A Study to Evaluate the Safety and Efficacy of Ipataserti... | NCT03800836 | Trialant
NCT03800836
Sponsor
Hoffmann-La Roche
Status
Completed
Last Update Posted
Oct 30, 2024Actual
Enrollment
139Actual
Phase
Phase 1
Conditions
Breast Cancer
Interventions
Ipatasertib
Paclitaxel
Atezolizumab
Nab-Paclitaxel
AC
Countries
United States
Australia
France
Spain
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT03800836
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
CO40151
Secondary IDs
ID
Type
Description
Link
2017-001957-15
EudraCT Number
Brief Title
A Study to Evaluate the Safety and Efficacy of Ipatasertib in Combination With Atezolizumab and Paclitaxel or Nab-Paclitaxel in Participants With Locally Advanced or Metastatic Triple-Negative Breast Cancer
Official Title
A Phase Ib, Open-Label, Multicenter Study Evaluating the Safety and Efficacy of Ipatasertib in Combination With Atezolizumab and Paclitaxel or Nab-Paclitaxel in Patients With Locally Advanced or Metastatic Triple-Negative Breast Cancer
Acronym
Not provided
Organization
Hoffmann-La RocheINDUSTRY
Status Module
Record Verification Date
Aug 2024
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Feb 13, 2018Actual
Primary Completion Date
Mar 16, 2022Actual
Completion Date
Mar 16, 2022Actual
First Submitted Date
Jan 7, 2019
First Submission Date that Met QC Criteria
Jan 9, 2019
First Posted Date
Jan 11, 2019Actual
Results Waived
Not provided
Results First Submitted Date
Mar 15, 2023
Results First Submitted that Met QC Criteria
Aug 12, 2024
Results First Posted Date
Oct 30, 2024Actual
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
Aug 12, 2024
Last Update Posted Date
Oct 30, 2024Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Hoffmann-La RocheINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Not provided
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
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 is a study consisting of four cohorts in this setting. In Cohort 1, the safety and efficacy of ipatasertib (ipat) in combination with atezolizumab (atezo) and paclitaxel (pac) or nab-paclitaxel will be evaluated for participants with locally advanced or metastatic triple-negative breast cancer (TNBC) who have not previously received chemotherapy. In Cohort 2, ipatasertib and atezolizumab (with no chemotherapy), will be administered to participants with locally advanced or metastatic TNBC. In Cohort 3, the safety and efficacy of neoadjuvant ipatasertib, atezolizumab, doxorubicin and cyclophosphamide (AC) (Ipat + Atezo + AC) followed by Ipat + Atezo + Pac will be evaluated in participants with locally advanced Type 2-4 (T2-4) TNBC. In Cohort 4, the safety and efficacy of Ipat + Atezo + Pac will be evaluated in participants with PD-L1 (Programmed Death-Ligand-1) positive locally advanced or metastatic TNBC that is not amenable to resection and who have not previously received chemotherapy in the advanced setting.
Detailed Description
Not provided
Conditions Module
Conditions
Breast Cancer
Keywords
Not provided
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 1
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
139Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Arm A1: Ipat + Atezo + Pacl
Experimental
Safety Run-In (Cohort 1): Participants will receive ipatasertib orally daily on Days 1-21 of each 28 day cycle, and atezolizumab will be administered by intravenous (IV) infusion on Days 1 and 15 of each 28 day cycle. Paclitaxel will be administered by IV infusion on Days 1, 8, and 15 of each 28 day cycle. All participants in this cohort will continue to be treated until loss of clinical benefit, unacceptable toxicity, or withdrawal of consent.
Drug: Ipatasertib
Drug: Paclitaxel
Drug: Atezolizumab
Arm A2: Ipat + Atezo + Pacl
Experimental
Expansion (Cohort 1): Participants will receive ipatasertib orally daily on Days 1-21 of each 28 day cycle, and atezolizumab will be administered by intravenous (IV) infusion on Days 1 and 15 of each 28 day cycle. Paclitaxel will be administered by IV infusion on Days 1, 8, and 15 of each 28 day cycle. All participants in this cohort will continue to be treated until loss of clinical benefit, unacceptable toxicity, or withdrawal of consent.
Drug: Ipatasertib
Drug: Paclitaxel
Drug: Atezolizumab
Arm A3: Ipat + Atezo + Pacl
Experimental
Expansion (Cohort 1): Participants will receive ipatasertib orally daily on Days 1-21 of each 28 day cycle, and atezolizumab will be administered by intravenous (IV) infusion on Days 1 and 15 of each 28 day cycle. Paclitaxel will be administered by IV infusion on Days 1, 8, and 15 of each 28 day cycle. All participants in this cohort will continue to be treated until loss of clinical benefit, unacceptable toxicity, or withdrawal of consent.
Drug: Ipatasertib
Drug: Paclitaxel
Drug: Atezolizumab
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Ipatasertib
Drug
Ipatasertib will be administered at a dose of 400 milligrams (mg) orally daily on Days 1-21 of each 28 day cycle for all arms except for arms F1/F2 where it will be administered at a dose of 300 milligrams (mg) orally daily for the first two cycles and 400 mg for the remaining three cycles.
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Cohort 1 and Cohort 4: Percentage of Participants With Objective Response (OR) as Assessed by Investigator Based on Response Evaluation Criteria in Solid Tumors (RECIST), Version (v) 1.1
Objective Response Rate: percentage participants with confirmed complete response (CR) or partial response (PR) on 2 consecutive occasions >or= 4 weeks apart, as determined by investigator according to RECIST v1.1. CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. PR: at least a 30% decrease in sum of diameters of target lesions, taking as reference baseline sum diameters. Percentages have been rounded off. No participants were enrolled in cohort 4, hence no data reported.
pCR rate was defined as the percentage of participants who had no residual invasive disease in the breast and no residual disease in the lymph nodes (ypT0/Tis ypN0 in the current American Joint Committee on Cancer (AJCC )staging system) based on hematoxylin and eosin evaluation of the complete resected breast specimen and all sampled regional lymph nodes following completion of neoadjuvant therapy.
2-6 weeks following last dose of study treatment (up to 69 weeks)
Cohort 1, Cohort 2, Cohort 3 and Cohort 4: Number of Participants With Adverse Events (AEs)
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any new disease or worsening of an existing disease are also considered as AEs. AEs were reported based on the National Cancer Institute Common Terminology Criteria for AEs, version 4.0 (NCI-CTCAE, v4.0). No participants were enrolled in cohort 3 Arm G and 4, and hence no data was reported.
Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month)
Secondary Outcomes
Measure
Description
Time Frame
Cohort 1 and Cohort 4: Duration of Response (DOR), as Determined by the Investigator According to RECIST v1.1
DOR was defined as the time from the first occurrence of a documented confirmed CR or PR to the first date of recorded disease progression (PD), as determined by the investigator according to RECIST v1.1 or death from any cause. CR was defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduced in short axis to < 10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. PD was defined as at least a 20% increase in the sum of diameter of target lesions, taking as reference the smallest sum on study (nadir) including baseline; the appearance of one or more new lesions. No participants were enrolled in cohort 4, and hence no data was reported. Participants who did not progress or died at time of analysis were censored at last disease assessment date.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
General:
Eastern Cooperative Oncology Group Performance Status of 0 or 1.
Adequate hematologic and organ function.
For Cohorts 1, 2 and 4: Life expectancy of at least 6 months.
For men and women of child bearing potential: agreement to remain abstinent or use protocol defined contraceptive measures during the treatment period and for at least 28 days after the last dose of ipatasertib, 6 months after the last dose of paclitaxel, nab-paclitaxel, or doxorubicin, and 12 months after the last dose of cyclophosphamide, and 5 months after the last dose of atezolizumab, whichever occurs later along with refraining from donating sperm or eggs during this same period.
Disease-specific:
For Cohorts 1, 2 and 4: histologically documented TNBC that is locally advanced or metastatic and is not amenable to resection with curative intent.
For Cohort 2: disease progression following one or two lines of systemic therapy for inoperable locally advanced or metastatic TNBC.
For Cohorts 1, 2 and 4: measurable disease according to RECIST v1.1 criteria.
For Cohort 2: Treated brain or spinal cord metastases are allowed if participants have stable disease and are not on steroid treatment.
For Cohort 3: histologically documented TNBC with a primary breast tumour size of > 2 cm by at least one radiographic or clinical measurement and disease stage at presentation of cT2-4 cN0-3 cM0.
For Cohort 3: participant agreement to undergo appropriate surgical management, including axillary lymph node surgery and partial or total mastectomy, after completion of neoadjuvant treatment.
For Cohort 4: participants must have centrally confirmed PD-L1-positive tumour.
Exclusion Criteria:
General:
History of malabsorption syndrome or other condition that would interfere with enteral absorption or results in the inability or unwillingness to swallow pills.
Active infection requiring antibiotics.
History of or current evidence of HIV infection.
Known clinically significant history of liver disease.
Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 1 of Cycle 1 or anticipation of need for a major surgical procedure (other than anticipated breast surgery for Cohort 3) during the course of the study.
Pregnant or breastfeeding.
New York Heart Association (NYHA) Class II, III, or IV heart failure; left ventricular ejection fraction < 50%; or active ventricular arrhythmia requiring medication.
Treatment with approved or investigational cancer therapy within 14 days prior to Day 1 of Cycle 1.
Prior treatment with an Akt inhibitor.
Disease-specific:
For Cohorts 1 and 4: history of or known presence of brain or spinal cord metastases.
For Cohorts 1 and 4: participants who have received previous systemic therapy for inoperable locally advanced or metastatic TNBC, including chemotherapy, immune checkpoint inhibitors, or targeted agents.
Unresolved, clinically significant toxicity from prior therapy, except for alopecia and Grade 1 peripheral neuropathy.
Participants who have received palliative radiation treatment to peripheral sites (e.g., bone metastases) for pain control and whose last treatment was completed 14 days prior to Day 1 of Cycle 1 and have recovered from all acute, reversible effects.
Uncontrolled pleural effusion, pericardial effusion, or ascites.
Uncontrolled tumor related complications.
Uncontrolled hypercalcaemia or symptomatic hypercalcaemia requiring continued use of bisphosphonate therapy.
Malignancies other than breast cancer within 5 years prior to Day 1 of Cycle 1.
For Cohort 3, participants with the following are excluded: [1] prior history of invasive breast cancer; [2] prior systemic therapy for treatment and/or prevention of invasive breast cancer; [3] previous therapy with anthracyclines or taxanes for any malignancy; [4] bilateral breast cancer; [5] undergone incisional and/or excisional biopsy of primary tumor and/or axillary lymph nodes; [6] undergone axillary lymph node dissection (ALND) prior to initiation of neoadjuvant therapy; [6] history of other malignancy within 5 years prior to screening; [7] history of cerebrovascular accident within 12 months prior to initiation of study treatment; [8] cardiopulmonary dysfunction; [9] known allergy or hypersensitivity to the components of cyclophosphamide/doxorubicin formulations and filgrastim or pegfilgrastim formulations; [10] severe infection within 4 weeks prior to initiation of study treatment; [11] treatment with therapeutic oral or IV (Intravenous) antibiotics within 2 weeks prior to initiation of study treatment and [12] prior treatment with CD137 agonists or immune checkpoint - blockade therapies.
Ipatasertib-specific:
History of Type I or Type II diabetes mellitus requiring insulin.
Grade >= 2 uncontrolled or untreated hypercholesterolemia or hypertriglyceridemia.
History of or active inflammatory bowel disease or active bowel inflammation.
Clinically significant lung disease.
Treatment with strong CYP3A inhibitors or strong CYP3A inducers.
Atezolizumab-specific:
Active or history of autoimmune disease or immune deficiency.
History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan.
Prior allogeneic stem cell or solid organ transplantation.
Treatment with a live, attenuated vaccine within 4 weeks prior to initiation of study treatment, or anticipation of need for such a vaccine during treatment with atezolizumab or within 5 months after the last dose of atezolizumab.
History of hypersensitivity reactions to study drug or any component of the study drug formulation.
Treatment with systemic immunostimulatory agents and immunosuppressive medication treatment, or anticipation of need for systemic immunosuppressive medication during the course of the study.
Paclitaxel-specific:
- Grade >= 2 peripheral neuropathy.
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Clinical Trials
Hoffmann-La Roche
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Pacific Shores Medical Group
Long Beach
California
90813
United States
St Vincents Hospital; Cardiopulmonary transplant Ambulatory Care Dept
Schmid P, Turner NC, Barrios CH, Isakoff SJ, Kim SB, Sablin MP, Saji S, Savas P, Vidal GA, Oliveira M, O'Shaughnessy J, Italiano A, Espinosa E, Boni V, White S, Rojas B, Freitas-Junior R, Chae Y, Bondarenko I, Lee J, Torres Mattos C, Martinez Rodriguez JL, Lam LH, Jones S, Reilly SJ, Huang X, Shah K, Dent R. First-Line Ipatasertib, Atezolizumab, and Taxane Triplet for Metastatic Triple-Negative Breast Cancer: Clinical and Biomarker Results. Clin Cancer Res. 2024 Feb 16;30(4):767-778. doi: 10.1158/1078-0432.CCR-23-2084.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
Participant Flow Module
Pre-assignment Details
139 participants were enrolled, 2 were not treated and excluded from analyses. 137 participants were enrolled in either Cohort 1 (Arms A [A1,2,3], B [B1,2], C [C1,2], and D [D1,2]), Cohort 2 (Arm E) or Arm F1 in Cohort 3. Sponsor made decision not to continue study enrollment before arms F2, G1, G2 (Cohort 3) and H (Cohort 4) enrolled any participants.
Recruitment Details
Participants took part in this study from 13 February 2018 to 16 March 2022.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Cohort 1-Arm A
Participants with locally advanced or metastatic triple-negative breast cancer (TNBC) who had not previously received chemotherapy in the advanced setting received 400 milligrams (mg) of ipatasertib (Ipat) orally, once daily (QD) on Days 1-21, 840 mg intravenous (IV) of atezolizumab (Atezo) on Days 1 and 15, and 80 milligrams per square meter (mg/m^2) IV paclitaxel (Pac) on Days 1, 8, and 15 of each 28-day cycle. Following completion of a safety run-in cohort (A1), subsequent expansion arms enrolled (A2 and A3). All participants in Arm A continued to receive treatment until loss of clinical benefit, unacceptable toxicity, withdrawal of consent, or end of the study.
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot_SAP
Yes
Yes
No
Study Protocol and Statistical Analysis Plan
Jan 26, 2021
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Non-Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
Arm B1: Ipat + Atezo + Nab-Pacl
Experimental
Safety Run-In (Cohort 1): Participants will receive ipatasertib orally daily on Days 1-21 of each 28 day cycle, and atezolizumab will be administered by IV infusion on Days 1 and 15 of each 28 day cycle. Nab-paclitaxel will be administered by IV infusion on Days 1, 8, and 15 of each 28 day cycle. All participants in this cohort will continue to be treated until loss of clinical benefit, unacceptable toxicity, or withdrawal of consent.
Drug: Ipatasertib
Drug: Atezolizumab
Drug: Nab-Paclitaxel
Arm B2: Ipat + Atezo + Nab-Pacl
Experimental
Expansion (Cohort 1): Participants will receive ipatasertib orally daily on Days 1-21 of each 28 day cycle, and atezolizumab will be administered by IV infusion on Days 1 and 15 of each 28 day cycle. Nab-paclitaxel will be administered by IV infusion on Days 1, 8, and 15 of each 28 day cycle. All participants in this cohort will continue to be treated until loss of clinical benefit, unacceptable toxicity, or withdrawal of consent.
Drug: Ipatasertib
Drug: Atezolizumab
Drug: Nab-Paclitaxel
Arm C1: (Ipat + Pacl) (2 weeks) + Atezo
Experimental
Safety Run-In (Cohort 1): Participants will receive a 2-week lead in of ipatasertib in combination with paclitaxel, followed by atezolizumab in an initial 28-day (1 cycle) period. Ipatasertib will be administered orally daily on Days 1-21, with paclitaxel administered by IV infusion on Days 1, 8 and 15. Atezolizumab will be administered by IV infusion on Day 15. In all subsequent treatment cycles, ipatasertib will be administered orally daily on Days 1-21, paclitaxel will be administered by IV infusion on Days 1, 8, and 15 and atezolizumab will be administered by IV infusion on Days 1 and 15. All participants in this cohort will continue to be treated until loss of clinical benefit, unacceptable toxicity, or withdrawal of consent.
Drug: Ipatasertib
Drug: Paclitaxel
Drug: Atezolizumab
Arm C2 (Ipat + Pacl) (2 weeks) + Atezo
Experimental
Expansion (Cohort 1): Participants will receive a 2-week lead in of ipatasertib in combination with paclitaxel, followed by atezolizumab in an initial 28-day (1 cycle) period. Ipatasertib will be administered orally daily on Days 1-21, with paclitaxel administered by IV infusion on Days 1, 8 and 15. Atezolizumab will be administered by IV infusion on Day 15. In all subsequent treatment cycles, ipatasertib will be administered orally daily on Days 1-21, paclitaxel will be administered by IV infusion on Days 1, 8, and 15 and atezolizumab will be administered by IV infusion on Days 1 and 15. All participants in this cohort will continue to be treated until loss of clinical benefit, unacceptable toxicity, or withdrawal of consent.
Drug: Ipatasertib
Drug: Paclitaxel
Drug: Atezolizumab
Arm D1: (Atezo + Pacl) (2 weeks) + Ipat
Experimental
Safety Run-In (Cohort 1): Participants will receive a 2-week lead in of atezolizumab in combination with paclitaxel, followed by ipatasertib in an initial 28-day (1 cycle) period. Atezolizumab will be administered via IV infusion on Days 1 and 15, with paclitaxel administered by IV infusion on Days 1, 8 and 15. Ipatasertib will be administered orally daily on Days 15-21. In all subsequent treatment cycles, ipatasertib will be administered orally daily on Days 1-21, paclitaxel will be administered by IV infusion on Days 1, 8, and 15 and atezolizumab will be administered by IV infusion on Days 1 and 15. All participants in this cohort will continue to be treated until loss of clinical benefit, unacceptable toxicity, or withdrawal of consent.
Drug: Ipatasertib
Drug: Paclitaxel
Drug: Atezolizumab
Arm D2: (Atezo + Pacl) (2 weeks) + Ipat
Experimental
Expansion (Cohort 1): Participants will receive a 2-week lead in of atezolizumab in combination with paclitaxel, followed by ipatasertib in an initial 28-day (1 cycle) period. Atezolizumab will be administered via IV infusion on Days 1 and 15, with paclitaxel administered by IV infusion on Days 1, 8 and 15. Ipatasertib will be administered orally daily on Days 15-21. In all subsequent treatment cycles, ipatasertib will be administered orally daily on Days 1-21, paclitaxel will be administered by IV infusion on Days 1, 8, and 15 and atezolizumab will be administered by IV infusion on Days 1 and 15. All participants in this cohort will continue to be treated until loss of clinical benefit, unacceptable toxicity, or withdrawal of consent.
Drug: Ipatasertib
Drug: Paclitaxel
Drug: Atezolizumab
Arm E: Ipat + Atezo
Experimental
Participants (Cohort 2) will receive Ipatasertib orally daily on Days 1-28 of Cycle 1 (35-day cycle) and on Days 1-21 of subsequent cycles (28-day cycles). Atezolizumab will be administered by IV infusion on Days 8 and 22 of Cycle 1 and on Days 1 and 15 of subsequent cycles. All participants in this cohort will continue to be treated until loss of clinical benefit, unacceptable toxicity, or withdrawal of consent.
Drug: Ipatasertib
Drug: Atezolizumab
Arm F1: Ipat + Atezol + AC / Ipat + Atezo + Pacl
Experimental
Safety Run-In (Cohort 3): Participants will receive in Cycles 1 and 2 (28 day cycles), Ipatasertib orally daily on Days 1-21, Atezolizumab via IV infusion on Days 1 and 15 and AC (Doxorubicin and Cyclophosphamide) via IV infusion on Days 1 and 15. In Cycles 3-5, participants will receive Ipatasertib orally daily on Days 1-21, Atezolizumab via IV infusion on Days 1 and 15, with Paclitaxel administered by IV infusion on Days 1, 8, 15 and 22. All participants in this cohort will continue to be treated for five cycles (28-day cycles; 20 weeks) or until disease progression or unacceptable toxicity, whichever occurs first.
Drug: Ipatasertib
Drug: Paclitaxel
Drug: Atezolizumab
Drug: AC
Arm F2: Ipat + Atezol + AC / Ipat + Atezo + Pacl
Experimental
Expansion (Cohort 3): Participants will receive in Cycles 1 and 2 (28 day cycles), Ipatasertib orally daily on Days 1-21, Atezolizumab via IV infusion on Days 1 and 15 and AC (Doxorubicin and Cyclophosphamide) via IV infusion on Days 1 and 15. In Cycles 3-5, participants will receive Ipatasertib orally daily on Days 1-21, Atezolizumab via IV infusion on Days 1 and 15, with Paclitaxel administered by IV infusion on Days 1, 8, 15 and 22. All participants in this cohort will continue to be treated for five cycles (28-day cycles; 20 weeks) or until disease progression or unacceptable toxicity, whichever occurs first.
Drug: Ipatasertib
Drug: Paclitaxel
Drug: Atezolizumab
Drug: AC
Arm G1: Ipat + Atezol + AC / Ipat + Atezo + Pacl
Experimental
Safety Run-In (Cohort 3): Participants will receive in Cycles 1 and 2 (28 day cycles), Ipatasertib orally daily on Days 1-21, Atezolizumab via IV infusion on Days 1 and 15 and AC (Doxorubicin and Cyclophosphamide) via IV infusion on Days 1 and 15. In Cycles 3-5, participants will receive Ipatasertib orally daily on Days 1-21, Atezolizumab via IV infusion on Days 1 and 15, with Paclitaxel administered by IV infusion on Days 1, 8, 15 and 22. All participants in this cohort will continue to be treated for five cycles (28-day cycles; 20 weeks) or until disease progression or unacceptable toxicity, whichever occurs first.
Drug: Ipatasertib
Drug: Paclitaxel
Drug: Atezolizumab
Drug: AC
Arm G2: Ipat + Atezol + AC / Ipat + Atezo + Pacl
Experimental
Expansion (Cohort 3): Participants will receive in Cycles 1 and 2 (28 day cycles), Ipatasertib orally daily on Days 1-21, Atezolizumab via IV infusion on Days 1 and 15 and AC (Doxorubicin and Cyclophosphamide) via IV infusion on Days 1 and 15. In Cycles 3-5, participants will receive Ipatasertib orally daily on Days 1-21, Atezolizumab via IV infusion on Days 1 and 15, with Paclitaxel administered by IV infusion on Days 1, 8, 15 and 22. All participants in this cohort will continue to be treated for five cycles (28-day cycles; 20 weeks) or until disease progression or unacceptable toxicity, whichever occurs first.
Drug: Ipatasertib
Drug: Paclitaxel
Drug: Atezolizumab
Drug: AC
Arm H: Ipat + Atezo + Pacl
Experimental
Participants (Cohort 4) will receive ipatasertib orally daily on Days 1-21 of each 28 day cycle, and atezolizumab will be administered by intravenous (IV) infusion on Days 1 and 15 of each 28 day cycle. Paclitaxel will be administered by IV infusion on Days 1, 8, and 15 of each 28 day cycle. All participants in this cohort will continue to be treated until loss of clinical benefit, unacceptable toxicity, or withdrawal of consent.
