ACP-196 (Acalabrutinib), a Novel Bruton Tyrosine Kinase (BTK) Inhibitor, for Treatment of Chronic Lymphocytic Leukemia, Richter's Syndrome or Prolymphocytic Leukemia
Official Title
A Phase 1/2, Multicenter, Open-label, and Dose-escalation Study of ACP-196 in Subjects With Chronic Lymphocytic Leukemia, Richter's Syndrome or Prolymphocytic Leukemia
Acronym
Not provided
Organization
Acerta Pharma BVINDUSTRY
Status Module
Record Verification Date
May 2026
Overall Recruitment Status or Expanded Access Status
Active, not recruiting
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Jan 30, 2014Actual
Primary Completion Date
Jul 15, 2021Actual
Completion Date
Jun 9, 2027Estimated
First Submitted Date
Jan 6, 2014
First Submission Date that Met QC Criteria
Jan 6, 2014
First Posted Date
Jan 8, 2014Estimated
Results Waived
Not provided
Results First Submitted Date
Jun 27, 2022
Results First Submitted that Met QC Criteria
Aug 17, 2022
Results First Posted Date
Sep 10, 2022Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
May 4, 2026
Last Update Posted Date
May 5, 2026Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Acerta Pharma BVINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
This study is evaluating the safety and efficacy of a new BTK inhibitor, acalabrutinib, for the treatment of chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL).
Detailed Description
Not provided
Conditions Module
Conditions
Chronic Lymphocytic Leukemia
Small Lymphocytic Lymphoma
Richter's Syndrome
Prolymphocytic Leukemia
Keywords
Bruton's tyrosine kinase inhibitor
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
306Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Relapsed/Refractory Cohort
Experimental
Phase 1 (dose-escalation) and Phase 2 (dose-expansion) will be conducted for participants with relapsed/refractory CLL or SLL. In Phase 1, participants will receive oral once daily (QD) acalabrutinib at Dose 1 (Cohort 1), Dose 2 (Cohort 2a), Dose 3 (Cohort 3), and Dose 4 (Cohort 4a), and twice daily (BID) acalabrutinib at Dose 1 (Cohort 2b) and Dose 5 (Cohort 4b) for 28 days (1 cycle). In Phase 2, participants will receive oral acalabrutinib at Dose 1 BID (Cohort 2b) or Dose 5 QD (Cohort 2c, later will be switched to Dose 1 BID per protocol amendment 6) until disease progression or until the investigator will consider the study treatment to be intolerable or no longer in the participant's best interest. Participants from Phase 1 will be continued to receive Dose 1 BID until disease progression or until the investigator will consider the study treatment to be intolerable or no longer in the participant's best interest.
Drug: Acalabrutinib
Treatment-naive Cohort
Experimental
Treatment-naïve participants with confirmed CLL or SLL, will receive oral acalabrutinib Dose 5 QD (Cohort 7, later will be switched to Dose 1 BID per protocol amendment 6) or Dose 1 BID (Cohort 11) until disease progression or until the investigator will consider the study treatment to be intolerable or no longer in the participant's best interest.
Drug: Acalabrutinib
Ibrutinib-intolerant Cohort
Experimental
Participants with confirmed CLL or SLL and were not tolerating ibrutinib treatment, will receive oral acalabrutinib Dose 5 QD (Cohort 8a, later switched to Dose 1 BID per protocol amendment 4) or Dose 1 BID (Cohort 8b) until disease progression or until the investigator will consider the study treatment to be intolerable or no longer in the participant's best interest.
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Acalabrutinib
Drug
Participants will receive acalabrutinib as stated in the arms' description.
Ibrutinib Relapsed/Refractory Cohort
Ibrutinib-intolerant Cohort
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Number of Participants With Dose Limiting Toxicities (DLTs) in Phase 1
Participants with DLTs in Phase 1 are reported. The DLT was defined as any of the following events unless the adverse event is clearly related to disease progression or the participant's current medical history and associated comorbidities: (1) Any Grade 3 or greater nonhematologic toxicity with the exceptions of alopecia and Grade 3 nausea, vomiting, and diarrhea that respond to supportive therapy; (2) Hematologic toxicities including Grade 4 neutropenia lasting more than 5 days, Grade 4 or Grade 3 thrombocytopenia with bleeding or any requirement for platelets transfusion, Grade 3 or greater febrile neutropenia (body temperature of 38.5 degrees Celsius or more), or Grade 4 anemia, unexplained by underlying disease; or (3) Dosing delay due to toxicity for > 7 consecutive days.
From Day 1 to Day 28 after first dose of study drug
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. The TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug.
Day 1 through the final data cutoff date (approximately 7 years 6 months)
Number of Participants With Treatment Emergent Events of Clinical Interest (ECI)
The treatment emergent ECI included the events identified based on preclinical findings, emerging data from clinical studies relating to acalabrutinib, and pharmacological effects of approved Bruton's tyrosine kinase (BTK) inhibitors and reported after the first dose of the study drug.
Day 1 through the final data cutoff date (approximately 7 years 6 months)
Secondary Outcomes
Measure
Description
Time Frame
Percentage of Participants With Objective Response (OR) as Assessed by the Investigator
For CLL/SLL, OR is defined as complete remission (CR), CR with incomplete marrow recovery (CRi), or partial remission (PR). CR: lymphocytes (lympho) <4×10^9/L, normocellular bone marrow (BM), normal lymph nodes (NLN), liver and spleen (L/S), absolute neutrophil count (ANC) >1.5×10^9/L, platelets >100×10^9/L, hemoglobin (Hb) >11g/dL. Cri: lympho <4×10^9/L, hypocellular BM, NLN, L/S, persistent anemia, hrombocytopenia, or neutropenia. PR: >=50% reduction in lymphadenopathy and/or enlargement of L/S or lympho (<5×10^9/L or >=50% decrease from baseline) and criteria of ANC/platelets/Hb per CR or >=50% improvement over baseline. Hematology result were without exogenous growth factors/transfusion. For RS, OR as CR or PR by Cheson et al. 2014 based on PET/CT scans and bone marrow. CR: disappearance of all detectable clinical evidence of disease and disease-related symptoms and PR: >=50% decrease in sum of the product diameter of 6 largest nodal masses and no new sites of disease.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Men and women ≥ 18 years of age with a confirmed diagnosis of CLL/SLL, which has relapsed after, or been refractory to, ≥ 2 previous treatments for CLL/SLL.
Must have measurable CLL/SLL defined as ≥ 1 lymph node ≥ 2 cm as measured in the longest diameter.
Active disease meeting ≥ 1 of the following International Workshop on Chronic Lymphocytic Leukemia (IWCLL) 2008 criteria for requiring treatment:
Evidence of progressive marrow failure as manifested by the development of, or worsening of, anemia (hemoglobin < 10 g/dL) and/or thrombocytopenia (platelets < 100,000/μL).
Massive (i.e., ≥ 6 cm below the left costal margin), progressive, or symptomatic splenomegaly.
Massive nodes (i.e., ≥ 10 cm in the longest diameter), progressive, or symptomatic lymphadenopathy.
Progressive lymphocytosis with an increase of > 50% over a 2-month period or a lymphocyte doubling time (LDT) of < 6 months. The LDT may be obtained by linear regression extrapolation of absolute lymphocyte counts (ALC) obtained at intervals of 2 weeks over an observation period of 2 to 3 months. In participants with initial blood lymphocyte counts of < 30 X 10^9/L (30,000/μL), LDT should not be used as a single parameter to define indication for treatment. In addition, factors contributing to lymphocytosis or lymphadenopathy other than CLL (eg, infections) should be excluded.
Autoimmune anemia and/or thrombocytopenia that is poorly responsive to standard therapy.
Constitutional symptoms documented in the participant's chart with supportive objective measures, as appropriate, defined as ≥ 1 of the following disease-related symptoms or signs:
i. Unintentional weight loss ≥ 10% within the previous 6 months before screening.
ii. Fevers higher than 100.5°F or 38.0°C for 2 or more weeks before screening without evidence of infection.
iii. Night sweats for > 1 month before screening without evidence of infection.
Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2.
Agreement to use highly effective methods of contraception during the study and for 2 days after the last dose of study drug if sexually active and able to bear or beget children (see Section 3.7.9 for list of highly effective methods of contraception).
Willing and able to participate in all required evaluations and procedures in this study protocol including swallowing capsules without difficulty.
Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (in accordance with national and local participant privacy regulations).
Inclusion Criteria for Treatment Subgroups
Treatment Naive only: Men and women ≥ 18 years of age with confirmed diagnosis of CLL/SLL, who require treatment per National Cancer Institute (NCI) or International Working Group guidelines and a) do not want to receive chemoimmunotherapy or b) have comorbidities that would preclude chemoimmunotherapy.
Ibrutinib Intolerant only: Men and women ≥ 18 years of age with confirmed diagnosis of CLL/SLL who are not tolerating ibrutinib due to ibrutinib-related AEs.
Richter's Syndrome/Prolymphocytic Leukemia Transformation only: Men and women ≥ 18 years of age and biopsy proven diffuse large B cell lymphoma (DLBCL) Richter's transformation or prolymphocytic leukemia transformation.
Ibrutinib relapsed/refractory (R/R) only: Men and women ≥ 18 years of age with confirmed diagnosis of CLL/SLL whose best response after 2 cycles of ibrutinib therapy was stable disease or nonresponse or who initially responded to ibrutinib therapy and now have signs of clinical progression.
Exclusion Criteria:
Prior malignancy, except for adequately treated basal cell, squamous cell skin cancer or in situ cervical cancer. Participants with other prior malignancies from which the participant has been disease free for ≥ 2 years may be included if approved by the medical monitor.
A life-threatening illness, medical condition or organ system dysfunction which, in the investigator's opinion, could compromise the participant's safety, interfere with the absorption or metabolism of acalabrutinib, or put the study outcomes at undue risk.
Significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of screening, or any Class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification, or left ventricular ejection fraction (LVEF) ≤ 40%.
Malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel, symptomatic inflammatory bowel disease, partial or complete bowel obstruction, or gastric restrictions and bariatric surgery, such as gastric bypass.
Any immunotherapy within 4 weeks of first dose of study drug.
For participants with recent chemotherapy or experimental therapy the first dose of study drug must occur after 5 times the half-life of the agent(s).
Relapsed after, or refractory to, prior BTK inhibitor therapy (Note: Does not apply to Ibrutinib R/R or Richter's Syndrome Group).
Any history of Richter's transformation (Note: Does not apply to Richter's Syndrome Group).
10. Central nervous system (CNS) involvement by lymphoma. 11. Grade ≥ 2 toxicity (other than alopecia) continuing from prior anticancer therapy including radiation.
12. Known history of human immunodeficiency virus (HIV) or serologic status indicating active hepatitis C virus (HCV) or hepatitis B virus (HBV) infection or any uncontrolled active systemic infection. Participants with hepatitis B core antibody positive who are surface antigen negative or who are hepatitis C antibody positive will need to have a negative polymerase chain reaction (PCR) result before enrollment. Those who are hepatitis B surface antigen positive or hepatitis B PCR positive and those who are hepatitis C PCR positive will be excluded.
13. Uncontrolled autoimmune hemolytic anemia (AIHA) or immune thrombocytopenic purpura (ITP) defined as declining hemoglobin or platelet count secondary to autoimmune destruction within the screening period or requirement for high doses of steroids (> 20 mg daily of prednisone daily or equivalent).
14. History of stroke or intracranial hemorrhage within 6 months prior to the first dose of study drug.
15. Requires treatment with proton-pump inhibitors (eg, omeprazole, esomeprazole, lansoprazole, dexlansoprazole, rabeprazole, or pantoprazole).
16. Requires anticoagulation with warfarin or equivalent vitamin K antagonists (eg, phenprocoumon) within 7 days of first dose of study drug.
17. Major surgery within 4 weeks before first dose of study drug. 18. ANC < 0.75 x 10^9/L or platelet count < 50 x 10^9/L unless there is bone marrow involvement.
19. Total bilirubin > 1.5 x upper limit of normal (ULN) (total bilirubin ≤ 2.5 x ULN allowed in participants with autoimmune hemolytic anemia that is otherwise controlled); and aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 3.0 x ULN unless disease related.
20. Serum amylase > 1.5 x ULN or serum lipase > 1.5 x ULN. 21. Significant screening electrocardiogram (ECG) abnormalities including, 2nd degree AV block type II, 3rd degree block, Grade 2 or higher bradycardia, or QTc ≥ 480 ms.
22. Cardiac troponin I levels above the limit of normal as specified by the manufacturer.
23. Breast feeding or pregnant. 24. History of bleeding diathesis (eg, hemophilia, von Willebrand disease). 25. Concurrent participation in another therapeutic clinical trial. 26. Estimated creatinine clearance of < 30 mL/min, calculated using the formula of Cockcroft and Gault [(140-Age) • Mass (kg)/(72 • creatinine mg/dL); multiply by 0.85 if female].
27. Presence of a gastrointestinal ulcer diagnosed by endoscopy within 3 months before screening.
Furman RR, Wierda WG, Patten PEM, Chaves JM, Brown JR, Munir T, Martin P, Awan FT, Stephens DM, Ghia P, Barrientos JC, Patel K, Woyach JA, de Borja M, Wang MH, Jain N, O'Brien SM, Byrd JC. Final phase 2 study results of acalabrutinib in treatment-naive and relapsed/refractory chronic lymphocytic leukemia. Blood Adv. 2026 Jun 9;10(11):3931-3941. doi: 10.1182/bloodadvances.2025018310.
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal.
All request will be evaluated as per the AZ disclosure commitment:
When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Out of 306 enrolled participates, 5 participants were not treated with the study drug. The data of "All treated population" was collected and analyzed. The results data are reported per the primary completion date (data cut-off date of 15Jul2021). There will be no updated results for all outcome measures at the time of end of study.
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Relapsed/Refractory Cohort
Phase 1 (dose-escalation) and Phase 2 (dose-expansion) were conducted for participants with relapsed/refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). In Phase 1, participants received oral once daily (QD) acalabrutinib at Dose 1 (Cohort 1), Dose 2 (Cohort 2a), Dose 3 (Cohort 3), and Dose 4 (Cohort 4a), and twice daily (BID) acalabrutinib at Dose 1 (Cohort 2b) and Dose 5 (Cohort 4b) for 28 days (1 cycle). In Phase 2, participants received oral acalabrutinib at Dose 1 BID (Cohort 2b) or Dose 5 QD (Cohort 2c, later switched to Dose 1 BID per protocol amendment 6) until disease progression or until the investigator considered the study treatment to be intolerable or no longer in the participant's best interest. Participants from Phase 1 continued to receive Dose 1 BID until disease progression or until the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
Participants with diffuse large B-cell lymphoma (DLBCL) Richter's transformation (RS) or prolymphocytic leukemia (PLL) transformation, will receive oral acalabrutinib Dose 5 BID (Cohort 9) until disease progression or until the investigator will consider the study treatment to be intolerable or no longer in the participant's best interest.
Drug: Acalabrutinib
Ibrutinib Relapsed/Refractory Cohort
Experimental
Participants with confirmed CLL/SLL and had relapsed/refractory to ibrutinib treatment, will receive oral acalabrutinib Dose 5 QD (Cohort 10) until disease progression or until the investigator will consider the study treatment to be intolerable or no longer in the participant's best interest.
Number of Participants With Clinically Important Laboratory Abnormalities With Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 or More
Participants with clinically important laboratory abnormalities with CTCAE Grade 3 or more are reported. Laboratory analysis included hematology, clinical chemistry, amylase, lipase, cardiac troponin I, hepatitis B and C testing, and urinalysis. The CTCAE version 4.03 is a descriptive terminology is used for AE reporting. The CTCAE v4.03 displays Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 3 as severe AE, Grade 4 as life-threatening or disabling AE, and Grade 5 as death related to AE.
Day 1 through the final data cutoff date (approximately 7 years 6 months)
Number of Participants With Clinically Abnormal Vital Signs Reported as TEAEs
Participants with clinically abnormal vital signs (blood pressure, respiratory rate, pulse rate, or body temperature) reported as TEAEs are reported.
Day 1 through the final data cutoff date (approximately 7 years 6 months)
Area Under the Plasma Concentration-time Curve From Time 0 to 6 Hours (AUC0-6) of Acalabrutinib
The AUC0-6 of acalabrutinib is reported.
Predose and at 0.25, 0.5, 0.75, 1, 2, 4, and 6 hours postdose on Day 1 and Day 8
Area Under the Plasma Concentration-time Curve From Time 0 to Last Measurable Concentration (AUC0-last) of Acalabrutinib
The AUC0-last of acalabrutinib is reported.
Predose and at 0.25, 0.5, 0.75, 1, 2, 4, 6, and 24 hours postdose on Day 1 and Day 8
Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC0-inf) of Acalabrutinib
The AUC0-inf of Acalabrutinib is reported.
Predose and at 0.25, 0.5, 0.75, 1, 2, 4, 6, and 24 hours postdose on Day 1 and Day 8
Maximum Observed Plasma Concentration (Cmax) of Acalabrutinib
The Cmax of Acalabrutinib is reported.
Predose and at 0.25, 0.5, 0.75, 1, 2, 4, 6, and 24 hours postdose on Day 1 and Day 8
Time of Maximum Plasma Concentration (Tmax) of Acalabrutinib
The Tmax of Acalabrutinib is reported.
Predose and at 0.25, 0.5, 0.75, 1, 2, 4, 6, and 24 hours postdose on Day 1 and Day 8
Terminal Elimination Half-life (t1/2) of Acalabrutinib
The t1/2 of acalabrutinib is reported.
Predose and at 0.25, 0.5, 0.75, 1, 2, 4, 6, and 24 hours postdose on Day 1 and Day 8
Terminal Elimination Rate Constant (λz) of Acalabrutinib
The λz of acalabrutinib is reported.
Predose and at 0.25, 0.5, 0.75, 1, 2, 4, 6, and 24 hours postdose on Day 1 and Day 8
Apparent Oral Clearance (CL/F) of Acalabrutinib
The CL/F of acalabrutinib is reported.
Predose and at 0.25, 0.5, 0.75, 1, 2, 4, 6, and 24 hours postdose on Day 1 and Day 8
Apparent Volume of Distribution (Vz/F) of Acalabrutinib
The Vz/F of acalabrutinib is reported.
Predose and at 0.25, 0.5, 0.75, 1, 2, 4, 6, and 24 hours postdose on Day 1 and Day 8
Day 1 through the final data cutoff date (approximately 7 years 6 months)
Duration of Response (DOR) as Assessed by the Investigator
The DoR is defined as the time from the date of achieving the first CR, CRi, or PR to the date of progressive disease (PD) or death due to any cause, whichever occurred first. The CR, CRi, or PR are defined in the above outcome measure. For CLL/SLL, PD is defined as lympho >=50% increase from baseline with >= 5000 B lymphocytes/µL, progressive cytopenias by bone marrow biopsy, appearance of any new lesion or new appearance of hepatomegaly or splenomegaly or >= 50 % increase in lymphadenopathy/hepatomegaly/splenomegaly, platelets decrease of >=50% from baseline secondary to CLL or < 100,000/µL and worsening bone marrow or Hb decrease of > 2 g/dL from baseline secondary to CLL or decrease to less than 100 g/L and worsening bone marrow. For RS, PD is defined as an increase by 25 % in longest diameter, new lesion or assessable disease progression. The DoR was estimated using Kaplan-Meier method.
Day 1 through the final data cutoff date (approximately 7 years 6 months)
Progression Free Survival (PFS) as Assessed by the Investigator
The PFS is defined as the time from the date of first dose of study drug to the date of first PD or death due to any cause, whichever occurred first. For CLL/SLL, PD is defined as lympho >= 50 % increase from baseline with >= 5000 B lymphocytes/µL, progressive cytopenias by bone marrow biopsy, appearance of any new lesion or new appearance of hepatomegaly or splenomegaly or >= 50 % increase in lymphadenopathy/hepatomegaly/splenomegaly, platelets decrease of >= 50 % from baseline secondary to CLL or < 100,000/µL and worsening bone marrow or Hb decrease of > 2 g/dL from baseline secondary to CLL or decrease to less than 100 g/L and worsening bone marrow. For RS, PD is defined as an increase by 25 % in longest diameter, new lesion or assessable disease progression. The PFS was estimated using Kaplan-Meier method.
Day 1 through the final data cutoff date (approximately 7 years 6 months)
New Hyde Park
New York
11042
United States
Research Site
New York
New York
10021
United States
Research Site
Columbus
Ohio
43210
United States
Research Site
Fort Worth
Texas
76104
United States
Research Site
Salt Lake City
Utah
84112
United States
Research Site
Seattle
Washington
98122
United States
Research Site
Tacoma
Washington
98405
United States
Research Site
Milan
20132
Italy
Research Site
Leeds
LS9 7TF
United Kingdom
Research Site
London
SE5 9RS
United Kingdom
Research Site
Oxford
OX3 7LE
United Kingdom
Derived
Nuttall B, Karl DL, Burke K, Callahan M, Mendler K, Cingolani P, Criscione S, Naumenko S, Bibikova E, Munugalavadla V, Byrd JC, Furman RR, Brown JR, Mortlock A, Dougherty BA, Carl Barrett J, Scaltriti M, Hadfield J. Comprehensive comparison of enzymatic and bisulfite DNA methylation analysis in clinically relevant samples. Clin Epigenetics. 2025 Oct 3;17(1):156. doi: 10.1186/s13148-025-01959-0.
Bibikova E, Parsa S, Floren M, Law B, Clevenger T, Cheung J, De Jesus G, Burke K, Gulrajani M, Yamaguchi K, Do P, Dougherty B, Whitston D, Brock G, Munugalavadla V, Frigault MM, Hartmann TN, Byrd JC, Furman RR, Brown JR, Covey T, Mortlock A. Molecular Profiling Identifies CD49d and CD79b as Predictive Markers for Acquired Acalabrutinib Resistance in Patients With Chronic Lymphocytic Leukemia. Hematol Oncol. 2025 Jan;43(1):e70008. doi: 10.1002/hon.70008.
Alfaifi A, Bahashwan S, Alsaadi M, Ageel AH, Ahmed HH, Fatima K, Malhan H, Qadri I, Almehdar H. Advancements in B-Cell Non-Hodgkin's Lymphoma: From Signaling Pathways to Targeted Therapies. Adv Hematol. 2024 Nov 12;2024:5948170. doi: 10.1155/2024/5948170. eCollection 2024.
Eyre TA, Schuh A, Wierda WG, Brown JR, Ghia P, Pagel JM, Furman RR, Cheung J, Hamdy A, Izumi R, Patel P, Wang MH, Xu Y, Byrd JC, Hillmen P. Acalabrutinib monotherapy for treatment of chronic lymphocytic leukaemia (ACE-CL-001): analysis of the Richter transformation cohort of an open-label, single-arm, phase 1-2 study. Lancet Haematol. 2021 Dec;8(12):e912-e921. doi: 10.1016/S2352-3026(21)00305-7. Epub 2021 Nov 1.
Awan FT, Schuh A, Brown JR, Furman RR, Pagel JM, Hillmen P, Stephens DM, Woyach J, Bibikova E, Charuworn P, Frigault MM, Hamdy A, Izumi R, Linghu B, Patel P, Wang MH, Byrd JC. Acalabrutinib monotherapy in patients with chronic lymphocytic leukemia who are intolerant to ibrutinib. Blood Adv. 2019 May 14;3(9):1553-1562. doi: 10.1182/bloodadvances.2018030007.
Long M, Beckwith K, Do P, Mundy BL, Gordon A, Lehman AM, Maddocks KJ, Cheney C, Jones JA, Flynn JM, Andritsos LA, Awan F, Fraietta JA, June CH, Maus MV, Woyach JA, Caligiuri MA, Johnson AJ, Muthusamy N, Byrd JC. Ibrutinib treatment improves T cell number and function in CLL patients. J Clin Invest. 2017 Aug 1;127(8):3052-3064. doi: 10.1172/JCI89756. Epub 2017 Jul 17.
