-330) in Older Patients With Relapsed AML
Study Details
Study Description
Brief Summary
This is a randomized, multicenter, open-label, phase 2 study of the SINE compound, selinexor given orally versus specified investigator choices (one of three potential salvage therapies). Participants age ≥ 60 years with relapsed or refractory AML of any type except for AML M3, after one prior therapy only, who have never undergone and who are not currently eligible for stem cell transplantation and are currently deemed unfit for intensive chemotherapy.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
Phase 2 |
Detailed Description
This is a randomized, multicenter, open-label phase 2 study of the SINE compound, selinexor given orally versus restricted investigator choice (i.e., one of three potential salvage therapies).
Participants who have never been transplant eligible, are currently deemed unfit for intensive chemotherapy, ≥ 60 years old, who have AML (except Acute Promyelocytic Leukemia: APL, AML M3) after one prior treatment of either hypomethylating agent or a regimen including Ara-C, and are meeting the inclusion and exclusion criteria will be randomized to receive either oral selinexor or physician's choice (one of three potential treatments: best supportive care (BSC) alone, or BSC + hypomethylating agent, or BSC + low dose Ara-C until disease progression, death or intolerance has occurred.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Selinexor approximately 55 mg/m^2 (60 to 120 mg based on BSA) Participants under protocol versions (PV) less than (<) 5.0 (those who had one prior line of acute myeloid leukemia (AML) therapy), receive oral selinexor tablets at a dose of approximately 55 mg/m^2 (milligrams per square meter) (60 to 120 mg based on body surface area [BSA]) twice weekly, on Day 1 and 3 of each week of 4-week cycle (28 days per cycle). |
Drug: Selinexor
Selinexor oral tablet.
Other Names:
|
Experimental: Selinexor 60 mg (PV <5) (Equivalent to 35 mg/m^2) Participants under PV < 5.0 (those who had one prior line of AML therapy), receive oral selinexor tablets at a fixed dose of 60 mg (equivalent to 35 mg/m^2), based on BSA, twice weekly, on Day 1 and 3 of each week of 4-week cycle (28 days per cycle). |
Drug: Selinexor
Selinexor oral tablet.
Other Names:
|
Experimental: Selinexor 60 mg (PV >=5) (Equivalent to 35 mg/m^2) Participants under PV >= 5 (PV 5: those who had at least one prior line of AML therapy, PV 5.1: who had at least two prior line of AML therapy), receive oral selinexor tablets at a dose of 60 mg (equivalent to 35 mg/m^2) twice weekly, on Day 1 and 3 of each week of 4-week cycle (28 days per cycle). |
Drug: Selinexor
Selinexor oral tablet.
Other Names:
|
Active Comparator: Physician's Choice 1 (PV <5) Participants under PV < 5.0 (those who had one prior line of AML therapy) received Best Supportive Care (BSC) which included blood product transfusions, antimicrobials, growth factors as needed, and hydroxyurea. |
Drug: Hydroxyurea
Other Names:
|
Active Comparator: Physician's Choice 2 (PV >=5) Participants under PV >= 5 (PV 5: those who had at least one prior line of AML therapy, PV 5.1: who had at least two prior line of AML therapy), received BSC along with subcutaneous injection of arabinoside cytosine (Ara-C), 20 mg, twice daily, for 10 days, repeated at 28 to 42 day intervals. |
Drug: Ara-C
Ara-C Subcutaneous Injection.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Overall Survival [Baseline until disease progression or discontinuation from the study, or death, whichever occurred first (up to a maximum of approximately 104 weeks)]
Overall survival was defined as the time (in days) from the date of randomization to the date of death due to any cause. Participants last known to be alive were censored at date of last contact.
Secondary Outcome Measures
- Percentage of Participants With Overall Survival of at Least 3 Months (OS3.0) [From randomization (Day 1) up to 3 months]
Overall survival was defined as the time (in days) from the date of randomization to the date of death due to any cause. Participants last known to be alive were censored at date of last contact. Analysis was performed using Kaplan-Meier method.
- Percentage of Participants With Complete Remission Rate (CRR) for Those Who Achieved Complete Remission (CR) [Baseline until disease progression or discontinuation from the study, or death, whichever occurred first (up to a maximum of approximately 104 weeks)]
CRR was analyzed using International Working Group (IWG) 2003 criteria, as the difference in the proportions of participants with IWG results of CR. CR per IWG 2003 criteria was defined as morphologic presence of < 5 percentage (%) myeloblasts in bone marrow, the absence of circulating blasts, hematologic recovery (as evidenced by a peripheral blood absolute neutrophil count (ANC) > 1000 cells/microliter (microL) and platelet count > 100,000/microL, with no need for red blood cell (RBC) transfusions), and the absence of extramedullary disease.
- Median Disease-Free Survival (DFS) for Participants Who Achieved Complete Remission (CR) [Baseline until disease progression or discontinuation from the study, or death, whichever occurred first (up to a maximum of approximately 104 weeks)]
DFS for CRR based on IWG criteria, was calculated from the first date of response of CR to the date of progression or recurrence, or date of death if progression or recurrence did not occur. Participants who discontinued prior to disease progression or recurrence or did not progress as of the time of the analysis were censored at the time of last radiologic assessment. CR per IWG 2003 criteria was defined as morphologic presence of < 5 % myeloblasts in bone marrow, the absence of circulating blasts, hematologic recovery (as evidenced by a peripheral blood ANC > 1000 cells/microL and platelet count > 100,000/microL, with no need for RBC transfusions), and the absence of extramedullary disease.
- Percentage of Participants With Modified Complete Remission Rate (mCRR) for Those Who Achieved Complete Remission (CR) or Complete Remission With Incomplete Hematologic Recovery (Cri) [Baseline until disease progression or discontinuation from the study, or death, whichever occurred first (up to a maximum of approximately 104 weeks)]
mCRR was defined as the point estimate of the percentage of participants who had CR, CRi, or CRp. Responses defined as per IWG 2003 response criteria: Morphologic CR:< 5% myeloblasts in bone marrow, the absence of circulating blasts, hematologic recovery (as evidenced by a peripheral blood ANC > 1000 cells/microL and platelet count > 100,000/microL, with no need for RBC transfusions), and the absence of extramedullary disease. Morphologic CRp: All criteria for CR except for residual neutropenia (<1x10^9/L) or thrombocytopenia (<100 x10^9/L), Cri (< 5% bone marrow blasts with residual neutropenia [ANC < 1000 cells/microL] or thrombocytopenia [platelets < 100,000/microL]), normal maturation of all cellular components in the bone marrow, no extramedullary disease and transfusion independent.
- Median Disease-Free Survival (DFS) for Participants Who Achieved Complete Remission or CR With Incomplete Hematologic Recovery (CRi) or Complete Remission With Incomplete Platelet Recovery (CRp) [Baseline until disease progression or discontinuation from the study, or death, whichever occurred first (up to a maximum of approximately 104 weeks)]
DFS based on IWG criteria was defined as the duration from start of the complete response achieved until disease progression or death from any cause. Responses defined by IWG 2003 Response Criteria: Morphologic CR: < 5% myeloblasts in bone marrow, the absence of circulating blasts, hematologic recovery (as evidenced by a peripheral blood ANC > 1000 cells/microL and platelet count > 100,000/microL, with no need for RBC transfusions), and the absence of extramedullary disease. Morphologic CRp: All criteria for CR except for residual neutropenia (<1x10^9/L) or thrombocytopenia (<100 x10^9/L), Cri (< 5% bone marrow blasts with residual neutropenia [ANC < 1000 cells/microL] or thrombocytopenia [platelets < 100,000/microL]), normal maturation of all cellular components in the bone marrow, no extramedullary disease and transfusion independent.
- Percentage of Participants With Overall Response Rate (ORR) [Baseline until disease progression or discontinuation from the study, or death, whichever occurred first (up to a maximum of approximately 104 weeks)]
Overall response rate was defined as the point estimate of the percentage of participants who achieved CR (disappearance of all target and non-target lesions), partial response (PR) (>=30 % decrease in sum of longest diameters of target lesions taking as reference baseline sum longest diameters associated to non-progressive disease response for non-target lesions). CRi; < 5% BM blasts with residual neutropenia [ANC < 1000 cells/microL] or thrombocytopenia [platelets < 100,000/microL]. CRp; All criteria for CR except for residual neutropenia (<1x10^9/L) or thrombocytopenia (<100 x10^9/L) and morphologic leukemia-free state (MLFS); morphologic BM blast clearance to <5% in a marrow sample in which <=200 cells enumerated or cellularity is ≥10%, in absence of blasts with Auer rods, no hematologic recovery required.
- Duration of Response (DOR) [Baseline until disease progression or discontinuation from the study, or death, whichever occurred first (up to a maximum of approximately 104 weeks)]
DOR was calculated from date of response of CR, CRi, CRp, MLFS, or PR to date of progression or recurrence based on IWG criteria. CR: <5% myeloblasts in bone marrow,absence of circulating blasts, hematologic recovery (peripheral blood ANC >1000 cells/microL, platelet count > 100,000/microL, no need for RBC transfusions), absence of extramedullary disease. PR: No circulating blasts, neutrophil count > =1.0 x10^9/L, platelet count >= 100 x10^9/L, >= 50 % reduction in bone marrow blast to 6% to 25%, or blasts less than or equal to (<=) 5% if Auer rods are present. CRp: All criteria for CR except for residual neutropenia (<1x10^9/L) or thrombocytopenia (<100 x10^9/L), CRi; < 5% bone marrow blasts with residual neutropenia [ANC < 1000 cells/microL] or thrombocytopenia [platelets < 100,000/microL]. MLFS: morphologic bone marrow blast clearance to < 5% in marrow sample, <= 200 cells enumerated/cellularity is ≥ 10%, in absence of blasts with Auer rods, no hematologic recovery required.
- Percentage of Participants With Disease Control Rate (DCR) [Up to 4 weeks from the date of randomization to the date of progression or recurrence based on IWG criteria]
DCR:Point estimate of % of participants with CR,CRi,CRp,MLFS,PR, or SD for <=4 weeks.CR:<5% myeloblasts in bone marrow (BM),absence of circulating blasts,hematologic recovery(peripheral blood ANC >1000 cells/microL and platelet count >100,000/microL, no need of RBC transfusions),absence of extramedullary disease. PR:No circulating blasts,Neutrophil count >=1.0 x10^9/L, Platelet count >= 100*10^9/L, >=50% reduction in BM blast to 6% to 25%, or blasts <=5% if Auer rods are present.CRp:All criteria for CR except for residual neutropenia (<1*10^9/L) or thrombocytopenia(<100 x10^9/L),CRi;< 5% BM blasts with residual neutropenia [ANC < 1000 cells/microL] or thrombocytopenia [platelets < 100,000/microL]. MLFS:morphologic BM blast clearance to <5% in a marrow sample in which <=200 cells enumerated or cellularity is ≥10%,in absence of blasts with Auer rods,no hematologic recovery required,SD:failure to achieve a response but not meeting criteria for disease progression over period of >4 weeks.
- Duration of Disease Control Rate [Up to 4 weeks from the date of randomization to the date of progression or recurrence based on IWG criteria]
Duration of DCR calculated for all participants with DCR. CR: < 5% myeloblasts in BM, absence of circulating blasts, hematologic recovery (peripheral blood ANC >1000 cells/microL and platelet count > 100,000/microL, no need for RBC transfusions), absence of extra medullary disease. PR: No circulating blasts, Neutrophil count >=1.0 x 10^9/L, Platelet count >= 100 x 10^9/L, >= 50 % reduction in BM blast to 6% to 25%, or blasts <= 5% if Auer rods are present. CRp: All criteria for CR except for residual neutropenia (<1 x 10^9/L) or thrombocytopenia (<100 x 10^9/L), CRi; < 5% BM blasts with residual neutropenia [ANC < 1000 cells/microL] or thrombocytopenia [platelets < 100,000/microL]. MLFS; morphologic BM blast clearance to < 5% in a marrow sample in which <=200 cells enumerated/cellularity is >= 10%, in absence of blasts with Auer rods, no hematologic recovery required and SD; failure to achieve a response but not meeting criteria for disease progression over period of > 4 weeks.
- Change From Baseline in Quality of Life (QoL) and Patient-Reported Outcomes (Functional Assessment of Cancer Therapy -Leukemia [FACT-Leu] [Baseline, Day 1 of each treatment cycle (a maximum of 20 cycles: 28 days per cycle) up to 30 days after last dose of study drug (final visit)]
QoL was assessed by the FACT-Leu. FACT-Leu combines the General version of the Functional Assessment of Cancer Therapy (FACT-G) with a leukemia-specific sub-scale (17 items). The sub-scales for the FACT-G are Physical Well-Being (7 items), Social/Family Well-Being (7 items), Emotional Well-Being (6 items), and Functional Well-Being (7 items). The trial outcomes index (TOI; total of 31 items) was the primary measurement of interest, comprising the Physical and Functional sub-scales plus the leukemia - specific sub-scale. Each item was rated on a 5-point Likert scale. Range from 0 = (Not at all) to 4 = (Very much); therefore, the TOI had a score ranging from 0 to 124. Higher scores indicated improvement in well being. The QoL assessment was performed at baseline (prior to first dose of study treatment), Day 1 of each cycle on or after the second, and at the final visit.
- Change From Baseline in European Quality of Life-5 Dimension (EQ-5D) Health Questionnaire Visual Analogue Scale (VAS) [Baseline, Day 1 of each treatment cycle (a maximum of 20 cycles: 28 days per cycle) up to 30 days after last dose of study drug (final visit)]
EQ-5D descriptive system comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems, and 5=extreme problems. EQ-5D-5L is a standardized instrument that measures health-related quality of life for men with prostate cancer. EQ-5D consists of EQ-5D descriptive system and EQ VAS. EQ-5D-5-VAS records participant's self-rated health on a vertical VAS that allows them to indicate their health state that can range from 0 (worst imaginable) to 100 (best imaginable), higher scores indicating a better health state.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Age ≥ 60 years with relapsed or refractory AML of any type except for acute promyelocytic leukemia (APL; AML M3), after at least 1 prior AML therapy , who have never undergone, and who are not currently eligible for, stem cell transplantation, and are currently deemed unfit for intensive chemotherapy.
-
Eastern Cooperative Oncology Group (ECOG) ≤ 2.
-
Must have available archival or recently acquired bone marrow biopsy/aspiration or tumor tissue for central review to be eligible.
-
Relapsed or refractory AML, defined as either: recurrence of disease after a complete remission (CR), or failure to achieve CR with initial therapy.
-
Must have received at least 1 prior line of AML therapy given at standard doses and must have progressed after their most recent therapy. Prior therapy must have included: a hypomethylating agent with at least 2 cycles.
-
At least 2 weeks must have elapsed since the last anti-leukemia treatment (with the exception of hydroxyurea) before first dose in this study.
Exclusion Criteria:
-
Treatment with any investigational agent within 3 weeks prior to first dose in this study.
-
Presence of central nervous system (CNS) leukemia.
-
In blast transformation of chronic myeloid leukemia (CML). Prior myelodysplastic syndrome (MDS) is acceptable; prior treatment for MDS does not count as an AML therapy.
-
Major surgery within 2 weeks of first dose of study drug. Participants must have recovered from the effects of any surgery performed greater than 2 weeks previously.
-
Concurrent active malignancy under treatment.
-
Known active hepatitis B virus (HBV) or C virus (HCV) infection; or known to be positive for HCV ribonucleic acid (RNA) or HBsAg (HBV surface antigen).
-
Known HIV infection.
-
Unable to swallow tablets, or participants with malabsorption syndrome, or any other disease significantly affecting gastrointestinal function.