Drug: Ipatasertib
Drug: Paclitaxel
Drug: Atezolizumab
Arm A1: Ipat + Atezo + Pacl
Arm A2: Ipat + Atezo + Pacl
Arm A3: Ipat + Atezo + Pacl
Arm B1: Ipat + Atezo + Nab-Pacl
Arm B2: Ipat + Atezo + Nab-Pacl
Arm C1: (Ipat + Pacl) (2 weeks) + Atezo
Arm C2 (Ipat + Pacl) (2 weeks) + Atezo
Arm D1: (Atezo + Pacl) (2 weeks) + Ipat
Arm D2: (Atezo + Pacl) (2 weeks) + Ipat
Arm E: Ipat + Atezo
Arm F1: Ipat + Atezol + AC / Ipat + Atezo + Pacl
Arm F2: Ipat + Atezol + AC / Ipat + Atezo + Pacl
Arm G1: Ipat + Atezol + AC / Ipat + Atezo + Pacl
Arm G2: Ipat + Atezol + AC / Ipat + Atezo + Pacl
Arm H: Ipat + Atezo + Pacl
Paclitaxel
Drug
Paclitaxel will be administered at a dose of 80 milligrams per square meter (mg/m^2) as IV infusion on Days 1, 8, and 15 of each 28 day cycle for all arms, with the exceptions of Arms F1, F2, G1 and G2, where it will be also administered on Day 22 as well, of each 28 day cycle.
Arm A1: Ipat + Atezo + Pacl
Arm A2: Ipat + Atezo + Pacl
Arm A3: Ipat + Atezo + Pacl
Arm C1: (Ipat + Pacl) (2 weeks) + Atezo
Arm C2 (Ipat + Pacl) (2 weeks) + Atezo
Arm D1: (Atezo + Pacl) (2 weeks) + Ipat
Arm D2: (Atezo + Pacl) (2 weeks) + Ipat
Arm F1: Ipat + Atezol + AC / Ipat + Atezo + Pacl
Arm F2: Ipat + Atezol + AC / Ipat + Atezo + Pacl
Arm G1: Ipat + Atezol + AC / Ipat + Atezo + Pacl
Arm G2: Ipat + Atezol + AC / Ipat + Atezo + Pacl
Arm H: Ipat + Atezo + Pacl
Atezolizumab
Drug
Atezolizumab will be administered by IV infusion at a fixed dose of 840 mg on Days 1 and 15 of each 28 day cycle for all arms, although in Arms C1/C2, it will be administered on Day 15 of Cycle 1 followed by Days 1 and 15 in subsequent cycles.
Arm A1: Ipat + Atezo + Pacl
Arm A2: Ipat + Atezo + Pacl
Arm A3: Ipat + Atezo + Pacl
Arm B1: Ipat + Atezo + Nab-Pacl
Arm B2: Ipat + Atezo + Nab-Pacl
Arm C1: (Ipat + Pacl) (2 weeks) + Atezo
Arm C2 (Ipat + Pacl) (2 weeks) + Atezo
Arm D1: (Atezo + Pacl) (2 weeks) + Ipat
Arm D2: (Atezo + Pacl) (2 weeks) + Ipat
Arm E: Ipat + Atezo
Arm F1: Ipat + Atezol + AC / Ipat + Atezo + Pacl
Arm F2: Ipat + Atezol + AC / Ipat + Atezo + Pacl
Arm G1: Ipat + Atezol + AC / Ipat + Atezo + Pacl
Arm G2: Ipat + Atezol + AC / Ipat + Atezo + Pacl
Arm H: Ipat + Atezo + Pacl
Nab-Paclitaxel
Drug
Nab-paclitaxel will be administered by IV infusion at a dose of 100 mg/m^2 on Days 1, 8, and 15 of each 28 day cycle.
Arm B1: Ipat + Atezo + Nab-Pacl
Arm B2: Ipat + Atezo + Nab-Pacl
AC
Drug
AC (Doxorubicin and Cyclophosphamide) will be administered by IV infusion at 60 mg/m^2 and 600 mg/m^2 respectively on Days 1 and 15 of Cycles 1 and 2 for Arms F1, F2, G1 and G2.
Arm F1: Ipat + Atezol + AC / Ipat + Atezo + Pacl
Arm F2: Ipat + Atezol + AC / Ipat + Atezo + Pacl
Arm G1: Ipat + Atezol + AC / Ipat + Atezo + Pacl
Arm G2: Ipat + Atezol + AC / Ipat + Atezo + Pacl
From the date of first documented confirmed response (CR or PR) to disease progression or death due to any cause (up to approximately 43.6 months)
Cohort 1 and Cohort 4: Progression-Free Survival (PFS), as Assessed by Investigator Based on RECIST v1.1
PFS: time from enrollment to date of 1st recorded occurrence of PD, as determined by investigator according to RECIST v1.1 or death from any cause, whichever occurs first. PD: at least a 20% increase in sum of diameters of target lesions, taking as reference smallest sum on study (nadir) including baseline; appearance of one or more new lesions. Data for participants who did not experience PD or death was censored at last date of evaluable tumor assessment. No participants were enrolled in cohort 4, and hence no data was reported.
From enrollment up to disease progression or death due to any cause whichever occurs first (up to approximately 43.6 months)
Cohort 1 and Cohort 4: Overall Survival (OS)
OS was defined as the time from enrollment to death from any cause.
From enrollment up to death due to any cause (up to approximately 43.6 months).
Cohort 1 and Cohort 4: Plasma Concentration of Ipatasertib
Since, Cohort 4 did not enroll any participants, data is only reported for Cohort 1.
Day 15 Cycle 1: pre-dose and 1, 2, 4 and 6 hours post-dose, Day 15 Cycle2: predose and 1, 2, 4 and 6 hours post-dose and Day 15 Cycle 3 - post dose up to - 3 hours (each cycle is of 28 days)
Cohort 1 and Cohort 4: Plasma Concentration of Ipatasertib Metabolite M1 (G-037720)
Since, Cohort 4 did not enroll any participants, data is only reported for Cohort 1.
Day 15 Cycle 1 - pre-dose and 1 hour, 2 hours, 4 hours and 6 hours post-dose, Day 15 Cycle2: predose and 1 hour, 2 hours, 4 hours and 6 hours post-dose and Day 15 Cycle 3 - post dose up to - 3 hours (each cycle is of 28 days)
Cohort 1 and Cohort 4: Number of Participants With Anti-Drug Antibodies (ADAs) for Atezolizumab During Study Treatment
Participants were considered to be ADA positive if they were ADA negative or were missing data at Baseline but developed an ADA response following study drug exposure (treatment-induced ADA response), or if they were ADA positive at Baseline and the titer of one or more postbaseline samples was at least 0.60 titer unit greater than the titer of the Baseline sample (treatment-enhanced ADA response). Participants were considered to be ADA negative if they were ADA negative or had missing data at Baseline and all postbaseline samples were negative, or if they were ADA positive at Baseline but did not have any postbaseline samples with a titer that was at least 0.60 titer unit greater than the titer of the baseline sample (treatment unaffected). Since, Cohort 4 did not enroll any participants, data is only reported for Cohort 1.
From baseline up to 30 days from the last dose of atezolizumab (to approximately 4 years 1.1 month)
Cohort 1 and Cohort 4: Plasma Concentration of Atezolizumab
Since, Cohort 4 did not enroll any participants, data is only reported for Cohort 1.
Cycle 1 Day 1 and 15: predose and 30 mins post dose; Cycle 2: Day 1 and 15 predose, Cycle 3, 4, 8, 12, and 16 Day 1: predose; treatment discontinuation visit
Cohort 1 and Cohort 4: Clinical Benefit Rate (CBR) as Assessed by Investigator Based on RECIST v1.1
CBR was defined as percentage of participants with stable disease (SD) for at least 24 weeks or with confirmed CR or PR as determined by the investigator according to RECIST v1.1. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum on study. CR was defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. Since, Cohort 4 did not enroll any participants, data is only reported for Cohort 1.
From screening up to confirmed SD or CR or PR (up to approximately 43.6 months)
Darlinghurst
New South Wales
2010
Australia
Austin Hospital
Heidelberg
Victoria
3084
Australia
Peter MacCallum Cancer Center
North Melbourne
Victoria
3051
Australia
Institut de Cancerologie de l Ouest
Angers
49055
France
Institut Bergonie
Bordeaux
33076
France
Centre Georges Francois Leclerc
Dijon
21000
France
Institut Curie
Paris
75005
France
Gustave Roussy
Villejuif
94805
France
Hospital de la Santa Creu i Sant Pau
Barcelona
8041
Spain
Hospital Universitario La Paz
Madrid
280146
Spain
Hospital Clinico San Carlos; Servicio de Oncologia
Madrid
28040
Spain
Hospital Universitario Fundacion Jimenez Diaz.
Madrid
28040
Spain
Hospital Universitario 12 de Octubre
Madrid
28041
Spain
Centro Integral Oncologico Clara Campal (CIOCC); Dirección Médica
Madrid
28050
Spain
Hospital Universitario Virgen del Rocío
Seville
41013
Spain
Barts Cancer Institute
London
E1 2AT
United Kingdom
Nottingham University Hospitals NHS Trust
Nottingham
NG7 2UH
United Kingdom
FG001
Cohort 1-Arm B
Participants with locally advanced or metastatic TNBC who had not previously received chemotherapy in the advanced setting received 400 mg of Ipat orally, QD on Days 1-21, 840 mg IV of Atezo on Days 1 and 15, and 100 mg/m^2 IV nab-paclitaxel (Nab-Pac) on Days 1, 8, and 15 of each 28-day cycle. Following completion of a safety run-in cohort (B1), a subsequent expansion arm enrolled (B2). All participants in Arm B continued to receive treatment until loss of clinical benefit, unacceptable toxicity, withdrawal of consent, or end of the study.
FG002
Cohort 1-Arm C
Participants with locally advanced or metastatic TNBC who had not previously received chemotherapy in the advanced setting received 400 mg of Ipat orally, QD on Days 1-21, 80 mg/m2 IV Pac on Days 1, 8, and 15 and 840 mg IV Atezo on Day 15 of Cycle 1 (28 day cycle). In Cycles ≥ 2, participants received 400 mg Ipat orally on Days 1-21, 840 mg IV Atezo on Days 1 and 15 and 80 mg/m2 IV Pac on Days 1, 8, and 15 of each 28-day Cycle. Following completion of the safety run-in cohort (C1), a subsequent expansion cohort (C2) enrolled. All participants in Arm C continued to receive treatment until loss of clinical benefit, unacceptable toxicity, withdrawal of consent, or end of the study.
FG003
Cohort 1-Arm D
Participants with locally advanced or metastatic TNBC who had not previously received chemotherapy in the advanced setting received 840 mg IV Atezo on Days 1 and 15, 80 mg/m2 IV Pac on Days 1, 8, and 15 and 400 mg Ipat orally on days 15-21 of Cycle 1 (28 day cycle). In Cycles ≥ 2, participants received 400 mg Ipat orally on Days 1-21, 80 mg/m2 IV Pac on Days 1, 8, and 15 and 840 mg IV Atezo on Days 1 and 15 of each 28 day Cycle. Following completion of the safety run-in cohort (D1), a subsequent expansion cohort (D2) enrolled. All participants in Arm D continued to receive treatment until loss of clinical benefit, unacceptable toxicity, withdrawal of consent, or end of the study.
FG004
Cohort 2-Arm E
Participants in the second-line and third-line setting with locally advanced or metastatic TNBC received 400 mg Ipat orally QD on Days 1-28 and 840 mg IV Atezo on Days 8 and 22 of Cycle 1 (Cycle 1 = 35 days). In Cycles ≥ 2, participants received 400 mg Ipat orally on Days 1-21 and 840 mg IV Atezo on Days 1 and 15 of each cycle (Cycles ≥ 2 = 28-days) until loss of clinical benefit, unacceptable toxicity, withdrawal of consent, or end of the study.
FG005
Cohort 3-Arm F
Participants in the safety run-in stage (arm F1) with locally advanced T2-4 TNBC received 300 mg Ipat orally QD on Days 1-21, 840mg IV Atezo on Days 1 and 15, 60 mg/m2 IV doxorubicin and 600 mg/m2 IV cyclophosphamide on Days 1 and 15 of Cycles 1 and 2 (1 Cycle=28-days). Participants then received 400 mg Ipat orally QD on Days 1-21, 840mg IV Atezo on Days 1 and 15 and 80 mg/m2 IV Pac on Days 1, 8, 15, and 22 of Cycles 3-5, until completion of 5 cycles or disease progression or unacceptable toxicity, whichever occurred first.
FG00071 subjects
FG00120 subjects
FG00213 subjects
FG00312 subjects
FG00417 subjects
FG0056 subjects
Safety Population
Safety population included all participants who received any study treatment.
FG00070 subjects
FG00120 subjects
FG00212 subjects
FG00312 subjects
FG00417 subjects
FG0056 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
NOT COMPLETED
FG00071 subjects
FG00120 subjects
FG00213 subjects
FG00312 subjects
FG00417 subjects
FG0056 subjects
Type
Comment
Reasons
Other
FG0002 subjects
FG0011 subjects
FG0020 subjects
FG0032 subjects
FG0040 subjects
FG0051 subjects
Lost to Follow-up
FG0002 subjects
FG0010 subjects
FG0021 subjects
FG0031 subjects
FG004
Withdrawal by Subject
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Physician Decision
FG00031 subjects
FG0013 subjects
FG0026 subjects
FG0034 subjects
FG004
Death
FG00034 subjects
FG00116 subjects
FG0025 subjects
FG0035 subjects
FG004
Symptomatic Deterioration
FG0001 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Safety population included all participants who received any study treatment.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Cohort 1-Arm A
Participants with locally advanced or metastatic triple-negative breast cancer (TNBC) who had not previously received chemotherapy in the advanced setting received 400 milligrams (mg) of ipatasertib (Ipat) orally, once daily (QD) on Days 1-21, 840 mg intravenous (IV) of atezolizumab (Atezo) on Days 1 and 15, and 80 milligrams per square meter (mg/m^2) IV paclitaxel (Pac) on Days 1, 8, and 15 of each 28-day cycle. Following completion of a safety run-in cohort (A1), subsequent expansion arms enrolled (A2 and A3). All participants in Arm A continued to receive treatment until loss of clinical benefit, unacceptable toxicity, withdrawal of consent, or end of the study.
BG001
Cohort 1-Arm B
Participants with locally advanced or metastatic TNBC who had not previously received chemotherapy in the advanced setting received 400 mg of Ipat orally, QD on Days 1-21, 840 mg IV of Atezo on Days 1 and 15, and 100 mg/m^2 IV nab-paclitaxel (Nab-Pac) on Days 1, 8, and 15 of each 28-day cycle. Following completion of a safety run-in cohort (B1), a subsequent expansion arm enrolled (B2). All participants in Arm B continued to receive treatment until loss of clinical benefit, unacceptable toxicity, withdrawal of consent, or end of the study.
BG002
Cohort 1-Arm C
Participants with locally advanced or metastatic TNBC who had not previously received chemotherapy in the advanced setting received 400 mg of Ipat orally, QD on Days 1-21, 80 mg/m2 IV Pac on Days 1, 8, and 15 and 840 mg IV Atezo on Day 15 of Cycle 1 (28 day cycle). In Cycles ≥ 2, participants received 400 mg Ipat orally on Days 1-21, 840 mg IV Atezo on Days 1 and 15 and 80 mg/m2 IV Pac on Days 1, 8, and 15 of each 28-day Cycle. Following completion of the safety run-in cohort (C1), a subsequent expansion cohort (C2) enrolled. All participants in Arm C continued to receive treatment until loss of clinical benefit, unacceptable toxicity, withdrawal of consent, or end of the study.
BG003
Cohort 1-Arm D
Participants with locally advanced or metastatic TNBC who had not previously received chemotherapy in the advanced setting received 840 mg IV Atezo on Days 1 and 15, 80 mg/m2 IV Pac on Days 1, 8, and 15 and 400 mg Ipat orally on days 15-21 of Cycle 1 (28 day cycle). In Cycles ≥ 2, participants received 400 mg Ipat orally on Days 1-21, 80 mg/m2 IV Pac on Days 1, 8, and 15 and 840 mg IV Atezo on Days 1 and 15 of each 28 day Cycle. Following completion of the safety run-in cohort (D1), a subsequent expansion cohort (D2) enrolled. All participants in Arm D continued to receive treatment until loss of clinical benefit, unacceptable toxicity, withdrawal of consent, or end of the study.
BG004
Cohort 2-Arm E
Participants in the second-line and third-line setting with locally advanced or metastatic TNBC received 400 mg Ipat orally QD on Days 1-28 and 840 mg IV Atezo on Days 8 and 22 of Cycle 1 (Cycle 1 = 35 days). In Cycles ≥ 2, participants received 400 mg Ipat orally on Days 1-21 and 840 mg IV Atezo on Days 1 and 15 of each cycle (Cycles ≥ 2 = 28-days) until loss of clinical benefit, unacceptable toxicity, withdrawal of consent, or end of the study.
BG005
Cohort 3-Arm F
Participants in the safety run-in stage (arm F1) with locally advanced T2-4 TNBC received 300 mg Ipat orally QD on Days 1-21, 840mg IV Atezo on Days 1 and 15, 60 mg/m2 IV doxorubicin and 600 mg/m2 IV cyclophosphamide on Days 1 and 15 of Cycles 1 and 2 (1 Cycle=28-days). Participants then received 400 mg Ipat orally QD on Days 1-21, 840mg IV Atezo on Days 1 and 15 and 80 mg/m2 IV Pac on Days 1, 8, 15, and 22 of Cycles 3-5, until completion of 5 cycles or disease progression or unacceptable toxicity, whichever occurred first.
BG006
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00070
BG00120
BG00212
BG00312
BG00417
BG0056
BG006137
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
BG00056.6± 13.0
BG00150.2± 9.6
BG00246.4± 14.0
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00070
BG00120
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0001
BG0010
BG002
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0007
BG0013
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
Cohort 1 and Cohort 4: Percentage of Participants With Objective Response (OR) as Assessed by Investigator Based on Response Evaluation Criteria in Solid Tumors (RECIST), Version (v) 1.1
Objective Response Rate: percentage participants with confirmed complete response (CR) or partial response (PR) on 2 consecutive occasions >or= 4 weeks apart, as determined by investigator according to RECIST v1.1. CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. PR: at least a 30% decrease in sum of diameters of target lesions, taking as reference baseline sum diameters. Percentages have been rounded off. No participants were enrolled in cohort 4, hence no data reported.
Efficacy evaluable population included all enrolled participants who received at least one dose of study treatment, regardless of treatment allocation. Participants without a postbaseline tumor assessment were considered as non-responders.
Posted
Number
95% Confidence Interval
percentage of participants
From screening up to approximately 43.6 months
ID
Title
Description
OG000
Cohort 1-Arm A
Participants with locally advanced or metastatic triple-negative breast cancer (TNBC) who had not previously received chemotherapy in the advanced setting received 400 milligrams (mg) of ipatasertib (Ipat) orally, once daily (QD) on Days 1-21, 840 mg intravenous (IV) of atezolizumab (Atezo) on Days 1 and 15, and 80 milligrams per square meter (mg/m^2) IV paclitaxel (Pac) on Days 1, 8, and 15 of each 28-day cycle. Following completion of a safety run-in cohort (A1), subsequent expansion arms enrolled (A2 and A3). All participants in Arm A continued to receive treatment until loss of clinical benefit, unacceptable toxicity, withdrawal of consent, or end of the study.
OG001
Cohort 1-Arm B
Participants with locally advanced or metastatic TNBC who had not previously received chemotherapy in the advanced setting received 400 mg of Ipat orally, QD on Days 1-21, 840 mg IV of Atezo on Days 1 and 15, and 100 mg/m^2 IV nab-paclitaxel (Nab-Pac) on Days 1, 8, and 15 of each 28-day cycle. Following completion of a safety run-in cohort (B1), a subsequent expansion arm enrolled (B2). All participants in Arm B continued to receive treatment until loss of clinical benefit, unacceptable toxicity, withdrawal of consent, or end of the study.
OG002
Cohort 1-Arm C
Participants with locally advanced or metastatic TNBC who had not previously received chemotherapy in the advanced setting received 400 mg of Ipat orally, QD on Days 1-21, 80 mg/m2 IV Pac on Days 1, 8, and 15 and 840 mg IV Atezo on Day 15 of Cycle 1 (28 day cycle). In Cycles ≥ 2, participants received 400 mg Ipat orally on Days 1-21, 840 mg IV Atezo on Days 1 and 15 and 80 mg/m2 IV Pac on Days 1, 8, and 15 of each 28-day Cycle. Following completion of the safety run-in cohort (C1), a subsequent expansion cohort (C2) enrolled. All participants in Arm C continued to receive treatment until loss of clinical benefit, unacceptable toxicity, withdrawal of consent, or end of the study.
OG003
Cohort 1-Arm D
Participants with locally advanced or metastatic TNBC who had not previously received chemotherapy in the advanced setting received 840 mg IV Atezo on Days 1 and 15, 80 mg/m2 IV Pac on Days 1, 8, and 15 and 400 mg Ipat orally on days 15-21 of Cycle 1 (28 day cycle). In Cycles ≥ 2, participants received 400 mg Ipat orally on Days 1-21, 80 mg/m2 IV Pac on Days 1, 8, and 15 and 840 mg IV Atezo on Days 1 and 15 of each 28 day Cycle. Following completion of the safety run-in cohort (D1), a subsequent expansion cohort (D2) enrolled. All participants in Arm D continued to receive treatment until loss of clinical benefit, unacceptable toxicity, withdrawal of consent, or end of the study.
Units
Counts
Participants
OG00070
OG00120
OG00212
OG003
Title
Denominators
Categories
Title
Measurements
OG00051.4(39.17 to 63.56)
OG00165.0(40.78 to 84.61)
OG00266.7(34.89 to 90.08)
OG003
Secondary
Cohort 1 and Cohort 4: Duration of Response (DOR), as Determined by the Investigator According to RECIST v1.1
DOR was defined as the time from the first occurrence of a documented confirmed CR or PR to the first date of recorded disease progression (PD), as determined by the investigator according to RECIST v1.1 or death from any cause. CR was defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduced in short axis to < 10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. PD was defined as at least a 20% increase in the sum of diameter of target lesions, taking as reference the smallest sum on study (nadir) including baseline; the appearance of one or more new lesions. No participants were enrolled in cohort 4, and hence no data was reported. Participants who did not progress or died at time of analysis were censored at last disease assessment date.
Efficacy evaluable population included all enrolled participants who received at least one dose of study treatment, regardless of treatment allocation. Number analyzed are participants who had OR (i.e., a confirmed CR or PR).
Posted
Median
95% Confidence Interval
months
From the date of first documented confirmed response (CR or PR) to disease progression or death due to any cause (up to approximately 43.6 months)
ID
Title
Description
OG000
Cohort 1-Arm A
Participants with locally advanced or metastatic triple-negative breast cancer (TNBC) who had not previously received chemotherapy in the advanced setting received 400 milligrams (mg) of ipatasertib (Ipat) orally, once daily (QD) on Days 1-21, 840 mg intravenous (IV) of atezolizumab (Atezo) on Days 1 and 15, and 80 milligrams per square meter (mg/m^2) IV paclitaxel (Pac) on Days 1, 8, and 15 of each 28-day cycle. Following completion of a safety run-in cohort (A1), subsequent expansion arms enrolled (A2 and A3). All participants in Arm A continued to receive treatment until loss of clinical benefit, unacceptable toxicity, withdrawal of consent, or end of the study.
pCR rate was defined as the percentage of participants who had no residual invasive disease in the breast and no residual disease in the lymph nodes (ypT0/Tis ypN0 in the current American Joint Committee on Cancer (AJCC )staging system) based on hematoxylin and eosin evaluation of the complete resected breast specimen and all sampled regional lymph nodes following completion of neoadjuvant therapy.