Treatment-naïve participants with confirmed CLL or SLL, received oral acalabrutinib Dose 5 QD (Cohort 7, later switched to Dose 1 BID per protocol amendment 6) or Dose 1 BID (Cohort 11) until disease progression or until the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
FG002
Ibrutinib-intolerant Cohort
Participants with confirmed CLL or SLL and were not tolerating ibrutinib treatment, received oral acalabrutinib Dose 5 QD (Cohort 8a, later switched to Dose 1 BID per protocol amendment 4) or Dose 1 BID (Cohort 8b) until disease progression or until the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
Participants with diffuse large B-cell lymphoma (DLBCL) Richter's transformation (RS) or prolymphocytic leukemia transformation (PLL), received oral acalabrutinib Dose 5 BID (Cohort 9) until disease progression or until the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
FG004
Ibrutinib Relapsed/Refractory Cohort
Participants with confirmed CLL/SLL and had relapsed/refractory to ibrutinib treatment, received oral acalabrutinib Dose 5 QD (Cohort 10) until disease progression or until the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
FG000134 subjects
FG00199 subjects
FG00233 subjects
FG00329 subjects
FG0046 subjects
COMPLETED
FG00041 subjects
FG00170 subjects
FG0026 subjects
FG0033 subjects
FG0040 subjects
NOT COMPLETED
FG00093 subjects
FG00129 subjects
FG00227 subjects
FG00326 subjects
FG0046 subjects
Type
Comment
Reasons
Completed 30-Day safety follow-up visit
FG00053 subjects
FG00116 subjects
FG00212 subjects
FG0032 subjects
FG0041 subjects
Death
FG00013 subjects
FG0012 subjects
FG0022 subjects
FG00311 subjects
FG004
Lost to Follow-up
FG0001 subjects
FG0010 subjects
FG0021 subjects
FG0031 subjects
FG004
Started other anti-cancer therapy
FG00017 subjects
FG0014 subjects
FG0027 subjects
FG0039 subjects
FG004
Withdrawal by Subject
FG0003 subjects
FG0011 subjects
FG0021 subjects
FG0031 subjects
FG004
Other
FG0006 subjects
FG0016 subjects
FG0024 subjects
FG0032 subjects
FG004
All-treated population included all enrolled participants who received 1 or more doses of study drug.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Relapsed/Refractory Cohort
Phase 1 (dose-escalation) and Phase 2 (dose-expansion) were conducted for participants with relapsed/refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). In Phase 1, participants received oral once daily (QD) acalabrutinib at Dose 1 (Cohort 1), Dose 2 (Cohort 2a), Dose 3 (Cohort 3), and Dose 4 (Cohort 4a), and twice daily (BID) acalabrutinib at Dose 1 (Cohort 2b) and Dose 5 (Cohort 4b) for 28 days (1 cycle). In Phase 2, participants received oral acalabrutinib at Dose 1 BID (Cohort 2b) or Dose 5 QD (Cohort 2c, later switched to Dose 1 BID per protocol amendment 6) until disease progression or until the investigator considered the study treatment to be intolerable or no longer in the participant's best interest. Participants from Phase 1 continued to receive Dose 1 BID until disease progression or until the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
BG001
Treatment-naive Cohort
Treatment-naïve participants with confirmed CLL or SLL, received oral acalabrutinib Dose 5 QD (Cohort 7, later switched to Dose 1 BID per protocol amendment 6) or Dose 1 BID (Cohort 11) until disease progression or until the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
BG002
Ibrutinib-intolerant Cohort
Participants with confirmed CLL or SLL and were not tolerating ibrutinib treatment, received oral acalabrutinib Dose 5 QD (Cohort 8a, later switched to Dose 1 BID per protocol amendment 4) or Dose 1 BID (Cohort 8b) until disease progression or until the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
Participants with diffuse large B-cell lymphoma (DLBCL) Richter's transformation (RS) or prolymphocytic leukemia transformation (PLL), received oral acalabrutinib Dose 5 BID (Cohort 9) until disease progression or until the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
BG004
Ibrutinib Relapsed/Refractory Cohort
Participants with confirmed CLL/SLL and had relapsed/refractory to ibrutinib treatment, received oral acalabrutinib Dose 5 QD (Cohort 10) until disease progression or until the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
BG005
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000134
BG00199
BG00233
BG00329
BG0046
BG005301
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
Years
Title
Denominators
Categories
Title
Measurements
BG00065.6± 9.2
BG00163.5± 9.7
BG00263.9± 8.9
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00035
BG00133
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0002
BG0013
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0001
BG0010
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Number of Participants With Dose Limiting Toxicities (DLTs) in Phase 1
Participants with DLTs in Phase 1 are reported. The DLT was defined as any of the following events unless the adverse event is clearly related to disease progression or the participant's current medical history and associated comorbidities: (1) Any Grade 3 or greater nonhematologic toxicity with the exceptions of alopecia and Grade 3 nausea, vomiting, and diarrhea that respond to supportive therapy; (2) Hematologic toxicities including Grade 4 neutropenia lasting more than 5 days, Grade 4 or Grade 3 thrombocytopenia with bleeding or any requirement for platelets transfusion, Grade 3 or greater febrile neutropenia (body temperature of 38.5 degrees Celsius or more), or Grade 4 anemia, unexplained by underlying disease; or (3) Dosing delay due to toxicity for > 7 consecutive days.
All-treated population included all participants enrolled in Phase 1 (dose-escalation) of the study, received 1 or more doses of study drug, and observed from Day 1 to Day 28 after first dose of study drug.
Posted
Count of Participants
Participants
From Day 1 to Day 28 after first dose of study drug
ID
Title
Description
OG000
Cohort 1
Participants with CLL/SLL received oral acalabrutinib Dose 1 QD for 28 days.
OG001
Cohort 2a
Participants with CLL/SLL received oral acalabrutinib Dose 2 QD for 28 days.
OG002
Cohort 2b
Participants with CLL/SLL received oral acalabrutinib Dose 2 BID for 28 days.
OG003
Cohort 3
Participants with CLL/SLL received oral acalabrutinib Dose 3 QD for 28 days.
OG004
Cohort 4a
Participants with CLL/SLL received oral acalabrutinib Dose 4 QD for 28 days.
OG005
Cohort 4b
Participants with CLL/SLL received oral acalabrutinib Dose 4 QD for 28 days.
Units
Counts
Participants
OG0009
OG0018
OG00229
OG003
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG003
Primary
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. The TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug.
All-treated population included all enrolled participants who received 1 or more doses of study drug.
Posted
Count of Participants
Participants
Day 1 through the final data cutoff date (approximately 7 years 6 months)
ID
Title
Description
OG000
Relapsed/Refractory Cohort
Phase 1 (dose-escalation) and Phase 2 (dose-expansion) were conducted for participants with relapsed/refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). In Phase 1, participants received oral once daily (QD) acalabrutinib at Dose 1 (Cohort 1), Dose 2 (Cohort 2a), Dose 3 (Cohort 3), and Dose 4 (Cohort 4a), and twice daily (BID) acalabrutinib at Dose 1 (Cohort 2b) and Dose 5 (Cohort 4b) for 28 days (1 cycle). In Phase 2, participants received oral acalabrutinib at Dose 1 BID (Cohort 2b) or Dose 5 QD (Cohort 2c, later switched to Dose 1 BID per protocol amendment 6) until disease progression or until the investigator considered the study treatment to be intolerable or no longer in the participant's best interest. Participants from Phase 1 continued to receive Dose 1 BID until disease progression or until the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
Primary
Number of Participants With Treatment Emergent Events of Clinical Interest (ECI)
The treatment emergent ECI included the events identified based on preclinical findings, emerging data from clinical studies relating to acalabrutinib, and pharmacological effects of approved Bruton's tyrosine kinase (BTK) inhibitors and reported after the first dose of the study drug.
All-treated population included all enrolled participants who received 1 or more doses of study drug.
Posted
Count of Participants
Participants
Day 1 through the final data cutoff date (approximately 7 years 6 months)
ID
Title
Description
OG000
Relapsed/Refractory Cohort
Phase 1 (dose-escalation) and Phase 2 (dose-expansion) were conducted for participants with relapsed/refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). In Phase 1, participants received oral once daily (QD) acalabrutinib at Dose 1 (Cohort 1), Dose 2 (Cohort 2a), Dose 3 (Cohort 3), and Dose 4 (Cohort 4a), and twice daily (BID) acalabrutinib at Dose 1 (Cohort 2b) and Dose 5 (Cohort 4b) for 28 days (1 cycle). In Phase 2, participants received oral acalabrutinib at Dose 1 BID (Cohort 2b) or Dose 5 QD (Cohort 2c, later switched to Dose 1 BID per protocol amendment 6) until disease progression or until the investigator considered the study treatment to be intolerable or no longer in the participant's best interest. Participants from Phase 1 continued to receive Dose 1 BID until disease progression or until the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
OG001
Primary
Number of Participants With Clinically Important Laboratory Abnormalities With Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 or More
Participants with clinically important laboratory abnormalities with CTCAE Grade 3 or more are reported. Laboratory analysis included hematology, clinical chemistry, amylase, lipase, cardiac troponin I, hepatitis B and C testing, and urinalysis. The CTCAE version 4.03 is a descriptive terminology is used for AE reporting. The CTCAE v4.03 displays Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 3 as severe AE, Grade 4 as life-threatening or disabling AE, and Grade 5 as death related to AE.
All-treated population included all enrolled participants who received 1 or more doses of study drug.
Posted
Count of Participants
Participants
Day 1 through the final data cutoff date (approximately 7 years 6 months)
ID
Title
Description
OG000
Relapsed/Refractory Cohort
Phase 1 (dose-escalation) and Phase 2 (dose-expansion) were conducted for participants with relapsed/refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). In Phase 1, participants received oral once daily (QD) acalabrutinib at Dose 1 (Cohort 1), Dose 2 (Cohort 2a), Dose 3 (Cohort 3), and Dose 4 (Cohort 4a), and twice daily (BID) acalabrutinib at Dose 1 (Cohort 2b) and Dose 5 (Cohort 4b) for 28 days (1 cycle). In Phase 2, participants received oral acalabrutinib at Dose 1 BID (Cohort 2b) or Dose 5 QD (Cohort 2c, later switched to Dose 1 BID per protocol amendment 6) until disease progression or until the investigator considered the study treatment to be intolerable or no longer in the participant's best interest. Participants from Phase 1 continued to receive Dose 1 BID until disease progression or until the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
Primary
Number of Participants With Clinically Abnormal Vital Signs Reported as TEAEs
Participants with clinically abnormal vital signs (blood pressure, respiratory rate, pulse rate, or body temperature) reported as TEAEs are reported.
All-treated population included all enrolled participants who received 1 or more doses of study drug.
Posted
Count of Participants
Participants
Day 1 through the final data cutoff date (approximately 7 years 6 months)
ID
Title
Description
OG000
Relapsed/Refractory Cohort
Phase 1 (dose-escalation) and Phase 2 (dose-expansion) were conducted for participants with relapsed/refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). In Phase 1, participants received oral once daily (QD) acalabrutinib at Dose 1 (Cohort 1), Dose 2 (Cohort 2a), Dose 3 (Cohort 3), and Dose 4 (Cohort 4a), and twice daily (BID) acalabrutinib at Dose 1 (Cohort 2b) and Dose 5 (Cohort 4b) for 28 days (1 cycle). In Phase 2, participants received oral acalabrutinib at Dose 1 BID (Cohort 2b) or Dose 5 QD (Cohort 2c, later switched to Dose 1 BID per protocol amendment 6) until disease progression or until the investigator considered the study treatment to be intolerable or no longer in the participant's best interest. Participants from Phase 1 continued to receive Dose 1 BID until disease progression or until the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
OG001
Treatment-naive Cohort
Primary
Area Under the Plasma Concentration-time Curve From Time 0 to 6 Hours (AUC0-6) of Acalabrutinib
The AUC0-6 of acalabrutinib is reported.
Pharmacokinetic (PK) population included all participants who complied with the protocol sufficiently and displayed an evaluable PK profile (e.g. exposure to treatment, availability and integrity of measurements, and absence of major protocol violations). 'Number of participants analyzed' denotes the number of participants evaluated for this outcome measure. 'Number analyzed' denotes the number of participants evaluated for the specified time point.
Posted
Mean
Standard Deviation
hr*ng/mL
Predose and at 0.25, 0.5, 0.75, 1, 2, 4, and 6 hours postdose on Day 1 and Day 8
ID
Title
Description
OG000
Cohort 1
Participants with CLL/SLL received oral acalabrutinib Dose 1 QD for 28 days and later switched to acalabrutinib Dose 1 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
OG001
Cohort 2a
Participants with CLL/SLL received oral acalabrutinib Dose 2 QD for 28 days and later switched to acalabrutinib Dose 1 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
OG002
Primary
Area Under the Plasma Concentration-time Curve From Time 0 to Last Measurable Concentration (AUC0-last) of Acalabrutinib
The AUC0-last of acalabrutinib is reported.
The PK population included all participants who complied with the protocol sufficiently and displayed an evaluable PK profile (e.g. exposure to treatment, availability and integrity of measurements, and absence of major protocol violations). 'Number of participants analyzed' denotes the number of participants evaluated for this outcome measure. 'Number analyzed' denotes the number of participants evaluated for the specified time point.
Posted
Mean
Standard Deviation
hr*ng/mL
Predose and at 0.25, 0.5, 0.75, 1, 2, 4, 6, and 24 hours postdose on Day 1 and Day 8
ID
Title
Description
OG000
Cohort 1
Participants with CLL/SLL received oral acalabrutinib Dose 1 QD for 28 days and later switched to acalabrutinib Dose 1 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
OG001
Cohort 2a
Participants with CLL/SLL received oral acalabrutinib Dose 2 QD for 28 days and later switched to acalabrutinib Dose 1 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
OG002
Primary
Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC0-inf) of Acalabrutinib
The AUC0-inf of Acalabrutinib is reported.
The PK population included all participants who complied with the protocol sufficiently and displayed an evaluable PK profile (e.g. exposure to treatment, availability and integrity of measurements, and absence of major protocol violations). 'Number of participants analyzed' denotes the number of participants evaluated for this outcome measure. 'Number analyzed' denotes the number of participants evaluated for the specified time point.
Posted
Mean
Standard Deviation
hr*ng/mL
Predose and at 0.25, 0.5, 0.75, 1, 2, 4, 6, and 24 hours postdose on Day 1 and Day 8
ID
Title
Description
OG000
Cohort 1
Participants with CLL/SLL received oral acalabrutinib Dose 1 QD for 28 days and later switched to acalabrutinib Dose 1 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
OG001
Cohort 2a
Participants with CLL/SLL received oral acalabrutinib Dose 2 QD for 28 days and later switched to acalabrutinib Dose 1 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
OG002
Primary
Maximum Observed Plasma Concentration (Cmax) of Acalabrutinib
The Cmax of Acalabrutinib is reported.
The PK population included all participants who complied with the protocol sufficiently and displayed an evaluable PK profile (e.g. exposure to treatment, availability and integrity of measurements, and absence of major protocol violations). 'Number of participants analyzed' denotes the number of participants evaluated for this outcome measure. 'Number analyzed' denotes the number of participants evaluated for the specified time point.
Posted
Mean
Standard Deviation
ng/mL
Predose and at 0.25, 0.5, 0.75, 1, 2, 4, 6, and 24 hours postdose on Day 1 and Day 8
ID
Title
Description
OG000
Cohort 1
Participants with CLL/SLL received oral acalabrutinib Dose 1 QD for 28 days and later switched to acalabrutinib Dose 1 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
OG001
Cohort 2a
Participants with CLL/SLL received oral acalabrutinib Dose 2 QD for 28 days and later switched to acalabrutinib Dose 1 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
OG002
Cohort 2b
Primary
Time of Maximum Plasma Concentration (Tmax) of Acalabrutinib
The Tmax of Acalabrutinib is reported.
The PK population included all participants who complied with the protocol sufficiently and displayed an evaluable PK profile (e.g. exposure to treatment, availability and integrity of measurements, and absence of major protocol violations). 'Number of participants analyzed' denotes the number of participants evaluated for this outcome measure. 'Number analyzed' denotes the number of participants evaluated for the specified time point.
Posted
Median
Full Range
Hours
Predose and at 0.25, 0.5, 0.75, 1, 2, 4, 6, and 24 hours postdose on Day 1 and Day 8
ID
Title
Description
OG000
Cohort 1
Participants with CLL/SLL received oral acalabrutinib Dose 1 QD for 28 days and later switched to acalabrutinib Dose 1 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
OG001
Cohort 2a
Participants with CLL/SLL received oral acalabrutinib Dose 2 QD for 28 days and later switched to acalabrutinib Dose 1 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
OG002
Cohort 2b
Primary
Terminal Elimination Half-life (t1/2) of Acalabrutinib
The t1/2 of acalabrutinib is reported.
The PK population included all participants who complied with the protocol sufficiently and displayed an evaluable PK profile (e.g. exposure to treatment, availability and integrity of measurements, and absence of major protocol violations). 'Number of participants analyzed' denotes the number of participants evaluated for this outcome measure. 'Number analyzed' denotes the number of participants evaluated for the specified time point.
Posted
Mean
Standard Deviation
Hours
Predose and at 0.25, 0.5, 0.75, 1, 2, 4, 6, and 24 hours postdose on Day 1 and Day 8
ID
Title
Description
OG000
Cohort 1
Participants with CLL/SLL received oral acalabrutinib Dose 1 QD for 28 days and later switched to acalabrutinib Dose 1 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
OG001
Cohort 2a
Participants with CLL/SLL received oral acalabrutinib Dose 2 QD for 28 days and later switched to acalabrutinib Dose 1 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
OG002
Cohort 2b
Primary
Terminal Elimination Rate Constant (λz) of Acalabrutinib
The λz of acalabrutinib is reported.
The PK population included all participants who complied with the protocol sufficiently and displayed an evaluable PK profile (e.g. exposure to treatment, availability and integrity of measurements, and absence of major protocol violations). 'Number of participants analyzed' denotes the number of participants evaluated for this outcome measure. 'Number analyzed' denotes the number of participants evaluated for the specified time point.
Posted
Mean
Standard Deviation
1/hr
Predose and at 0.25, 0.5, 0.75, 1, 2, 4, 6, and 24 hours postdose on Day 1 and Day 8
ID
Title
Description
OG000
Cohort 1
Participants with CLL/SLL received oral acalabrutinib Dose 1 QD for 28 days and later switched to acalabrutinib Dose 1 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
OG001
Cohort 2a
Participants with CLL/SLL received oral acalabrutinib Dose 2 QD for 28 days and later switched to acalabrutinib Dose 1 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
OG002
Cohort 2b
Primary
Apparent Oral Clearance (CL/F) of Acalabrutinib
The CL/F of acalabrutinib is reported.
The PK population included all participants who complied with the protocol sufficiently and displayed an evaluable PK profile (e.g. exposure to treatment, availability and integrity of measurements, and absence of major protocol violations). 'Number of participants analyzed' denotes the number of participants evaluated for this outcome measure. 'Number analyzed' denotes the number of participants evaluated for the specified time point.
Posted
Mean
Standard Deviation
L/hr
Predose and at 0.25, 0.5, 0.75, 1, 2, 4, 6, and 24 hours postdose on Day 1 and Day 8
ID
Title
Description
OG000
Cohort 1
Participants with CLL/SLL received oral acalabrutinib Dose 1 QD for 28 days and later switched to acalabrutinib Dose 1 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
OG001
Cohort 2a
Participants with CLL/SLL received oral acalabrutinib Dose 2 QD for 28 days and later switched to acalabrutinib Dose 1 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
OG002
Cohort 2b
Primary
Apparent Volume of Distribution (Vz/F) of Acalabrutinib
The Vz/F of acalabrutinib is reported.
The PK population included all participants who complied with the protocol sufficiently and displayed an evaluable PK profile (e.g. exposure to treatment, availability and integrity of measurements, and absence of major protocol violations). 'Number of participants analyzed' denotes the number of participants evaluated for this outcome measure. 'Number analyzed' denotes the number of participants evaluated for the specified time point.
Posted
Mean
Standard Deviation
L
Predose and at 0.25, 0.5, 0.75, 1, 2, 4, 6, and 24 hours postdose on Day 1 and Day 8
ID
Title
Description
OG000
Cohort 1
Participants with CLL/SLL received oral acalabrutinib Dose 1 QD for 28 days and later switched to acalabrutinib Dose 1 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
OG001
Cohort 2a
Participants with CLL/SLL received oral acalabrutinib Dose 2 QD for 28 days and later switched to acalabrutinib Dose 1 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
OG002
Cohort 2b
Secondary
Percentage of Participants With Objective Response (OR) as Assessed by the Investigator
For CLL/SLL, OR is defined as complete remission (CR), CR with incomplete marrow recovery (CRi), or partial remission (PR). CR: lymphocytes (lympho) <4×10^9/L, normocellular bone marrow (BM), normal lymph nodes (NLN), liver and spleen (L/S), absolute neutrophil count (ANC) >1.5×10^9/L, platelets >100×10^9/L, hemoglobin (Hb) >11g/dL. Cri: lympho <4×10^9/L, hypocellular BM, NLN, L/S, persistent anemia, hrombocytopenia, or neutropenia. PR: >=50% reduction in lymphadenopathy and/or enlargement of L/S or lympho (<5×10^9/L or >=50% decrease from baseline) and criteria of ANC/platelets/Hb per CR or >=50% improvement over baseline. Hematology result were without exogenous growth factors/transfusion. For RS, OR as CR or PR by Cheson et al. 2014 based on PET/CT scans and bone marrow. CR: disappearance of all detectable clinical evidence of disease and disease-related symptoms and PR: >=50% decrease in sum of the product diameter of 6 largest nodal masses and no new sites of disease.
Efficacy evaluable population included all enrolled participants who received 1 or more doses of study drug and had 1 or more response assessments after the first dose of study drug.
Posted
Number
95% Confidence Interval
Percentage of participants
Day 1 through the final data cutoff date (approximately 7 years 6 months)
ID
Title
Description
OG000
Cohort 1
Participants with CLL/SLL received oral acalabrutinib Dose 1 QD for 28 days and later switched to acalabrutinib Dose 1 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
Secondary
Duration of Response (DOR) as Assessed by the Investigator
The DoR is defined as the time from the date of achieving the first CR, CRi, or PR to the date of progressive disease (PD) or death due to any cause, whichever occurred first. The CR, CRi, or PR are defined in the above outcome measure. For CLL/SLL, PD is defined as lympho >=50% increase from baseline with >= 5000 B lymphocytes/µL, progressive cytopenias by bone marrow biopsy, appearance of any new lesion or new appearance of hepatomegaly or splenomegaly or >= 50 % increase in lymphadenopathy/hepatomegaly/splenomegaly, platelets decrease of >=50% from baseline secondary to CLL or < 100,000/µL and worsening bone marrow or Hb decrease of > 2 g/dL from baseline secondary to CLL or decrease to less than 100 g/L and worsening bone marrow. For RS, PD is defined as an increase by 25 % in longest diameter, new lesion or assessable disease progression. The DoR was estimated using Kaplan-Meier method.
Efficacy evaluable population included all enrolled participants who received 1 or more doses of study drug and had 1 or more response assessments after the first dose of study drug. The DoR was analyzed for participants who achieved OR.
Posted
Median
95% Confidence Interval
Months
Day 1 through the final data cutoff date (approximately 7 years 6 months)
ID
Title
Description
OG000
Cohort 1
Participants with CLL/SLL received oral acalabrutinib Dose 1 QD for 28 days and later switched to acalabrutinib Dose 1 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
Secondary
Progression Free Survival (PFS) as Assessed by the Investigator
The PFS is defined as the time from the date of first dose of study drug to the date of first PD or death due to any cause, whichever occurred first. For CLL/SLL, PD is defined as lympho >= 50 % increase from baseline with >= 5000 B lymphocytes/µL, progressive cytopenias by bone marrow biopsy, appearance of any new lesion or new appearance of hepatomegaly or splenomegaly or >= 50 % increase in lymphadenopathy/hepatomegaly/splenomegaly, platelets decrease of >= 50 % from baseline secondary to CLL or < 100,000/µL and worsening bone marrow or Hb decrease of > 2 g/dL from baseline secondary to CLL or decrease to less than 100 g/L and worsening bone marrow. For RS, PD is defined as an increase by 25 % in longest diameter, new lesion or assessable disease progression. The PFS was estimated using Kaplan-Meier method.
Efficacy evaluable population included all enrolled participants who received 1 or more doses of study drug and had 1 or more response assessments after the first dose of study drug.
