A Phase 1b/2 Study to Evaluate the Safety, Pharmacokinetics, and Clinical Activity of Oleclumab (MEDI9447) With or Without Durvalumab in Combination With Chemotherapy in Subjects With Metastatic Pancreatic Ductal Adenocarcinoma
Acronym
Not provided
Organization
MedImmune LLCINDUSTRY
Status Module
Record Verification Date
Sep 2023
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
Jun 21, 2018Actual
Primary Completion Date
Jul 22, 2022Actual
Completion Date
Jul 22, 2022Actual
First Submitted Date
May 18, 2018
First Submission Date that Met QC Criteria
Jul 26, 2018
First Posted Date
Aug 2, 2018Actual
Results Waived
Not provided
Results First Submitted Date
Jul 20, 2023
Results First Submitted that Met QC Criteria
Sep 8, 2023
Results First Posted Date
Oct 3, 2023Actual
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
Sep 8, 2023
Last Update Posted Date
Oct 3, 2023Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
MedImmune LLCINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
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
The objective of this study is to evaluate the safety, tolerability, and antitumor activity of oleclumab (MEDI9447) in combination with or without durvalumab plus chemotherapy in participants with metastatic pancreatic cancer.
Detailed Description
This is a Phase 1b/2, multicenter, open-label, dose-escalation, and dose-expansion study to assess the safety, preliminary antitumor activity, immunogenicity, and pharmacokinetics (PK) of oleclumab with or without durvalumab in combination with chemotherapy administered in participants with metastatic pancreatic ductal adenocarcinoma (PDAC). Participants with previously untreated metastatic PDAC (first-line [1L] metastatic PDAC) will be enrolled in Cohort A. Participants with metastatic PDAC previously treated with gemcitabine-based chemotherapy (without exposure to 5-fluorouracil [5-FU], capecitabine, or oxaliplatin; second-line [2L] metastatic PDAC) will be enrolled in Cohort B. The study consists of 2 parts, dose escalation (Part 1) and dose expansion (Part 2).
Participants with 1L metastatic disease will receive intravenous (IV) infusions of oleclumab 1500 mg every 2 weeks for 4 doses, then every 4 weeks (Q4W) in combination with durvalumab 1500 mg Q4W plus chemotherapy of gemcitabine 1000 mg/m^2 and nab-paclitaxel 125 mg/m^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion is met.
Participants with 1L metastatic disease will receive IV infusions of oleclumab 3000 mg every 2 weeks for 4 doses, then Q4W in combination with durvalumab 1500 mg Q4W plus chemotherapy of gemcitabine 1000 mg/m^2 and nab-paclitaxel 125 mg/m^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion is met.
Participants with 2L metastatic disease will receive IV infusions of oleclumab 1500 mg every 2 weeks for 4 doses, then Q4W in combination with durvalumab 1500 mg Q4W plus chemotherapy of mFOLFOX (oxaliplatin 85 mg/m^2 IV; folinic acid 400 mg/m^2 IV; 5-FU 400 mg/m^2 IV bolus followed by 2400 mg/m^2 continuous IV infusion over 46 to 48 hours) on Days 1 and 15 and then repeated on a Q4W schedule, until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion is met.
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Oleclumab
Drug
Participants will receive IV infusion of oleclumab as stated in arm description.
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) in Dose Escalation Phase
An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. The TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug.
Day 1 through 65.7 weeks (maximum observed duration)
Number of Participants With Dose-limiting Toxicities (DLTs) in Dose Escalation Phase
DLT: Any study drug related Grade (G)3 or higher toxicity including: any G4 immune-mediated AEs, >=G3 colitis/pneumonitis/interstitial lung disease (ILD), >=G3 nausea/vomiting/diarrhea that does not resolve to G2 or less within 3 days of maximal supportive care (MSC), G2 pneumonitis/ILD that does not resolve within 7 days of initiation of MSC, G4 anemia, G3 anemia with clinical sequelae/requires >2 units of red blood cells transfusion, G4 thrombocytopenia/neutropenia >=7 days, G3/4 thrombocytopenia with >=G3 hemorrhage, G4 febrile neutropenia (FN), G3 FN lasting >=5 days while receiving MSC, isolated G3 liver transaminase elevation (LTE)/ isolated G3 total bilirubin (TBL) that does not downgrade to G1 or less within 14 days of onset, isolated G4 LTE or TBL, elevated aspartate aminotransferase/alanine aminotransferase >3×upper limit of normal (ULN) and concurrent TBL >2×ULN without cholestasis or alternative explanations, any other toxicity judged as a DLT by Dose Escalation Committee.
From Day 1 to 28 days after the first dose of study drugs
Number of Participants With Abnormal Vital Signs Reported as TEAEs in Dose Escalation Phase
Number of participants with abnormal vital signs (temperature, blood pressure, pulse rate, and respiratory rate) reported as TEAEs are reported.
Secondary Outcomes
Measure
Description
Time Frame
Number of Participants With TEAEs and TESAEs in Dose Expansion Phase
An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. The TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Age >= 18
Written and signed informed consent must be obtained
Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1
Weight >= 35 kg
Participants must have histologically or cytologically, confirmed pancreatic adenocarcinoma:
Cohort A: Participants with previously untreated metastatic pancreatic adenocarcinoma (1L metastatic disease) not previously treated with systemic therapies Cohort B: Participants with metastatic pancreatic adenocarcinoma previously treated with gemcitabine-based chemotherapy (without exposure to 5-FU, capecitabine, oxaliplatin) 2L metastatic disease
Participants must have at least 1 measurable lesion according to RECIST v1.1
All Participants must consent to providing archival tumor specimens.
Exclusion Criteria:
Receipt of any conventional or investigational anticancer therapy within 21 days or palliative radiotherapy within 14 days prior to the scheduled first dose of study treatment.
Prior receipt of any immune-related therapy
Concurrent enrollment in another therapeutic clinical study. Enrollment in observational studies will be allowed.
Participants with a history of venous thrombosis within the past 3 months
Participants with prior history of myocardial infarction, transient ischemic attack, or stroke in the last 3 months prior to start of treatment
Active or prior documented autoimmune or inflammatory disorders within the past 3 years prior to the start of treatment
Other invasive malignancy within 2 years
Any history of leptomeningeal disease or cord compression
Current or prior use of immunosuppressive medication within 14 days prior to the first dose.
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool. Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
A total of 25 participants were treated in dose escalation part of this study. A total of 188 participants were randomised in dose expansion part of this study of which 170 participants were treated (18 participants were randomised but not treated). Results are presented for 195 treated participants only.
Participants with first-line (1L) metastatic disease received intravenous (IV) infusions of oleclumab 1500 mg every 2 weeks for 4 doses, then every 4 weeks (Q4W) in combination with durvalumab 1500 mg Q4W plus chemotherapy of gemcitabine 1000 mg/m^2 and nab-paclitaxel 125 mg/m^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.
Participants with 2L metastatic disease will receive IV infusions of oleclumab 3000 mg every 2 weeks for 4 doses, then Q4W in combination with durvalumab 1500 mg Q4W plus chemotherapy of mFOLFOX (oxaliplatin 85 mg/m^2 IV; folinic acid 400 mg/m^2 IV; 5-FU 400 mg/m^2 IV bolus followed by 2400 mg/m^2 continuous IV infusion over 46 to 48 hours) on Days 1 and 15 and then repeated on a Q4W schedule, until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion is met.
Drug: Oleclumab
Drug: Durvalumab
Drug: Oxaliplatin
Drug: Folinic acid
Drug: 5-FU
Dose-expansion, Gemcitabine + nab-paclitaxel
Active Comparator
Participants with 1L metastatic disease will receive IV infusions of chemotherapy of gemcitabine 1000 mg/m^2 and nab-paclitaxel 125 mg/m^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion is met.
Participants with 1L metastatic disease will receive IV infusions of oleclumab 3000 mg every 2 weeks for 4 doses, then Q4W in combination with chemotherapy of gemcitabine 1000 mg/m^2 and nab-paclitaxel 125 mg/m^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion is met.
Participants with 1L metastatic disease will receive IV infusions of oleclumab 3000 mg every 2 weeks for 4 doses, then Q4W in combination with durvalumab 1500 mg Q4W plus chemotherapy of gemcitabine 1000 mg/m^2 and nab-paclitaxel 125 mg/m^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion is met.
Modified FOLFOX (oxaliplatin, folinic acid, and 5-FU)
Day 1 through 65.7 weeks (maximum observed duration)
Number of Participants With Abnormal Electrocardiogram (ECG) Parameters Reported as TEAEs in Dose Escalation Phase
Number of participants with abnormal ECG parameters reported as TEAEs are reported.
Day 1 through 65.7 weeks (maximum observed duration)
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs in Dose Escalation Phase
Number of participants with abnormal clinical laboratory parameters reported as TEAEs are reported.
Day 1 through 65.7 weeks (maximum observed duration)
Percentage of Participants With Objective Response (OR) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) in Dose Expansion Phase
The OR is defined as best overall response of confirmed complete response (CR) or confirmed partial response (PR) based on RECIST v1.1 guidelines. The CR is defined as disappearance of all target lesions (TLs) and non-target lesions (NTLs), any pathological lymph nodes (target and non-target) must have reduction in short axis < 10 mm, and no new lesions. The PR is defined as at least a 30% decrease in the sum of the diameters (SoD) of TLs (compared to baseline) and no new lesions. Confirmation of CR and PR is required by a repeat, consecutive assessment no less than 4 weeks from the date of first documentation. Percentage of participants with OR is reported.
Baseline (Days -28 to -1) through 36.1 months (maximum observed duration)
Day 1 through 172.1 weeks (maximum observed duration)
Number of Participants With Abnormal Vital Signs Reported as TEAEs in Dose Expansion Phase
Number of participants with abnormal vital signs (temperature, blood pressure, pulse rate, and respiratory rate) reported as TEAEs are reported.
Day 1 through 172.1 weeks (maximum observed duration)
Number of Participants With Abnormal ECG Parameters Reported as TEAEs in Dose Expansion Phase
Number of participants with abnormal ECG parameters reported as TEAEs are reported.
Day 1 through 172.1 weeks (maximum observed duration)
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs in Dose Expansion Phase
Number of participants with abnormal clinical laboratory parameters reported as TEAEs are reported.
Day 1 through 172.1 weeks (maximum observed duration)
Percentage of Participants With OR According to RECIST v1.1 in Dose Escalation Phase
The OR is defined as best overall response of confirmed CR or confirmed PR based on RECIST v1.1 guidelines. The CR is defined as disappearance of all target and non-target lesions, any pathological lymph nodes (target and non-target) must have reduction in short axis < 10 mm, and no new lesions. The PR is defined as at least a 30% decrease in the sum of the diameters of target lesions (compared to baseline) and no new lesions. Confirmation of CR and PR is required by a repeat, consecutive assessment no less than 4 weeks from the date of first documentation. Percentage of participants with OR is reported.
Baseline (Days -28 to -1) through 24.5 months (maximum observed duration)
Percentage of Participants With Disease Control (DC) According to RECIST v1.1 in Dose Escalation Phase
The DC is defined as confirmed CR, PR, or stable disease (SD) (maintained for >=8 weeks). The CR is defined as disappearance of all TLs and NTLs, any pathological lymph nodes (target and non-target) must have reduction in short axis <10 mm, and no new lesions. The PR is defined as at least a 30% decrease in the SoD of TLs (compared to baseline) and no new lesions. Confirmation of CR and PR is required by a repeat, consecutive assessment no less than 4 weeks from date of first documentation. The SD is defined as neither sufficient shrinkage of TLs to qualify for PR nor sufficient increase of TLs to qualify for progressive disease (PD), taking as reference the smallest SoD while on study, and no new lesions. The PD is defined as at least a 20% increase in SoD of TLs, taking as reference the smallest sum on study and an absolute increase of at least 5 mm of SoD, or unequivocal progression of existing NTLs, or the appearance of new lesion/s. Percentage of participants with DC is reported.
Baseline (Days -28 to -1) through 24.5 months (maximum observed duration)
Number of Participants With Overall Survival Events in Dose Expansion Phase
The overall survival is defined as the time from the randomization until death due to any cause. For participants who were alive at the time of data cut off, overall survival was censored on the last date when participants were known to be alive. The overall survival is assessed using the Kaplan-Meier method. The number of participants with overall survival events (deaths) is reported.
Baseline (Days -28 to -1) through 38.7 months (maximum observed duration)
Overall Survival in Dose Expansion Phase
The overall survival is defined as the time from the randomization until death due to any cause. For participants who were alive at the time of data cut off, overall survival was censored on the last date when participants were known to be alive. The overall survival is assessed using the Kaplan-Meier method.
Baseline (Days -28 to -1) through 38.7 months (maximum observed duration)
Number of Participants With Progression-free Survival Events According to RECIST v1.1 in Dose Expansion Phase
Progression-free survival (PFS) is defined as the time from randomization until the first documentation of a PD or death due to any cause, whichever occurred first, regardless of whether the participant received subsequent anticancer treatment prior to progression. The PD is defined as at least a 20% increase in sum of the diameters of target lesions, taking as reference the smallest sum on study and an absolute increase of at least 5 mm of sum of the diameters, or unequivocal progression of existing non-target lesions, or the appearance of new lesion/s. Participants who had no documented progression and were still alive at the time of analysis were censored at the time of the latest date of assessment from their last evaluable RECIST v1.1 assessment. The PFS is assessed using the Kaplan-Meier method. The number of participants with PFS events is reported.
Baseline (Days -28 to -1) through 36.1 months (maximum observed duration)
Progression-free Survival According to RECIST v1.1 in Dose Expansion Phase
The PFS is defined as the time from randomization until the first documentation of a PD or death due to any cause, whichever occurred first, regardless of whether the participant received subsequent anticancer treatment prior to progression. The PD is defined as at least a 20% increase in sum of the diameters of target lesions, taking as reference the smallest sum on study and an absolute increase of at least 5 mm of sum of the diameters, or unequivocal progression of existing non-target lesions, or the appearance of new lesion/s. Participants who had no documented progression and were still alive at the time of analysis were censored at the time of the latest date of assessment from their last evaluable RECIST v1.1 assessment. The PFS is assessed using the Kaplan-Meier method.
Baseline (Days -28 to -1) through 36.1 months (maximum observed duration)
Duration of Response (DoR) According to RECIST v1.1 in Dose Expansion Phase
The DoR is defined as the time from the first documentation of an OR until the first documentation of a PD or death due to any cause, whichever occurs first. The OR is defined as best overall response of confirmed CR or PR based on RECIST v1.1 guidelines. The CR is defined as disappearance of all TLs and NTLs, any pathological lymph nodes (target and non-target) must have reduction in short axis < 10 mm, and no new lesions. The PR is defined as at least a 30% decrease in the SoD of TLs (compared to baseline) and no new lesions. Confirmation of CR and PR is required by a repeat, consecutive assessment no less than 4 weeks from the date of first documentation. The PD is defined as at least a 20% increase in SoD of TLs, taking as reference the smallest sum on study and an absolute increase of at least 5 mm of SoD, or unequivocal progression of existing NTLs, or the appearance of new lesion/s. The DoR is assessed using the Kaplan-Meier method.
Baseline (Days -28 to -1) through 36.1 months (maximum observed duration)
Percentage of Participants With DC According to RECIST v1.1 in Dose Expansion Phase
The DC is defined as confirmed CR, PR, or stable disease (SD) (maintained for >=8 weeks). The CR is defined as disappearance of all TLs and NTLs, any pathological lymph nodes (target and non-target) must have reduction in short axis <10 mm, and no new lesions. The PR is defined as at least a 30% decrease in the SoD of TLs (compared to baseline) and no new lesions. Confirmation of CR and PR is required by a repeat, consecutive assessment no less than 4 weeks from date of first documentation. The SD is defined as neither sufficient shrinkage of TLs to qualify for PR nor sufficient increase of TLs to qualify for PD, taking as reference the smallest SoD while on study, and no new lesions. The PD is defined as at least a 20% increase in SoD of TLs, taking as reference the smallest sum on study and an absolute increase of at least 5 mm of SoD, or unequivocal progression of existing NTLs, or the appearance of new lesion/s. Percentage of participants with DC is reported.