Efficacy evaluable population included all enrolled participants who received at least one dose of study treatment, regardless of treatment allocation.
Posted
Number
percentage of participants
2-6 weeks following last dose of study treatment (up to 69 weeks)
ID
Title
Description
OG000
Cohort 3-Arm F
Participants in the safety run-in stage (arm F1) with locally advanced T2-4 TNBC received 300 mg Ipat orally QD on Days 1-21, 840mg IV Atezo on Days 1 and 15, 60 mg/m2 IV doxorubicin and 600 mg/m2 IV cyclophosphamide on Days 1 and 15 of Cycles 1 and 2 (1 Cycle=28-days). Participants then received 400 mg Ipat orally QD on Days 1-21, 840mg IV Atezo on Days 1 and 15 and 80 mg/m2 IV Pac on Days 1, 8, 15, and 22 of Cycles 3-5, until completion of 5 cycles or disease progression or unacceptable toxicity, whichever occurred first.
Units
Counts
Participants
Primary
Cohort 1, Cohort 2, Cohort 3 and Cohort 4: Number of Participants With Adverse Events (AEs)
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any new disease or worsening of an existing disease are also considered as AEs. AEs were reported based on the National Cancer Institute Common Terminology Criteria for AEs, version 4.0 (NCI-CTCAE, v4.0). No participants were enrolled in cohort 3 Arm G and 4, and hence no data was reported.
Safety population included all participants who received any study treatment.
Posted
Count of Participants
Participants
Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month)
ID
Title
Description
OG000
Cohort 1-Arm A
Participants with locally advanced or metastatic triple-negative breast cancer (TNBC) who had not previously received chemotherapy in the advanced setting received 400 milligrams (mg) of ipatasertib (Ipat) orally, once daily (QD) on Days 1-21, 840 mg intravenous (IV) of atezolizumab (Atezo) on Days 1 and 15, and 80 milligrams per square meter (mg/m^2) IV paclitaxel (Pac) on Days 1, 8, and 15 of each 28-day cycle. Following completion of a safety run-in cohort (A1), subsequent expansion arms enrolled (A2 and A3). All participants in Arm A continued to receive treatment until loss of clinical benefit, unacceptable toxicity, withdrawal of consent, or end of the study.
Secondary
Cohort 1 and Cohort 4: Progression-Free Survival (PFS), as Assessed by Investigator Based on RECIST v1.1
PFS: time from enrollment to date of 1st recorded occurrence of PD, as determined by investigator according to RECIST v1.1 or death from any cause, whichever occurs first. PD: at least a 20% increase in sum of diameters of target lesions, taking as reference smallest sum on study (nadir) including baseline; appearance of one or more new lesions. Data for participants who did not experience PD or death was censored at last date of evaluable tumor assessment. No participants were enrolled in cohort 4, and hence no data was reported.
Efficacy evaluable population included all enrolled participants who received at least one dose of study treatment, regardless of treatment allocation.
Posted
Median
95% Confidence Interval
months
From enrollment up to disease progression or death due to any cause whichever occurs first (up to approximately 43.6 months)
ID
Title
Description
OG000
Cohort 1-Arm A
Participants with locally advanced or metastatic triple-negative breast cancer (TNBC) who had not previously received chemotherapy in the advanced setting received 400 milligrams (mg) of ipatasertib (Ipat) orally, once daily (QD) on Days 1-21, 840 mg intravenous (IV) of atezolizumab (Atezo) on Days 1 and 15, and 80 milligrams per square meter (mg/m^2) IV paclitaxel (Pac) on Days 1, 8, and 15 of each 28-day cycle. Following completion of a safety run-in cohort (A1), subsequent expansion arms enrolled (A2 and A3). All participants in Arm A continued to receive treatment until loss of clinical benefit, unacceptable toxicity, withdrawal of consent, or end of the study.
Secondary
Cohort 1 and Cohort 4: Overall Survival (OS)
OS was defined as the time from enrollment to death from any cause.
Efficacy evaluable population included all enrolled participants who received at least one dose of study treatment, regardless of treatment allocation.
Posted
Median
95% Confidence Interval
months
From enrollment up to death due to any cause (up to approximately 43.6 months).
ID
Title
Description
OG000
Cohort 1-Arm A
Participants with locally advanced or metastatic triple-negative breast cancer (TNBC) who had not previously received chemotherapy in the advanced setting received 400 milligrams (mg) of ipatasertib (Ipat) orally, once daily (QD) on Days 1-21, 840 mg intravenous (IV) of atezolizumab (Atezo) on Days 1 and 15, and 80 milligrams per square meter (mg/m^2) IV paclitaxel (Pac) on Days 1, 8, and 15 of each 28-day cycle. Following completion of a safety run-in cohort (A1), subsequent expansion arms enrolled (A2 and A3). All participants in Arm A continued to receive treatment until loss of clinical benefit, unacceptable toxicity, withdrawal of consent, or end of the study.
OG001
Cohort 1-Arm B
Participants with locally advanced or metastatic TNBC who had not previously received chemotherapy in the advanced setting received 400 mg of Ipat orally, QD on Days 1-21, 840 mg IV of Atezo on Days 1 and 15, and 100 mg/m^2 IV nab-paclitaxel (Nab-Pac) on Days 1, 8, and 15 of each 28-day cycle. Following completion of a safety run-in cohort (B1), a subsequent expansion arm enrolled (B2). All participants in Arm B continued to receive treatment until loss of clinical benefit, unacceptable toxicity, withdrawal of consent, or end of the study.
Secondary
Cohort 1 and Cohort 4: Plasma Concentration of Ipatasertib
Since, Cohort 4 did not enroll any participants, data is only reported for Cohort 1.
Pharmacokinetic (PK) evaluable population included all participants who had at least 1 evaluable PK concentration post ipatasertib administration. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at a given time point.
Posted
Geometric Mean
Geometric Coefficient of Variation
nanograms per milliliter (ng/mL)
Day 15 Cycle 1: pre-dose and 1, 2, 4 and 6 hours post-dose, Day 15 Cycle2: predose and 1, 2, 4 and 6 hours post-dose and Day 15 Cycle 3 - post dose up to - 3 hours (each cycle is of 28 days)
ID
Title
Description
OG000
Cohort 1- Arm A1
Participants with locally advanced or metastatic TNBC who had not previously received chemotherapy in the advanced setting received 400 mg of Ipat orally, QD on Days 1-21, 840 mg IV of Atezo on Days 1 and 15, and 80 mg/m^2 IV Pac on Days 1, 8, and 15 of each 28-day cycle during the safety run-in stage (A1) until loss of clinical benefit, unacceptable toxicity, withdrawal of consent, or end of the study.
OG001
Cohort 1- A2
Participants with locally advanced or metastatic TNBC who had not previously received chemotherapy in the advanced setting received 400 mg of Ipat orally, QD on Days 1-21, 840 mg IV of Atezo on Days 1 and 15, and 80 mg/m^2 IV Pac on Days 1, 8, and 15 of each 28-day cycle in expansion stage A2 until loss of clinical benefit, unacceptable toxicity, withdrawal of consent, or end of the study.
Secondary
Cohort 1 and Cohort 4: Plasma Concentration of Ipatasertib Metabolite M1 (G-037720)
Since, Cohort 4 did not enroll any participants, data is only reported for Cohort 1.
PK evaluable population included all participants who had at least 1 evaluable PK concentration post ipatasertib administration. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at a given time point.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng/mL
Day 15 Cycle 1 - pre-dose and 1 hour, 2 hours, 4 hours and 6 hours post-dose, Day 15 Cycle2: predose and 1 hour, 2 hours, 4 hours and 6 hours post-dose and Day 15 Cycle 3 - post dose up to - 3 hours (each cycle is of 28 days)
ID
Title
Description
OG000
Cohort 1- Arm A1
Participants with locally advanced or metastatic TNBC who had not previously received chemotherapy in the advanced setting received 400 mg of Ipat orally, QD on Days 1-21, 840 mg IV of Atezo on Days 1 and 15, and 80 mg/m^2 IV Pac on Days 1, 8, and 15 of each 28-day cycle during the safety run-in stage (A1) until loss of clinical benefit, unacceptable toxicity, withdrawal of consent, or end of the study.
OG001
Cohort 1-Arm A2
Participants with locally advanced or metastatic TNBC who had not previously received chemotherapy in the advanced setting received 400 mg of Ipat orally, QD on Days 1-21, 840 mg IV of Atezo on Days 1 and 15, and 80 mg/m^2 IV Pac on Days 1, 8, and 15 of each 28-day cycle in expansion stage A2 until loss of clinical benefit, unacceptable toxicity, withdrawal of consent, or end of the study.
Secondary
Cohort 1 and Cohort 4: Number of Participants With Anti-Drug Antibodies (ADAs) for Atezolizumab During Study Treatment
Participants were considered to be ADA positive if they were ADA negative or were missing data at Baseline but developed an ADA response following study drug exposure (treatment-induced ADA response), or if they were ADA positive at Baseline and the titer of one or more postbaseline samples was at least 0.60 titer unit greater than the titer of the Baseline sample (treatment-enhanced ADA response). Participants were considered to be ADA negative if they were ADA negative or had missing data at Baseline and all postbaseline samples were negative, or if they were ADA positive at Baseline but did not have any postbaseline samples with a titer that was at least 0.60 titer unit greater than the titer of the baseline sample (treatment unaffected). Since, Cohort 4 did not enroll any participants, data is only reported for Cohort 1.
Immunogenicity evaluable population included all participants with atleast 1 ADA assessment. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at a given time point.
Posted
Count of Participants
Participants
From baseline up to 30 days from the last dose of atezolizumab (to approximately 4 years 1.1 month)
ID
Title
Description
OG000
Cohort 1-Arm A1
Participants with locally advanced or metastatic TNBC who had not previously received chemotherapy in the advanced setting received 400 mg of Ipat orally, QD on Days 1-21, 840 mg IV of Atezo on Days 1 and 15, and 80 mg/m^2 IV Pac on Days 1, 8, and 15 of each 28-day cycle during the safety run-in stage (A1) until loss of clinical benefit, unacceptable toxicity, withdrawal of consent, or end of the study.
Secondary
Cohort 1 and Cohort 4: Plasma Concentration of Atezolizumab
Since, Cohort 4 did not enroll any participants, data is only reported for Cohort 1.
PK evaluable population included all participants who had at least 1 evaluable PK concentration post atezolizumab administration. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at a given time point.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng/mL
Cycle 1 Day 1 and 15: predose and 30 mins post dose; Cycle 2: Day 1 and 15 predose, Cycle 3, 4, 8, 12, and 16 Day 1: predose; treatment discontinuation visit
ID
Title
Description
OG000
Cohort 1- Arm A1
Participants with locally advanced or metastatic TNBC who had not previously received chemotherapy in the advanced setting received 400 mg of Ipat orally, QD on Days 1-21, 840 mg IV of Atezo on Days 1 and 15, and 80 mg/m^2 IV Pac on Days 1, 8, and 15 of each 28-day cycle during the safety run-in stage (A1) until loss of clinical benefit, unacceptable toxicity, withdrawal of consent, or end of the study.
OG001
Cohort 1-Arm A2
Participants with locally advanced or metastatic TNBC who had not previously received chemotherapy in the advanced setting received 400 mg of Ipat orally, QD on Days 1-21, 840 mg IV of Atezo on Days 1 and 15, and 80 mg/m^2 IV Pac on Days 1, 8, and 15 of each 28-day cycle in expansion stage A2 until loss of clinical benefit, unacceptable toxicity, withdrawal of consent, or end of the study.
Secondary
Cohort 1 and Cohort 4: Clinical Benefit Rate (CBR) as Assessed by Investigator Based on RECIST v1.1
CBR was defined as percentage of participants with stable disease (SD) for at least 24 weeks or with confirmed CR or PR as determined by the investigator according to RECIST v1.1. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum on study. CR was defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. Since, Cohort 4 did not enroll any participants, data is only reported for Cohort 1.
Efficacy evaluable population included all enrolled participants who received at least one dose of study treatment, regardless of treatment allocation.
Posted
Number
95% Confidence Interval
percentage of participants
From screening up to confirmed SD or CR or PR (up to approximately 43.6 months)
ID
Title
Description
OG000
Cohort 1-Arm A
Participants with locally advanced or metastatic triple-negative breast cancer (TNBC) who had not previously received chemotherapy in the advanced setting received 400 milligrams (mg) of ipatasertib (Ipat) orally, once daily (QD) on Days 1-21, 840 mg intravenous (IV) of atezolizumab (Atezo) on Days 1 and 15, and 80 milligrams per square meter (mg/m^2) IV paclitaxel (Pac) on Days 1, 8, and 15 of each 28-day cycle. Following completion of a safety run-in cohort (A1), subsequent expansion arms enrolled (A2 and A3). All participants in Arm A continued to receive treatment until loss of clinical benefit, unacceptable toxicity, withdrawal of consent, or end of the study.
Time Frame
Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month)
Description
Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
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
Cohort 1- Arm A
Participants with locally advanced or metastatic triple-negative breast cancer (TNBC) who had not previously received chemotherapy in the advanced setting received 400 milligrams (mg) of ipatasertib (Ipat) orally, once daily (QD) on Days 1-21, 840 mg intravenous (IV) of atezolizumab (Atezo) on Days 1 and 15, and 80 milligrams per square meter (mg/m^2) IV paclitaxel (Pac) on Days 1, 8, and 15 of each 28-day cycle. Following completion of a safety run-in cohort (A1), subsequent expansion arms enrolled (A2 and A3). All participants in Arm A continued to receive treatment until loss of clinical benefit, unacceptable toxicity, withdrawal of consent, or end of the study.
34
70
26
70
70
70
EG001
Cohort 1- Arm B
Participants with locally advanced or metastatic TNBC who had not previously received chemotherapy in the advanced setting received 400 mg of Ipat orally, QD on Days 1-21, 840 mg IV of Atezo on Days 1 and 15, and 100 mg/m^2 IV nab-paclitaxel (Nab-Pac) on Days 1, 8, and 15 of each 28-day cycle. Following completion of a safety run-in cohort (B1), a subsequent expansion arm enrolled (B2). All participants in Arm B continued to receive treatment until loss of clinical benefit, unacceptable toxicity, withdrawal of consent, or end of the study.
16
20
9
20
20
20
EG002
Cohort 1- Arm C
Participants with locally advanced or metastatic TNBC who had not previously received chemotherapy in the advanced setting received 400 mg of Ipat orally, QD on Days 1-21, 80 mg/m2 IV Pac on Days 1, 8, and 15 and 840 mg IV Atezo on Day 15 of Cycle 1 (28 day cycle). In Cycles ≥ 2, participants received 400 mg Ipat orally on Days 1-21, 840 mg IV Atezo on Days 1 and 15 and 80 mg/m2 IV Pac on Days 1, 8, and 15 of each 28-day Cycle. Following completion of the safety run-in cohort (C1), a subsequent expansion cohort (C2) enrolled. All participants in Arm C continued to receive treatment until loss of clinical benefit, unacceptable toxicity, withdrawal of consent, or end of the study.
5
12
5
12
12
12
EG003
Cohort 1- Arm D
Participants with locally advanced or metastatic TNBC who had not previously received chemotherapy in the advanced setting received 840 mg IV Atezo on Days 1 and 15, 80 mg/m2 IV Pac on Days 1, 8, and 15 and 400 mg Ipat orally on days 15-21 of Cycle 1 (28 day cycle). In Cycles ≥ 2, participants received 400 mg Ipat orally on Days 1-21, 80 mg/m2 IV Pac on Days 1, 8, and 15 and 840 mg IV Atezo on Days 1 and 15 of each 28 day Cycle. Following completion of the safety run-in cohort (D1), a subsequent expansion cohort (D2) enrolled. All participants in Arm D continued to receive treatment until loss of clinical benefit, unacceptable toxicity, withdrawal of consent, or end of the study.
5
12
4
12
12
12
EG004
Cohort 2- Arm E
Participants in the second-line and third-line setting with locally advanced or metastatic TNBC received 400 mg Ipat orally QD on Days 1-28 and 840 mg IV Atezo on Days 8 and 22 of Cycle 1 (Cycle 1 = 35 days). In Cycles ≥ 2, participants received 400 mg Ipat orally on Days 1-21 and 840 mg IV Atezo on Days 1 and 15 of each cycle (Cycles ≥ 2 = 28 days) until loss of clinical benefit, unacceptable toxicity, withdrawal of consent, or end of the study.
10
17
5
17
17
17
EG005
Cohort 3- Arm F
Participants in the safety run-in stage (arm F1) with locally advanced T2-4 TNBC received 300 mg Ipat orally QD on Days 1-21, 840mg IV Atezo on Days 1 and 15, 60 mg/m2 IV doxorubicin and 600 mg/m2 IV cyclophosphamide on Days 1 and 15 of Cycles 1 and 2 (1 Cycle=28-days). Participants then received 400 mg Ipat orally QD on Days 1-21, 840mg IV Atezo on Days 1 and 15 and 80 mg/m2 IV Pac on Days 1, 8, 15, and 22 of Cycles 3-5, until completion of 5 cycles or disease progression or unacceptable toxicity, whichever occurred first.