Posted
Median
95% Confidence Interval
Months
Day 1 through the final data cutoff date (approximately 7 years 6 months)
ID
Title
Description
OG000
Cohort 1
Participants with CLL/SLL received oral acalabrutinib Dose 1 QD for 28 days and later switched to acalabrutinib Dose 1 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
OG001
Cohort 2a
Time Frame
Day 1 through the final data cutoff date (approximately 7 years 6 months)
Description
Not provided
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Relapsed/Refractory Cohort
Phase 1 (dose-escalation) and Phase 2 (dose-expansion) were conducted for participants with relapsed/refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). In Phase 1, participants received oral once daily (QD) acalabrutinib at Dose 1 (Cohort 1), Dose 2 (Cohort 2a), Dose 3 (Cohort 3), and Dose 4 (Cohort 4a), and twice daily (BID) acalabrutinib at Dose 1 (Cohort 2b) and Dose 5 (Cohort 4b) for 28 days (1 cycle). In Phase 2, participants received oral acalabrutinib at Dose 1 BID (Cohort 2b) or Dose 5 QD (Cohort 2c, later switched to Dose 1 BID per protocol amendment 6) until disease progression or until the investigator considered the study treatment to be intolerable or no longer in the participant's best interest. Participants from Phase 1 continued to receive Dose 1 BID until disease progression or until the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
13
134
86
134
134
134
EG001
Treatment-naive Cohort
Treatment-naïve participants with confirmed CLL or SLL, received oral acalabrutinib Dose 5 QD (Cohort 7, later switched to Dose 1 BID per protocol amendment 6) or Dose 1 BID (Cohort 11) until disease progression or until the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
2
99
50
99
99
99
EG002
Ibrutinib-intolerant Cohort
Participants with confirmed CLL or SLL and were not tolerating ibrutinib treatment, received oral acalabrutinib Dose 5 QD (Cohort 8a, later switched to Dose 1 BID per protocol amendment 4) or Dose 1 BID (Cohort 8b) until disease progression or until the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
Participants with diffuse large B-cell lymphoma (DLBCL) Richter's transformation (RS) or prolymphocytic leukemia transformation (PLL), received oral acalabrutinib Dose 5 BID (Cohort 9) until disease progression or until the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
11
29
18
29
28
29
EG004
Ibrutinib Relapsed/Refractory Cohort
Participants with confirmed CLL/SLL and had relapsed/refractory to ibrutinib treatment, received oral acalabrutinib Dose 5 QD (Cohort 10) until disease progression or until the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
2
6
3
6
6
6
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Leukocytosis
Blood and lymphatic system disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG0030 events0 affected29 at risk
EG0040 events0 affected6 at risk
Hypertension
Vascular disorders
MedDRA 24.0
Systematic Assessment
EG0003 events2 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Hypotension
Vascular disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Malignant hypertension
Vascular disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Orthostatic hypotension
Vascular disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Phlebitis superficial
Vascular disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0010 events0 affected99 at risk
EG0021 events1 affected33 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0003 events3 affected134 at risk
EG0010 events0 affected99 at risk
EG0021 events1 affected33 at risk
EG003
Lymphadenitis
Blood and lymphatic system disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Colitis
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0005 events4 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Epiploic appendagitis
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Gastric haemorrhage
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Methaemoglobinaemia
Blood and lymphatic system disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Inguinal hernia
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Large intestinal haemorrhage
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Lower gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Splenic infarction
Blood and lymphatic system disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Anaemia
Blood and lymphatic system disorders
MedDRA 24.0
Systematic Assessment
EG0004 events4 affected134 at risk
EG0011 events1 affected99 at risk
EG0021 events1 affected33 at risk
EG003
Pancreatitis
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0012 events2 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Pancreatitis acute
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 24.0
Systematic Assessment
EG0002 events2 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Rectal haemorrhage
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0002 events2 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Small intestinal obstruction
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Acute coronary syndrome
Cardiac disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0021 events1 affected33 at risk
EG003
Tongue haematoma
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Upper gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Asthenia
General disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0010 events0 affected99 at risk
EG0021 events1 affected33 at risk
EG003
Acute myocardial infarction
Cardiac disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Chest pain
General disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0021 events1 affected33 at risk
EG003
Angina pectoris
Cardiac disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Fatigue
General disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Infusion site injury
General disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0010 events0 affected99 at risk
EG0021 events1 affected33 at risk
EG003
Malaise
General disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Multiple organ dysfunction syndrome
General disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0011 events1 affected99 at risk
EG0021 events1 affected33 at risk
EG003
Pain
General disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Pyrexia
General disorders
MedDRA 24.0
Systematic Assessment
EG0002 events2 affected134 at risk
EG0012 events2 affected99 at risk
EG0022 events2 affected33 at risk
EG003
Bile duct stone
Hepatobiliary disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Cholecystitis
Hepatobiliary disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0021 events1 affected33 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA 24.0
Systematic Assessment
EG0006 events4 affected134 at risk
EG0012 events2 affected99 at risk
EG0021 events1 affected33 at risk
EG003
Cholelithiasis
Hepatobiliary disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Perforation bile duct
Hepatobiliary disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Anaphylactic reaction
Immune system disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Atrial flutter
Cardiac disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0010 events0 affected99 at risk
EG0021 events1 affected33 at risk
EG003
Abscess limb
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Acute sinusitis
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0002 events2 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Appendicitis
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Autoimmune haemolytic anaemia
Blood and lymphatic system disorders
MedDRA 24.0
Systematic Assessment
EG0003 events2 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Atrioventricular block complete
Cardiac disorders
MedDRA 24.0
Systematic Assessment
EG0002 events2 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Aspergillus infection
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0010 events0 affected99 at risk
EG0021 events1 affected33 at risk
EG003
Bacterial infection
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0010 events0 affected99 at risk
EG0021 events1 affected33 at risk
EG003
Brain abscess
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Bronchitis bacterial
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0010 events0 affected99 at risk
EG0021 events1 affected33 at risk
EG003
Atrioventricular block second degree
Cardiac disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Covid-19
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0002 events2 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Covid-19 pneumonia
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0004 events3 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Campylobacter gastroenteritis
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Campylobacter infection
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Candida sepsis
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0011 events1 affected99 at risk
EG0022 events2 affected33 at risk
EG003
Clostridium difficile colitis
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Bradycardia
Cardiac disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Clostridium difficile infection
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Cytomegalovirus infection reactivation
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Diverticulitis
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0012 events2 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Escherichia sepsis
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0021 events1 affected33 at risk
EG003
Gastroenteritis rotavirus
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Genital abscess
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Genital infection fungal
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Gingivitis
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Groin abscess
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0010 events0 affected99 at risk
EG0021 events1 affected33 at risk
EG003
Cardiac arrest
Cardiac disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0021 events1 affected33 at risk
EG003
Herpes simplex
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Herpes virus infection
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0010 events0 affected99 at risk
EG0021 events1 affected33 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0022 events1 affected33 at risk
EG003
Infection
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Influenza
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0013 events3 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Cardiac failure
Cardiac disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Kidney infection
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Klebsiella bacteraemia
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Lower respiratory tract infection
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0021 events1 affected33 at risk
EG003
Lymphangitis
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Cardiac failure congestive
Cardiac disorders
MedDRA 24.0
Systematic Assessment
EG0002 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Mycobacterium avium complex infection
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Neutropenic sepsis
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Cardiac tamponade
Cardiac disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Parainfluenzae virus infection
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Pelvic abscess
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG00024 events19 affected134 at risk
EG0018 events6 affected99 at risk
EG0028 events3 affected33 at risk
EG003
Pneumonia fungal
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Pneumonia parainfluenzae viral
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Pneumonia pneumococcal
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Pneumonia streptococcal
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Febrile neutropenia
Blood and lymphatic system disorders
MedDRA 24.0
Systematic Assessment
EG0003 events3 affected134 at risk
EG0012 events1 affected99 at risk
EG0022 events1 affected33 at risk
EG003
Coronary artery stenosis
Cardiac disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Pseudomonal sepsis
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Pseudomonas infection
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0010 events0 affected99 at risk
EG0021 events1 affected33 at risk
EG003
Pyelitis
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Respiratory tract infection
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Salmonellosis
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0021 events1 affected33 at risk
EG003
Sepsis
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0006 events3 affected134 at risk
EG0013 events2 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Septic shock
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Sinusitis
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0013 events2 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Skin infection
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0010 events0 affected99 at risk
EG0021 events1 affected33 at risk
EG003
Subcutaneous abscess
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0002 events2 affected134 at risk
EG0010 events0 affected99 at risk
EG0022 events1 affected33 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0006 events3 affected134 at risk
EG0016 events2 affected99 at risk
EG0022 events2 affected33 at risk
EG003
Viral myocarditis
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Viral pharyngitis
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Viral sepsis
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Wound infection
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Myocardial infarction
Cardiac disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Femoral neck fracture
Injury, poisoning and procedural complications
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Fracture
Injury, poisoning and procedural complications
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Hip fracture
Injury, poisoning and procedural complications
MedDRA 24.0
Systematic Assessment
EG0002 events2 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Stress cardiomyopathy
Cardiac disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Post procedural haemorrhage
Injury, poisoning and procedural complications
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Supraventricular tachycardia
Cardiac disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0021 events1 affected33 at risk
EG003
Rib fracture
Injury, poisoning and procedural complications
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Spinal compression fracture
Injury, poisoning and procedural complications
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Haemolysis
Blood and lymphatic system disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0021 events1 affected33 at risk
EG003
Tibia fracture
Injury, poisoning and procedural complications
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Traumatic intracranial haemorrhage
Injury, poisoning and procedural complications
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Ventricular fibrillation
Cardiac disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Cytomegalovirus test positive
Investigations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Immunosuppressant drug level increased
Investigations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Troponin i increased
Investigations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0010 events0 affected99 at risk
EG0021 events1 affected33 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA 24.0
Systematic Assessment
EG0004 events4 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Arthritis
Musculoskeletal and connective tissue disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0012 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0010 events0 affected99 at risk
EG0021 events1 affected33 at risk
EG003
Flank pain
Musculoskeletal and connective tissue disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Joint effusion
Musculoskeletal and connective tissue disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0010 events0 affected99 at risk
EG0021 events1 affected33 at risk
EG003
Vertebral column mass
Musculoskeletal and connective tissue disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Adenocarcinoma of colon
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Angiosarcoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Basal cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0013 events2 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Benign lung neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Bladder cancer recurrent
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 24.0
Systematic Assessment
EG0002 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Central nervous system leukaemia
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0010 events0 affected99 at risk
EG0021 events1 affected33 at risk
EG003
Chronic myeloid leukaemia
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Colon cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Endometrial cancer metastatic
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0010 events0 affected99 at risk
EG0021 events1 affected33 at risk
EG003
Glioblastoma multiforme
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Lung adenocarcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Lung adenocarcinoma stage 0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Lung neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Lung neoplasm malignant
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Metastases to meninges
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Myelodysplastic syndrome
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Neuroendocrine carcinoma of the skin
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0010 events0 affected99 at risk
EG0021 events1 affected33 at risk
EG003
Papillary renal cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Plasmablastic lymphoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Prostate cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 24.0
Systematic Assessment
EG0002 events2 affected134 at risk
EG0012 events2 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Prostate cancer metastatic
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Rectal adenocarcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Renal cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Small cell lung cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Squamous cell carcinoma of skin
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0014 events4 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Tumour flare
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Amyotrophic lateral sclerosis
Nervous system disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Cerebral haemorrhage
Nervous system disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Cerebrovascular accident
Nervous system disorders
MedDRA 24.0
Systematic Assessment
EG0002 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0021 events1 affected33 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Encephalopathy
Nervous system disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Haemorrhage intracranial
Nervous system disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Hemiparesis
Nervous system disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Memory impairment
Nervous system disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0010 events0 affected99 at risk
EG0021 events1 affected33 at risk
EG003
Multiple system atrophy
Nervous system disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0010 events0 affected99 at risk
EG0021 events1 affected33 at risk
EG003
Seizure
Nervous system disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Syncope
Nervous system disorders
MedDRA 24.0
Systematic Assessment
EG0004 events3 affected134 at risk
EG0010 events0 affected99 at risk
EG0022 events1 affected33 at risk
EG003
Transient ischaemic attack
Nervous system disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0010 events0 affected99 at risk
EG0021 events1 affected33 at risk
EG003
Delirium
Psychiatric disorders
MedDRA 24.0
Systematic Assessment
EG0002 events2 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Suicidal ideation
Psychiatric disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA 24.0
Systematic Assessment
EG0005 events5 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Renal impairment
Renal and urinary disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Subcapsular renal haematoma
Renal and urinary disorders
MedDRA 24.0
Systematic Assessment
EG0002 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Pelvic pain
Reproductive system and breast disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Acute respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 24.0
Systematic Assessment
EG0002 events2 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Pneumothorax
Respiratory, thoracic and mediastinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Respiratory alkalosis
Respiratory, thoracic and mediastinal disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 24.0
Systematic Assessment
EG0006 events2 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Respiratory tract haemorrhage
Respiratory, thoracic and mediastinal disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Aortic stenosis
Vascular disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Haematoma
Vascular disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0010 events0 affected99 at risk
EG0021 events1 affected33 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Leukocytosis
Blood and lymphatic system disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG0030 events0 affected29 at risk
EG0040 events0 affected6 at risk
Eyelid ptosis
Eye disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Haemorrhage
Vascular disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Hot flush
Vascular disorders
MedDRA 24.0
Systematic Assessment
EG0006 events5 affected134 at risk
EG0016 events5 affected99 at risk
EG0021 events1 affected33 at risk
EG003
Hypertension
Vascular disorders
MedDRA 24.0
Systematic Assessment
EG00039 events29 affected134 at risk
EG00160 events28 affected99 at risk
EG0028 events6 affected33 at risk
EG003
Hypertensive crisis
Vascular disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Hypotension
Vascular disorders
MedDRA 24.0
Systematic Assessment
EG0007 events7 affected134 at risk
EG00111 events11 affected99 at risk
EG0026 events5 affected33 at risk
EG003
Lymphoedema
Vascular disorders
MedDRA 24.0
Systematic Assessment
EG0002 events1 affected134 at risk
EG0011 events1 affected99 at risk
EG0021 events1 affected33 at risk
EG003
Orthostatic hypotension
Vascular disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0017 events5 affected99 at risk
EG0021 events1 affected33 at risk
EG003
Peripheral coldness
Vascular disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0012 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Eyelid thickening
Eye disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Plethoric face
Vascular disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Poor peripheral circulation
Vascular disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Thrombophlebitis superficial
Vascular disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0010 events0 affected99 at risk
EG0021 events1 affected33 at risk
EG003
Varicose vein
Vascular disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Vasculitis
Vascular disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Lacrimation increased
Eye disorders
MedDRA 24.0
Systematic Assessment
EG0002 events2 affected134 at risk
EG0012 events2 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Macular degeneration
Eye disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0013 events3 affected99 at risk
EG0022 events1 affected33 at risk
EG003
Metamorphopsia
Eye disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Night blindness
Eye disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0010 events0 affected99 at risk
EG0021 events1 affected33 at risk
EG003
Ocular hyperaemia
Eye disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Ocular hypertension
Eye disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Photophobia
Eye disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Photopsia
Eye disorders
MedDRA 24.0
Systematic Assessment
EG0002 events2 affected134 at risk
EG0010 events0 affected99 at risk
EG0021 events1 affected33 at risk
EG003
Leukopenia
Blood and lymphatic system disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Posterior capsule opacification
Eye disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0010 events0 affected99 at risk
EG0021 events1 affected33 at risk
EG003
Retinal artery occlusion
Eye disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Retinal detachment
Eye disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0014 events3 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Retinal haemorrhage
Eye disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0021 events1 affected33 at risk
EG003
Retinal tear
Eye disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Scleral haemorrhage
Eye disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Strabismus
Eye disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Vision blurred
Eye disorders
MedDRA 24.0
Systematic Assessment
EG0006 events5 affected134 at risk
EG0019 events9 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Visual acuity reduced
Eye disorders
MedDRA 24.0
Systematic Assessment
EG0002 events2 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Visual impairment
Eye disorders
MedDRA 24.0
Systematic Assessment
EG0002 events2 affected134 at risk
EG0010 events0 affected99 at risk
EG0021 events1 affected33 at risk
EG003
Lymph node pain
Blood and lymphatic system disorders
MedDRA 24.0
Systematic Assessment
EG0007 events7 affected134 at risk
EG0016 events6 affected99 at risk
EG0023 events3 affected33 at risk
EG003
Vitreous degeneration
Eye disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Vitreous floaters
Eye disorders
MedDRA 24.0
Systematic Assessment
EG0002 events2 affected134 at risk
EG0012 events2 affected99 at risk
EG0021 events1 affected33 at risk
EG003
Vitreous haemorrhage
Eye disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Abdominal discomfort
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0004 events4 affected134 at risk
EG0015 events5 affected99 at risk
EG0021 events1 affected33 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG00012 events11 affected134 at risk
EG0018 events8 affected99 at risk
EG0023 events3 affected33 at risk
EG003
Abdominal hernia
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0002 events2 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG00024 events16 affected134 at risk
EG00117 events10 affected99 at risk
EG0024 events3 affected33 at risk
EG003
Abdominal pain lower
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0014 events3 affected99 at risk
EG0021 events1 affected33 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG00012 events11 affected134 at risk
EG0016 events6 affected99 at risk
EG0021 events1 affected33 at risk
EG003
Abdominal tenderness
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Anal fissure
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Anal fissure haemorrhage
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0010 events0 affected99 at risk
EG0021 events1 affected33 at risk
EG003
Anal haemorrhage
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Anal pruritus
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0012 events2 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Anorectal discomfort
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Aphthous ulcer
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0004 events3 affected134 at risk
EG0013 events3 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Barrett's oesophagus
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Breath odour
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0010 events0 affected99 at risk
EG0021 events1 affected33 at risk
EG003
Cheilitis
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Coeliac disease
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0010 events0 affected99 at risk
EG0021 events1 affected33 at risk
EG003
Lymphadenopathy
Blood and lymphatic system disorders
MedDRA 24.0
Systematic Assessment
EG0004 events4 affected134 at risk
EG0012 events2 affected99 at risk
EG0021 events1 affected33 at risk
EG003
Colitis
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Colitis ischaemic
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG00041 events35 affected134 at risk
EG00122 events20 affected99 at risk
EG0029 events7 affected33 at risk
EG003
Dental caries
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG00013 events11 affected134 at risk
EG0016 events5 affected99 at risk
EG0022 events2 affected33 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG000131 events71 affected134 at risk
EG00193 events53 affected99 at risk
EG00231 events20 affected33 at risk
EG003
Diverticulum
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0012 events2 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Diverticulum intestinal
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0004 events4 affected134 at risk
EG0016 events6 affected99 at risk
EG0021 events1 affected33 at risk
EG003
Dumping syndrome
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0010 events0 affected99 at risk
EG0021 events1 affected33 at risk
EG003
Duodenitis
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Lymphopenia
Blood and lymphatic system disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG00014 events14 affected134 at risk
EG00111 events10 affected99 at risk
EG0026 events6 affected33 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0009 events9 affected134 at risk
EG0010 events0 affected99 at risk
EG0021 events1 affected33 at risk
EG003
Enterocolitis
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Eosinophilic oesophagitis
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Flatulence
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0007 events7 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Food poisoning
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0013 events3 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Gastric haemorrhage
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0010 events0 affected99 at risk
EG0021 events1 affected33 at risk
EG003
Gastric polyps
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0002 events2 affected134 at risk
EG0014 events4 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Gastrointestinal disorder
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Gastrointestinal pain
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0003 events3 affected134 at risk
EG0010 events0 affected99 at risk
EG0021 events1 affected33 at risk
EG003
Gastrointestinal ulcer
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG00012 events12 affected134 at risk
EG00120 events17 affected99 at risk
EG0022 events2 affected33 at risk
EG003
Gingival bleeding
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0011 events1 affected99 at risk
EG0021 events1 affected33 at risk
EG003
Gingival blister
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Gingival discolouration
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Gingival disorder
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Gingival pain
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0010 events0 affected99 at risk
EG0021 events1 affected33 at risk
EG003
Microcytic anaemia
Blood and lymphatic system disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Haematemesis
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Haematochezia
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0013 events3 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0002 events2 affected134 at risk
EG0014 events4 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Hiatus hernia
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0002 events2 affected134 at risk
EG0013 events3 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Hyperaesthesia teeth
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0010 events0 affected99 at risk
EG0021 events1 affected33 at risk
EG003
Hypoaesthesia oral
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0010 events0 affected99 at risk
EG0021 events1 affected33 at risk
EG003
Ileus
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Impaired gastric emptying
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Inguinal hernia
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0013 events3 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Irritable bowel syndrome
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA 24.0
Systematic Assessment
EG00042 events21 affected134 at risk
EG00114 events8 affected99 at risk
EG0028 events4 affected33 at risk
EG003
Large intestinal ulcer
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Large intestine polyp
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0003 events3 affected134 at risk
EG0015 events5 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Lip blister
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Lip dry
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Lip erythema
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Lip pain
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Lip swelling
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Lip ulceration
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Melaena
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Mouth haemorrhage
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0003 events3 affected134 at risk
EG0011 events1 affected99 at risk
EG0021 events1 affected33 at risk
EG003
Mouth ulceration
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0003 events2 affected134 at risk
EG0012 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG00067 events47 affected134 at risk
EG00153 events34 affected99 at risk
EG00216 events11 affected33 at risk
EG003
Odynophagia
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Oesophageal obstruction
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0012 events2 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Oesophageal pain
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Oesophageal spasm
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0012 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Oesophagitis
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Oesophagitis ulcerative
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Anaemia
Blood and lymphatic system disorders
MedDRA 24.0
Systematic Assessment
EG00027 events18 affected134 at risk
EG00112 events9 affected99 at risk
EG0027 events4 affected33 at risk
EG003
Spontaneous haemorrhage
Blood and lymphatic system disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Oral blood blister