-
Participants whose AML is classified as favorable according to the European LeukemiaNet (ELN) disease risk assessment.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Jonsson Comprehensive Cancer Center / University of California, Los Angeles | Los Angeles | California | United States | 90024 |
2 | Sutter Oncology & Hematology | Sacramento | California | United States | 95816 |
3 | Stanford Cancer Institute / Stanford University | Stanford | California | United States | 94304 |
4 | Colorado Blood Cancer Institute/Sarah Cannon Research Institute | Denver | Colorado | United States | 80218 |
5 | Yale Cancer Center / Yale University | New Haven | Connecticut | United States | 06510 |
6 | H. Lee Moffitt Cancer Center and Research Institute | Tampa | Florida | United States | 33612 |
7 | Winship Cancer Institute / Emory University | Atlanta | Georgia | United States | 30322 |
8 | Northwestern University | Chicago | Illinois | United States | 60611 |
9 | University of Chicago Medicine | Chicago | Illinois | United States | 60637 |
10 | University of Kansas Hospital | Kansas City | Kansas | United States | 66160 |
11 | Sidney Kimmel Comprehensive Cancer Center / John Hopkins University | Baltimore | Maryland | United States | 21287 |
12 | University of Massachusetts Medical School | Worcester | Massachusetts | United States | 01655 |
13 | University of Michigan Comprehensive Cancer Center | Ann Arbor | Michigan | United States | 48109-0944 |
14 | Hackensack University Medical Center | Hackensack | New Jersey | United States | 07601 |
15 | Roswell Park Cancer Institute | Buffalo | New York | United States | 14263 |
16 | Westchester Medical Center / New York Medical College | Hawthorne | New York | United States | 10532 |
17 | Memorial Sloan Kettering Cancer Center | New York | New York | United States | 10065 |
18 | New York Presbyterian Hospital / Weill Cornell Medical College | New York | New York | United States | 10065 |
19 | Duke Cancer Care | Durham | North Carolina | United States | 27705 |
20 | Gabrail Cancer Center | Canton | Ohio | United States | 44718 |
21 | Ohio State University Comprehensive Cancer Center | Columbus | Ohio | United States | 43210 |
22 | Milton S. Hershey Medical Center / Penn State | Hershey | Pennsylvania | United States | 17033 |
23 | Tennessee Oncology/Sarah Cannon Research Institute | Nashville | Tennessee | United States | 37203 |
24 | Vanderbilt-Ingram Cancer Center / Vanderbilt University | Nashville | Tennessee | United States | 37215 |
25 | MD Anderson Cancer Center / University of Texas | Houston | Texas | United States | 77030 |
26 | Texas Transplant Institute/Sarah Cannon Research Institute | San Antonio | Texas | United States | 78229 |
27 | Tom Baker Cancer Centre | Calgary | Alberta | Canada | T2N 4N2 |
28 | University of Alberta | Edmonton | Alberta | Canada | T6G 2G3 |
29 | Sir Mortimer B. Davis Jewish General Hospital / McGill University | Montreal | Quebec | Canada | H2W1S6 |
30 | Aarhus University Hospital | Aarhus | Denmark | ||
31 | Department of Haematology, National University Hospital, Rigshospitalet | Copenhagen | Denmark | ||
32 | Herlev Hospital | Herlev | Denmark | ||
33 | Odense University Hospital, Department of Hematology | Odense | Denmark | ||
34 | CHU Bordeaux- Hôpital Haut Lévêque | Bordeaux | France | ||
35 | Centre Hospitalier Lyon | Lyon | France | ||
36 | Hopital Saint Louis | Paris | France | ||
37 | Hôpital Avicenne | Paris | France | ||
38 | Institut Universitaire du Cancer Toulouse | Toulouse | France | ||
39 | Stellvertretende Klinikleiterin Charité, Campus Benjamin Franklin | Berlin | Germany | 12203 | |
40 | Ev. Diakonie-Krankenhaus Gemeinnutzige GMBH Medizinische Klinik 2 | Bremen | Germany | ||
41 | UNIVERSITÄTSKLINIKUM TU DRESDEN Medizinische Klinik und Poliklinik I, | Dresden | Germany | ||
42 | University Hospital Frankfurt | Frankfurt | Germany | ||
43 | Medizinische Hochschule Hannover (Hannover Medical School) Dept. of Hematology, Hemostasis, Oncology, and Stem Cell Transplantation | Hanover | Germany | ||
44 | Abteilung Hämatologie, internistische Onkologie und Hämostaseologie | Leipzig | Germany | ||
45 | UNIVERSITY HOSPITAL OF MÜNSTER Medizinische Klinik und Poliklinik A, Universitätsklinikum Münster | Münster | Germany | ||
46 | Universitätsklinikum Ulm | ULM | Germany | ||
47 | Sororka MC | Beer Sheva | Israel | 85025 | |
48 | Rambam Health Care Campus | Haifa | Israel | 3109601 | |
49 | Wolfson Medical Center | Holon | Israel | ||
50 | Hadassah Medical Center | Jerusalem | Israel | 91120 | |
51 | Rabin Medical Center | Petach Tikva | Israel | 4941492 | |
52 | Tel Aviv Sourasky Medical Centre | Tel Aviv | Israel | ||
53 | Chaim Sheba Medical Center | Tel Hashomer | Israel | 52621 | |
54 | AOU Ospedali Riuniti di Ancona | Ancona | Italy | ||
55 | A.O Spedali Civili di Brescia | Brescia | Italy | ||
56 | AORN Cardarelli / UOSC di Ematologia con TMO | Naples | Italy | ||
57 | AMC, Academisch Medisch Centrum Afdeling Klinische Hematologie | Amsterdam | Netherlands | ||
58 | VU University Medical Center | Amsterdam | Netherlands | ||
59 | Universitair Medisch Centrum Groningen Department of Haematology | Groningen | Netherlands | ||
60 | Radboud University Medical Center Department of Haematology (476) | Nijmegen | Netherlands | ||
61 | Erasmus MC, location Daniel den Hoed | Rotterdam | Netherlands | ||
62 | University Medical Center Utrecht | Utrecht | Netherlands | ||
63 | Isala Kliniecken Zwolle | Zwolle | Netherlands | ||
64 | Wojewódzki Szpital Specjalistyczny im. M. Kopernika, Klinika Hematologii | Lodz | Poland | ||
65 | Samodzielny Publiczny Zakład Opieki Zdrowotnej Ministerstwa Spraw Wewnętrznych | Olsztyn | Poland | ||
66 | Instytut Hematologii i Transfuzjologii | Warszawa | Poland | ||
67 | Samodzielny Publiczny Szpital Kliniczny Nr 1 we Wrocławiu | Wroclaw | Poland | ||
68 | ICO Badalona | Badalona | Spain | 08916 | |
69 | Hospital del Mar | Barcelona | Spain | ||
70 | Hospital Universitario de Salamanca Servicio de Hematologia | Salamanca | Spain | ||
71 | Hospital Universitario y Politécnico La Fe | Valencia | Spain | ||
72 | Northwick Park Hospital | Harrow | England | United Kingdom | HA1 3UJ |
73 | Royal Liverpool University Hospital, Dept of Cellular and Molecular Physiology, Molecular and Clinical Cancer Medicine | Liverpool | Lancashire | United Kingdom | L7 8XP |
74 | Royal Marsden NHS Trust | Sutton | Surrey | United Kingdom | SM2 5PT |
75 | University Hospital Wales | Cardiff | Wales | United Kingdom | CF14 4XW |
76 | Hull and East Yorkshire Hospitals NHS Trust Queens Centre for Oncology and Haematology | Hull | Yorkshire | United Kingdom | HU3 2JZ |
77 | Ninewells Hospital and Medical School NHS Tayside | Dundee | United Kingdom | DD1 9SY | |
78 | Plymouth Hospitals NHS Trust/Derriford Hospital | Plymouth | United Kingdom |
Sponsors and Collaborators
- Karyopharm Therapeutics Inc
Investigators
- Study Director: Michael Kauffman, MD, PhD, Karyopharm Therapeutics Inc
Study Documents (Full-Text)
More Information
Publications
None provided.- KCP-330-008
Study Results
Participant Flow
Recruitment Details | |
---|---|
Pre-assignment Detail |
Arm/Group Title | Selinexor Approximately 55 mg/m^2 (60 to 120 mg Based on BSA) | Selinexor 60 mg (PV <5) (Equivalent to 35 mg/m^2) | Selinexor 60 mg (PV >=5) (Equivalent to 35 mg/m^2) | Physician's Choice 1 (PV <5) | Physician's Choice 2 (PV >=5) |
---|---|---|---|---|---|
Arm/Group Description | Participants under protocol versions (PV) less than (<) 5.0 (those who had one prior line of acute myeloid leukemia (AML) therapy), received oral selinexor tablets at a dose of approximately 55 mg/m^2 (milligrams per square meter) (60 to 120 mg based on body surface area [BSA]) twice weekly, on Day 1 and 3 of each week of 4-week cycle (28 days per cycle). | Participants under PV < 5.0 (those who had one prior line of AML therapy), received oral selinexor tablets at a fixed dose of 60 mg (equivalent to 35 mg/m^2), twice weekly, on Day 1 and 3 of each week of 4-week cycle (28 days per cycle). | Participants under PV greater than or equal to (>=) 5 (PV 5: those who had at least one prior line of AML therapy, PV 5.1: who had at least two prior line of AML therapy), received oral selinexor tablets at a dose of 60 mg (equivalent to 35 mg/m^2) twice weekly, on Day 1 and 3 of each week of 4-week cycle (28 days per cycle). | Participants under PV < 5.0 (those who had one prior line of AML therapy) received Best Supportive Care (BSC) which included blood product transfusions, antimicrobials, growth factors as needed, and hydroxyurea. | Participants under PV>= 5 (PV 5: those who had at least one prior line of AML therapy, PV 5.1: who had at least two prior line of AML therapy), received BSC along with subcutaneous injection of arabinoside cytosine (Ara-C), 20 mg, twice daily, for 10 days, repeated at 28 to 42 day intervals. |
Period Title: Overall Study | |||||
STARTED | 71 | 27 | 117 | 44 | 58 |
Safety Population | 71 | 27 | 115 | 39 | 45 |
Intent-to-treat (ITT) Population | 0 | 0 | 118 | 0 | 57 |
COMPLETED | 0 | 0 | 0 | 0 | 0 |
NOT COMPLETED | 71 | 27 | 117 | 44 | 58 |
Baseline Characteristics
Arm/Group Title | Selinexor Approximately 55 mg/m^2 (60 to 120 mg Based on BSA) | Selinexor 60 mg (PV<5) (Equivalent to 35 mg/m^2) | Selinexor 60 mg (PV >=5) (Equivalent to 35 mg/m^2) | Physician's Choice 1 (PV <5) | Physician's Choice 2 (PV >=5) | Total |
---|---|---|---|---|---|---|
Arm/Group Description | Participants under PV < 5.0 (those who had one prior line of AML therapy), received oral selinexor tablets at a dose of approximately 55 mg/m^2 (60 to 120 mg based on BSA) twice weekly, on Day 1 and 3 of each week of 4-week cycle (28 days per cycle). | Participants under PV < 5.0 (those who had one prior line of AML therapy), received oral selinexor tablets at a fixed dose of 60 mg (equivalent to 35 mg/m^2), based on BSA, twice weekly, on Day 1 and 3 of each week of 4-week cycle (28 days per cycle). | Participants under PV >= 5 (PV 5: those who had at least one prior line of AML therapy, PV 5.1: who had at least two prior line of AML therapy), received oral selinexor tablets at a dose of 60 mg (equivalent to 35 mg/m^2) twice weekly, on Day 1 and 3 of each week of 4-week cycle (28 days per cycle). | Participants under PV < 5.0 (those who had one prior line of AML therapy) received Best Supportive Care (BSC) which included blood product transfusions, antimicrobials, growth factors as needed, and hydroxyurea. | Participants under PV>= 5 (PV 5: those who had at least one prior line of AML therapy, PV 5.1: who had at least two prior line of AML therapy), received BSC along with subcutaneous injection of arabinoside cytosine (Ara-C), 20 mg, twice daily, for 10 days, repeated at 28 to 42 day intervals. | Total of all reporting groups |
Overall Participants | 71 | 27 | 115 | 39 | 45 | 297 |
Age (years) [Mean (Standard Deviation) ] | ||||||
Mean (Standard Deviation) [years] |
72.4
(6.49)
|
73.2
(4.64)
|
73.6
(5.99)
|
72.6
(5.24)
|
74.2
(5.92)
|
73.2
(5.90)
|
Sex: Female, Male (Count of Participants) | ||||||
Female |
26
36.6%
|
11
40.7%
|
46
40%
|
17
43.6%
|
15
33.3%
|
115
38.7%
|
Male |
45
63.4%
|
16
59.3%
|
69
60%
|
22
56.4%
|
30
66.7%
|
182
61.3%
|
Ethnicity (NIH/OMB) (Count of Participants) | ||||||
Hispanic or Latino |
4
5.6%
|
3
11.1%
|
9
7.8%
|
4
10.3%
|
6
13.3%
|
26
8.8%
|
Not Hispanic or Latino |
65
91.5%
|
23
85.2%
|
93
80.9%
|
34
87.2%
|
31
68.9%
|
246
82.8%
|
Unknown or Not Reported |
2
2.8%
|
1
3.7%
|
13
11.3%
|
1
2.6%
|
8
17.8%
|
25
8.4%
|
Race/Ethnicity, Customized (Count of Participants) [Number] | ||||||
White |
67
94.4%
|
22
81.5%
|
95
82.6%
|
39
100%
|
37
82.2%
|
260
87.5%
|
Black or African American |
3
4.2%
|
1
3.7%
|
3
2.6%
|
0
0%
|
0
0%
|
7
2.4%
|
Asian |
0
0%
|
2
7.4%
|
0
0%
|
0
0%
|
0
0%
|
2
0.7%
|
Other |
0
0%
|
1
3.7%
|
15
13%
|
0
0%
|
6
13.3%
|
22
7.4%
|
Unknown |
1
1.4%
|
1
3.7%
|
2
1.7%
|
0
0%
|
2
4.4%
|
6
2%
|
Outcome Measures
Title | Overall Survival |
---|---|
Description | Overall survival was defined as the time (in days) from the date of randomization to the date of death due to any cause. Participants last known to be alive were censored at date of last contact. |
Time Frame | Baseline until disease progression or discontinuation from the study, or death, whichever occurred first (up to a maximum of approximately 104 weeks) |
Outcome Measure Data
Analysis Population Description |
---|
Intent-to-treat (ITT) population included all participants who were randomized to study treatment under PV>=5.0, regardless of whether or not they received study treatment. One participant was randomized to receive selinexor 60 mg (PV>=5) but was treated with physician's choice 2. Hence, this participant was counted under selinexor 60 mg (PV>=5). |
Arm/Group Title | Selinexor 60 mg (PV >=5) (Equivalent to 35 mg/m^2) | Physician's Choice 2 (PV >=5) |
---|---|---|
Arm/Group Description | Participants under PV >=5 (PV 5: those who had at least one prior line of AML therapy, PV 5.1: who had at least two prior line of AML therapy), received oral selinexor tablets at a dose of 60 mg (equivalent to 35 mg/m^2) twice weekly, on Day 1 and 3 of each week of 4- week cycle (28 days per cycle). | Participants under PV >= 5 (PV 5: those who had at least one prior line of AML therapy, PV 5.1: who had at least two prior line of AML therapy), received BSC along with subcutaneous injection of arabinoside cytosine (Ara-C), 20 mg, twice daily, for 10 days, repeated at 28 to 42 day intervals. |
Measure Participants | 118 | 57 |
Median (95% Confidence Interval) [Days] |
94.0
|
170.0
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Selinexor 60 mg (PV >=5) (Equivalent to 35 mg/m^2), Physician's Choice 2 (PV >=5) |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.4221 |
Comments | ||
Method | Log Rank | |
Comments | ||
Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
Estimated Value | 1.18 | |
Confidence Interval |
(2-Sided) 95% 0.79 to 1.75 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Title | Percentage of Participants With Overall Survival of at Least 3 Months (OS3.0) |
---|---|
Description | Overall survival was defined as the time (in days) from the date of randomization to the date of death due to any cause. Participants last known to be alive were censored at date of last contact. Analysis was performed using Kaplan-Meier method. |
Time Frame | From randomization (Day 1) up to 3 months |
Outcome Measure Data
Analysis Population Description |
---|
ITT population included all participants who were randomized to study treatment under PV >=5.0, regardless of whether or not they received study treatment. One participant was randomized to receive selinexor 60 mg (PV>=5) but was treated with physician's choice 2. Hence, this participant was counted under selinexor 60 mg (PV>=5). |
Arm/Group Title | Selinexor 60 mg (PV >=5) (Equivalent to 35 mg/m^2) | Physician's Choice 2 (PV >=5) |
---|---|---|
Arm/Group Description | Participants under PV >=5 (PV 5: those who had at least one prior line of AML therapy, PV 5.1: who had at least two prior line of AML therapy), received oral selinexor tablets at a dose of 60 mg (equivalent to 35 mg/m^2) twice weekly, on Day 1 and 3 of each week of 4- week cycle (28 days per cycle). | Participants under PV >= 5 (PV 5: those who had at least one prior line of AML therapy, PV 5.1: who had at least two prior line of AML therapy), received BSC along with subcutaneous injection of arabinoside cytosine (Ara-C), 20 mg, twice daily, for 10 days, repeated at 28 to 42 day intervals. |
Measure Participants | 118 | 57 |
Number (95% Confidence Interval) [Percentage of participants] |
53.49
75.3%
|
70.73
262%
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Selinexor 60 mg (PV >=5) (Equivalent to 35 mg/m^2), Physician's Choice 2 (PV >=5) |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.9464 |
Comments | ||
Method | Log Rank | |
Comments |
Title | Percentage of Participants With Complete Remission Rate (CRR) for Those Who Achieved Complete Remission (CR) |
---|---|
Description | CRR was analyzed using International Working Group (IWG) 2003 criteria, as the difference in the proportions of participants with IWG results of CR. CR per IWG 2003 criteria was defined as morphologic presence of < 5 percentage (%) myeloblasts in bone marrow, the absence of circulating blasts, hematologic recovery (as evidenced by a peripheral blood absolute neutrophil count (ANC) > 1000 cells/microliter (microL) and platelet count > 100,000/microL, with no need for red blood cell (RBC) transfusions), and the absence of extramedullary disease. |
Time Frame | Baseline until disease progression or discontinuation from the study, or death, whichever occurred first (up to a maximum of approximately 104 weeks) |
Outcome Measure Data
Analysis Population Description |
---|
ITT population included all participants who were randomized to study treatment under PV>=5.0, regardless of whether or not they received study treatment. One participant was randomized to receive selinexor 60 mg (PV>=5) but was treated with physician's choice 2. Hence, this participant was counted under selinexor 60 mg (PV>=5). |
Arm/Group Title | Selinexor 60 mg (PV >=5) (Equivalent to 35 mg/m^2) | Physician's Choice 2 (PV >=5) |
---|---|---|
Arm/Group Description | Participants under PV >=5 (PV 5: those who had at least one prior line of AML therapy, PV 5.1: who had at least two prior line of AML therapy), received oral selinexor tablets at a dose of 60 mg (equivalent to 35 mg/m^2) twice weekly, on Day 1 and 3 of each week of 4- week cycle (28 days per cycle). | Participants under PV >= 5 (PV 5: those who had at least one prior line of AML therapy, PV 5.1: who had at least two prior line of AML therapy), received BSC along with subcutaneous injection of arabinoside cytosine (Ara-C), 20 mg, twice daily, for 10 days, repeated at 28 to 42 day intervals. |