0
6
4
6
6
6
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Neutropenia
Blood and lymphatic system disorders
MedDRA version: 24.1
Systematic Assessment
EG0001 events1 affected70 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected12 at risk
EG0030 events0 affected12 at risk
EG0040 events0 affected17 at risk
EG0052 events2 affected6 at risk
Acute coronary syndrome
Cardiac disorders
MedDRA version: 24.1
Systematic Assessment
EG0001 events1 affected70 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected12 at risk
EG003
Diplopia
Eye disorders
MedDRA version: 24.1
Systematic Assessment
EG0000 events0 affected70 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected12 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA version: 24.1
Systematic Assessment
EG0001 events1 affected70 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected12 at risk
EG003
Colitis
Gastrointestinal disorders
MedDRA version: 24.1
Systematic Assessment
EG0000 events0 affected70 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected12 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA version: 24.1
Systematic Assessment
EG0002 events2 affected70 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected12 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA version: 24.1
Systematic Assessment
EG0001 events1 affected70 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected12 at risk
EG003
Asthenia
General disorders
MedDRA version: 24.1
Systematic Assessment
EG0001 events1 affected70 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected12 at risk
EG003
Chest pain
General disorders
MedDRA version: 24.1
Systematic Assessment
EG0000 events0 affected70 at risk
EG0010 events0 affected20 at risk
EG0021 events1 affected12 at risk
EG003
General physical health deterioration
General disorders
MedDRA version: 24.1
Systematic Assessment
EG0001 events1 affected70 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected12 at risk
EG003
Mucosal inflammation
General disorders
MedDRA version: 24.1
Systematic Assessment
EG0001 events1 affected70 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected12 at risk
EG003
Pyrexia
General disorders
MedDRA version: 24.1
Systematic Assessment
EG0001 events1 affected70 at risk
EG0012 events2 affected20 at risk
EG0021 events1 affected12 at risk
EG003
Cholangitis acute
Hepatobiliary disorders
MedDRA version: 24.1
Systematic Assessment
EG0001 events1 affected70 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected12 at risk
EG003
Anal abscess
Infections and infestations
MedDRA version: 24.1
Systematic Assessment
EG0000 events0 affected70 at risk
EG0010 events0 affected20 at risk
EG0021 events1 affected12 at risk
EG003
Arthritis bacterial
Infections and infestations
MedDRA version: 24.1
Systematic Assessment
EG0001 events1 affected70 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected12 at risk
EG003
COVID-19
Infections and infestations
MedDRA version: 24.1
Systematic Assessment
EG0001 events1 affected70 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected12 at risk
EG003
Cellulitis
Infections and infestations
MedDRA version: 24.1
Systematic Assessment
EG0001 events1 affected70 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected12 at risk
EG003
Device related infection
Infections and infestations
MedDRA version: 24.1
Systematic Assessment
EG0002 events2 affected70 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected12 at risk
EG003
Endocarditis
Infections and infestations
MedDRA version: 24.1
Systematic Assessment
EG0001 events1 affected70 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected12 at risk
EG003
Neutropenic sepsis
Infections and infestations
MedDRA version: 24.1
Systematic Assessment
EG0000 events0 affected70 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected12 at risk
EG003
Pneumonia
Infections and infestations
MedDRA version: 24.1
Systematic Assessment
EG0004 events4 affected70 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected12 at risk
EG003
Postoperative wound infection
Infections and infestations
MedDRA version: 24.1
Systematic Assessment
EG0000 events0 affected70 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected12 at risk
EG003
Pyelonephritis
Infections and infestations
MedDRA version: 24.1
Systematic Assessment
EG0000 events0 affected70 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected12 at risk
EG003
Respiratory tract infection
Infections and infestations
MedDRA version: 24.1
Systematic Assessment
EG0000 events0 affected70 at risk
EG0010 events0 affected20 at risk
EG0021 events1 affected12 at risk
EG003
Sepsis
Infections and infestations
MedDRA version: 24.1
Systematic Assessment
EG0001 events1 affected70 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected12 at risk
EG003
Skin infection
Infections and infestations
MedDRA version: 24.1
Systematic Assessment
EG0001 events1 affected70 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected12 at risk
EG003
Tuberculosis
Infections and infestations
MedDRA version: 24.1
Systematic Assessment
EG0000 events0 affected70 at risk
EG0010 events0 affected20 at risk
EG0021 events1 affected12 at risk
EG003
Wound infection
Infections and infestations
MedDRA version: 24.1
Systematic Assessment
EG0001 events1 affected70 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected12 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA version: 24.1
Systematic Assessment
EG0000 events0 affected70 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected12 at risk
EG003
Transaminases increased
Investigations
MedDRA version: 24.1
Systematic Assessment
EG0001 events1 affected70 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected12 at risk
EG003
Troponin I increased
Investigations
MedDRA version: 24.1
Systematic Assessment
EG0001 events1 affected70 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected12 at risk
EG003
Hyperamylasaemia
Metabolism and nutrition disorders
MedDRA version: 24.1
Systematic Assessment
EG0001 events1 affected70 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected12 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA version: 24.1
Systematic Assessment
EG0000 events0 affected70 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected12 at risk
EG003
Bone pain
Musculoskeletal and connective tissue disorders
MedDRA version: 24.1
Systematic Assessment
EG0000 events0 affected70 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected12 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA version: 24.1
Systematic Assessment
EG0000 events0 affected70 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected12 at risk
EG003
Spinal pain
Musculoskeletal and connective tissue disorders
MedDRA version: 24.1
Systematic Assessment
EG0000 events0 affected70 at risk
EG0010 events0 affected20 at risk
EG0021 events1 affected12 at risk
EG003
Infected neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version: 24.1
Systematic Assessment
EG0001 events1 affected70 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected12 at risk
EG003
Cerebrovascular accident
Nervous system disorders
MedDRA version: 24.1
Systematic Assessment
EG0001 events1 affected70 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected12 at risk
EG003
Ischaemic stroke
Nervous system disorders
MedDRA version: 24.1
Systematic Assessment
EG0001 events1 affected70 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected12 at risk
EG003
Presyncope
Nervous system disorders
MedDRA version: 24.1
Systematic Assessment
EG0000 events0 affected70 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected12 at risk
EG003
Seizure
Nervous system disorders
MedDRA version: 24.1
Systematic Assessment
EG0001 events1 affected70 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected12 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA version: 24.1
Systematic Assessment
EG0001 events1 affected70 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected12 at risk
EG003
Nephritis
Renal and urinary disorders
MedDRA version: 24.1
Systematic Assessment
EG0000 events0 affected70 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected12 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA version: 24.1
Systematic Assessment
EG0000 events0 affected70 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected12 at risk
EG003
Interstitial lung disease
Respiratory, thoracic and mediastinal disorders
MedDRA version: 24.1
Systematic Assessment
EG0000 events0 affected70 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected12 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA version: 24.1
Systematic Assessment
EG0001 events1 affected70 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected12 at risk
EG003
Pneumothorax
Respiratory, thoracic and mediastinal disorders
MedDRA version: 24.1
Systematic Assessment
EG0003 events2 affected70 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected12 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA version: 24.1
Systematic Assessment
EG0001 events1 affected70 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected12 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA version: 24.1
Systematic Assessment
EG0003 events3 affected70 at risk
EG0012 events2 affected20 at risk
EG0022 events2 affected12 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA version: 24.1
Systematic Assessment
EG0001 events1 affected70 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected12 at risk
EG003
Skin ulcer
Skin and subcutaneous tissue disorders
MedDRA version: 24.1
Systematic Assessment
EG0001 events1 affected70 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected12 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA version: 24.1
Systematic Assessment
EG00020 events17 affected70 at risk
EG00110 events6 affected20 at risk
EG0025 events3 affected12 at risk
EG0033 events2 affected12 at risk
EG0041 events1 affected17 at risk
EG0055 events4 affected6 at risk
Lymphopenia
Blood and lymphatic system disorders
MedDRA version: 24.1
Systematic Assessment
EG0000 events0 affected70 at risk
EG0012 events2 affected20 at risk
EG0020 events0 affected12 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA version: 24.1
Systematic Assessment
EG00043 events15 affected70 at risk
EG0016 events3 affected20 at risk
EG0026 events2 affected12 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA version: 24.1
Systematic Assessment
EG0000 events0 affected70 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected12 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA version: 24.1
Systematic Assessment
EG0000 events0 affected70 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected12 at risk
EG003
Hyperthyroidism
Endocrine disorders
MedDRA version: 24.1
Systematic Assessment
EG0006 events5 affected70 at risk
EG0011 events1 affected20 at risk
EG0022 events2 affected12 at risk
EG003
Hypothyroidism
Endocrine disorders
MedDRA version: 24.1
Systematic Assessment
EG0008 events7 affected70 at risk
EG0012 events2 affected20 at risk
EG0021 events1 affected12 at risk
EG003
Conjunctivitis allergic
Eye disorders
MedDRA version: 24.1
Systematic Assessment
EG0000 events0 affected70 at risk
EG0010 events0 affected20 at risk
EG0021 events1 affected12 at risk
EG003
Dry eye
Eye disorders
MedDRA version: 24.1
Systematic Assessment
EG0006 events6 affected70 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected12 at risk
EG003
Eyelid ptosis
Eye disorders
MedDRA version: 24.1
Systematic Assessment
EG0000 events0 affected70 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected12 at risk
EG003
Lacrimation increased
Eye disorders
MedDRA version: 24.1
Systematic Assessment
EG0002 events2 affected70 at risk
EG0011 events1 affected20 at risk
EG0021 events1 affected12 at risk
EG003
Visual acuity reduced
Eye disorders
MedDRA version: 24.1
Systematic Assessment
EG0000 events0 affected70 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected12 at risk
EG003
Xerophthalmia
Eye disorders
MedDRA version: 24.1
Systematic Assessment
EG0001 events1 affected70 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected12 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA version: 24.1
Systematic Assessment
EG00015 events12 affected70 at risk
EG0012 events2 affected20 at risk
EG0023 events3 affected12 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA version: 24.1
Systematic Assessment
EG0006 events5 affected70 at risk
EG0011 events1 affected20 at risk
EG0021 events1 affected12 at risk
EG003
Anal fissure
Gastrointestinal disorders
MedDRA version: 24.1
Systematic Assessment
EG0000 events0 affected70 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected12 at risk
EG003
Aphthous ulcer
Gastrointestinal disorders
MedDRA version: 24.1
Systematic Assessment
EG0000 events0 affected70 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected12 at risk
EG003
Colitis
Gastrointestinal disorders
MedDRA version: 24.1
Systematic Assessment
EG0000 events0 affected70 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected12 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA version: 24.1
Systematic Assessment
EG00034 events25 affected70 at risk
EG0018 events7 affected20 at risk
EG0026 events4 affected12 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA version: 24.1
Systematic Assessment
EG000127 events59 affected70 at risk
EG00151 events15 affected20 at risk
EG00222 events10 affected12 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA version: 24.1
Systematic Assessment
EG0002 events2 affected70 at risk
EG0012 events1 affected20 at risk
EG0020 events0 affected12 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA version: 24.1
Systematic Assessment
EG00011 events10 affected70 at risk
EG0015 events3 affected20 at risk
EG0020 events0 affected12 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA version: 24.1
Systematic Assessment
EG0005 events5 affected70 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected12 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA version: 24.1
Systematic Assessment
EG0005 events4 affected70 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected12 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
MedDRA version: 24.1
Systematic Assessment
EG0002 events2 affected70 at risk
EG0015 events4 affected20 at risk
EG0020 events0 affected12 at risk
EG003
Large intestine polyp
Gastrointestinal disorders
MedDRA version: 24.1
Systematic Assessment
EG0000 events0 affected70 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected12 at risk
EG003
Mouth ulceration
Gastrointestinal disorders
MedDRA version: 24.1
Systematic Assessment
EG0003 events2 affected70 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected12 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA version: 24.1
Systematic Assessment
EG00055 events37 affected70 at risk
EG00129 events16 affected20 at risk
EG0024 events4 affected12 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA version: 24.1
Systematic Assessment
EG00012 events8 affected70 at risk
EG0013 events3 affected20 at risk
EG0020 events0 affected12 at risk
EG003
Toothache
Gastrointestinal disorders
MedDRA version: 24.1
Systematic Assessment
EG0002 events2 affected70 at risk
EG0011 events1 affected20 at risk
EG0021 events1 affected12 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA version: 24.1
Systematic Assessment
EG00029 events15 affected70 at risk
EG00119 events11 affected20 at risk
EG0025 events4 affected12 at risk
EG003
Asthenia
General disorders
MedDRA version: 24.1
Systematic Assessment
EG00028 events19 affected70 at risk
EG00112 events7 affected20 at risk
EG0023 events3 affected12 at risk
EG003
Chest pain
General disorders
MedDRA version: 24.1
Systematic Assessment
EG0003 events3 affected70 at risk
EG0012 events1 affected20 at risk
EG0020 events0 affected12 at risk
EG003
Chills
General disorders
MedDRA version: 24.1
Systematic Assessment
EG0001 events1 affected70 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected12 at risk
EG003
Face oedema
General disorders
MedDRA version: 24.1
Systematic Assessment
EG0001 events1 affected70 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected12 at risk
EG003
Fatigue
General disorders
MedDRA version: 24.1
Systematic Assessment
EG00046 events32 affected70 at risk
EG0018 events6 affected20 at risk
EG0029 events5 affected12 at risk
EG003
Feeling hot
General disorders
MedDRA version: 24.1
Systematic Assessment
EG0000 events0 affected70 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected12 at risk
EG003
General physical health deterioration
General disorders
MedDRA version: 24.1
Systematic Assessment
EG0000 events0 affected70 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected12 at risk
EG003
Influenza like illness
General disorders
MedDRA version: 24.1
Systematic Assessment
EG0000 events0 affected70 at risk
EG0011 events1 affected20 at risk
EG0021 events1 affected12 at risk
EG003
Malaise
General disorders
MedDRA version: 24.1
Systematic Assessment
EG0003 events2 affected70 at risk
EG0015 events2 affected20 at risk
EG0021 events1 affected12 at risk
EG003
Mucosal inflammation
General disorders
MedDRA version: 24.1
Systematic Assessment
EG0007 events5 affected70 at risk
EG0013 events1 affected20 at risk
EG0021 events1 affected12 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA version: 24.1
Systematic Assessment
EG0001 events1 affected70 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected12 at risk
EG003
Oedema peripheral
General disorders
MedDRA version: 24.1
Systematic Assessment
EG0007 events5 affected70 at risk
EG0012 events2 affected20 at risk
EG0020 events0 affected12 at risk
EG003
Pain
General disorders
MedDRA version: 24.1
Systematic Assessment
EG0005 events5 affected70 at risk
EG0011 events1 affected20 at risk
EG0021 events1 affected12 at risk
EG003
Peripheral swelling
General disorders
MedDRA version: 24.1
Systematic Assessment
EG0001 events1 affected70 at risk
EG0012 events2 affected20 at risk
EG0022 events2 affected12 at risk
EG003
Pyrexia
General disorders
MedDRA version: 24.1
Systematic Assessment
EG00026 events17 affected70 at risk
EG0016 events6 affected20 at risk
EG00212 events5 affected12 at risk
EG003
Hypertransaminasaemia
Hepatobiliary disorders
MedDRA version: 24.1
Systematic Assessment
EG0000 events0 affected70 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected12 at risk
EG003
Hypersensitivity
Immune system disorders
MedDRA version: 24.1
Systematic Assessment
EG0000 events0 affected70 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected12 at risk
EG003
Alveolar osteitis
Infections and infestations
MedDRA version: 24.1
Systematic Assessment
EG0000 events0 affected70 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected12 at risk
EG003
Bronchitis
Infections and infestations
MedDRA version: 24.1
Systematic Assessment
EG0003 events3 affected70 at risk
EG0012 events1 affected20 at risk
EG0020 events0 affected12 at risk
EG003
Cellulitis
Infections and infestations
MedDRA version: 24.1
Systematic Assessment
EG0003 events1 affected70 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected12 at risk
EG003
Conjunctivitis
Infections and infestations
MedDRA version: 24.1
Systematic Assessment
EG0002 events2 affected70 at risk
EG0011 events1 affected20 at risk
EG0021 events1 affected12 at risk
EG003
Cystitis
Infections and infestations
MedDRA version: 24.1
Systematic Assessment
EG0001 events1 affected70 at risk
EG0011 events1 affected20 at risk
EG0021 events1 affected12 at risk
EG003
Folliculitis
Infections and infestations
MedDRA version: 24.1
Systematic Assessment
EG0001 events1 affected70 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected12 at risk
EG003
Furuncle
Infections and infestations
MedDRA version: 24.1
Systematic Assessment
EG0000 events0 affected70 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected12 at risk
EG003
Gastroenteritis viral
Infections and infestations
MedDRA version: 24.1
Systematic Assessment
EG0000 events0 affected70 at risk
EG0010 events0 affected20 at risk
EG0021 events1 affected12 at risk
EG003
Genital herpes
Infections and infestations
MedDRA version: 24.1
Systematic Assessment
EG0000 events0 affected70 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected12 at risk
EG003
Herpes virus infection
Infections and infestations
MedDRA version: 24.1
Systematic Assessment
EG0000 events0 affected70 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected12 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA version: 24.1
Systematic Assessment
EG0003 events2 affected70 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected12 at risk
EG003
Hordeolum
Infections and infestations
MedDRA version: 24.1
Systematic Assessment
EG0001 events1 affected70 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected12 at risk
EG003
Influenza
Infections and infestations
MedDRA version: 24.1
Systematic Assessment
EG0002 events2 affected70 at risk
EG0011 events1 affected20 at risk
EG0021 events1 affected12 at risk
EG003
Lower respiratory tract infection
Infections and infestations
MedDRA version: 24.1
Systematic Assessment
EG0005 events5 affected70 at risk
EG0010 events0 affected20 at risk
EG0021 events1 affected12 at risk
EG003
Mastitis
Infections and infestations
MedDRA version: 24.1
Systematic Assessment
EG0000 events0 affected70 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected12 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA version: 24.1
Systematic Assessment
EG0002 events2 affected70 at risk
EG0010 events0 affected20 at risk
EG0021 events1 affected12 at risk
EG003
Oral candidiasis
Infections and infestations
MedDRA version: 24.1
Systematic Assessment
EG0005 events3 affected70 at risk
EG0011 events1 affected20 at risk
EG0021 events1 affected12 at risk
EG003
Paronychia
Infections and infestations
MedDRA version: 24.1
Systematic Assessment
EG0001 events1 affected70 at risk
EG0014 events4 affected20 at risk
EG0021 events1 affected12 at risk
EG003
Pharyngotonsillitis
Infections and infestations
MedDRA version: 24.1
Systematic Assessment
EG0000 events0 affected70 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected12 at risk
EG003
Pneumonia
Infections and infestations
MedDRA version: 24.1
Systematic Assessment
EG0000 events0 affected70 at risk
EG0011 events1 affected20 at risk
EG0021 events1 affected12 at risk
EG003
Rash pustular
Infections and infestations
MedDRA version: 24.1
Systematic Assessment
EG0000 events0 affected70 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected12 at risk
EG003
Respiratory tract infection
Infections and infestations
MedDRA version: 24.1
Systematic Assessment
EG0001 events1 affected70 at risk
EG0012 events2 affected20 at risk
EG0020 events0 affected12 at risk
EG003
Rhinitis
Infections and infestations
MedDRA version: 24.1
Systematic Assessment
EG0001 events1 affected70 at risk
EG0012 events2 affected20 at risk
EG0021 events1 affected12 at risk
EG003
Sinusitis
Infections and infestations
MedDRA version: 24.1
Systematic Assessment
EG0002 events2 affected70 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected12 at risk
EG003
Tonsillitis
Infections and infestations
MedDRA version: 24.1
Systematic Assessment
EG0000 events0 affected70 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected12 at risk
EG003
Tooth infection
Infections and infestations
MedDRA version: 24.1
Systematic Assessment
EG0001 events1 affected70 at risk
EG0011 events1 affected20 at risk
EG0023 events2 affected12 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA version: 24.1
Systematic Assessment
EG0009 events7 affected70 at risk
EG0012 events1 affected20 at risk
EG0020 events0 affected12 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA version: 24.1
Systematic Assessment
EG0009 events8 affected70 at risk
EG0010 events0 affected20 at risk
EG0023 events3 affected12 at risk
EG003
Urinary tract infection bacterial
Infections and infestations
MedDRA version: 24.1
Systematic Assessment
EG0000 events0 affected70 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected12 at risk
EG003
Vascular access site infection
Infections and infestations
MedDRA version: 24.1
Systematic Assessment
EG0000 events0 affected70 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected12 at risk
EG003
Viral upper respiratory tract infection
Infections and infestations
MedDRA version: 24.1
Systematic Assessment
EG0002 events2 affected70 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected12 at risk
EG003
Abdominal injury
Injury, poisoning and procedural complications
MedDRA version: 24.1
Systematic Assessment
EG0000 events0 affected70 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected12 at risk
EG003
Accidental overdose
Injury, poisoning and procedural complications
MedDRA version: 24.1
Systematic Assessment
EG0002 events2 affected70 at risk
EG0010 events0 affected20 at risk
EG0022 events2 affected12 at risk
EG003
Ankle fracture
Injury, poisoning and procedural complications
MedDRA version: 24.1
Systematic Assessment
EG0000 events0 affected70 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected12 at risk
EG003
Hand fracture
Injury, poisoning and procedural complications
MedDRA version: 24.1
Systematic Assessment
EG0000 events0 affected70 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected12 at risk
EG003
Infusion related reaction
Injury, poisoning and procedural complications
MedDRA version: 24.1
Systematic Assessment
EG00015 events10 affected70 at risk
EG0010 events0 affected20 at risk
EG0021 events1 affected12 at risk
EG003
Procedural pain
Injury, poisoning and procedural complications
MedDRA version: 24.1
Systematic Assessment
EG0002 events2 affected70 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected12 at risk
EG003
Vascular access site pain
Injury, poisoning and procedural complications
MedDRA version: 24.1
Systematic Assessment
EG0000 events0 affected70 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected12 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA version: 24.1
Systematic Assessment
EG00022 events14 affected70 at risk
EG0012 events2 affected20 at risk
EG0024 events1 affected12 at risk
EG003
Amylase increased
Investigations
MedDRA version: 24.1
Systematic Assessment
EG0004 events4 affected70 at risk
EG0011 events1 affected20 at risk
EG0021 events1 affected12 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA version: 24.1
Systematic Assessment
EG00013 events9 affected70 at risk
EG0011 events1 affected20 at risk
EG0027 events2 affected12 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA version: 24.1
Systematic Assessment
EG0003 events3 affected70 at risk
EG0010 events0 affected20 at risk
EG0021 events1 affected12 at risk
EG003
Blood creatinine increased
Investigations
MedDRA version: 24.1
Systematic Assessment
EG0003 events2 affected70 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected12 at risk
EG003
Blood thyroid stimulating hormone increased
Investigations
MedDRA version: 24.1
Systematic Assessment
EG0001 events1 affected70 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected12 at risk
EG003
Gamma-glutamyltransferase increased
Investigations
MedDRA version: 24.1
Systematic Assessment
EG0003 events3 affected70 at risk
EG0010 events0 affected20 at risk
EG0021 events1 affected12 at risk
EG003
Lipase increased
Investigations
MedDRA version: 24.1
Systematic Assessment
EG0005 events3 affected70 at risk
EG0012 events1 affected20 at risk
EG0023 events2 affected12 at risk
EG003
Lymphocyte count decreased
Investigations
MedDRA version: 24.1
Systematic Assessment
EG0000 events0 affected70 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected12 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA version: 24.1
Systematic Assessment
EG0005 events3 affected70 at risk
EG0014 events2 affected20 at risk
EG0020 events0 affected12 at risk
EG003
Platelet count decreased
Investigations
MedDRA version: 24.1
Systematic Assessment
EG0000 events0 affected70 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected12 at risk
EG003
Transaminases increased
Investigations
MedDRA version: 24.1
Systematic Assessment
EG0002 events2 affected70 at risk
EG0010 events0 affected20 at risk
EG0021 events1 affected12 at risk
EG003
Weight decreased
Investigations
MedDRA version: 24.1
Systematic Assessment
EG0005 events5 affected70 at risk
EG0011 events1 affected20 at risk
EG0022 events2 affected12 at risk
EG003
Weight increased
Investigations
MedDRA version: 24.1
Systematic Assessment
EG0000 events0 affected70 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected12 at risk
EG003
White blood cell count decreased
Investigations
MedDRA version: 24.1
Systematic Assessment
EG0003 events2 affected70 at risk
EG0013 events2 affected20 at risk
EG0020 events0 affected12 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA version: 24.1
Systematic Assessment
EG00017 events14 affected70 at risk
EG0014 events3 affected20 at risk
EG0021 events1 affected12 at risk
EG003
Food intolerance
Metabolism and nutrition disorders
MedDRA version: 24.1
Systematic Assessment
EG0000 events0 affected70 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected12 at risk
EG003
Hypercholesterolaemia
Metabolism and nutrition disorders
MedDRA version: 24.1
Systematic Assessment
EG0003 events3 affected70 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected12 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA version: 24.1
Systematic Assessment
EG0006 events6 affected70 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected12 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA version: 24.1
Systematic Assessment
EG0000 events0 affected70 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected12 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
MedDRA version: 24.1