Baseline (Days -28 to -1) through 36.1 months (maximum observed duration)
Percentage of Participants With OR According to RECIST v1.1 by CD73 Expression at Baseline in Dose Expansion Phase
The OR is defined as best overall response of confirmed CR or confirmed PR based on RECIST v1.1. The CR is defined as disappearance of all TLs and NTLs, any pathological lymph nodes (target and non-target) must have reduction in short axis <10 mm, and no new lesions. The PR is defined as at least a 30% decrease in the SoD of TLs (compared to baseline) and no new lesions. Confirmation of CR and PR is required by a repeat, consecutive assessment no less than 4 weeks from the date of first documentation. The OR is assessed by cluster of differentiation 73 (CD73) expression level either low or high at baseline. The CD73 low is defined as no CD73 expression in tumor cells or <50% of tumor cells with 2+ or 3+ intensity and CD73 high is defined as CD73 expression with 2+ or 3+ intensity in >=50% of tumor cells.
Baseline (Days -28 to -1) through 36.1 months (maximum observed duration)
Number of Participants With Overall Survival Events by CD73 Expression at Baseline in Dose Expansion Phase
The overall survival is defined as the time from the randomization until death due to any cause. For participants who were alive at the time of data cut off, overall survival was censored on the last date when participants were known to be alive. The overall survival is assessed by CD73 expression level either low or high at baseline using the Kaplan-Meier method. The CD73 low is defined as no CD73 expression in tumor cells or <50% of tumor cells with 2+ or 3+ intensity and CD73 high is defined as CD73 expression with 2+ or 3+ intensity in >=50% of tumor cells. The number of participants with overall survival events (deaths) is reported.
Baseline (Days -28 to -1) through 38.7 months (maximum observed duration)
Overall Survival by CD73 Expression at Baseline in Dose Expansion Phase
The overall survival is defined as the time from the randomization until death due to any cause. For participants who were alive at the time of data cut off, overall survival was censored on the last date when participants were known to be alive. The overall survival is assessed by CD73 expression level either low or high at baseline using the Kaplan-Meier method. The CD73 low is defined as no CD73 expression in tumor cells or <50% of tumor cells with 2+ or 3+ intensity and CD73 high is defined as CD73 expression with 2+ or 3+ intensity in >=50% of tumor cells.
Baseline (Days -28 to -1) through 38.7 months (maximum observed duration)
Number of Participants With Progression-free Survival Events According to RECIST v1.1 by CD73 Expression at Baseline in Dose Expansion Phase
PFS: Time from randomization until first documentation of PD/death due to any cause, whichever occurred first, regardless of whether participant received subsequent anticancer treatment prior to progression. PD:>=20% increase in SoD of TLs and an absolute increase of >= 5 mm of SoD/unequivocal progression of existing NTLs/appearance of new lesion. Participants who had no documented progression and were still alive at the time of analysis were censored at time of latest date of assessment from their last evaluable RECIST v1.1 assessment. PFS is assessed by CD73 expression level either low/high at baseline using Kaplan-Meier method. CD73 low: No CD73 expression in tumor cells/<50% of tumor cells with 2+/3+ intensity. CD73 high: CD73 expression with 2+/3+ intensity in >=50% of tumor cells. Number of participants with PFS events is reported.
Baseline (Days -28 to -1) through 36.1 months (maximum observed duration)
Progression-free Survival According to RECIST v1.1 by CD73 Expression at Baseline in Dose Expansion Phase
The PFS is defined as the time from randomization until the first documentation of a PD or death due to any cause, whichever occurred first, regardless of whether the participant receives subsequent anticancer treatment prior to progression. The PD is defined as at least a 20% increase in SoD of TLs, taking as reference the smallest sum on study and an absolute increase of at least 5 mm of SoD, or unequivocal progression of existing NTLs, or the appearance of new lesion/s. Participants who had no documented progression and were still alive at time of analysis were censored at time of latest date of assessment from their last evaluable RECIST v1.1 assessment. PFS is assessed by CD73 expression level either low/high at baseline using Kaplan-Meier method. CD73 low: No CD73 expression in tumor cells/<50% of tumor cells with 2+/3+ intensity. CD73 high: CD73 expression with 2+/3+ intensity in >=50% of tumor cells.
Baseline (Days -28 to -1) through 36.1 months (maximum observed duration)
Number of Participants With Positive Anti-drug Antibodies (ADA) to Oleclumab
Number of participants with positive ADA to oleclumab are reported. Persistent positive is defined as positive at >= 2 post-baseline assessments (with >=16 weeks between first and last positive) or positive at last post-baseline assessment. Transient positive is defined as negative at last post-baseline assessment and positive at only one post-baseline assessment or at >= 2 post-baseline assessments (with <16 weeks between first and last positive). Treatment-boosted ADA is defined as baseline ADA positive titer that was boosted to a 4-fold or higher level following drug administration.
Day 1 through 172.1 weeks (Pre-dose on Cycle [C] 1 Day [D] 1, C2D1, C3D1, Day 1 of every 3 cycles starting with C5, through 12 weeks post last dose of oleclumab)
Number of Participants With Positive ADA to Durvalumab
Number of participants with positive ADA to durvalumab are reported. Persistent positive is defined as positive at >= 2 post-baseline assessments (with >=16 weeks between first and last positive) or positive at last post-baseline assessment. Transient positive is defined as negative at last post-baseline assessment and positive at only one post-baseline assessment or at >= 2 post-baseline assessments (with <16 weeks between first and last positive). Treatment-boosted ADA is defined as baseline ADA positive titer that was boosted to a 4-fold or higher level following drug administration.
Day 1 through 128 weeks (Pre-dose on C1D1, C2D1, C3D1, Day 1 of every 3 cycles starting with C5, through 12 weeks post last dose of durvalumab)
Serum Concentrations of Oleclumab
Serum concentrations of oleclumab are reported.
Ten minutes (mins) (± 5 mins) post end of infusion (EOI), approximately 1 hour (+ 15 mins) after start of infusion on C1D1, C3D1, and C5D1; and pre-dose on C3D1 and C5D1
Serum Concentrations of Durvalumab
Serum concentrations of durvalumab are reported.
Ten mins (± 5 mins) post EOI, approximately 1 hour (+ 15 mins) after start of infusion on C1D1 and C5D1; and pre-dose on C2D1 and C5D1
Plasma Concentrations of Gemcitabine and Metabolite 2',2'-Difluorodeoxyuridine (dFdU)
Plasma concentrations of gemcitabine and metabolite dFdU are reported.
Ten mins (± 5 mins) post EOI, approximately 30-40 mins after start of infusion on C1D1 and C4D1; and pre-dose on C4D1
Plasma Concentrations of Nab-paclitaxel
Plasma concentrations of nab-paclitaxel are reported.
Ten mins (± 5 mins) post EOI, approximately 30-40 mins after start of infusion on C1D1 and C4D1; and pre-dose on C4D1
Participants with 1L metastatic disease received IV infusions of oleclumab 3000 mg every 2 weeks for 4 doses, then Q4W in combination with durvalumab 1500 mg Q4W plus chemotherapy of gemcitabine 1000 mg/m^2 and nab-paclitaxel 125 mg/m^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.
Participants with second-line (2L) metastatic disease received IV infusions of oleclumab 1500 mg every 2 weeks for 4 doses, then Q4W in combination with durvalumab 1500 mg Q4W plus chemotherapy of mFOLFOX (oxaliplatin 85 mg/m^2 IV; folinic acid 400 mg/m^2 IV; fluorouracil [5-FU] 400 mg/m^2 IV bolus followed by 2400 mg/m^2 continuous IV infusion over 46 to 48 hours) on Days 1 and 15 and then repeated on a Q4W schedule, until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.
Participants with 2L metastatic disease received IV infusions of oleclumab 3000 mg every 2 weeks for 4 doses, then Q4W in combination with durvalumab 1500 mg Q4W plus chemotherapy of mFOLFOX (oxaliplatin 85 mg/m^2 IV; folinic acid 400 mg/m^2 IV; 5-FU 400 mg/m^2 IV bolus followed by 2400 mg/m^2 continuous IV infusion over 46 to 48 hours) on Days 1 and 15 and then repeated on a Q4W schedule, until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.
FG004
Dose-expansion, Gemcitabine + Nab-paclitaxel
Participants with 1L metastatic disease received IV infusions of chemotherapy of gemcitabine 1000 mg/m^2 and nab-paclitaxel 125 mg/m^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.
Participants with 1L metastatic disease received IV infusions of oleclumab 3000 mg every 2 weeks for 4 doses, then Q4W in combination with chemotherapy of gemcitabine 1000 mg/m^2 and nab-paclitaxel 125 mg/m^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.
Participants with 1L metastatic disease received IV infusions of oleclumab 3000 mg every 2 weeks for 4 doses, then Q4W in combination with durvalumab 1500 mg Q4W plus chemotherapy of gemcitabine 1000 mg/m^2 and nab-paclitaxel 125 mg/m^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.
FG0007 subjects
FG0017 subjects
FG0023 subjects
FG0038 subjects
FG00462 subjects
FG00538 subjects
FG00670 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
NOT COMPLETED
FG0007 subjects
FG0017 subjects
FG0023 subjects
FG0038 subjects
FG00462 subjects
FG00538 subjects
FG00670 subjects
Type
Comment
Reasons
Death
FG0007 subjects
FG0017 subjects
FG0023 subjects
FG0038 subjects
FG00447 subjects
FG00532 subjects
FG00653 subjects
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Sponsor decision
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Reasons
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Participants with 1L metastatic disease received IV infusions of oleclumab 1500 mg every 2 weeks for 4 doses, then Q4W in combination with durvalumab 1500 mg Q4W plus chemotherapy of gemcitabine 1000 mg/m^2 and nab-paclitaxel 125 mg/m^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.
Participants with 1L metastatic disease received IV infusions of oleclumab 3000 mg every 2 weeks for 4 doses, then Q4W in combination with durvalumab 1500 mg Q4W plus chemotherapy of gemcitabine 1000 mg/m^2 and nab-paclitaxel 125 mg/m^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.
Participants with second-line (2L) metastatic disease received IV infusions of oleclumab 1500 mg every 2 weeks for 4 doses, then Q4W in combination with durvalumab 1500 mg Q4W plus chemotherapy of mFOLFOX (oxaliplatin 85 mg/m^2 IV; folinic acid 400 mg/m^2 IV; fluorouracil [5-FU] 400 mg/m^2 IV bolus followed by 2400 mg/m^2 continuous IV infusion over 46 to 48 hours) on Days 1 and 15 and then repeated on a Q4W schedule, until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.
Participants with 2L metastatic disease received IV infusions of oleclumab 3000 mg every 2 weeks for 4 doses, then Q4W in combination with durvalumab 1500 mg Q4W plus chemotherapy of mFOLFOX (oxaliplatin 85 mg/m^2 IV; folinic acid 400 mg/m^2 IV; 5-FU 400 mg/m^2 IV bolus followed by 2400 mg/m^2 continuous IV infusion over 46 to 48 hours) on Days 1 and 15 and then repeated on a Q4W schedule, until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.
BG004
Dose-expansion, Gemcitabine + Nab-paclitaxel
Participants with 1L metastatic disease received IV infusions of chemotherapy of gemcitabine 1000 mg/m^2 and nab-paclitaxel 125 mg/m^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.
Participants with 1L metastatic disease received IV infusions of oleclumab 3000 mg every 2 weeks for 4 doses, then Q4W in combination with chemotherapy of gemcitabine 1000 mg/m^2 and nab-paclitaxel 125 mg/m^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.
Participants with 1L metastatic disease received IV infusions of oleclumab 3000 mg every 2 weeks for 4 doses, then Q4W in combination with durvalumab 1500 mg Q4W plus chemotherapy of gemcitabine 1000 mg/m^2 and nab-paclitaxel 125 mg/m^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.
BG007
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0007
BG0017
BG0023
BG0038
BG00462
BG00538
BG00670
BG007195
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
BG00066.7± 12.8
BG00159.6± 11.4
BG00267.0± 14.9
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0003
BG0014
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0000
BG0010
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) in Dose Escalation Phase
An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. The TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug.
As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Posted
Count of Participants
Participants
Day 1 through 65.7 weeks (maximum observed duration)
Participants with 1L metastatic disease received IV infusions of oleclumab 1500 mg every 2 weeks for 4 doses, then Q4W in combination with durvalumab 1500 mg Q4W plus chemotherapy of gemcitabine 1000 mg/m^2 and nab-paclitaxel 125 mg/m^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.
Participants with 1L metastatic disease received IV infusions of oleclumab 3000 mg every 2 weeks for 4 doses, then Q4W in combination with durvalumab 1500 mg Q4W plus chemotherapy of gemcitabine 1000 mg/m^2 and nab-paclitaxel 125 mg/m^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.
Participants with 2L metastatic disease received IV infusions of oleclumab 1500 mg every 2 weeks for 4 doses, then Q4W in combination with durvalumab 1500 mg Q4W plus chemotherapy of mFOLFOX (oxaliplatin 85 mg/m^2 IV; folinic acid 400 mg/m^2 IV; fluorouracil [5-FU] 400 mg/m^2 IV bolus followed by 2400 mg/m^2 continuous IV infusion over 46 to 48 hours) on Days 1 and 15 and then repeated on a Q4W schedule, until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.
Participants with 2L metastatic disease received IV infusions of oleclumab 3000 mg every 2 weeks for 4 doses, then Q4W in combination with durvalumab 1500 mg Q4W plus chemotherapy of mFOLFOX (oxaliplatin 85 mg/m^2 IV; folinic acid 400 mg/m^2 IV; 5-FU 400 mg/m^2 IV bolus followed by 2400 mg/m^2 continuous IV infusion over 46 to 48 hours) on Days 1 and 15 and then repeated on a Q4W schedule, until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.
Units
Counts
Participants
OG0007
OG0017
OG0023
OG003
Title
Denominators
Categories
Any TEAEs
Title
Measurements
OG0007
OG0017
OG0023
OG003
Primary
Number of Participants With Dose-limiting Toxicities (DLTs) in Dose Escalation Phase
DLT: Any study drug related Grade (G)3 or higher toxicity including: any G4 immune-mediated AEs, >=G3 colitis/pneumonitis/interstitial lung disease (ILD), >=G3 nausea/vomiting/diarrhea that does not resolve to G2 or less within 3 days of maximal supportive care (MSC), G2 pneumonitis/ILD that does not resolve within 7 days of initiation of MSC, G4 anemia, G3 anemia with clinical sequelae/requires >2 units of red blood cells transfusion, G4 thrombocytopenia/neutropenia >=7 days, G3/4 thrombocytopenia with >=G3 hemorrhage, G4 febrile neutropenia (FN), G3 FN lasting >=5 days while receiving MSC, isolated G3 liver transaminase elevation (LTE)/ isolated G3 total bilirubin (TBL) that does not downgrade to G1 or less within 14 days of onset, isolated G4 LTE or TBL, elevated aspartate aminotransferase/alanine aminotransferase >3×upper limit of normal (ULN) and concurrent TBL >2×ULN without cholestasis or alternative explanations, any other toxicity judged as a DLT by Dose Escalation Committee.
The DLT-evaluable population included all participants enrolled in the dose-escalation phase who received all planned doses of study drugs during the DLT evaluation period and completed the safety follow-up through the DLT evaluation period or experienced any DLT during the DLT-evaluation period.
Posted
Count of Participants
Participants
From Day 1 to 28 days after the first dose of study drugs
Participants with 1L metastatic disease received IV infusions of oleclumab 1500 mg every 2 weeks for 4 doses, then Q4W in combination with durvalumab 1500 mg Q4W plus chemotherapy of gemcitabine 1000 mg/m^2 and nab-paclitaxel 125 mg/m^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.
Primary
Number of Participants With Abnormal Vital Signs Reported as TEAEs in Dose Escalation Phase
Number of participants with abnormal vital signs (temperature, blood pressure, pulse rate, and respiratory rate) reported as TEAEs are reported.
As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Posted
Count of Participants
Participants
Day 1 through 65.7 weeks (maximum observed duration)
Participants with 1L metastatic disease received IV infusions of oleclumab 1500 mg every 2 weeks for 4 doses, then Q4W in combination with durvalumab 1500 mg Q4W plus chemotherapy of gemcitabine 1000 mg/m^2 and nab-paclitaxel 125 mg/m^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.