Measure Participants | 118 | 57 |
Number (95% Confidence Interval) [Percentage of participants] |
5.1
7.2%
|
0
0%
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Selinexor 60 mg (PV >=5) (Equivalent to 35 mg/m^2), Physician's Choice 2 (PV >=5) |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.0986 |
Comments | ||
Method | Cochran-Mantel-Haenszel | |
Comments |
Title | Median Disease-Free Survival (DFS) for Participants Who Achieved Complete Remission (CR) |
---|---|
Description | DFS for CRR based on IWG criteria, was calculated from the first date of response of CR to the date of progression or recurrence, or date of death if progression or recurrence did not occur. Participants who discontinued prior to disease progression or recurrence or did not progress as of the time of the analysis were censored at the time of last radiologic assessment. CR per IWG 2003 criteria was defined as morphologic presence of < 5 % myeloblasts in bone marrow, the absence of circulating blasts, hematologic recovery (as evidenced by a peripheral blood ANC > 1000 cells/microL and platelet count > 100,000/microL, with no need for RBC transfusions), and the absence of extramedullary disease. |
Time Frame | Baseline until disease progression or discontinuation from the study, or death, whichever occurred first (up to a maximum of approximately 104 weeks) |
Outcome Measure Data
Analysis Population Description |
---|
ITT population:all participants who randomized to study treatment under PV>=5.0, regardless of whether or not they received study treatment. This outcome measure(OM) was only defined for CR participants. For Physician Choice 2,there was zero CR participants."Overall Number of Participants Analyzed (N)": Number of participants evaluable for this OM. |
Arm/Group Title | Selinexor 60 mg (PV >=5) (Equivalent to 35 mg/m^2) | Physician's Choice 2 (PV >=5) |
---|---|---|
Arm/Group Description | Participants under PV >=5, received oral selinexor tablets at a dose of 60 mg (equivalent to 35 mg/m^2) twice weekly, on Day 1 and 3 of each week of 4-week cycle (28 days per cycle). | Participants under PV >= 5 (PV 5: those who had at least one prior line of AML therapy, PV 5.1: who had at least two prior line of AML therapy), received BSC along with subcutaneous injection of arabinoside cytosine (Ara-C), 20 mg, twice daily, for 10 days, repeated at 28 to 42 day intervals. |
Measure Participants | 6 | 0 |
Median (95% Confidence Interval) [Days] |
121.0
|
Title | Percentage of Participants With Modified Complete Remission Rate (mCRR) for Those Who Achieved Complete Remission (CR) or Complete Remission With Incomplete Hematologic Recovery (Cri) |
---|---|
Description | mCRR was defined as the point estimate of the percentage of participants who had CR, CRi, or CRp. Responses defined as per IWG 2003 response criteria: Morphologic CR:< 5% myeloblasts in bone marrow, the absence of circulating blasts, hematologic recovery (as evidenced by a peripheral blood ANC > 1000 cells/microL and platelet count > 100,000/microL, with no need for RBC transfusions), and the absence of extramedullary disease. Morphologic CRp: All criteria for CR except for residual neutropenia (<1x10^9/L) or thrombocytopenia (<100 x10^9/L), Cri (< 5% bone marrow blasts with residual neutropenia [ANC < 1000 cells/microL] or thrombocytopenia [platelets < 100,000/microL]), normal maturation of all cellular components in the bone marrow, no extramedullary disease and transfusion independent. |
Time Frame | Baseline until disease progression or discontinuation from the study, or death, whichever occurred first (up to a maximum of approximately 104 weeks) |
Outcome Measure Data
Analysis Population Description |
---|
ITT population included all participants who were randomized to study treatment under PV>=5.0, regardless of whether or not they received study treatment. One participant was randomized to receive selinexor 60 mg (PV>=5) but was treated with physician's choice 2. Hence, this participant was counted under selinexor 60 mg (PV>=5). |
Arm/Group Title | Selinexor 60 mg (PV >=5) (Equivalent to 35 mg/m^2) | Physician's Choice 2 (PV >=5) |
---|---|---|
Arm/Group Description | Participants under PV >=5 (PV 5: those who had at least one prior line of AML therapy, PV 5.1: who had at least two prior line of AML therapy), received oral selinexor tablets at a dose of 60 mg (equivalent to 35 mg/m^2) twice weekly, on Day 1 and 3 of each week of 4- week cycle (28 days per cycle). | Participants under PV >= 5 (PV 5: those who had at least one prior line of AML therapy, PV 5.1: who had at least two prior line of AML therapy), received BSC along with subcutaneous injection of arabinoside cytosine (Ara-C), 20 mg, twice daily, for 10 days, repeated at 28 to 42 day intervals. |
Measure Participants | 118 | 57 |
Number (95% Confidence Interval) [Percentage of participants] |
11.9
16.8%
|
3.5
13%
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Selinexor 60 mg (PV >=5) (Equivalent to 35 mg/m^2), Physician's Choice 2 (PV >=5) |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.0844 |
Comments | ||
Method | Cochran-Mantel-Haenszel | |
Comments |
Title | Median Disease-Free Survival (DFS) for Participants Who Achieved Complete Remission or CR With Incomplete Hematologic Recovery (CRi) or Complete Remission With Incomplete Platelet Recovery (CRp) |
---|---|
Description | DFS based on IWG criteria was defined as the duration from start of the complete response achieved until disease progression or death from any cause. Responses defined by IWG 2003 Response Criteria: Morphologic CR: < 5% myeloblasts in bone marrow, the absence of circulating blasts, hematologic recovery (as evidenced by a peripheral blood ANC > 1000 cells/microL and platelet count > 100,000/microL, with no need for RBC transfusions), and the absence of extramedullary disease. Morphologic CRp: All criteria for CR except for residual neutropenia (<1x10^9/L) or thrombocytopenia (<100 x10^9/L), Cri (< 5% bone marrow blasts with residual neutropenia [ANC < 1000 cells/microL] or thrombocytopenia [platelets < 100,000/microL]), normal maturation of all cellular components in the bone marrow, no extramedullary disease and transfusion independent. |
Time Frame | Baseline until disease progression or discontinuation from the study, or death, whichever occurred first (up to a maximum of approximately 104 weeks) |
Outcome Measure Data
Analysis Population Description |
---|
ITT population included all participants who were randomized to study treatment under PV >=5.0, regardless of whether or not they received study treatment. Here, "N" signifies number of participants evaluable for this outcome measure. |
Arm/Group Title | Selinexor 60 mg (PV >=5) (Equivalent to 35 mg/m^2) | Physician's Choice 2 (PV >=5) |
---|---|---|
Arm/Group Description | Participants under PV >=5, received oral selinexor tablets at a dose of 60 mg (equivalent to 35 mg/m^2) twice weekly, on Day 1 and 3 of each week of 4-week cycle (28 days per cycle). | Participants under PV >= 5 (PV 5: those who had at least one prior line of AML therapy, PV 5.1: who had at least two prior line of AML therapy), received BSC along with subcutaneous injection of arabinoside cytosine (Ara-C), 20 mg, twice daily, for 10 days, repeated at 28 to 42 day intervals. |
Measure Participants | 14 | 2 |
Median (95% Confidence Interval) [Days] |
175.0
|
106.0
|
Title | Percentage of Participants With Overall Response Rate (ORR) |
---|---|
Description | Overall response rate was defined as the point estimate of the percentage of participants who achieved CR (disappearance of all target and non-target lesions), partial response (PR) (>=30 % decrease in sum of longest diameters of target lesions taking as reference baseline sum longest diameters associated to non-progressive disease response for non-target lesions). CRi; < 5% BM blasts with residual neutropenia [ANC < 1000 cells/microL] or thrombocytopenia [platelets < 100,000/microL]. CRp; All criteria for CR except for residual neutropenia (<1x10^9/L) or thrombocytopenia (<100 x10^9/L) and morphologic leukemia-free state (MLFS); morphologic BM blast clearance to <5% in a marrow sample in which <=200 cells enumerated or cellularity is ≥10%, in absence of blasts with Auer rods, no hematologic recovery required. |
Time Frame | Baseline until disease progression or discontinuation from the study, or death, whichever occurred first (up to a maximum of approximately 104 weeks) |
Outcome Measure Data
Analysis Population Description |
---|
ITT population included all participants who were randomized to study treatment under PV>=5.0, regardless of whether or not they received study treatment. One participant was randomized to receive selinexor 60 mg (PV>=5) but was treated with physician's choice 2. Hence, this participant was counted under selinexor 60 mg (PV>=5). |
Arm/Group Title | Selinexor 60 mg (PV >=5) (Equivalent to 35 mg/m^2) | Physician's Choice 2 (PV >=5) |
---|---|---|
Arm/Group Description | Participants under PV >=5 (PV 5: those who had at least one prior line of AML therapy, PV 5.1: who had at least two prior line of AML therapy), received oral selinexor tablets at a dose of 60 mg (equivalent to 35 mg/m^2) twice weekly, on Day 1 and 3 of each week of 4- week cycle (28 days per cycle). | Participants under PV >= 5 (PV 5: those who had at least one prior line of AML therapy, PV 5.1: who had at least two prior line of AML therapy), received BSC along with subcutaneous injection of arabinoside cytosine (Ara-C), 20 mg, twice daily, for 10 days, repeated at 28 to 42 day intervals. |
Measure Participants | 118 | 57 |
Number (95% Confidence Interval) [Percentage of participants] |
13.6
19.2%
|
8.8
32.6%
|
Title | Duration of Response (DOR) |
---|---|
Description | DOR was calculated from date of response of CR, CRi, CRp, MLFS, or PR to date of progression or recurrence based on IWG criteria. CR: <5% myeloblasts in bone marrow,absence of circulating blasts, hematologic recovery (peripheral blood ANC >1000 cells/microL, platelet count > 100,000/microL, no need for RBC transfusions), absence of extramedullary disease. PR: No circulating blasts, neutrophil count > =1.0 x10^9/L, platelet count >= 100 x10^9/L, >= 50 % reduction in bone marrow blast to 6% to 25%, or blasts less than or equal to (<=) 5% if Auer rods are present. CRp: All criteria for CR except for residual neutropenia (<1x10^9/L) or thrombocytopenia (<100 x10^9/L), CRi; < 5% bone marrow blasts with residual neutropenia [ANC < 1000 cells/microL] or thrombocytopenia [platelets < 100,000/microL]. MLFS: morphologic bone marrow blast clearance to < 5% in marrow sample, <= 200 cells enumerated/cellularity is ≥ 10%, in absence of blasts with Auer rods, no hematologic recovery required. |
Time Frame | Baseline until disease progression or discontinuation from the study, or death, whichever occurred first (up to a maximum of approximately 104 weeks) |
Outcome Measure Data
Analysis Population Description |
---|
ITT population included all participants who were randomized to study treatment under PV>=5.0, regardless of whether or not they received study treatment. Here, "N" signifies number of participants evaluable for this outcome measure. |
Arm/Group Title | Selinexor 60 mg (PV >=5) (Equivalent to 35 mg/m^2) | Physician's Choice 2 (PV >=5) |
---|---|---|
Arm/Group Description | Participants under PV >=5 (PV 5: those who had at least one prior line of AML therapy, PV 5.1: who had at least two prior line of AML therapy), received oral selinexor tablets at a dose of 60 mg (equivalent to 35 mg/m^2) twice weekly, on Day 1 and 3 of each week of 4- week cycle (28 days per cycle). | Participants under PV >= 5 (PV 5: those who had at least one prior line of AML therapy, PV 5.1: who had at least two prior line of AML therapy), received BSC along with subcutaneous injection of arabinoside cytosine (Ara-C), 20 mg, twice daily, for 10 days, repeated at 28 to 42 day intervals. |
Measure Participants | 16 | 5 |
Median (95% Confidence Interval) [Days] |
204.0
|
148.0
|
Title | Percentage of Participants With Disease Control Rate (DCR) |
---|---|
Description | DCR:Point estimate of % of participants with CR,CRi,CRp,MLFS,PR, or SD for <=4 weeks.CR:<5% myeloblasts in bone marrow (BM),absence of circulating blasts,hematologic recovery(peripheral blood ANC >1000 cells/microL and platelet count >100,000/microL, no need of RBC transfusions),absence of extramedullary disease. PR:No circulating blasts,Neutrophil count >=1.0 x10^9/L, Platelet count >= 100*10^9/L, >=50% reduction in BM blast to 6% to 25%, or blasts <=5% if Auer rods are present.CRp:All criteria for CR except for residual neutropenia (<1*10^9/L) or thrombocytopenia(<100 x10^9/L),CRi;< 5% BM blasts with residual neutropenia [ANC < 1000 cells/microL] or thrombocytopenia [platelets < 100,000/microL]. MLFS:morphologic BM blast clearance to <5% in a marrow sample in which <=200 cells enumerated or cellularity is ≥10%,in absence of blasts with Auer rods,no hematologic recovery required,SD:failure to achieve a response but not meeting criteria for disease progression over period of >4 weeks. |
Time Frame | Up to 4 weeks from the date of randomization to the date of progression or recurrence based on IWG criteria |
Outcome Measure Data
Analysis Population Description |
---|
ITT Population included all participants who were randomized to study treatment under PV>=5.0, regardless of whether or not they received study treatment. One participant was randomized to receive selinexor 60 mg (PV>=5) but was treated with physician's choice 2. Hence, this participant was counted under selinexor 60 mg (PV>=5). |
Arm/Group Title | Selinexor 60 mg (PV >=5) (Equivalent to 35 mg/m^2) | Physician's Choice 2 (PV >=5) |
---|---|---|
Arm/Group Description | Participants under PV >=5 (PV 5: those who had at least one prior line of AML therapy, PV 5.1: who had at least two prior line of AML therapy), received oral selinexor tablets at a dose of 60 mg (equivalent to 35 mg/m^2) twice weekly, on Day 1 and 3 of each week of 4- week cycle (28 days per cycle). | Participants under PV >= 5 (PV 5: those who had at least one prior line of AML therapy, PV 5.1: who had at least two prior line of AML therapy), received BSC along with subcutaneous injection of arabinoside cytosine (Ara-C), 20 mg, twice daily, for 10 days, repeated at 28 to 42 day intervals. |
Measure Participants | 118 | 57 |
Number (95% Confidence Interval) [Percentage of participants] |
50.8
71.5%
|
40.4
149.6%
|
Title | Duration of Disease Control Rate |
---|---|
Description | Duration of DCR calculated for all participants with DCR. CR: < 5% myeloblasts in BM, absence of circulating blasts, hematologic recovery (peripheral blood ANC >1000 cells/microL and platelet count > 100,000/microL, no need for RBC transfusions), absence of extra medullary disease. PR: No circulating blasts, Neutrophil count >=1.0 x 10^9/L, Platelet count >= 100 x 10^9/L, >= 50 % reduction in BM blast to 6% to 25%, or blasts <= 5% if Auer rods are present. CRp: All criteria for CR except for residual neutropenia (<1 x 10^9/L) or thrombocytopenia (<100 x 10^9/L), CRi; < 5% BM blasts with residual neutropenia [ANC < 1000 cells/microL] or thrombocytopenia [platelets < 100,000/microL]. MLFS; morphologic BM blast clearance to < 5% in a marrow sample in which <=200 cells enumerated/cellularity is >= 10%, in absence of blasts with Auer rods, no hematologic recovery required and SD; failure to achieve a response but not meeting criteria for disease progression over period of > 4 weeks. |
Time Frame | Up to 4 weeks from the date of randomization to the date of progression or recurrence based on IWG criteria |
Outcome Measure Data
Analysis Population Description |
---|
ITT population included all participants who were randomized to study treatment under PV>=5.0, regardless of whether or not they received study treatment. Here," N" signifies number of participants evaluable for this measure. |
Arm/Group Title | Selinexor 60 mg (PV >=5) (Equivalent to 35 mg/m^2) | Physician's Choice 2 (PV >=5) |
---|---|---|
Arm/Group Description | Participants under PV >=5 (PV 5: those who had at least one prior line of AML therapy, PV 5.1: who had at least two prior line of AML therapy), received oral selinexor tablets at a dose of 60 mg (equivalent to 35 mg/m^2) twice weekly, on Day 1 and 3 of each week of 4- week cycle (28 days per cycle). | Participants under PV >= 5 (PV 5: those who had at least one prior line of AML therapy, PV 5.1: who had at least two prior line of AML therapy), received BSC along with subcutaneous injection of arabinoside cytosine (Ara-C), 20 mg, twice daily, for 10 days, repeated at 28 to 42 day intervals. |
Measure Participants | 60 | 23 |
Median (95% Confidence Interval) [Days] |
187.0
|
233.0
|
Title | Change From Baseline in Quality of Life (QoL) and Patient-Reported Outcomes (Functional Assessment of Cancer Therapy -Leukemia [FACT-Leu] |
---|---|