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0005 events5 affected134 at risk
EG0011 events1 affected99 at risk
EG0022 events1 affected33 at risk
EG003
Oral disorder
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0003 events3 affected134 at risk
EG0012 events2 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Oral mucosa haematoma
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Oral mucosal blistering
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Oral pain
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0005 events5 affected134 at risk
EG0014 events4 affected99 at risk
EG0021 events1 affected33 at risk
EG003
Peritoneal haematoma
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Pharyngo-oesophageal diverticulum
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Proctalgia
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0004 events2 affected134 at risk
EG0012 events2 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 24.0
Systematic Assessment
EG00017 events5 affected134 at risk
EG0011 events1 affected99 at risk
EG0025 events3 affected33 at risk
EG003
Pseudopolyposis
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Rectal discharge
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Rectal haemorrhage
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0004 events3 affected134 at risk
EG0016 events6 affected99 at risk
EG0021 events1 affected33 at risk
EG003
Rectal polyp
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Rectal prolapse
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Retching
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Salivary gland enlargement
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Spigelian hernia
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG00016 events13 affected134 at risk
EG00123 events14 affected99 at risk
EG0026 events5 affected33 at risk
EG003
Acute coronary syndrome
Cardiac disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Swollen tongue
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Tongue geographic
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0021 events1 affected33 at risk
EG003
Tongue haematoma
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Tongue ulceration
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Toothache
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0008 events6 affected134 at risk
EG0018 events7 affected99 at risk
EG0021 events1 affected33 at risk
EG003
Umbilical hernia
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0003 events3 affected134 at risk
EG0014 events4 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Upper gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG00044 events33 affected134 at risk
EG00130 events24 affected99 at risk
EG00212 events9 affected33 at risk
EG003
Asthenia
General disorders
MedDRA 24.0
Systematic Assessment
EG0007 events6 affected134 at risk
EG0011 events1 affected99 at risk
EG0021 events1 affected33 at risk
EG003
Axillary pain
General disorders
MedDRA 24.0
Systematic Assessment
EG0002 events2 affected134 at risk
EG0010 events0 affected99 at risk
EG0021 events1 affected33 at risk
EG003
Catheter site haemorrhage
General disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Chest discomfort
General disorders
MedDRA 24.0
Systematic Assessment
EG0005 events4 affected134 at risk
EG0014 events3 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Chest pain
General disorders
MedDRA 24.0
Systematic Assessment
EG0004 events3 affected134 at risk
EG0012 events2 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Chills
General disorders
MedDRA 24.0
Systematic Assessment
EG00018 events16 affected134 at risk
EG00114 events13 affected99 at risk
EG0023 events3 affected33 at risk
EG003
Complication associated with device
General disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0010 events0 affected99 at risk
EG0021 events1 affected33 at risk
EG003
Crepitations
General disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Cyst
General disorders
MedDRA 24.0
Systematic Assessment
EG0002 events2 affected134 at risk
EG0013 events3 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Early satiety
General disorders
MedDRA 24.0
Systematic Assessment
EG0003 events2 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Face oedema
General disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Facial pain
General disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0014 events4 affected99 at risk
EG0023 events3 affected33 at risk
EG003
Angina pectoris
Cardiac disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0012 events2 affected99 at risk
EG0021 events1 affected33 at risk
EG003
Fat necrosis
General disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Fatigue
General disorders
MedDRA 24.0
Systematic Assessment
EG00058 events49 affected134 at risk
EG00131 events22 affected99 at risk
EG00210 events7 affected33 at risk
EG003
Feeling cold
General disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Feeling hot
General disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Gait disturbance
General disorders
MedDRA 24.0
Systematic Assessment
EG0003 events3 affected134 at risk
EG0013 events3 affected99 at risk
EG0021 events1 affected33 at risk
EG003
General physical health deterioration
General disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Granuloma
General disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Hernia
General disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Hyperpyrexia
General disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Hypothermia
General disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Aortic valve disease
Cardiac disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Influenza like illness
General disorders
MedDRA 24.0
Systematic Assessment
EG00014 events12 affected134 at risk
EG00114 events13 affected99 at risk
EG0023 events2 affected33 at risk
EG003
Infusion site rash
General disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Injection site bruising
General disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Injection site phlebitis
General disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Injection site reaction
General disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Injection site swelling
General disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Localised oedema
General disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0021 events1 affected33 at risk
EG003
Malaise
General disorders
MedDRA 24.0
Systematic Assessment
EG0007 events6 affected134 at risk
EG0015 events4 affected99 at risk
EG0022 events2 affected33 at risk
EG003
Mass
General disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Aortic valve incompetence
Cardiac disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Medical device site bruise
General disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Mucosal inflammation
General disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Nodule
General disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0010 events0 affected99 at risk
EG0021 events1 affected33 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA 24.0
Systematic Assessment
EG00011 events8 affected134 at risk
EG00116 events12 affected99 at risk
EG0028 events8 affected33 at risk
EG003
Oedema
General disorders
MedDRA 24.0
Systematic Assessment
EG0002 events2 affected134 at risk
EG0012 events2 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Oedema peripheral
General disorders
MedDRA 24.0
Systematic Assessment
EG00036 events28 affected134 at risk
EG00125 events18 affected99 at risk
EG0027 events7 affected33 at risk
EG003
Pain
General disorders
MedDRA 24.0
Systematic Assessment
EG0003 events3 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Peripheral swelling
General disorders
MedDRA 24.0
Systematic Assessment
EG0004 events4 affected134 at risk
EG0013 events2 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Physical deconditioning
General disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Arteriosclerosis coronary artery
Cardiac disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Polyp
General disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Pyrexia
General disorders
MedDRA 24.0
Systematic Assessment
EG00069 events39 affected134 at risk
EG00119 events13 affected99 at risk
EG00217 events10 affected33 at risk
EG003
Suprapubic pain
General disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Swelling
General disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0021 events1 affected33 at risk
EG003
Swelling face
General disorders
MedDRA 24.0
Systematic Assessment
EG0003 events3 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Systemic inflammatory response syndrome
General disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Vaccination site mass
General disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Vaccination site pain
General disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0012 events2 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Cholecystitis
Hepatobiliary disorders
MedDRA 24.0
Systematic Assessment
EG0003 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA 24.0
Systematic Assessment
EG00011 events10 affected134 at risk
EG0018 events5 affected99 at risk
EG0022 events2 affected33 at risk
EG003
Cholelithiasis
Hepatobiliary disorders
MedDRA 24.0
Systematic Assessment
EG0003 events2 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Hepatic mass
Hepatobiliary disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0010 events0 affected99 at risk
EG0021 events1 affected33 at risk
EG003
Hepatic steatosis
Hepatobiliary disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Allergy to arthropod bite
Immune system disorders
MedDRA 24.0
Systematic Assessment
EG0007 events7 affected134 at risk
EG0014 events4 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Allergy to arthropod sting
Immune system disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Contrast media allergy
Immune system disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0012 events2 affected99 at risk
EG0021 events1 affected33 at risk
EG003
Drug hypersensitivity
Immune system disorders
MedDRA 24.0
Systematic Assessment
EG0003 events3 affected134 at risk
EG0014 events4 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Food allergy
Immune system disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0021 events1 affected33 at risk
EG003
Atrial flutter
Cardiac disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Graft versus host disease in gastrointestinal tract
Immune system disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Graft versus host disease in skin
Immune system disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Hypersensitivity
Immune system disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0012 events2 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Hypogammaglobulinaemia
Immune system disorders
MedDRA 24.0
Systematic Assessment
EG0003 events3 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Immunodeficiency
Immune system disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0012 events2 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Seasonal allergy
Immune system disorders
MedDRA 24.0
Systematic Assessment
EG0002 events2 affected134 at risk
EG0012 events2 affected99 at risk
EG0021 events1 affected33 at risk
EG003
Abscess
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Acute sinusitis
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Appendicitis
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Aspergillus infection
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0010 events0 affected99 at risk
EG0021 events1 affected33 at risk
EG003
Bacteraemia
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0021 events1 affected33 at risk
EG003
Bacteriuria
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Body tinea
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Breast abscess
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG00018 events14 affected134 at risk
EG00116 events14 affected99 at risk
EG0029 events6 affected33 at risk
EG003
Bronchopulmonary aspergillosis
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Burkholderia cepacia complex infection
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Covid-19
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0005 events4 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Campylobacter gastroenteritis
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Campylobacter infection
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Candida infection
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG00013 events12 affected134 at risk
EG0011 events1 affected99 at risk
EG0027 events3 affected33 at risk
EG003
Chronic sinusitis
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Clostridium difficile colitis
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0010 events0 affected99 at risk
EG0022 events1 affected33 at risk
EG003
Bradycardia
Cardiac disorders
MedDRA 24.0
Systematic Assessment
EG0008 events5 affected134 at risk
EG0012 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Clostridium difficile infection
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Coccidioidomycosis
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Conjunctivitis
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0007 events7 affected134 at risk
EG0015 events5 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Cystitis
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Diverticulitis
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0014 events3 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Ear infection
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0008 events7 affected134 at risk
EG0013 events3 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Encephalitis
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0010 events0 affected99 at risk
EG0021 events1 affected33 at risk
EG003
Enterocolitis infectious
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Epididymitis
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0012 events2 affected99 at risk
EG0022 events1 affected33 at risk
EG003
Bundle branch block left
Cardiac disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Epstein-barr virus infection reactivation
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Escherichia bacteraemia
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
External ear cellulitis
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0010 events0 affected99 at risk
EG0021 events1 affected33 at risk
EG003
Eye infection
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0005 events4 affected134 at risk
EG0012 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Folliculitis
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0002 events2 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Fungal infection
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0002 events1 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Fungal skin infection
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0002 events2 affected134 at risk
EG0012 events2 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Furuncle
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0012 events2 affected99 at risk
EG0022 events2 affected33 at risk
EG003
Bundle branch block right
Cardiac disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Gastroenteritis viral
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0005 events5 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Gastrointestinal bacterial infection
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0010 events0 affected99 at risk
EG0021 events1 affected33 at risk
EG003
Gastrointestinal viral infection
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Genital infection fungal
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0012 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Gingivitis
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0002 events2 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Groin abscess
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0021 events1 affected33 at risk
EG003
Haemophilus infection
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0021 events1 affected33 at risk
EG003
Hand-foot-and-mouth disease
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Helicobacter infection
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Hepatic infection
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0010 events0 affected99 at risk
EG0021 events1 affected33 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0007 events6 affected134 at risk
EG0011 events1 affected99 at risk
EG0022 events2 affected33 at risk
EG003
Infected bite
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0002 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Infected dermal cyst
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Influenza
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG00013 events12 affected134 at risk
EG0016 events6 affected99 at risk
EG0021 events1 affected33 at risk
EG003
Intervertebral discitis
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Cardiac failure
Cardiac disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Laryngitis
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0012 events1 affected99 at risk
EG0021 events1 affected33 at risk
EG003
Localised infection
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0021 events1 affected33 at risk
EG003
Lower respiratory tract infection
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG00012 events9 affected134 at risk
EG0011 events1 affected99 at risk
EG0025 events3 affected33 at risk
EG003
Lyme disease
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0002 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Lymphangitis
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0010 events0 affected99 at risk
EG0021 events1 affected33 at risk
EG003
Mastoiditis
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Metapneumovirus infection
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Moraxella infection
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Mycobacterial infection
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Myringitis
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Nail infection
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0003 events3 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG00012 events11 affected134 at risk
EG00111 events9 affected99 at risk
EG0026 events3 affected33 at risk
EG003
Onychomycosis
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Oral candidiasis
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Oral herpes
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0005 events5 affected134 at risk
EG0012 events2 affected99 at risk
EG0023 events3 affected33 at risk
EG003
Oropharyngeal candidiasis
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Otitis externa
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0013 events3 affected99 at risk
EG0023 events3 affected33 at risk
EG003
Otitis media
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0006 events6 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Paronychia
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0003 events2 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Parotitis
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Pelvic abscess
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Perirectal abscess
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0003 events3 affected134 at risk
EG0013 events3 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Pharyngitis streptococcal
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0002 events2 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG00029 events26 affected134 at risk
EG00116 events12 affected99 at risk
EG0029 events3 affected33 at risk
EG003
Coronary artery disease
Cardiac disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Pneumonia bacterial
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Pneumonia cryptococcal
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Pneumonia pseudomonal
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0010 events0 affected99 at risk
EG0021 events1 affected33 at risk
EG003
Pneumonia streptococcal
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Post-acute covid-19 syndrome
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Postoperative wound infection
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Propionibacterium infection
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Febrile neutropenia
Blood and lymphatic system disorders
MedDRA 24.0
Systematic Assessment
EG0003 events3 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Coronary artery stenosis
Cardiac disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0012 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Prostatic abscess
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Pseudomonas infection
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0012 events2 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Rash pustular
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Respiratory tract infection
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0002 events2 affected134 at risk
EG0010 events0 affected99 at risk
EG0021 events1 affected33 at risk
EG003
Rhinitis
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0004 events4 affected134 at risk
EG0012 events2 affected99 at risk
EG0021 events1 affected33 at risk
EG003
Rhinovirus infection
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0010 events0 affected99 at risk
EG0021 events1 affected33 at risk
EG003
Salmonellosis
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Scrotal infection
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Extrasystoles
Cardiac disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Sepsis
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Sinusitis
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG00044 events33 affected134 at risk
EG00134 events22 affected99 at risk
EG0026 events3 affected33 at risk
EG003
Sinusitis bacterial
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0021 events1 affected33 at risk
EG003
Skin bacterial infection
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Skin infection
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0002 events2 affected134 at risk
EG0010 events0 affected99 at risk
EG0024 events3 affected33 at risk
EG003
Staphylococcal infection
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0003 events3 affected134 at risk
EG0012 events2 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Subcutaneous abscess
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Testicular abscess
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Tinea cruris
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0002 events2 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Left ventricular failure
Cardiac disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Tinea infection
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Tinea pedis
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0010 events0 affected99 at risk
EG0021 events1 affected33 at risk
EG003
Tinea versicolour
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Tonsillitis
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Tooth abscess
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Tooth infection
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0004 events3 affected134 at risk
EG0016 events6 affected99 at risk
EG0023 events2 affected33 at risk
EG003
Tracheitis
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG00088 events54 affected134 at risk
EG00185 events49 affected99 at risk
EG00225 events15 affected33 at risk
EG003
Ureteritis
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG00032 events15 affected134 at risk
EG00124 events13 affected99 at risk
EG00211 events5 affected33 at risk
EG003
Mitral valve disease
Cardiac disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0012 events2 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Urinary tract infection bacterial
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Urinary tract infection enterococcal
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Vaginal infection
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0002 events2 affected134 at risk
EG0010 events0 affected99 at risk
EG0021 events1 affected33 at risk
EG003
Vascular device infection
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Viral pharyngitis
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Viral upper respiratory tract infection
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0003 events3 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Vulvovaginal mycotic infection
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0010 events0 affected99 at risk
EG0021 events1 affected33 at risk
EG003
Wound infection
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0003 events2 affected134 at risk
EG0012 events2 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Anaemia postoperative
Injury, poisoning and procedural complications
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Animal bite
Injury, poisoning and procedural complications
MedDRA 24.0
Systematic Assessment
EG0005 events5 affected134 at risk
EG0010 events0 affected99 at risk
EG0021 events1 affected33 at risk
EG003
Arthropod bite
Injury, poisoning and procedural complications
MedDRA 24.0
Systematic Assessment
EG00010 events10 affected134 at risk
EG00113 events8 affected99 at risk
EG0021 events1 affected33 at risk
EG003
Axillary web syndrome
Injury, poisoning and procedural complications
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Bone contusion
Injury, poisoning and procedural complications
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Cartilage injury
Injury, poisoning and procedural complications
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Chest injury
Injury, poisoning and procedural complications
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Clavicle fracture
Injury, poisoning and procedural complications
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Concussion
Injury, poisoning and procedural complications
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA 24.0
Systematic Assessment
EG00060 events42 affected134 at risk
EG00162 events50 affected99 at risk
EG00213 events11 affected33 at risk
EG003
Palpitations
Cardiac disorders
MedDRA 24.0
Systematic Assessment
EG00015 events13 affected134 at risk
EG0014 events4 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Dental restoration failure
Injury, poisoning and procedural complications
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Eye contusion
Injury, poisoning and procedural complications
MedDRA 24.0
Systematic Assessment
EG0002 events2 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Face injury
Injury, poisoning and procedural complications
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Facial bones fracture
Injury, poisoning and procedural complications
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0012 events2 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 24.0
Systematic Assessment
EG00041 events21 affected134 at risk
EG00134 events23 affected99 at risk
EG00211 events6 affected33 at risk
EG003
Foot fracture
Injury, poisoning and procedural complications
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0012 events1 affected99 at risk
EG0022 events1 affected33 at risk
EG003
Foreign body in eye
Injury, poisoning and procedural complications
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0021 events1 affected33 at risk
EG003
Fracture
Injury, poisoning and procedural complications
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Fractured coccyx
Injury, poisoning and procedural complications
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Sinus bradycardia
Cardiac disorders
MedDRA 24.0
Systematic Assessment
EG0006 events5 affected134 at risk
EG0012 events2 affected99 at risk
EG0021 events1 affected33 at risk
EG003
Hand fracture
Injury, poisoning and procedural complications
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Human bite
Injury, poisoning and procedural complications
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Humerus fracture
Injury, poisoning and procedural complications
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Infusion related reaction
Injury, poisoning and procedural complications
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0011 events1 affected99 at risk
EG0022 events2 affected33 at risk
EG003
Injury
Injury, poisoning and procedural complications
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Joint injury
Injury, poisoning and procedural complications
MedDRA 24.0
Systematic Assessment
EG0003 events3 affected134 at risk
EG0013 events2 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Ligament injury
Injury, poisoning and procedural complications
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Ligament rupture
Injury, poisoning and procedural complications
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Ligament sprain
Injury, poisoning and procedural complications
MedDRA 24.0
Systematic Assessment
EG0003 events3 affected134 at risk
EG0014 events4 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Sinus tachycardia
Cardiac disorders
MedDRA 24.0
Systematic Assessment
EG0006 events5 affected134 at risk
EG00111 events10 affected99 at risk
EG0021 events1 affected33 at risk
EG003
Limb injury
Injury, poisoning and procedural complications
MedDRA 24.0
Systematic Assessment
EG0004 events4 affected134 at risk
EG0015 events4 affected99 at risk
EG0021 events1 affected33 at risk
EG003
Meniscus injury
Injury, poisoning and procedural complications
MedDRA 24.0
Systematic Assessment
EG0002 events2 affected134 at risk
EG0012 events2 affected99 at risk
EG0021 events1 affected33 at risk
EG003
Muscle rupture
Injury, poisoning and procedural complications
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0021 events1 affected33 at risk
EG003
Muscle strain
Injury, poisoning and procedural complications
MedDRA 24.0
Systematic Assessment
EG0005 events5 affected134 at risk
EG0015 events5 affected99 at risk
EG0021 events1 affected33 at risk
EG003
Musculoskeletal injury
Injury, poisoning and procedural complications
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Nail injury
Injury, poisoning and procedural complications
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Patella fracture
Injury, poisoning and procedural complications
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Periorbital haemorrhage
Injury, poisoning and procedural complications
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Post procedural complication
Injury, poisoning and procedural complications
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Post procedural contusion
Injury, poisoning and procedural complications
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0012 events2 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Post procedural haemorrhage
Injury, poisoning and procedural complications
MedDRA 24.0
Systematic Assessment
EG0002 events2 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Post procedural inflammation
Injury, poisoning and procedural complications
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Post procedural swelling
Injury, poisoning and procedural complications
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0012 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Post-traumatic pain
Injury, poisoning and procedural complications
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Procedural hypotension
Injury, poisoning and procedural complications
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Procedural pain
Injury, poisoning and procedural complications
MedDRA 24.0
Systematic Assessment
EG0002 events2 affected134 at risk
EG0015 events3 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Radiation pneumonitis
Injury, poisoning and procedural complications
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Radiation proctitis
Injury, poisoning and procedural complications
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Reactive gastropathy
Injury, poisoning and procedural complications
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Respiratory fume inhalation disorder
Injury, poisoning and procedural complications
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Rib fracture
Injury, poisoning and procedural complications
MedDRA 24.0
Systematic Assessment
EG0004 events4 affected134 at risk
EG0013 events3 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Road traffic accident
Injury, poisoning and procedural complications
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Scar
Injury, poisoning and procedural complications
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Scratch
Injury, poisoning and procedural complications
MedDRA 24.0
Systematic Assessment
EG0002 events2 affected134 at risk
EG0012 events2 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Scrotal haematoma
Injury, poisoning and procedural complications
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Skin abrasion
Injury, poisoning and procedural complications
MedDRA 24.0
Systematic Assessment
EG0003 events2 affected134 at risk
EG0013 events3 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Skin laceration
Injury, poisoning and procedural complications
MedDRA 24.0
Systematic Assessment
EG0007 events6 affected134 at risk
EG0015 events5 affected99 at risk
EG0021 events1 affected33 at risk
EG003
Skin wound
Injury, poisoning and procedural complications
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Spinal compression fracture
Injury, poisoning and procedural complications
MedDRA 24.0
Systematic Assessment
EG0003 events3 affected134 at risk
EG0012 events2 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Spinal fracture
Injury, poisoning and procedural complications
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Haemolysis
Blood and lymphatic system disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0010 events0 affected99 at risk
EG0021 events1 affected33 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA 24.0
Systematic Assessment
EG0003 events3 affected134 at risk
EG0019 events8 affected99 at risk
EG0022 events2 affected33 at risk
EG003
Stoma site reaction
Injury, poisoning and procedural complications
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Stomal hernia
Injury, poisoning and procedural complications
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Tendon injury
Injury, poisoning and procedural complications
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0013 events2 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Tendon rupture
Injury, poisoning and procedural complications
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0013 events3 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Thermal burn
Injury, poisoning and procedural complications
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0011 events1 affected99 at risk
EG0021 events1 affected33 at risk
EG003
Thoracic vertebral fracture
Injury, poisoning and procedural complications
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Tooth fracture