Systematic Assessment
EG0002 events2 affected70 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected12 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA version: 24.1
Systematic Assessment
EG0008 events3 affected70 at risk
EG0012 events2 affected20 at risk
EG0020 events0 affected12 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA version: 24.1
Systematic Assessment
EG0001 events1 affected70 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected12 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
MedDRA version: 24.1
Systematic Assessment
EG0000 events0 affected70 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected12 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA version: 24.1
Systematic Assessment
EG00015 events13 affected70 at risk
EG0015 events2 affected20 at risk
EG0024 events4 affected12 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA version: 24.1
Systematic Assessment
EG00014 events11 affected70 at risk
EG0015 events4 affected20 at risk
EG0024 events3 affected12 at risk
EG003
Limb discomfort
Musculoskeletal and connective tissue disorders
MedDRA version: 24.1
Systematic Assessment
EG0000 events0 affected70 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected12 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA version: 24.1
Systematic Assessment
EG0005 events3 affected70 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected12 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA version: 24.1
Systematic Assessment
EG0009 events8 affected70 at risk
EG0011 events1 affected20 at risk
EG0023 events2 affected12 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA version: 24.1
Systematic Assessment
EG0003 events3 affected70 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected12 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA version: 24.1
Systematic Assessment
EG0009 events7 affected70 at risk
EG0011 events1 affected20 at risk
EG0023 events2 affected12 at risk
EG003
Rotator cuff syndrome
Musculoskeletal and connective tissue disorders
MedDRA version: 24.1
Systematic Assessment
EG0000 events0 affected70 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected12 at risk
EG003
Sacral pain
Musculoskeletal and connective tissue disorders
MedDRA version: 24.1
Systematic Assessment
EG0000 events0 affected70 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected12 at risk
EG003
Spinal pain
Musculoskeletal and connective tissue disorders
MedDRA version: 24.1
Systematic Assessment
EG0000 events0 affected70 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected12 at risk
EG003
Tumour ulceration
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version: 24.1
Systematic Assessment
EG0000 events0 affected70 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected12 at risk
EG003
Amnesia
Nervous system disorders
MedDRA version: 24.1
Systematic Assessment
EG0000 events0 affected70 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected12 at risk
EG003
Dizziness
Nervous system disorders
MedDRA version: 24.1
Systematic Assessment
EG0007 events6 affected70 at risk
EG0013 events3 affected20 at risk
EG0020 events0 affected12 at risk
EG003
Dysaesthesia
Nervous system disorders
MedDRA version: 24.1
Systematic Assessment
EG0001 events1 affected70 at risk
EG0010 events0 affected20 at risk
EG0022 events2 affected12 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA version: 24.1
Systematic Assessment
EG0009 events8 affected70 at risk
EG0012 events2 affected20 at risk
EG0022 events1 affected12 at risk
EG003
Headache
Nervous system disorders
MedDRA version: 24.1
Systematic Assessment
EG00029 events19 affected70 at risk
EG0014 events4 affected20 at risk
EG0022 events2 affected12 at risk
EG003
Hypoaesthesia
Nervous system disorders
MedDRA version: 24.1
Systematic Assessment
EG0000 events0 affected70 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected12 at risk
EG003
Neuralgia
Nervous system disorders
MedDRA version: 24.1
Systematic Assessment
EG0001 events1 affected70 at risk
EG0010 events0 affected20 at risk
EG0021 events1 affected12 at risk
EG003
Neuropathy peripheral
Nervous system disorders
MedDRA version: 24.1
Systematic Assessment
EG00024 events20 affected70 at risk
EG00111 events9 affected20 at risk
EG0028 events7 affected12 at risk
EG003
Neurotoxicity
Nervous system disorders
MedDRA version: 24.1
Systematic Assessment
EG0003 events3 affected70 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected12 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA version: 24.1
Systematic Assessment
EG0009 events9 affected70 at risk
EG0010 events0 affected20 at risk
EG0021 events1 affected12 at risk
EG003
Peripheral sensory neuropathy
Nervous system disorders
MedDRA version: 24.1
Systematic Assessment
EG0007 events7 affected70 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected12 at risk
EG003
Presyncope
Nervous system disorders
MedDRA version: 24.1
Systematic Assessment
EG0001 events1 affected70 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected12 at risk
EG003
Sciatica
Nervous system disorders
MedDRA version: 24.1
Systematic Assessment
EG0000 events0 affected70 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected12 at risk
EG003
Sensory disturbance
Nervous system disorders
MedDRA version: 24.1
Systematic Assessment
EG0000 events0 affected70 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected12 at risk
EG003
Syncope
Nervous system disorders
MedDRA version: 24.1
Systematic Assessment
EG0001 events1 affected70 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected12 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA version: 24.1
Systematic Assessment
EG0004 events3 affected70 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected12 at risk
EG003
Depressed mood
Psychiatric disorders
MedDRA version: 24.1
Systematic Assessment
EG0000 events0 affected70 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected12 at risk
EG003
Euphoric mood
Psychiatric disorders
MedDRA version: 24.1
Systematic Assessment
EG0000 events0 affected70 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected12 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA version: 24.1
Systematic Assessment
EG0006 events5 affected70 at risk
EG0012 events2 affected20 at risk
EG0020 events0 affected12 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA version: 24.1
Systematic Assessment
EG0002 events1 affected70 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected12 at risk
EG003
Dysuria
Renal and urinary disorders
MedDRA version: 24.1
Systematic Assessment
EG0003 events3 affected70 at risk
EG0012 events2 affected20 at risk
EG0022 events2 affected12 at risk
EG003
Renal failure
Renal and urinary disorders
MedDRA version: 24.1
Systematic Assessment
EG0000 events0 affected70 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected12 at risk
EG003
Breast pain
Reproductive system and breast disorders
MedDRA version: 24.1
Systematic Assessment
EG0000 events0 affected70 at risk
EG0010 events0 affected20 at risk
EG0021 events1 affected12 at risk
EG003
Vulvovaginal inflammation
Reproductive system and breast disorders
MedDRA version: 24.1
Systematic Assessment
EG0000 events0 affected70 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected12 at risk
EG003
Asthmatic crisis
Respiratory, thoracic and mediastinal disorders
MedDRA version: 24.1
Systematic Assessment
EG0000 events0 affected70 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected12 at risk
EG003
Bronchospasm
Respiratory, thoracic and mediastinal disorders
MedDRA version: 24.1
Systematic Assessment
EG0000 events0 affected70 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected12 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA version: 24.1
Systematic Assessment
EG00015 events13 affected70 at risk
EG0014 events3 affected20 at risk
EG0023 events2 affected12 at risk
EG003
Dysphonia
Respiratory, thoracic and mediastinal disorders
MedDRA version: 24.1
Systematic Assessment
EG0002 events2 affected70 at risk
EG0012 events2 affected20 at risk
EG0021 events1 affected12 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA version: 24.1
Systematic Assessment
EG00011 events10 affected70 at risk
EG0012 events2 affected20 at risk
EG0021 events1 affected12 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA version: 24.1
Systematic Assessment
EG0006 events6 affected70 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected12 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA version: 24.1
Systematic Assessment
EG0000 events0 affected70 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected12 at risk
EG003
Rhinitis allergic
Respiratory, thoracic and mediastinal disorders
MedDRA version: 24.1
Systematic Assessment
EG0002 events2 affected70 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected12 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA version: 24.1
Systematic Assessment
EG0002 events1 affected70 at risk
EG0013 events3 affected20 at risk
EG0020 events0 affected12 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA version: 24.1
Systematic Assessment
EG00027 events26 affected70 at risk
EG00113 events11 affected20 at risk
EG0026 events6 affected12 at risk
EG003
Dermatitis acneiform
Skin and subcutaneous tissue disorders
MedDRA version: 24.1
Systematic Assessment
EG0007 events5 affected70 at risk
EG0012 events2 affected20 at risk
EG0021 events1 affected12 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA version: 24.1
Systematic Assessment
EG0007 events6 affected70 at risk
EG0012 events2 affected20 at risk
EG0021 events1 affected12 at risk
EG003
Eczema
Skin and subcutaneous tissue disorders
MedDRA version: 24.1
Systematic Assessment
EG0001 events1 affected70 at risk
EG0012 events2 affected20 at risk
EG0020 events0 affected12 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA version: 24.1
Systematic Assessment
EG0001 events1 affected70 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected12 at risk
EG003
Intertrigo
Skin and subcutaneous tissue disorders
MedDRA version: 24.1
Systematic Assessment
EG0001 events1 affected70 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected12 at risk
EG003
Nail discolouration
Skin and subcutaneous tissue disorders
MedDRA version: 24.1
Systematic Assessment
EG0001 events1 affected70 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected12 at risk
EG003
Nail disorder
Skin and subcutaneous tissue disorders
MedDRA version: 24.1
Systematic Assessment
EG0000 events0 affected70 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected12 at risk
EG003
Nail dystrophy
Skin and subcutaneous tissue disorders
MedDRA version: 24.1
Systematic Assessment
EG0002 events2 affected70 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected12 at risk
EG003
Onychalgia
Skin and subcutaneous tissue disorders
MedDRA version: 24.1
Systematic Assessment
EG0002 events2 affected70 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected12 at risk
EG003
Onycholysis
Skin and subcutaneous tissue disorders
MedDRA version: 24.1
Systematic Assessment
EG0005 events5 affected70 at risk
EG0011 events1 affected20 at risk
EG0022 events2 affected12 at risk
EG003
Palmar-plantar erythrodysaesthesia syndrome
Skin and subcutaneous tissue disorders
MedDRA version: 24.1
Systematic Assessment
EG0000 events0 affected70 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected12 at risk
EG003
Papule
Skin and subcutaneous tissue disorders
MedDRA version: 24.1
Systematic Assessment
EG0000 events0 affected70 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected12 at risk
EG003
Prurigo
Skin and subcutaneous tissue disorders
MedDRA version: 24.1
Systematic Assessment
EG0000 events0 affected70 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected12 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA version: 24.1
Systematic Assessment
EG00015 events11 affected70 at risk
EG0014 events4 affected20 at risk
EG0024 events3 affected12 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA version: 24.1
Systematic Assessment
EG00039 events25 affected70 at risk
EG00111 events8 affected20 at risk
EG00214 events3 affected12 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA version: 24.1
Systematic Assessment
EG00010 events7 affected70 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected12 at risk
EG003
Rash papular
Skin and subcutaneous tissue disorders
MedDRA version: 24.1
Systematic Assessment
EG0001 events1 affected70 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected12 at risk
EG003
Rash pruritic
Skin and subcutaneous tissue disorders
MedDRA version: 24.1
Systematic Assessment
EG0002 events2 affected70 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected12 at risk
EG003
Seborrhoeic dermatitis
Skin and subcutaneous tissue disorders
MedDRA version: 24.1
Systematic Assessment
EG0000 events0 affected70 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected12 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA version: 24.1
Systematic Assessment
EG0002 events2 affected70 at risk
EG0012 events2 affected20 at risk
EG0021 events1 affected12 at risk
EG003
Hot flush
Vascular disorders
MedDRA version: 24.1
Systematic Assessment
EG0004 events4 affected70 at risk
EG0013 events3 affected20 at risk
EG0022 events1 affected12 at risk
EG003
Hypertension
Vascular disorders
MedDRA version: 24.1
Systematic Assessment
EG0006 events6 affected70 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected12 at risk
EG003
Lymphoedema
Vascular disorders
MedDRA version: 24.1
Systematic Assessment
EG0005 events5 affected70 at risk
EG0010 events0 affected20 at risk
EG0022 events2 affected12 at risk
EG003
Raynaud's phenomenon
Vascular disorders
MedDRA version: 24.1
Systematic Assessment
EG0000 events0 affected70 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected12 at risk
EG003
Venous thrombosis
Vascular disorders
MedDRA version: 24.1
Systematic Assessment
EG0000 events0 affected70 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected12 at risk
EG003
Leukocytosis
Blood and lymphatic system disorders
MedDRA version: 24.1
Systematic Assessment
EG0000 events0 affected70 at risk
EG0010 events0 affected20 at risk
EG0021 events1 affected12 at risk
EG003
Blepharitis
Eye disorders
MedDRA version: 24.1
Systematic Assessment
EG0001 events1 affected70 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected12 at risk
EG003
Ocular discomfort
Eye disorders
MedDRA version: 24.1
Systematic Assessment
EG0000 events0 affected70 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected12 at risk
EG003
Papilloedema
Eye disorders
MedDRA version: 24.1
Systematic Assessment
EG0000 events0 affected70 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected12 at risk
EG003
Vision blurred
Eye disorders
MedDRA version: 24.1
Systematic Assessment
EG0004 events3 affected70 at risk
EG0010 events0 affected20 at risk
EG0021 events1 affected12 at risk
EG003
Abdominal discomfort
Gastrointestinal disorders
MedDRA version: 24.1
Systematic Assessment
EG0000 events0 affected70 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected12 at risk
EG003
Anal fistula
Gastrointestinal disorders
MedDRA version: 24.1
Systematic Assessment
EG0000 events0 affected70 at risk
EG0010 events0 affected20 at risk
EG0021 events1 affected12 at risk
EG003
Proctitis
Gastrointestinal disorders
MedDRA version: 24.1
Systematic Assessment
EG0000 events0 affected70 at risk
EG0010 events0 affected20 at risk
EG0021 events1 affected12 at risk
EG003
Swelling
General disorders
MedDRA version: 24.1
Systematic Assessment
EG0000 events0 affected70 at risk
EG0010 events0 affected20 at risk
EG0021 events1 affected12 at risk
EG003
COVID-19
Infections and infestations
MedDRA version: 24.1
Systematic Assessment
EG0002 events2 affected70 at risk
EG0010 events0 affected20 at risk
EG0021 events1 affected12 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA version: 24.1
Systematic Assessment
EG0004 events3 affected70 at risk
EG0010 events0 affected20 at risk
EG0021 events1 affected12 at risk
EG003
Gingivitis
Infections and infestations
MedDRA version: 24.1
Systematic Assessment
EG0000 events0 affected70 at risk
EG0010 events0 affected20 at risk
EG0021 events1 affected12 at risk
EG003
Impetigo
Infections and infestations
MedDRA version: 24.1
Systematic Assessment
EG0000 events0 affected70 at risk
EG0010 events0 affected20 at risk
EG0021 events1 affected12 at risk
EG003
Onychomycosis
Infections and infestations
MedDRA version: 24.1
Systematic Assessment
EG0001 events1 affected70 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected12 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA version: 24.1
Systematic Assessment
EG0001 events1 affected70 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected12 at risk
EG003
Respiratory tract infection viral
Infections and infestations
MedDRA version: 24.1
Systematic Assessment
EG0000 events0 affected70 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected12 at risk
EG003
Viral infection
Infections and infestations
MedDRA version: 24.1
Systematic Assessment
EG0002 events2 affected70 at risk
EG0010 events0 affected20 at risk
EG0021 events1 affected12 at risk
EG003
Vulvovaginal candidiasis
Infections and infestations
MedDRA version: 24.1
Systematic Assessment
EG0001 events1 affected70 at risk
EG0010 events0 affected20 at risk
EG0021 events1 affected12 at risk
EG003
Vulvovaginal mycotic infection
Infections and infestations
MedDRA version: 24.1
Systematic Assessment
EG0000 events0 affected70 at risk
EG0010 events0 affected20 at risk
EG0021 events1 affected12 at risk
EG003
Wound infection
Infections and infestations
MedDRA version: 24.1
Systematic Assessment
EG0001 events1 affected70 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected12 at risk
EG003
Animal bite
Injury, poisoning and procedural complications
MedDRA version: 24.1
Systematic Assessment
EG0000 events0 affected70 at risk
EG0010 events0 affected20 at risk
EG0021 events1 affected12 at risk
EG003
Animal scratch
Injury, poisoning and procedural complications
MedDRA version: 24.1
Systematic Assessment
EG0000 events0 affected70 at risk
EG0010 events0 affected20 at risk
EG0021 events1 affected12 at risk
EG003
Seroma
Injury, poisoning and procedural complications
MedDRA version: 24.1
Systematic Assessment
EG0002 events1 affected70 at risk
EG0010 events0 affected20 at risk
EG0021 events1 affected12 at risk
EG003
Blood cholesterol increased
Investigations
MedDRA version: 24.1
Systematic Assessment
EG0002 events2 affected70 at risk
EG0010 events0 affected20 at risk
EG0021 events1 affected12 at risk
EG003
Blood creatinine decreased
Investigations
MedDRA version: 24.1
Systematic Assessment
EG0000 events0 affected70 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected12 at risk
EG003
Blood triglycerides increased
Investigations
MedDRA version: 24.1
Systematic Assessment
EG0000 events0 affected70 at risk
EG0010 events0 affected20 at risk
EG0021 events1 affected12 at risk
EG003
Cortisol decreased
Investigations
MedDRA version: 24.1
Systematic Assessment
EG0000 events0 affected70 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected12 at risk
EG003
Haemoglobin decreased
Investigations
MedDRA version: 24.1
Systematic Assessment
EG0000 events0 affected70 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected12 at risk
EG003
Hypertriglyceridaemia
Metabolism and nutrition disorders
MedDRA version: 24.1
Systematic Assessment
EG0002 events2 affected70 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected12 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA version: 24.1
Systematic Assessment
EG0003 events3 affected70 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected12 at risk
EG003
Flank pain
Musculoskeletal and connective tissue disorders
MedDRA version: 24.1
Systematic Assessment
EG0000 events0 affected70 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected12 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA version: 24.1
Systematic Assessment
EG0001 events1 affected70 at risk
EG0010 events0 affected20 at risk
EG0021 events1 affected12 at risk
EG003
Dysarthria
Nervous system disorders
MedDRA version: 24.1
Systematic Assessment
EG0000 events0 affected70 at risk
EG0010 events0 affected20 at risk
EG0021 events1 affected12 at risk
EG003
Memory impairment
Nervous system disorders
MedDRA version: 24.1
Systematic Assessment
EG0000 events0 affected70 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected12 at risk
EG003
Retinal migraine
Nervous system disorders
MedDRA version: 24.1
Systematic Assessment
EG0000 events0 affected70 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected12 at risk
EG003
Depression
Psychiatric disorders
MedDRA version: 24.1
Systematic Assessment
EG0002 events2 affected70 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected12 at risk
EG003
Urinary incontinence
Renal and urinary disorders
MedDRA version: 24.1
Systematic Assessment
EG0001 events1 affected70 at risk
EG0010 events0 affected20 at risk
EG0021 events1 affected12 at risk
EG003
Vaginal haemorrhage
Reproductive system and breast disorders
MedDRA version: 24.1
Systematic Assessment
EG0000 events0 affected70 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected12 at risk
EG003
Vulvovaginal burning sensation
Reproductive system and breast disorders
MedDRA version: 24.1
Systematic Assessment
EG0000 events0 affected70 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected12 at risk
EG003
Haemoptysis
Respiratory, thoracic and mediastinal disorders
MedDRA version: 24.1
Systematic Assessment
EG0000 events0 affected70 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected12 at risk
EG003
Lung opacity
Respiratory, thoracic and mediastinal disorders
MedDRA version: 24.1
Systematic Assessment
EG0000 events0 affected70 at risk
EG0010 events0 affected20 at risk
EG0021 events1 affected12 at risk
EG003
Sinus pain
Respiratory, thoracic and mediastinal disorders
MedDRA version: 24.1
Systematic Assessment
EG0000 events0 affected70 at risk
EG0010 events0 affected20 at risk
EG0021 events1 affected12 at risk
EG003
Stridor
Respiratory, thoracic and mediastinal disorders
MedDRA version: 24.1
Systematic Assessment
EG0000 events0 affected70 at risk
EG0010 events0 affected20 at risk
EG0021 events1 affected12 at risk
EG003
Dermatitis allergic
Skin and subcutaneous tissue disorders
MedDRA version: 24.1
Systematic Assessment
EG0000 events0 affected70 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected12 at risk
EG003
Erythema annulare
Skin and subcutaneous tissue disorders
MedDRA version: 24.1
Systematic Assessment
EG0000 events0 affected70 at risk
EG0010 events0 affected20 at risk
EG0021 events1 affected12 at risk
EG003
Perioral dermatitis
Skin and subcutaneous tissue disorders
MedDRA version: 24.1
Systematic Assessment
EG0000 events0 affected70 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected12 at risk
EG003
Rash macular
Skin and subcutaneous tissue disorders
MedDRA version: 24.1
Systematic Assessment
EG0000 events0 affected70 at risk
EG0010 events0 affected20 at risk
EG0021 events1 affected12 at risk
EG003
Skin exfoliation
Skin and subcutaneous tissue disorders
MedDRA version: 24.1
Systematic Assessment
EG0001 events1 affected70 at risk
EG0010 events0 affected20 at risk
EG0021 events1 affected12 at risk
EG003
Flushing
Vascular disorders
MedDRA version: 24.1
Systematic Assessment
EG0003 events3 affected70 at risk
EG0010 events0 affected20 at risk
EG0021 events1 affected12 at risk
EG003
Thrombosis
Vascular disorders
MedDRA version: 24.1
Systematic Assessment
EG0000 events0 affected70 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected12 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
Participants with locally advanced or metastatic TNBC who had not previously received chemotherapy in the advanced setting received 400 mg of Ipat orally, QD on Days 1-21, 840 mg IV of Atezo on Days 1 and 15, and 100 mg/m^2 IV nab-paclitaxel (Nab-Pac) on Days 1, 8, and 15 of each 28-day cycle. Following completion of a safety run-in cohort (B1), a subsequent expansion arm enrolled (B2). All participants in Arm B continued to receive treatment until loss of clinical benefit, unacceptable toxicity, withdrawal of consent, or end of the study.
OG002
Cohort 1-Arm C
Participants with locally advanced or metastatic TNBC who had not previously received chemotherapy in the advanced setting received 400 mg of Ipat orally, QD on Days 1-21, 80 mg/m2 IV Pac on Days 1, 8, and 15 and 840 mg IV Atezo on Day 15 of Cycle 1 (28 day cycle). In Cycles ≥ 2, participants received 400 mg Ipat orally on Days 1-21, 840 mg IV Atezo on Days 1 and 15 and 80 mg/m2 IV Pac on Days 1, 8, and 15 of each 28-day Cycle. Following completion of the safety run-in cohort (C1), a subsequent expansion cohort (C2) enrolled. All participants in Arm C continued to receive treatment until loss of clinical benefit, unacceptable toxicity, withdrawal of consent, or end of the study.
OG003
Cohort 1-Arm D
Participants with locally advanced or metastatic TNBC who had not previously received chemotherapy in the advanced setting received 840 mg IV Atezo on Days 1 and 15, 80 mg/m2 IV Pac on Days 1, 8, and 15 and 400 mg Ipat orally on days 15-21 of Cycle 1 (28 day cycle). In Cycles ≥ 2, participants received 400 mg Ipat orally on Days 1-21, 80 mg/m2 IV Pac on Days 1, 8, and 15 and 840 mg IV Atezo on Days 1 and 15 of each 28 day Cycle. Following completion of the safety run-in cohort (D1), a subsequent expansion cohort (D2) enrolled. All participants in Arm D continued to receive treatment until loss of clinical benefit, unacceptable toxicity, withdrawal of consent, or end of the study.
Units
Counts
Participants
OG00036
OG00113
OG0028
OG0034
Title
Denominators
Categories
Title
Measurements
OG0007.8(5.6 to 12.9)
OG0017.3(5.0 to 9.2)
OG0029.2(3.9 to 14.7)
OG0034.8(3.7 to NA)The median and upper limit of confidence interval (CI) were not estimable due to less number of participants with events.
OG0006
Title
Denominators
Categories
Title
Measurements
OG00050
OG001
Cohort 1-Arm B
Participants with locally advanced or metastatic TNBC who had not previously received chemotherapy in the advanced setting received 400 mg of Ipat orally, QD on Days 1-21, 840 mg IV of Atezo on Days 1 and 15, and 100 mg/m^2 IV nab-paclitaxel (Nab-Pac) on Days 1, 8, and 15 of each 28-day cycle. Following completion of a safety run-in cohort (B1), a subsequent expansion arm enrolled (B2). All participants in Arm B continued to receive treatment until loss of clinical benefit, unacceptable toxicity, withdrawal of consent, or end of the study.
OG002
Cohort 1-Arm C
Participants with locally advanced or metastatic TNBC who had not previously received chemotherapy in the advanced setting received 400 mg of Ipat orally, QD on Days 1-21, 80 mg/m2 IV Pac on Days 1, 8, and 15 and 840 mg IV Atezo on Day 15 of Cycle 1 (28 day cycle). In Cycles ≥ 2, participants received 400 mg Ipat orally on Days 1-21, 840 mg IV Atezo on Days 1 and 15 and 80 mg/m2 IV Pac on Days 1, 8, and 15 of each 28-day Cycle. Following completion of the safety run-in cohort (C1), a subsequent expansion cohort (C2) enrolled. All participants in Arm C continued to receive treatment until loss of clinical benefit, unacceptable toxicity, withdrawal of consent, or end of the study.
OG003
Cohort 1-Arm D
Participants with locally advanced or metastatic TNBC who had not previously received chemotherapy in the advanced setting received 840 mg IV Atezo on Days 1 and 15, 80 mg/m2 IV Pac on Days 1, 8, and 15 and 400 mg Ipat orally on days 15-21 of Cycle 1 (28 day cycle). In Cycles ≥ 2, participants received 400 mg Ipat orally on Days 1-21, 80 mg/m2 IV Pac on Days 1, 8, and 15 and 840 mg IV Atezo on Days 1 and 15 of each 28 day Cycle. Following completion of the safety run-in cohort (D1), a subsequent expansion cohort (D2) enrolled. All participants in Arm D continued to receive treatment until loss of clinical benefit, unacceptable toxicity, withdrawal of consent, or end of the study.
OG004
Cohort 2-Arm E
Participants in the second-line and third-line setting with locally advanced or metastatic TNBC received 400 mg Ipat orally QD on Days 1-28 and 840 mg IV Atezo on Days 8 and 22 of Cycle 1 (Cycle 1 = 35 days). In Cycles ≥ 2, participants received 400 mg Ipat orally on Days 1-21 and 840 mg IV Atezo on Days 1 and 15 of each cycle (Cycles ≥ 2 = 28-days) until loss of clinical benefit, unacceptable toxicity, withdrawal of consent, or end of the study.
OG005
Cohort 3-Arm F
Participants in the safety run-in stage (arm F1) with locally advanced T2-4 TNBC received 300 mg Ipat orally QD on Days 1-21, 840mg IV Atezo on Days 1 and 15, 60 mg/m2 IV doxorubicin and 600 mg/m2 IV cyclophosphamide on Days 1 and 15 of Cycles 1 and 2 (1 Cycle=28-days). Participants then received 400 mg Ipat orally QD on Days 1-21, 840mg IV Atezo on Days 1 and 15 and 80 mg/m2 IV Pac on Days 1, 8, 15, and 22 of Cycles 3-5, until completion of 5 cycles or disease progression or unacceptable toxicity, whichever occurred first.
Units
Counts
Participants
OG00070
OG00120
OG00212
OG00312
OG00417
OG0056
Title
Denominators
Categories
Title
Measurements
OG00070
OG00120
OG00212
OG00312
OG00417
OG0056
OG001
Cohort 1-Arm B
Participants with locally advanced or metastatic TNBC who had not previously received chemotherapy in the advanced setting received 400 mg of Ipat orally, QD on Days 1-21, 840 mg IV of Atezo on Days 1 and 15, and 100 mg/m^2 IV nab-paclitaxel (Nab-Pac) on Days 1, 8, and 15 of each 28-day cycle. Following completion of a safety run-in cohort (B1), a subsequent expansion arm enrolled (B2). All participants in Arm B continued to receive treatment until loss of clinical benefit, unacceptable toxicity, withdrawal of consent, or end of the study.