Description | QoL was assessed by the FACT-Leu. FACT-Leu combines the General version of the Functional Assessment of Cancer Therapy (FACT-G) with a leukemia-specific sub-scale (17 items). The sub-scales for the FACT-G are Physical Well-Being (7 items), Social/Family Well-Being (7 items), Emotional Well-Being (6 items), and Functional Well-Being (7 items). The trial outcomes index (TOI; total of 31 items) was the primary measurement of interest, comprising the Physical and Functional sub-scales plus the leukemia - specific sub-scale. Each item was rated on a 5-point Likert scale. Range from 0 = (Not at all) to 4 = (Very much); therefore, the TOI had a score ranging from 0 to 124. Higher scores indicated improvement in well being. The QoL assessment was performed at baseline (prior to first dose of study treatment), Day 1 of each cycle on or after the second, and at the final visit. |
Time Frame | Baseline, Day 1 of each treatment cycle (a maximum of 20 cycles: 28 days per cycle) up to 30 days after last dose of study drug (final visit) |
Outcome Measure Data
Analysis Population Description |
---|
Per-Protocol (PP) population: all participants randomized to study treatment under PV>=5.0 who received any amount of study treatment and had no major protocol violations that compromised assessment of efficacy. Here, N= number of participants evaluable for this measure and n=participants evaluable for this outcome measure at specified categories. |
Arm/Group Title | Selinexor 60 mg (PV >=5) (Equivalent to 35 mg/m^2) | Physician's Choice 2 (PV >=5) |
---|---|---|
Arm/Group Description | Participants under PV >=5 (PV 5: those who had at least one prior line of AML therapy, PV 5.1: who had at least two prior line of AML therapy), received oral selinexor tablets at a dose of 60 mg (equivalent to 35 mg/m^2) twice weekly, on Day 1 and 3 of each week of 4- week cycle (28 days per cycle). | Participants under PV >= 5 (PV 5: those who had at least one prior line of AML therapy, PV 5.1: who had at least two prior line of AML therapy), received BSC along with subcutaneous injection of arabinoside cytosine (Ara-C), 20 mg, twice daily, for 10 days, repeated at 28 to 42 day intervals. |
Measure Participants | 71 | 34 |
Baseline |
70.5
(15.20)
|
75.4
(14.74)
|
C2D1 |
0.5
(16.50)
|
-1.9
(15.18)
|
C3D1 |
-1.9
(16.88)
|
-5.4
(22.25)
|
C4D1 |
-1.2
(15.70)
|
-7.4
(25.41)
|
C5D1 |
-2.4
(16.84)
|
1.9
(8.40)
|
C6D1 |
-3.4
(15.66)
|
-4.7
(13.20)
|
C7D1 |
-5.0
(17.21)
|
-11.8
(27.43)
|
C8D1 |
-3.9
(15.78)
|
-10.6
(7.83)
|
C9D1 |
-2.7
(7.47)
|
-8.0
(8.49)
|
C10D1 |
2.4
(13.19)
|
-10.7
(12.70)
|
C11D1 |
-0.1
(8.65)
|
-10.0
(9.90)
|
C12D1 |
-3.7
(11.69)
|
-7.0
(16.97)
|
C13D1 |
-3.3
(6.40)
|
-9.0
(NA)
|
C14D1 |
-4.0
(3.46)
|
-15.0
|
C15D1 |
1.5
(3.54)
|
-10.0
(NA)
|
C16D1 |
-15.0
(NA)
|
|
C17D1 |
-15.0
(NA)
|
-7.0
(NA)
|
C18D1 |
-1.0
(NA)
|
|
C19D1 |
-12.0
(NA)
|
|
C20D1 |
-14.0
(NA)
|
|
Final visit |
2.5
(17.71)
|
-1.7
(20.46)
|
Title | Change From Baseline in European Quality of Life-5 Dimension (EQ-5D) Health Questionnaire Visual Analogue Scale (VAS) |
---|---|
Description | EQ-5D descriptive system comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems, and 5=extreme problems. EQ-5D-5L is a standardized instrument that measures health-related quality of life for men with prostate cancer. EQ-5D consists of EQ-5D descriptive system and EQ VAS. EQ-5D-5-VAS records participant's self-rated health on a vertical VAS that allows them to indicate their health state that can range from 0 (worst imaginable) to 100 (best imaginable), higher scores indicating a better health state. |
Time Frame | Baseline, Day 1 of each treatment cycle (a maximum of 20 cycles: 28 days per cycle) up to 30 days after last dose of study drug (final visit) |
Outcome Measure Data
Analysis Population Description |
---|
PP Population included all participants randomized to study treatment under PV >=5.0 who received any amount of study treatment and who had no major protocol violations that compromised assessment of efficacy. Here, N= number of participants evaluable for this measure and n =Participants evaluable for this outcome measure at specified categories |
Arm/Group Title | Selinexor 60 mg (PV >=5) (Equivalent to 35 mg/m^2) | Physician's Choice 2 (PV >=5) |
---|---|---|
Arm/Group Description | Participants under PV >=5 (PV 5: those who had at least one prior line of AML therapy, PV 5.1: who had at least two prior line of AML therapy), received oral selinexor tablets at a dose of 60 mg (equivalent to 35 mg/m^2) twice weekly, on Day 1 and 3 of each week of 4- week cycle (28 days per cycle). | Participants under PV >= 5 (PV 5: those who had at least one prior line of AML therapy, PV 5.1: who had at least two prior line of AML therapy), received BSC along with subcutaneous injection of arabinoside cytosine (Ara-C), 20 mg, twice daily, for 10 days, repeated at 28 to 42 day intervals. |
Measure Participants | 71 | 34 |
Baseline |
67.9
(19.51)
|
63.5
(21.10)
|
C2D1 |
-7.5
(23.45)
|
0.8
(15.82)
|
C3D1 |
-13.3
(25.04)
|
-5.2
(23.54)
|
C4D1 |
-6.1
(20.80)
|
-5.0
(11.46)
|
C5D1 |
-0.9
(20.83)
|
-2.0
(15.31)
|
C6D1 |
-11.2
(25.90)
|
-1.4
(24.10)
|
C7D1 |
-3.7
(23.91)
|
4.0
(10.84)
|
C8D1 |
0.1
(16.77)
|
5.0
(9.35)
|
C9D1 |
4.6
(13.25)
|
5.0
(10.80)
|
C10D1 |
0.7
(18.58)
|
6.3
(15.48)
|
C11D1 |
0.8
(18.55)
|
-5.0
(21.21)
|
C12D1 |
3.3
(16.63)
|
-5.0
(28.28)
|
C13D1 |
6.7
(20.21)
|
10.0
(NA)
|
C14D1 |
6.7
(25.66)
|
15.0
(NA)
|
C15D1 |
3.5
(30.41)
|
-10.0
(NA)
|
C16D1 |
20.0
(NA)
|
|
C17D1 |
25.0
(NA)
|
-5.0
(NA)
|
C18D1 |
25.0
(NA)
|
|
C19D1 |
30.0
(NA)
|
|
C20D1 |
35.0
(NA)
|
Adverse Events
Time Frame | From start of study drug administration to 30 days after last dose of study drug (approximately 48 months) | |||||||||
---|---|---|---|---|---|---|---|---|---|---|
Adverse Event Reporting Description | Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population. | |||||||||
Arm/Group Title | Selinexor Approximately 55 mg/m^2 (60 to 120 mg Based on BSA) | Selinexor 60mg (PV<5) (Equivalent to 35 mg/m^2) | Selinexor 60mg (PV >=5) (Equivalent to 35 mg/m^2) | Physician's Choice 1 (PV <5) | Physician's Choice 2 (PV >=5) | |||||
Arm/Group Description | Participants under PV <5.0 (those who had one prior line of AML therapy), received oral selinexor tablets at a dose of approximately 55 mg/m^2 (60 to 120 mg based on BSA) twice weekly, on Day 1 and 3 of each week of 4-week cycle (28 days per cycle). | Participants under PV <5.0 (those who had one prior line of AML therapy), received oral selinexor tablets at a fixed dose of 60 mg (equivalent to 35 mg/m^2), based on BSA, twice weekly, on Day 1 and 3 of each week of 4-week cycle (28 days per cycle). | Participants under PV >=5 (PV 5: those who had at least one prior line of AML therapy, PV 5.1: who had at least two prior line of AML therapy), received oral selinexor tablets at a dose of 60 mg (equivalent to 35 mg/m^2) twice weekly, on Day 1 and 3 of each week of 4- week cycle (28 days per cycle). | Participants under PV < 5.0 (those who had one prior line of AML therapy) received Best Supportive Care (BSC) which included blood product transfusions, antimicrobials, growth factors as needed, and hydroxyurea. | Participants under PV >= 5 (PV 5: those who had at least one prior line of AML therapy, PV 5.1: who had at least two prior line of AML therapy), received BSC along with subcutaneous injection of arabinoside cytosine (Ara-C), 20 mg, twice daily, for 10 days, repeated at 28 to 42 day intervals. | |||||
All Cause Mortality |
||||||||||
Selinexor Approximately 55 mg/m^2 (60 to 120 mg Based on BSA) | Selinexor 60mg (PV<5) (Equivalent to 35 mg/m^2) | Selinexor 60mg (PV >=5) (Equivalent to 35 mg/m^2) | Physician's Choice 1 (PV <5) | Physician's Choice 2 (PV >=5) | ||||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 24/71 (33.8%) | 3/27 (11.1%) | 28/115 (24.3%) | 7/39 (17.9%) | 9/45 (20%) | |||||
Serious Adverse Events |
||||||||||
Selinexor Approximately 55 mg/m^2 (60 to 120 mg Based on BSA) | Selinexor 60mg (PV<5) (Equivalent to 35 mg/m^2) | Selinexor 60mg (PV >=5) (Equivalent to 35 mg/m^2) | Physician's Choice 1 (PV <5) | Physician's Choice 2 (PV >=5) | ||||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 58/71 (81.7%) | 15/27 (55.6%) | 89/115 (77.4%) | 25/39 (64.1%) | 30/45 (66.7%) | |||||
Blood and lymphatic system disorders | ||||||||||
Anaemia | 2/71 (2.8%) | 0/27 (0%) | 2/115 (1.7%) | 0/39 (0%) | 3/45 (6.7%) | |||||
Febrile Neutropenia | 16/71 (22.5%) | 4/27 (14.8%) | 20/115 (17.4%) | 8/39 (20.5%) | 16/45 (35.6%) | |||||
Leukostasis Syndrome | 0/71 (0%) | 0/27 (0%) | 0/115 (0%) | 0/39 (0%) | 1/45 (2.2%) | |||||
Neutropenia | 1/71 (1.4%) | 0/27 (0%) | 1/115 (0.9%) | 0/39 (0%) | 0/45 (0%) | |||||
Splenic Infarction | 0/71 (0%) | 0/27 (0%) | 0/115 (0%) | 0/39 (0%) | 1/45 (2.2%) | |||||
Thrombocytopenia | 1/71 (1.4%) | 1/27 (3.7%) | 1/115 (0.9%) | 0/39 (0%) | 0/45 (0%) | |||||
Cardiac disorders | ||||||||||
Acute Coronary Syndrome | 0/71 (0%) | 1/27 (3.7%) | 0/115 (0%) | 0/39 (0%) | 0/45 (0%) | |||||
Atrial Fibrillation | 2/71 (2.8%) | 0/27 (0%) | 0/115 (0%) | 0/39 (0%) | 1/45 (2.2%) | |||||
Bradycardia | 0/71 (0%) | 0/27 (0%) | 1/115 (0.9%) | 0/39 (0%) | 0/45 (0%) | |||||
Cardiac Failure | 1/71 (1.4%) | 0/27 (0%) | 3/115 (2.6%) | 0/39 (0%) | 0/45 (0%) | |||||
Cardiac Failure Congestive | 0/71 (0%) | 0/27 (0%) | 1/115 (0.9%) | 0/39 (0%) | 0/45 (0%) | |||||
Cardio-Respiratory Arrest | 0/71 (0%) | 0/27 (0%) | 0/115 (0%) | 0/39 (0%) | 1/45 (2.2%) | |||||
Sinus Bradycardia | 1/71 (1.4%) | 0/27 (0%) | 0/115 (0%) | 0/39 (0%) | 0/45 (0%) | |||||
Tachyarrhythmia | 0/71 (0%) | 1/27 (3.7%) | 0/115 (0%) | 0/39 (0%) | 0/45 (0%) | |||||
Ventricular Fibrillation | 0/71 (0%) | 0/27 (0%) | 1/115 (0.9%) | 0/39 (0%) | 0/45 (0%) | |||||
Ear and labyrinth disorders | ||||||||||
Vertigo | 0/71 (0%) | 1/27 (3.7%) | 0/115 (0%) | 0/39 (0%) | 0/45 (0%) | |||||
Eye disorders | ||||||||||
Cataract | 0/71 (0%) | 0/27 (0%) | 3/115 (2.6%) | 0/39 (0%) | 0/45 (0%) | |||||
Gastrointestinal disorders | ||||||||||
Abdominal Pain Upper | 0/71 (0%) | 0/27 (0%) | 1/115 (0.9%) | 0/39 (0%) | 0/45 (0%) | |||||
Constipation | 1/71 (1.4%) | 0/27 (0%) | 0/115 (0%) | 0/39 (0%) | 0/45 (0%) | |||||
Diarrhoea | 3/71 (4.2%) | 1/27 (3.7%) | 6/115 (5.2%) | 0/39 (0%) | 0/45 (0%) | |||||
Diverticular Perforation | 0/71 (0%) | 0/27 (0%) | 1/115 (0.9%) | 0/39 (0%) | 0/45 (0%) | |||||
Gastrointestinal Haemorrhage | 0/71 (0%) | 1/27 (3.7%) | 1/115 (0.9%) | 1/39 (2.6%) | 0/45 (0%) | |||||
Large Intestinal Haemorrhage | 0/71 (0%) | 0/27 (0%) | 1/115 (0.9%) | 0/39 (0%) | 0/45 (0%) | |||||
Mouth Ulceration | 1/71 (1.4%) | 0/27 (0%) | 0/115 (0%) | 0/39 (0%) | 0/45 (0%) | |||||
Nausea | 0/71 (0%) | 0/27 (0%) | 1/115 (0.9%) | 0/39 (0%) | 0/45 (0%) | |||||
Tooth Loss | 0/71 (0%) | 0/27 (0%) | 1/115 (0.9%) | 0/39 (0%) | 0/45 (0%) | |||||
Vomiting | 4/71 (5.6%) | 0/27 (0%) | 3/115 (2.6%) | 0/39 (0%) | 0/45 (0%) | |||||
General disorders | ||||||||||
Asthenia | 3/71 (4.2%) | 0/27 (0%) | 2/115 (1.7%) | 2/39 (5.1%) | 0/45 (0%) | |||||
Condition Aggravated | 0/71 (0%) | 0/27 (0%) | 0/115 (0%) | 0/39 (0%) | 1/45 (2.2%) | |||||
General Physical Health Deterioration | 1/71 (1.4%) | 0/27 (0%) | 2/115 (1.7%) | 0/39 (0%) | 0/45 (0%) | |||||
Malaise | 0/71 (0%) | 0/27 (0%) | 0/115 (0%) | 1/39 (2.6%) | 0/45 (0%) | |||||
Multiple Organ Dysfunction Syndrome | 1/71 (1.4%) | 0/27 (0%) | 0/115 (0%) | 0/39 (0%) | 0/45 (0%) | |||||
Pain | 0/71 (0%) | 0/27 (0%) | 1/115 (0.9%) | 0/39 (0%) | 0/45 (0%) | |||||
Pyrexia | 4/71 (5.6%) | 1/27 (3.7%) | 7/115 (6.1%) | 2/39 (5.1%) | 1/45 (2.2%) | |||||
Fatigue | 1/71 (1.4%) | 0/27 (0%) | 8/115 (7%) | 0/39 (0%) | 0/45 (0%) | |||||
Hepatobiliary disorders | ||||||||||
Cholecystitis Acute | 0/71 (0%) | 0/27 (0%) | 2/115 (1.7%) | 0/39 (0%) | 0/45 (0%) | |||||
Hyperbilirubinaemia | 1/71 (1.4%) | 0/27 (0%) | 0/115 (0%) | 0/39 (0%) | 0/45 (0%) | |||||
Infections and infestations | ||||||||||
Arthritis Bacterial | 0/71 (0%) | 0/27 (0%) | 1/115 (0.9%) | 0/39 (0%) | 0/45 (0%) | |||||
Aspergillus Infection | 0/71 (0%) | 0/27 (0%) | 1/115 (0.9%) | 0/39 (0%) | 0/45 (0%) | |||||
Biliary Sepsis | 0/71 (0%) | 0/27 (0%) | 1/115 (0.9%) | 0/39 (0%) | 0/45 (0%) | |||||
Biliary Tract Infection | 0/71 (0%) | 0/27 (0%) | 1/115 (0.9%) | 0/39 (0%) | 0/45 (0%) | |||||
Cellulitis | 2/71 (2.8%) | 0/27 (0%) | 1/115 (0.9%) | 1/39 (2.6%) | 1/45 (2.2%) | |||||
Clostridium Difficile Infection | 1/71 (1.4%) | 0/27 (0%) | 0/115 (0%) | 0/39 (0%) | 0/45 (0%) | |||||
Device Related Infection | 0/71 (0%) | 0/27 (0%) | 1/115 (0.9%) | 1/39 (2.6%) | 1/45 (2.2%) | |||||
Diverticulitis | 0/71 (0%) | 0/27 (0%) | 1/115 (0.9%) | 0/39 (0%) | 0/45 (0%) | |||||
Escherichia Sepsis | 1/71 (1.4%) | 0/27 (0%) | 0/115 (0%) | 1/39 (2.6%) | 1/45 (2.2%) | |||||
Fungal Infection | 0/71 (0%) | 0/27 (0%) | 1/115 (0.9%) | 0/39 (0%) | 0/45 (0%) | |||||
Infection | 0/71 (0%) | 0/27 (0%) | 1/115 (0.9%) | 0/39 (0%) | 2/45 (4.4%) | |||||
Klebsiella Sepsis | 1/71 (1.4%) | 0/27 (0%) | 0/115 (0%) | 0/39 (0%) | 0/45 (0%) | |||||
Laryngitis | 0/71 (0%) | 0/27 (0%) | 1/115 (0.9%) | 0/39 (0%) | 0/45 (0%) | |||||
Lower Respiratory Tract Infection | 1/71 (1.4%) | 0/27 (0%) | 1/115 (0.9%) | 0/39 (0%) | 0/45 (0%) | |||||
Lung Infection | 3/71 (4.2%) | 1/27 (3.7%) | 1/115 (0.9%) | 3/39 (7.7%) | 0/45 (0%) | |||||
Necrotising Fasciitis | 0/71 (0%) | 0/27 (0%) | 1/115 (0.9%) | 0/39 (0%) | 0/45 (0%) | |||||
Neutropenic Sepsis | 0/71 (0%) | 0/27 (0%) | 1/115 (0.9%) | 0/39 (0%) | 0/45 (0%) | |||||
Penile Infection | 0/71 (0%) | 0/27 (0%) | 1/115 (0.9%) | 0/39 (0%) | 0/45 (0%) | |||||
Perirectal Abscess | 0/71 (0%) | 0/27 (0%) | 1/115 (0.9%) | 0/39 (0%) | 0/45 (0%) | |||||
Pneumocystis Jirovecii Pneumonia | 1/71 (1.4%) | 0/27 (0%) | 0/115 (0%) | 0/39 (0%) | 0/45 (0%) | |||||
Pneumonia | 10/71 (14.1%) | 4/27 (14.8%) | 10/115 (8.7%) | 4/39 (10.3%) | 3/45 (6.7%) | |||||
Pneumonia Fungal | 2/71 (2.8%) | 0/27 (0%) | 0/115 (0%) | 0/39 (0%) | 1/45 (2.2%) | |||||
Sepsis | 8/71 (11.3%) | 1/27 (3.7%) | 3/115 (2.6%) | 3/39 (7.7%) | 1/45 (2.2%) | |||||
Septic Shock | 1/71 (1.4%) | 0/27 (0%) | 3/115 (2.6%) | 1/39 (2.6%) | 0/45 (0%) | |||||
Sialoadenitis | 0/71 (0%) | 0/27 (0%) | 1/115 (0.9%) | 0/39 (0%) | 0/45 (0%) | |||||
Sinusitis | 2/71 (2.8%) | 0/27 (0%) | 0/115 (0%) | 0/39 (0%) | 0/45 (0%) | |||||
Skin Infection | 0/71 (0%) | 0/27 (0%) | 1/115 (0.9%) | 0/39 (0%) | 0/45 (0%) | |||||
Soft Tissue Infection | 1/71 (1.4%) | 0/27 (0%) | 0/115 (0%) | 0/39 (0%) | 0/45 (0%) | |||||
Tonsillitis | 0/71 (0%) | 0/27 (0%) | 0/115 (0%) | 1/39 (2.6%) | 0/45 (0%) | |||||
Upper Respiratory Tract Infection | 1/71 (1.4%) | 0/27 (0%) | 0/115 (0%) | 0/39 (0%) | 0/45 (0%) | |||||
Urinary Tract Infection | 0/71 (0%) | 0/27 (0%) | 3/115 (2.6%) | 1/39 (2.6%) | 0/45 (0%) | |||||
Urosepsis | 0/71 (0%) | 0/27 (0%) | 0/115 (0%) | 0/39 (0%) | 1/45 (2.2%) | |||||
Vaginal Abscess | 0/71 (0%) | 0/27 (0%) | 1/115 (0.9%) | 0/39 (0%) | 0/45 (0%) | |||||
Vulval Cellulitis | 0/71 (0%) | 0/27 (0%) | 0/115 (0%) | 0/39 (0%) | 1/45 (2.2%) | |||||
Injury, poisoning and procedural complications | ||||||||||
Fall | 0/71 (0%) | 0/27 (0%) | 2/115 (1.7%) | 0/39 (0%) | 1/45 (2.2%) | |||||
Femur Fracture | 0/71 (0%) | 0/27 (0%) | 1/115 (0.9%) | 0/39 (0%) | 0/45 (0%) | |||||
Subarachnoid Haemorrhage | 0/71 (0%) | 0/27 (0%) | 1/115 (0.9%) | 0/39 (0%) | 0/45 (0%) | |||||
Subdural Haematoma | 0/71 (0%) | 0/27 (0%) | 1/115 (0.9%) | 1/39 (2.6%) | 0/45 (0%) | |||||
Subdural Haemorrhage | 1/71 (1.4%) | 0/27 (0%) | 0/115 (0%) | 0/39 (0%) | 0/45 (0%) | |||||
Investigations | ||||||||||
Blood Alkaline Phosphatase Increased | 1/71 (1.4%) | 0/27 (0%) | 0/115 (0%) | 0/39 (0%) | 0/45 (0%) | |||||
C-Reactive Protein Increased | 0/71 (0%) | 0/27 (0%) | 1/115 (0.9%) | 0/39 (0%) | 0/45 (0%) | |||||
Electrocardiogram Change | 0/71 (0%) | 0/27 (0%) | 1/115 (0.9%) | 0/39 (0%) | 0/45 (0%) | |||||
Enterococcus Test Positive | 0/71 (0%) | 0/27 (0%) | 0/115 (0%) | 1/39 (2.6%) | 0/45 (0%) | |||||
Troponin T Increased | 0/71 (0%) | 0/27 (0%) | 1/115 (0.9%) | 0/39 (0%) | 0/45 (0%) | |||||
Vitamin B12 Decreased | 0/71 (0%) | 0/27 (0%) | 1/115 (0.9%) | 0/39 (0%) | 0/45 (0%) | |||||
Weight Decreased | 1/71 (1.4%) | 0/27 (0%) | 1/115 (0.9%) | 0/39 (0%) | 0/45 (0%) | |||||
Metabolism and nutrition disorders | ||||||||||
Decreased Appetite | 1/71 (1.4%) | 0/27 (0%) | 6/115 (5.2%) | 0/39 (0%) | 0/45 (0%) | |||||
Dehydration | 5/71 (7%) | 0/27 (0%) | 2/115 (1.7%) | 1/39 (2.6%) | 0/45 (0%) | |||||
Failure To Thrive | 0/71 (0%) | 0/27 (0%) | 1/115 (0.9%) | 0/39 (0%) | 0/45 (0%) | |||||
Fluid Overload | 0/71 (0%) | 0/27 (0%) | 1/115 (0.9%) | 1/39 (2.6%) | 0/45 (0%) | |||||
Hypercreatininaemia | 0/71 (0%) | 0/27 (0%) | 2/115 (1.7%) | 0/39 (0%) | 0/45 (0%) | |||||
Hyperglycaemia | 5/71 (7%) | 0/27 (0%) | 0/115 (0%) | 0/39 (0%) | 0/45 (0%) | |||||
Hyperkalaemia | 1/71 (1.4%) | 0/27 (0%) | 0/115 (0%) | 0/39 (0%) | 0/45 (0%) | |||||
Hyponatraemia | 3/71 (4.2%) | 1/27 (3.7%) | 0/115 (0%) | 0/39 (0%) | 0/45 (0%) | |||||
Hypophagia | 1/71 (1.4%) | 0/27 (0%) | 0/115 (0%) | 0/39 (0%) | 0/45 (0%) | |||||
Musculoskeletal and connective tissue disorders | ||||||||||
Bone Pain | 0/71 (0%) | 0/27 (0%) | 0/115 (0%) | 1/39 (2.6%) | 0/45 (0%) | |||||
Muscular Weakness | 0/71 (0%) | 0/27 (0%) | 1/115 (0.9%) | 0/39 (0%) | 0/45 (0%) | |||||
Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||||||
Basal Cell Carcinoma | 0/71 (0%) | 0/27 (0%) | 1/115 (0.9%) | 0/39 (0%) | 0/45 (0%) | |||||
Cerebellar Tumour | 0/71 (0%) | 0/27 (0%) | 0/115 (0%) | 1/39 (2.6%) | 0/45 (0%) | |||||
Squamous Cell Carcinoma | 0/71 (0%) | 0/27 (0%) | 1/115 (0.9%) | 0/39 (0%) | 0/45 (0%) | |||||
Nervous system disorders | ||||||||||
Ataxia | 0/71 (0%) | 0/27 (0%) | 1/115 (0.9%) | 0/39 (0%) | 0/45 (0%) | |||||
Cerebral Haemorrhage | 1/71 (1.4%) | 0/27 (0%) | 2/115 (1.7%) | 0/39 (0%) | 1/45 (2.2%) | |||||
Cerebral Infarction | 0/71 (0%) | 0/27 (0%) | 1/115 (0.9%) | 0/39 (0%) | 0/45 (0%) | |||||
Cerebrovascular Accident | 0/71 (0%) | 0/27 (0%) | 1/115 (0.9%) | 0/39 (0%) | 0/45 (0%) | |||||
Dizziness | 1/71 (1.4%) | 0/27 (0%) | 2/115 (1.7%) | 0/39 (0%) | 0/45 (0%) | |||||