Participants with 1L metastatic disease received IV infusions of oleclumab 3000 mg every 2 weeks for 4 doses, then Q4W in combination with durvalumab 1500 mg Q4W plus chemotherapy of gemcitabine 1000 mg/m^2 and nab-paclitaxel 125 mg/m^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.
Primary
Number of Participants With Abnormal Electrocardiogram (ECG) Parameters Reported as TEAEs in Dose Escalation Phase
Number of participants with abnormal ECG parameters reported as TEAEs are reported.
As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Posted
Count of Participants
Participants
Day 1 through 65.7 weeks (maximum observed duration)
Participants with 1L metastatic disease received IV infusions of oleclumab 1500 mg every 2 weeks for 4 doses, then Q4W in combination with durvalumab 1500 mg Q4W plus chemotherapy of gemcitabine 1000 mg/m^2 and nab-paclitaxel 125 mg/m^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.
Participants with 1L metastatic disease received IV infusions of oleclumab 3000 mg every 2 weeks for 4 doses, then Q4W in combination with durvalumab 1500 mg Q4W plus chemotherapy of gemcitabine 1000 mg/m^2 and nab-paclitaxel 125 mg/m^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.
Primary
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs in Dose Escalation Phase
Number of participants with abnormal clinical laboratory parameters reported as TEAEs are reported.
As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Posted
Count of Participants
Participants
Day 1 through 65.7 weeks (maximum observed duration)
Participants with 1L metastatic disease received IV infusions of oleclumab 1500 mg every 2 weeks for 4 doses, then Q4W in combination with durvalumab 1500 mg Q4W plus chemotherapy of gemcitabine 1000 mg/m^2 and nab-paclitaxel 125 mg/m^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.
Participants with 1L metastatic disease received IV infusions of oleclumab 3000 mg every 2 weeks for 4 doses, then Q4W in combination with durvalumab 1500 mg Q4W plus chemotherapy of gemcitabine 1000 mg/m^2 and nab-paclitaxel 125 mg/m^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.
Primary
Percentage of Participants With Objective Response (OR) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) in Dose Expansion Phase
The OR is defined as best overall response of confirmed complete response (CR) or confirmed partial response (PR) based on RECIST v1.1 guidelines. The CR is defined as disappearance of all target lesions (TLs) and non-target lesions (NTLs), any pathological lymph nodes (target and non-target) must have reduction in short axis < 10 mm, and no new lesions. The PR is defined as at least a 30% decrease in the sum of the diameters (SoD) of TLs (compared to baseline) and no new lesions. Confirmation of CR and PR is required by a repeat, consecutive assessment no less than 4 weeks from the date of first documentation. Percentage of participants with OR is reported.
The intent-to treat (ITT) population included all participants who were randomized and received any study drugs and were analyzed according to randomized treatment assignment.
Posted
Number
95% Confidence Interval
Percentage of Participants
Baseline (Days -28 to -1) through 36.1 months (maximum observed duration)
ID
Title
Description
OG000
Dose-expansion, Gemcitabine + Nab-paclitaxel
Participants with 1L metastatic disease received IV infusions of chemotherapy of gemcitabine 1000 mg/m^2 and nab-paclitaxel 125 mg/m^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.
Number of Participants With TEAEs and TESAEs in Dose Expansion Phase
An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. The TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug.
As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Posted
Count of Participants
Participants
Day 1 through 172.1 weeks (maximum observed duration)
ID
Title
Description
OG000
Dose-expansion, Gemcitabine + Nab-paclitaxel
Participants with 1L metastatic disease received IV infusions of chemotherapy of gemcitabine 1000 mg/m^2 and nab-paclitaxel 125 mg/m^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.
Participants with 1L metastatic disease received IV infusions of oleclumab 3000 mg every 2 weeks for 4 doses, then Q4W in combination with chemotherapy of gemcitabine 1000 mg/m^2 and nab-paclitaxel 125 mg/m^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.
Secondary
Number of Participants With Abnormal Vital Signs Reported as TEAEs in Dose Expansion Phase
Number of participants with abnormal vital signs (temperature, blood pressure, pulse rate, and respiratory rate) reported as TEAEs are reported.
As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Posted
Count of Participants
Participants
Day 1 through 172.1 weeks (maximum observed duration)
ID
Title
Description
OG000
Dose-expansion, Gemcitabine + Nab-paclitaxel
Participants with 1L metastatic disease received IV infusions of chemotherapy of gemcitabine 1000 mg/m^2 and nab-paclitaxel 125 mg/m^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.
Participants with 1L metastatic disease received IV infusions of oleclumab 3000 mg every 2 weeks for 4 doses, then Q4W in combination with chemotherapy of gemcitabine 1000 mg/m^2 and nab-paclitaxel 125 mg/m^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.
Secondary
Number of Participants With Abnormal ECG Parameters Reported as TEAEs in Dose Expansion Phase
Number of participants with abnormal ECG parameters reported as TEAEs are reported.
As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Posted
Count of Participants
Participants
Day 1 through 172.1 weeks (maximum observed duration)
ID
Title
Description
OG000
Dose-expansion, Gemcitabine + Nab-paclitaxel
Participants with 1L metastatic disease received IV infusions of chemotherapy of gemcitabine 1000 mg/m^2 and nab-paclitaxel 125 mg/m^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.
Participants with 1L metastatic disease received IV infusions of oleclumab 3000 mg every 2 weeks for 4 doses, then Q4W in combination with chemotherapy of gemcitabine 1000 mg/m^2 and nab-paclitaxel 125 mg/m^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.
OG002
Secondary
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs in Dose Expansion Phase
Number of participants with abnormal clinical laboratory parameters reported as TEAEs are reported.
As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Posted
Count of Participants
Participants
Day 1 through 172.1 weeks (maximum observed duration)
ID
Title
Description
OG000
Dose-expansion, Gemcitabine + Nab-paclitaxel
Participants with 1L metastatic disease received IV infusions of chemotherapy of gemcitabine 1000 mg/m^2 and nab-paclitaxel 125 mg/m^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.
Participants with 1L metastatic disease received IV infusions of oleclumab 3000 mg every 2 weeks for 4 doses, then Q4W in combination with chemotherapy of gemcitabine 1000 mg/m^2 and nab-paclitaxel 125 mg/m^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.
OG002
Secondary
Percentage of Participants With OR According to RECIST v1.1 in Dose Escalation Phase
The OR is defined as best overall response of confirmed CR or confirmed PR based on RECIST v1.1 guidelines. The CR is defined as disappearance of all target and non-target lesions, any pathological lymph nodes (target and non-target) must have reduction in short axis < 10 mm, and no new lesions. The PR is defined as at least a 30% decrease in the sum of the diameters of target lesions (compared to baseline) and no new lesions. Confirmation of CR and PR is required by a repeat, consecutive assessment no less than 4 weeks from the date of first documentation. Percentage of participants with OR is reported.
As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Posted
Number
95% Confidence Interval
Percentage of Participants
Baseline (Days -28 to -1) through 24.5 months (maximum observed duration)
Participants with 1L metastatic disease received IV infusions of oleclumab 1500 mg every 2 weeks for 4 doses, then Q4W in combination with durvalumab 1500 mg Q4W plus chemotherapy of gemcitabine 1000 mg/m^2 and nab-paclitaxel 125 mg/m^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.
Percentage of Participants With Disease Control (DC) According to RECIST v1.1 in Dose Escalation Phase
The DC is defined as confirmed CR, PR, or stable disease (SD) (maintained for >=8 weeks). The CR is defined as disappearance of all TLs and NTLs, any pathological lymph nodes (target and non-target) must have reduction in short axis <10 mm, and no new lesions. The PR is defined as at least a 30% decrease in the SoD of TLs (compared to baseline) and no new lesions. Confirmation of CR and PR is required by a repeat, consecutive assessment no less than 4 weeks from date of first documentation. The SD is defined as neither sufficient shrinkage of TLs to qualify for PR nor sufficient increase of TLs to qualify for progressive disease (PD), taking as reference the smallest SoD while on study, and no new lesions. The PD is defined as at least a 20% increase in SoD of TLs, taking as reference the smallest sum on study and an absolute increase of at least 5 mm of SoD, or unequivocal progression of existing NTLs, or the appearance of new lesion/s. Percentage of participants with DC is reported.
As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Posted
Number
95% Confidence Interval
Percentage of Participants
Baseline (Days -28 to -1) through 24.5 months (maximum observed duration)
Participants with 1L metastatic disease received IV infusions of oleclumab 1500 mg every 2 weeks for 4 doses, then Q4W in combination with durvalumab 1500 mg Q4W plus chemotherapy of gemcitabine 1000 mg/m^2 and nab-paclitaxel 125 mg/m^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.
Secondary
Number of Participants With Overall Survival Events in Dose Expansion Phase
The overall survival is defined as the time from the randomization until death due to any cause. For participants who were alive at the time of data cut off, overall survival was censored on the last date when participants were known to be alive. The overall survival is assessed using the Kaplan-Meier method. The number of participants with overall survival events (deaths) is reported.
The ITT population included all participants who were randomized and received any amount of study drugs and were analyzed according to randomized treatment assignment.
Posted
Number
Participants with event
Baseline (Days -28 to -1) through 38.7 months (maximum observed duration)
ID
Title
Description
OG000
Dose-expansion, Gemcitabine + Nab-paclitaxel
Participants with 1L metastatic disease received IV infusions of chemotherapy of gemcitabine 1000 mg/m^2 and nab-paclitaxel 125 mg/m^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.
Participants with 1L metastatic disease received IV infusions of oleclumab 3000 mg every 2 weeks for 4 doses, then Q4W in combination with chemotherapy of gemcitabine 1000 mg/m^2 and nab-paclitaxel 125 mg/m^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.
Secondary
Overall Survival in Dose Expansion Phase
The overall survival is defined as the time from the randomization until death due to any cause. For participants who were alive at the time of data cut off, overall survival was censored on the last date when participants were known to be alive. The overall survival is assessed using the Kaplan-Meier method.
The ITT population included all participants who were randomized and received any amount of study drugs and were analyzed according to randomized treatment assignment.
Posted
Median
95% Confidence Interval
Months
Baseline (Days -28 to -1) through 38.7 months (maximum observed duration)
ID
Title
Description
OG000
Dose-expansion, Gemcitabine + Nab-paclitaxel
Participants with 1L metastatic disease received IV infusions of chemotherapy of gemcitabine 1000 mg/m^2 and nab-paclitaxel 125 mg/m^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.
Participants with 1L metastatic disease received IV infusions of oleclumab 3000 mg every 2 weeks for 4 doses, then Q4W in combination with chemotherapy of gemcitabine 1000 mg/m^2 and nab-paclitaxel 125 mg/m^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.
Secondary
Number of Participants With Progression-free Survival Events According to RECIST v1.1 in Dose Expansion Phase
Progression-free survival (PFS) is defined as the time from randomization until the first documentation of a PD or death due to any cause, whichever occurred first, regardless of whether the participant received subsequent anticancer treatment prior to progression. The PD is defined as at least a 20% increase in sum of the diameters of target lesions, taking as reference the smallest sum on study and an absolute increase of at least 5 mm of sum of the diameters, or unequivocal progression of existing non-target lesions, or the appearance of new lesion/s. Participants who had no documented progression and were still alive at the time of analysis were censored at the time of the latest date of assessment from their last evaluable RECIST v1.1 assessment. The PFS is assessed using the Kaplan-Meier method. The number of participants with PFS events is reported.
The ITT population included all participants who were randomized and received any amount of study drugs and were analyzed according to randomized treatment assignment.
Posted
Number
Participants with event
Baseline (Days -28 to -1) through 36.1 months (maximum observed duration)
ID
Title
Description
OG000
Dose-expansion, Gemcitabine + Nab-paclitaxel
Participants with 1L metastatic disease received IV infusions of chemotherapy of gemcitabine 1000 mg/m^2 and nab-paclitaxel 125 mg/m^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.
Secondary
Progression-free Survival According to RECIST v1.1 in Dose Expansion Phase
The PFS is defined as the time from randomization until the first documentation of a PD or death due to any cause, whichever occurred first, regardless of whether the participant received subsequent anticancer treatment prior to progression. The PD is defined as at least a 20% increase in sum of the diameters of target lesions, taking as reference the smallest sum on study and an absolute increase of at least 5 mm of sum of the diameters, or unequivocal progression of existing non-target lesions, or the appearance of new lesion/s. Participants who had no documented progression and were still alive at the time of analysis were censored at the time of the latest date of assessment from their last evaluable RECIST v1.1 assessment. The PFS is assessed using the Kaplan-Meier method.
The ITT population included all participants who were randomized and received any amount of study drugs and were analyzed according to randomized treatment assignment.
Posted
Median
95% Confidence Interval
Months
Baseline (Days -28 to -1) through 36.1 months (maximum observed duration)
ID
Title
Description
OG000
Dose-expansion, Gemcitabine + Nab-paclitaxel
Participants with 1L metastatic disease received IV infusions of chemotherapy of gemcitabine 1000 mg/m^2 and nab-paclitaxel 125 mg/m^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.
OG001
Secondary
Duration of Response (DoR) According to RECIST v1.1 in Dose Expansion Phase
The DoR is defined as the time from the first documentation of an OR until the first documentation of a PD or death due to any cause, whichever occurs first. The OR is defined as best overall response of confirmed CR or PR based on RECIST v1.1 guidelines. The CR is defined as disappearance of all TLs and NTLs, any pathological lymph nodes (target and non-target) must have reduction in short axis < 10 mm, and no new lesions. The PR is defined as at least a 30% decrease in the SoD of TLs (compared to baseline) and no new lesions. Confirmation of CR and PR is required by a repeat, consecutive assessment no less than 4 weeks from the date of first documentation. The PD is defined as at least a 20% increase in SoD of TLs, taking as reference the smallest sum on study and an absolute increase of at least 5 mm of SoD, or unequivocal progression of existing NTLs, or the appearance of new lesion/s. The DoR is assessed using the Kaplan-Meier method.
The ITT population included all participants who were randomized and received any amount of study drugs and were analyzed according to randomized treatment assignment. The DoR is assessed for only those participants who had OR.
Posted
Median
95% Confidence Interval
Months
Baseline (Days -28 to -1) through 36.1 months (maximum observed duration)
ID
Title
Description
OG000
Dose-expansion, Gemcitabine + Nab-paclitaxel
Participants with 1L metastatic disease received IV infusions of chemotherapy of gemcitabine 1000 mg/m^2 and nab-paclitaxel 125 mg/m^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.
Secondary
Percentage of Participants With DC According to RECIST v1.1 in Dose Expansion Phase
The DC is defined as confirmed CR, PR, or stable disease (SD) (maintained for >=8 weeks). The CR is defined as disappearance of all TLs and NTLs, any pathological lymph nodes (target and non-target) must have reduction in short axis <10 mm, and no new lesions. The PR is defined as at least a 30% decrease in the SoD of TLs (compared to baseline) and no new lesions. Confirmation of CR and PR is required by a repeat, consecutive assessment no less than 4 weeks from date of first documentation. The SD is defined as neither sufficient shrinkage of TLs to qualify for PR nor sufficient increase of TLs to qualify for PD, taking as reference the smallest SoD while on study, and no new lesions. The PD is defined as at least a 20% increase in SoD of TLs, taking as reference the smallest sum on study and an absolute increase of at least 5 mm of SoD, or unequivocal progression of existing NTLs, or the appearance of new lesion/s. Percentage of participants with DC is reported.
The ITT population included all participants who were randomized and received any amount of study drugs and were analyzed according to randomized treatment assignment.
Posted
Number
95% Confidence Interval
Percentage of Participants
Baseline (Days -28 to -1) through 36.1 months (maximum observed duration)
ID
Title
Description
OG000
Dose-expansion, Gemcitabine + Nab-paclitaxel
Participants with 1L metastatic disease received IV infusions of chemotherapy of gemcitabine 1000 mg/m^2 and nab-paclitaxel 125 mg/m^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.
Secondary
Percentage of Participants With OR According to RECIST v1.1 by CD73 Expression at Baseline in Dose Expansion Phase
The OR is defined as best overall response of confirmed CR or confirmed PR based on RECIST v1.1. The CR is defined as disappearance of all TLs and NTLs, any pathological lymph nodes (target and non-target) must have reduction in short axis <10 mm, and no new lesions. The PR is defined as at least a 30% decrease in the SoD of TLs (compared to baseline) and no new lesions. Confirmation of CR and PR is required by a repeat, consecutive assessment no less than 4 weeks from the date of first documentation. The OR is assessed by cluster of differentiation 73 (CD73) expression level either low or high at baseline. The CD73 low is defined as no CD73 expression in tumor cells or <50% of tumor cells with 2+ or 3+ intensity and CD73 high is defined as CD73 expression with 2+ or 3+ intensity in >=50% of tumor cells.