Injury, poisoning and procedural complications
MedDRA 24.0
Systematic Assessment
EG0004 events4 affected134 at risk
EG0012 events2 affected99 at risk
EG0022 events2 affected33 at risk
EG003
Upper limb fracture
Injury, poisoning and procedural complications
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Tricuspid valve disease
Cardiac disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Vaccination complication
Injury, poisoning and procedural complications
MedDRA 24.0
Systematic Assessment
EG0009 events6 affected134 at risk
EG00112 events8 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Vascular access complication
Injury, poisoning and procedural complications
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Venous injury
Injury, poisoning and procedural complications
MedDRA 24.0
Systematic Assessment
EG0002 events1 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Wound
Injury, poisoning and procedural complications
MedDRA 24.0
Systematic Assessment
EG0003 events3 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Wound dehiscence
Injury, poisoning and procedural complications
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Wound haemorrhage
Injury, poisoning and procedural complications
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0010 events0 affected99 at risk
EG0021 events1 affected33 at risk
EG003
Wrist fracture
Injury, poisoning and procedural complications
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Activated partial thromboplastin time prolonged
Investigations
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0013 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 24.0
Systematic Assessment
EG0003 events3 affected134 at risk
EG0014 events2 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Amylase increased
Investigations
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Ventricular extrasystoles
Cardiac disorders
MedDRA 24.0
Systematic Assessment
EG0003 events3 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Antinuclear antibody positive
Investigations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 24.0
Systematic Assessment
EG0004 events4 affected134 at risk
EG0013 events2 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Bk polyomavirus test positive
Investigations
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Blood albumin decreased
Investigations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0010 events0 affected99 at risk
EG0021 events1 affected33 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Blood beta-d-glucan increased
Investigations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Blood cholesterol increased
Investigations
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Blood creatinine increased
Investigations
MedDRA 24.0
Systematic Assessment
EG0009 events7 affected134 at risk
EG0012 events2 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Blood folate decreased
Investigations
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Blood immunoglobulin g decreased
Investigations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0010 events0 affected99 at risk
EG0022 events2 affected33 at risk
EG003
Blood lactate dehydrogenase increased
Investigations
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Blood phosphorus decreased
Investigations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0010 events0 affected99 at risk
EG0021 events1 affected33 at risk
EG003
Blood potassium decreased
Investigations
MedDRA 24.0
Systematic Assessment
EG0002 events2 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Blood pressure increased
Investigations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Blood sodium decreased
Investigations
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Blood testosterone decreased
Investigations
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Bone density decreased
Investigations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Breath sounds abnormal
Investigations
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
C-reactive protein increased
Investigations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Ventricular tachycardia
Cardiac disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Cardiac murmur
Investigations
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0015 events5 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Coagulation time prolonged
Investigations
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Computerised tomogram thorax abnormal
Investigations
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Eastern cooperative oncology group performance status worsened
Investigations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Electrocardiogram qt prolonged
Investigations
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0013 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Haemoglobin decreased
Investigations
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Influenza a virus test positive
Investigations
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Influenza b virus test positive
Investigations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0010 events0 affected99 at risk
EG0021 events1 affected33 at risk
EG003
Hypertrophic cardiomyopathy
Congenital, familial and genetic disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0012 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Influenza virus test positive
Investigations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0010 events0 affected99 at risk
EG0021 events1 affected33 at risk
EG003
International normalised ratio increased
Investigations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0014 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Lipase increased
Investigations
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Lymphocyte count decreased
Investigations
MedDRA 24.0
Systematic Assessment
EG0004 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Lymphocyte count increased
Investigations
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0021 events1 affected33 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA 24.0
Systematic Assessment
EG0003 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Neutrophil count increased
Investigations
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Norovirus test positive
Investigations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Platelet count decreased
Investigations
MedDRA 24.0
Systematic Assessment
EG0007 events4 affected134 at risk
EG0010 events0 affected99 at risk
EG0028 events1 affected33 at risk
EG003
Prostatic specific antigen increased
Investigations
MedDRA 24.0
Systematic Assessment
EG0002 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Laryngocele
Congenital, familial and genetic disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Thyroid hormones increased
Investigations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Transaminases increased
Investigations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Troponin i increased
Investigations
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Troponin increased
Investigations
MedDRA 24.0
Systematic Assessment
EG0002 events1 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Weight decreased
Investigations
MedDRA 24.0
Systematic Assessment
EG00043 events27 affected134 at risk
EG00113 events8 affected99 at risk
EG0025 events3 affected33 at risk
EG003
Weight increased
Investigations
MedDRA 24.0
Systematic Assessment
EG00097 events34 affected134 at risk
EG001105 events33 affected99 at risk
EG00222 events10 affected33 at risk
EG003
White blood cell count decreased
Investigations
MedDRA 24.0
Systematic Assessment
EG0003 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0021 events1 affected33 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 24.0
Systematic Assessment
EG00026 events22 affected134 at risk
EG00119 events13 affected99 at risk
EG0022 events2 affected33 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 24.0
Systematic Assessment
EG0005 events4 affected134 at risk
EG0017 events7 affected99 at risk
EG0023 events2 affected33 at risk
EG003
Failure to thrive
Metabolism and nutrition disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Porokeratosis
Congenital, familial and genetic disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0010 events0 affected99 at risk
EG0021 events1 affected33 at risk
EG003
Fluid overload
Metabolism and nutrition disorders
MedDRA 24.0
Systematic Assessment
EG0002 events2 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Fluid retention
Metabolism and nutrition disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Gout
Metabolism and nutrition disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0012 events2 affected99 at risk
EG0021 events1 affected33 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA 24.0
Systematic Assessment
EG0006 events3 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA 24.0
Systematic Assessment
EG0004 events4 affected134 at risk
EG0014 events3 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Hyperlipidaemia
Metabolism and nutrition disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Hypernatraemia
Metabolism and nutrition disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Hyperphagia
Metabolism and nutrition disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Hyperuricaemia
Metabolism and nutrition disorders
MedDRA 24.0
Systematic Assessment
EG0004 events4 affected134 at risk
EG0016 events6 affected99 at risk
EG0022 events1 affected33 at risk
EG003
Deafness
Ear and labyrinth disorders
MedDRA 24.0
Systematic Assessment
EG0002 events2 affected134 at risk
EG0012 events2 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
MedDRA 24.0
Systematic Assessment
EG0002 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0021 events1 affected33 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0012 events1 affected99 at risk
EG0023 events2 affected33 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 24.0
Systematic Assessment
EG0008 events7 affected134 at risk
EG0014 events4 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA 24.0
Systematic Assessment
EG0002 events2 affected134 at risk
EG0012 events2 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 24.0
Systematic Assessment
EG0002 events2 affected134 at risk
EG0012 events2 affected99 at risk
EG0021 events1 affected33 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
MedDRA 24.0
Systematic Assessment
EG0005 events4 affected134 at risk
EG0010 events0 affected99 at risk
EG0021 events1 affected33 at risk
EG003
Iron deficiency
Metabolism and nutrition disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0014 events4 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Polydipsia
Metabolism and nutrition disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Tumour lysis syndrome
Metabolism and nutrition disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Deafness unilateral
Ear and labyrinth disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0012 events2 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Type 2 diabetes mellitus
Metabolism and nutrition disorders
MedDRA 24.0
Systematic Assessment
EG0002 events2 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Vitamin b complex deficiency
Metabolism and nutrition disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Vitamin b12 deficiency
Metabolism and nutrition disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Vitamin d deficiency
Metabolism and nutrition disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0011 events1 affected99 at risk
EG0021 events1 affected33 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 24.0
Systematic Assessment
EG00078 events47 affected134 at risk
EG00183 events55 affected99 at risk
EG00213 events9 affected33 at risk
EG003
Arthritis
Musculoskeletal and connective tissue disorders
MedDRA 24.0
Systematic Assessment
EG0008 events7 affected134 at risk
EG00110 events10 affected99 at risk
EG0022 events2 affected33 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 24.0
Systematic Assessment
EG00021 events19 affected134 at risk
EG00126 events22 affected99 at risk
EG0023 events3 affected33 at risk
EG003
Bone pain
Musculoskeletal and connective tissue disorders
MedDRA 24.0
Systematic Assessment
EG0004 events4 affected134 at risk
EG0011 events1 affected99 at risk
EG0024 events3 affected33 at risk
EG003
Bursa disorder
Musculoskeletal and connective tissue disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0010 events0 affected99 at risk
EG0021 events1 affected33 at risk
EG003
Bursitis
Musculoskeletal and connective tissue disorders
MedDRA 24.0
Systematic Assessment
EG0002 events2 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Haemolytic anaemia
Blood and lymphatic system disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Ear congestion
Ear and labyrinth disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Cervical spinal stenosis
Musculoskeletal and connective tissue disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Chondrocalcinosis pyrophosphate
Musculoskeletal and connective tissue disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Dupuytren's contracture
Musculoskeletal and connective tissue disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Exostosis
Musculoskeletal and connective tissue disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Flank pain
Musculoskeletal and connective tissue disorders
MedDRA 24.0
Systematic Assessment
EG0003 events3 affected134 at risk
EG0016 events6 affected99 at risk
EG0021 events1 affected33 at risk
EG003
Groin pain
Musculoskeletal and connective tissue disorders
MedDRA 24.0
Systematic Assessment
EG0005 events5 affected134 at risk
EG0013 events3 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Haemarthrosis
Musculoskeletal and connective tissue disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Intervertebral disc degeneration
Musculoskeletal and connective tissue disorders
MedDRA 24.0
Systematic Assessment
EG0002 events2 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Intervertebral disc protrusion
Musculoskeletal and connective tissue disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Joint effusion
Musculoskeletal and connective tissue disorders
MedDRA 24.0
Systematic Assessment
EG0002 events2 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Ear discomfort
Ear and labyrinth disorders
MedDRA 24.0
Systematic Assessment
EG0003 events3 affected134 at risk
EG0012 events2 affected99 at risk
EG0022 events1 affected33 at risk
EG003
Joint hyperextension
Musculoskeletal and connective tissue disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Joint stiffness
Musculoskeletal and connective tissue disorders
MedDRA 24.0
Systematic Assessment
EG0002 events2 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Joint swelling
Musculoskeletal and connective tissue disorders
MedDRA 24.0
Systematic Assessment
EG0003 events3 affected134 at risk
EG0012 events2 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Limb discomfort
Musculoskeletal and connective tissue disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Limb mass
Musculoskeletal and connective tissue disorders
MedDRA 24.0
Systematic Assessment
EG0004 events4 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Medial tibial stress syndrome
Musculoskeletal and connective tissue disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Muscle atrophy
Musculoskeletal and connective tissue disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA 24.0
Systematic Assessment
EG00014 events11 affected134 at risk
EG00120 events14 affected99 at risk
EG0024 events3 affected33 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA 24.0
Systematic Assessment
EG0006 events4 affected134 at risk
EG0017 events7 affected99 at risk
EG0021 events1 affected33 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA 24.0
Systematic Assessment
EG0002 events2 affected134 at risk
EG0012 events2 affected99 at risk
EG0022 events2 affected33 at risk
EG003
Ear haemorrhage
Ear and labyrinth disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Musculoskeletal deformity
Musculoskeletal and connective tissue disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Musculoskeletal discomfort
Musculoskeletal and connective tissue disorders
MedDRA 24.0
Systematic Assessment
EG0003 events3 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Musculoskeletal disorder
Musculoskeletal and connective tissue disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0012 events2 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Musculoskeletal stiffness
Musculoskeletal and connective tissue disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0012 events2 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 24.0
Systematic Assessment
EG00022 events18 affected134 at risk
EG00117 events14 affected99 at risk
EG00210 events8 affected33 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA 24.0
Systematic Assessment
EG0005 events5 affected134 at risk
EG0014 events4 affected99 at risk
EG0021 events1 affected33 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA 24.0
Systematic Assessment
EG0003 events2 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Osteonecrosis
Musculoskeletal and connective tissue disorders
MedDRA 24.0
Systematic Assessment
EG0002 events2 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Osteopenia
Musculoskeletal and connective tissue disorders
MedDRA 24.0
Systematic Assessment
EG0002 events2 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Ear pain
Ear and labyrinth disorders
MedDRA 24.0
Systematic Assessment
EG0005 events5 affected134 at risk
EG0016 events6 affected99 at risk
EG0022 events2 affected33 at risk
EG003
Osteoporosis
Musculoskeletal and connective tissue disorders
MedDRA 24.0
Systematic Assessment
EG0005 events5 affected134 at risk
EG0013 events3 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 24.0
Systematic Assessment
EG00032 events24 affected134 at risk
EG00114 events11 affected99 at risk
EG0027 events5 affected33 at risk
EG003
Pain in jaw
Musculoskeletal and connective tissue disorders
MedDRA 24.0
Systematic Assessment
EG0002 events2 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Plantar fasciitis
Musculoskeletal and connective tissue disorders
MedDRA 24.0
Systematic Assessment
EG0002 events2 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Polymyalgia rheumatica
Musculoskeletal and connective tissue disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Rheumatoid arthritis
Musculoskeletal and connective tissue disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Rotator cuff syndrome
Musculoskeletal and connective tissue disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0011 events1 affected99 at risk
EG0021 events1 affected33 at risk
EG003
Scoliosis
Musculoskeletal and connective tissue disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Sinus tarsi syndrome
Musculoskeletal and connective tissue disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0010 events0 affected99 at risk
EG0021 events1 affected33 at risk
EG003
Spinal osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA 24.0
Systematic Assessment
EG0002 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Ear pruritus
Ear and labyrinth disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Spinal pain
Musculoskeletal and connective tissue disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Spinal stenosis
Musculoskeletal and connective tissue disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Spondylolisthesis
Musculoskeletal and connective tissue disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Synovial cyst
Musculoskeletal and connective tissue disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Temporomandibular joint syndrome
Musculoskeletal and connective tissue disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Tendon pain
Musculoskeletal and connective tissue disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Tendonitis
Musculoskeletal and connective tissue disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0014 events4 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Trigger finger
Musculoskeletal and connective tissue disorders
MedDRA 24.0
Systematic Assessment
EG0002 events2 affected134 at risk
EG0012 events2 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Vertebral column mass
Musculoskeletal and connective tissue disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Eustachian tube disorder
Ear and labyrinth disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Basal cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 24.0
Systematic Assessment
EG00012 events11 affected134 at risk
EG00117 events11 affected99 at risk
EG0024 events4 affected33 at risk
EG003
Basosquamous carcinoma of skin
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Benign neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Benign neoplasm of urethra
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Bladder cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Bladder cancer recurrent
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Bowen's disease
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Eustachian tube dysfunction
Ear and labyrinth disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Clear cell renal cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Colon adenoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0012 events2 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Dysplastic naevus
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Eye naevus
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Fibroma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 24.0
Systematic Assessment
EG0002 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Fibrous histiocytoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
External ear inflammation
Ear and labyrinth disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Haemangioma of skin
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Large intestine benign neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Leukaemia cutis
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 24.0
Systematic Assessment
EG0002 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Lip neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Lip squamous cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Lipoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 24.0
Systematic Assessment
EG0002 events2 affected134 at risk
EG0012 events2 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Lung adenocarcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Lung neoplasm malignant
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
External ear pain
Ear and labyrinth disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Malignant melanoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 24.0
Systematic Assessment
EG0003 events2 affected134 at risk
EG0011 events1 affected99 at risk
EG0021 events1 affected33 at risk
EG003
Malignant melanoma in situ
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Melanocytic naevus
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 24.0
Systematic Assessment
EG0002 events2 affected134 at risk
EG0013 events3 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Metastases to spine
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Nasal neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Neoplasm skin
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Hyperacusis
Ear and labyrinth disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Ovarian neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Pancreatic neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Paraneoplastic syndrome
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Prostate cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 24.0
Systematic Assessment
EG0002 events2 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Renal cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Renal neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 24.0
Systematic Assessment
EG0003 events3 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Increased tendency to bruise
Blood and lymphatic system disorders
MedDRA 24.0
Systematic Assessment
EG00015 events15 affected134 at risk
EG00110 events10 affected99 at risk
EG0023 events3 affected33 at risk
EG003
Hypoacusis
Ear and labyrinth disorders
MedDRA 24.0
Systematic Assessment
EG0003 events3 affected134 at risk
EG0016 events6 affected99 at risk
EG0021 events1 affected33 at risk
EG003
Sebaceous adenoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Seborrhoeic keratosis
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 24.0
Systematic Assessment
EG0006 events6 affected134 at risk
EG0015 events5 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Sinonasal papilloma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Skin cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0012 events2 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Skin neoplasm bleeding
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Skin papilloma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 24.0
Systematic Assessment
EG0004 events4 affected134 at risk
EG0013 events2 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Squamous cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 24.0
Systematic Assessment
EG0002 events2 affected134 at risk
EG0015 events4 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Squamous cell carcinoma of skin
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 24.0
Systematic Assessment
EG0009 events8 affected134 at risk
EG0017 events7 affected99 at risk
EG0021 events1 affected33 at risk
EG003
Tongue neoplasm benign
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Middle ear effusion
Ear and labyrinth disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0012 events2 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Transitional cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Uterine leiomyoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Amnesia
Nervous system disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0012 events2 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Aphasia
Nervous system disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Balance disorder
Nervous system disorders
MedDRA 24.0
Systematic Assessment
EG0002 events2 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Burning sensation
Nervous system disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0021 events1 affected33 at risk
EG003
Carotid arteriosclerosis
Nervous system disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Carotid artery aneurysm
Nervous system disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Motion sickness
Ear and labyrinth disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Carpal tunnel syndrome
Nervous system disorders
MedDRA 24.0
Systematic Assessment
EG0006 events5 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Cerebral microhaemorrhage
Nervous system disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0010 events0 affected99 at risk
EG0021 events1 affected33 at risk
EG003
Cerebrovascular accident
Nervous system disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Cervical radiculopathy
Nervous system disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Cognitive disorder
Nervous system disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Dementia alzheimer's type
Nervous system disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Depressed level of consciousness
Nervous system disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Disturbance in attention
Nervous system disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 24.0
Systematic Assessment
EG00027 events24 affected134 at risk
EG00122 events20 affected99 at risk
EG0027 events6 affected33 at risk
EG003
Tinnitus
Ear and labyrinth disorders
MedDRA 24.0
Systematic Assessment
EG0004 events4 affected134 at risk
EG0011 events1 affected99 at risk
EG0023 events3 affected33 at risk
EG003
Dizziness postural
Nervous system disorders
MedDRA 24.0
Systematic Assessment
EG0003 events3 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Dysarthria
Nervous system disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0010 events0 affected99 at risk
EG0021 events1 affected33 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA 24.0
Systematic Assessment
EG0004 events4 affected134 at risk
EG0012 events2 affected99 at risk
EG0021 events1 affected33 at risk
EG003
Encephalopathy
Nervous system disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Facial paralysis
Nervous system disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Headache
Nervous system disorders
MedDRA 24.0
Systematic Assessment
EG00098 events68 affected134 at risk
EG00179 events48 affected99 at risk
EG00218 events14 affected33 at risk
EG003
Hemianopia
Nervous system disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Hemiparesis
Nervous system disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0012 events2 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Hypersomnia
Nervous system disorders
MedDRA 24.0
Systematic Assessment
EG0003 events2 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Tympanic membrane perforation
Ear and labyrinth disorders
MedDRA 24.0
Systematic Assessment
EG0002 events2 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Hypoaesthesia
Nervous system disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0013 events3 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Hypogeusia
Nervous system disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Idiopathic partial epilepsy
Nervous system disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Intracranial pressure increased
Nervous system disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Lethargy
Nervous system disorders
MedDRA 24.0
Systematic Assessment
EG0002 events2 affected134 at risk
EG0012 events2 affected99 at risk
EG0021 events1 affected33 at risk
EG003
Memory impairment
Nervous system disorders
MedDRA 24.0
Systematic Assessment
EG0006 events5 affected134 at risk
EG0016 events5 affected99 at risk
EG0023 events2 affected33 at risk
EG003
Mental impairment
Nervous system disorders
MedDRA 24.0
Systematic Assessment
EG0002 events2 affected134 at risk
EG0011 events1 affected99 at risk
EG0021 events1 affected33 at risk
EG003
Migraine
Nervous system disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0012 events2 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Neuralgia
Nervous system disorders
MedDRA 24.0
Systematic Assessment
EG0003 events3 affected134 at risk
EG0011 events1 affected99 at risk
EG0021 events1 affected33 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA 24.0
Systematic Assessment
EG0009 events8 affected134 at risk
EG0014 events4 affected99 at risk
EG0026 events5 affected33 at risk
EG003
Neuropathy peripheral
Nervous system disorders
MedDRA 24.0
Systematic Assessment
EG0004 events4 affected134 at risk
EG0011 events1 affected99 at risk
EG0021 events1 affected33 at risk
EG003
Nystagmus
Nervous system disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0010 events0 affected99 at risk
EG0021 events1 affected33 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA 24.0
Systematic Assessment
EG00019 events19 affected134 at risk
EG00115 events14 affected99 at risk
EG0025 events5 affected33 at risk
EG003
Parosmia
Nervous system disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0010 events0 affected99 at risk
EG0021 events1 affected33 at risk
EG003
Peripheral motor neuropathy
Nervous system disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0021 events1 affected33 at risk
EG003
Peripheral sensory neuropathy
Nervous system disorders
MedDRA 24.0
Systematic Assessment
EG0005 events4 affected134 at risk
EG0015 events5 affected99 at risk
EG0022 events2 affected33 at risk
EG003
Post herpetic neuralgia
Nervous system disorders
MedDRA 24.0
Systematic Assessment
EG0002 events2 affected134 at risk
EG0011 events1 affected99 at risk
EG0022 events1 affected33 at risk
EG003
Presyncope
Nervous system disorders
MedDRA 24.0
Systematic Assessment
EG0007 events6 affected134 at risk
EG0014 events4 affected99 at risk
EG0021 events1 affected33 at risk
EG003
Radiculopathy
Nervous system disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Resting tremor
Nervous system disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Vertigo positional
Ear and labyrinth disorders
MedDRA 24.0
Systematic Assessment
EG0002 events2 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Restless legs syndrome
Nervous system disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0012 events2 affected99 at risk
EG0021 events1 affected33 at risk
EG003
Retinal migraine
Nervous system disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Sciatica
Nervous system disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0017 events6 affected99 at risk
EG0021 events1 affected33 at risk
EG003
Seizure
Nervous system disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Sinus headache
Nervous system disorders
MedDRA 24.0
Systematic Assessment
EG0003 events3 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Somnolence
Nervous system disorders
MedDRA 24.0
Systematic Assessment
EG0002 events2 affected134 at risk
EG0012 events2 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Spinal cord disorder
Nervous system disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Subarachnoid haemorrhage
Nervous system disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Syncope
Nervous system disorders
MedDRA 24.0
Systematic Assessment
EG0006 events6 affected134 at risk
EG0019 events7 affected99 at risk
EG0022 events2 affected33 at risk
EG003
Taste disorder
Nervous system disorders
MedDRA 24.0
Systematic Assessment
EG0002 events2 affected134 at risk
EG0010 events0 affected99 at risk
EG0021 events1 affected33 at risk
EG003
Vestibular disorder
Ear and labyrinth disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Tremor
Nervous system disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0012 events2 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Device dislocation
Product Issues
MedDRA 24.0
Systematic Assessment
EG0002 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Abnormal dreams
Psychiatric disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Affect lability
Psychiatric disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0012 events2 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Anger
Psychiatric disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA 24.0
Systematic Assessment
EG00015 events14 affected134 at risk
EG00112 events9 affected99 at risk
EG0022 events2 affected33 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA 24.0
Systematic Assessment
EG0004 events2 affected134 at risk
EG0013 events3 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Depressed mood
Psychiatric disorders
MedDRA 24.0
Systematic Assessment
EG0002 events2 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Goitre
Endocrine disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Depression
Psychiatric disorders
MedDRA 24.0
Systematic Assessment
EG00010 events10 affected134 at risk
EG0015 events5 affected99 at risk
EG0021 events1 affected33 at risk