Embolic Stroke | 1/71 (1.4%) | 0/27 (0%) | 0/115 (0%) | 0/39 (0%) | 0/45 (0%) | |||||
Encephalopathy | 0/71 (0%) | 0/27 (0%) | 1/115 (0.9%) | 0/39 (0%) | 0/45 (0%) | |||||
Haemorrhage Intracranial | 2/71 (2.8%) | 0/27 (0%) | 1/115 (0.9%) | 0/39 (0%) | 0/45 (0%) | |||||
Haemorrhagic Cerebral Infarction | 0/71 (0%) | 0/27 (0%) | 1/115 (0.9%) | 0/39 (0%) | 0/45 (0%) | |||||
Headache | 0/71 (0%) | 0/27 (0%) | 1/115 (0.9%) | 0/39 (0%) | 0/45 (0%) | |||||
Ischaemic Stroke | 0/71 (0%) | 0/27 (0%) | 1/115 (0.9%) | 0/39 (0%) | 0/45 (0%) | |||||
Loss Of Consciousness | 0/71 (0%) | 0/27 (0%) | 1/115 (0.9%) | 0/39 (0%) | 0/45 (0%) | |||||
Nervous System Disorders | 8/71 (11.3%) | 1/27 (3.7%) | 15/115 (13%) | 0/39 (0%) | 1/45 (2.2%) | |||||
Presyncope | 1/71 (1.4%) | 0/27 (0%) | 0/115 (0%) | 0/39 (0%) | 0/45 (0%) | |||||
Syncope | 2/71 (2.8%) | 1/27 (3.7%) | 3/115 (2.6%) | 0/39 (0%) | 0/45 (0%) | |||||
Psychiatric disorders | ||||||||||
Confusional State | 4/71 (5.6%) | 0/27 (0%) | 2/115 (1.7%) | 0/39 (0%) | 0/45 (0%) | |||||
Hallucination | 0/71 (0%) | 0/27 (0%) | 1/115 (0.9%) | 0/39 (0%) | 0/45 (0%) | |||||
Mental Status Changes | 1/71 (1.4%) | 0/27 (0%) | 2/115 (1.7%) | 0/39 (0%) | 0/45 (0%) | |||||
Organic Brain Syndrome | 0/71 (0%) | 0/27 (0%) | 1/115 (0.9%) | 0/39 (0%) | 0/45 (0%) | |||||
Renal and urinary disorders | ||||||||||
Acute Kidney Injury | 0/71 (0%) | 0/27 (0%) | 1/115 (0.9%) | 0/39 (0%) | 0/45 (0%) | |||||
Oliguria | 0/71 (0%) | 0/27 (0%) | 1/115 (0.9%) | 0/39 (0%) | 0/45 (0%) | |||||
Renal Failure | 1/71 (1.4%) | 0/27 (0%) | 0/115 (0%) | 0/39 (0%) | 0/45 (0%) | |||||
Reproductive system and breast disorders | ||||||||||
Vaginal Haemorrhage | 0/71 (0%) | 0/27 (0%) | 1/115 (0.9%) | 0/39 (0%) | 0/45 (0%) | |||||
Respiratory, thoracic and mediastinal disorders | ||||||||||
Acute Respiratory Failure | 1/71 (1.4%) | 0/27 (0%) | 0/115 (0%) | 0/39 (0%) | 0/45 (0%) | |||||
Cough | 0/71 (0%) | 0/27 (0%) | 1/115 (0.9%) | 0/39 (0%) | 0/45 (0%) | |||||
Dyspnoea | 2/71 (2.8%) | 1/27 (3.7%) | 3/115 (2.6%) | 1/39 (2.6%) | 0/45 (0%) | |||||
Epistaxis | 2/71 (2.8%) | 0/27 (0%) | 1/115 (0.9%) | 0/39 (0%) | 2/45 (4.4%) | |||||
Haemoptysis | 0/71 (0%) | 0/27 (0%) | 0/115 (0%) | 0/39 (0%) | 1/45 (2.2%) | |||||
Pleural Effusion | 0/71 (0%) | 0/27 (0%) | 1/115 (0.9%) | 0/39 (0%) | 1/45 (2.2%) | |||||
Pneumonia Aspiration | 2/71 (2.8%) | 0/27 (0%) | 0/115 (0%) | 0/39 (0%) | 0/45 (0%) | |||||
Pulmonary Embolism | 0/71 (0%) | 0/27 (0%) | 1/115 (0.9%) | 0/39 (0%) | 0/45 (0%) | |||||
Pulmonary Mass | 0/71 (0%) | 0/27 (0%) | 1/115 (0.9%) | 0/39 (0%) | 0/45 (0%) | |||||
Respiratory Failure | 2/71 (2.8%) | 0/27 (0%) | 2/115 (1.7%) | 0/39 (0%) | 0/45 (0%) | |||||
Social circumstances | ||||||||||
Social Stay Hospitalisation | 0/71 (0%) | 1/27 (3.7%) | 0/115 (0%) | 0/39 (0%) | 0/45 (0%) | |||||
Vascular disorders | ||||||||||
Aortic Aneurysm | 1/71 (1.4%) | 0/27 (0%) | 0/115 (0%) | 0/39 (0%) | 0/45 (0%) | |||||
Haematoma | 1/71 (1.4%) | 0/27 (0%) | 0/115 (0%) | 0/39 (0%) | 0/45 (0%) | |||||
Hypotension | 1/71 (1.4%) | 0/27 (0%) | 4/115 (3.5%) | 0/39 (0%) | 0/45 (0%) | |||||
Peripheral Ischaemia | 0/71 (0%) | 0/27 (0%) | 1/115 (0.9%) | 0/39 (0%) | 0/45 (0%) | |||||
Thrombophlebitis | 0/71 (0%) | 0/27 (0%) | 0/115 (0%) | 1/39 (2.6%) | 0/45 (0%) | |||||
Venous Thrombosis | 0/71 (0%) | 0/27 (0%) | 1/115 (0.9%) | 0/39 (0%) | 0/45 (0%) | |||||
Other (Not Including Serious) Adverse Events |
||||||||||
Selinexor Approximately 55 mg/m^2 (60 to 120 mg Based on BSA) | Selinexor 60mg (PV<5) (Equivalent to 35 mg/m^2) | Selinexor 60mg (PV >=5) (Equivalent to 35 mg/m^2) | Physician's Choice 1 (PV <5) | Physician's Choice 2 (PV >=5) | ||||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 71/71 (100%) | 27/27 (100%) | 113/115 (98.3%) | 37/39 (94.9%) | 40/45 (88.9%) | |||||
Blood and lymphatic system disorders | ||||||||||
Thrombocytopenia | 29/71 (40.8%) | 29 | 7/27 (25.9%) | 7 | 38/115 (33%) | 38 | 18/39 (46.2%) | 18 | 11/45 (24.4%) | 11 |
Anaemia | 20/71 (28.2%) | 20 | 7/27 (25.9%) | 7 | 29/115 (25.2%) | 29 | 17/39 (43.6%) | 17 | 10/45 (22.2%) | 10 |
Neutropenia | 6/71 (8.5%) | 6 | 5/27 (18.5%) | 5 | 17/115 (14.8%) | 17 | 10/39 (25.6%) | 10 | 9/45 (20%) | 9 |
Leukopenia | 2/71 (2.8%) | 2 | 3/27 (11.1%) | 3 | 10/115 (8.7%) | 10 | 5/39 (12.8%) | 5 | 4/45 (8.9%) | 4 |
Febrile Neutropenia | 9/71 (12.7%) | 9 | 2/27 (7.4%) | 2 | 7/115 (6.1%) | 7 | 3/39 (7.7%) | 3 | 2/45 (4.4%) | 2 |
Leukocytosis | 6/71 (8.5%) | 6 | 2/27 (7.4%) | 2 | 6/115 (5.2%) | 6 | 4/39 (10.3%) | 4 | 0/45 (0%) | 0 |
Lymphopenia | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 2/115 (1.7%) | 2 | 2/39 (5.1%) | 2 | 1/45 (2.2%) | 1 |
Pancytopenia | 1/71 (1.4%) | 1 | 0/27 (0%) | 0 | 2/115 (1.7%) | 2 | 2/39 (5.1%) | 2 | 0/45 (0%) | 0 |
Coagulopathy | 0/71 (0%) | 0 | 1/27 (3.7%) | 1 | 2/115 (1.7%) | 2 | 1/39 (2.6%) | 1 | 0/45 (0%) | 0 |
Lymphadenopathy | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 1/115 (0.9%) | 1 | 1/39 (2.6%) | 1 | 1/45 (2.2%) | 1 |
Increased Tendency To Bruise | 1/71 (1.4%) | 1 | 0/27 (0%) | 0 | 0/115 (0%) | 0 | 0/39 (0%) | 0 | 1/45 (2.2%) | 1 |
Polycythaemia | 0/71 (0%) | 0 | 1/27 (3.7%) | 1 | 0/115 (0%) | 0 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Splenomegaly | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 0/115 (0%) | 0 | 0/39 (0%) | 0 | 1/45 (2.2%) | 1 |
Thrombocytosis | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 0/115 (0%) | 0 | 1/39 (2.6%) | 1 | 0/45 (0%) | 0 |
Cardiac disorders | ||||||||||
Tachycardia | 5/71 (7%) | 5 | 1/27 (3.7%) | 1 | 4/115 (3.5%) | 4 | 0/39 (0%) | 0 | 2/45 (4.4%) | 2 |
Sinus Tachycardia | 4/71 (5.6%) | 4 | 1/27 (3.7%) | 1 | 2/115 (1.7%) | 2 | 1/39 (2.6%) | 1 | 0/45 (0%) | 0 |
Atrial Fibrillation | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 1/115 (0.9%) | 1 | 2/39 (5.1%) | 2 | 1/45 (2.2%) | 1 |
Bradycardia | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 1/115 (0.9%) | 1 | 0/39 (0%) | 0 | 1/45 (2.2%) | 1 |
Acute Left Ventricular Failure | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 0/115 (0%) | 0 | 0/39 (0%) | 0 | 1/45 (2.2%) | 1 |
Angina Pectoris | 0/71 (0%) | 0 | 1/27 (3.7%) | 1 | 0/115 (0%) | 0 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Arrhythmia | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 0/115 (0%) | 0 | 1/39 (2.6%) | 1 | 0/45 (0%) | 0 |
Bundle Branch Block Right | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 0/115 (0%) | 0 | 1/39 (2.6%) | 1 | 0/45 (0%) | 0 |
Cardiac Failure | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 1/115 (0.9%) | 1 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Cardiac Flutter | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 0/115 (0%) | 0 | 1/39 (2.6%) | 1 | 0/45 (0%) | 0 |
Extrasystoles | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 0/115 (0%) | 0 | 1/39 (2.6%) | 1 | 0/45 (0%) | 0 |
Palpitations | 1/71 (1.4%) | 1 | 0/27 (0%) | 0 | 0/115 (0%) | 0 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Sinus Bradycardia | 0/71 (0%) | 0 | 1/27 (3.7%) | 1 | 0/115 (0%) | 0 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Supraventricular Tachycardia | 1/71 (1.4%) | 1 | 0/27 (0%) | 0 | 0/115 (0%) | 0 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Tachycardia Paroxysmal | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 0/115 (0%) | 0 | 1/39 (2.6%) | 1 | 0/45 (0%) | 0 |
Ear and labyrinth disorders | ||||||||||
Deafness | 2/71 (2.8%) | 2 | 0/27 (0%) | 0 | 2/115 (1.7%) | 2 | 0/39 (0%) | 0 | 1/45 (2.2%) | 1 |
Ear Discomfort | 0/71 (0%) | 0 | 2/27 (7.4%) | 2 | 2/115 (1.7%) | 2 | 0/39 (0%) | 0 | 1/45 (2.2%) | 1 |
Vertigo | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 3/115 (2.6%) | 3 | 0/39 (0%) | 0 | 1/45 (2.2%) | 1 |
Ear Pain | 2/71 (2.8%) | 2 | 0/27 (0%) | 0 | 1/115 (0.9%) | 1 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Tinnitus | 3/71 (4.2%) | 3 | 0/27 (0%) | 0 | 0/115 (0%) | 0 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Ear Congestion | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 1/115 (0.9%) | 1 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Eustachian Tube Dysfunction | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 1/115 (0.9%) | 1 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Excessive Cerumen Production | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 1/115 (0.9%) | 1 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Hypoacusis | 1/71 (1.4%) | 1 | 0/27 (0%) | 0 | 0/115 (0%) | 0 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Endocrine disorders | ||||||||||
Hypothyroidism | 0/71 (0%) | 0 | 1/27 (3.7%) | 1 | 4/115 (3.5%) | 4 | 1/39 (2.6%) | 1 | 0/45 (0%) | 0 |
Cushingoid | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 1/115 (0.9%) | 1 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Hyperthyroidism | 0/71 (0%) | 0 | 1/27 (3.7%) | 1 | 0/115 (0%) | 0 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Eye disorders | ||||||||||
Vision Blurred | 8/71 (11.3%) | 8 | 1/27 (3.7%) | 1 | 9/115 (7.8%) | 9 | 1/39 (2.6%) | 1 | 0/45 (0%) | 0 |
Visual Impairment | 4/71 (5.6%) | 4 | 0/27 (0%) | 0 | 2/115 (1.7%) | 2 | 0/39 (0%) | 0 | 1/45 (2.2%) | 1 |
Cataract | 0/71 (0%) | 0 | 1/27 (3.7%) | 1 | 3/115 (2.6%) | 3 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Dry Eye | 1/71 (1.4%) | 1 | 1/27 (3.7%) | 1 | 1/115 (0.9%) | 1 | 1/39 (2.6%) | 1 | 0/45 (0%) | 0 |
Visual Acuity Reduced | 1/71 (1.4%) | 1 | 0/27 (0%) | 0 | 2/115 (1.7%) | 2 | 0/39 (0%) | 0 | 1/45 (2.2%) | 1 |
Conjunctival Haemorrhage | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 1/115 (0.9%) | 1 | 2/39 (5.1%) | 2 | 0/45 (0%) | 0 |
Eye Pain | 1/71 (1.4%) | 1 | 0/27 (0%) | 0 | 2/115 (1.7%) | 2 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Lacrimation Increased | 1/71 (1.4%) | 1 | 1/27 (3.7%) | 1 | 1/115 (0.9%) | 1 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Eye Haemorrhage | 1/71 (1.4%) | 1 | 0/27 (0%) | 0 | 0/115 (0%) | 0 | 1/39 (2.6%) | 1 | 0/45 (0%) | 0 |
Eyelid Oedema | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 2/115 (1.7%) | 2 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Ocular Hyperaemia | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 1/115 (0.9%) | 1 | 0/39 (0%) | 0 | 1/45 (2.2%) | 1 |
Periorbital Oedema | 1/71 (1.4%) | 1 | 1/27 (3.7%) | 1 | 0/115 (0%) | 0 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Photopsia | 2/71 (2.8%) | 2 | 0/27 (0%) | 0 | 0/115 (0%) | 0 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Retinal Haemorrhage | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 1/115 (0.9%) | 1 | 1/39 (2.6%) | 1 | 0/45 (0%) | 0 |
Diplopia | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 1/115 (0.9%) | 1 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Eye Inflammation | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 0/115 (0%) | 0 | 0/39 (0%) | 0 | 1/45 (2.2%) | 1 |
Eye Swelling | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 0/115 (0%) | 0 | 1/39 (2.6%) | 1 | 0/45 (0%) | 0 |
Eyelid Ptosis | 1/71 (1.4%) | 1 | 0/27 (0%) | 0 | 0/115 (0%) | 0 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Vitreous Floaters | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 1/115 (0.9%) | 1 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Vitreous Haemorrhage | 1/71 (1.4%) | 1 | 0/27 (0%) | 0 | 0/115 (0%) | 0 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Gastrointestinal disorders | ||||||||||
Nausea | 41/71 (57.7%) | 41 | 16/27 (59.3%) | 16 | 68/115 (59.1%) | 68 | 13/39 (33.3%) | 13 | 8/45 (17.8%) | 8 |
Diarrhoea | 17/71 (23.9%) | 17 | 13/27 (48.1%) | 13 | 41/115 (35.7%) | 41 | 8/39 (20.5%) | 8 | 6/45 (13.3%) | 6 |
Constipation | 20/71 (28.2%) | 20 | 8/27 (29.6%) | 8 | 25/115 (21.7%) | 25 | 16/39 (41%) | 16 | 15/45 (33.3%) | 15 |
Vomiting | 19/71 (26.8%) | 19 | 10/27 (37%) | 10 | 30/115 (26.1%) | 30 | 7/39 (17.9%) | 7 | 6/45 (13.3%) | 6 |
Stomatitis | 8/71 (11.3%) | 8 | 0/27 (0%) | 0 | 8/115 (7%) | 8 | 3/39 (7.7%) | 3 | 3/45 (6.7%) | 3 |
Abdominal Pain | 1/71 (1.4%) | 1 | 0/27 (0%) | 0 | 12/115 (10.4%) | 12 | 2/39 (5.1%) | 2 | 6/45 (13.3%) | 6 |
Abdominal Pain Upper | 1/71 (1.4%) | 1 | 1/27 (3.7%) | 1 | 6/115 (5.2%) | 6 | 1/39 (2.6%) | 1 | 1/45 (2.2%) | 1 |
Dyspepsia | 3/71 (4.2%) | 3 | 2/27 (7.4%) | 2 | 3/115 (2.6%) | 3 | 1/39 (2.6%) | 1 | 1/45 (2.2%) | 1 |
Gingival Bleeding | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 7/115 (6.1%) | 7 | 1/39 (2.6%) | 1 | 2/45 (4.4%) | 2 |
Haemorrhoids | 1/71 (1.4%) | 1 | 0/27 (0%) | 0 | 3/115 (2.6%) | 3 | 2/39 (5.1%) | 2 | 3/45 (6.7%) | 3 |
Aphthous Ulcer | 1/71 (1.4%) | 1 | 1/27 (3.7%) | 1 | 1/115 (0.9%) | 1 | 2/39 (5.1%) | 2 | 2/45 (4.4%) | 2 |
Mouth Haemorrhage | 1/71 (1.4%) | 1 | 1/27 (3.7%) | 1 | 4/115 (3.5%) | 4 | 1/39 (2.6%) | 1 | 0/45 (0%) | 0 |
Abdominal Discomfort | 0/71 (0%) | 0 | 1/27 (3.7%) | 1 | 1/115 (0.9%) | 1 | 2/39 (5.1%) | 2 | 2/45 (4.4%) | 2 |
Gingival Pain | 1/71 (1.4%) | 1 | 0/27 (0%) | 0 | 3/115 (2.6%) | 3 | 2/39 (5.1%) | 2 | 0/45 (0%) | 0 |
Odynophagia | 1/71 (1.4%) | 1 | 1/27 (3.7%) | 1 | 0/115 (0%) | 0 | 2/39 (5.1%) | 2 | 2/45 (4.4%) | 2 |
Toothache | 2/71 (2.8%) | 2 | 0/27 (0%) | 0 | 3/115 (2.6%) | 3 | 0/39 (0%) | 0 | 1/45 (2.2%) | 1 |
Dry Mouth | 2/71 (2.8%) | 2 | 1/27 (3.7%) | 1 | 1/115 (0.9%) | 1 | 1/39 (2.6%) | 1 | 0/45 (0%) | 0 |
Gastrooesophageal Reflux Disease | 3/71 (4.2%) | 3 | 0/27 (0%) | 0 | 2/115 (1.7%) | 2 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Dysphagia | 2/71 (2.8%) | 2 | 0/27 (0%) | 0 | 1/115 (0.9%) | 1 | 1/39 (2.6%) | 1 | 0/45 (0%) | 0 |
Flatulence | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 3/115 (2.6%) | 3 | 1/39 (2.6%) | 1 | 0/45 (0%) | 0 |
Melaena | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 1/115 (0.9%) | 1 | 1/39 (2.6%) | 1 | 2/45 (4.4%) | 2 |
Oral Pain | 1/71 (1.4%) | 1 | 0/27 (0%) | 0 | 1/115 (0.9%) | 1 | 2/39 (5.1%) | 2 | 0/45 (0%) | 0 |
Abdominal Pain Lower | 1/71 (1.4%) | 1 | 0/27 (0%) | 0 | 0/115 (0%) | 0 | 1/39 (2.6%) | 1 | 0/45 (0%) | 0 |
Anal Fissure | 0/71 (0%) | 0 | 1/27 (3.7%) | 1 | 0/115 (0%) | 0 | 0/39 (0%) | 0 | 1/45 (2.2%) | 1 |
Angina Bullosa Haemorrhagica | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 0/115 (0%) | 0 | 2/39 (5.1%) | 2 | 0/45 (0%) | 0 |
Enterocolitis | 0/71 (0%) | 0 | 1/27 (3.7%) | 1 | 1/115 (0.9%) | 1 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Eructation | 1/71 (1.4%) | 1 | 0/27 (0%) | 0 | 1/115 (0.9%) | 1 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Gastritis | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 1/115 (0.9%) | 1 | 1/39 (2.6%) | 1 | 0/45 (0%) | 0 |
Gastrointestinal Haemorrhage | 1/71 (1.4%) | 1 | 0/27 (0%) | 0 | 1/115 (0.9%) | 1 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Mouth Ulceration | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 1/115 (0.9%) | 1 | 1/39 (2.6%) | 1 | 0/45 (0%) | 0 |
Oral Disorder | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 2/115 (1.7%) | 2 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Oral Mucosa Haematoma | 0/71 (0%) | 0 | 1/27 (3.7%) | 1 | 0/115 (0%) | 0 | 1/39 (2.6%) | 1 | 0/45 (0%) | 0 |
Oral Mucosal Blistering | 1/71 (1.4%) | 1 | 0/27 (0%) | 0 | 1/115 (0.9%) | 1 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Abdominal Tenderness | 1/71 (1.4%) | 1 | 0/27 (0%) | 0 | 0/115 (0%) | 0 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Anal Incontinence | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 1/115 (0.9%) | 1 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Breath Odour | 0/71 (0%) | 0 | 1/27 (3.7%) | 1 | 0/115 (0%) | 0 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Diverticulum | 1/71 (1.4%) | 1 | 0/27 (0%) | 0 | 0/115 (0%) | 0 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Faeces Soft | 0/71 (0%) | 0 | 1/27 (3.7%) | 1 | 0/115 (0%) | 0 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Gastrointestinal Pain | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 0/115 (0%) | 0 | 0/39 (0%) | 0 | 1/45 (2.2%) | 1 |
Gingival Hypertrophy | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 0/115 (0%) | 0 | 1/39 (2.6%) | 1 | 0/45 (0%) | 0 |
Glossitis | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 1/115 (0.9%) | 1 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Ileus | 1/71 (1.4%) | 1 | 0/27 (0%) | 0 | 0/115 (0%) | 0 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Inguinal Hernia | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 1/115 (0.9%) | 1 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Lip Blister | 1/71 (1.4%) | 1 | 0/27 (0%) | 0 | 0/115 (0%) | 0 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Lip Dry | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 0/115 (0%) | 0 | 0/39 (0%) | 0 | 1/45 (2.2%) | 1 |
Lip Oedema | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 0/115 (0%) | 0 | 0/39 (0%) | 0 | 1/45 (2.2%) | 1 |
Lip Pain | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 0/115 (0%) | 0 | 0/39 (0%) | 0 | 1/45 (2.2%) | 1 |
Lip Swelling | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 1/115 (0.9%) | 1 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Lip Ulceration | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 0/115 (0%) | 0 | 0/39 (0%) | 0 | 1/45 (2.2%) | 1 |
Mouth Swelling | 0/71 (0%) | 0 | 1/27 (3.7%) | 1 | 0/115 (0%) | 0 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Oesophagitis | 1/71 (1.4%) | 1 | 0/27 (0%) | 0 | 0/115 (0%) | 0 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Oral Contusion | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 0/115 (0%) | 0 | 1/39 (2.6%) | 1 | 0/45 (0%) | 0 |