OG002
Cohort 1-Arm C
Participants with locally advanced or metastatic TNBC who had not previously received chemotherapy in the advanced setting received 400 mg of Ipat orally, QD on Days 1-21, 80 mg/m2 IV Pac on Days 1, 8, and 15 and 840 mg IV Atezo on Day 15 of Cycle 1 (28 day cycle). In Cycles ≥ 2, participants received 400 mg Ipat orally on Days 1-21, 840 mg IV Atezo on Days 1 and 15 and 80 mg/m2 IV Pac on Days 1, 8, and 15 of each 28-day Cycle. Following completion of the safety run-in cohort (C1), a subsequent expansion cohort (C2) enrolled. All participants in Arm C continued to receive treatment until loss of clinical benefit, unacceptable toxicity, withdrawal of consent, or end of the study.
OG003
Cohort 1-Arm D
Participants with locally advanced or metastatic TNBC who had not previously received chemotherapy in the advanced setting received 840 mg IV Atezo on Days 1 and 15, 80 mg/m2 IV Pac on Days 1, 8, and 15 and 400 mg Ipat orally on days 15-21 of Cycle 1 (28 day cycle). In Cycles ≥ 2, participants received 400 mg Ipat orally on Days 1-21, 80 mg/m2 IV Pac on Days 1, 8, and 15 and 840 mg IV Atezo on Days 1 and 15 of each 28 day Cycle. Following completion of the safety run-in cohort (D1), a subsequent expansion cohort (D2) enrolled. All participants in Arm D continued to receive treatment until loss of clinical benefit, unacceptable toxicity, withdrawal of consent, or end of the study.
Units
Counts
Participants
OG00070
OG00120
OG00212
OG00312
Title
Denominators
Categories
Title
Measurements
OG0007.2(5.3 to 7.4)
OG0016.6(3.4 to 9.2)
OG0028.8(5.6 to 12.9)
OG0036.5(5.2 to 11.3)
OG002
Cohort 1-Arm C
Participants with locally advanced or metastatic TNBC who had not previously received chemotherapy in the advanced setting received 400 mg of Ipat orally, QD on Days 1-21, 80 mg/m2 IV Pac on Days 1, 8, and 15 and 840 mg IV Atezo on Day 15 of Cycle 1 (28 day cycle). In Cycles ≥ 2, participants received 400 mg Ipat orally on Days 1-21, 840 mg IV Atezo on Days 1 and 15 and 80 mg/m2 IV Pac on Days 1, 8, and 15 of each 28-day Cycle. Following completion of the safety run-in cohort (C1), a subsequent expansion cohort (C2) enrolled. All participants in Arm C continued to receive treatment until loss of clinical benefit, unacceptable toxicity, withdrawal of consent, or end of the study.
OG003
Cohort 1-Arm D
Participants with locally advanced or metastatic TNBC who had not previously received chemotherapy in the advanced setting received 840 mg IV Atezo on Days 1 and 15, 80 mg/m2 IV Pac on Days 1, 8, and 15 and 400 mg Ipat orally on days 15-21 of Cycle 1 (28 day cycle). In Cycles ≥ 2, participants received 400 mg Ipat orally on Days 1-21, 80 mg/m2 IV Pac on Days 1, 8, and 15 and 840 mg IV Atezo on Days 1 and 15 of each 28 day Cycle. Following completion of the safety run-in cohort (D1), a subsequent expansion cohort (D2) enrolled. All participants in Arm D continued to receive treatment until loss of clinical benefit, unacceptable toxicity, withdrawal of consent, or end of the study.
Units
Counts
Participants
OG00070
OG00120
OG00212
OG00312
Title
Denominators
Categories
Title
Measurements
OG00028.3(17.2 to 43.0)
OG00120.1(11.1 to 30.8)
OG002NA(21.2 to NA)The median and upper limit of confidence interval (CI) were not estimable due to less number of participants with events.
OG003NA(11.7 to NA)The median and upper limit of CI were not estimable due to less number of participants with events.
OG002
Cohort1- Arm A3
Participants with locally advanced or metastatic TNBC who had not previously received chemotherapy in the advanced setting received 400 mg of Ipat orally, QD on Days 1-21, 840 mg IV of Atezo on Days 1 and 15, and 80 mg/m^2 IV Pac on Days 1, 8, and 15 of each 28-day cycle in expansion stage A3 until loss of clinical benefit, unacceptable toxicity, withdrawal of consent, or end of the study.
OG003
Cohort 1- Arm B1
Participants with locally advanced or metastatic TNBC who had not previously received chemotherapy in the advanced setting received 400 mg of Ipat orally, QD on Days 1-21, 840 mg IV of Atezo on Days 1 and 15, and 100 mg/m^2 IV Nab-Pac on Days 1, 8, and 15 of each 28-day cycle during the safety run-in stage (B1) until loss of clinical benefit, unacceptable toxicity, withdrawal of consent, or end of the study.
OG004
Cohort 1- Arm B2
Participants with locally advanced or metastatic TNBC who had not previously received chemotherapy in the advanced setting received 400 mg of Ipat orally, QD on Days 1-21, 840 mg IV of Atezo on Days 1 and 15, and 100 mg/m^2 IV Nab-Pac on Days 1, 8, and 15 of each 28-day cycle in the expansion stage B2 until loss of clinical benefit, unacceptable toxicity, withdrawal of consent, or end of the study.
OG005
Cohort 1- Arm C1
Participants with locally advanced or metastatic TNBC who had not previously received chemotherapy in the advanced setting received 400 mg of Ipat orally, QD on Days 1-21, 80 mg/m2 IV Pac on Days 1, 8, and 15 of Cycle 1 and 840 mg IV Atezo on Day 15 of Cycle 1 (1 Cycle=28days). In Cycles ≥ 2, participants received 400 mg Ipat orally on Days 1-21, 840 mg IV Atezo on Days 1 and 15 and 80 mg/m2 IV Pac on Days 1, 8, and 15 of each 28-day cycle during the safety run-in stage (C1) until loss of clinical benefit, unacceptable toxicity, withdrawal of consent, or end of the study.
OG006
Cohort 1- Arm C2
Participants with locally advanced or metastatic TNBC who had not previously received chemotherapy in the advanced setting received 400 mg of Ipat orally, QD on Days 1-21, 80 mg/m2 IV Pac on Days 1, 8, and 15 of Cycle 1 and 840 mg IV Atezo on Day 15 of Cycle 1 (1Cycle=28days). In Cycles ≥ 2, participants received 400 mg Ipat orally on Days 1-21, 840 mg IV Atezo on Days 1 and 15 and 80 mg/m2 IV Pac on Days 1, 8, and 15 of each 28-day cycle in the expansion stage C2 until loss of clinical benefit, unacceptable toxicity, withdrawal of consent, or end of the study.
OG007
Cohort 1- Arm D1
Participants with locally advanced or metastatic TNBC received 840 mg IV Atezo on Days 1 and 15, 80 mg/m2 IV Pac on Days 1, 8, and 15 and 400 mg Ipat orally on days 15-21 of Cycle 1. In Cycles ≥ 2, participants received 400 mg Ipat orally on Days 1-21, 80 mg/m2 IV Pac on Days 1, 8, and 15 and 840 mg IV Atezo on Days 1 and 15 of each 28-day Cycle during the safety run-in stage (D1) until loss of clinical benefit, unacceptable toxicity, withdrawal of consent, or end of the study.
OG008
Cohort 1- Arm D2
Participants with locally advanced or metastatic TNBC received 840 mg IV Atezo on Days 1 and 15, 80 mg/m2 IV Pac on Days 1, 8, and 15 and 400 mg Ipat on days 15-21 of cycle 1. In Cycles ≥ 2, participants received 400 mg Ipat orally on Days 1-21, 80 mg/m2 IV Pac on Days 1, 8, and 15 and 840 mg IV Atezo on days 1 and 15 of each 28-day cycle in the expansion stage D2 until loss of clinical benefit, unacceptable toxicity, withdrawal of consent, or end of the study.
Units
Counts
Participants
OG0006
OG00114
OG00250
OG0036
OG00414
OG0056
OG0066
OG0076
OG0086
Title
Denominators
Categories
Cycle 1 Day 15 Pre-dose
ParticipantsOG0005
ParticipantsOG00111
ParticipantsOG00226
ParticipantsOG0035
ParticipantsOG00411
ParticipantsOG0054
ParticipantsOG0066
ParticipantsOG0070
ParticipantsOG0080
Title
Measurements
OG00047.9± 47.2
OG00113.6± 783.4
OG00229.4± 163.1
OG003
Cycle 1 Day 15 1 hour Post-dose
ParticipantsOG0005
ParticipantsOG00110
ParticipantsOG00225
ParticipantsOG0035
Cycle 1 Day 15 2 hour Post-dose
ParticipantsOG0005
ParticipantsOG00110
ParticipantsOG00233
ParticipantsOG0035
Cycle 1 Day 15 4 hour Post-dose
ParticipantsOG0003
ParticipantsOG00110
ParticipantsOG00233
ParticipantsOG0035
Cycle 1 Day 15 6 hour Post-dose
ParticipantsOG0000
ParticipantsOG0019
ParticipantsOG00233
ParticipantsOG0035
Cycle 2 Day 15 Pre-dose
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Cycle 2 Day 15 1 hour Post-dose
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Cycle 2 Day 15 2 hour Post-dose
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Cycle 2 Day 15 4 hour Post-dose
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Cycle 2 Day 15 6 hour Post-dose
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Cycle 3 Day 15 1 to 3 hour Post-dose
ParticipantsOG0000
ParticipantsOG00111
ParticipantsOG00226
ParticipantsOG0034
OG002
Cohort 1-Arm A3
Participants with locally advanced or metastatic TNBC who had not previously received chemotherapy in the advanced setting received 400 mg of Ipat orally, QD on Days 1-21, 840 mg IV of Atezo on Days 1 and 15, and 80 mg/m^2 IV Pac on Days 1, 8, and 15 of each 28-day cycle in expansion stage A3 until loss of clinical benefit, unacceptable toxicity, withdrawal of consent, or end of the study.
OG003
Cohort 1- Arm B1
Participants with locally advanced or metastatic TNBC who had not previously received chemotherapy in the advanced setting received 400 mg of Ipat orally, QD on Days 1-21, 840 mg IV of Atezo on Days 1 and 15, and 100 mg/m^2 IV Nab-Pac on Days 1, 8, and 15 of each 28-day cycle during the safety run-in stage (B1) until loss of clinical benefit, unacceptable toxicity, withdrawal of consent, or end of the study.
OG004
Cohort 1- Arm B2
Participants with locally advanced or metastatic TNBC who had not previously received chemotherapy in the advanced setting received 400 mg of Ipat orally, QD on Days 1-21, 840 mg IV of Atezo on Days 1 and 15, and 100 mg/m^2 IV Nab-Pac on Days 1, 8, and 15 of each 28-day cycle in the expansion stage B2 until loss of clinical benefit, unacceptable toxicity, withdrawal of consent, or end of the study.
OG005
Cohort 1- Arm C1
Participants with locally advanced or metastatic TNBC who had not previously received chemotherapy in the advanced setting received 400 mg of Ipat orally, QD on Days 1-21, 80 mg/m2 IV Pac on Days 1, 8, and 15 of Cycle 1 and 840 mg IV Atezo on Day 15 of Cycle 1 (1Cycle=28days). In Cycles ≥ 2, participants received 400 mg Ipat orally on Days 1-21, 840 mg IV Atezo on Days 1 and 15 and 80 mg/m2 IV Pac on Days 1, 8, and 15 of each 28-day Cycle during the safety run-in stage (C1) until loss of clinical benefit, unacceptable toxicity, withdrawal of consent, or end of the study.
OG006
Cohort 1- Arm C2
Participants with locally advanced or metastatic TNBC who had not previously received chemotherapy in the advanced setting received 400 mg of Ipat orally, QD on Days 1-21, 80 mg/m2 IV Pac on Days 1, 8, and 15 of Cycle 1 and 840 mg IV Atezo on Day 15 of Cycle 1 (1Cycle=28days). In Cycles ≥ 2, participants received 400 mg Ipat orally on Days 1-21, 840 mg IV Atezo on Days 1 and 15 and 80 mg/m2 IV Pac on Days 1, 8, and 15 of each 28-day Cycle in the expansion stage C2 until loss of clinical benefit, unacceptable toxicity, withdrawal of consent, or end of the study.
OG007
Cohort 1- Arm D1
Participants with locally advanced or metastatic TNBC received 840 mg IV Atezo on Days 1 and 15, 80 mg/m2 IV Pac on Days 1, 8, and 15 and 400 mg Ipat orally on days 15-21 of Cycle 1. In Cycles ≥ 2, participants received 400 mg Ipat orally on Days 1-21, 80 mg/m2 IV Pac on Days 1, 8, and 15 and 840 mg IV Atezo on Days 1 and 15 of each 28-day Cycle during the safety run-in stage (D1) until loss of clinical benefit, unacceptable toxicity, withdrawal of consent, or end of the study.
OG008
Cohort 1- Arm D2
Participants with locally advanced or metastatic TNBC received 840 mg IV Atezo on Days 1 and 15, 80 mg/m2 IV Pac on Days 1, 8, and 15 and 400 mg Ipat orally on days 15-21 of Cycle 1. In Cycles ≥ 2, participants received 400 mg Ipat orally on Days 1-21, 80 mg/m2 IV Pac on Days 1, 8, and 15 and 840 mg IV Atezo on Days 1 and 15 of each 28-day Cycle in the expansion stage D2 until loss of clinical benefit, unacceptable toxicity, withdrawal of consent, or end of the study.
Units
Counts
Participants
OG0006
OG00114
OG00250
OG0036
OG00414
OG0056
OG0066
OG0076
OG0086
Title
Denominators
Categories
Cycle 1 Day 15 Pre-dose
ParticipantsOG0005
ParticipantsOG00111
ParticipantsOG00227
ParticipantsOG0035
ParticipantsOG00411
ParticipantsOG0054
ParticipantsOG0066
ParticipantsOG0070
ParticipantsOG0080
Title
Measurements
OG00027.0± 32.4
OG0018.27± 404.3
OG00215.0± 165.9
OG003
Cycle 1 Day 15 1 hour Post-dose
ParticipantsOG0005
ParticipantsOG00110
ParticipantsOG00225
ParticipantsOG0035
Cycle 1 Day 15 2 hour Post-dose
ParticipantsOG0005
ParticipantsOG00110
ParticipantsOG00233
ParticipantsOG0035
Cycle 1 Day 15 4 hour Post-dose
ParticipantsOG0003
ParticipantsOG00110
ParticipantsOG00233
ParticipantsOG0035
Cycle 1 Day 15 6 hour Post-dose
ParticipantsOG0000
ParticipantsOG0019
ParticipantsOG00233
ParticipantsOG0035
Cycle 2 Day 15 Pre-dose
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Cycle 2 Day 15 1 hour Post-dose
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Cycle 2 Day 15 2 hour Post-dose
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Cycle 2 Day 15 4 hour Post-dose
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Cycle 2 Day 15 6 hour Post-dose
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Cycle 3 Day 15 1 to 3 hour Posst-dose
ParticipantsOG0000
ParticipantsOG00111
ParticipantsOG00226
ParticipantsOG0034
OG001
Cohort 1- Arm A2
Participants with locally advanced or metastatic TNBC who had not previously received chemotherapy in the advanced setting received 400 mg of Ipat orally, QD on Days 1-21, 840 mg IV of Atezo on Days 1 and 15, and 80 mg/m^2 IV Pac on Days 1, 8, and 15 of each 28-day cycle in expansion stage A2 until loss of clinical benefit, unacceptable toxicity, withdrawal of consent, or end of the study.
OG002
Cohort 1- Arm A3
Participants with locally advanced or metastatic TNBC who had not previously received chemotherapy in the advanced setting received 400 mg of Ipat orally, QD on Days 1-21, 840 mg IV of Atezo on Days 1 and 15, and 80 mg/m^2 IV Pac on Days 1, 8, and 15 of each 28-day cycle in expansion stage A3 until loss of clinical benefit, unacceptable toxicity, withdrawal of consent, or end of the study.
OG003
Cohort 1-Arm B1
Participants with locally advanced or metastatic TNBC who had not previously received chemotherapy in the advanced setting received 400 mg of Ipat orally, QD on Days 1-21, 840 mg IV of Atezo on Days 1 and 15, and 100 mg/m^2 IV Nab-Pac on Days 1, 8, and 15 of each 28-day cycle during the safety run-in stage (B1) until loss of clinical benefit, unacceptable toxicity, withdrawal of consent, or end of the study.
OG004
Cohort 1- Arm B2
Participants with locally advanced or metastatic TNBC who had not previously received chemotherapy in the advanced setting received 400 mg of Ipat orally, QD on Days 1-21, 840 mg IV of Atezo on Days 1 and 15, and 100 mg/m^2 IV Nab-Pac on Days 1, 8, and 15 of each 28-day cycle in the expansion stage B2 until loss of clinical benefit, unacceptable toxicity, withdrawal of consent, or end of the study.
OG005
Cohort 1-Arm C1
Participants with locally advanced or metastatic TNBC who had not previously received chemotherapy in the advanced setting received 400 mg of Ipat orally, QD on Days 1-21, 80 mg/m2 IV Pac on Days 1, 8, and 15 of Cycle 1 and 840 mg IV Atezo on Day 15 of Cycle 1 (1Cycle=28days). In Cycles ≥ 2, participants received 400 mg Ipat orally on Days 1-21, 840 mg IV Atezo on Days 1 and 15 and 80 mg/m2 IV Pac on Days 1, 8, and 15 of each 28-day Cycle during the safety run-in stage (C1) until loss of clinical benefit, unacceptable toxicity, withdrawal of consent, or end of the study.
OG006
Cohort 1- Arm C2
Participants with locally advanced or metastatic TNBC who had not previously received chemotherapy in the advanced setting received 400 mg of Ipat orally, QD on Days 1-21, 80 mg/m2 IV Pac on Days 1, 8, and 15 of Cycle 1 and 840 mg IV Atezo on Day 15 of Cycle 1 (1Cycle=28days). In Cycles ≥ 2, participants received 400 mg Ipat orally on Days 1-21, 840 mg IV Atezo on Days 1 and 15 and 80 mg/m2 IV Pac on Days 1, 8, and 15 of each 28-day Cycle in the expansion stage C2 until loss of clinical benefit, unacceptable toxicity, withdrawal of consent, or end of the study.
OG007
Cohort 1- Arm D1
Participants with locally advanced or metastatic TNBC received 840 mg IV Atezo on Days 1 and 15, 80 mg/m2 IV Pac on Days 1, 8, and 15 and 400 mg Ipat orally on days 15-21 of Cycle 1. In Cycles ≥ 2, participants received 400 mg Ipat orally on Days 1-21, 80 mg/m2 IV Pac on Days 1, 8, and 15 and 840 mg IV Atezo on Days 1 and 15 of each 28-day Cycle during the safety run-in stage (D1) until loss of clinical benefit, unacceptable toxicity, withdrawal of consent, or end of the study.
OG008
Cohort 1- Arm D2
Participants with locally advanced or metastatic TNBC received 840 mg IV Atezo on Days 1 and 15, 80 mg/m2 IV Pac on Days 1, 8, and 15 and 400 mg Ipat orally on days 15-21 of Cycle 1. In Cycles ≥ 2, participants received 400 mg Ipat orally on Days 1-21, 80 mg/m2 IV Pac on Days 1, 8, and 15 and 840 mg IV Atezo on Days 1 and 15 of each 28-day Cycle in the expansion stage D2 until loss of clinical benefit, unacceptable toxicity, withdrawal of consent, or end of the study.
Units
Counts
Participants
OG0006
OG00113
OG00243
OG0036
OG00414
OG0056
OG0066
OG0076
OG0086
Title
Denominators
Categories
Baseline: Positive for ADA
ParticipantsOG0006
ParticipantsOG00113
ParticipantsOG00243
ParticipantsOG0036
ParticipantsOG00414
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0076
ParticipantsOG0086
Title
Measurements
OG0000
OG0010
OG0020
OG003
Baseline: Negative for ADA
ParticipantsOG0006
ParticipantsOG00113
ParticipantsOG00243
ParticipantsOG0036
Post Baseline: Positive for Treatment Emergent ADA
ParticipantsOG0006
ParticipantsOG00113
ParticipantsOG00240
ParticipantsOG003
Post Baseline: Negative for Treatment Emergent ADA
ParticipantsOG0006
ParticipantsOG00113
ParticipantsOG00240
ParticipantsOG003
OG002
Cohort 1-Arm A3
Participants with locally advanced or metastatic TNBC who had not previously received chemotherapy in the advanced setting received 400 mg of Ipat orally, QD on Days 1-21, 840 mg IV of Atezo on Days 1 and 15, and 80 mg/m^2 IV Pac on Days 1, 8, and 15 of each 28-day cycle in expansion stage A3 until loss of clinical benefit, unacceptable toxicity, withdrawal of consent, or end of the study.
OG003
Cohort 1- Arm B1
Participants with locally advanced or metastatic TNBC who had not previously received chemotherapy in the advanced setting received 400 mg of Ipat orally, QD on Days 1-21, 840 mg IV of Atezo on Days 1 and 15, and 100 mg/m^2 IV Nab-Pac on Days 1, 8, and 15 of each 28-day cycle during the safety run-in stage (B1) until loss of clinical benefit, unacceptable toxicity, withdrawal of consent, or end of the study.
OG004
Cohort 1- Arm B2
Participants with locally advanced or metastatic TNBC who had not previously received chemotherapy in the advanced setting received 400 mg of Ipat orally, QD on Days 1-21, 840 mg IV of Atezo on Days 1 and 15, and 100 mg/m^2 IV Nab-Pac on Days 1, 8, and 15 of each 28-day cycle in the expansion stage B2 until loss of clinical benefit, unacceptable toxicity, withdrawal of consent, or end of the study.
OG005
Cohort 1-Arm C1
Participants with locally advanced or metastatic TNBC who had not previously received chemotherapy in the advanced setting received 400 mg of Ipat orally, QD on Days 1-21, 80 mg/m2 IV Pac on Days 1, 8, and 15 of Cycle 1 and 840 mg IV Atezo on Day 15 of Cycle 1 (1Cycle=28days). In Cycles ≥ 2, participants received 400 mg Ipat orally on Days 1-21, 840 mg IV Atezo on Days 1 and 15 and 80 mg/m2 IV Pac on Days 1, 8, and 15 of each 28-day Cycle during the safety run-in stage (C1) until loss of clinical benefit, unacceptable toxicity, withdrawal of consent, or end of the study.
OG006
Cohort 1-Arm C2
Participants with locally advanced or metastatic TNBC who had not previously received chemotherapy in the advanced setting received 400 mg of Ipat orally, QD on Days 1-21, 80 mg/m2 IV Pac on Days 1, 8, and 15 of Cycle 1 and 840 mg IV Atezo on Day 15 of Cycle 1 (1Cycle=28days). In Cycles ≥ 2, participants received 400 mg Ipat orally on Days 1-21, 840 mg IV Atezo on Days 1 and 15 and 80 mg/m2 IV Pac on Days 1, 8, and 15 of each 28-day Cycle in the expansion stage C2 until loss of clinical benefit, unacceptable toxicity, withdrawal of consent, or end of the study.