EG003
Emotional distress
Psychiatric disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Homicidal ideation
Psychiatric disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 24.0
Systematic Assessment
EG00020 events18 affected134 at risk
EG00120 events19 affected99 at risk
EG0025 events5 affected33 at risk
EG003
Libido decreased
Psychiatric disorders
MedDRA 24.0
Systematic Assessment
EG0003 events3 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Mental status changes
Psychiatric disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Panic attack
Psychiatric disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Phonophobia
Psychiatric disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Premature ejaculation
Psychiatric disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Sleep disorder
Psychiatric disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Hypothyroidism
Endocrine disorders
MedDRA 24.0
Systematic Assessment
EG0003 events3 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Stress
Psychiatric disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Suicidal ideation
Psychiatric disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA 24.0
Systematic Assessment
EG0009 events7 affected134 at risk
EG0011 events1 affected99 at risk
EG0021 events1 affected33 at risk
EG003
Bladder hypertrophy
Renal and urinary disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Chronic kidney disease
Renal and urinary disorders
MedDRA 24.0
Systematic Assessment
EG0006 events3 affected134 at risk
EG0011 events1 affected99 at risk
EG0021 events1 affected33 at risk
EG003
Dysuria
Renal and urinary disorders
MedDRA 24.0
Systematic Assessment
EG0008 events6 affected134 at risk
EG0012 events2 affected99 at risk
EG0021 events1 affected33 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA 24.0
Systematic Assessment
EG0008 events7 affected134 at risk
EG00113 events10 affected99 at risk
EG0023 events3 affected33 at risk
EG003
Lower urinary tract symptoms
Renal and urinary disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Micturition urgency
Renal and urinary disorders
MedDRA 24.0
Systematic Assessment
EG0006 events6 affected134 at risk
EG0012 events2 affected99 at risk
EG0022 events2 affected33 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
MedDRA 24.0
Systematic Assessment
EG0009 events7 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Iron deficiency anaemia
Blood and lymphatic system disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0013 events3 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Thyroid calcification
Endocrine disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Nocturia
Renal and urinary disorders
MedDRA 24.0
Systematic Assessment
EG0009 events9 affected134 at risk
EG0015 events5 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Pollakiuria
Renal and urinary disorders
MedDRA 24.0
Systematic Assessment
EG00020 events18 affected134 at risk
EG0018 events8 affected99 at risk
EG0024 events3 affected33 at risk
EG003
Proteinuria
Renal and urinary disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0010 events0 affected99 at risk
EG0021 events1 affected33 at risk
EG003
Renal colic
Renal and urinary disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Renal failure
Renal and urinary disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0012 events2 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Renal impairment
Renal and urinary disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Renal mass
Renal and urinary disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Renal pain
Renal and urinary disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Subcapsular renal haematoma
Renal and urinary disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Urge incontinence
Renal and urinary disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Thyroid disorder
Endocrine disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Urinary hesitation
Renal and urinary disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Urinary incontinence
Renal and urinary disorders
MedDRA 24.0
Systematic Assessment
EG0005 events5 affected134 at risk
EG0014 events4 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Urinary retention
Renal and urinary disorders
MedDRA 24.0
Systematic Assessment
EG0004 events4 affected134 at risk
EG0014 events4 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Urinary tract obstruction
Renal and urinary disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Urinary tract pain
Renal and urinary disorders
MedDRA 24.0
Systematic Assessment
EG0002 events2 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Benign prostatic hyperplasia
Reproductive system and breast disorders
MedDRA 24.0
Systematic Assessment
EG0004 events4 affected134 at risk
EG0013 events3 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Breast mass
Reproductive system and breast disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Breast pain
Reproductive system and breast disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Erectile dysfunction
Reproductive system and breast disorders
MedDRA 24.0
Systematic Assessment
EG0006 events5 affected134 at risk
EG0013 events3 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Genital haemorrhage
Reproductive system and breast disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Thyroid mass
Endocrine disorders
MedDRA 24.0
Systematic Assessment
EG0002 events2 affected134 at risk
EG0011 events1 affected99 at risk
EG0021 events1 affected33 at risk
EG003
Gynaecomastia
Reproductive system and breast disorders
MedDRA 24.0
Systematic Assessment
EG0002 events2 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Haematospermia
Reproductive system and breast disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Oedema genital
Reproductive system and breast disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Ovarian cyst
Reproductive system and breast disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Pelvic pain
Reproductive system and breast disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0013 events2 affected99 at risk
EG0021 events1 affected33 at risk
EG003
Penile oedema
Reproductive system and breast disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Peyronie's disease
Reproductive system and breast disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Postmenopausal haemorrhage
Reproductive system and breast disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Prostatic obstruction
Reproductive system and breast disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Prostatitis
Reproductive system and breast disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Cataract
Eye disorders
MedDRA 24.0
Systematic Assessment
EG0009 events7 affected134 at risk
EG0017 events6 affected99 at risk
EG0021 events1 affected33 at risk
EG003
Scrotal haemorrhage
Reproductive system and breast disorders
MedDRA 24.0
Systematic Assessment
EG0002 events2 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Testicular cyst
Reproductive system and breast disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Testicular mass
Reproductive system and breast disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Testicular pain
Reproductive system and breast disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Vaginal discharge
Reproductive system and breast disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Vaginal haemorrhage
Reproductive system and breast disorders
MedDRA 24.0
Systematic Assessment
EG0003 events2 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Vulvovaginal dryness
Reproductive system and breast disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0010 events0 affected99 at risk
EG0021 events1 affected33 at risk
EG003
Vulvovaginal pruritus
Reproductive system and breast disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Acquired diaphragmatic eventration
Respiratory, thoracic and mediastinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Cataract nuclear
Eye disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Asthma
Respiratory, thoracic and mediastinal disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0011 events1 affected99 at risk
EG0021 events1 affected33 at risk
EG003
Asthma exercise induced
Respiratory, thoracic and mediastinal disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Atelectasis
Respiratory, thoracic and mediastinal disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Bronchitis chronic
Respiratory, thoracic and mediastinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Catarrh
Respiratory, thoracic and mediastinal disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Chronic obstructive pulmonary disease
Respiratory, thoracic and mediastinal disorders
MedDRA 24.0
Systematic Assessment
EG0002 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 24.0
Systematic Assessment
EG00063 events47 affected134 at risk
EG00141 events32 affected99 at risk
EG00219 events13 affected33 at risk
EG003
Dysphonia
Respiratory, thoracic and mediastinal disorders
MedDRA 24.0
Systematic Assessment
EG0007 events5 affected134 at risk
EG0014 events4 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 24.0
Systematic Assessment
EG00036 events27 affected134 at risk
EG00118 events17 affected99 at risk
EG0026 events6 affected33 at risk
EG003
Dyspnoea exertional
Respiratory, thoracic and mediastinal disorders
MedDRA 24.0
Systematic Assessment
EG0005 events5 affected134 at risk
EG0015 events5 affected99 at risk
EG0021 events1 affected33 at risk
EG003
Chorioretinopathy
Eye disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Emphysema
Respiratory, thoracic and mediastinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA 24.0
Systematic Assessment
EG00025 events16 affected134 at risk
EG00119 events12 affected99 at risk
EG0027 events4 affected33 at risk
EG003
Haemoptysis
Respiratory, thoracic and mediastinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0021 events1 affected33 at risk
EG003
Haemothorax
Respiratory, thoracic and mediastinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Hiccups
Respiratory, thoracic and mediastinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA 24.0
Systematic Assessment
EG0006 events2 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Interstitial lung disease
Respiratory, thoracic and mediastinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Laryngeal haemorrhage
Respiratory, thoracic and mediastinal disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Laryngeal inflammation
Respiratory, thoracic and mediastinal disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0011 events1 affected99 at risk
EG0021 events1 affected33 at risk
EG003
Lung infiltration
Respiratory, thoracic and mediastinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Conjunctival haemorrhage
Eye disorders
MedDRA 24.0
Systematic Assessment
EG0004 events4 affected134 at risk
EG0011 events1 affected99 at risk
EG0021 events1 affected33 at risk
EG003
Lung opacity
Respiratory, thoracic and mediastinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 24.0
Systematic Assessment
EG00030 events20 affected134 at risk
EG00130 events28 affected99 at risk
EG0027 events6 affected33 at risk
EG003
Nasal discomfort
Respiratory, thoracic and mediastinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Nasal septum deviation
Respiratory, thoracic and mediastinal disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 24.0
Systematic Assessment
EG00026 events23 affected134 at risk
EG00122 events17 affected99 at risk
EG0024 events4 affected33 at risk
EG003
Orthopnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Paranasal sinus hypersecretion
Respiratory, thoracic and mediastinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Pharyngeal disorder
Respiratory, thoracic and mediastinal disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 24.0
Systematic Assessment
EG0003 events3 affected134 at risk
EG0016 events4 affected99 at risk
EG0021 events1 affected33 at risk
EG003
Pleurisy
Respiratory, thoracic and mediastinal disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Conjunctival hyperaemia
Eye disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Pleuritic pain
Respiratory, thoracic and mediastinal disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0012 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Pneumonia aspiration
Respiratory, thoracic and mediastinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0012 events2 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Pneumothorax
Respiratory, thoracic and mediastinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Productive cough
Respiratory, thoracic and mediastinal disorders
MedDRA 24.0
Systematic Assessment
EG00028 events20 affected134 at risk
EG0019 events8 affected99 at risk
EG0025 events3 affected33 at risk
EG003
Pulmonary hypertension
Respiratory, thoracic and mediastinal disorders
MedDRA 24.0
Systematic Assessment
EG0002 events2 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Pulmonary mass
Respiratory, thoracic and mediastinal disorders
MedDRA 24.0
Systematic Assessment
EG0004 events4 affected134 at risk
EG0016 events6 affected99 at risk
EG0021 events1 affected33 at risk
EG003
Pulmonary oedema
Respiratory, thoracic and mediastinal disorders
MedDRA 24.0
Systematic Assessment
EG0002 events2 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Pulmonary pain
Respiratory, thoracic and mediastinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Rales
Respiratory, thoracic and mediastinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Reflux laryngitis
Respiratory, thoracic and mediastinal disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0021 events1 affected33 at risk
EG003
Dacryostenosis acquired
Eye disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0012 events2 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Respiratory acidosis
Respiratory, thoracic and mediastinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Respiratory disorder
Respiratory, thoracic and mediastinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Respiratory symptom
Respiratory, thoracic and mediastinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0013 events3 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Respiratory tract congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 24.0
Systematic Assessment
EG0003 events3 affected134 at risk
EG0012 events2 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Rhinalgia
Respiratory, thoracic and mediastinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0010 events0 affected99 at risk
EG0021 events1 affected33 at risk
EG003
Rhinitis allergic
Respiratory, thoracic and mediastinal disorders
MedDRA 24.0
Systematic Assessment
EG00015 events13 affected134 at risk
EG00114 events14 affected99 at risk
EG0021 events1 affected33 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA 24.0
Systematic Assessment
EG00017 events16 affected134 at risk
EG00110 events9 affected99 at risk
EG0022 events1 affected33 at risk
EG003
Dry eye
Eye disorders
MedDRA 24.0
Systematic Assessment
EG0005 events5 affected134 at risk
EG0015 events5 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Sinus congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 24.0
Systematic Assessment
EG0007 events6 affected134 at risk
EG0016 events6 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Sinus disorder
Respiratory, thoracic and mediastinal disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Sinus pain
Respiratory, thoracic and mediastinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0013 events3 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Sleep apnoea syndrome
Respiratory, thoracic and mediastinal disorders
MedDRA 24.0
Systematic Assessment
EG0007 events7 affected134 at risk
EG0015 events5 affected99 at risk
EG0021 events1 affected33 at risk
EG003
Sneezing
Respiratory, thoracic and mediastinal disorders
MedDRA 24.0
Systematic Assessment
EG0002 events2 affected134 at risk
EG0013 events3 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Sputum increased
Respiratory, thoracic and mediastinal disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Stridor
Respiratory, thoracic and mediastinal disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Tachypnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Throat irritation
Respiratory, thoracic and mediastinal disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0011 events1 affected99 at risk
EG0021 events1 affected33 at risk
EG003
Tonsillolith
Respiratory, thoracic and mediastinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Jaundice acholuric
Blood and lymphatic system disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Episcleritis
Eye disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Upper respiratory tract congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Upper-airway cough syndrome
Respiratory, thoracic and mediastinal disorders
MedDRA 24.0
Systematic Assessment
EG00016 events16 affected134 at risk
EG00116 events11 affected99 at risk
EG0025 events5 affected33 at risk
EG003
Vocal cord polyp
Respiratory, thoracic and mediastinal disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Wheezing
Respiratory, thoracic and mediastinal disorders
MedDRA 24.0
Systematic Assessment
EG0002 events2 affected134 at risk
EG0013 events3 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Acne
Skin and subcutaneous tissue disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Actinic keratosis
Skin and subcutaneous tissue disorders
MedDRA 24.0
Systematic Assessment
EG00011 events10 affected134 at risk
EG0015 events5 affected99 at risk
EG0024 events2 affected33 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA 24.0
Systematic Assessment
EG0009 events8 affected134 at risk
EG0018 events8 affected99 at risk
EG0021 events1 affected33 at risk
EG003
Blister
Skin and subcutaneous tissue disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0021 events1 affected33 at risk
EG003
Blood blister
Skin and subcutaneous tissue disorders
MedDRA 24.0
Systematic Assessment
EG0003 events3 affected134 at risk
EG0013 events2 affected99 at risk
EG0021 events1 affected33 at risk
EG003
Brachioradial pruritus
Skin and subcutaneous tissue disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Eye disorder
Eye disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Cold sweat
Skin and subcutaneous tissue disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0021 events1 affected33 at risk
EG003
Decubitus ulcer
Skin and subcutaneous tissue disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Dermal cyst
Skin and subcutaneous tissue disorders
MedDRA 24.0
Systematic Assessment
EG0003 events3 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Dermatitis
Skin and subcutaneous tissue disorders
MedDRA 24.0
Systematic Assessment
EG0003 events3 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Dermatitis acneiform
Skin and subcutaneous tissue disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0014 events4 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Dermatitis allergic
Skin and subcutaneous tissue disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Dermatitis bullous
Skin and subcutaneous tissue disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0021 events1 affected33 at risk
EG003
Dermatitis contact
Skin and subcutaneous tissue disorders
MedDRA 24.0
Systematic Assessment
EG0005 events5 affected134 at risk
EG0015 events5 affected99 at risk
EG0022 events2 affected33 at risk
EG003
Dermatitis exfoliative generalised
Skin and subcutaneous tissue disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Dermatitis psoriasiform
Skin and subcutaneous tissue disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Eye haemorrhage
Eye disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0021 events1 affected33 at risk
EG003
Dermatosis
Skin and subcutaneous tissue disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Drug eruption
Skin and subcutaneous tissue disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0010 events0 affected99 at risk
EG0024 events3 affected33 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA 24.0
Systematic Assessment
EG00014 events13 affected134 at risk
EG0017 events6 affected99 at risk
EG0027 events6 affected33 at risk
EG003
Ecchymosis
Skin and subcutaneous tissue disorders
MedDRA 24.0
Systematic Assessment
EG00018 events17 affected134 at risk
EG00117 events16 affected99 at risk
EG0025 events5 affected33 at risk
EG003
Eczema
Skin and subcutaneous tissue disorders
MedDRA 24.0
Systematic Assessment
EG0005 events5 affected134 at risk
EG0015 events5 affected99 at risk
EG0023 events3 affected33 at risk
EG003
Eczema nummular
Skin and subcutaneous tissue disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA 24.0
Systematic Assessment
EG00012 events12 affected134 at risk
EG0013 events3 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Erythema annulare
Skin and subcutaneous tissue disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0012 events2 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Erythema nodosum
Skin and subcutaneous tissue disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0021 events1 affected33 at risk
EG003
Follicular mucinosis
Skin and subcutaneous tissue disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Eye inflammation
Eye disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0021 events1 affected33 at risk
EG003
Granulomatous dermatitis
Skin and subcutaneous tissue disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Hair texture abnormal
Skin and subcutaneous tissue disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Hand dermatitis
Skin and subcutaneous tissue disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Hyperhidrosis
Skin and subcutaneous tissue disorders
MedDRA 24.0
Systematic Assessment
EG00014 events12 affected134 at risk
EG00114 events11 affected99 at risk
EG0022 events2 affected33 at risk
EG003
Hypertrichosis
Skin and subcutaneous tissue disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Ingrowing nail
Skin and subcutaneous tissue disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0012 events2 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Ingrown hair
Skin and subcutaneous tissue disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0010 events0 affected99 at risk
EG0021 events1 affected33 at risk
EG003
Keratosis pilaris
Skin and subcutaneous tissue disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Lichenoid keratosis
Skin and subcutaneous tissue disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Macule
Skin and subcutaneous tissue disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0012 events2 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Eye irritation
Eye disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Madarosis
Skin and subcutaneous tissue disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Miliaria
Skin and subcutaneous tissue disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Nail bed bleeding
Skin and subcutaneous tissue disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Nail bed inflammation
Skin and subcutaneous tissue disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Nail discolouration
Skin and subcutaneous tissue disorders
MedDRA 24.0
Systematic Assessment
EG0003 events3 affected134 at risk
EG0011 events1 affected99 at risk
EG0021 events1 affected33 at risk
EG003
Nail disorder
Skin and subcutaneous tissue disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0010 events0 affected99 at risk
EG0021 events1 affected33 at risk
EG003
Nail ridging
Skin and subcutaneous tissue disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Necrobiosis lipoidica diabeticorum
Skin and subcutaneous tissue disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Neurodermatitis
Skin and subcutaneous tissue disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Night sweats
Skin and subcutaneous tissue disorders
MedDRA 24.0
Systematic Assessment
EG00024 events21 affected134 at risk
EG00119 events15 affected99 at risk
EG0023 events2 affected33 at risk
EG003
Eye movement disorder
Eye disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Nodular rash
Skin and subcutaneous tissue disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Onychoclasis
Skin and subcutaneous tissue disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0012 events2 affected99 at risk
EG0022 events2 affected33 at risk
EG003
Pain of skin
Skin and subcutaneous tissue disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Panniculitis
Skin and subcutaneous tissue disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0010 events0 affected99 at risk
EG0021 events1 affected33 at risk
EG003
Papule
Skin and subcutaneous tissue disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Petechiae
Skin and subcutaneous tissue disorders
MedDRA 24.0
Systematic Assessment
EG00034 events28 affected134 at risk
EG00124 events18 affected99 at risk
EG0023 events3 affected33 at risk
EG003
Photosensitivity reaction
Skin and subcutaneous tissue disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Pigmentation disorder
Skin and subcutaneous tissue disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Pityriasis rosea
Skin and subcutaneous tissue disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Poikiloderma
Skin and subcutaneous tissue disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Eye pain
Eye disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0012 events2 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Precancerous skin lesion
Skin and subcutaneous tissue disorders
MedDRA 24.0
Systematic Assessment
EG0003 events3 affected134 at risk
EG0014 events3 affected99 at risk
EG0021 events1 affected33 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 24.0
Systematic Assessment
EG00015 events12 affected134 at risk
EG00110 events8 affected99 at risk
EG0022 events2 affected33 at risk
EG003
Pruritus allergic
Skin and subcutaneous tissue disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Psoriasis
Skin and subcutaneous tissue disorders
MedDRA 24.0
Systematic Assessment
EG0004 events2 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Purpura
Skin and subcutaneous tissue disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0012 events2 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Purpura senile
Skin and subcutaneous tissue disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0013 events3 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 24.0
Systematic Assessment
EG00023 events21 affected134 at risk
EG00123 events18 affected99 at risk
EG0026 events6 affected33 at risk
EG003
Rash erythematous
Skin and subcutaneous tissue disorders
MedDRA 24.0
Systematic Assessment
EG0006 events6 affected134 at risk
EG0015 events4 affected99 at risk
EG0021 events1 affected33 at risk
EG003
Rash macular
Skin and subcutaneous tissue disorders
MedDRA 24.0
Systematic Assessment
EG0003 events3 affected134 at risk
EG0012 events2 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA 24.0
Systematic Assessment
EG00018 events17 affected134 at risk
EG00113 events12 affected99 at risk
EG0024 events3 affected33 at risk
EG003
Eye pruritus
Eye disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Rash papular
Skin and subcutaneous tissue disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Rash pruritic
Skin and subcutaneous tissue disorders
MedDRA 24.0
Systematic Assessment
EG0002 events2 affected134 at risk
EG0013 events3 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Rash vesicular
Skin and subcutaneous tissue disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0010 events0 affected99 at risk
EG0022 events1 affected33 at risk
EG003
Rosacea
Skin and subcutaneous tissue disorders
MedDRA 24.0
Systematic Assessment
EG0002 events2 affected134 at risk
EG0013 events3 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Scab
Skin and subcutaneous tissue disorders
MedDRA 24.0
Systematic Assessment
EG0004 events4 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Skin discolouration
Skin and subcutaneous tissue disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Skin exfoliation
Skin and subcutaneous tissue disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Skin fragility
Skin and subcutaneous tissue disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Skin haemorrhage
Skin and subcutaneous tissue disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Skin hyperpigmentation
Skin and subcutaneous tissue disorders
MedDRA 24.0
Systematic Assessment
EG0002 events2 affected134 at risk
EG0013 events3 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Eye swelling
Eye disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Skin lesion
Skin and subcutaneous tissue disorders
MedDRA 24.0
Systematic Assessment
EG00022 events18 affected134 at risk
EG0015 events5 affected99 at risk
EG0025 events5 affected33 at risk
EG003
Skin mass
Skin and subcutaneous tissue disorders
MedDRA 24.0
Systematic Assessment
EG0002 events2 affected134 at risk
EG0015 events3 affected99 at risk
EG0023 events3 affected33 at risk
EG003
Skin plaque
Skin and subcutaneous tissue disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Solar lentigo
Skin and subcutaneous tissue disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Stasis dermatitis
Skin and subcutaneous tissue disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Transient acantholytic dermatosis
Skin and subcutaneous tissue disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
MedDRA 24.0
Systematic Assessment
EG0006 events4 affected134 at risk
EG0013 events3 affected99 at risk
EG0021 events1 affected33 at risk
EG003
Excessive exercise
Social circumstances
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Aortic aneurysm
Vascular disorders
MedDRA 24.0
Systematic Assessment
EG0002 events2 affected134 at risk
EG0012 events2 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Eyelid pain
Eye disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Arterial thrombosis
Vascular disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Arteriosclerosis
Vascular disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Brachiocephalic vein thrombosis
Vascular disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0010 events0 affected99 at risk
EG0021 events1 affected33 at risk
EG003
Capillary disorder
Vascular disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Capillary leak syndrome
Vascular disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected134 at risk
EG0010 events0 affected99 at risk
EG0021 events1 affected33 at risk
EG003
Essential hypertension
Vascular disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected134 at risk
EG0010 events0 affected99 at risk
EG0021 events1 affected33 at risk
EG003
Extravasation blood
Vascular disorders
MedDRA 24.0
Systematic Assessment
EG0002 events2 affected134 at risk
EG0010 events0 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Flushing
Vascular disorders
MedDRA 24.0
Systematic Assessment
EG0003 events3 affected134 at risk
EG0011 events1 affected99 at risk
EG0020 events0 affected33 at risk
EG003
Haematoma
Vascular disorders
MedDRA 24.0
Systematic Assessment
EG0006 events6 affected134 at risk
EG0016 events5 affected99 at risk
EG0020 events0 affected33 at risk
EG003
The Phase 2 dose was chosen on the basis of the pharmacodynamics data.
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
MedImmune has 60 days to review results communications prior to public release and may delete information that compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that results shall be published regardless of outcome.
Treatment-naïve participants with confirmed CLL or SLL, received oral acalabrutinib Dose 5 QD (Cohort 7, later switched to Dose 1 BID per protocol amendment 6) or Dose 1 BID (Cohort 11) until disease progression or until the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
OG002
Ibrutinib-intolerant Cohort
Participants with confirmed CLL or SLL and were not tolerating ibrutinib treatment, received oral acalabrutinib Dose 5 QD (Cohort 8a, later switched to Dose 1 BID per protocol amendment 4) or Dose 1 BID (Cohort 8b) until disease progression or until the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
Participants with diffuse large B-cell lymphoma (DLBCL) Richter's transformation (RS) or prolymphocytic leukemia transformation (PLL), received oral acalabrutinib Dose 5 BID (Cohort 9) until disease progression or until the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
OG004
Ibrutinib Relapsed/Refractory Cohort
Participants with confirmed CLL/SLL and had relapsed/refractory to ibrutinib treatment, received oral acalabrutinib Dose 5 QD (Cohort 10) until disease progression or until the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
Units
Counts
Participants
OG000134
OG00199
OG00233
OG00329
OG0046
Title
Denominators
Categories
Any TEAEs
Title
Measurements
OG000134
OG00199
OG00233
OG00328
OG0046
Any TESAEs
Title
Measurements
OG00086
OG00150
OG00220
OG003
Treatment-naive Cohort
Treatment-naïve participants with confirmed CLL or SLL, received oral acalabrutinib Dose 5 QD (Cohort 7, later switched to Dose 1 BID per protocol amendment 6) or Dose 1 BID (Cohort 11) until disease progression or until the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
OG002
Ibrutinib-intolerant Cohort
Participants with confirmed CLL or SLL and were not tolerating ibrutinib treatment, received oral acalabrutinib Dose 5 QD (Cohort 8a, later switched to Dose 1 BID per protocol amendment 4) or Dose 1 BID (Cohort 8b) until disease progression or until the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
Participants with diffuse large B-cell lymphoma (DLBCL) Richter's transformation (RS) or prolymphocytic leukemia transformation (PLL), received oral acalabrutinib Dose 5 BID (Cohort 9) until disease progression or until the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
OG004
Ibrutinib Relapsed/Refractory Cohort
Participants with confirmed CLL/SLL and had relapsed/refractory to ibrutinib treatment, received oral acalabrutinib Dose 5 QD (Cohort 10) until disease progression or until the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
Units
Counts
Participants
OG000134
OG00199
OG00233
OG00329
OG0046
Title
Denominators
Categories
Atrial fibrillation
Title
Measurements
OG00012
OG0016
OG0024
OG0033
OG0040
Ventricular tachyarrhythmias
Title
Measurements
OG0002
OG0010
OG0020
OG003
Anemia
Title
Measurements
OG00022
OG00110
OG0024
OG003
Neutropenia
Title
Measurements
OG00026
OG0019
OG0025
OG003
Other Leukopenia
Title
Measurements
OG0002
OG0011
OG0021
OG003
Thrombocytopenia
Title
Measurements
OG00010
OG0011
OG0024
OG003
Major hemorrhage
Title
Measurements
OG00011
OG0018
OG0024
OG003
Hepatotoxicity
Title
Measurements
OG0004
OG0014
OG0021
OG003
Hypertension
Title
Measurements
OG00031
OG00129
OG0027
OG003
Infections
Title
Measurements
OG000118
OG00186
OG00225
OG003
Interstitial lung disease/Pneumonitis
Title
Measurements
OG0001
OG0013
OG0020
OG003
Second primary malignancies, excluding non-melanoma skin
Title
Measurements
OG00023
OG00114
OG0023
OG003
Tumor lysis syndrome
Title
Measurements
OG0001
OG0010
OG0020
OG003
OG001
Treatment-naive Cohort