The ITT population included all participants who were randomized and received any amount of study drugs and were analyzed according to randomized treatment assignment. Here, "number of participants analyzed" (N) signified those participants who had high or low levels of CD73.
Posted
Number
95% Confidence Interval
Percentage of Participants
Baseline (Days -28 to -1) through 36.1 months (maximum observed duration)
ID
Title
Description
OG000
Gemcitabine + Nab-paclitaxel: CD73 Level = High
In dose-expansion phase, participants with 1L metastatic disease and high CD73 levels received IV infusions of chemotherapy of gemcitabine 1000 mg/m^2 and nab-paclitaxel 125 mg/m^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.
Secondary
Number of Participants With Overall Survival Events by CD73 Expression at Baseline in Dose Expansion Phase
The overall survival is defined as the time from the randomization until death due to any cause. For participants who were alive at the time of data cut off, overall survival was censored on the last date when participants were known to be alive. The overall survival is assessed by CD73 expression level either low or high at baseline using the Kaplan-Meier method. The CD73 low is defined as no CD73 expression in tumor cells or <50% of tumor cells with 2+ or 3+ intensity and CD73 high is defined as CD73 expression with 2+ or 3+ intensity in >=50% of tumor cells. The number of participants with overall survival events (deaths) is reported.
The ITT population included all participants who were randomized and received any amount of study drugs and were analyzed according to randomized treatment assignment. Here, "number of participants analyzed" (N) signified those participants who had high or low levels of CD73.
Posted
Number
Participants with event
Baseline (Days -28 to -1) through 38.7 months (maximum observed duration)
ID
Title
Description
OG000
Gemcitabine + Nab-paclitaxel: CD73 Level = High
In dose-expansion phase, participants with 1L metastatic disease and high CD73 levels received IV infusions of chemotherapy of gemcitabine 1000 mg/m^2 and nab-paclitaxel 125 mg/m^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.
OG001
Secondary
Overall Survival by CD73 Expression at Baseline in Dose Expansion Phase
The overall survival is defined as the time from the randomization until death due to any cause. For participants who were alive at the time of data cut off, overall survival was censored on the last date when participants were known to be alive. The overall survival is assessed by CD73 expression level either low or high at baseline using the Kaplan-Meier method. The CD73 low is defined as no CD73 expression in tumor cells or <50% of tumor cells with 2+ or 3+ intensity and CD73 high is defined as CD73 expression with 2+ or 3+ intensity in >=50% of tumor cells.
The ITT population included all participants who were randomized and received any amount of study drugs and were analyzed according to randomized treatment assignment. Here, "number of participants analyzed" (N) signified those participants who had high or low levels of CD73.
Posted
Median
95% Confidence Interval
Months
Baseline (Days -28 to -1) through 38.7 months (maximum observed duration)
ID
Title
Description
OG000
Gemcitabine + Nab-paclitaxel: CD73 Level = High
In dose-expansion phase, participants with 1L metastatic disease and high CD73 levels received IV infusions of chemotherapy of gemcitabine 1000 mg/m^2 and nab-paclitaxel 125 mg/m^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.
Number of Participants With Progression-free Survival Events According to RECIST v1.1 by CD73 Expression at Baseline in Dose Expansion Phase
PFS: Time from randomization until first documentation of PD/death due to any cause, whichever occurred first, regardless of whether participant received subsequent anticancer treatment prior to progression. PD:>=20% increase in SoD of TLs and an absolute increase of >= 5 mm of SoD/unequivocal progression of existing NTLs/appearance of new lesion. Participants who had no documented progression and were still alive at the time of analysis were censored at time of latest date of assessment from their last evaluable RECIST v1.1 assessment. PFS is assessed by CD73 expression level either low/high at baseline using Kaplan-Meier method. CD73 low: No CD73 expression in tumor cells/<50% of tumor cells with 2+/3+ intensity. CD73 high: CD73 expression with 2+/3+ intensity in >=50% of tumor cells. Number of participants with PFS events is reported.
The ITT population included all participants who were randomized and received any amount of study drugs and were analyzed according to randomized treatment assignment. Here, "number of participants analyzed" (N) signified those participants who had high or low levels of CD73.
Posted
Number
Participants with event
Baseline (Days -28 to -1) through 36.1 months (maximum observed duration)
ID
Title
Description
OG000
Gemcitabine + Nab-paclitaxel: CD73 Level = High
In dose-expansion phase, participants with 1L metastatic disease and high CD73 levels received IV infusions of chemotherapy of gemcitabine 1000 mg/m^2 and nab-paclitaxel 125 mg/m^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.
Secondary
Progression-free Survival According to RECIST v1.1 by CD73 Expression at Baseline in Dose Expansion Phase
The PFS is defined as the time from randomization until the first documentation of a PD or death due to any cause, whichever occurred first, regardless of whether the participant receives subsequent anticancer treatment prior to progression. The PD is defined as at least a 20% increase in SoD of TLs, taking as reference the smallest sum on study and an absolute increase of at least 5 mm of SoD, or unequivocal progression of existing NTLs, or the appearance of new lesion/s. Participants who had no documented progression and were still alive at time of analysis were censored at time of latest date of assessment from their last evaluable RECIST v1.1 assessment. PFS is assessed by CD73 expression level either low/high at baseline using Kaplan-Meier method. CD73 low: No CD73 expression in tumor cells/<50% of tumor cells with 2+/3+ intensity. CD73 high: CD73 expression with 2+/3+ intensity in >=50% of tumor cells.
The ITT population included all participants who were randomized and received any amount of study drugs and were analyzed according to randomized treatment assignment. Here, "number of participants analyzed" (N) signified those participants who had high or low levels of CD73.
Posted
Median
95% Confidence Interval
Months
Baseline (Days -28 to -1) through 36.1 months (maximum observed duration)
ID
Title
Description
OG000
Gemcitabine + Nab-paclitaxel: CD73 Level = High
In dose-expansion phase, participants with 1L metastatic disease and high CD73 levels received IV infusions of chemotherapy of gemcitabine 1000 mg/m^2 and nab-paclitaxel 125 mg/m^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.
Secondary
Number of Participants With Positive Anti-drug Antibodies (ADA) to Oleclumab
Number of participants with positive ADA to oleclumab are reported. Persistent positive is defined as positive at >= 2 post-baseline assessments (with >=16 weeks between first and last positive) or positive at last post-baseline assessment. Transient positive is defined as negative at last post-baseline assessment and positive at only one post-baseline assessment or at >= 2 post-baseline assessments (with <16 weeks between first and last positive). Treatment-boosted ADA is defined as baseline ADA positive titer that was boosted to a 4-fold or higher level following drug administration.
The ADA evaluable oleclumab population included all participants who received oleclumab, analyzed according to the treatment they actually received, and who had a non-missing baseline ADA result and at least one non-missing post-baseline ADA result.
Posted
Count of Participants
Participants
Day 1 through 172.1 weeks (Pre-dose on Cycle [C] 1 Day [D] 1, C2D1, C3D1, Day 1 of every 3 cycles starting with C5, through 12 weeks post last dose of oleclumab)
Participants with 1L metastatic disease received IV infusions of oleclumab 1500 mg every 2 weeks for 4 doses, then Q4W in combination with durvalumab 1500 mg Q4W plus chemotherapy of gemcitabine 1000 mg/m^2 and nab-paclitaxel 125 mg/m^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.
Secondary
Number of Participants With Positive ADA to Durvalumab
Number of participants with positive ADA to durvalumab are reported. Persistent positive is defined as positive at >= 2 post-baseline assessments (with >=16 weeks between first and last positive) or positive at last post-baseline assessment. Transient positive is defined as negative at last post-baseline assessment and positive at only one post-baseline assessment or at >= 2 post-baseline assessments (with <16 weeks between first and last positive). Treatment-boosted ADA is defined as baseline ADA positive titer that was boosted to a 4-fold or higher level following drug administration.
The ADA evaluable durvalumab population included all participants who received durvalumab, analyzed according to the treatment they actually received, and who had a non-missing baseline ADA result and at least one non-missing post-baseline ADA result.
Posted
Count of Participants
Participants
Day 1 through 128 weeks (Pre-dose on C1D1, C2D1, C3D1, Day 1 of every 3 cycles starting with C5, through 12 weeks post last dose of durvalumab)
Participants with 1L metastatic disease received IV infusions of oleclumab 1500 mg every 2 weeks for 4 doses, then Q4W in combination with durvalumab 1500 mg Q4W plus chemotherapy of gemcitabine 1000 mg/m^2 and nab-paclitaxel 125 mg/m^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.
Secondary
Serum Concentrations of Oleclumab
Serum concentrations of oleclumab are reported.
Pharmacokinetic (PK) evaluable oleclumab population included all participants who received at least one dose of oleclumab and who had at least one reportable PK concentration. Here, number analyzed (n) denotes those participants who were analyzed for the specified time points.
Posted
Geometric Mean
Geometric Coefficient of Variation
μg/mL
Ten minutes (mins) (± 5 mins) post end of infusion (EOI), approximately 1 hour (+ 15 mins) after start of infusion on C1D1, C3D1, and C5D1; and pre-dose on C3D1 and C5D1
Participants with 1L metastatic disease received IV infusions of oleclumab 1500 mg every 2 weeks for 4 doses, then Q4W in combination with durvalumab 1500 mg Q4W plus chemotherapy of gemcitabine 1000 mg/m^2 and nab-paclitaxel 125 mg/m^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.
Participants with 1L metastatic disease received IV infusions of oleclumab 3000 mg every 2 weeks for 4 doses, then Q4W in combination with durvalumab 1500 mg Q4W plus chemotherapy of gemcitabine 1000 mg/m^2 and nab-paclitaxel 125 mg/m^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.
Secondary
Serum Concentrations of Durvalumab
Serum concentrations of durvalumab are reported.
The PK evaluable durvalumab population included all participants who received at least one dose of durvalumab and who had at least one reportable PK concentration. Here, number of participants analyzed (N) indicates those participants who had adequate PK samples. Here, number analyzed (n) denotes those participants who were analyzed for the specified time points.
Posted
Geometric Mean
Geometric Coefficient of Variation
μg/mL
Ten mins (± 5 mins) post EOI, approximately 1 hour (+ 15 mins) after start of infusion on C1D1 and C5D1; and pre-dose on C2D1 and C5D1
Participants with 1L metastatic disease received IV infusions of oleclumab 1500 mg every 2 weeks for 4 doses, then Q4W in combination with durvalumab 1500 mg Q4W plus chemotherapy of gemcitabine 1000 mg/m^2 and nab-paclitaxel 125 mg/m^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.
Participants with 1L metastatic disease received IV infusions of oleclumab 3000 mg every 2 weeks for 4 doses, then Q4W in combination with durvalumab 1500 mg Q4W plus chemotherapy of gemcitabine 1000 mg/m^2 and nab-paclitaxel 125 mg/m^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.
Secondary
Plasma Concentrations of Gemcitabine and Metabolite 2',2'-Difluorodeoxyuridine (dFdU)
Plasma concentrations of gemcitabine and metabolite dFdU are reported.
The PK evaluable gemcitabine population included all participants who received at least one dose of gemcitabine and who had at least one reportable PK concentration. Here, number analyzed (n) denotes those participants who were analyzed for the specified time points.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng/mL
Ten mins (± 5 mins) post EOI, approximately 30-40 mins after start of infusion on C1D1 and C4D1; and pre-dose on C4D1
Participants with 1L metastatic disease received IV infusions of oleclumab 1500 mg every 2 weeks for 4 doses, then Q4W in combination with durvalumab 1500 mg Q4W plus chemotherapy of gemcitabine 1000 mg/m^2 and nab-paclitaxel 125 mg/m^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.
Participants with 1L metastatic disease received IV infusions of oleclumab 3000 mg every 2 weeks for 4 doses, then Q4W in combination with durvalumab 1500 mg Q4W plus chemotherapy of gemcitabine 1000 mg/m^2 and nab-paclitaxel 125 mg/m^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.
Secondary
Plasma Concentrations of Nab-paclitaxel
Plasma concentrations of nab-paclitaxel are reported.
The PK evaluable nab-paclitaxel population included all participants who received at least one dose of nab-paclitaxel and who had at least one reportable PK concentration. Here, number of participants analyzed (N) indicates those participants who had adequate PK samples. Here, number analyzed (n) denotes those participants who were analyzed for the specified time points.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng/mL
Ten mins (± 5 mins) post EOI, approximately 30-40 mins after start of infusion on C1D1 and C4D1; and pre-dose on C4D1
Participants with 1L metastatic disease received IV infusions of oleclumab 1500 mg every 2 weeks for 4 doses, then Q4W in combination with durvalumab 1500 mg Q4W plus chemotherapy of gemcitabine 1000 mg/m^2 and nab-paclitaxel 125 mg/m^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.
Participants with 1L metastatic disease received IV infusions of oleclumab 3000 mg every 2 weeks for 4 doses, then Q4W in combination with durvalumab 1500 mg Q4W plus chemotherapy of gemcitabine 1000 mg/m^2 and nab-paclitaxel 125 mg/m^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.
Time Frame
Day 1 through 172.1 weeks (maximum observed duration)
Participants with 1L metastatic disease received IV infusions of oleclumab 1500 mg every 2 weeks for 4 doses, then Q4W in combination with durvalumab 1500 mg Q4W plus chemotherapy of gemcitabine 1000 mg/m^2 and nab-paclitaxel 125 mg/m^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.
Participants with 1L metastatic disease received IV infusions of oleclumab 3000 mg every 2 weeks for 4 doses, then Q4W in combination with durvalumab 1500 mg Q4W plus chemotherapy of gemcitabine 1000 mg/m^2 and nab-paclitaxel 125 mg/m^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.
Participants with 2L metastatic disease received IV infusions of oleclumab 1500 mg every 2 weeks for 4 doses, then Q4W in combination with durvalumab 1500 mg Q4W plus chemotherapy of mFOLFOX (oxaliplatin 85 mg/m^2 IV; folinic acid 400 mg/m^2 IV; fluorouracil [5-FU] 400 mg/m^2 IV bolus followed by 2400 mg/m^2 continuous IV infusion over 46 to 48 hours) on Days 1 and 15 and then repeated on a Q4W schedule, until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.
Participants with 2L metastatic disease received IV infusions of oleclumab 3000 mg every 2 weeks for 4 doses, then Q4W in combination with durvalumab 1500 mg Q4W plus chemotherapy of mFOLFOX (oxaliplatin 85 mg/m^2 IV; folinic acid 400 mg/m^2 IV; 5-FU 400 mg/m^2 IV bolus followed by 2400 mg/m^2 continuous IV infusion over 46 to 48 hours) on Days 1 and 15 and then repeated on a Q4W schedule, until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.
8
8
4
8
8
8
EG004
Dose-expansion, Gemcitabine + Nab-paclitaxel
Participants with 1L metastatic disease received IV infusions of chemotherapy of gemcitabine 1000 mg/m^2 and nab-paclitaxel 125 mg/m^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.
Participants with 1L metastatic disease received IV infusions of oleclumab 3000 mg every 2 weeks for 4 doses, then Q4W in combination with chemotherapy of gemcitabine 1000 mg/m^2 and nab-paclitaxel 125 mg/m^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.
Participants with 1L metastatic disease received IV infusions of oleclumab 3000 mg every 2 weeks for 4 doses, then Q4W in combination with durvalumab 1500 mg Q4W plus chemotherapy of gemcitabine 1000 mg/m^2 and nab-paclitaxel 125 mg/m^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.