OG007
Cohort 1- Arm D1
Participants with locally advanced or metastatic TNBC received 840 mg IV Atezo on Days 1 and 15, 80 mg/m2 IV Pac on Days 1, 8, and 15 and 400 mg Ipat orally on days 15-21 of Cycle 1. In Cycles ≥ 2, participants received 400 mg Ipat orally on Days 1-21, 80 mg/m2 IV Pac on Days 1, 8, and 15 and 840 mg IV Atezo on Days 1 and 15 of each 28-day Cycle during the safety run-in stage (D1) until loss of clinical benefit, unacceptable toxicity, withdrawal of consent, or end of the study.
OG008
Cohort 1- Arm D2
Participants with locally advanced or metastatic TNBC received 840 mg IV Atezo on Days 1 and 15, 80 mg/m2 IV Pac on Days 1, 8, and 15 and 400 mg Ipat orally on days 15-21 of Cycle 1. In Cycles ≥ 2, participants received 400 mg Ipat orally on Days 1-21, 80 mg/m2 IV Pac on Days 1, 8, and 15 and 840 mg IV Atezo on Days 1 and 15 of each 28-day Cycle in the expansion stage D2 until loss of clinical benefit, unacceptable toxicity, withdrawal of consent, or end of the study.
Units
Counts
Participants
OG0006
OG00114
OG00250
OG0036
OG00414
OG0056
OG0066
OG0076
OG0086
Title
Denominators
Categories
Cycle 1 Day 1 Pre-dose
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0022
ParticipantsOG0030
ParticipantsOG0042
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0072
ParticipantsOG0080
Title
Measurements
OG002853± 1344.8
OG00465.3± 3.4
OG00782.5± 7.6
Cycle 1 Day 1 30 min Post-dose
ParticipantsOG0004
ParticipantsOG00113
ParticipantsOG00237
ParticipantsOG0035
Cycle 1 Day 15 Pre-Dose
ParticipantsOG0005
ParticipantsOG00110
ParticipantsOG00240
ParticipantsOG0035
Cycle 1 Day 15 30 min Post-dose
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG00214
ParticipantsOG0030
Cycle 2 Day 1 Pre-Dose
ParticipantsOG0005
ParticipantsOG00111
ParticipantsOG00233
ParticipantsOG0036
Cycle 2 Day 15 Pre-Dose
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0021
ParticipantsOG0030
Cycle 3 Day 1 Pre-Dose
ParticipantsOG0006
ParticipantsOG00112
ParticipantsOG00230
ParticipantsOG0036
Cycle 4 Day 1 Pre-Dose
ParticipantsOG0005
ParticipantsOG00111
ParticipantsOG00222
ParticipantsOG0036
Cycle 8 Day 1 Pre-Dose
ParticipantsOG0005
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG0033
Cycle 12 Day 1 Pre-Dose
ParticipantsOG0001
ParticipantsOG0013
ParticipantsOG0020
ParticipantsOG0030
Cycle 16 Day 1Pre-Dose
ParticipantsOG0003
ParticipantsOG0015
ParticipantsOG0020
ParticipantsOG0031
Treatment Discontinuation
ParticipantsOG0000
ParticipantsOG0015
ParticipantsOG0028
ParticipantsOG0034
OG001
Cohort 1-Arm B
Participants with locally advanced or metastatic TNBC who had not previously received chemotherapy in the advanced setting received 400 mg of Ipat orally, QD on Days 1-21, 840 mg IV of Atezo on Days 1 and 15, and 100 mg/m^2 IV nab-paclitaxel (Nab-Pac) on Days 1, 8, and 15 of each 28-day cycle. Following completion of a safety run-in cohort (B1), a subsequent expansion arm enrolled (B2). All participants in Arm B continued to receive treatment until loss of clinical benefit, unacceptable toxicity, withdrawal of consent, or end of the study.
OG002
Cohort 1-Arm C
Participants with locally advanced or metastatic TNBC who had not previously received chemotherapy in the advanced setting received 400 mg of Ipat orally, QD on Days 1-21, 80 mg/m2 IV Pac on Days 1, 8, and 15 and 840 mg IV Atezo on Day 15 of Cycle 1 (28 day cycle). In Cycles ≥ 2, participants received 400 mg Ipat orally on Days 1-21, 840 mg IV Atezo on Days 1 and 15 and 80 mg/m2 IV Pac on Days 1, 8, and 15 of each 28-day Cycle. Following completion of the safety run-in cohort (C1), a subsequent expansion cohort (C2) enrolled. All participants in Arm C continued to receive treatment until loss of clinical benefit, unacceptable toxicity, withdrawal of consent, or end of the study.
OG003
Cohort 1-Arm D
Participants with locally advanced or metastatic TNBC who had not previously received chemotherapy in the advanced setting received 840 mg IV Atezo on Days 1 and 15, 80 mg/m2 IV Pac on Days 1, 8, and 15 and 400 mg Ipat orally on days 15-21 of Cycle 1 (28 day cycle). In Cycles ≥ 2, participants received 400 mg Ipat orally on Days 1-21, 80 mg/m2 IV Pac on Days 1, 8, and 15 and 840 mg IV Atezo on Days 1 and 15 of each 28 day Cycle. Following completion of the safety run-in cohort (D1), a subsequent expansion cohort (D2) enrolled. All participants in Arm D continued to receive treatment until loss of clinical benefit, unacceptable toxicity, withdrawal of consent, or end of the study.
Units
Counts
Participants
OG00070
OG00120
OG00212
OG00312
Title
Denominators
Categories
Title
Measurements
OG00058.6(46.17 to 70.23)
OG00165.0(40.78 to 84.61)
OG00275.0(42.81 to 94.51)
OG00358.3(27.67 to 84.83)
0 events
0 affected
12 at risk
EG0040 events0 affected17 at risk
EG0050 events0 affected6 at risk
0 events
0 affected
12 at risk
EG0040 events0 affected17 at risk
EG0050 events0 affected6 at risk
0 events
0 affected
12 at risk
EG0040 events0 affected17 at risk
EG0050 events0 affected6 at risk
1 events
1 affected
12 at risk
EG0040 events0 affected17 at risk
EG0050 events0 affected6 at risk
1 events
1 affected
12 at risk
EG0041 events1 affected17 at risk
EG0050 events0 affected6 at risk
0 events
0 affected
12 at risk
EG0040 events0 affected17 at risk
EG0050 events0 affected6 at risk
0 events
0 affected
12 at risk
EG0040 events0 affected17 at risk
EG0050 events0 affected6 at risk
0 events
0 affected
12 at risk
EG0040 events0 affected17 at risk
EG0050 events0 affected6 at risk
0 events
0 affected
12 at risk
EG0040 events0 affected17 at risk
EG0050 events0 affected6 at risk
0 events
0 affected
12 at risk
EG0040 events0 affected17 at risk
EG0050 events0 affected6 at risk
0 events
0 affected
12 at risk
EG0041 events1 affected17 at risk
EG0050 events0 affected6 at risk
0 events
0 affected
12 at risk
EG0040 events0 affected17 at risk
EG0050 events0 affected6 at risk
0 events
0 affected
12 at risk
EG0040 events0 affected17 at risk
EG0050 events0 affected6 at risk
0 events
0 affected
12 at risk
EG0040 events0 affected17 at risk
EG0050 events0 affected6 at risk
0 events
0 affected
12 at risk
EG0040 events0 affected17 at risk
EG0050 events0 affected6 at risk
0 events
0 affected
12 at risk
EG0041 events1 affected17 at risk
EG0050 events0 affected6 at risk
0 events
0 affected
12 at risk
EG0040 events0 affected17 at risk
EG0050 events0 affected6 at risk
0 events
0 affected
12 at risk
EG0040 events0 affected17 at risk
EG0050 events0 affected6 at risk
0 events
0 affected
12 at risk
EG0041 events1 affected17 at risk
EG0050 events0 affected6 at risk
0 events
0 affected
12 at risk
EG0040 events0 affected17 at risk
EG0050 events0 affected6 at risk
0 events
0 affected
12 at risk
EG0040 events0 affected17 at risk
EG0051 events1 affected6 at risk
0 events
0 affected
12 at risk
EG0040 events0 affected17 at risk
EG0051 events1 affected6 at risk
0 events
0 affected
12 at risk
EG0040 events0 affected17 at risk
EG0050 events0 affected6 at risk
1 events
1 affected
12 at risk
EG0040 events0 affected17 at risk
EG0050 events0 affected6 at risk
0 events
0 affected
12 at risk
EG0040 events0 affected17 at risk
EG0050 events0 affected6 at risk
0 events
0 affected
12 at risk
EG0040 events0 affected17 at risk
EG0050 events0 affected6 at risk
0 events
0 affected
12 at risk
EG0040 events0 affected17 at risk
EG0050 events0 affected6 at risk
0 events
0 affected
12 at risk
EG0041 events1 affected17 at risk
EG0050 events0 affected6 at risk
0 events
0 affected
12 at risk
EG0040 events0 affected17 at risk
EG0050 events0 affected6 at risk
0 events
0 affected
12 at risk
EG0040 events0 affected17 at risk
EG0050 events0 affected6 at risk
0 events
0 affected
12 at risk
EG0040 events0 affected17 at risk
EG0050 events0 affected6 at risk
0 events
0 affected
12 at risk
EG0040 events0 affected17 at risk
EG0051 events1 affected6 at risk
0 events
0 affected
12 at risk
EG0040 events0 affected17 at risk
EG0050 events0 affected6 at risk
0 events
0 affected
12 at risk
EG0041 events1 affected17 at risk
EG0050 events0 affected6 at risk
0 events
0 affected
12 at risk
EG0040 events0 affected17 at risk
EG0050 events0 affected6 at risk
0 events
0 affected
12 at risk
EG0040 events0 affected17 at risk
EG0050 events0 affected6 at risk
0 events
0 affected
12 at risk
EG0040 events0 affected17 at risk
EG0050 events0 affected6 at risk
0 events
0 affected
12 at risk
EG0040 events0 affected17 at risk
EG0050 events0 affected6 at risk
1 events
1 affected
12 at risk
EG0040 events0 affected17 at risk
EG0050 events0 affected6 at risk
0 events
0 affected
12 at risk
EG0040 events0 affected17 at risk
EG0050 events0 affected6 at risk
0 events
0 affected
12 at risk
EG0040 events0 affected17 at risk
EG0050 events0 affected6 at risk
0 events
0 affected
12 at risk
EG0040 events0 affected17 at risk
EG0050 events0 affected6 at risk
0 events
0 affected
12 at risk
EG0040 events0 affected17 at risk
EG0050 events0 affected6 at risk
0 events
0 affected
12 at risk
EG0040 events0 affected17 at risk
EG0050 events0 affected6 at risk
0 events
0 affected
12 at risk
EG0040 events0 affected17 at risk
EG0050 events0 affected6 at risk
0 events
0 affected
12 at risk
EG0041 events1 affected17 at risk
EG0050 events0 affected6 at risk
0 events
0 affected
12 at risk
EG0040 events0 affected17 at risk
EG0050 events0 affected6 at risk
0 events
0 affected
12 at risk
EG0040 events0 affected17 at risk
EG0050 events0 affected6 at risk
1 events
1 affected
12 at risk
EG0040 events0 affected17 at risk
EG0050 events0 affected6 at risk
0 events
0 affected
12 at risk
EG0040 events0 affected17 at risk
EG0050 events0 affected6 at risk
0 events
0 affected
12 at risk
EG0040 events0 affected17 at risk
EG0050 events0 affected6 at risk
5 events
2 affected
12 at risk
EG0041 events1 affected17 at risk
EG0052 events1 affected6 at risk
0 events
0 affected
12 at risk
EG0041 events1 affected17 at risk
EG0050 events0 affected6 at risk
0 events
0 affected
12 at risk
EG0040 events0 affected17 at risk
EG0050 events0 affected6 at risk
5 events
3 affected
12 at risk
EG0040 events0 affected17 at risk
EG0051 events1 affected6 at risk
0 events
0 affected
12 at risk
EG0040 events0 affected17 at risk
EG0052 events2 affected6 at risk
0 events
0 affected
12 at risk
EG0040 events0 affected17 at risk
EG0051 events1 affected6 at risk
0 events
0 affected
12 at risk
EG0040 events0 affected17 at risk
EG0052 events2 affected6 at risk
0 events
0 affected
12 at risk
EG0040 events0 affected17 at risk
EG0050 events0 affected6 at risk
1 events
1 affected
12 at risk
EG0040 events0 affected17 at risk
EG0050 events0 affected6 at risk
0 events
0 affected
12 at risk
EG0040 events0 affected17 at risk
EG0050 events0 affected6 at risk
0 events
0 affected
12 at risk
EG0040 events0 affected17 at risk
EG0050 events0 affected6 at risk
4 events
3 affected
12 at risk
EG0040 events0 affected17 at risk
EG0052 events1 affected6 at risk
1 events
1 affected
12 at risk
EG0041 events1 affected17 at risk
EG0050 events0 affected6 at risk
0 events
0 affected
12 at risk
EG0041 events1 affected17 at risk
EG0050 events0 affected6 at risk
0 events
0 affected
12 at risk
EG0040 events0 affected17 at risk
EG0051 events1 affected6 at risk
0 events
0 affected
12 at risk
EG0040 events0 affected17 at risk
EG0051 events1 affected6 at risk
6 events
5 affected
12 at risk
EG0043 events3 affected17 at risk
EG0052 events2 affected6 at risk
18 events
9 affected
12 at risk
EG00414 events9 affected17 at risk
EG00519 events6 affected6 at risk
1 events
1 affected
12 at risk
EG0040 events0 affected17 at risk
EG0051 events1 affected6 at risk
0 events
0 affected
12 at risk
EG0040 events0 affected17 at risk
EG0052 events2 affected6 at risk
0 events
0 affected
12 at risk
EG0041 events1 affected17 at risk
EG0050 events0 affected6 at risk
1 events
1 affected
12 at risk
EG0040 events0 affected17 at risk
EG0050 events0 affected6 at risk
0 events
0 affected
12 at risk
EG0040 events0 affected17 at risk
EG0050 events0 affected6 at risk
0 events
0 affected
12 at risk
EG0040 events0 affected17 at risk
EG0050 events0 affected6 at risk
1 events
1 affected
12 at risk
EG0040 events0 affected17 at risk
EG0050 events0 affected6 at risk
10 events
5 affected
12 at risk
EG0047 events5 affected17 at risk
EG0059 events5 affected6 at risk
0 events
0 affected
12 at risk
EG0040 events0 affected17 at risk
EG0050 events0 affected6 at risk
0 events
0 affected
12 at risk
EG0040 events0 affected17 at risk
EG0050 events0 affected6 at risk
3 events
3 affected
12 at risk
EG0043 events3 affected17 at risk
EG0051 events1 affected6 at risk
9 events
4 affected
12 at risk
EG00410 events9 affected17 at risk
EG0056 events3 affected6 at risk
1 events
1 affected
12 at risk
EG0040 events0 affected17 at risk
EG0050 events0 affected6 at risk
0 events
0 affected
12 at risk
EG0040 events0 affected17 at risk
EG0050 events0 affected6 at risk
0 events
0 affected
12 at risk
EG0040 events0 affected17 at risk
EG0050 events0 affected6 at risk
5 events
4 affected
12 at risk
EG0042 events2 affected17 at risk
EG0052 events2 affected6 at risk
0 events
0 affected
12 at risk
EG0040 events0 affected17 at risk
EG0050 events0 affected6 at risk
0 events
0 affected
12 at risk
EG0040 events0 affected17 at risk
EG0050 events0 affected6 at risk
0 events
0 affected
12 at risk
EG0040 events0 affected17 at risk
EG0050 events0 affected6 at risk
0 events
0 affected
12 at risk
EG0040 events0 affected17 at risk
EG0051 events1 affected6 at risk
3 events
2 affected
12 at risk
EG0043 events2 affected17 at risk
EG0052 events1 affected6 at risk
0 events
0 affected
12 at risk
EG0041 events1 affected17 at risk
EG0050 events0 affected6 at risk
0 events
0 affected
12 at risk
EG0040 events0 affected17 at risk
EG0050 events0 affected6 at risk
0 events
0 affected
12 at risk
EG0041 events1 affected17 at risk
EG0050 events0 affected6 at risk
1 events
1 affected
12 at risk
EG0040 events0 affected17 at risk
EG0050 events0 affected6 at risk
3 events
1 affected
12 at risk
EG0044 events4 affected17 at risk
EG0051 events1 affected6 at risk
0 events
0 affected
12 at risk
EG0041 events1 affected17 at risk
EG0050 events0 affected6 at risk
0 events
0 affected
12 at risk
EG0041 events1 affected17 at risk
EG0050 events0 affected6 at risk
0 events
0 affected
12 at risk
EG0040 events0 affected17 at risk
EG0050 events0 affected6 at risk
0 events
0 affected
12 at risk
EG0040 events0 affected17 at risk
EG0050 events0 affected6 at risk
0 events
0 affected
12 at risk
EG0041 events1 affected17 at risk
EG0050 events0 affected6 at risk
1 events
1 affected
12 at risk
EG0040 events0 affected17 at risk
EG0050 events0 affected6 at risk
0 events
0 affected
12 at risk
EG0040 events0 affected17 at risk
EG0050 events0 affected6 at risk
2 events
1 affected
12 at risk
EG0040 events0 affected17 at risk
EG0051 events1 affected6 at risk
0 events
0 affected
12 at risk
EG0040 events0 affected17 at risk
EG0051 events1 affected6 at risk
1 events
1 affected
12 at risk
EG0040 events0 affected17 at risk
EG0050 events0 affected6 at risk
0 events
0 affected
12 at risk
EG0040 events0 affected17 at risk
EG0050 events0 affected6 at risk
0 events
0 affected
12 at risk
EG0040 events0 affected17 at risk
EG0050 events0 affected6 at risk
0 events
0 affected
12 at risk
EG0040 events0 affected17 at risk
EG0051 events1 affected6 at risk
1 events
1 affected
12 at risk
EG0040 events0 affected17 at risk
EG0050 events0 affected6 at risk
0 events
0 affected
12 at risk
EG0040 events0 affected17 at risk
EG0050 events0 affected6 at risk
0 events
0 affected
12 at risk
EG0040 events0 affected17 at risk
EG0050 events0 affected6 at risk
0 events
0 affected
12 at risk
EG0041 events1 affected17 at risk
EG0050 events0 affected6 at risk
2 events
2 affected
12 at risk
EG0040 events0 affected17 at risk
EG0050 events0 affected6 at risk
0 events
0 affected
12 at risk
EG0040 events0 affected17 at risk
EG0050 events0 affected6 at risk
1 events
1 affected
12 at risk
EG0040 events0 affected17 at risk
EG0051 events1 affected6 at risk
0 events
0 affected
12 at risk
EG0041 events1 affected17 at risk
EG0050 events0 affected6 at risk
0 events
0 affected
12 at risk
EG0040 events0 affected17 at risk
EG0050 events0 affected6 at risk
0 events
0 affected
12 at risk
EG0040 events0 affected17 at risk
EG0050 events0 affected6 at risk
0 events
0 affected
12 at risk
EG0040 events0 affected17 at risk
EG0050 events0 affected6 at risk
2 events
2 affected
12 at risk
EG0041 events1 affected17 at risk
EG0050 events0 affected6 at risk
0 events
0 affected
12 at risk
EG0041 events1 affected17 at risk
EG0050 events0 affected6 at risk
0 events
0 affected
12 at risk
EG0040 events0 affected17 at risk
EG0051 events1 affected6 at risk
0 events
0 affected
12 at risk
EG0040 events0 affected17 at risk
EG0050 events0 affected6 at risk
2 events
2 affected
12 at risk
EG0040 events0 affected17 at risk
EG0050 events0 affected6 at risk
1 events
1 affected
12 at risk
EG0040 events0 affected17 at risk
EG0052 events2 affected6 at risk
0 events
0 affected
12 at risk
EG0040 events0 affected17 at risk
EG0050 events0 affected6 at risk
0 events
0 affected
12 at risk
EG0040 events0 affected17 at risk
EG0051 events1 affected6 at risk
0 events
0 affected
12 at risk
EG0040 events0 affected17 at risk
EG0050 events0 affected6 at risk
0 events
0 affected
12 at risk
EG0040 events0 affected17 at risk
EG0050 events0 affected6 at risk
0 events
0 affected
12 at risk
EG0040 events0 affected17 at risk
EG0050 events0 affected6 at risk
0 events
0 affected
12 at risk
EG0040 events0 affected17 at risk
EG0050 events0 affected6 at risk
0 events
0 affected
12 at risk
EG0040 events0 affected17 at risk
EG0050 events0 affected6 at risk
6 events
3 affected
12 at risk
EG0040 events0 affected17 at risk
EG0050 events0 affected6 at risk
0 events
0 affected
12 at risk
EG0041 events1 affected17 at risk
EG0050 events0 affected6 at risk
0 events
0 affected
12 at risk
EG0040 events0 affected17 at risk
EG0051 events1 affected6 at risk
7 events
3 affected
12 at risk
EG0041 events1 affected17 at risk
EG0050 events0 affected6 at risk
2 events
2 affected
12 at risk
EG0040 events0 affected17 at risk
EG0051 events1 affected6 at risk
6 events
3 affected
12 at risk
EG0041 events1 affected17 at risk
EG0050 events0 affected6 at risk
2 events
2 affected
12 at risk
EG0042 events2 affected17 at risk
EG0050 events0 affected6 at risk
0 events
0 affected
12 at risk
EG0041 events1 affected17 at risk
EG0051 events1 affected6 at risk
0 events
0 affected
12 at risk
EG0041 events1 affected17 at risk
EG0050 events0 affected6 at risk
2 events
2 affected
12 at risk
EG0041 events1 affected17 at risk
EG0050 events0 affected6 at risk
7 events
2 affected
12 at risk
EG0040 events0 affected17 at risk
EG0051 events1 affected6 at risk
0 events
0 affected
12 at risk
EG0040 events0 affected17 at risk
EG0050 events0 affected6 at risk
0 events
0 affected
12 at risk
EG0040 events0 affected17 at risk
EG0050 events0 affected6 at risk
0 events
0 affected
12 at risk
EG0040 events0 affected17 at risk
EG0051 events1 affected6 at risk
0 events
0 affected
12 at risk
EG0041 events1 affected17 at risk
EG0050 events0 affected6 at risk
0 events
0 affected
12 at risk
EG0040 events0 affected17 at risk
EG0050 events0 affected6 at risk
0 events
0 affected
12 at risk
EG0040 events0 affected17 at risk
EG0051 events1 affected6 at risk
0 events
0 affected
12 at risk
EG0042 events2 affected17 at risk
EG0050 events0 affected6 at risk
4 events
4 affected
12 at risk
EG0043 events3 affected17 at risk
EG0051 events1 affected6 at risk
0 events
0 affected
12 at risk
EG0040 events0 affected17 at risk
EG0050 events0 affected6 at risk
0 events
0 affected
12 at risk
EG0040 events0 affected17 at risk
EG0050 events0 affected6 at risk
1 events
1 affected
12 at risk
EG0040 events0 affected17 at risk
EG0052 events1 affected6 at risk
0 events
0 affected
12 at risk
EG0041 events1 affected17 at risk
EG0050 events0 affected6 at risk
0 events
0 affected
12 at risk
EG0040 events0 affected17 at risk