Oral Dysaesthesia | 1/71 (1.4%) | 1 | 0/27 (0%) | 0 | 0/115 (0%) | 0 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Palatal Disorder | 1/71 (1.4%) | 1 | 0/27 (0%) | 0 | 0/115 (0%) | 0 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Perianal Erythema | 1/71 (1.4%) | 1 | 0/27 (0%) | 0 | 0/115 (0%) | 0 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Proctalgia | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 1/115 (0.9%) | 1 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Rectal Fissure | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 0/115 (0%) | 0 | 1/39 (2.6%) | 1 | 0/45 (0%) | 0 |
Rectal Haemorrhage | 1/71 (1.4%) | 1 | 0/27 (0%) | 0 | 0/115 (0%) | 0 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Retching | 1/71 (1.4%) | 1 | 0/27 (0%) | 0 | 0/115 (0%) | 0 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Salivary Hypersecretion | 1/71 (1.4%) | 1 | 0/27 (0%) | 0 | 0/115 (0%) | 0 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Tongue Haematoma | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 0/115 (0%) | 0 | 1/39 (2.6%) | 1 | 0/45 (0%) | 0 |
Tongue Ulceration | 1/71 (1.4%) | 1 | 0/27 (0%) | 0 | 0/115 (0%) | 0 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Tooth Loss | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 1/115 (0.9%) | 1 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Trichoglossia | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 0/115 (0%) | 0 | 1/39 (2.6%) | 1 | 0/45 (0%) | 0 |
General disorders | ||||||||||
Fatigue | 33/71 (46.5%) | 33 | 13/27 (48.1%) | 13 | 50/115 (43.5%) | 50 | 15/39 (38.5%) | 15 | 13/45 (28.9%) | 13 |
Pyrexia | 8/71 (11.3%) | 8 | 5/27 (18.5%) | 5 | 28/115 (24.3%) | 28 | 13/39 (33.3%) | 13 | 13/45 (28.9%) | 13 |
Oedema Peripheral | 17/71 (23.9%) | 17 | 5/27 (18.5%) | 5 | 21/115 (18.3%) | 21 | 10/39 (25.6%) | 10 | 5/45 (11.1%) | 5 |
Asthenia | 17/71 (23.9%) | 17 | 6/27 (22.2%) | 6 | 22/115 (19.1%) | 22 | 5/39 (12.8%) | 5 | 5/45 (11.1%) | 5 |
Malaise | 2/71 (2.8%) | 2 | 1/27 (3.7%) | 1 | 8/115 (7%) | 8 | 3/39 (7.7%) | 3 | 1/45 (2.2%) | 1 |
Oedema | 2/71 (2.8%) | 2 | 0/27 (0%) | 0 | 5/115 (4.3%) | 5 | 4/39 (10.3%) | 4 | 2/45 (4.4%) | 2 |
Chills | 1/71 (1.4%) | 1 | 1/27 (3.7%) | 1 | 5/115 (4.3%) | 5 | 3/39 (7.7%) | 3 | 1/45 (2.2%) | 1 |
Mucosal Inflammation | 3/71 (4.2%) | 3 | 0/27 (0%) | 0 | 1/115 (0.9%) | 1 | 4/39 (10.3%) | 4 | 3/45 (6.7%) | 3 |
Pain | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 7/115 (6.1%) | 7 | 1/39 (2.6%) | 1 | 1/45 (2.2%) | 1 |
Gait Disturbance | 2/71 (2.8%) | 2 | 0/27 (0%) | 0 | 2/115 (1.7%) | 2 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
General Physical Health Deterioration | 1/71 (1.4%) | 1 | 0/27 (0%) | 0 | 2/115 (1.7%) | 2 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Injection Site Bruising | 1/71 (1.4%) | 1 | 0/27 (0%) | 0 | 0/115 (0%) | 0 | 1/39 (2.6%) | 1 | 1/45 (2.2%) | 1 |
Non-Cardiac Chest Pain | 1/71 (1.4%) | 1 | 0/27 (0%) | 0 | 2/115 (1.7%) | 2 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Ulcer | 2/71 (2.8%) | 2 | 0/27 (0%) | 0 | 1/115 (0.9%) | 1 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Catheter Site Haemorrhage | 1/71 (1.4%) | 1 | 0/27 (0%) | 0 | 0/115 (0%) | 0 | 1/39 (2.6%) | 1 | 0/45 (0%) | 0 |
Face Oedema | 1/71 (1.4%) | 1 | 0/27 (0%) | 0 | 0/115 (0%) | 0 | 1/39 (2.6%) | 1 | 0/45 (0%) | 0 |
Generalised Oedema | 0/71 (0%) | 0 | 1/27 (3.7%) | 1 | 0/115 (0%) | 0 | 1/39 (2.6%) | 1 | 0/45 (0%) | 0 |
Secretion Discharge | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 2/115 (1.7%) | 2 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Catheter Site Haematoma | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 1/115 (0.9%) | 1 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Chest Pain | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 1/115 (0.9%) | 1 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Drug Intolerance | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 1/115 (0.9%) | 1 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Extravasation | 1/71 (1.4%) | 1 | 0/27 (0%) | 0 | 0/115 (0%) | 0 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Feeling Cold | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 1/115 (0.9%) | 1 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Granuloma | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 0/115 (0%) | 0 | 0/39 (0%) | 0 | 1/45 (2.2%) | 1 |
Hernia | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 1/115 (0.9%) | 1 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Impaired Healing | 0/71 (0%) | 0 | 1/27 (3.7%) | 1 | 0/115 (0%) | 0 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Infusion Site Haemorrhage | 0/71 (0%) | 0 | 1/27 (3.7%) | 1 | 0/115 (0%) | 0 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Injection Site Discolouration | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 0/115 (0%) | 0 | 1/39 (2.6%) | 1 | 0/45 (0%) | 0 |
Injection Site Pain | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 0/115 (0%) | 0 | 0/39 (0%) | 0 | 1/45 (2.2%) | 1 |
Mucosal Dryness | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 0/115 (0%) | 0 | 0/39 (0%) | 0 | 1/45 (2.2%) | 1 |
Nodule | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 0/115 (0%) | 0 | 1/39 (2.6%) | 1 | 0/45 (0%) | 0 |
Peripheral Swelling | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 0/115 (0%) | 0 | 0/39 (0%) | 0 | 1/45 (2.2%) | 1 |
Swelling | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 1/115 (0.9%) | 1 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Decreased Appetite | 41/71 (57.7%) | 41 | 12/27 (44.4%) | 12 | 61/115 (53%) | 61 | 9/39 (23.1%) | 9 | 7/45 (15.6%) | 7 |
Hepatobiliary disorders | ||||||||||
Hyperbilirubinaemia | 2/71 (2.8%) | 2 | 0/27 (0%) | 0 | 5/115 (4.3%) | 5 | 1/39 (2.6%) | 1 | 1/45 (2.2%) | 1 |
Cholelithiasis | 1/71 (1.4%) | 1 | 0/27 (0%) | 0 | 0/115 (0%) | 0 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Hepatomegaly | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 0/115 (0%) | 0 | 0/39 (0%) | 0 | 1/45 (2.2%) | 1 |
Jaundice | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 1/115 (0.9%) | 1 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Ocular Icterus | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 1/115 (0.9%) | 1 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Immune system disorders | ||||||||||
Hypersensitivity | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 1/115 (0.9%) | 1 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Infections and infestations | ||||||||||
Urinary Tract Infection | 6/71 (8.5%) | 6 | 2/27 (7.4%) | 2 | 9/115 (7.8%) | 9 | 5/39 (12.8%) | 5 | 2/45 (4.4%) | 2 |
Oral Herpes | 2/71 (2.8%) | 2 | 0/27 (0%) | 0 | 3/115 (2.6%) | 3 | 4/39 (10.3%) | 4 | 4/45 (8.9%) | 4 |
Nasopharyngitis | 1/71 (1.4%) | 1 | 0/27 (0%) | 0 | 5/115 (4.3%) | 5 | 1/39 (2.6%) | 1 | 3/45 (6.7%) | 3 |
Oral Candidiasis | 4/71 (5.6%) | 4 | 0/27 (0%) | 0 | 4/115 (3.5%) | 4 | 1/39 (2.6%) | 1 | 1/45 (2.2%) | 1 |
Pneumonia | 1/71 (1.4%) | 1 | 0/27 (0%) | 0 | 4/115 (3.5%) | 4 | 3/39 (7.7%) | 3 | 1/45 (2.2%) | 1 |
Cellulitis | 2/71 (2.8%) | 2 | 0/27 (0%) | 0 | 2/115 (1.7%) | 2 | 1/39 (2.6%) | 1 | 1/45 (2.2%) | 1 |
Lung Infection | 2/71 (2.8%) | 2 | 1/27 (3.7%) | 1 | 1/115 (0.9%) | 1 | 0/39 (0%) | 0 | 1/45 (2.2%) | 1 |
Sinusitis | 0/71 (0%) | 0 | 1/27 (3.7%) | 1 | 2/115 (1.7%) | 2 | 2/39 (5.1%) | 2 | 0/45 (0%) | 0 |
Upper Respiratory Tract Infection | 1/71 (1.4%) | 1 | 0/27 (0%) | 0 | 2/115 (1.7%) | 2 | 1/39 (2.6%) | 1 | 1/45 (2.2%) | 1 |
Device Related Infection | 1/71 (1.4%) | 1 | 0/27 (0%) | 0 | 2/115 (1.7%) | 2 | 1/39 (2.6%) | 1 | 0/45 (0%) | 0 |
Periodontitis | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 2/115 (1.7%) | 2 | 0/39 (0%) | 0 | 2/45 (4.4%) | 2 |
Pneumonia Fungal | 1/71 (1.4%) | 1 | 0/27 (0%) | 0 | 0/115 (0%) | 0 | 0/39 (0%) | 0 | 3/45 (6.7%) | 3 |
Sepsis | 1/71 (1.4%) | 1 | 1/27 (3.7%) | 1 | 1/115 (0.9%) | 1 | 0/39 (0%) | 0 | 1/45 (2.2%) | 1 |
Candida Infection | 3/71 (4.2%) | 3 | 0/27 (0%) | 0 | 0/115 (0%) | 0 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Folliculitis | 0/71 (0%) | 0 | 1/27 (3.7%) | 1 | 2/115 (1.7%) | 2 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Oesophageal Candidiasis | 0/71 (0%) | 0 | 2/27 (7.4%) | 2 | 0/115 (0%) | 0 | 1/39 (2.6%) | 1 | 0/45 (0%) | 0 |
Skin Infection | 1/71 (1.4%) | 1 | 0/27 (0%) | 0 | 1/115 (0.9%) | 1 | 1/39 (2.6%) | 1 | 0/45 (0%) | 0 |
Staphylococcal Infection | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 1/115 (0.9%) | 1 | 0/39 (0%) | 0 | 2/45 (4.4%) | 2 |
Clostridium Difficile Colitis | 0/71 (0%) | 0 | 1/27 (3.7%) | 1 | 1/115 (0.9%) | 1 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Clostridium Difficile Infection | 1/71 (1.4%) | 1 | 0/27 (0%) | 0 | 0/115 (0%) | 0 | 0/39 (0%) | 0 | 1/45 (2.2%) | 1 |
Conjunctivitis | 0/71 (0%) | 0 | 1/27 (3.7%) | 1 | 1/115 (0.9%) | 1 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Ear Infection | 1/71 (1.4%) | 1 | 0/27 (0%) | 0 | 1/115 (0.9%) | 1 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Fungal Infection | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 2/115 (1.7%) | 2 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Herpes Dermatitis | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 1/115 (0.9%) | 1 | 0/39 (0%) | 0 | 1/45 (2.2%) | 1 |
Infection | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 0/115 (0%) | 0 | 1/39 (2.6%) | 1 | 1/45 (2.2%) | 1 |
Lip Infection | 0/71 (0%) | 0 | 1/27 (3.7%) | 1 | 1/115 (0.9%) | 1 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Nasal Herpes | 1/71 (1.4%) | 1 | 0/27 (0%) | 0 | 1/115 (0.9%) | 1 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Pharyngitis | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 0/115 (0%) | 0 | 2/39 (5.1%) | 2 | 0/45 (0%) | 0 |
Pseudomonas Infection | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 1/115 (0.9%) | 1 | 0/39 (0%) | 0 | 1/45 (2.2%) | 1 |
Rash Pustular | 0/71 (0%) | 0 | 1/27 (3.7%) | 1 | 0/115 (0%) | 0 | 1/39 (2.6%) | 1 | 0/45 (0%) | 0 |
Rhinovirus Infection | 1/71 (1.4%) | 1 | 0/27 (0%) | 0 | 0/115 (0%) | 0 | 0/39 (0%) | 0 | 1/45 (2.2%) | 1 |
Soft Tissue Infection | 2/71 (2.8%) | 2 | 0/27 (0%) | 0 | 0/115 (0%) | 0 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Abscess Limb | 1/71 (1.4%) | 1 | 0/27 (0%) | 0 | 0/115 (0%) | 0 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Acute Sinusitis | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 1/115 (0.9%) | 1 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Anal Abscess | 1/71 (1.4%) | 1 | 0/27 (0%) | 0 | 0/115 (0%) | 0 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Aspergillus Infection | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 1/115 (0.9%) | 1 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Asymptomatic Bacteriuria | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 1/115 (0.9%) | 1 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Bacterial Infection | 0/71 (0%) | 0 | 1/27 (3.7%) | 1 | 0/115 (0%) | 0 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Bacteriuria | 0/71 (0%) | 0 | 1/27 (3.7%) | 1 | 0/115 (0%) | 0 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Bronchitis | 1/71 (1.4%) | 1 | 0/27 (0%) | 0 | 0/115 (0%) | 0 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Catheter Site Cellulitis | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 0/115 (0%) | 0 | 1/39 (2.6%) | 1 | 0/45 (0%) | 0 |
Clostridium Colitis | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 1/115 (0.9%) | 1 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Dermo-Hypodermitis | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 0/115 (0%) | 0 | 0/39 (0%) | 0 | 1/45 (2.2%) | 1 |
Diverticulitis | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 1/115 (0.9%) | 1 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Empyema | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 0/115 (0%) | 0 | 0/39 (0%) | 0 | 1/45 (2.2%) | 1 |
Encephalitis | 1/71 (1.4%) | 1 | 0/27 (0%) | 0 | 0/115 (0%) | 0 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Enterobiasis | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 0/115 (0%) | 0 | 1/39 (2.6%) | 1 | 0/45 (0%) | 0 |
Enterococcal Infection | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 1/115 (0.9%) | 1 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Furuncle | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 0/115 (0%) | 0 | 1/39 (2.6%) | 1 | 0/45 (0%) | 0 |
Genital Herpes | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 1/115 (0.9%) | 1 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Gingivitis | 1/71 (1.4%) | 1 | 0/27 (0%) | 0 | 0/115 (0%) | 0 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Groin Infection | 1/71 (1.4%) | 1 | 0/27 (0%) | 0 | 0/115 (0%) | 0 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Herpes Simplex | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 0/115 (0%) | 0 | 0/39 (0%) | 0 | 1/45 (2.2%) | 1 |
Herpes Zoster | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 0/115 (0%) | 0 | 0/39 (0%) | 0 | 1/45 (2.2%) | 1 |
Infected Dermal Cyst | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 1/115 (0.9%) | 1 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Influenza | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 0/115 (0%) | 0 | 1/39 (2.6%) | 1 | 0/45 (0%) | 0 |
Lower Respiratory Tract Infection | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 0/115 (0%) | 0 | 1/39 (2.6%) | 1 | 0/45 (0%) | 0 |
Lymph Gland Infection | 1/71 (1.4%) | 1 | 0/27 (0%) | 0 | 0/115 (0%) | 0 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Meningitis | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 1/115 (0.9%) | 1 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Metapneumovirus Infection | 0/71 (0%) | 0 | 1/27 (3.7%) | 1 | 0/115 (0%) | 0 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Mucosal Infection | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 1/115 (0.9%) | 1 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Oesophageal Infection | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 1/115 (0.9%) | 1 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Ophthalmic Herpes Simplex | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 0/115 (0%) | 0 | 0/39 (0%) | 0 | 1/45 (2.2%) | 1 |
Oral Fungal Infection | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 0/115 (0%) | 0 | 1/39 (2.6%) | 1 | 0/45 (0%) | 0 |
Oral Infection | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 0/115 (0%) | 0 | 1/39 (2.6%) | 1 | 0/45 (0%) | 0 |
Osteomyelitis | 1/71 (1.4%) | 1 | 0/27 (0%) | 0 | 0/115 (0%) | 0 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Parotitis | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 1/115 (0.9%) | 1 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Pneumonia Klebsiella | 1/71 (1.4%) | 1 | 0/27 (0%) | 0 | 0/115 (0%) | 0 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Proteus Infection | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 0/115 (0%) | 0 | 0/39 (0%) | 0 | 1/45 (2.2%) | 1 |
Pseudomembranous Colitis | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 1/115 (0.9%) | 1 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Respiratory Tract Infection | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 1/115 (0.9%) | 1 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Rhinitis | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 1/115 (0.9%) | 1 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Septic Shock | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 1/115 (0.9%) | 1 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Sialoadenitis | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 1/115 (0.9%) | 1 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Staphylococcal Bacteraemia | 1/71 (1.4%) | 1 | 0/27 (0%) | 0 | 0/115 (0%) | 0 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Stenotrophomonas Infection | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 1/115 (0.9%) | 1 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Tonsillitis | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 0/115 (0%) | 0 | 1/39 (2.6%) | 1 | 0/45 (0%) | 0 |
Tonsillitis Bacterial | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 1/115 (0.9%) | 1 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Tooth Abscess | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 1/115 (0.9%) | 1 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Tooth Infection | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 0/115 (0%) | 0 | 1/39 (2.6%) | 1 | 0/45 (0%) | 0 |
Varicella Zoster Virus Infection | 1/71 (1.4%) | 1 | 0/27 (0%) | 0 | 0/115 (0%) | 0 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Hallucination | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 3/115 (2.6%) | 3 | 0/39 (0%) | 0 | 1/45 (2.2%) | 1 |
Personality Change | 1/71 (1.4%) | 1 | 0/27 (0%) | 0 | 2/115 (1.7%) | 2 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Facial Bones Fracture | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 0/115 (0%) | 0 | 1/39 (2.6%) | 1 | 0/45 (0%) | 0 |
Injury, poisoning and procedural complications | ||||||||||
Fall | 6/71 (8.5%) | 6 | 2/27 (7.4%) | 2 | 9/115 (7.8%) | 9 | 2/39 (5.1%) | 2 | 2/45 (4.4%) | 2 |
Contusion | 5/71 (7%) | 5 | 2/27 (7.4%) | 2 | 5/115 (4.3%) | 5 | 3/39 (7.7%) | 3 | 1/45 (2.2%) | 1 |
Infusion Related Reaction | 1/71 (1.4%) | 1 | 0/27 (0%) | 0 | 0/115 (0%) | 0 | 1/39 (2.6%) | 1 | 1/45 (2.2%) | 1 |
Laceration | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 2/115 (1.7%) | 2 | 1/39 (2.6%) | 1 | 0/45 (0%) | 0 |
Procedural Pain | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 1/115 (0.9%) | 1 | 0/39 (0%) | 0 | 1/45 (2.2%) | 1 |
Skin Abrasion | 1/71 (1.4%) | 1 | 0/27 (0%) | 0 | 1/115 (0.9%) | 1 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Transfusion Reaction | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 1/115 (0.9%) | 1 | 1/39 (2.6%) | 1 | 0/45 (0%) | 0 |
Allergic Transfusion Reaction | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 0/115 (0%) | 0 | 1/39 (2.6%) | 1 | 0/45 (0%) | 0 |