53
70
37
70
70
70
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Neutropenia
Blood and lymphatic system disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected62 at risk
EG0051 events1 affected38 at risk
EG0061 events1 affected70 at risk
Asthenia
General disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Death
General disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Fatigue
General disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
General physical health deterioration
General disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Splenic infarction
Blood and lymphatic system disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Generalised oedema
General disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Localised oedema
General disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Oedema peripheral
General disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Pain
General disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Pyrexia
General disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0012 events2 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Biliary obstruction
Hepatobiliary disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Cholangitis
Hepatobiliary disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Cholestasis
Hepatobiliary disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Gallbladder rupture
Hepatobiliary disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Hepatic failure
Hepatobiliary disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Hepatitis
Hepatobiliary disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Jaundice cholestatic
Hepatobiliary disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Abdominal infection
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Bacteraemia
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Bacterial infection
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Biliary sepsis
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Biliary tract infection
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Thrombotic microangiopathy
Blood and lymphatic system disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Bullous impetigo
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Covid-19
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Clostridium difficile infection
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Enterocolitis infectious
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Escherichia bacteraemia
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Hepatic infection
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Infection
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Liver abscess
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Lower respiratory tract infection
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0012 events1 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Oesophageal candidiasis
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Pneumocystis jirovecii pneumonia
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0002 events2 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Sepsis
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Spontaneous bacterial peritonitis
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Tooth abscess
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Myocarditis
Cardiac disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Lumbar vertebral fracture
Injury, poisoning and procedural complications
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Anaemia
Blood and lymphatic system disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Pericarditis
Cardiac disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Blood creatinine increased
Investigations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Acidosis
Metabolism and nutrition disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Diabetic ketoacidosis
Metabolism and nutrition disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Electrolyte imbalance
Metabolism and nutrition disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Failure to thrive
Metabolism and nutrition disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Cancer pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Malignant ascites
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Cerebral ischaemia
Nervous system disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Cerebrovascular accident
Nervous system disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Haemorrhage intracranial
Nervous system disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Intraventricular haemorrhage
Nervous system disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Disseminated intravascular coagulation
Blood and lymphatic system disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Syncope
Nervous system disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Device occlusion
Product Issues
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0013 events2 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Glomerulonephritis
Renal and urinary disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Embolism
Vascular disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Febrile neutropenia
Blood and lymphatic system disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Hypertension
Vascular disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Shock
Vascular disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Venous thrombosis
Vascular disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Vision blurred
Eye disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Haemolytic uraemic syndrome
Blood and lymphatic system disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Ascites
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Colitis
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Duodenal obstruction
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Ileus
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Ileus paralytic
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Impaired gastric emptying
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Intestinal obstruction
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Large intestinal haemorrhage
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Neutropenic colitis
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Obstruction gastric
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Pancreatitis
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Small intestinal obstruction
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Upper gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0012 events2 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Neutropenia
Blood and lymphatic system disorders
MedDRA 25.0
Systematic Assessment
EG0002 events2 affected7 at risk
EG00113 events2 affected7 at risk
EG0023 events2 affected3 at risk
EG0031 events1 affected8 at risk
EG00437 events22 affected62 at risk
EG00525 events14 affected38 at risk
EG00636 events16 affected70 at risk
Asthenia
General disorders
MedDRA 25.0
Systematic Assessment
EG0002 events2 affected7 at risk
EG0012 events2 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Catheter site pain
General disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Chills
General disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Early satiety
General disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Face oedema
General disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Fatigue
General disorders
MedDRA 25.0
Systematic Assessment
EG0006 events6 affected7 at risk
EG0019 events7 affected7 at risk
EG0022 events2 affected3 at risk
EG003
Feeling abnormal
General disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Gait disturbance
General disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Splenic infarction
Blood and lymphatic system disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Generalised oedema
General disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Hypothermia
General disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Illness
General disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Influenza like illness
General disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Infusion site extravasation
General disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Injection site haemorrhage
General disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Injection site pain
General disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Injection site reaction
General disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Localised oedema
General disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Malaise
General disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Splenic vein thrombosis
Blood and lymphatic system disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Mucosal inflammation
General disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Oedema
General disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected3 at risk
EG003
Oedema peripheral
General disorders
MedDRA 25.0
Systematic Assessment
EG0004 events2 affected7 at risk
EG0014 events3 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Pain
General disorders
MedDRA 25.0
Systematic Assessment
EG0002 events2 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Peripheral swelling
General disorders
MedDRA 25.0
Systematic Assessment
EG0002 events2 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Pyrexia
General disorders
MedDRA 25.0
Systematic Assessment
EG0004 events3 affected7 at risk
EG0012 events1 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Temperature intolerance
General disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected3 at risk
EG003
Unevaluable event
General disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Bile duct stone
Hepatobiliary disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 25.0
Systematic Assessment
EG0005 events2 affected7 at risk
EG0013 events2 affected7 at risk
EG0023 events2 affected3 at risk
EG003
Cholangitis
Hepatobiliary disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Congestive hepatopathy
Hepatobiliary disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Haemorrhagic hepatic cyst
Hepatobiliary disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected3 at risk
EG003
Hepatitis
Hepatobiliary disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Hypertransaminasaemia
Hepatobiliary disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Thrombocytosis
Blood and lymphatic system disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Portal vein occlusion
Hepatobiliary disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Portal vein thrombosis
Hepatobiliary disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Anaphylactic reaction
Immune system disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Immunisation reaction
Immune system disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Infusion related hypersensitivity reaction
Immune system disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Abdominal infection
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Bacteraemia
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Thrombotic microangiopathy
Blood and lymphatic system disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Covid-19
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Candida infection
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Catheter site infection
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Conjunctivitis
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Diverticulitis
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Angina pectoris
Cardiac disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
External ear cellulitis
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Eye infection
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Folliculitis
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Fungal infection
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Herpes simplex
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Infection
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Liver abscess
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Lower respiratory tract infection
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Mucosal infection
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Oesophageal infection
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Oral candidiasis
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Otitis media
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Paronychia
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Atrioventricular block
Cardiac disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Rash pustular
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Sepsis
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Sinusitis
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected7 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Skin infection
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Sputum purulent
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Tonsillitis
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Tooth infection
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Vaginal infection
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Animal bite
Injury, poisoning and procedural complications
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Foot fracture
Injury, poisoning and procedural complications
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Infusion related reaction
Injury, poisoning and procedural complications
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Limb injury
Injury, poisoning and procedural complications
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Procedural complication
Injury, poisoning and procedural complications
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Anaemia
Blood and lymphatic system disorders
MedDRA 25.0
Systematic Assessment
EG0004 events3 affected7 at risk
EG0014 events3 affected7 at risk
EG0022 events1 affected3 at risk
EG003
Pericardial effusion
Cardiac disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Rib fracture
Injury, poisoning and procedural complications
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Skin abrasion
Injury, poisoning and procedural complications
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Skin laceration
Injury, poisoning and procedural complications
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Spinal compression fracture
Injury, poisoning and procedural complications
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Subcutaneous haematoma
Injury, poisoning and procedural complications
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Thermal burn
Injury, poisoning and procedural complications
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Wound
Injury, poisoning and procedural complications
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Alanine aminotransferase decreased
Investigations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 25.0
Systematic Assessment
EG0003 events3 affected7 at risk
EG0014 events4 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Amylase increased
Investigations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected3 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 25.0
Systematic Assessment
EG0003 events3 affected7 at risk
EG0016 events3 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Blood albumin decreased
Investigations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA 25.0
Systematic Assessment
EG0002 events2 affected7 at risk
EG0013 events1 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Blood creatinine increased
Investigations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0013 events2 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Blood glucose decreased
Investigations
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Blood glucose increased
Investigations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Blood lactate dehydrogenase increased
Investigations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Blood magnesium decreased
Investigations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Blood oestrogen decreased
Investigations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Supraventricular tachycardia
Cardiac disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Gamma-glutamyltransferase increased
Investigations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Haemoglobin decreased
Investigations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
International normalised ratio increased
Investigations
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Lipase increased
Investigations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Liver function test increased
Investigations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Lymphocyte count decreased
Investigations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0012 events1 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Neutrophil count
Investigations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0013 events2 affected7 at risk
EG0022 events1 affected3 at risk
EG003
Platelet count decreased
Investigations
MedDRA 25.0
Systematic Assessment
EG0002 events1 affected7 at risk
EG0016 events3 affected7 at risk
EG0022 events1 affected3 at risk
EG003
Troponin i increased
Investigations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Urine output decreased
Investigations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Weight decreased
Investigations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected3 at risk
EG003
Weight increased
Investigations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
White blood cell count decreased
Investigations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0014 events2 affected7 at risk
EG0020 events0 affected3 at risk
EG003
White blood cell count increased
Investigations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 25.0
Systematic Assessment
EG0004 events4 affected7 at risk
EG0013 events3 affected7 at risk
EG0021 events1 affected3 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 25.0
Systematic Assessment
EG0004 events4 affected7 at risk
EG0012 events2 affected7 at risk
EG0021 events1 affected3 at risk
EG003
Ear congestion
Ear and labyrinth disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Gout
Metabolism and nutrition disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0012 events2 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0014 events1 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0015 events3 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected7 at risk
EG0014 events2 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0014 events2 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Ear pain
Ear and labyrinth disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected7 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Hypovolaemia
Metabolism and nutrition disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Iron deficiency
Metabolism and nutrition disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Type 2 diabetes mellitus
Metabolism and nutrition disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 25.0
Systematic Assessment
EG0002 events2 affected7 at risk
EG0012 events2 affected7 at risk
EG0022 events1 affected3 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Bone pain
Musculoskeletal and connective tissue disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Flank pain
Musculoskeletal and connective tissue disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Joint swelling
Musculoskeletal and connective tissue disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Limb discomfort
Musculoskeletal and connective tissue disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Hypoacusis
Ear and labyrinth disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Muscle tightness
Musculoskeletal and connective tissue disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected3 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA 25.0
Systematic Assessment
EG0002 events2 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Musculoskeletal discomfort
Musculoskeletal and connective tissue disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected3 at risk
EG003
Myopathy
Musculoskeletal and connective tissue disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Myositis
Musculoskeletal and connective tissue disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Meniere's disease
Ear and labyrinth disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Rheumatoid arthritis
Musculoskeletal and connective tissue disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Synovial cyst
Musculoskeletal and connective tissue disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Cancer fatigue
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Cancer pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Tumour pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Ageusia
Nervous system disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Akathisia
Nervous system disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Amnesia
Nervous system disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Burning sensation
Nervous system disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Cerebral ischaemia
Nervous system disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Disturbance in attention
Nervous system disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0013 events3 affected7 at risk
EG0022 events2 affected3 at risk
EG003
Headache
Nervous system disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0012 events2 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Hypersomnia
Nervous system disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Hypoaesthesia
Nervous system disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Hyperthyroidism
Endocrine disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Lethargy
Nervous system disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Memory impairment
Nervous system disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Neuralgia
Nervous system disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Neuropathy peripheral
Nervous system disorders
MedDRA 25.0
Systematic Assessment
EG0005 events3 affected7 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Neurotoxicity
Nervous system disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Peripheral motor neuropathy
Nervous system disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Peripheral sensory neuropathy
Nervous system disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0013 events1 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Polyneuropathy in malignant disease
Nervous system disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Hypothyroidism
Endocrine disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Presyncope
Nervous system disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Restless legs syndrome
Nervous system disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Sciatica
Nervous system disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Subarachnoid haemorrhage
Nervous system disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Syncope
Nervous system disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Taste disorder
Nervous system disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Agitation
Psychiatric disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected7 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Blepharitis
Eye disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Depression
Psychiatric disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected7 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Depressive symptom
Psychiatric disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Disorientation
Psychiatric disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 25.0
Systematic Assessment
EG0002 events2 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Mania
Psychiatric disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Mental status changes
Psychiatric disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Persistent depressive disorder
Psychiatric disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Restlessness
Psychiatric disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Tic
Psychiatric disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Cataract
Eye disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Dysuria
Renal and urinary disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Micturition urgency
Renal and urinary disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Pollakiuria
Renal and urinary disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Proteinuria
Renal and urinary disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Renal failure
Renal and urinary disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Tubulointerstitial nephritis
Renal and urinary disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Urinary incontinence
Renal and urinary disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Dry eye
Eye disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Urinary retention
Renal and urinary disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Urinary tract pain
Renal and urinary disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Breast oedema
Reproductive system and breast disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Erectile dysfunction
Reproductive system and breast disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Pelvic discomfort
Reproductive system and breast disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Prostatitis
Reproductive system and breast disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Vaginal discharge
Reproductive system and breast disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Vaginal haemorrhage
Reproductive system and breast disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Acute pulmonary oedema
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Bronchiectasis
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Eye allergy
Eye disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Chronic obstructive pulmonary disease
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected7 at risk
EG0012 events2 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Dysphonia
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Dyspnoea exertional
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Systematic Assessment
EG0002 events1 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Hiccups
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Nasal ulcer
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Eye irritation
Eye disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Orthopnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Pulmonary congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Pulmonary oedema
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Rhinitis allergic
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Sinus congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected7 at risk
EG0012 events2 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Eyelid irritation
Eye disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Throat irritation
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Upper-airway cough syndrome
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Actinic keratosis
Skin and subcutaneous tissue disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected7 at risk
EG0013 events3 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Dermal cyst
Skin and subcutaneous tissue disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Dermatitis
Skin and subcutaneous tissue disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Dermatitis acneiform
Skin and subcutaneous tissue disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Eczema
Skin and subcutaneous tissue disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Eyelid ptosis
Eye disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Hair colour changes
Skin and subcutaneous tissue disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Hyperhidrosis
Skin and subcutaneous tissue disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Nail discolouration
Skin and subcutaneous tissue disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Night sweats
Skin and subcutaneous tissue disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected3 at risk
EG003
Onychalgia
Skin and subcutaneous tissue disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Onycholysis
Skin and subcutaneous tissue disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Onychomadesis
Skin and subcutaneous tissue disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Pain of skin
Skin and subcutaneous tissue disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Palmar-plantar erythrodysaesthesia syndrome
Skin and subcutaneous tissue disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Petechiae
Skin and subcutaneous tissue disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Glaucoma
Eye disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected7 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Purpura
Skin and subcutaneous tissue disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected7 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Rash erythematous
Skin and subcutaneous tissue disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Rash macular
Skin and subcutaneous tissue disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Rash papular
Skin and subcutaneous tissue disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Rash pruritic
Skin and subcutaneous tissue disorders
MedDRA 25.0
Systematic Assessment
EG0002 events2 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Skin discolouration
Skin and subcutaneous tissue disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Skin exfoliation
Skin and subcutaneous tissue disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Hypermetropia
Eye disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Skin fissures
Skin and subcutaneous tissue disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Skin hyperpigmentation
Skin and subcutaneous tissue disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Skin ulcer
Skin and subcutaneous tissue disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Vitiligo
Skin and subcutaneous tissue disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Capillary leak syndrome
Vascular disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Cryoglobulinaemia
Vascular disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected7 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Embolism
Vascular disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Flushing
Vascular disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Febrile neutropenia
Blood and lymphatic system disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Lacrimation increased
Eye disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Haematoma
Vascular disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Haemorrhage
Vascular disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Hot flush
Vascular disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Hypertension
Vascular disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Hypotension
Vascular disorders
MedDRA 25.0
Systematic Assessment
EG0002 events2 affected7 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Orthostatic hypotension
Vascular disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Phlebitis
Vascular disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Subclavian vein thrombosis
Vascular disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Superficial vein thrombosis
Vascular disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Ocular hyperaemia
Eye disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Thrombosis
Vascular disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Venous thrombosis
Vascular disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Orbital haematoma
Eye disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Periorbital oedema
Eye disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Periorbital pain
Eye disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Photopsia
Eye disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Vision blurred
Eye disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Visual field defect
Eye disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Visual impairment
Eye disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Vitreous floaters
Eye disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Haemolytic uraemic syndrome
Blood and lymphatic system disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Abdominal discomfort
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0002 events2 affected7 at risk
EG0013 events2 affected7 at risk
EG0022 events2 affected3 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Abdominal tenderness
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Anal incontinence
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Anorectal discomfort
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Ascites
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Colitis
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0002 events2 affected7 at risk
EG0015 events5 affected7 at risk
EG0022 events2 affected3 at risk
EG003
Leukocytosis
Blood and lymphatic system disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0006 events5 affected7 at risk
EG0012 events2 affected7 at risk
EG0021 events1 affected3 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Faeces discoloured
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Flatulence
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Gastrointestinal pain
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Leukopenia
Blood and lymphatic system disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0003 events2 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Gingival bleeding
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Gingival pain
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Haematochezia
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Haemorrhoidal haemorrhage
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected7 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected3 at risk
EG003
Inguinal hernia
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Lymphadenopathy
Blood and lymphatic system disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Melaena
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Mouth ulceration
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0006 events6 affected7 at risk
EG0018 events6 affected7 at risk
EG0022 events2 affected3 at risk
EG003
Odynophagia
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Oedema mouth
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Oral dysaesthesia
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected3 at risk
EG003
Lymphopenia
Blood and lymphatic system disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Oral pain
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Pancreatitis
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Periodontal disease
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Proctitis
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Tongue blistering
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Toothache
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0004 events3 affected7 at risk
EG0012 events2 affected7 at risk
EG0021 events1 affected3 at risk
EG003
Dose escalation phase: Participants not enrolled in oleclumab 750 mg cohort. Dose expansion phase: Outcomes of mFOLFOX cohorts not included as enrollment was not opened. Non-compartmental PK data analysis were planned to be performed from each dose cohort if data allowed, but as sparse PK samples were collected, no non-compartmental PK parameters were calculated. Consequently, PK concentration time data only have been reported.