EG0050 events0 affected6 at risk
1 events
1 affected
12 at risk
EG0041 events1 affected17 at risk
EG0050 events0 affected6 at risk
0 events
0 affected
12 at risk
EG0041 events1 affected17 at risk
EG0050 events0 affected6 at risk
1 events
1 affected
12 at risk
EG0041 events1 affected17 at risk
EG0050 events0 affected6 at risk
2 events
2 affected
12 at risk
EG0043 events3 affected17 at risk
EG0050 events0 affected6 at risk
1 events
1 affected
12 at risk
EG0040 events0 affected17 at risk
EG0052 events2 affected6 at risk
0 events
0 affected
12 at risk
EG0041 events1 affected17 at risk
EG0050 events0 affected6 at risk
0 events
0 affected
12 at risk
EG0041 events1 affected17 at risk
EG0050 events0 affected6 at risk
2 events
2 affected
12 at risk
EG0040 events0 affected17 at risk
EG0050 events0 affected6 at risk
0 events
0 affected
12 at risk
EG0041 events1 affected17 at risk
EG0050 events0 affected6 at risk
1 events
1 affected
12 at risk
EG0041 events1 affected17 at risk
EG0050 events0 affected6 at risk
0 events
0 affected
12 at risk
EG0040 events0 affected17 at risk
EG0050 events0 affected6 at risk
0 events
0 affected
12 at risk
EG0040 events0 affected17 at risk
EG0050 events0 affected6 at risk
0 events
0 affected
12 at risk
EG0040 events0 affected17 at risk
EG0050 events0 affected6 at risk
0 events
0 affected
12 at risk
EG0040 events0 affected17 at risk
EG0050 events0 affected6 at risk
0 events
0 affected
12 at risk
EG0040 events0 affected17 at risk
EG0050 events0 affected6 at risk
2 events
2 affected
12 at risk
EG0040 events0 affected17 at risk
EG0050 events0 affected6 at risk
0 events
0 affected
12 at risk
EG0040 events0 affected17 at risk
EG0050 events0 affected6 at risk
2 events
2 affected
12 at risk
EG0040 events0 affected17 at risk
EG0051 events1 affected6 at risk
1 events
1 affected
12 at risk
EG0046 events5 affected17 at risk
EG0052 events1 affected6 at risk
0 events
0 affected
12 at risk
EG0041 events1 affected17 at risk
EG0050 events0 affected6 at risk
2 events
2 affected
12 at risk
EG0040 events0 affected17 at risk
EG0050 events0 affected6 at risk
0 events
0 affected
12 at risk
EG0041 events1 affected17 at risk
EG0050 events0 affected6 at risk
0 events
0 affected
12 at risk
EG0040 events0 affected17 at risk
EG0053 events2 affected6 at risk
3 events
3 affected
12 at risk
EG0040 events0 affected17 at risk
EG0050 events0 affected6 at risk
3 events
3 affected
12 at risk
EG0040 events0 affected17 at risk
EG0050 events0 affected6 at risk
0 events
0 affected
12 at risk
EG0040 events0 affected17 at risk
EG0050 events0 affected6 at risk
0 events
0 affected
12 at risk
EG0040 events0 affected17 at risk
EG0051 events1 affected6 at risk
0 events
0 affected
12 at risk
EG0041 events1 affected17 at risk
EG0050 events0 affected6 at risk
0 events
0 affected
12 at risk
EG0040 events0 affected17 at risk
EG0050 events0 affected6 at risk
4 events
4 affected
12 at risk
EG0040 events0 affected17 at risk
EG0050 events0 affected6 at risk
0 events
0 affected
12 at risk
EG0040 events0 affected17 at risk
EG0050 events0 affected6 at risk
0 events
0 affected
12 at risk
EG0040 events0 affected17 at risk
EG0050 events0 affected6 at risk
1 events
1 affected
12 at risk
EG0040 events0 affected17 at risk
EG0052 events2 affected6 at risk
0 events
0 affected
12 at risk
EG0041 events1 affected17 at risk
EG0050 events0 affected6 at risk
0 events
0 affected
12 at risk
EG0040 events0 affected17 at risk
EG0052 events2 affected6 at risk
0 events
0 affected
12 at risk
EG0040 events0 affected17 at risk
EG0051 events1 affected6 at risk
0 events
0 affected
12 at risk
EG0041 events1 affected17 at risk
EG0050 events0 affected6 at risk
0 events
0 affected
12 at risk
EG0040 events0 affected17 at risk
EG0051 events1 affected6 at risk
0 events
0 affected
12 at risk
EG0040 events0 affected17 at risk
EG0050 events0 affected6 at risk
0 events
0 affected
12 at risk
EG0040 events0 affected17 at risk
EG0050 events0 affected6 at risk
2 events
2 affected
12 at risk
EG0040 events0 affected17 at risk
EG0050 events0 affected6 at risk
0 events
0 affected
12 at risk
EG0040 events0 affected17 at risk
EG0050 events0 affected6 at risk
1 events
1 affected
12 at risk
EG0041 events1 affected17 at risk
EG0050 events0 affected6 at risk
2 events
2 affected
12 at risk
EG0040 events0 affected17 at risk
EG0050 events0 affected6 at risk
0 events
0 affected
12 at risk
EG0042 events2 affected17 at risk
EG0050 events0 affected6 at risk
0 events
0 affected
12 at risk
EG0040 events0 affected17 at risk
EG0051 events1 affected6 at risk
1 events
1 affected
12 at risk
EG0040 events0 affected17 at risk
EG0050 events0 affected6 at risk
7 events
7 affected
12 at risk
EG0040 events0 affected17 at risk
EG0054 events4 affected6 at risk
2 events
2 affected
12 at risk
EG0040 events0 affected17 at risk
EG0050 events0 affected6 at risk
1 events
1 affected
12 at risk
EG0040 events0 affected17 at risk
EG0051 events1 affected6 at risk
0 events
0 affected
12 at risk
EG0040 events0 affected17 at risk
EG0050 events0 affected6 at risk
1 events
1 affected
12 at risk
EG0041 events1 affected17 at risk
EG0050 events0 affected6 at risk
0 events
0 affected
12 at risk
EG0040 events0 affected17 at risk
EG0051 events1 affected6 at risk
0 events
0 affected
12 at risk
EG0040 events0 affected17 at risk
EG0051 events1 affected6 at risk
0 events
0 affected
12 at risk
EG0040 events0 affected17 at risk
EG0050 events0 affected6 at risk
0 events
0 affected
12 at risk
EG0040 events0 affected17 at risk
EG0054 events3 affected6 at risk
0 events
0 affected
12 at risk
EG0040 events0 affected17 at risk
EG0050 events0 affected6 at risk
0 events
0 affected
12 at risk
EG0040 events0 affected17 at risk
EG0050 events0 affected6 at risk
0 events
0 affected
12 at risk
EG0040 events0 affected17 at risk
EG0050 events0 affected6 at risk
0 events
0 affected
12 at risk
EG0040 events0 affected17 at risk
EG0050 events0 affected6 at risk
0 events
0 affected
12 at risk
EG0040 events0 affected17 at risk
EG0050 events0 affected6 at risk
2 events
2 affected
12 at risk
EG0041 events1 affected17 at risk
EG0050 events0 affected6 at risk
4 events
4 affected
12 at risk
EG0047 events7 affected17 at risk
EG0055 events3 affected6 at risk
0 events
0 affected
12 at risk
EG0040 events0 affected17 at risk
EG0050 events0 affected6 at risk
0 events
0 affected
12 at risk
EG0041 events1 affected17 at risk
EG0050 events0 affected6 at risk
0 events
0 affected
12 at risk
EG0040 events0 affected17 at risk
EG0051 events1 affected6 at risk
0 events
0 affected
12 at risk
EG0040 events0 affected17 at risk
EG0050 events0 affected6 at risk
0 events
0 affected
12 at risk
EG0040 events0 affected17 at risk
EG0050 events0 affected6 at risk
0 events
0 affected
12 at risk
EG0040 events0 affected17 at risk
EG0051 events1 affected6 at risk
0 events
0 affected
12 at risk
EG0040 events0 affected17 at risk
EG0050 events0 affected6 at risk
0 events
0 affected
12 at risk
EG0041 events1 affected17 at risk
EG0050 events0 affected6 at risk
0 events
0 affected
12 at risk
EG0040 events0 affected17 at risk
EG0050 events0 affected6 at risk
0 events
0 affected
12 at risk
EG0040 events0 affected17 at risk
EG0051 events1 affected6 at risk
0 events
0 affected
12 at risk
EG0040 events0 affected17 at risk
EG0050 events0 affected6 at risk
1 events
1 affected
12 at risk
EG0040 events0 affected17 at risk
EG0050 events0 affected6 at risk
1 events
1 affected
12 at risk
EG0040 events0 affected17 at risk
EG0050 events0 affected6 at risk
1 events
1 affected
12 at risk
EG0040 events0 affected17 at risk
EG0050 events0 affected6 at risk
0 events
0 affected
12 at risk
EG0040 events0 affected17 at risk
EG0050 events0 affected6 at risk
1 events
1 affected
12 at risk
EG0040 events0 affected17 at risk
EG0050 events0 affected6 at risk
0 events
0 affected
12 at risk
EG0040 events0 affected17 at risk
EG0050 events0 affected6 at risk
0 events
0 affected
12 at risk
EG0040 events0 affected17 at risk
EG0050 events0 affected6 at risk
0 events
0 affected
12 at risk
EG0040 events0 affected17 at risk
EG0050 events0 affected6 at risk
0 events
0 affected
12 at risk
EG0040 events0 affected17 at risk
EG0050 events0 affected6 at risk
0 events
0 affected
12 at risk
EG0040 events0 affected17 at risk
EG0050 events0 affected6 at risk
0 events
0 affected
12 at risk
EG0040 events0 affected17 at risk
EG0050 events0 affected6 at risk
0 events
0 affected
12 at risk
EG0040 events0 affected17 at risk
EG0050 events0 affected6 at risk
1 events
1 affected
12 at risk
EG0040 events0 affected17 at risk
EG0050 events0 affected6 at risk
1 events
1 affected
12 at risk
EG0040 events0 affected17 at risk
EG0050 events0 affected6 at risk
1 events
1 affected
12 at risk
EG0040 events0 affected17 at risk
EG0050 events0 affected6 at risk
0 events
0 affected
12 at risk
EG0040 events0 affected17 at risk
EG0050 events0 affected6 at risk
0 events
0 affected
12 at risk
EG0040 events0 affected17 at risk
EG0050 events0 affected6 at risk
0 events
0 affected
12 at risk
EG0040 events0 affected17 at risk
EG0050 events0 affected6 at risk
2 events
1 affected
12 at risk
EG0040 events0 affected17 at risk
EG0050 events0 affected6 at risk
0 events
0 affected
12 at risk
EG0040 events0 affected17 at risk
EG0050 events0 affected6 at risk
0 events
0 affected
12 at risk
EG0040 events0 affected17 at risk
EG0050 events0 affected6 at risk
0 events
0 affected
12 at risk
EG0040 events0 affected17 at risk
EG0050 events0 affected6 at risk
0 events
0 affected
12 at risk
EG0040 events0 affected17 at risk
EG0050 events0 affected6 at risk
1 events
1 affected
12 at risk
EG0040 events0 affected17 at risk
EG0050 events0 affected6 at risk
0 events
0 affected
12 at risk
EG0040 events0 affected17 at risk
EG0050 events0 affected6 at risk
1 events
1 affected
12 at risk
EG0040 events0 affected17 at risk
EG0050 events0 affected6 at risk
1 events
1 affected
12 at risk
EG0040 events0 affected17 at risk
EG0050 events0 affected6 at risk
1 events
1 affected
12 at risk
EG0040 events0 affected17 at risk
EG0050 events0 affected6 at risk
1 events
1 affected
12 at risk
EG0040 events0 affected17 at risk
EG0050 events0 affected6 at risk
1 events
1 affected
12 at risk
EG0040 events0 affected17 at risk
EG0050 events0 affected6 at risk
0 events
0 affected
12 at risk
EG0040 events0 affected17 at risk
EG0050 events0 affected6 at risk
0 events
0 affected
12 at risk
EG0040 events0 affected17 at risk
EG0050 events0 affected6 at risk
1 events
1 affected
12 at risk
EG0040 events0 affected17 at risk
EG0050 events0 affected6 at risk
1 events
1 affected
12 at risk
EG0040 events0 affected17 at risk
EG0050 events0 affected6 at risk
1 events
1 affected
12 at risk
EG0040 events0 affected17 at risk
EG0050 events0 affected6 at risk
0 events
0 affected
12 at risk
EG0040 events0 affected17 at risk
EG0050 events0 affected6 at risk
1 events
1 affected
12 at risk
EG0040 events0 affected17 at risk
EG0050 events0 affected6 at risk
1 events
1 affected
12 at risk
EG0040 events0 affected17 at risk
EG0050 events0 affected6 at risk
1 events
1 affected
12 at risk
EG0040 events0 affected17 at risk
EG0050 events0 affected6 at risk
0 events
0 affected
12 at risk
EG0040 events0 affected17 at risk
EG0050 events0 affected6 at risk
0 events
0 affected
12 at risk
EG0040 events0 affected17 at risk
EG0050 events0 affected6 at risk
0 events
0 affected
12 at risk
EG0040 events0 affected17 at risk
EG0050 events0 affected6 at risk
1 events
1 affected
12 at risk
EG0040 events0 affected17 at risk
EG0050 events0 affected6 at risk
0 events
0 affected
12 at risk
EG0040 events0 affected17 at risk
EG0050 events0 affected6 at risk
1 events
1 affected
12 at risk
EG0040 events0 affected17 at risk
EG0050 events0 affected6 at risk
0 events
0 affected
12 at risk
EG0040 events0 affected17 at risk
EG0050 events0 affected6 at risk
0 events
0 affected
12 at risk
EG0040 events0 affected17 at risk
EG0050 events0 affected6 at risk
0 events
0 affected
12 at risk
EG0040 events0 affected17 at risk
EG0050 events0 affected6 at risk
1 events
1 affected
12 at risk
EG0040 events0 affected17 at risk
EG0050 events0 affected6 at risk
30.2
± 37.1
OG00446.9± 172.8
OG00561.1± 94.3
OG00677.3± 207.0
ParticipantsOG00410
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
Title
Measurements
OG000507± 43.6
OG001182± 167.0
OG002258± 127.2
OG003253± 128.0
OG004219± 186.6
ParticipantsOG00410
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0076
ParticipantsOG0085
Title
Measurements
OG000318± 21.4
OG001318± 47.8
OG002421± 51.5
OG003287± 35.7
OG004282± 235.6
OG007225± 41.9
OG008190± 484.7
ParticipantsOG00410
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
Title
Measurements
OG000226± 32.7
OG001255± 39.7
OG002305± 40.8
OG003225± 10.0
OG004266± 78.1
ParticipantsOG00410
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
Title
Measurements
OG001182± 39.2
OG002233± 46.7
OG003165± 25.0
OG004186± 80.3
ParticipantsOG0040
ParticipantsOG0054
ParticipantsOG0065
ParticipantsOG0074
ParticipantsOG0082
Title
Measurements
OG00544.9± 43.3
OG00650.3± 31.4
OG00729.2± 59.5
OG00831.6± 53.1
ParticipantsOG0040
ParticipantsOG0055
ParticipantsOG0065
ParticipantsOG0074
ParticipantsOG0082
Title
Measurements
OG005260± 21.6
OG006614± 34.2
OG007232± 150.0
OG008364± 81.4
ParticipantsOG0040
ParticipantsOG0055
ParticipantsOG0065
ParticipantsOG0074
ParticipantsOG0082
Title
Measurements
OG005575± 22.5
OG006500± 18.3
OG007311± 67.5
OG008610± 36.7
ParticipantsOG0040
ParticipantsOG0054
ParticipantsOG0065
ParticipantsOG0073
ParticipantsOG0082
Title
Measurements
OG005402± 44.9
OG006340± 29.9
OG007258± 20.6
OG008433± 41.7
ParticipantsOG0040
ParticipantsOG0053
ParticipantsOG0065
ParticipantsOG0073
ParticipantsOG0082
Title
Measurements
OG005253± 31.7
OG006273± 15.3
OG007162± 8.2
OG008234± 32.6
ParticipantsOG0049
ParticipantsOG0056
ParticipantsOG0065
ParticipantsOG0076
ParticipantsOG0084
Title
Measurements
OG001126± 241.7
OG002196± 133.7
OG003134± 82.8
OG004214± 130.8
OG005127± 369.0
OG006155± 282.3
OG007233± 120.9
OG008382± 87.9
23.3
± 58.3
OG00424.1± 97.7
OG00530.9± 48.3
OG00636.4± 356.1
ParticipantsOG00410
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
Title
Measurements
OG000200± 58.3
OG00161.8± 209.2
OG00285.9± 119.9
OG003126± 158.4
OG00486.4± 135.3
ParticipantsOG00410
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0076
ParticipantsOG0084
Title
Measurements
OG000151± 29.9
OG001124± 55.0
OG002153± 68.8
OG003166± 102.2
OG004120± 193.0
OG00778.1± 125.6
OG008177± 37.1
ParticipantsOG00410
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
Title
Measurements
OG000118± 26.1
OG001121± 41.5
OG002157± 62.9
OG003154± 39.8
OG004134± 99.2
ParticipantsOG00410
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
Title
Measurements
OG001106± 47.3
OG002133± 60.3
OG003120± 45.6
OG004101± 82.8
ParticipantsOG0040
ParticipantsOG0054
ParticipantsOG0065
ParticipantsOG0074
ParticipantsOG0082
Title
Measurements
OG00522.5± 27.6
OG00620.5± 38.4
OG00715.2± 81.4
OG00824.4± 76.7
ParticipantsOG0040
ParticipantsOG0055
ParticipantsOG0065
ParticipantsOG0074
ParticipantsOG0082
Title
Measurements
OG00541.3± 90.1
OG006148± 39.4
OG00770.5± 244.4
OG008140± 94.2
ParticipantsOG0040
ParticipantsOG0055
ParticipantsOG0065
ParticipantsOG0074
ParticipantsOG0082
Title
Measurements
OG005206± 35.1
OG006184± 28.0
OG007120± 171.0
OG008355± 22.9
ParticipantsOG0040
ParticipantsOG0054
ParticipantsOG0065
ParticipantsOG0073
ParticipantsOG0082
Title
Measurements
OG005185± 30.2
OG006146± 46.5
OG007131± 30.8
OG008402± 43.4
ParticipantsOG0040
ParticipantsOG0053
ParticipantsOG0065
ParticipantsOG0073
ParticipantsOG0082
Title
Measurements
OG005124± 11.4
OG006137± 30.4
OG00798.8± 77.3
OG008232± 57.4
ParticipantsOG0049
ParticipantsOG0056
ParticipantsOG0065
ParticipantsOG0076
ParticipantsOG0084
Title
Measurements
OG00147.1± 238.3
OG00269.4± 161.2
OG00368.6± 131.8
OG00479.4± 150.8
OG00550.4± 299.8
OG00645.0± 182.3
OG00784.6± 227.5
OG008144± 121.6
0
OG0040
OG0050
OG0060
OG0070
OG0080
ParticipantsOG00414
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0076
ParticipantsOG0086
Title
Measurements
OG0006
OG00113
OG00243
OG0036
OG00414
OG0050
OG0060
OG0076
OG0086
6
ParticipantsOG00412
ParticipantsOG0056
ParticipantsOG0066
ParticipantsOG0076
ParticipantsOG0086
Title
Measurements
OG0000
OG0013
OG0022
OG0030
OG0043
OG0052
OG0061
OG0070
OG0080
6
ParticipantsOG00412
ParticipantsOG0056
ParticipantsOG0066
ParticipantsOG0076
ParticipantsOG0086
Title
Measurements
OG0006
OG00110
OG00238
OG0036
OG0049
OG0054
OG0065
OG0076
OG0086
ParticipantsOG00412
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0076
ParticipantsOG0085
Title
Measurements
OG000354000± 12.2
OG001330000± 18.1
OG002329000± 25.3
OG003315000± 5.4
OG004365000± 19.2
OG007335000± 13.9
OG008339000± 13.6
ParticipantsOG00411
ParticipantsOG0051
ParticipantsOG0060
ParticipantsOG0075
ParticipantsOG0085
Title
Measurements
OG000106000± 12.1
OG00175200± 170.2
OG00294500± 27.8
OG00393100± 15.6
OG00491700± 21
OG005126± NASince only 1 participant was analyzed, the geometric coefficient of variation was not calculated.
OG00787100± 31.6
OG008108000± 32.2
ParticipantsOG0041
ParticipantsOG0054
ParticipantsOG0064
ParticipantsOG0071
ParticipantsOG0081
Title
Measurements
OG002351000± 49
OG004393000± NASince only 1 participant was analyzed, the geometric coefficient of variation was not calculated.
OG005362000± 8.8
OG006370000± 9.8
OG007274000± NASince only 1 participant was analyzed, the geometric coefficient of variation was not calculated.
OG008345000± NASince only 1 participant was analyzed, the geometric coefficient of variation was not calculated.
ParticipantsOG00412
ParticipantsOG0055
ParticipantsOG0066
ParticipantsOG0076
ParticipantsOG0086
Title
Measurements
OG000143000± 34.3
OG00190200± 883.4
OG002149000± 45
OG00399700± 118.4
OG004132000± 45
OG005101000± 39.1
OG006121000± 21.6
OG007147000± 35.3
OG008156000± 20
ParticipantsOG0041
ParticipantsOG0055
ParticipantsOG0064
ParticipantsOG0073
ParticipantsOG0082
Title
Measurements
OG002120000± NASince only 1 participant was analyzed, the geometric coefficient of variation was not calculated.
OG004180000± NASince only 1 participant was analyzed, the geometric coefficient of variation was not calculated.
OG005124000± 83.8
OG006189000± 18.2
OG007178000± 41.7
OG008194000± 26.1
ParticipantsOG00411
ParticipantsOG0055
ParticipantsOG0065
ParticipantsOG0075
ParticipantsOG0084
Title
Measurements
OG000193000± 85.5
OG001105000± 1195.9
OG002216000± 50.7
OG003219000± 32
OG004246000± 33
OG005166000± 34.7
OG006230000± 16.1
OG007197000± 32.4
OG008247000± 9.7
ParticipantsOG00410
ParticipantsOG0056
ParticipantsOG0065
ParticipantsOG0076
ParticipantsOG0084
Title
Measurements
OG000347000± 12.4
OG001179000± 256.2
OG002283000± 23.8
OG003239000± 37
OG004283000± 16.7
OG005293000± 40.3
OG006293000± 18.3
OG007250000± 43.9
OG008247000± 46
ParticipantsOG0044
ParticipantsOG0054
ParticipantsOG0062
ParticipantsOG0073
ParticipantsOG0082
Title
Measurements
OG000376000± 11.9
OG001398000± 34.4
OG002345000± 55.9
OG003385000± 19.2
OG004293000± 7.1
OG005386000± 32.5
OG006545000± 29.6
OG007153000± 119.9
OG008357000± 10.3
ParticipantsOG0041
ParticipantsOG0051
ParticipantsOG0062
ParticipantsOG0072
ParticipantsOG0080
Title
Measurements
OG000333000± NASince only 1 participant was analyzed, the geometric coefficient of variation was not calculated.
OG001505000± 14.4
OG004285000± NASince only 1 participant was analyzed, the geometric coefficient of variation was not calculated.
OG005122000± NASince only 1 participant was analyzed, the geometric coefficient of variation was not calculated.
OG006384000± 11.8
OG007393000± 26
ParticipantsOG0040
ParticipantsOG0051
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
Title
Measurements
OG000562000± 40.3
OG001408000± 42
OG003388000± NASince only 1 participant was analyzed, the geometric coefficient of variation was not calculated.
OG005135000± NASince only 1 participant was analyzed, the geometric coefficient of variation was not calculated.