Animal Bite | 0/71 (0%) | 0 | 1/27 (3.7%) | 1 | 0/115 (0%) | 0 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Head Injury | 1/71 (1.4%) | 1 | 0/27 (0%) | 0 | 0/115 (0%) | 0 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Joint Injury | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 1/115 (0.9%) | 1 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Overdose | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 1/115 (0.9%) | 1 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Periorbital Haematoma | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 0/115 (0%) | 0 | 0/39 (0%) | 0 | 1/45 (2.2%) | 1 |
Post Procedural Contusion | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 1/115 (0.9%) | 1 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Post Procedural Haemorrhage | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 0/115 (0%) | 0 | 0/39 (0%) | 0 | 1/45 (2.2%) | 1 |
Sunburn | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 0/115 (0%) | 0 | 1/39 (2.6%) | 1 | 0/45 (0%) | 0 |
Tooth Fracture | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 1/115 (0.9%) | 1 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Wound | 1/71 (1.4%) | 1 | 0/27 (0%) | 0 | 0/115 (0%) | 0 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Investigations | ||||||||||
Weight Decreased | 15/71 (21.1%) | 15 | 4/27 (14.8%) | 4 | 20/115 (17.4%) | 20 | 3/39 (7.7%) | 3 | 3/45 (6.7%) | 3 |
Alanine Aminotransferase Increased | 2/71 (2.8%) | 2 | 2/27 (7.4%) | 2 | 5/115 (4.3%) | 5 | 2/39 (5.1%) | 2 | 1/45 (2.2%) | 1 |
Aspartate Aminotransferase Increased | 2/71 (2.8%) | 2 | 0/27 (0%) | 0 | 5/115 (4.3%) | 5 | 2/39 (5.1%) | 2 | 1/45 (2.2%) | 1 |
International Normalised Ratio Increased | 1/71 (1.4%) | 1 | 2/27 (7.4%) | 2 | 4/115 (3.5%) | 4 | 3/39 (7.7%) | 3 | 0/45 (0%) | 0 |
Weight Increased | 2/71 (2.8%) | 2 | 1/27 (3.7%) | 1 | 0/115 (0%) | 0 | 6/39 (15.4%) | 6 | 1/45 (2.2%) | 1 |
Blood Lactate Dehydrogenase Increased | 5/71 (7%) | 5 | 0/27 (0%) | 0 | 1/115 (0.9%) | 1 | 1/39 (2.6%) | 1 | 0/45 (0%) | 0 |
Blood Alkaline Phosphatase Increased | 2/71 (2.8%) | 2 | 0/27 (0%) | 0 | 2/115 (1.7%) | 2 | 1/39 (2.6%) | 1 | 1/45 (2.2%) | 1 |
C-Reactive Protein Increased | 1/71 (1.4%) | 1 | 1/27 (3.7%) | 1 | 2/115 (1.7%) | 2 | 2/39 (5.1%) | 2 | 0/45 (0%) | 0 |
Blood Uric Acid Increased | 2/71 (2.8%) | 2 | 0/27 (0%) | 0 | 2/115 (1.7%) | 2 | 1/39 (2.6%) | 1 | 0/45 (0%) | 0 |
Electrocardiogram Qt Prolonged | 1/71 (1.4%) | 1 | 0/27 (0%) | 0 | 2/115 (1.7%) | 2 | 1/39 (2.6%) | 1 | 1/45 (2.2%) | 1 |
Activated Partial Thromboplastin Time Prolonged | 1/71 (1.4%) | 1 | 0/27 (0%) | 0 | 2/115 (1.7%) | 2 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Blood Creatine Phosphokinase Increased | 1/71 (1.4%) | 1 | 0/27 (0%) | 0 | 1/115 (0.9%) | 1 | 1/39 (2.6%) | 1 | 0/45 (0%) | 0 |
Blood Thyroid Stimulating Hormone Increased | 2/71 (2.8%) | 2 | 0/27 (0%) | 0 | 0/115 (0%) | 0 | 1/39 (2.6%) | 1 | 0/45 (0%) | 0 |
General Physical Condition Abnormal | 0/71 (0%) | 0 | 1/27 (3.7%) | 1 | 0/115 (0%) | 0 | 0/39 (0%) | 0 | 2/45 (4.4%) | 2 |
Blood Creatine Phosphokinase Decreased | 2/71 (2.8%) | 2 | 0/27 (0%) | 0 | 0/115 (0%) | 0 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Blood Pressure Decreased | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 1/115 (0.9%) | 1 | 0/39 (0%) | 0 | 1/45 (2.2%) | 1 |
Blood Urea Increased | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 1/115 (0.9%) | 1 | 1/39 (2.6%) | 1 | 0/45 (0%) | 0 |
Cardiac Murmur | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 2/115 (1.7%) | 2 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Ejection Fraction Decreased | 1/71 (1.4%) | 1 | 0/27 (0%) | 0 | 1/115 (0.9%) | 1 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Electrocardiogram Change | 1/71 (1.4%) | 1 | 0/27 (0%) | 0 | 1/115 (0.9%) | 1 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Hypophonesis | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 2/115 (1.7%) | 2 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Oxygen Saturation Decreased | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 2/115 (1.7%) | 2 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Transaminases Increased | 1/71 (1.4%) | 1 | 0/27 (0%) | 0 | 0/115 (0%) | 0 | 0/39 (0%) | 0 | 1/45 (2.2%) | 1 |
Alpha 1 Foetoprotein Increased | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 0/115 (0%) | 0 | 1/39 (2.6%) | 1 | 0/45 (0%) | 0 |
Astrovirus Test Positive | 0/71 (0%) | 0 | 1/27 (3.7%) | 1 | 0/115 (0%) | 0 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Bilirubin Urine | 1/71 (1.4%) | 1 | 0/27 (0%) | 0 | 0/115 (0%) | 0 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Blast Cell Count Increased | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 0/115 (0%) | 0 | 1/39 (2.6%) | 1 | 0/45 (0%) | 0 |
Bleeding Time Prolonged | 1/71 (1.4%) | 1 | 0/27 (0%) | 0 | 0/115 (0%) | 0 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Blood Alkaline Phosphatase Decreased | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 1/115 (0.9%) | 1 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Blood Lactic Acid Increased | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 0/115 (0%) | 0 | 0/39 (0%) | 0 | 1/45 (2.2%) | 1 |
Blood Test Abnormal | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 1/115 (0.9%) | 1 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Body Temperature Increased | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 0/115 (0%) | 0 | 1/39 (2.6%) | 1 | 0/45 (0%) | 0 |
Gamma-Glutamyltransferase Increased | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 0/115 (0%) | 0 | 1/39 (2.6%) | 1 | 0/45 (0%) | 0 |
Glomerular Filtration Rate Decreased | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 1/115 (0.9%) | 1 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Liver Function Test Increased | 1/71 (1.4%) | 1 | 0/27 (0%) | 0 | 0/115 (0%) | 0 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Prothrombin Time Prolonged | 1/71 (1.4%) | 1 | 0/27 (0%) | 0 | 0/115 (0%) | 0 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
White Blood Cell Count | 1/71 (1.4%) | 1 | 0/27 (0%) | 0 | 0/115 (0%) | 0 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
White Blood Cell Count Increased | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 0/115 (0%) | 0 | 0/39 (0%) | 0 | 1/45 (2.2%) | 1 |
Metabolism and nutrition disorders | ||||||||||
Hyponatraemia | 26/71 (36.6%) | 26 | 6/27 (22.2%) | 6 | 25/115 (21.7%) | 25 | 3/39 (7.7%) | 3 | 1/45 (2.2%) | 1 |
Hypokalaemia | 10/71 (14.1%) | 10 | 1/27 (3.7%) | 1 | 9/115 (7.8%) | 9 | 5/39 (12.8%) | 5 | 6/45 (13.3%) | 6 |
Hypocalcaemia | 5/71 (7%) | 5 | 2/27 (7.4%) | 2 | 11/115 (9.6%) | 11 | 2/39 (5.1%) | 2 | 4/45 (8.9%) | 4 |
Hypercreatininaemia | 5/71 (7%) | 5 | 0/27 (0%) | 0 | 13/115 (11.3%) | 13 | 2/39 (5.1%) | 2 | 1/45 (2.2%) | 1 |
Hypomagnesaemia | 7/71 (9.9%) | 7 | 0/27 (0%) | 0 | 9/115 (7.8%) | 9 | 2/39 (5.1%) | 2 | 3/45 (6.7%) | 3 |
Hyperglycaemia | 6/71 (8.5%) | 6 | 3/27 (11.1%) | 3 | 7/115 (6.1%) | 7 | 1/39 (2.6%) | 1 | 3/45 (6.7%) | 3 |
Hyperkalaemia | 8/71 (11.3%) | 8 | 2/27 (7.4%) | 2 | 9/115 (7.8%) | 9 | 1/39 (2.6%) | 1 | 0/45 (0%) | 0 |
Dehydration | 8/71 (11.3%) | 8 | 0/27 (0%) | 0 | 6/115 (5.2%) | 6 | 3/39 (7.7%) | 3 | 2/45 (4.4%) | 2 |
Hypophosphataemia | 9/71 (12.7%) | 9 | 1/27 (3.7%) | 1 | 5/115 (4.3%) | 5 | 0/39 (0%) | 0 | 1/45 (2.2%) | 1 |
Hyperuricaemia | 5/71 (7%) | 5 | 1/27 (3.7%) | 1 | 2/115 (1.7%) | 2 | 1/39 (2.6%) | 1 | 1/45 (2.2%) | 1 |
Hypoalbuminaemia | 4/71 (5.6%) | 4 | 1/27 (3.7%) | 1 | 1/115 (0.9%) | 1 | 2/39 (5.1%) | 2 | 2/45 (4.4%) | 2 |
Hypercalcaemia | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 4/115 (3.5%) | 4 | 1/39 (2.6%) | 1 | 0/45 (0%) | 0 |
Hypermagnesaemia | 3/71 (4.2%) | 3 | 0/27 (0%) | 0 | 1/115 (0.9%) | 1 | 0/39 (0%) | 0 | 1/45 (2.2%) | 1 |
Cachexia | 0/71 (0%) | 0 | 1/27 (3.7%) | 1 | 3/115 (2.6%) | 3 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Hyperlipasaemia | 1/71 (1.4%) | 1 | 0/27 (0%) | 0 | 3/115 (2.6%) | 3 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Hyperphosphataemia | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 3/115 (2.6%) | 3 | 0/39 (0%) | 0 | 1/45 (2.2%) | 1 |
Hypoglycaemia | 3/71 (4.2%) | 3 | 0/27 (0%) | 0 | 1/115 (0.9%) | 1 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Fluid Retention | 1/71 (1.4%) | 1 | 0/27 (0%) | 0 | 0/115 (0%) | 0 | 1/39 (2.6%) | 1 | 1/45 (2.2%) | 1 |
Hyperamylasaemia | 1/71 (1.4%) | 1 | 0/27 (0%) | 0 | 2/115 (1.7%) | 2 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Fluid Overload | 2/71 (2.8%) | 2 | 0/27 (0%) | 0 | 0/115 (0%) | 0 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Tumour Lysis Syndrome | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 1/115 (0.9%) | 1 | 0/39 (0%) | 0 | 1/45 (2.2%) | 1 |
Type 2 Diabetes Mellitus | 1/71 (1.4%) | 1 | 0/27 (0%) | 0 | 0/115 (0%) | 0 | 1/39 (2.6%) | 1 | 0/45 (0%) | 0 |
Diabetes Mellitus | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 1/115 (0.9%) | 1 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Failure To Thrive | 1/71 (1.4%) | 1 | 0/27 (0%) | 0 | 0/115 (0%) | 0 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Gout | 1/71 (1.4%) | 1 | 0/27 (0%) | 0 | 0/115 (0%) | 0 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Hyperglycaemic Hyperosmolar Nonketotic Syndrome | 1/71 (1.4%) | 1 | 0/27 (0%) | 0 | 0/115 (0%) | 0 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Hyperhomocysteinaemia | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 1/115 (0.9%) | 1 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Hypernatraemia | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 1/115 (0.9%) | 1 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Hypouricaemia | 0/71 (0%) | 0 | 1/27 (3.7%) | 1 | 0/115 (0%) | 0 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Metabolic Acidosis | 1/71 (1.4%) | 1 | 0/27 (0%) | 0 | 0/115 (0%) | 0 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Polydipsia | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 1/115 (0.9%) | 1 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Musculoskeletal and connective tissue disorders | ||||||||||
Arthralgia | 5/71 (7%) | 5 | 0/27 (0%) | 0 | 6/115 (5.2%) | 6 | 5/39 (12.8%) | 5 | 1/45 (2.2%) | 1 |
Back Pain | 0/71 (0%) | 0 | 1/27 (3.7%) | 1 | 6/115 (5.2%) | 6 | 5/39 (12.8%) | 5 | 5/45 (11.1%) | 5 |
Muscular Weakness | 5/71 (7%) | 5 | 0/27 (0%) | 0 | 4/115 (3.5%) | 4 | 3/39 (7.7%) | 3 | 0/45 (0%) | 0 |
Pain In Extremity | 4/71 (5.6%) | 4 | 0/27 (0%) | 0 | 3/115 (2.6%) | 3 | 1/39 (2.6%) | 1 | 2/45 (4.4%) | 2 |
Muscle Spasms | 1/71 (1.4%) | 1 | 2/27 (7.4%) | 2 | 2/115 (1.7%) | 2 | 1/39 (2.6%) | 1 | 3/45 (6.7%) | 3 |
Bone Pain | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 5/115 (4.3%) | 5 | 1/39 (2.6%) | 1 | 0/45 (0%) | 0 |
Musculoskeletal Pain | 1/71 (1.4%) | 1 | 0/27 (0%) | 0 | 2/115 (1.7%) | 2 | 2/39 (5.1%) | 2 | 0/45 (0%) | 0 |
Myalgia | 2/71 (2.8%) | 2 | 0/27 (0%) | 0 | 1/115 (0.9%) | 1 | 2/39 (5.1%) | 2 | 0/45 (0%) | 0 |
Neck Pain | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 2/115 (1.7%) | 2 | 1/39 (2.6%) | 1 | 2/45 (4.4%) | 2 |
Arthritis | 0/71 (0%) | 0 | 1/27 (3.7%) | 1 | 1/115 (0.9%) | 1 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Flank Pain | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 0/115 (0%) | 0 | 1/39 (2.6%) | 1 | 1/45 (2.2%) | 1 |
Hypercreatinaemia | 2/71 (2.8%) | 2 | 0/27 (0%) | 0 | 0/115 (0%) | 0 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Joint Swelling | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 2/115 (1.7%) | 2 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Musculoskeletal Chest Pain | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 0/115 (0%) | 0 | 1/39 (2.6%) | 1 | 1/45 (2.2%) | 1 |
Pain In Jaw | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 1/115 (0.9%) | 1 | 1/39 (2.6%) | 1 | 0/45 (0%) | 0 |
Bursitis | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 1/115 (0.9%) | 1 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Groin Pain | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 0/115 (0%) | 0 | 1/39 (2.6%) | 1 | 0/45 (0%) | 0 |
Ligament Pain | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 0/115 (0%) | 0 | 0/39 (0%) | 0 | 1/45 (2.2%) | 1 |
Limb Discomfort | 1/71 (1.4%) | 1 | 0/27 (0%) | 0 | 0/115 (0%) | 0 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Limb Mass | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 1/115 (0.9%) | 1 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Muscle Mass | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 1/115 (0.9%) | 1 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Muscle Tightness | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 1/115 (0.9%) | 1 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Muscle Twitching | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 1/115 (0.9%) | 1 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Osteitis | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 0/115 (0%) | 0 | 1/39 (2.6%) | 1 | 0/45 (0%) | 0 |
Osteoarthritis | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 0/115 (0%) | 0 | 1/39 (2.6%) | 1 | 0/45 (0%) | 0 |
Spinal Osteoarthritis | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 0/115 (0%) | 0 | 0/39 (0%) | 0 | 1/45 (2.2%) | 1 |
Torticollis | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 0/115 (0%) | 0 | 0/39 (0%) | 0 | 1/45 (2.2%) | 1 |
Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||||||
Acute Myeloid Leukaemia | 1/71 (1.4%) | 1 | 0/27 (0%) | 0 | 0/115 (0%) | 0 | 1/39 (2.6%) | 1 | 0/45 (0%) | 0 |
Basal Cell Carcinoma | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 0/115 (0%) | 0 | 0/39 (0%) | 0 | 1/45 (2.2%) | 1 |
Chloroma | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 0/115 (0%) | 0 | 0/39 (0%) | 0 | 1/45 (2.2%) | 1 |
Leukaemic Infiltration | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 0/115 (0%) | 0 | 1/39 (2.6%) | 1 | 0/45 (0%) | 0 |
Uterine Leiomyoma | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 1/115 (0.9%) | 1 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Nervous system disorders | ||||||||||
Dysgeusia | 7/71 (9.9%) | 7 | 3/27 (11.1%) | 3 | 12/115 (10.4%) | 12 | 3/39 (7.7%) | 3 | 2/45 (4.4%) | 2 |
Headache | 5/71 (7%) | 5 | 3/27 (11.1%) | 3 | 3/115 (2.6%) | 3 | 7/39 (17.9%) | 7 | 6/45 (13.3%) | 6 |
Syncope | 3/71 (4.2%) | 3 | 1/27 (3.7%) | 1 | 5/115 (4.3%) | 5 | 2/39 (5.1%) | 2 | 0/45 (0%) | 0 |
Dizziness | 12/71 (16.9%) | 12 | 2/27 (7.4%) | 2 | 18/115 (15.7%) | 18 | 8/39 (20.5%) | 8 | 2/45 (4.4%) | 2 |
Presyncope | 1/71 (1.4%) | 1 | 3/27 (11.1%) | 3 | 3/115 (2.6%) | 3 | 0/39 (0%) | 0 | 2/45 (4.4%) | 2 |
Somnolence | 4/71 (5.6%) | 4 | 0/27 (0%) | 0 | 2/115 (1.7%) | 2 | 1/39 (2.6%) | 1 | 0/45 (0%) | 0 |
Ageusia | 1/71 (1.4%) | 1 | 1/27 (3.7%) | 1 | 2/115 (1.7%) | 2 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Balance Disorder | 2/71 (2.8%) | 2 | 1/27 (3.7%) | 1 | 1/115 (0.9%) | 1 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Memory Impairment | 3/71 (4.2%) | 3 | 0/27 (0%) | 0 | 1/115 (0.9%) | 1 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Ataxia | 1/71 (1.4%) | 1 | 1/27 (3.7%) | 1 | 1/115 (0.9%) | 1 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Lethargy | 1/71 (1.4%) | 1 | 0/27 (0%) | 0 | 1/115 (0.9%) | 1 | 0/39 (0%) | 0 | 1/45 (2.2%) | 1 |
Polyneuropathy | 1/71 (1.4%) | 1 | 0/27 (0%) | 0 | 1/115 (0.9%) | 1 | 0/39 (0%) | 0 | 1/45 (2.2%) | 1 |
Tremor | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 2/115 (1.7%) | 2 | 1/39 (2.6%) | 1 | 0/45 (0%) | 0 |
Aphasia | 1/71 (1.4%) | 1 | 0/27 (0%) | 0 | 1/115 (0.9%) | 1 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Cognitive Disorder | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 1/115 (0.9%) | 1 | 1/39 (2.6%) | 1 | 0/45 (0%) | 0 |
Dysarthria | 2/71 (2.8%) | 2 | 0/27 (0%) | 0 | 0/115 (0%) | 0 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Neuropathy Peripheral | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 2/115 (1.7%) | 2 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Paraesthesia | 0/71 (0%) | 0 | 2/27 (7.4%) | 2 | 0/115 (0%) | 0 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Speech Disorder | 1/71 (1.4%) | 1 | 1/27 (3.7%) | 1 | 0/115 (0%) | 0 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Aphonia | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 1/115 (0.9%) | 1 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Cogwheel Rigidity | 1/71 (1.4%) | 1 | 0/27 (0%) | 0 | 0/115 (0%) | 0 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Coordination Abnormal | 1/71 (1.4%) | 1 | 0/27 (0%) | 0 | 0/115 (0%) | 0 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Drooling | 1/71 (1.4%) | 1 | 0/27 (0%) | 0 | 0/115 (0%) | 0 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Dysaesthesia | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 1/115 (0.9%) | 1 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Encephalopathy | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 0/115 (0%) | 0 | 1/39 (2.6%) | 1 | 0/45 (0%) | 0 |
Haemorrhage Intracranial | 1/71 (1.4%) | 1 | 0/27 (0%) | 0 | 0/115 (0%) | 0 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Hemianopia | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 1/115 (0.9%) | 1 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Hemianopia Homonymous | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 1/115 (0.9%) | 1 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Hypersomnia | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 1/115 (0.9%) | 1 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Hypoaesthesia | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 0/115 (0%) | 0 | 0/39 (0%) | 0 | 1/45 (2.2%) | 1 |