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
MedImmune has 60 days to review results communications prior to public release and may delete information that compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that results shall be published regardless of outcome.
Participants with 1L metastatic disease received IV infusions of oleclumab 3000 mg every 2 weeks for 4 doses, then Q4W in combination with durvalumab 1500 mg Q4W plus chemotherapy of gemcitabine 1000 mg/m^2 and nab-paclitaxel 125 mg/m^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.
Participants with 2L metastatic disease received IV infusions of oleclumab 1500 mg every 2 weeks for 4 doses, then Q4W in combination with durvalumab 1500 mg Q4W plus chemotherapy of mFOLFOX (oxaliplatin 85 mg/m^2 IV; folinic acid 400 mg/m^2 IV; fluorouracil [5-FU] 400 mg/m^2 IV bolus followed by 2400 mg/m^2 continuous IV infusion over 46 to 48 hours) on Days 1 and 15 and then repeated on a Q4W schedule, until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.
Participants with 2L metastatic disease received IV infusions of oleclumab 3000 mg every 2 weeks for 4 doses, then Q4W in combination with durvalumab 1500 mg Q4W plus chemotherapy of mFOLFOX (oxaliplatin 85 mg/m^2 IV; folinic acid 400 mg/m^2 IV; 5-FU 400 mg/m^2 IV bolus followed by 2400 mg/m^2 continuous IV infusion over 46 to 48 hours) on Days 1 and 15 and then repeated on a Q4W schedule, until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.
Participants with 2L metastatic disease received IV infusions of oleclumab 1500 mg every 2 weeks for 4 doses, then Q4W in combination with durvalumab 1500 mg Q4W plus chemotherapy of mFOLFOX (oxaliplatin 85 mg/m^2 IV; folinic acid 400 mg/m^2 IV; fluorouracil [5-FU] 400 mg/m^2 IV bolus followed by 2400 mg/m^2 continuous IV infusion over 46 to 48 hours) on Days 1 and 15 and then repeated on a Q4W schedule, until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.
Participants with 2L metastatic disease received IV infusions of oleclumab 3000 mg every 2 weeks for 4 doses, then Q4W in combination with durvalumab 1500 mg Q4W plus chemotherapy of mFOLFOX (oxaliplatin 85 mg/m^2 IV; folinic acid 400 mg/m^2 IV; 5-FU 400 mg/m^2 IV bolus followed by 2400 mg/m^2 continuous IV infusion over 46 to 48 hours) on Days 1 and 15 and then repeated on a Q4W schedule, until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.
Participants with 2L metastatic disease received IV infusions of oleclumab 1500 mg every 2 weeks for 4 doses, then Q4W in combination with durvalumab 1500 mg Q4W plus chemotherapy of mFOLFOX (oxaliplatin 85 mg/m^2 IV; folinic acid 400 mg/m^2 IV; fluorouracil [5-FU] 400 mg/m^2 IV bolus followed by 2400 mg/m^2 continuous IV infusion over 46 to 48 hours) on Days 1 and 15 and then repeated on a Q4W schedule, until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.
Participants with 2L metastatic disease received IV infusions of oleclumab 3000 mg every 2 weeks for 4 doses, then Q4W in combination with durvalumab 1500 mg Q4W plus chemotherapy of mFOLFOX (oxaliplatin 85 mg/m^2 IV; folinic acid 400 mg/m^2 IV; 5-FU 400 mg/m^2 IV bolus followed by 2400 mg/m^2 continuous IV infusion over 46 to 48 hours) on Days 1 and 15 and then repeated on a Q4W schedule, until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.
Participants with 2L metastatic disease received IV infusions of oleclumab 1500 mg every 2 weeks for 4 doses, then Q4W in combination with durvalumab 1500 mg Q4W plus chemotherapy of mFOLFOX (oxaliplatin 85 mg/m^2 IV; folinic acid 400 mg/m^2 IV; fluorouracil [5-FU] 400 mg/m^2 IV bolus followed by 2400 mg/m^2 continuous IV infusion over 46 to 48 hours) on Days 1 and 15 and then repeated on a Q4W schedule, until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.
Participants with 2L metastatic disease received IV infusions of oleclumab 3000 mg every 2 weeks for 4 doses, then Q4W in combination with durvalumab 1500 mg Q4W plus chemotherapy of mFOLFOX (oxaliplatin 85 mg/m^2 IV; folinic acid 400 mg/m^2 IV; 5-FU 400 mg/m^2 IV bolus followed by 2400 mg/m^2 continuous IV infusion over 46 to 48 hours) on Days 1 and 15 and then repeated on a Q4W schedule, until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.
Units
Counts
Participants
OG0007
OG0017
OG0023
OG0038
Title
Denominators
Categories
Anaemia
Title
Measurements
OG0003
OG0013
OG0021
OG0030
Neutropenia
Title
Measurements
OG0002
OG0012
OG0022
OG003
Thrombocytopenia
Title
Measurements
OG0002
OG0012
OG0022
OG003
Hypothyroidism
Title
Measurements
OG0000
OG0011
OG0020
OG003
Alanine aminotransferase increased
Title
Measurements
OG0003
OG0014
OG0020
OG003
Aspartate aminotransferase increased
Title
Measurements
OG0003
OG0013
OG0020
OG003
Blood alkaline phosphatase increased
Title
Measurements
OG0002
OG0011
OG0020
OG003
Blood bilirubin increased
Title
Measurements
OG0001
OG0010
OG0020
OG003
Blood creatinine increased
Title
Measurements
OG0000
OG0013
OG0020
OG003
Blood glucose decreased
Title
Measurements
OG0001
OG0010
OG0020
OG003
International normalised ratio increased
Title
Measurements
OG0001
OG0010
OG0020
OG003
Lymphocyte count decreased
Title
Measurements
OG0000
OG0011
OG0020
OG003
Neutrophil count decreased
Title
Measurements
OG0000
OG0012
OG0021
OG003
Platelet count decreased
Title
Measurements
OG0001
OG0013
OG0021
OG003
White blood cell count decreased
Title
Measurements
OG0000
OG0012
OG0020
OG003
Hypoalbuminaemia
Title
Measurements
OG0000
OG0012
OG0020
OG003
Hypocalcaemia
Title
Measurements
OG0000
OG0011
OG0020
OG003
Hypokalaemia
Title
Measurements
OG0000
OG0013
OG0020
OG003
Hypomagnesaemia
Title
Measurements
OG0001
OG0012
OG0020
OG003
Hyponatraemia
Title
Measurements
OG0000
OG0012
OG0020
OG003
Hypophosphataemia
Title
Measurements
OG0000
OG0011
OG0020
OG003
Proteinuria
Title
Measurements
OG0001
OG0010
OG0020
OG003
Hyperthyroidism
Title
Measurements
OG0000
OG0010
OG0020
OG003
Amylase increased
Title
Measurements
OG0000
OG0010
OG0021
OG003
Gamma-glutamyltransferase increased
Title
Measurements
OG0000
OG0010
OG0020
OG003
Lipase increased
Title
Measurements
OG0000
OG0010
OG0020
OG003
Participants with 1L metastatic disease received IV infusions of oleclumab 3000 mg every 2 weeks for 4 doses, then Q4W in combination with chemotherapy of gemcitabine 1000 mg/m^2 and nab-paclitaxel 125 mg/m^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.
Participants with 1L metastatic disease received IV infusions of oleclumab 3000 mg every 2 weeks for 4 doses, then Q4W in combination with durvalumab 1500 mg Q4W plus chemotherapy of gemcitabine 1000 mg/m^2 and nab-paclitaxel 125 mg/m^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.
Units
Counts
Participants
OG00062
OG00138
OG00270
Title
Denominators
Categories
Title
Measurements
OG00029.0(18.2 to 41.9)
OG00121.1(9.6 to 37.3)
OG00232.9(22.1 to 45.1)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Cochran-Mantel-Haenszel
0.3614
Nominal P-value for comparison of treatment groups obtained from Cochran-Mantel-Haenszel-test was stratified by cluster of differentiation 73 (CD73) level.
Rate difference
-8.0
2-Sided
95
-27.6
12.1
Superiority
80% Confidence Interval 2-Sided: -20.9 to 5.2
OG000
OG002
Cochran-Mantel-Haenszel
0.6503
Nominal P-value for comparison of treatment groups obtained from Cochran-Mantel-Haenszel-test was stratified by CD73 level.
Participants with 1L metastatic disease received IV infusions of oleclumab 3000 mg every 2 weeks for 4 doses, then Q4W in combination with durvalumab 1500 mg Q4W plus chemotherapy of gemcitabine 1000 mg/m^2 and nab-paclitaxel 125 mg/m^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.
Participants with 1L metastatic disease received IV infusions of oleclumab 3000 mg every 2 weeks for 4 doses, then Q4W in combination with durvalumab 1500 mg Q4W plus chemotherapy of gemcitabine 1000 mg/m^2 and nab-paclitaxel 125 mg/m^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.
Participants with 1L metastatic disease received IV infusions of oleclumab 3000 mg every 2 weeks for 4 doses, then Q4W in combination with durvalumab 1500 mg Q4W plus chemotherapy of gemcitabine 1000 mg/m^2 and nab-paclitaxel 125 mg/m^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.
Participants with 1L metastatic disease received IV infusions of oleclumab 3000 mg every 2 weeks for 4 doses, then Q4W in combination with durvalumab 1500 mg Q4W plus chemotherapy of gemcitabine 1000 mg/m^2 and nab-paclitaxel 125 mg/m^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.
Units
Counts
Participants
OG00062
OG00138
OG00270
Title
Denominators
Categories
Anaemia
Title
Measurements
OG00017
OG00114
OG00228
Febrile neutropenia
Title
Measurements
OG0000
OG0011
OG0023
Leukocytosis
Title
Measurements
OG0001
OG0010
OG0021
Leukopenia
Title
Measurements
OG0001
OG0012
OG0023
Lymphopenia
Title
Measurements
OG0002
OG0010
OG0022
Neutropenia
Title
Measurements
OG00022
OG00115
OG00216
Thrombocytopenia
Title
Measurements
OG0006
OG0017
OG00213
Thrombocytosis
Title
Measurements
OG0002
OG0010
OG0021
Hyperthyroidism
Title
Measurements
OG0000
OG0010
OG0023
Hypothyroidism
Title
Measurements
OG0000
OG0010
OG0027
Hypertransaminasaemia
Title
Measurements
OG0000
OG0011
OG0020
Alanine aminotransferase decreased
Title
Measurements
OG0001
OG0010
OG0020
Alanine aminotransferase increased
Title
Measurements
OG0008
OG0019
OG00216
Amylase increased
Title
Measurements
OG0001
OG0010
OG0021
Aspartate aminotransferase increased
Title
Measurements
OG00011
OG0018
OG00215
Blood albumin decreased
Title
Measurements
OG0001
OG0010
OG0020
Blood alkaline phosphatase increased
Title
Measurements
OG0003
OG0012
OG0028
Blood bilirubin increased
Title
Measurements
OG0003
OG0013
OG0022
Blood creatinine increased
Title
Measurements
OG0002
OG0010
OG0028
Blood glucose increased
Title
Measurements
OG0000
OG0012
OG0020
Blood lactate dehydrogenase increased
Title
Measurements
OG0001
OG0010
OG0023
Blood magnesium decreased
Title
Measurements
OG0000
OG0011
OG0020
Blood oestrogen decreased
Title
Measurements
OG0000
OG0011
OG0020
Gamma-glutamyltransferase increased
Title
Measurements
OG0006
OG0011
OG0028
Haemoglobin decreased
Title
Measurements
OG0000
OG0010
OG0021
International normalised ratio increased
Title
Measurements
OG0000
OG0010
OG0021
Lipase increased
Title
Measurements
OG0000
OG0011
OG0022
Liver function test increased
Title
Measurements
OG0001
OG0010
OG0020
Lymphocyte count decreased
Title
Measurements
OG0004
OG0012
OG0026
Neutrophil count
Title
Measurements
OG0000
OG0010
OG0021
Neutrophil count decreased
Title
Measurements
OG00019
OG0018
OG00224
Platelet count decreased
Title
Measurements
OG00013
OG0019
OG00220
Troponin I increased
Title
Measurements
OG0001
OG0010
OG0020
White blood cell count decreased
Title
Measurements
OG0006
OG0016
OG00210
White blood cell count increased
Title
Measurements
OG0000
OG0011
OG0020
Hyperglycaemia
Title
Measurements
OG0004
OG0012
OG0026
Hyperkalaemia
Title
Measurements
OG0001
OG0011
OG0021
Hypoalbuminaemia
Title
Measurements
OG0003
OG0012
OG0026
Hypocalcaemia
Title
Measurements
OG0002
OG0012
OG0023
Hypoglycaemia
Title
Measurements
OG0000
OG0010
OG0022
Hypokalaemia
Title
Measurements
OG0004
OG0012
OG0028
Hypomagnesaemia
Title
Measurements
OG0004
OG0013
OG0026
Hyponatraemia
Title
Measurements
OG0008
OG0010
OG0023
Hypophosphataemia
Title
Measurements
OG0001
OG0010
OG0020
Hypovolaemia
Title
Measurements
OG0001
OG0010
OG0020
Iron deficiency
Title
Measurements
OG0000
OG0010
OG0021
Type 2 diabetes mellitus
Title
Measurements
OG0000
OG0011
OG0020
Proteinuria
Title
Measurements
OG0000
OG0011
OG0021
Participants with 1L metastatic disease received IV infusions of oleclumab 3000 mg every 2 weeks for 4 doses, then Q4W in combination with durvalumab 1500 mg Q4W plus chemotherapy of gemcitabine 1000 mg/m^2 and nab-paclitaxel 125 mg/m^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.
Participants with 2L metastatic disease received IV infusions of oleclumab 1500 mg every 2 weeks for 4 doses, then Q4W in combination with durvalumab 1500 mg Q4W plus chemotherapy of mFOLFOX (oxaliplatin 85 mg/m^2 IV; folinic acid 400 mg/m^2 IV; fluorouracil [5-FU] 400 mg/m^2 IV bolus followed by 2400 mg/m^2 continuous IV infusion over 46 to 48 hours) on Days 1 and 15 and then repeated on a Q4W schedule, until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.
Participants with 2L metastatic disease received IV infusions of oleclumab 3000 mg every 2 weeks for 4 doses, then Q4W in combination with durvalumab 1500 mg Q4W plus chemotherapy of mFOLFOX (oxaliplatin 85 mg/m^2 IV; folinic acid 400 mg/m^2 IV; 5-FU 400 mg/m^2 IV bolus followed by 2400 mg/m^2 continuous IV infusion over 46 to 48 hours) on Days 1 and 15 and then repeated on a Q4W schedule, until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.
Units
Counts
Participants
OG0007
OG0017
OG0023
OG0038
Title
Denominators
Categories
Title
Measurements
OG0000(NA to NA)There was zero responder in this cohort, so 95% confidence interval (CI) could not be calculated.