Treatment-naïve participants with confirmed CLL or SLL, received oral acalabrutinib Dose 5 QD (Cohort 7, later switched to Dose 1 BID per protocol amendment 6) or Dose 1 BID (Cohort 11) until disease progression or until the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
OG002
Ibrutinib-intolerant Cohort
Participants with confirmed CLL or SLL and were not tolerating ibrutinib treatment, received oral acalabrutinib Dose 5 QD (Cohort 8a, later switched to Dose 1 BID per protocol amendment 4) or Dose 1 BID (Cohort 8b) until disease progression or until the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
Participants with diffuse large B-cell lymphoma (DLBCL) Richter's transformation (RS) or prolymphocytic leukemia transformation (PLL), received oral acalabrutinib Dose 5 BID (Cohort 9) until disease progression or until the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
OG004
Ibrutinib Relapsed/Refractory Cohort
Participants with confirmed CLL/SLL and had relapsed/refractory to ibrutinib treatment, received oral acalabrutinib Dose 5 QD (Cohort 10) until disease progression or until the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
Units
Counts
Participants
OG000134
OG00199
OG00233
OG00329
OG0046
Title
Denominators
Categories
Hemoglobin, platelets or neutrophils decreased
Title
Measurements
OG00072
OG00130
OG00214
OG00319
OG0044
Absolute neutrophil count (decreased)
Title
Measurements
OG00057
OG00123
OG00211
OG003
Hemoglobin (decreased)
Title
Measurements
OG00017
OG0015
OG0023
OG003
Platelets (decreased)
Title
Measurements
OG00020
OG0013
OG0024
OG003
Leukocytes (decreased)
Title
Measurements
OG00012
OG0012
OG0023
OG003
Leukocytes (increased)
Title
Measurements
OG00029
OG00121
OG0027
OG003
Absolute lymphocyte count (decreased)
Title
Measurements
OG00020
OG0017
OG0022
OG003
Absolute lymphocyte count (increased)
Title
Measurements
OG00029
OG0018
OG0027
OG003
Urate (increased)
Title
Measurements
OG00024
OG00115
OG0028
OG003
Sodium (decreased)
Title
Measurements
OG00012
OG0015
OG0022
OG003
Phosphate (decreased)
Title
Measurements
OG0009
OG0011
OG0021
OG003
Potassium (increased)
Title
Measurements
OG0003
OG0015
OG0021
OG003
Glucose (increased)
Title
Measurements
OG0003
OG0011
OG0023
OG003
Alanine aminotransferase (increased)
Title
Measurements
OG0003
OG0011
OG0021
OG003
Calcium (increased)
Title
Measurements
OG0005
OG0010
OG0020
OG003
Aspartate aminotransferase (increased)
Title
Measurements
OG0002
OG0012
OG0020
OG003
Magnesium (increased)
Title
Measurements
OG0002
OG0012
OG0020
OG003
Potassium (decreased)
Title
Measurements
OG0002
OG0011
OG0020
OG003
Albumin (decreased)
Title
Measurements
OG0002
OG0011
OG0020
OG003
Calcium (decreased)
Title
Measurements
OG0002
OG0010
OG0020
OG003
Alkaline phosphatase (increased)
Title
Measurements
OG0001
OG0010
OG0020
OG003
Amylase (increased)
Title
Measurements
OG0002
OG0010
OG0020
OG003
Bilirubin (increased)
Title
Measurements
OG0002
OG0010
OG0020
OG003
Creatinine (increased)
Title
Measurements
OG0002
OG0010
OG0020
OG003
Lipase (increased)
Title
Measurements
OG0001
OG0011
OG0020
OG003
Treatment-naïve participants with confirmed CLL or SLL, received oral acalabrutinib Dose 5 QD (Cohort 7, later switched to Dose 1 BID per protocol amendment 6) or Dose 1 BID (Cohort 11) until disease progression or until the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
OG002
Ibrutinib-intolerant Cohort
Participants with confirmed CLL or SLL and were not tolerating ibrutinib treatment, received oral acalabrutinib Dose 5 QD (Cohort 8a, later switched to Dose 1 BID per protocol amendment 4) or Dose 1 BID (Cohort 8b) until disease progression or until the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
Participants with diffuse large B-cell lymphoma (DLBCL) Richter's transformation (RS) or prolymphocytic leukemia transformation (PLL), received oral acalabrutinib Dose 5 BID (Cohort 9) until disease progression or until the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
OG004
Ibrutinib Relapsed/Refractory Cohort
Participants with confirmed CLL/SLL and had relapsed/refractory to ibrutinib treatment, received oral acalabrutinib Dose 5 QD (Cohort 10) until disease progression or until the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
Units
Counts
Participants
OG000134
OG00199
OG00233
OG00329
OG0046
Title
Denominators
Categories
Tachycardia
Title
Measurements
OG0003
OG0018
OG0022
OG0033
OG0040
Bradycardia
Title
Measurements
OG0006
OG0011
OG0020
OG003
Pyrexia
Title
Measurements
OG00039
OG00114
OG00210
OG003
Hyperpyrexia
Title
Measurements
OG0000
OG0010
OG0020
OG003
Hypothermia
Title
Measurements
OG0000
OG0011
OG0020
OG003
Procedural hypotension
Title
Measurements
OG0000
OG0011
OG0020
OG003
Blood pressure increased
Title
Measurements
OG0000
OG0011
OG0020
OG003
Dyspnoea
Title
Measurements
OG00027
OG00118
OG0026
OG003
Dyspnoea exertional
Title
Measurements
OG0005
OG0015
OG0021
OG003
Hypertension
Title
Measurements
OG00030
OG00128
OG0026
OG003
Hypotension
Title
Measurements
OG0007
OG00112
OG0025
OG003
Orthostatic hypotension
Title
Measurements
OG0000
OG0015
OG0021
OG003
Essential hypertension
Title
Measurements
OG0000
OG0010
OG0021
OG003
Hypertensive crisis
Title
Measurements
OG0001
OG0010
OG0020
OG003
Malignant hypertension
Title
Measurements
OG0000
OG0010
OG0020
OG003
Palpitations
Title
Measurements
OG00013
OG0014
OG0020
OG003
Cohort 2b
Participants with CLL received oral acalabrutinib Dose 1 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
OG003
Cohort 2c
Participants with CLL received oral acalabrutinib Dose 5 QD (later switched to Dose 1 BID per protocol amendment 6) until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
OG004
Cohort 3
Participants with CLL received oral acalabrutinib Dose 3 QD (later switched to Dose 1 BID per protocol amendment 6) until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
OG005
Cohort 4a
Participants with CLL received oral acalabrutinib Dose 4 QD for 28 days and later switched to acalabrutinib Dose 1 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
OG006
Cohort 4b
Participants with CLL received oral acalabrutinib Dose 5 BID (later switched to Dose 1 BID per protocol amendment 6) until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
OG007
Cohort 7
Treatment-naïve participants with CLL or SLL received oral acalabrutinib Dose 5 QD (later switched to Dose 1 BID per protocol amendment 6) until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
OG008
Cohort 8a
Participants with CLL or SLL and were not tolerating ibrutinib treatment, received oral acalabrutinib Dose 5 QD (which switched to Dose 1 BID per protocol amendment 4) until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
OG009
Cohort 8b
Participants with CLL or SLL and were not tolerating ibrutinib treatment, received oral acalabrutinib Dose 1 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
OG010
Cohort 9
Participants with DLBCLRS or PLL transformation, received oral acalabrutinib Dose 5 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
OG011
Cohort 10
Participants with CLL/SLL and had relapsed/refractory ibrutinib treatment, received oral acalabrutinib Dose 5 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
OG012
Cohort 11
Treatment-naïve participants with CLL/SLL, received oral acalabrutinib Dose 1 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
Units
Counts
Participants
OG0008
OG0017
OG00224
OG00312
OG0046
OG0056
OG0066
OG00733
OG0083
OG0097
OG0106
OG0115
OG01216
Title
Denominators
Categories
Day 1
ParticipantsOG0008
ParticipantsOG0017
ParticipantsOG00224
ParticipantsOG00312
ParticipantsOG0046
ParticipantsOG0056
ParticipantsOG0066
ParticipantsOG00733
ParticipantsOG0083
ParticipantsOG0096
ParticipantsOG0105
ParticipantsOG0115
ParticipantsOG01216
Title
Measurements
OG000971± 564
OG0011250± 836
OG002819± 493
OG003
Day 8
ParticipantsOG0005
ParticipantsOG0017
ParticipantsOG00222
ParticipantsOG00312
Cohort 2b
Participants with CLL received oral acalabrutinib Dose 1 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
OG003
Cohort 2c
Participants with CLL received oral acalabrutinib Dose 5 QD (later switched to Dose 1 BID per protocol amendment 6) until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
OG004
Cohort 3
Participants with CLL received oral acalabrutinib Dose 3 QD (later switched to Dose 1 BID per protocol amendment 6) until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
OG005
Cohort 4a
Participants with CLL received oral acalabrutinib Dose 4 QD for 28 days and later switched to acalabrutinib Dose 1 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
OG006
Cohort 4b
Participants with CLL received oral acalabrutinib Dose 5 BID (later switched to Dose 1 BID per protocol amendment 6) until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
OG007
Cohort 7
Treatment-naïve participants with CLL or SLL received oral acalabrutinib Dose 5 QD (later switched to Dose 1 BID per protocol amendment 6) until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
OG008
Cohort 8a
Participants with CLL or SLL and were not tolerating ibrutinib treatment, received oral acalabrutinib Dose 5 QD (which switched to Dose 1 BID per protocol amendment 4) until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
OG009
Cohort 8b
Participants with CLL or SLL and were not tolerating ibrutinib treatment, received oral acalabrutinib Dose 1 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
OG010
Cohort 9
Participants with CLL/SLL received oral acalabrutinib Dose 5 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
OG011
Cohort 10
Participants with CLL/SLL and had relapsed/refractory ibrutinib treatment, received oral acalabrutinib Dose 5 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
OG012
Cohort 11
Treatment-naïve participants with CLL/SLL, received oral acalabrutinib Dose 1 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
Units
Counts
Participants
OG0008
OG0018
OG00228
OG00313
OG0047
OG0056
OG0066
OG00737
OG0083
OG0098
OG01010
OG0115
OG01217
Title
Denominators
Categories
Day 1
ParticipantsOG0008
ParticipantsOG0018
ParticipantsOG00228
ParticipantsOG00313
ParticipantsOG0047
ParticipantsOG0056
ParticipantsOG0066
ParticipantsOG00737
ParticipantsOG0083
ParticipantsOG0098
ParticipantsOG01010
ParticipantsOG0115
ParticipantsOG01217
Title
Measurements
OG0001030± 529
OG0011270± 775
OG002795± 502
OG003
Day 8
ParticipantsOG0007
ParticipantsOG0017
ParticipantsOG00228
ParticipantsOG00313
Cohort 2b
Participants with CLL received oral acalabrutinib Dose 1 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
OG003
Cohort 2c
Participants with CLL received oral acalabrutinib Dose 5 QD (later switched to Dose 1 BID per protocol amendment 6) until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
OG004
Cohort 3
Participants with CLL received oral acalabrutinib Dose 3 QD (later switched to Dose 1 BID per protocol amendment 6) until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
OG005
Cohort 4a
Participants with CLL received oral acalabrutinib Dose 4 QD for 28 days and later switched to acalabrutinib Dose 1 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
OG006
Cohort 4b
Participants with CLL received oral acalabrutinib Dose 5 BID (later switched to Dose 1 BID per protocol amendment 6) until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
OG007
Cohort 7
Treatment-naïve participants with CLL or SLL received oral acalabrutinib Dose 5 QD (later switched to Dose 1 BID per protocol amendment 6) until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
OG008
Cohort 8a
Participants with CLL or SLL and were not tolerating ibrutinib treatment, received oral acalabrutinib Dose 5 QD (which switched to Dose 1 BID per protocol amendment 4) until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
OG009
Cohort 8b
Participants with CLL or SLL and were not tolerating ibrutinib treatment, received oral acalabrutinib Dose 1 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
OG010
Cohort 9
Participants with DLBCLRS or PLL transformation, received oral acalabrutinib Dose 5 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
OG011
Cohort 10
Participants with CLL/SLL and had relapsed/refractory ibrutinib treatment, received oral acalabrutinib Dose 5 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
OG012
Cohort 11
Treatment-naïve participants with CLL/SLL, received oral acalabrutinib Dose 1 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
Units
Counts
Participants
OG0008
OG0017
OG00224
OG00311
OG0047
OG0055
OG0066
OG00732
OG0083
OG0096
OG0108
OG0114
OG01215
Title
Denominators
Categories
Day 1
ParticipantsOG0008
ParticipantsOG0017
ParticipantsOG00222
ParticipantsOG00311
ParticipantsOG0047
ParticipantsOG0055
ParticipantsOG0066
ParticipantsOG00732
ParticipantsOG0083
ParticipantsOG0095
ParticipantsOG0106
ParticipantsOG0114
ParticipantsOG01215
Title
Measurements
OG0001040± 534
OG0011320± 827
OG002855± 517
OG003
Day 8
ParticipantsOG0006
ParticipantsOG0017
ParticipantsOG00224
ParticipantsOG0039
Participants with CLL received oral acalabrutinib Dose 1 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
OG003
Cohort 2c
Participants with CLL received oral acalabrutinib Dose 5 QD (later switched to Dose 1 BID per protocol amendment 6) until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
OG004
Cohort 3
Participants with CLL received oral acalabrutinib Dose 3 QD (later switched to Dose 1 BID per protocol amendment 6) until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
OG005
Cohort 4a
Participants with CLL received oral acalabrutinib Dose 4 QD for 28 days and later switched to acalabrutinib Dose 1 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
OG006
Cohort 4b
Participants with CLL received oral acalabrutinib Dose 5 BID (later switched to Dose 1 BID per protocol amendment 6) until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
OG007
Cohort 7
Treatment-naïve participants with CLL or SLL received oral acalabrutinib Dose 5 QD (later switched to Dose 1 BID per protocol amendment 6) until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
OG008
Cohort 8a
Participants with CLL or SLL and were not tolerating ibrutinib treatment, received oral acalabrutinib Dose 5 QD (which switched to Dose 1 BID per protocol amendment 4) until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
OG009
Cohort 8b
Participants with CLL or SLL and were not tolerating ibrutinib treatment, received oral acalabrutinib Dose 1 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
OG010
Cohort 9
Participants with DLBCLRS or PLL transformation, received oral acalabrutinib Dose 5 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
OG011
Cohort 10
Participants with CLL/SLL and had relapsed/refractory ibrutinib treatment, received oral acalabrutinib Dose 5 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
OG012
Cohort 11
Treatment-naïve participants with CLL/SLL, received oral acalabrutinib Dose 1 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
Units
Counts
Participants
OG0008
OG0018
OG00228
OG00313
OG0047
OG0055
OG0066
OG00737
OG0083
OG0098
OG01010
OG0115
OG01216
Title
Denominators
Categories
Day 1
ParticipantsOG0008
ParticipantsOG0018
ParticipantsOG00228
ParticipantsOG00312
ParticipantsOG0047
ParticipantsOG0055
ParticipantsOG0066
ParticipantsOG00737
ParticipantsOG0083
ParticipantsOG0098
ParticipantsOG01010
ParticipantsOG0115
ParticipantsOG01216
Title
Measurements
OG000685± 475
OG001754± 540
OG002706± 499
OG003
Day 8
ParticipantsOG0007
ParticipantsOG0016
ParticipantsOG00227
ParticipantsOG00313
Participants with CLL received oral acalabrutinib Dose 1 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
OG003
Cohort 2c
Participants with CLL received oral acalabrutinib Dose 5 QD (later switched to Dose 1 BID per protocol amendment 6) until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
OG004
Cohort 3
Participants with CLL received oral acalabrutinib Dose 3 QD (later switched to Dose 1 BID per protocol amendment 6) until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
OG005
Cohort 4a
Participants with CLL received oral acalabrutinib Dose 4 QD for 28 days and later switched to acalabrutinib Dose 1 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
OG006
Cohort 4b
Participants with CLL received oral acalabrutinib Dose 5 BID (later switched to Dose 1 BID per protocol amendment 6) until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
OG007
Cohort 7
Treatment-naïve participants with CLL or SLL received oral acalabrutinib Dose 5 QD (later switched to Dose 1 BID per protocol amendment 6) until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
OG008
Cohort 8a
Participants with CLL or SLL and were not tolerating ibrutinib treatment, received oral acalabrutinib Dose 5 QD (which switched to Dose 1 BID per protocol amendment 4) until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
OG009
Cohort 8b
Participants with CLL or SLL and were not tolerating ibrutinib treatment, received oral acalabrutinib Dose 1 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
OG010
Cohort 9
Participants with DLBCLRS or PLL transformation, received oral acalabrutinib Dose 5 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
OG011
Cohort 10
Participants with CLL/SLL and had relapsed/refractory ibrutinib treatment, received oral acalabrutinib Dose 5 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
OG012
Cohort 11
Treatment-naïve participants with CLL/SLL, received oral acalabrutinib Dose 1 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
Units
Counts
Participants
OG0008
OG0018
OG00228
OG00313
OG0047
OG0055
OG0066
OG00737
OG0083
OG0098
OG01010
OG0115
OG01216
Title
Denominators
Categories
Day 1
ParticipantsOG0008
ParticipantsOG0018
ParticipantsOG00228
ParticipantsOG00312
ParticipantsOG0047
ParticipantsOG0055
ParticipantsOG0066
ParticipantsOG00737
ParticipantsOG0083
ParticipantsOG0098
ParticipantsOG01010
ParticipantsOG0115
ParticipantsOG01216
Title
Measurements
OG0001.01(0.417 to 2.00)
OG0010.917(0.500 to 3.83)
OG0020.750(0.500 to 2.30)
OG003
Day 8
ParticipantsOG0007
ParticipantsOG0016
ParticipantsOG00227
ParticipantsOG00313
Participants with CLL received oral acalabrutinib Dose 1 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
OG003
Cohort 2c
Participants with CLL received oral acalabrutinib Dose 5 QD (later switched to Dose 1 BID per protocol amendment 6) until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
OG004
Cohort 3
Participants with CLL received oral acalabrutinib Dose 3 QD (later switched to Dose 1 BID per protocol amendment 6) until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
OG005
Cohort 4a
Participants with CLL received oral acalabrutinib Dose 4 QD for 28 days and later switched to acalabrutinib Dose 1 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
OG006
Cohort 4b
Participants with CLL received oral acalabrutinib Dose 5 BID (later switched to Dose 1 BID per protocol amendment 6) until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
OG007
Cohort 7
Treatment-naïve participants with CLL or SLL received oral acalabrutinib Dose 5 QD (later switched to Dose 1 BID per protocol amendment 6) until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
OG008
Cohort 8a
Participants with CLL or SLL and were not tolerating ibrutinib treatment, received oral acalabrutinib Dose 5 QD (which switched to Dose 1 BID per protocol amendment 4) until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
OG009
Cohort 8b
Participants with CLL or SLL and were not tolerating ibrutinib treatment, received oral acalabrutinib Dose 1 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
OG010
Cohort 9
Participants with DLBCLRS or PLL transformation, received oral acalabrutinib Dose 5 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
OG011
Cohort 10
Participants with CLL/SLL and had relapsed/refractory ibrutinib treatment, received oral acalabrutinib Dose 5 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
OG012
Cohort 11
Treatment-naïve participants with CLL/SLL, received oral acalabrutinib Dose 1 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
Units
Counts
Participants
OG0008
OG0017
OG00224
OG00311
OG0047
OG0055
OG0066
OG00732
OG0083
OG0096
OG0108
OG0114
OG01215
Title
Denominators
Categories
Day 1
ParticipantsOG0008
ParticipantsOG0017
ParticipantsOG00222
ParticipantsOG00311
ParticipantsOG0047
ParticipantsOG0055
ParticipantsOG0066
ParticipantsOG00732
ParticipantsOG0083
ParticipantsOG0095
ParticipantsOG0106
ParticipantsOG0114
ParticipantsOG01215
Title
Measurements
OG0001.48± 1.50
OG0011.44± 1.60
OG0020.914± 0.452
OG003
Day 8
ParticipantsOG0006
ParticipantsOG0017
ParticipantsOG00224
ParticipantsOG0039
Participants with CLL received oral acalabrutinib Dose 1 twice daily until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
OG003
Cohort 2c
Participants with CLL received oral acalabrutinib Dose 5 QD (later switched to Dose 1 BID per protocol amendment 6) until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
OG004
Cohort 3
Participants with CLL received oral acalabrutinib Dose 3 QD (later switched to Dose 1 BID per protocol amendment 6) until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
OG005
Cohort 4a
Participants with CLL received oral acalabrutinib Dose 4 QD for 28 days and later switched to acalabrutinib Dose 1 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
OG006
Cohort 4b
Participants with CLL received oral acalabrutinib Dose 5 BID (later switched to Dose 1 BID per protocol amendment 6) until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
OG007
Cohort 7
Treatment-naïve participants with CLL or SLL received oral acalabrutinib Dose 5 QD (later switched to Dose 1 BID per protocol amendment 6) until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
OG008
Cohort 8a
Participants with CLL or SLL and were not tolerating ibrutinib treatment, received oral acalabrutinib Dose 5 QD (which switched to Dose 1 BID per protocol amendment 4) until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
OG009
Cohort 8b
Participants with CLL or SLL and were not tolerating ibrutinib treatment, received oral acalabrutinib Dose 1 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
OG010
Cohort 9
Participants with DLBCLRS or PLL transformation, received oral acalabrutinib Dose 5 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
OG011
Cohort 10
Participants with CLL/SLL and had relapsed/refractory ibrutinib treatment, received oral acalabrutinib Dose 5 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
OG012
Cohort 11
Treatment-naïve participants with CLL/SLL, received oral acalabrutinib Dose 1 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
Units
Counts
Participants
OG0008
OG0017
OG00224
OG00311
OG0047
OG0055
OG0066
OG00732
OG0083
OG0096
OG0108
OG0114
OG01215
Title
Denominators
Categories
Day 1
ParticipantsOG0008
ParticipantsOG0017
ParticipantsOG00222
ParticipantsOG00311
ParticipantsOG0047
ParticipantsOG0055
ParticipantsOG0066
ParticipantsOG00732
ParticipantsOG0083
ParticipantsOG0095
ParticipantsOG0106
ParticipantsOG0114
ParticipantsOG01215
Title
Measurements
OG0000.679± 0.276
OG0010.750± 0.307
OG0020.848± 0.214
OG003
Day 8
ParticipantsOG0006
ParticipantsOG0017
ParticipantsOG00224
ParticipantsOG0039
Participants with CLL received oral acalabrutinib Dose 1 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
OG003
Cohort 2c
Participants with CLL received oral acalabrutinib Dose 5 QD (later switched to Dose 1 BID per protocol amendment 6) until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
OG004
Cohort 3
Participants with CLL received oral acalabrutinib Dose 3 QD (later switched to Dose 1 BID per protocol amendment 6) until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
OG005
Cohort 4a
Participants with CLL received oral acalabrutinib Dose 4 QD for 28 days and later switched to acalabrutinib Dose 1 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
OG006
Cohort 4b
Participants with CLL received oral acalabrutinib Dose 5 BID (later switched to Dose 1 BID per protocol amendment 6) until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
OG007
Cohort 7
Treatment-naïve participants with CLL or SLL received oral acalabrutinib Dose 5 QD (later switched to Dose 1 BID per protocol amendment 6) until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
OG008
Cohort 8a
Participants with CLL or SLL and were not tolerating ibrutinib treatment, received oral acalabrutinib Dose 5 QD (which switched to Dose 1 BID per protocol amendment 4) until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
OG009
Cohort 8b
Participants with CLL or SLL and were not tolerating ibrutinib treatment, received oral acalabrutinib Dose 1 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
OG010
Cohort 9
Participants with DLBCLRS or PLL transformation, received oral acalabrutinib Dose 5 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
OG011
Cohort 10
Participants with CLL/SLL and had relapsed/refractory ibrutinib treatment, received oral acalabrutinib Dose 5 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
OG012
Cohort 11
Treatment-naïve participants with CLL/SLL, received oral acalabrutinib Dose 1 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
Units
Counts
Participants
OG0008
OG0017
OG00224
OG00311
OG0047
OG0055
OG0066
OG00732
OG0083
OG0096
OG0108
OG0114
OG01215
Title
Denominators
Categories
Day 1
ParticipantsOG0008
ParticipantsOG0017
ParticipantsOG00222
ParticipantsOG00311
ParticipantsOG0047
ParticipantsOG0055
ParticipantsOG0066
ParticipantsOG00732
ParticipantsOG0083
ParticipantsOG0095
ParticipantsOG0106
ParticipantsOG0114
ParticipantsOG01215
Title
Measurements
OG000114± 44.4
OG001193± 121
OG002212± 302
OG003
Day 8
ParticipantsOG0006
ParticipantsOG0017
ParticipantsOG00224
ParticipantsOG0039
Participants with CLL received oral acalabrutinib Dose 1 twice daily until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
OG003
Cohort 2c
Participants with CLL received oral acalabrutinib Dose 5 QD (later switched to Dose 1 BID per protocol amendment 6) until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
OG004
Cohort 3
Participants with CLL received oral acalabrutinib Dose 3 QD (later switched to Dose 1 BID per protocol amendment 6) until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
OG005
Cohort 4a
Participants with CLL received oral acalabrutinib Dose 4 QD for 28 days and later switched to acalabrutinib Dose 1 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
OG006
Cohort 4b
Participants with CLL received oral acalabrutinib Dose 5 BID (later switched to Dose 1 BID per protocol amendment 6) until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
OG007
Cohort 7
Treatment-naïve participants with CLL or SLL received oral acalabrutinib Dose 5 QD (later switched to Dose 1 BID per protocol amendment 6) until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
OG008
Cohort 8a
Participants with CLL or SLL and were not tolerating ibrutinib treatment, received oral acalabrutinib Dose 5 QD (which switched to Dose 1 BID per protocol amendment 4) until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
OG009
Cohort 8b
Participants with CLL or SLL and were not tolerating ibrutinib treatment, received oral acalabrutinib Dose 1 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
OG010
Cohort 9
Participants with DLBCLRS or PLL transformation, received oral acalabrutinib Dose 5 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
OG011
Cohort 10
Participants with CLL/SLL and had relapsed/refractory ibrutinib treatment, received oral acalabrutinib Dose 5 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
OG012
Cohort 11
Treatment-naïve participants with CLL/SLL, received oral acalabrutinib Dose 1 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
Units
Counts
Participants
OG0008
OG0017
OG00224
OG00311
OG0047
OG0055
OG0066
OG00732
OG0083
OG0096
OG0108
OG0114
OG01215
Title
Denominators
Categories
Day 1
ParticipantsOG0008
ParticipantsOG0017
ParticipantsOG00222
ParticipantsOG00311
ParticipantsOG0047
ParticipantsOG0055
ParticipantsOG0066
ParticipantsOG00732
ParticipantsOG0083
ParticipantsOG0095
ParticipantsOG0106
ParticipantsOG0114
ParticipantsOG01215
Title
Measurements
OG000268± 332
OG001574± 992
OG002450± 1250
OG003
Day 8
ParticipantsOG0006
ParticipantsOG0017
ParticipantsOG00224
ParticipantsOG0039
OG001
Cohort 2a
Participants with CLL/SLL received oral acalabrutinib Dose 2 QD for 28 days and later switched to acalabrutinib Dose 1 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
OG002
Cohort 2b
Participants with CLL received oral acalabrutinib Dose 1 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
OG003
Cohort 2c
Participants with CLL received oral acalabrutinib Dose 5 QD (later switched to Dose 1 BID per protocol amendment 6) until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
OG004
Cohort 3
Participants with CLL received oral acalabrutinib Dose 3 QD (later switched to Dose 1 BID per protocol amendment 6) until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
OG005
Cohort 4a
Participants with CLL received oral acalabrutinib Dose 4 QD for 28 days and later switched to acalabrutinib Dose 1 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
OG006
Cohort 4b
Participants with CLL received oral acalabrutinib Dose 5 BID (later switched to Dose 1 BID per protocol amendment 6) until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
OG007
Cohort 7
Treatment-naïve participants with CLL or SLL received oral acalabrutinib Dose 5 QD (later switched to Dose 1 BID per protocol amendment 6) until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
OG008
Cohort 11
Treatment-naïve participants with CLL/SLL, received oral acalabrutinib Dose 1 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
Units
Counts
Participants
OG0008
OG0018
OG00263
OG00332
OG0047
OG0056
OG0066
OG00737
OG00860
Title
Denominators
Categories
Title
Measurements
OG000100.0(63.1 to 100.0)
OG00175(34.9 to 96.8)
OG00292.1(82.4 to 97.4)
OG00393.8(79.2 to 99.2)
OG004100.0(59.0 to 100.0)
OG005100.0(54.1 to 100.0)
OG006100.0(54.1 to 100.0)
OG00797.3(85.8 to 99.9)
OG008100.0(94.0 to 100.0)
OG001
Cohort 2a
Participants with CLL/SLL received oral acalabrutinib Dose 2 QD for 28 days and later switched to acalabrutinib Dose 1 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
OG002
Cohort 2b
Participants with CLL received oral acalabrutinib Dose 1 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
OG003
Cohort 2c
Participants with CLL received oral acalabrutinib Dose 5 QD (later switched to Dose 1 BID per protocol amendment 6) until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
OG004
Cohort 3
Participants with CLL received oral acalabrutinib Dose 3 QD (later switched to Dose 1 BID per protocol amendment 6) until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
OG005
Cohort 4a
Participants with CLL received oral acalabrutinib Dose 4 QD for 28 days and later switched to acalabrutinib Dose 1 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
OG006
Cohort 4b
Participants with CLL received oral acalabrutinib Dose 5 BID (later switched to Dose 1 BID per protocol amendment 6) until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
OG007
Cohort 7
Treatment-naïve participants with CLL or SLL received oral acalabrutinib Dose 5 QD (later switched to Dose 1 BID per protocol amendment 6) until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
OG008
Cohort 11
Treatment-naïve participants with CLL/SLL, received oral acalabrutinib Dose 1 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
Units
Counts
Participants
OG0008
OG0016
OG00258
OG00330
OG0047
OG0056
OG0066
OG00736
OG00860
Title
Denominators
Categories
Title
Measurements
OG00033.3(13.8 to NA)Upper limit of 95% confidence interval (CI) was not calculated because insufficient number of participants had DoR.
OG00126.7(13.9 to NA)Upper limit of 95% CI was not calculated because insufficient number of participants had DoR.
OG00277.3(46.3 to NA)Upper limit of 95% CI was not calculated because insufficient number of participants had DoR.
OG00343.0(29.4 to NA)Upper limit of 95% CI was not calculated because insufficient number of participants had DoR.
OG004NA(9.0 to NA)Median and upper limit of 95% CI were not calculated because insufficient number of participants had DoR.
OG00564.1(19.4 to NA)Upper limit of 95% CI was not calculated because insufficient number of participants had DoR.
OG006NA(38.9 to NA)Median and upper limit of 95% CI were not calculated because insufficient number of participants had DoR.
OG007NA(NA to NA)Median and 95% CI were not calculated because insufficient number of participants had DoR.
OG008NA(NA to NA)Median and 95% CI were not calculated because insufficient number of participants had DoR.
Participants with CLL/SLL received oral acalabrutinib Dose 2 QD for 28 days and later switched to acalabrutinib Dose 1 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
OG002
Cohort 2b
Participants with CLL received oral acalabrutinib Dose 1 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
OG003
Cohort 2c
Participants with CLL received oral acalabrutinib Dose 5 QD (later switched to Dose 1 BID per protocol amendment 6) until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
OG004
Cohort 3
Participants with CLL received oral acalabrutinib Dose 3 QD (later switched to Dose 1 BID per protocol amendment 6) until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
OG005
Cohort 4a
Participants with CLL received oral acalabrutinib Dose 4 QD for 28 days and later switched to acalabrutinib Dose 1 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
OG006
Cohort 4b
Participants with CLL received oral acalabrutinib Dose 5 BID (later switched to Dose 1 BID per protocol amendment 6) until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
OG007
Cohort 7
Treatment-naïve participants with CLL or SLL received oral acalabrutinib Dose 5 QD (later switched to Dose 1 BID per protocol amendment 6) until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
OG008
Cohort 11
Treatment-naïve participants with CLL/SLL, received oral acalabrutinib Dose 1 BID until disease progression or per the investigator considered the study treatment to be intolerable or no longer in the participant's best interest.
Units
Counts
Participants
OG0009
OG0018
OG00265
OG00333
OG0047
OG0056
OG0066
OG00737
OG00862
Title
Denominators
Categories
Title
Measurements
OG00038.3(15.5 to NA)Upper limit of 95% CI was not calculated because insufficient number of participants had PFS.
OG00133.1(15.8 to NA)Upper limit of 95% CI was not calculated because insufficient number of participants had PFS.
OG00279.1(49.8 to NA)Upper limit of 95% CI was not calculated because insufficient number of participants had PFS.
OG00346.6(33.9 to NA)Upper limit of 95% CI was not calculated because insufficient number of participants had PFS.
OG004NA(12.7 to NA)Median and upper limit of 95% CI were not calculated because insufficient number of participants had PFS..
OG00567.8(33.2 to NA)Upper limit of 95% CI was not calculated because insufficient number of participants had PFS.
OG006NA(40.7 to NA)Median and upper limit of 95% CI were not calculated because insufficient number of participants had PFS..
OG007NA(NA to NA)Median and 95% CI were not calculated because insufficient number of participants had PFS..
OG008NA(NA to NA)Median and 95% CI were not calculated because insufficient number of participants had PFS..