Hyposmia | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 1/115 (0.9%) | 1 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Migraine | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 1/115 (0.9%) | 1 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Parosmia | 0/71 (0%) | 0 | 1/27 (3.7%) | 1 | 0/115 (0%) | 0 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Peripheral Sensory Neuropathy | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 1/115 (0.9%) | 1 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Sensory Loss | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 0/115 (0%) | 0 | 1/39 (2.6%) | 1 | 0/45 (0%) | 0 |
Synaesthesia | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 1/115 (0.9%) | 1 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Psychiatric disorders | ||||||||||
Insomnia | 10/71 (14.1%) | 10 | 4/27 (14.8%) | 4 | 7/115 (6.1%) | 7 | 4/39 (10.3%) | 4 | 3/45 (6.7%) | 3 |
Confusional State | 5/71 (7%) | 5 | 2/27 (7.4%) | 2 | 8/115 (7%) | 8 | 2/39 (5.1%) | 2 | 3/45 (6.7%) | 3 |
Anxiety | 2/71 (2.8%) | 2 | 2/27 (7.4%) | 2 | 4/115 (3.5%) | 4 | 2/39 (5.1%) | 2 | 1/45 (2.2%) | 1 |
Depression | 2/71 (2.8%) | 2 | 2/27 (7.4%) | 2 | 2/115 (1.7%) | 2 | 3/39 (7.7%) | 3 | 1/45 (2.2%) | 1 |
Agitation | 6/71 (8.5%) | 6 | 0/27 (0%) | 0 | 0/115 (0%) | 0 | 1/39 (2.6%) | 1 | 0/45 (0%) | 0 |
Restlessness | 0/71 (0%) | 0 | 2/27 (7.4%) | 2 | 0/115 (0%) | 0 | 0/39 (0%) | 0 | 1/45 (2.2%) | 1 |
Abnormal Dreams | 1/71 (1.4%) | 1 | 0/27 (0%) | 0 | 0/115 (0%) | 0 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Bulimia Nervosa | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 1/115 (0.9%) | 1 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Delirium | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 1/115 (0.9%) | 1 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Disorientation | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 1/115 (0.9%) | 1 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Flat Affect | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 1/115 (0.9%) | 1 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Hallucination, Visual | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 0/115 (0%) | 0 | 1/39 (2.6%) | 1 | 0/45 (0%) | 0 |
Irritability | 1/71 (1.4%) | 1 | 0/27 (0%) | 0 | 0/115 (0%) | 0 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Listless | 1/71 (1.4%) | 1 | 0/27 (0%) | 0 | 0/115 (0%) | 0 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Mental Disorder | 1/71 (1.4%) | 1 | 0/27 (0%) | 0 | 0/115 (0%) | 0 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Mental Status Changes | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 1/115 (0.9%) | 1 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Nervousness | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 1/115 (0.9%) | 1 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Psychomotor Retardation | 1/71 (1.4%) | 1 | 0/27 (0%) | 0 | 0/115 (0%) | 0 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Renal and urinary disorders | ||||||||||
Acute Kidney Injury | 8/71 (11.3%) | 8 | 2/27 (7.4%) | 2 | 3/115 (2.6%) | 3 | 2/39 (5.1%) | 2 | 3/45 (6.7%) | 3 |
Haematuria | 3/71 (4.2%) | 3 | 3/27 (11.1%) | 3 | 1/115 (0.9%) | 1 | 2/39 (5.1%) | 2 | 3/45 (6.7%) | 3 |
Pollakiuria | 2/71 (2.8%) | 2 | 0/27 (0%) | 0 | 3/115 (2.6%) | 3 | 1/39 (2.6%) | 1 | 2/45 (4.4%) | 2 |
Proteinuria | 3/71 (4.2%) | 3 | 1/27 (3.7%) | 1 | 1/115 (0.9%) | 1 | 2/39 (5.1%) | 2 | 1/45 (2.2%) | 1 |
Dysuria | 1/71 (1.4%) | 1 | 1/27 (3.7%) | 1 | 2/115 (1.7%) | 2 | 0/39 (0%) | 0 | 2/45 (4.4%) | 2 |
Renal Failure | 2/71 (2.8%) | 2 | 1/27 (3.7%) | 1 | 1/115 (0.9%) | 1 | 1/39 (2.6%) | 1 | 1/45 (2.2%) | 1 |
Urinary Incontinence | 2/71 (2.8%) | 2 | 1/27 (3.7%) | 1 | 1/115 (0.9%) | 1 | 1/39 (2.6%) | 1 | 0/45 (0%) | 0 |
Urinary Retention | 0/71 (0%) | 0 | 1/27 (3.7%) | 1 | 2/115 (1.7%) | 2 | 1/39 (2.6%) | 1 | 0/45 (0%) | 0 |
Bladder Dilatation | 1/71 (1.4%) | 1 | 0/27 (0%) | 0 | 1/115 (0.9%) | 1 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Chronic Kidney Disease | 1/71 (1.4%) | 1 | 0/27 (0%) | 0 | 0/115 (0%) | 0 | 1/39 (2.6%) | 1 | 0/45 (0%) | 0 |
Micturition Urgency | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 1/115 (0.9%) | 1 | 0/39 (0%) | 0 | 1/45 (2.2%) | 1 |
Bladder Pain | 0/71 (0%) | 0 | 1/27 (3.7%) | 1 | 0/115 (0%) | 0 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Chromaturia | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 1/115 (0.9%) | 1 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Incontinence | 1/71 (1.4%) | 1 | 0/27 (0%) | 0 | 0/115 (0%) | 0 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Nocturia | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 1/115 (0.9%) | 1 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Polyuria | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 1/115 (0.9%) | 1 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Urethral Caruncle | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 1/115 (0.9%) | 1 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Urethral Haemorrhage | 1/71 (1.4%) | 1 | 0/27 (0%) | 0 | 0/115 (0%) | 0 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Urge Incontinence | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 1/115 (0.9%) | 1 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Urinary Tract Obstruction | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 0/115 (0%) | 0 | 0/39 (0%) | 0 | 1/45 (2.2%) | 1 |
Urinary Tract Pain | 0/71 (0%) | 0 | 1/27 (3.7%) | 1 | 0/115 (0%) | 0 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Reproductive system and breast disorders | ||||||||||
Breast Pain | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 0/115 (0%) | 0 | 0/39 (0%) | 0 | 1/45 (2.2%) | 1 |
Breast Swelling | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 1/115 (0.9%) | 1 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Gynaecomastia | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 0/115 (0%) | 0 | 0/39 (0%) | 0 | 1/45 (2.2%) | 1 |
Nipple Pain | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 1/115 (0.9%) | 1 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Oedema Genital | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 1/115 (0.9%) | 1 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Ovarian Cyst | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 1/115 (0.9%) | 1 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Testicular Oedema | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 0/115 (0%) | 0 | 0/39 (0%) | 0 | 1/45 (2.2%) | 1 |
Vaginal Haemorrhage | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 1/115 (0.9%) | 1 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Respiratory, thoracic and mediastinal disorders | ||||||||||
Dyspnoea | 14/71 (19.7%) | 14 | 5/27 (18.5%) | 5 | 24/115 (20.9%) | 24 | 8/39 (20.5%) | 8 | 10/45 (22.2%) | 10 |
Epistaxis | 13/71 (18.3%) | 13 | 3/27 (11.1%) | 3 | 25/115 (21.7%) | 25 | 7/39 (17.9%) | 7 | 7/45 (15.6%) | 7 |
Cough | 12/71 (16.9%) | 12 | 3/27 (11.1%) | 3 | 15/115 (13%) | 15 | 5/39 (12.8%) | 5 | 8/45 (17.8%) | 8 |
Oropharyngeal Pain | 3/71 (4.2%) | 3 | 2/27 (7.4%) | 2 | 3/115 (2.6%) | 3 | 2/39 (5.1%) | 2 | 3/45 (6.7%) | 3 |
Productive Cough | 4/71 (5.6%) | 4 | 0/27 (0%) | 0 | 3/115 (2.6%) | 0 | 3/39 (7.7%) | 3 | 1/45 (2.2%) | 1 |
Haemoptysis | 2/71 (2.8%) | 2 | 0/27 (0%) | 0 | 2/115 (1.7%) | 2 | 1/39 (2.6%) | 1 | 3/45 (6.7%) | 3 |
Dyspnoea Exertional | 1/71 (1.4%) | 1 | 0/27 (0%) | 0 | 4/115 (3.5%) | 4 | 1/39 (2.6%) | 1 | 1/45 (2.2%) | 1 |
Nasal Congestion | 1/71 (1.4%) | 1 | 1/27 (3.7%) | 1 | 4/115 (3.5%) | 4 | 0/39 (0%) | 0 | 1/45 (2.2%) | 1 |
Pleural Effusion | 1/71 (1.4%) | 1 | 2/27 (7.4%) | 2 | 2/115 (1.7%) | 2 | 2/39 (5.1%) | 2 | 0/45 (0%) | 0 |
Hypoxia | 2/71 (2.8%) | 2 | 0/27 (0%) | 0 | 1/115 (0.9%) | 1 | 1/39 (2.6%) | 1 | 2/45 (4.4%) | 2 |
Rhinorrhoea | 1/71 (1.4%) | 1 | 0/27 (0%) | 0 | 2/115 (1.7%) | 2 | 0/39 (0%) | 0 | 2/45 (4.4%) | 2 |
Wheezing | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 2/115 (1.7%) | 2 | 1/39 (2.6%) | 1 | 2/45 (4.4%) | 2 |
Atelectasis | 2/71 (2.8%) | 2 | 0/27 (0%) | 0 | 0/115 (0%) | 0 | 0/39 (0%) | 0 | 1/45 (2.2%) | 1 |
Hiccups | 1/71 (1.4%) | 1 | 0/27 (0%) | 0 | 2/115 (1.7%) | 2 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Pleuritic Pain | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 1/115 (0.9%) | 1 | 1/39 (2.6%) | 1 | 1/45 (2.2%) | 1 |
Respiratory Failure | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 2/115 (1.7%) | 2 | 0/39 (0%) | 0 | 1/45 (2.2%) | 1 |
Pulmonary Oedema | 1/71 (1.4%) | 1 | 0/27 (0%) | 0 | 0/115 (0%) | 0 | 1/39 (2.6%) | 1 | 0/45 (0%) | 0 |
Sinus Congestion | 1/71 (1.4%) | 1 | 0/27 (0%) | 0 | 1/115 (0.9%) | 1 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Sinus Pain | 1/71 (1.4%) | 1 | 0/27 (0%) | 0 | 1/115 (0.9%) | 1 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Upper-Airway Cough Syndrome | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 0/115 (0%) | 0 | 1/39 (2.6%) | 1 | 1/45 (2.2%) | 1 |
Chronic Obstructive Pulmonary Disease | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 0/115 (0%) | 0 | 0/39 (0%) | 0 | 1/45 (2.2%) | 1 |
Dysphonia | 0/71 (0%) | 0 | 1/27 (3.7%) | 1 | 0/115 (0%) | 0 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Laryngeal Pain | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 0/115 (0%) | 0 | 1/39 (2.6%) | 1 | 0/45 (0%) | 0 |
Lung Consolidation | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 0/115 (0%) | 0 | 0/39 (0%) | 0 | 1/45 (2.2%) | 1 |
Lung Infiltration | 1/71 (1.4%) | 1 | 0/27 (0%) | 0 | 0/115 (0%) | 0 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Nasal Dryness | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 1/115 (0.9%) | 1 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Nasal Inflammation | 0/71 (0%) | 0 | 1/27 (3.7%) | 1 | 0/115 (0%) | 0 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Paranasal Sinus Discomfort | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 1/115 (0.9%) | 1 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Pharyngeal Inflammation | 0/71 (0%) | 0 | 1/27 (3.7%) | 1 | 0/115 (0%) | 0 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Pneumonitis | 1/71 (1.4%) | 1 | 0/27 (0%) | 0 | 0/115 (0%) | 0 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Pulmonary Mass | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 0/115 (0%) | 0 | 0/39 (0%) | 0 | 1/45 (2.2%) | 1 |
Rales | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 0/115 (0%) | 0 | 0/39 (0%) | 0 | 1/45 (2.2%) | 1 |
Respiratory Tract Congestion | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 0/115 (0%) | 0 | 1/39 (2.6%) | 1 | 0/45 (0%) | 0 |
Rhinitis Allergic | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 1/115 (0.9%) | 1 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Rhonchi | 1/71 (1.4%) | 1 | 0/27 (0%) | 0 | 0/115 (0%) | 0 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Sinus Disorder | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 0/115 (0%) | 0 | 1/39 (2.6%) | 1 | 0/45 (0%) | 0 |
Tachypnoea | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 1/115 (0.9%) | 1 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Tonsillar Erythema | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 0/115 (0%) | 0 | 1/39 (2.6%) | 1 | 0/45 (0%) | 0 |
Tonsillar Hypertrophy | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 0/115 (0%) | 0 | 1/39 (2.6%) | 1 | 0/45 (0%) | 0 |
Skin and subcutaneous tissue disorders | ||||||||||
Night Sweats | 8/71 (11.3%) | 8 | 3/27 (11.1%) | 3 | 10/115 (8.7%) | 10 | 1/39 (2.6%) | 1 | 4/45 (8.9%) | 4 |
Petechiae | 4/71 (5.6%) | 4 | 0/27 (0%) | 0 | 3/115 (2.6%) | 3 | 7/39 (17.9%) | 7 | 6/45 (13.3%) | 6 |
Hyperhidrosis | 6/71 (8.5%) | 6 | 0/27 (0%) | 0 | 3/115 (2.6%) | 3 | 1/39 (2.6%) | 1 | 1/45 (2.2%) | 1 |
Rash | 2/71 (2.8%) | 2 | 1/27 (3.7%) | 1 | 1/115 (0.9%) | 1 | 4/39 (10.3%) | 4 | 2/45 (4.4%) | 2 |
Rash Maculo-Papular | 1/71 (1.4%) | 1 | 0/27 (0%) | 0 | 3/115 (2.6%) | 3 | 2/39 (5.1%) | 2 | 2/45 (4.4%) | 2 |
Ecchymosis | 3/71 (4.2%) | 3 | 0/27 (0%) | 0 | 1/115 (0.9%) | 1 | 1/39 (2.6%) | 1 | 2/45 (4.4%) | 2 |
Pruritus | 1/71 (1.4%) | 1 | 1/27 (3.7%) | 1 | 2/115 (1.7%) | 2 | 2/39 (5.1%) | 2 | 1/45 (2.2%) | 1 |
Skin Lesion | 3/71 (4.2%) | 3 | 0/27 (0%) | 0 | 1/115 (0.9%) | 1 | 2/39 (5.1%) | 2 | 0/45 (0%) | 0 |
Skin Ulcer | 1/71 (1.4%) | 1 | 1/27 (3.7%) | 1 | 2/115 (1.7%) | 2 | 0/39 (0%) | 0 | 1/45 (2.2%) | 1 |
Alopecia | 1/71 (1.4%) | 1 | 0/27 (0%) | 0 | 2/115 (1.7%) | 2 | 1/39 (2.6%) | 1 | 0/45 (0%) | 0 |
Decubitus Ulcer | 2/71 (2.8%) | 2 | 0/27 (0%) | 0 | 0/115 (0%) | 0 | 2/39 (5.1%) | 2 | 0/45 (0%) | 0 |
Erythema | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 2/115 (1.7%) | 2 | 0/39 (0%) | 0 | 2/45 (4.4%) | 2 |
Cold Sweat | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 0/115 (0%) | 0 | 2/39 (5.1%) | 2 | 0/45 (0%) | 0 |
Dermatitis | 1/71 (1.4%) | 1 | 0/27 (0%) | 0 | 1/115 (0.9%) | 1 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Purpura | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 1/115 (0.9%) | 1 | 1/39 (2.6%) | 1 | 0/45 (0%) | 0 |
Skin Mass | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 1/115 (0.9%) | 1 | 0/39 (0%) | 0 | 1/45 (2.2%) | 1 |
Swelling Face | 1/71 (1.4%) | 1 | 0/27 (0%) | 0 | 1/115 (0.9%) | 1 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Dermal Cyst | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 0/115 (0%) | 0 | 1/39 (2.6%) | 1 | 0/45 (0%) | 0 |
Dermatitis Acneiform | 1/71 (1.4%) | 1 | 0/27 (0%) | 0 | 0/115 (0%) | 0 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Dermatitis Bullous | 0/71 (0%) | 0 | 1/27 (3.7%) | 1 | 0/115 (0%) | 0 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Dry Skin | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 0/115 (0%) | 0 | 1/39 (2.6%) | 1 | 0/45 (0%) | 0 |
Facial Wasting | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 1/115 (0.9%) | 1 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Macule | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 1/115 (0.9%) | 1 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Miliaria | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 1/115 (0.9%) | 1 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Nail Disorder | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 1/115 (0.9%) | 1 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Photosensitivity Reaction | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 1/115 (0.9%) | 1 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Rash Erythematous | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 0/115 (0%) | 0 | 0/39 (0%) | 0 | 1/45 (2.2%) | 1 |
Rash Pruritic | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 0/115 (0%) | 0 | 1/39 (2.6%) | 1 | 0/45 (0%) | 0 |
Skin Discolouration | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 1/115 (0.9%) | 1 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Skin Hyperpigmentation | 1/71 (1.4%) | 1 | 0/27 (0%) | 0 | 0/115 (0%) | 0 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Skin Induration | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 0/115 (0%) | 0 | 0/39 (0%) | 0 | 1/45 (2.2%) | 1 |
Skin Maceration | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 0/115 (0%) | 0 | 1/39 (2.6%) | 1 | 0/45 (0%) | 0 |
Urticaria | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 0/115 (0%) | 0 | 1/39 (2.6%) | 1 | 0/45 (0%) | 0 |
Vascular disorders | ||||||||||
Hypotension | 6/71 (8.5%) | 6 | 1/27 (3.7%) | 1 | 11/115 (9.6%) | 11 | 4/39 (10.3%) | 4 | 1/45 (2.2%) | 1 |
Haematoma | 0/71 (0%) | 0 | 2/27 (7.4%) | 2 | 5/115 (4.3%) | 5 | 7/39 (17.9%) | 7 | 1/45 (2.2%) | 1 |
Hypertension | 4/71 (5.6%) | 4 | 2/27 (7.4%) | 2 | 2/115 (1.7%) | 2 | 1/39 (2.6%) | 1 | 1/45 (2.2%) | 1 |
Pallor | 1/71 (1.4%) | 1 | 0/27 (0%) | 0 | 3/115 (2.6%) | 3 | 2/39 (5.1%) | 2 | 1/45 (2.2%) | 1 |
Haemorrhage | 1/71 (1.4%) | 1 | 0/27 (0%) | 0 | 2/115 (1.7%) | 2 | 0/39 (0%) | 0 | 1/45 (2.2%) | 1 |
Phlebitis | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 1/115 (0.9%) | 1 | 3/39 (7.7%) | 3 | 0/45 (0%) | 0 |
Thrombophlebitis | 2/71 (2.8%) | 2 | 0/27 (0%) | 0 | 0/115 (0%) | 0 | 1/39 (2.6%) | 1 | 1/45 (2.2%) | 1 |
Orthostatic Hypotension | 2/71 (2.8%) | 2 | 0/27 (0%) | 0 | 1/115 (0.9%) | 1 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Deep Vein Thrombosis | 2/71 (2.8%) | 2 | 0/27 (0%) | 0 | 0/115 (0%) | 0 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Flushing | 1/71 (1.4%) | 1 | 0/27 (0%) | 0 | 1/115 (0.9%) | 1 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Circulatory Collapse | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 1/115 (0.9%) | 1 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Embolism | 1/71 (1.4%) | 1 | 0/27 (0%) | 0 | 0/115 (0%) | 0 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Hot Flush | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 0/115 (0%) | 0 | 1/39 (2.6%) | 1 | 0/45 (0%) | 0 |
Intermittent Claudication | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 1/115 (0.9%) | 1 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Lymphoedema | 0/71 (0%) | 0 | 1/27 (3.7%) | 1 | 0/115 (0%) | 0 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Poor Peripheral Circulation | 1/71 (1.4%) | 1 | 0/27 (0%) | 0 | 0/115 (0%) | 0 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Thrombophlebitis Superficial | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 0/115 (0%) | 0 | 0/39 (0%) | 0 | 1/45 (2.2%) | 1 |
Venous Thrombosis | 0/71 (0%) | 0 | 0/27 (0%) | 0 | 1/115 (0.9%) | 1 | 0/39 (0%) | 0 | 0/45 (0%) | 0 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Results Point of Contact
Name/Title | Jatin Shah, MD |
---|---|
Organization | Karyopharm Therapeutics Inc. |
Phone | (617) 658-0600 |
jshah@karyopharm.com |
- KCP-330-008