OG00114.3(0.4 to 57.9)
OG0020(NA to NA)There was zero responder in this cohort, so 95% CI could not be calculated.
Participants with 1L metastatic disease received IV infusions of oleclumab 3000 mg every 2 weeks for 4 doses, then Q4W in combination with durvalumab 1500 mg Q4W plus chemotherapy of gemcitabine 1000 mg/m^2 and nab-paclitaxel 125 mg/m^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.
Participants with 2L metastatic disease received IV infusions of oleclumab 1500 mg every 2 weeks for 4 doses, then Q4W in combination with durvalumab 1500 mg Q4W plus chemotherapy of mFOLFOX (oxaliplatin 85 mg/m^2 IV; folinic acid 400 mg/m^2 IV; fluorouracil [5-FU] 400 mg/m^2 IV bolus followed by 2400 mg/m^2 continuous IV infusion over 46 to 48 hours) on Days 1 and 15 and then repeated on a Q4W schedule, until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.
Participants with 2L metastatic disease received IV infusions of oleclumab 3000 mg every 2 weeks for 4 doses, then Q4W in combination with durvalumab 1500 mg Q4W plus chemotherapy of mFOLFOX (oxaliplatin 85 mg/m^2 IV; folinic acid 400 mg/m^2 IV; 5-FU 400 mg/m^2 IV bolus followed by 2400 mg/m^2 continuous IV infusion over 46 to 48 hours) on Days 1 and 15 and then repeated on a Q4W schedule, until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.
Participants with 1L metastatic disease received IV infusions of oleclumab 3000 mg every 2 weeks for 4 doses, then Q4W in combination with durvalumab 1500 mg Q4W plus chemotherapy of gemcitabine 1000 mg/m^2 and nab-paclitaxel 125 mg/m^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.
Units
Counts
Participants
OG00062
OG00138
OG00270
Title
Denominators
Categories
Title
Measurements
OG00047
OG00132
OG00253
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Hazard Ratio (HR)
1.260
2-Sided
95
0.790
1.983
Hazard ratio for comparison between treatment groups obtained from Cox Proportional Hazards model stratified by CD73 level with ties handled by the Efron method.
Superiority
OG000
OG002
Hazard Ratio (HR)
0.750
2-Sided
95
0.498
1.131
Hazard ratio for comparison between treatment groups obtained from Cox Proportional Hazards model stratified by CD73 level with ties handled by the Efron method.
Participants with 1L metastatic disease received IV infusions of oleclumab 3000 mg every 2 weeks for 4 doses, then Q4W in combination with durvalumab 1500 mg Q4W plus chemotherapy of gemcitabine 1000 mg/m^2 and nab-paclitaxel 125 mg/m^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.
Participants with 1L metastatic disease received IV infusions of oleclumab 3000 mg every 2 weeks for 4 doses, then Q4W in combination with chemotherapy of gemcitabine 1000 mg/m^2 and nab-paclitaxel 125 mg/m^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.
Participants with 1L metastatic disease received IV infusions of oleclumab 3000 mg every 2 weeks for 4 doses, then Q4W in combination with durvalumab 1500 mg Q4W plus chemotherapy of gemcitabine 1000 mg/m^2 and nab-paclitaxel 125 mg/m^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.
Units
Counts
Participants
OG00062
OG00138
OG00270
Title
Denominators
Categories
Title
Measurements
OG00043
OG00132
OG00251
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Hazard Ratio (HR)
1.160
2-Sided
95
0.726
1.837
Hazard ratio for comparison between treatment groups obtained from Cox Proportional Hazards model stratified by CD73 level with ties handled by the Efron method.
Superiority
OG000
OG002
Hazard Ratio (HR)
0.719
2-Sided
95
0.468
1.105
Hazard ratio for comparison between treatment groups obtained from Cox Proportional Hazards model stratified by CD73 level with ties handled by the Efron method.
Participants with 1L metastatic disease received IV infusions of oleclumab 3000 mg every 2 weeks for 4 doses, then Q4W in combination with chemotherapy of gemcitabine 1000 mg/m^2 and nab-paclitaxel 125 mg/m^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.
Participants with 1L metastatic disease received IV infusions of oleclumab 3000 mg every 2 weeks for 4 doses, then Q4W in combination with durvalumab 1500 mg Q4W plus chemotherapy of gemcitabine 1000 mg/m^2 and nab-paclitaxel 125 mg/m^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.
Participants with 1L metastatic disease received IV infusions of oleclumab 3000 mg every 2 weeks for 4 doses, then Q4W in combination with chemotherapy of gemcitabine 1000 mg/m^2 and nab-paclitaxel 125 mg/m^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.
Participants with 1L metastatic disease received IV infusions of oleclumab 3000 mg every 2 weeks for 4 doses, then Q4W in combination with durvalumab 1500 mg Q4W plus chemotherapy of gemcitabine 1000 mg/m^2 and nab-paclitaxel 125 mg/m^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.
Units
Counts
Participants
OG00018
OG0018
OG00223
Title
Denominators
Categories
Title
Measurements
OG0007.2(4.9 to NA)Upper limit of 95% CI was not calculated because an insufficient number of participants had event.
OG00112.9(2.2 to NA)Upper limit of 95% CI was not calculated because an insufficient number of participants had event.
Participants with 1L metastatic disease received IV infusions of oleclumab 3000 mg every 2 weeks for 4 doses, then Q4W in combination with chemotherapy of gemcitabine 1000 mg/m^2 and nab-paclitaxel 125 mg/m^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.
Participants with 1L metastatic disease received IV infusions of oleclumab 3000 mg every 2 weeks for 4 doses, then Q4W in combination with durvalumab 1500 mg Q4W plus chemotherapy of gemcitabine 1000 mg/m^2 and nab-paclitaxel 125 mg/m^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.
In dose-expansion phase, participants with 1L metastatic disease and high CD73 levels received IV infusions of oleclumab 3000 mg every 2 weeks for 4 doses, then Q4W in combination with chemotherapy of gemcitabine 1000 mg/m^2 and nab-paclitaxel 125 mg/m^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.
In dose-expansion phase, participants with 1L metastatic disease and high CD73 levels received IV infusions of oleclumab 3000 mg every 2 weeks for 4 doses, then Q4W in combination with durvalumab 1500 mg Q4W plus chemotherapy of gemcitabine 1000 mg/m^2 and nab-paclitaxel 125 mg/m^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.
OG003
Gemcitabine + Nab-paclitaxel: CD73 Level = Low
In dose-expansion phase, participants with 1L metastatic disease and low CD73 levels received IV infusions of chemotherapy of gemcitabine 1000 mg/m^2 and nab-paclitaxel 125 mg/m^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.
In dose-expansion phase, participants with 1L metastatic disease and low CD73 levels received IV infusions of oleclumab 3000 mg every 2 weeks for 4 doses, then Q4W in combination with chemotherapy of gemcitabine 1000 mg/m^2 and nab-paclitaxel 125 mg/m^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.
In dose-expansion phase, participants with 1L metastatic disease and low CD73 levels received IV infusions of oleclumab 3000 mg every 2 weeks for 4 doses, then Q4W in combination with durvalumab 1500 mg Q4W plus chemotherapy of gemcitabine 1000 mg/m^2 and nab-paclitaxel 125 mg/m^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.
In dose-expansion phase, participants with 1L metastatic disease and high CD73 levels received IV infusions of oleclumab 3000 mg every 2 weeks for 4 doses, then Q4W in combination with chemotherapy of gemcitabine 1000 mg/m^2 and nab-paclitaxel 125 mg/m^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.
In dose-expansion phase, participants with 1L metastatic disease and high CD73 levels received IV infusions of oleclumab 3000 mg every 2 weeks for 4 doses, then Q4W in combination with durvalumab 1500 mg Q4W plus chemotherapy of gemcitabine 1000 mg/m^2 and nab-paclitaxel 125 mg/m^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.
OG003
Gemcitabine + Nab-paclitaxel: CD73 Level = Low
In dose-expansion phase, participants with 1L metastatic disease and low CD73 levels received IV infusions of chemotherapy of gemcitabine 1000 mg/m^2 and nab-paclitaxel 125 mg/m^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.
In dose-expansion phase, participants with 1L metastatic disease and low CD73 levels received IV infusions of oleclumab 3000 mg every 2 weeks for 4 doses, then Q4W in combination with chemotherapy of gemcitabine 1000 mg/m^2 and nab-paclitaxel 125 mg/m^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.
In dose-expansion phase, participants with 1L metastatic disease and low CD73 levels received IV infusions of oleclumab 3000 mg every 2 weeks for 4 doses, then Q4W in combination with durvalumab 1500 mg Q4W plus chemotherapy of gemcitabine 1000 mg/m^2 and nab-paclitaxel 125 mg/m^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.
Units
Counts
Participants
OG00046
OG00127
OG00251
OG00316
OG00411
OG00519
Title
Denominators
Categories
Title
Measurements
OG00037
OG00122
OG00239
OG00310
OG00410
OG00514
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Hazard Ratio (HR)
1.173
2-Sided
95
0.676
1.985
Hazard ratio for comparison between treatment groups obtained from Cox Proportional Hazards model with ties handled by the Efron method.
Superiority
OG000
OG002
Hazard Ratio (HR)
0.605
2-Sided
95
0.377
0.968
Hazard ratio for comparison between treatment groups obtained from Cox Proportional Hazards model with ties handled by the Efron method.
Superiority
OG003
OG004
Hazard Ratio (HR)
1.549
2-Sided
95
0.622
3.917
Hazard ratio for comparison between treatment groups obtained from Cox Proportional Hazards model with ties handled by the Efron method.
Superiority
OG003
OG005
Hazard Ratio (HR)
1.472
2-Sided
95
0.638
3.576
Hazard ratio for comparison between treatment groups obtained from Cox Proportional Hazards model with ties handled by the Efron method.
Superiority
In dose-expansion phase, participants with 1L metastatic disease and high CD73 levels received IV infusions of oleclumab 3000 mg every 2 weeks for 4 doses, then Q4W in combination with chemotherapy of gemcitabine 1000 mg/m^2 and nab-paclitaxel 125 mg/m^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.
In dose-expansion phase, participants with 1L metastatic disease and high CD73 levels received IV infusions of oleclumab 3000 mg every 2 weeks for 4 doses, then Q4W in combination with durvalumab 1500 mg Q4W plus chemotherapy of gemcitabine 1000 mg/m^2 and nab-paclitaxel 125 mg/m^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.
OG003
Gemcitabine + Nab-paclitaxel: CD73 Level = Low
In dose-expansion phase, participants with 1L metastatic disease and low CD73 levels received IV infusions of chemotherapy of gemcitabine 1000 mg/m^2 and nab-paclitaxel 125 mg/m^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.
In dose-expansion phase, participants with 1L metastatic disease and low CD73 levels received IV infusions of oleclumab 3000 mg every 2 weeks for 4 doses, then Q4W in combination with chemotherapy of gemcitabine 1000 mg/m^2 and nab-paclitaxel 125 mg/m^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.
In dose-expansion phase, participants with 1L metastatic disease and low CD73 levels received IV infusions of oleclumab 3000 mg every 2 weeks for 4 doses, then Q4W in combination with durvalumab 1500 mg Q4W plus chemotherapy of gemcitabine 1000 mg/m^2 and nab-paclitaxel 125 mg/m^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.
In dose-expansion phase, participants with 1L metastatic disease and high CD73 levels received IV infusions of oleclumab 3000 mg every 2 weeks for 4 doses, then Q4W in combination with chemotherapy of gemcitabine 1000 mg/m^2 and nab-paclitaxel 125 mg/m^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.
In dose-expansion phase, participants with 1L metastatic disease and high CD73 levels received IV infusions of oleclumab 3000 mg every 2 weeks for 4 doses, then Q4W in combination with durvalumab 1500 mg Q4W plus chemotherapy of gemcitabine 1000 mg/m^2 and nab-paclitaxel 125 mg/m^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.
OG003
Gemcitabine + Nab-paclitaxel: CD73 Level = Low
In dose-expansion phase, participants with 1L metastatic disease and low CD73 levels received IV infusions of chemotherapy of gemcitabine 1000 mg/m^2 and nab-paclitaxel 125 mg/m^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.
In dose-expansion phase, participants with 1L metastatic disease and low CD73 levels received IV infusions of oleclumab 3000 mg every 2 weeks for 4 doses, then Q4W in combination with chemotherapy of gemcitabine 1000 mg/m^2 and nab-paclitaxel 125 mg/m^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.
In dose-expansion phase, participants with 1L metastatic disease and low CD73 levels received IV infusions of oleclumab 3000 mg every 2 weeks for 4 doses, then Q4W in combination with durvalumab 1500 mg Q4W plus chemotherapy of gemcitabine 1000 mg/m^2 and nab-paclitaxel 125 mg/m^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.
Units
Counts
Participants
OG00046
OG00127
OG00251
OG00316
OG00411
OG00519
Title
Denominators
Categories
Title
Measurements
OG00035
OG00123
OG00239
OG0038
OG0049
OG00512
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Hazard Ratio (HR)
1.004
2-Sided
95
0.584
1.693
Hazard ratio for comparison between treatment groups obtained from Cox Proportional Hazards model with ties handled by the Efron method.
Superiority
OG000
OG002
Hazard Ratio (HR)
0.598
2-Sided
95
0.366
0.973
Hazard ratio for comparison between treatment groups obtained from Cox Proportional Hazards model with ties handled by the Efron method.
Superiority
OG003
OG004
Hazard Ratio (HR)
1.933
2-Sided
95
0.716
5.437
Hazard ratio for comparison between treatment groups obtained from Cox Proportional Hazards model with ties handled by the Efron method.
Superiority
OG003
OG005
Hazard Ratio (HR)
1.374
2-Sided
95
0.550
3.707
Hazard ratio for comparison between treatment groups obtained from Cox Proportional Hazards model with ties handled by the Efron method.
In dose-expansion phase, participants with 1L metastatic disease and high CD73 levels received IV infusions of oleclumab 3000 mg every 2 weeks for 4 doses, then Q4W in combination with chemotherapy of gemcitabine 1000 mg/m^2 and nab-paclitaxel 125 mg/m^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.
In dose-expansion phase, participants with 1L metastatic disease and high CD73 levels received IV infusions of oleclumab 3000 mg every 2 weeks for 4 doses, then Q4W in combination with durvalumab 1500 mg Q4W plus chemotherapy of gemcitabine 1000 mg/m^2 and nab-paclitaxel 125 mg/m^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.
OG003
Gemcitabine + Nab-paclitaxel: CD73 Level = Low
In dose-expansion phase, participants with 1L metastatic disease and low CD73 levels received IV infusions of chemotherapy of gemcitabine 1000 mg/m^2 and nab-paclitaxel 125 mg/m^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.
In dose-expansion phase, participants with 1L metastatic disease and low CD73 levels received IV infusions of oleclumab 3000 mg every 2 weeks for 4 doses, then Q4W in combination with chemotherapy of gemcitabine 1000 mg/m^2 and nab-paclitaxel 125 mg/m^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.
In dose-expansion phase, participants with 1L metastatic disease and low CD73 levels received IV infusions of oleclumab 3000 mg every 2 weeks for 4 doses, then Q4W in combination with durvalumab 1500 mg Q4W plus chemotherapy of gemcitabine 1000 mg/m^2 and nab-paclitaxel 125 mg/m^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.
Units
Counts
Participants
OG00046
OG00127
OG00251
OG00316
OG00411
OG00519
Title
Denominators
Categories
Title
Measurements
OG0005.6(3.7 to 7.4)
OG0015.2(1.9 to 6.3)
OG0025.5(4.4 to 9.3)
OG00310.5(6.9 to NA)Upper limit of 95% CI was not calculated because an insufficient number of participants had event.
Participants with 1L metastatic disease received IV infusions of oleclumab 3000 mg every 2 weeks for 4 doses, then Q4W in combination with durvalumab 1500 mg Q4W plus chemotherapy of gemcitabine 1000 mg/m^2 and nab-paclitaxel 125 mg/m^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.
Participants with 2L metastatic disease received IV infusions of oleclumab 1500 mg every 2 weeks for 4 doses, then Q4W in combination with durvalumab 1500 mg Q4W plus chemotherapy of mFOLFOX (oxaliplatin 85 mg/m^2 IV; folinic acid 400 mg/m^2 IV; fluorouracil [5-FU] 400 mg/m^2 IV bolus followed by 2400 mg/m^2 continuous IV infusion over 46 to 48 hours) on Days 1 and 15 and then repeated on a Q4W schedule, until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.