0 events
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1 affected
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2 events
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1 events
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1 events
1 affected
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1 events
1 affected
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EG0040 events0 affected6 at risk
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EG0040 events0 affected6 at risk
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EG0040 events0 affected6 at risk
2 events
2 affected
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EG0040 events0 affected6 at risk
0 events
0 affected
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EG0040 events0 affected6 at risk
0 events
0 affected
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EG0040 events0 affected6 at risk
1 events
1 affected
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EG0040 events0 affected6 at risk
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0 affected
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EG0040 events0 affected6 at risk
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EG0040 events0 affected6 at risk
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EG0040 events0 affected6 at risk
1 events
1 affected
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EG0040 events0 affected6 at risk
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EG0040 events0 affected6 at risk
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EG0040 events0 affected6 at risk
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EG0040 events0 affected6 at risk
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0 affected
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EG0040 events0 affected6 at risk
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0 affected
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EG0040 events0 affected6 at risk
1 events
1 affected
29 at risk
EG0040 events0 affected6 at risk
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0 affected
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EG0040 events0 affected6 at risk
0 events
0 affected
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EG0040 events0 affected6 at risk
0 events
0 affected
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EG0040 events0 affected6 at risk
0 events
0 affected
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EG0040 events0 affected6 at risk
3 events
3 affected
29 at risk
EG0040 events0 affected6 at risk
0 events
0 affected
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EG0040 events0 affected6 at risk
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0 affected
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EG0040 events0 affected6 at risk
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EG0040 events0 affected6 at risk
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0 affected
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EG0040 events0 affected6 at risk
1 events
1 affected
29 at risk
EG0040 events0 affected6 at risk
0 events
0 affected
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EG0040 events0 affected6 at risk
2 events
2 affected
29 at risk
EG0041 events1 affected6 at risk
0 events
0 affected
29 at risk
EG0041 events1 affected6 at risk
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EG0040 events0 affected6 at risk
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EG0040 events0 affected6 at risk
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0 affected
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EG0041 events1 affected6 at risk
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1 events
1 affected
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EG0040 events0 affected6 at risk
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EG0040 events0 affected6 at risk
1 events
1 affected
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EG0040 events0 affected6 at risk
1 events
1 affected
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EG0040 events0 affected6 at risk
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0 affected
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EG0040 events0 affected6 at risk
1 events
1 affected
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EG0040 events0 affected6 at risk
5 events
3 affected
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EG0040 events0 affected6 at risk
0 events
0 affected
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EG0040 events0 affected6 at risk
0 events
0 affected
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EG0040 events0 affected6 at risk
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0 affected
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EG0040 events0 affected6 at risk
1 events
1 affected
29 at risk
EG0040 events0 affected6 at risk
0 events
0 affected
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EG0040 events0 affected6 at risk
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0 affected
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EG0040 events0 affected6 at risk
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EG0040 events0 affected6 at risk
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EG0040 events0 affected6 at risk
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EG0040 events0 affected6 at risk
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EG0040 events0 affected6 at risk
0 events
0 affected
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EG0040 events0 affected6 at risk
2 events
2 affected
29 at risk
EG0040 events0 affected6 at risk
0 events
0 affected
29 at risk
EG0040 events0 affected6 at risk
0 events
0 affected
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EG0040 events0 affected6 at risk
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0 affected
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EG0040 events0 affected6 at risk
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0 affected
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EG0040 events0 affected6 at risk
0 events
0 affected
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0 affected
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EG0040 events0 affected6 at risk
0 events
0 affected
29 at risk
EG0040 events0 affected6 at risk
1 events
1 affected
29 at risk
EG0040 events0 affected6 at risk
0 events
0 affected
29 at risk
EG0040 events0 affected6 at risk
0 events
0 affected
29 at risk
EG0040 events0 affected6 at risk
1 events
1 affected
29 at risk
EG0040 events0 affected6 at risk
0 events
0 affected
29 at risk
EG0040 events0 affected6 at risk
1 events
1 affected
29 at risk
EG0040 events0 affected6 at risk
0 events
0 affected
29 at risk
EG0040 events0 affected6 at risk
0 events
0 affected
29 at risk
EG0040 events0 affected6 at risk
0 events
0 affected
29 at risk
EG0040 events0 affected6 at risk
0 events
0 affected
29 at risk
EG0040 events0 affected6 at risk
0 events
0 affected
29 at risk
EG0040 events0 affected6 at risk
1 events
1 affected
29 at risk
EG0040 events0 affected6 at risk
0 events
0 affected
29 at risk
EG0040 events0 affected6 at risk
1 events
1 affected
29 at risk
EG0042 events2 affected6 at risk
0 events
0 affected
29 at risk
EG0040 events0 affected6 at risk
0 events
0 affected
29 at risk
EG0040 events0 affected6 at risk
0 events
0 affected
29 at risk
EG0040 events0 affected6 at risk
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0 affected
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EG0040 events0 affected6 at risk
0 events
0 affected
29 at risk
EG0040 events0 affected6 at risk
0 events
0 affected
29 at risk
EG0040 events0 affected6 at risk
0 events
0 affected
29 at risk
EG0040 events0 affected6 at risk
0 events
0 affected
29 at risk
EG0040 events0 affected6 at risk
0 events
0 affected
29 at risk
EG0040 events0 affected6 at risk
0 events
0 affected
29 at risk
EG0040 events0 affected6 at risk
0 events
0 affected
29 at risk
EG0040 events0 affected6 at risk
0 events
0 affected
29 at risk
EG0040 events0 affected6 at risk
0 events
0 affected
29 at risk
EG0040 events0 affected6 at risk
0 events
0 affected
29 at risk
EG0040 events0 affected6 at risk
0 events
0 affected
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EG0040 events0 affected6 at risk
0 events
0 affected
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EG0040 events0 affected6 at risk
0 events
0 affected
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EG0040 events0 affected6 at risk
0 events
0 affected
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EG0040 events0 affected6 at risk
0 events
0 affected
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EG0040 events0 affected6 at risk
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0 affected
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EG0040 events0 affected6 at risk
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0 affected
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EG0040 events0 affected6 at risk
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0 affected
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EG0040 events0 affected6 at risk
0 events
0 affected
29 at risk
EG0040 events0 affected6 at risk
0 events
0 affected
29 at risk
EG0040 events0 affected6 at risk
0 events
0 affected
29 at risk
EG0040 events0 affected6 at risk
1 events
1 affected
29 at risk
EG0040 events0 affected6 at risk
0 events
0 affected
29 at risk
EG0040 events0 affected6 at risk
0 events
0 affected
29 at risk
EG0040 events0 affected6 at risk
1 events
1 affected
29 at risk
EG0040 events0 affected6 at risk
0 events
0 affected
29 at risk
EG0040 events0 affected6 at risk
0 events
0 affected
29 at risk
EG0040 events0 affected6 at risk
0 events
0 affected
29 at risk
EG0040 events0 affected6 at risk
0 events
0 affected
29 at risk
EG0040 events0 affected6 at risk
2 events
2 affected
29 at risk
EG0041 events1 affected6 at risk
0 events
0 affected
29 at risk
EG0040 events0 affected6 at risk
1 events
1 affected
29 at risk
EG0041 events1 affected6 at risk
0 events
0 affected
29 at risk
EG0040 events0 affected6 at risk
1 events
1 affected
29 at risk
EG0040 events0 affected6 at risk
1 events
1 affected
29 at risk
EG0040 events0 affected6 at risk
0 events
0 affected
29 at risk
EG0040 events0 affected6 at risk
0 events
0 affected
29 at risk
EG0040 events0 affected6 at risk
0 events
0 affected
29 at risk
EG0040 events0 affected6 at risk
0 events
0 affected
29 at risk
EG0040 events0 affected6 at risk
0 events
0 affected
29 at risk
EG0040 events0 affected6 at risk
0 events
0 affected
29 at risk
EG0040 events0 affected6 at risk
0 events
0 affected
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EG0040 events0 affected6 at risk
0 events
0 affected
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EG0040 events0 affected6 at risk
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0 affected
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EG0040 events0 affected6 at risk
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0 affected
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EG0040 events0 affected6 at risk
0 events
0 affected
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EG0040 events0 affected6 at risk
0 events
0 affected
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EG0040 events0 affected6 at risk
0 events
0 affected
29 at risk
EG0040 events0 affected6 at risk
2 events
2 affected
29 at risk
EG0041 events1 affected6 at risk
0 events
0 affected
29 at risk
EG0040 events0 affected6 at risk
19 events
14 affected
29 at risk
EG0040 events0 affected6 at risk
0 events
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0 events
0 affected
29 at risk
EG0040 events0 affected6 at risk
0 events
0 affected
29 at risk
EG0040 events0 affected6 at risk
0 events
0 affected
29 at risk
EG0040 events0 affected6 at risk
1 events
1 affected
29 at risk
EG0040 events0 affected6 at risk
0 events
0 affected
29 at risk
EG0040 events0 affected6 at risk
0 events
0 affected
29 at risk
EG0040 events0 affected6 at risk
0 events
0 affected
29 at risk
EG0040 events0 affected6 at risk
0 events
0 affected
29 at risk
EG0040 events0 affected6 at risk
0 events
0 affected
29 at risk
EG0040 events0 affected6 at risk
0 events
0 affected
29 at risk
EG0040 events0 affected6 at risk
6 events
5 affected
29 at risk
EG0040 events0 affected6 at risk
0 events
0 affected
29 at risk
EG0040 events0 affected6 at risk
0 events
0 affected
29 at risk
EG0040 events0 affected6 at risk
0 events
0 affected
29 at risk
EG0040 events0 affected6 at risk
0 events
0 affected
29 at risk
EG0040 events0 affected6 at risk
0 events
0 affected
29 at risk
EG0040 events0 affected6 at risk
2 events
2 affected
29 at risk
EG0040 events0 affected6 at risk
0 events
0 affected
29 at risk
EG0040 events0 affected6 at risk
0 events
0 affected
29 at risk
EG0040 events0 affected6 at risk
1 events
1 affected
29 at risk
EG0040 events0 affected6 at risk
0 events
0 affected
29 at risk
EG0040 events0 affected6 at risk
0 events
0 affected
29 at risk
EG0040 events0 affected6 at risk
1 events
1 affected
29 at risk
EG0040 events0 affected6 at risk
0 events
0 affected
29 at risk
EG0040 events0 affected6 at risk
0 events
0 affected
29 at risk
EG0040 events0 affected6 at risk
0 events
0 affected
29 at risk
EG0040 events0 affected6 at risk
0 events
0 affected
29 at risk
EG0040 events0 affected6 at risk
1 events
1 affected
29 at risk
EG0040 events0 affected6 at risk
0 events
0 affected
29 at risk
EG0040 events0 affected6 at risk
0 events
0 affected
29 at risk
EG0040 events0 affected6 at risk
1 events
1 affected
29 at risk
EG0040 events0 affected6 at risk
0 events
0 affected
29 at risk
EG0040 events0 affected6 at risk
0 events
0 affected
29 at risk
EG0040 events0 affected6 at risk
0 events
0 affected
29 at risk
EG0040 events0 affected6 at risk
0 events
0 affected
29 at risk
EG0040 events0 affected6 at risk
0 events
0 affected
29 at risk
EG0040 events0 affected6 at risk
0 events
0 affected
29 at risk
EG0040 events0 affected6 at risk
0 events
0 affected
29 at risk
EG0040 events0 affected6 at risk
0 events
0 affected
29 at risk
EG0040 events0 affected6 at risk
1 events
1 affected
29 at risk
EG0040 events0 affected6 at risk
0 events
0 affected
29 at risk
EG0040 events0 affected6 at risk
0 events
0 affected
29 at risk
EG0040 events0 affected6 at risk
0 events
0 affected
29 at risk
EG0040 events0 affected6 at risk
0 events
0 affected
29 at risk
EG0040 events0 affected6 at risk
0 events
0 affected
29 at risk
EG0040 events0 affected6 at risk
0 events
0 affected
29 at risk
EG0040 events0 affected6 at risk
0 events
0 affected
29 at risk
EG0040 events0 affected6 at risk
0 events
0 affected
29 at risk
EG0040 events0 affected6 at risk
0 events
0 affected
29 at risk
EG0040 events0 affected6 at risk
0 events
0 affected
29 at risk
EG0040 events0 affected6 at risk
1 events
1 affected
29 at risk
EG0040 events0 affected6 at risk
0 events
0 affected
29 at risk
EG0040 events0 affected6 at risk
0 events
0 affected
29 at risk
EG0040 events0 affected6 at risk
0 events
0 affected
29 at risk
EG0040 events0 affected6 at risk
0 events
0 affected
29 at risk
EG0040 events0 affected6 at risk
0 events
0 affected
29 at risk
EG0040 events0 affected6 at risk
0 events
0 affected
29 at risk
EG0040 events0 affected6 at risk
0 events
0 affected
29 at risk
EG0040 events0 affected6 at risk
0 events
0 affected
29 at risk
EG0040 events0 affected6 at risk
0 events
0 affected
29 at risk
EG0040 events0 affected6 at risk
0 events
0 affected
29 at risk
EG0040 events0 affected6 at risk
0 events
0 affected
29 at risk
EG0040 events0 affected6 at risk
0 events
0 affected
29 at risk
EG0040 events0 affected6 at risk
0 events
0 affected
29 at risk
EG0040 events0 affected6 at risk
0 events
0 affected
29 at risk
EG0040 events0 affected6 at risk
0 events
0 affected
29 at risk
EG0040 events0 affected6 at risk
0 events
0 affected
29 at risk
EG0040 events0 affected6 at risk
0 events
0 affected
29 at risk
EG0040 events0 affected6 at risk
0 events
0 affected
29 at risk
EG0041 events1 affected6 at risk
0 events
0 affected
29 at risk
EG0041 events1 affected6 at risk
0 events
0 affected
29 at risk
EG0040 events0 affected6 at risk
0 events
0 affected
29 at risk
EG0040 events0 affected6 at risk
0 events
0 affected
29 at risk
EG0040 events0 affected6 at risk
0 events
0 affected
29 at risk
EG0040 events0 affected6 at risk
0 events
0 affected
29 at risk
EG0040 events0 affected6 at risk
0 events
0 affected
29 at risk
EG0040 events0 affected6 at risk
0 events
0 affected
29 at risk
EG0040 events0 affected6 at risk
0 events
0 affected
29 at risk
EG0040 events0 affected6 at risk
0 events
0 affected
29 at risk
EG0040 events0 affected6 at risk
0 events
0 affected
29 at risk
EG0040 events0 affected6 at risk
2 events
2 affected
29 at risk
EG0040 events0 affected6 at risk
0 events
0 affected
29 at risk
EG0040 events0 affected6 at risk
0 events
0 affected
29 at risk
EG0040 events0 affected6 at risk
0 events
0 affected
29 at risk
EG0040 events0 affected6 at risk
0 events
0 affected
29 at risk
EG0040 events0 affected6 at risk
1 events
1 affected
29 at risk
EG0040 events0 affected6 at risk
0 events
0 affected
29 at risk
EG0040 events0 affected6 at risk
0 events
0 affected
29 at risk
EG0040 events0 affected6 at risk
0 events
0 affected
29 at risk
EG0040 events0 affected6 at risk
0 events
0 affected
29 at risk
EG0040 events0 affected6 at risk
0 events
0 affected
29 at risk
EG0040 events0 affected6 at risk
0 events
0 affected
29 at risk
EG0040 events0 affected6 at risk
0 events
0 affected
29 at risk
EG0040 events0 affected6 at risk
0 events
0 affected
29 at risk
EG0040 events0 affected6 at risk
0 events
0 affected
29 at risk
EG0040 events0 affected6 at risk
0 events
0 affected
29 at risk
EG0040 events0 affected6 at risk
0 events
0 affected
29 at risk
EG0040 events0 affected6 at risk
2 events
2 affected
29 at risk
EG0040 events0 affected6 at risk
0 events
0 affected
29 at risk
EG0040 events0 affected6 at risk
0 events
0 affected
29 at risk
EG0040 events0 affected6 at risk
1 events
1 affected
29 at risk
EG0040 events0 affected6 at risk
0 events
0 affected
29 at risk
EG0040 events0 affected6 at risk
0 events
0 affected
29 at risk
EG0040 events0 affected6 at risk
0 events
0 affected
29 at risk
EG0040 events0 affected6 at risk
2 events
2 affected
29 at risk
EG0040 events0 affected6 at risk
0 events
0 affected
29 at risk
EG0040 events0 affected6 at risk
0 events
0 affected
29 at risk
EG0040 events0 affected6 at risk
0 events
0 affected
29 at risk
EG0040 events0 affected6 at risk
0 events
0 affected
29 at risk
EG0040 events0 affected6 at risk
0 events
0 affected
29 at risk
EG0040 events0 affected6 at risk
0 events
0 affected
29 at risk
EG0040 events0 affected6 at risk
3 events
2 affected
29 at risk
EG0040 events0 affected6 at risk
0 events
0 affected
29 at risk
EG0040 events0 affected6 at risk
0 events
0 affected
29 at risk
EG0040 events0 affected6 at risk
0 events
0 affected
29 at risk
EG0040 events0 affected6 at risk
0 events
0 affected
29 at risk
EG0040 events0 affected6 at risk
2 events
2 affected
29 at risk
EG0041 events1 affected6 at risk
0 events
0 affected
29 at risk
EG0040 events0 affected6 at risk
0 events
0 affected
29 at risk
EG0040 events0 affected6 at risk
0 events
0 affected
29 at risk
EG0040 events0 affected6 at risk
0 events
0 affected
29 at risk
EG0040 events0 affected6 at risk
0 events
0 affected
29 at risk
EG0040 events0 affected6 at risk
0 events
0 affected
29 at risk
EG0040 events0 affected6 at risk
0 events
0 affected
29 at risk
EG0040 events0 affected6 at risk
0 events
0 affected
29 at risk
EG0040 events0 affected6 at risk
0 events
0 affected
29 at risk
EG0040 events0 affected6 at risk
0 events
0 affected
29 at risk
EG0040 events0 affected6 at risk
0 events
0 affected
29 at risk
EG0040 events0 affected6 at risk
0 events
0 affected
29 at risk
EG0040 events0 affected6 at risk
2 events
1 affected
29 at risk
EG0040 events0 affected6 at risk
0 events
0 affected
29 at risk
EG0040 events0 affected6 at risk
0 events
0 affected
29 at risk
EG0040 events0 affected6 at risk
0 events
0 affected
29 at risk
EG0040 events0 affected6 at risk
0 events
0 affected
29 at risk
EG0040 events0 affected6 at risk
0 events
0 affected
29 at risk
EG0040 events0 affected6 at risk
0 events
0 affected
29 at risk
EG0040 events0 affected6 at risk
0 events
0 affected
29 at risk
EG0040 events0 affected6 at risk
0 events
0 affected
29 at risk
EG0040 events0 affected6 at risk
0 events
0 affected
29 at risk
EG0041 events1 affected6 at risk
0 events
0 affected
29 at risk
EG0040 events0 affected6 at risk
0 events
0 affected
29 at risk
EG0040 events0 affected6 at risk
0 events
0 affected
29 at risk
EG0040 events0 affected6 at risk
0 events
0 affected
29 at risk
EG0041 events1 affected6 at risk
0 events
0 affected
29 at risk
EG0040 events0 affected6 at risk
0 events
0 affected
29 at risk
EG0040 events0 affected6 at risk
0 events
0 affected
29 at risk
EG0040 events0 affected6 at risk
0 events
0 affected
29 at risk
EG0040 events0 affected6 at risk
0 events
0 affected
29 at risk
EG0040 events0 affected6 at risk
0 events
0 affected
29 at risk
EG0040 events0 affected6 at risk
0 events
0 affected
29 at risk
EG0040 events0 affected6 at risk
0 events
0 affected
29 at risk
EG0040 events0 affected6 at risk
1 events
1 affected
29 at risk
EG0040 events0 affected6 at risk
18
OG0043
0
OG0040
10
OG0041
13
OG0041
0
OG0040
4
OG0040
0
OG0041
3
OG0040
2
OG0040
18
OG0044
0
OG0040
1
OG0040
0
OG0040
13
OG0043
8
OG0043
5
OG0041
6
OG0040
0
OG0042
6
OG0040
3
OG0041
5
OG0042
3
OG0040
1
OG0040
0
OG0040
0
OG0040
1
OG0040
1
OG0040
0
OG0040
0
OG0040
1
OG0040
0
OG0040
1
OG0040
1
OG0040
0
OG0040
0
OG0040
0
OG0040
0
OG0040
0
OG0040
6
OG0040
1
OG0040
0
OG0040
0
OG0040
0
OG0040
3
OG0042
0
OG0041
1
OG0040
1
OG0042
0
OG0040
0
OG0040
0
OG0040
1
OG0040
0
OG0040
2170
± 1180
OG0041880± 1810
OG0052960± 1570
OG0061950± 487
OG0071740± 1540
OG008362± 221
OG009670± 471
OG0101690± 849
OG0111100± 590
OG012789± 398
Participants
OG004
4
ParticipantsOG0055
ParticipantsOG0065
ParticipantsOG00729
ParticipantsOG0081
ParticipantsOG0097
ParticipantsOG0106
ParticipantsOG0115
ParticipantsOG01214
Title
Measurements
OG000631± 193
OG0011180± 859
OG002858± 419
OG0031660± 554
OG0041750± 518
OG0051630± 1050
OG0061690± 1090
OG0071480± 986
OG0082080± NAStandard deviation (SD) was not calculated as only one participant was evaluated at the time of the analysis.
OG009834± 713
OG0101860± 786
OG0111250± 1050
OG012642± 310
2280
± 1060
OG0042030± 1670
OG0053430± 1640
OG0061950± 487
OG0071790± 1470
OG008539± 106
OG009570± 451
OG0101860± 1570
OG0111100± 590
OG012850± 462
Participants
OG004
7
ParticipantsOG0056
ParticipantsOG0066
ParticipantsOG00737
ParticipantsOG0082
ParticipantsOG0098
ParticipantsOG0109
ParticipantsOG0115
ParticipantsOG01216
Title
Measurements
OG000729± 380
OG0011180± 861
OG002850± 660
OG0031850± 882
OG0042020± 1170
OG0051750± 979
OG0061560± 1020
OG0071400± 929
OG0081180± NAThe SD could not be derived due to insufficient number of participants were evaluated at the time of the analysis.
OG009748± 701
OG0101710± 669
OG0111260± 1060
OG012660± 294
2440
± 1010
OG0042050± 1680
OG0053250± 1630
OG0061970± 495
OG0071910± 1530
OG008574± 76.3
OG009801± 410
OG0101770± 776
OG0111350± 373
OG012940± 430
Participants
OG004
5
ParticipantsOG0055
ParticipantsOG0064
ParticipantsOG00730
ParticipantsOG0081
ParticipantsOG0096
ParticipantsOG0108
ParticipantsOG0114
ParticipantsOG01215
Title
Measurements
OG000621± 187
OG0011200± 865
OG002956± 665
OG0031990± 1020
OG0042360± 1210
OG0051750± 1140
OG0061780± 1230
OG0071540± 973
OG0082120± NAThe SD could not be calculated as only one participant was evaluated at the time of the analysis.
OG009963± 728
OG0101750± 701
OG0111580± 1030
OG012652± 298
1950
± 1460
OG0041350± 1170
OG0051550± 1230
OG0061600± 291
OG0071390± 1260
OG008206± 240
OG009554± 500
OG0101190± 925
OG011727± 436
OG012930± 595
Participants
OG004
7
ParticipantsOG0055
ParticipantsOG0066
ParticipantsOG00736
ParticipantsOG0082
ParticipantsOG0098
ParticipantsOG0109
ParticipantsOG0114
ParticipantsOG01216
Title
Measurements
OG000521± 308
OG001805± 757
OG002812± 829
OG0031350± 809
OG0041350± 933
OG005902± 638
OG0061320± 1540
OG0071020± 747
OG008939± NAThe SD was not calculated due to insufficient number of participants were evaluated at the time of the analysis.
OG009616± 660
OG0101460± 913
OG011610± 751
OG012633± 449
1.00
(0.250 to 5.92)
OG0041.00(0.500 to 1.83)
OG0051.00(0.750 to 4.00)
OG0060.758(0.250 to 1.08)
OG0070.783(0.250 to 2.10)
OG0081.30(0.750 to 2.20)
OG0090.783(0.500 to 5.83)
OG0100.992(0.500 to 4.05)
OG0111.00(0.500 to 1.08)
OG0120.642(0.483 to 2.00)
Participants
OG004
7
ParticipantsOG0055
ParticipantsOG0066
ParticipantsOG00736
ParticipantsOG0082
ParticipantsOG0098
ParticipantsOG0109
ParticipantsOG0114
ParticipantsOG01216
Title
Measurements
OG0001.05(0.500 to 1.17)
OG0010.517(0.467 to 1.00)
OG0020.750(0.450 to 5.75)
OG0031.03(0.500 to 2.10)
OG0041.00(0.500 to 1.97)
OG0050.700(0.500 to 1.95)
OG0060.758(0.500 to 2.07)
OG0070.750(0.250 to 2.22)
OG0081.49(1.08 to 1.90)
OG0090.908(0.467 to 2.03)
OG0101.00(0.500 to 2.08)
OG0111.58(0.467 to 4.08)
OG0120.533(0.250 to 1.85)
0.993
± 0.303
OG0042.89± 3.12
OG0053.52± 4.93
OG0060.869± 0.0811
OG0071.41± 1.73
OG0084.83± 3.69
OG0090.900± 0.140
OG0100.798± 0.0973
OG0111.01± 0.209
OG0120.781± 0.137
Participants
OG004
5
ParticipantsOG0055
ParticipantsOG0064
ParticipantsOG00730
ParticipantsOG0081
ParticipantsOG0096
ParticipantsOG0108
ParticipantsOG0114
ParticipantsOG01215
Title
Measurements
OG0001.09± 0.216
OG0010.942± 0.107
OG0020.995± 0.621
OG0030.902± 0.187
OG0040.886± 0.131
OG0051.38± 0.546
OG0061.13± 0.408
OG0071.02± 0.454
OG0080.914± NAThe SD was not calculated as only one participant was evaluated at the time of the analysis.
OG0091.25± 0.494
OG0100.867± 0.289
OG0111.67± 1.41
OG0120.811± 0.174
0.755
± 0.209
OG0040.502± 0.300
OG0050.557± 0.386
OG0060.804± 0.0793
OG0070.756± 0.292
OG0080.373± 0.468
OG0090.784± 0.112
OG0100.880± 0.114
OG0110.706± 0.144
OG0120.916± 0.177
Participants
OG004
5
ParticipantsOG0055
ParticipantsOG0064
ParticipantsOG00730
ParticipantsOG0081
ParticipantsOG0096
ParticipantsOG0108
ParticipantsOG0114
ParticipantsOG01215
Title
Measurements
OG0000.655± 0.132
OG0010.744± 0.0866
OG0020.793± 0.191
OG0030.798± 0.161
OG0040.797± 0.128
OG0050.578± 0.243
OG0060.679± 0.251
OG0070.745± 0.174
OG0080.758± NAThe SD was not calculated as only one participant was evaluated at the time of the analysis.
OG0090.623± 0.218
OG0100.857± 0.209
OG0110.603± 0.324
OG0120.894± 0.204
112
± 98.4
OG004265± 263
OG005169± 123
OG006108± 32.0
OG007315± 488
OG008352± 43.7
OG009311± 166
OG010142± 88.9
OG011156± 40.3
OG012137± 77.4
Participants
OG004
5
ParticipantsOG0055
ParticipantsOG0064
ParticipantsOG00730
ParticipantsOG0081
ParticipantsOG0096
ParticipantsOG0108
ParticipantsOG0114
ParticipantsOG01215
Title
Measurements
OG000176± 62.1
OG001216± 154
OG002162± 141
OG003122± 55.5
OG004131± 70.3
OG005344± 242
OG006191± 180
OG007389± 1070
OG00894.5± NAThe SD was not calculated as only one participant was evaluated at the time of the analysis.
OG009336± 258
OG010132± 51.8
OG011167± 95.1
OG012188± 92.5
182
± 230
OG0042100± 3290
OG0051480± 2850
OG006133± 30.0
OG007930± 1750
OG0082600± 2030
OG009422± 290
OG010171± 125
OG011235± 105
OG012158± 102
Participants
OG004
5
ParticipantsOG0055
ParticipantsOG0064
ParticipantsOG00730
ParticipantsOG0081
ParticipantsOG0096
ParticipantsOG0108
ParticipantsOG0114
ParticipantsOG01215
Title
Measurements
OG000286± 150
OG001302± 238
OG002333± 729
OG003165± 104
OG004172± 114
OG005739± 745
OG006384± 466
OG0071180± 4940
OG008125± NAThe SD was not calculated as only one participant was evaluated at the time of the analysis.