Participants with 2L metastatic disease received IV infusions of oleclumab 3000 mg every 2 weeks for 4 doses, then Q4W in combination with durvalumab 1500 mg Q4W plus chemotherapy of mFOLFOX (oxaliplatin 85 mg/m^2 IV; folinic acid 400 mg/m^2 IV; 5-FU 400 mg/m^2 IV bolus followed by 2400 mg/m^2 continuous IV infusion over 46 to 48 hours) on Days 1 and 15 and then repeated on a Q4W schedule, until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.
Participants with 1L metastatic disease received IV infusions of oleclumab 3000 mg every 2 weeks for 4 doses, then Q4W in combination with chemotherapy of gemcitabine 1000 mg/m^2 and nab-paclitaxel 125 mg/m^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.
Participants with 1L metastatic disease received IV infusions of oleclumab 3000 mg every 2 weeks for 4 doses, then Q4W in combination with durvalumab 1500 mg Q4W plus chemotherapy of gemcitabine 1000 mg/m^2 and nab-paclitaxel 125 mg/m^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.
Participants with 1L metastatic disease received IV infusions of oleclumab 3000 mg every 2 weeks for 4 doses, then Q4W in combination with durvalumab 1500 mg Q4W plus chemotherapy of gemcitabine 1000 mg/m^2 and nab-paclitaxel 125 mg/m^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.
Participants with 2L metastatic disease received IV infusions of oleclumab 1500 mg every 2 weeks for 4 doses, then Q4W in combination with durvalumab 1500 mg Q4W plus chemotherapy of mFOLFOX (oxaliplatin 85 mg/m^2 IV; folinic acid 400 mg/m^2 IV; fluorouracil [5-FU] 400 mg/m^2 IV bolus followed by 2400 mg/m^2 continuous IV infusion over 46 to 48 hours) on Days 1 and 15 and then repeated on a Q4W schedule, until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.
Participants with 2L metastatic disease received IV infusions of oleclumab 3000 mg every 2 weeks for 4 doses, then Q4W in combination with durvalumab 1500 mg Q4W plus chemotherapy of mFOLFOX (oxaliplatin 85 mg/m^2 IV; folinic acid 400 mg/m^2 IV; 5-FU 400 mg/m^2 IV bolus followed by 2400 mg/m^2 continuous IV infusion over 46 to 48 hours) on Days 1 and 15 and then repeated on a Q4W schedule, until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.
Participants with 1L metastatic disease received IV infusions of oleclumab 3000 mg every 2 weeks for 4 doses, then Q4W in combination with durvalumab 1500 mg Q4W plus chemotherapy of gemcitabine 1000 mg/m^2 and nab-paclitaxel 125 mg/m^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.
Participants with 2L metastatic disease received IV infusions of oleclumab 1500 mg every 2 weeks for 4 doses, then Q4W in combination with durvalumab 1500 mg Q4W plus chemotherapy of mFOLFOX (oxaliplatin 85 mg/m^2 IV; folinic acid 400 mg/m^2 IV; fluorouracil [5-FU] 400 mg/m^2 IV bolus followed by 2400 mg/m^2 continuous IV infusion over 46 to 48 hours) on Days 1 and 15 and then repeated on a Q4W schedule, until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.
Participants with 2L metastatic disease received IV infusions of oleclumab 3000 mg every 2 weeks for 4 doses, then Q4W in combination with durvalumab 1500 mg Q4W plus chemotherapy of mFOLFOX (oxaliplatin 85 mg/m^2 IV; folinic acid 400 mg/m^2 IV; 5-FU 400 mg/m^2 IV bolus followed by 2400 mg/m^2 continuous IV infusion over 46 to 48 hours) on Days 1 and 15 and then repeated on a Q4W schedule, until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.
Participants with 1L metastatic disease received IV infusions of oleclumab 3000 mg every 2 weeks for 4 doses, then Q4W in combination with chemotherapy of gemcitabine 1000 mg/m^2 and nab-paclitaxel 125 mg/m^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.
Participants with 1L metastatic disease received IV infusions of oleclumab 3000 mg every 2 weeks for 4 doses, then Q4W in combination with durvalumab 1500 mg Q4W plus chemotherapy of gemcitabine 1000 mg/m^2 and nab-paclitaxel 125 mg/m^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.
Participants with 2L metastatic disease received IV infusions of oleclumab 1500 mg every 2 weeks for 4 doses, then Q4W in combination with durvalumab 1500 mg Q4W plus chemotherapy of mFOLFOX (oxaliplatin 85 mg/m^2 IV; folinic acid 400 mg/m^2 IV; fluorouracil [5-FU] 400 mg/m^2 IV bolus followed by 2400 mg/m^2 continuous IV infusion over 46 to 48 hours) on Days 1 and 15 and then repeated on a Q4W schedule, until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.
Participants with 2L metastatic disease received IV infusions of oleclumab 3000 mg every 2 weeks for 4 doses, then Q4W in combination with durvalumab 1500 mg Q4W plus chemotherapy of mFOLFOX (oxaliplatin 85 mg/m^2 IV; folinic acid 400 mg/m^2 IV; 5-FU 400 mg/m^2 IV bolus followed by 2400 mg/m^2 continuous IV infusion over 46 to 48 hours) on Days 1 and 15 and then repeated on a Q4W schedule, until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.
Participants with 1L metastatic disease received IV infusions of oleclumab 3000 mg every 2 weeks for 4 doses, then Q4W in combination with durvalumab 1500 mg Q4W plus chemotherapy of gemcitabine 1000 mg/m^2 and nab-paclitaxel 125 mg/m^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.
Units
Counts
Participants
OG0007
OG0017
OG0023
OG0038
OG00470
Title
Denominators
Categories
C1D1 (EOI)
ParticipantsOG0007
ParticipantsOG0017
ParticipantsOG0023
ParticipantsOG0038
ParticipantsOG00470
Title
Measurements
OG000292.5± 11.72
OG001374.5± 27.50
OG002309.0± 11.58
OG003
C2D1 (pre-dose)
ParticipantsOG0005
ParticipantsOG0016
ParticipantsOG0023
ParticipantsOG0037
C5D1 (pre-dose)
ParticipantsOG0001
ParticipantsOG0013
ParticipantsOG0020
ParticipantsOG0034
C5D1 (EOI)
ParticipantsOG0001
ParticipantsOG0013
ParticipantsOG0020
ParticipantsOG0034
OG002
Dose-expansion, Gemcitabine + Nab-paclitaxel
Participants with 1L metastatic disease received IV infusions of chemotherapy of gemcitabine 1000 mg/m^2 and nab-paclitaxel 125 mg/m^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.
Participants with 1L metastatic disease received IV infusions of oleclumab 3000 mg every 2 weeks for 4 doses, then Q4W in combination with chemotherapy of gemcitabine 1000 mg/m^2 and nab-paclitaxel 125 mg/m^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.
Participants with 1L metastatic disease received IV infusions of oleclumab 3000 mg every 2 weeks for 4 doses, then Q4W in combination with durvalumab 1500 mg Q4W plus chemotherapy of gemcitabine 1000 mg/m^2 and nab-paclitaxel 125 mg/m^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.
Units
Counts
Participants
OG0007
OG0017
OG00257
OG00338
OG00470
Title
Denominators
Categories
Gemcitabine C1D1 (EOI)
ParticipantsOG0007
ParticipantsOG0017
ParticipantsOG00254
ParticipantsOG00336
ParticipantsOG00465
Title
Measurements
OG0003194± 64.74
OG0014659± 67.41
OG0023301± 192.0
OG003
Gemcitabine C4D1 (pre-dose)
ParticipantsOG0002
ParticipantsOG0014
ParticipantsOG00233
ParticipantsOG00325
Gemcitabine C4D1 (EOI)
ParticipantsOG0002
ParticipantsOG0014
ParticipantsOG00228
ParticipantsOG00325
dFdU C1D1 (EOI)
ParticipantsOG0007
ParticipantsOG0017
ParticipantsOG00254
ParticipantsOG00336
dFdU C4D1 (pre-dose)
ParticipantsOG0002
ParticipantsOG0014
ParticipantsOG00233
ParticipantsOG00325
dFdU C4D1 (EOI)
ParticipantsOG0002
ParticipantsOG0014
ParticipantsOG00228
ParticipantsOG00325
OG002
Dose-expansion, Gemcitabine + Nab-paclitaxel
Participants with 1L metastatic disease received IV infusions of chemotherapy of gemcitabine 1000 mg/m^2 and nab-paclitaxel 125 mg/m^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.
Participants with 1L metastatic disease received IV infusions of oleclumab 3000 mg every 2 weeks for 4 doses, then Q4W in combination with chemotherapy of gemcitabine 1000 mg/m^2 and nab-paclitaxel 125 mg/m^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.
Participants with 1L metastatic disease received IV infusions of oleclumab 3000 mg every 2 weeks for 4 doses, then Q4W in combination with durvalumab 1500 mg Q4W plus chemotherapy of gemcitabine 1000 mg/m^2 and nab-paclitaxel 125 mg/m^2, both on Days 1, 8, and 15 and then repeated on Q4W schedule until disease progression, intolerable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.
Units
Counts
Participants
OG0007
OG0017
OG00260
OG00338
OG00470
Title
Denominators
Categories
C1D1 (EOI)
ParticipantsOG0007
ParticipantsOG0017
ParticipantsOG00258
ParticipantsOG00335
ParticipantsOG00469
Title
Measurements
OG0001711± 80.37
OG0012685± 63.55
OG0022381± 105.2
OG003
C4D1 (pre-dose)
ParticipantsOG0002
ParticipantsOG0014
ParticipantsOG00235
ParticipantsOG00324
C4D1 (EOI)
ParticipantsOG0002
ParticipantsOG0014
ParticipantsOG00231
ParticipantsOG00324
0 events
0 affected
8 at risk
EG0041 events1 affected62 at risk
EG0051 events1 affected38 at risk
EG0060 events0 affected70 at risk
0 events
0 affected
8 at risk
EG0040 events0 affected62 at risk
EG0051 events1 affected38 at risk
EG0060 events0 affected70 at risk
0 events
0 affected
8 at risk
EG0040 events0 affected62 at risk
EG0050 events0 affected38 at risk
EG0061 events1 affected70 at risk
0 events
0 affected
8 at risk
EG0040 events0 affected62 at risk
EG0051 events1 affected38 at risk
EG0060 events0 affected70 at risk
0 events
0 affected
8 at risk
EG0040 events0 affected62 at risk
EG0051 events1 affected38 at risk
EG0060 events0 affected70 at risk
0 events
0 affected
8 at risk
EG0040 events0 affected62 at risk
EG0050 events0 affected38 at risk
EG0061 events1 affected70 at risk
1 events
1 affected
8 at risk
EG0040 events0 affected62 at risk
EG0051 events1 affected38 at risk
EG0060 events0 affected70 at risk
0 events
0 affected
8 at risk
EG0040 events0 affected62 at risk
EG0052 events2 affected38 at risk
EG0060 events0 affected70 at risk
0 events
0 affected
8 at risk
EG0040 events0 affected62 at risk
EG0050 events0 affected38 at risk
EG0061 events1 affected70 at risk
0 events
0 affected
8 at risk
EG0046 events5 affected62 at risk
EG0053 events3 affected38 at risk
EG0069 events8 affected70 at risk
0 events
0 affected
8 at risk
EG0042 events2 affected62 at risk
EG0051 events1 affected38 at risk
EG0063 events3 affected70 at risk
0 events
0 affected
8 at risk
EG0040 events0 affected62 at risk
EG0051 events1 affected38 at risk
EG0063 events3 affected70 at risk
0 events
0 affected
8 at risk
EG0040 events0 affected62 at risk
EG0051 events1 affected38 at risk
EG0060 events0 affected70 at risk
0 events
0 affected
8 at risk
EG0041 events1 affected62 at risk
EG0050 events0 affected38 at risk
EG0060 events0 affected70 at risk
0 events
0 affected
8 at risk
EG0040 events0 affected62 at risk
EG0050 events0 affected38 at risk
EG0061 events1 affected70 at risk
0 events
0 affected
8 at risk
EG0040 events0 affected62 at risk
EG0050 events0 affected38 at risk
EG0061 events1 affected70 at risk
0 events
0 affected
8 at risk
EG0040 events0 affected62 at risk
EG0051 events1 affected38 at risk
EG0060 events0 affected70 at risk
0 events
0 affected
8 at risk
EG0041 events1 affected62 at risk
EG0050 events0 affected38 at risk
EG0061 events1 affected70 at risk
0 events
0 affected
8 at risk
EG0040 events0 affected62 at risk
EG0050 events0 affected38 at risk
EG0062 events2 affected70 at risk
1 events
1 affected
8 at risk
EG0040 events0 affected62 at risk
EG0050 events0 affected38 at risk
EG0060 events0 affected70 at risk
0 events
0 affected
8 at risk
EG0041 events1 affected62 at risk
EG0050 events0 affected38 at risk
EG0062 events2 affected70 at risk
1 events
1 affected
8 at risk
EG0040 events0 affected62 at risk
EG0050 events0 affected38 at risk
EG0062 events1 affected70 at risk
0 events
0 affected
8 at risk
EG0040 events0 affected62 at risk
EG0050 events0 affected38 at risk
EG0061 events1 affected70 at risk
0 events
0 affected
8 at risk
EG0040 events0 affected62 at risk
EG0051 events1 affected38 at risk
EG0060 events0 affected70 at risk
0 events
0 affected
8 at risk
EG0040 events0 affected62 at risk
EG0050 events0 affected38 at risk
EG0061 events1 affected70 at risk
0 events
0 affected
8 at risk
EG0041 events1 affected62 at risk
EG0052 events2 affected38 at risk
EG0060 events0 affected70 at risk
0 events
0 affected
8 at risk
EG0040 events0 affected62 at risk
EG0050 events0 affected38 at risk
EG0061 events1 affected70 at risk
0 events
0 affected
8 at risk
EG0041 events1 affected62 at risk
EG0050 events0 affected38 at risk
EG0060 events0 affected70 at risk
0 events
0 affected
8 at risk
EG0040 events0 affected62 at risk
EG0050 events0 affected38 at risk
EG0061 events1 affected70 at risk
0 events
0 affected
8 at risk
EG0041 events1 affected62 at risk
EG0050 events0 affected38 at risk
EG0060 events0 affected70 at risk
0 events
0 affected
8 at risk
EG0041 events1 affected62 at risk
EG0050 events0 affected38 at risk
EG0060 events0 affected70 at risk
0 events
0 affected
8 at risk
EG0040 events0 affected62 at risk
EG0050 events0 affected38 at risk
EG0060 events0 affected70 at risk
0 events
0 affected
8 at risk
EG0041 events1 affected62 at risk
EG0050 events0 affected38 at risk
EG0060 events0 affected70 at risk
0 events
0 affected
8 at risk
EG0040 events0 affected62 at risk
EG0050 events0 affected38 at risk
EG0060 events0 affected70 at risk
0 events
0 affected
8 at risk
EG0040 events0 affected62 at risk
EG0050 events0 affected38 at risk
EG0061 events1 affected70 at risk
0 events
0 affected
8 at risk
EG0040 events0 affected62 at risk
EG0051 events1 affected38 at risk
EG0060 events0 affected70 at risk
0 events
0 affected
8 at risk
EG0043 events3 affected62 at risk
EG0052 events2 affected38 at risk
EG0061 events1 affected70 at risk
0 events
0 affected
8 at risk
EG0044 events4 affected62 at risk
EG0050 events0 affected38 at risk
EG0064 events3 affected70 at risk
0 events
0 affected
8 at risk
EG0040 events0 affected62 at risk
EG0050 events0 affected38 at risk
EG0060 events0 affected70 at risk
0 events
0 affected
8 at risk
EG0041 events1 affected62 at risk
EG0050 events0 affected38 at risk
EG0060 events0 affected70 at risk
0 events
0 affected
8 at risk
EG0040 events0 affected62 at risk
EG0050 events0 affected38 at risk
EG0061 events1 affected70 at risk
0 events
0 affected
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0 affected
8 at risk
EG0040 events0 affected62 at risk
EG0050 events0 affected38 at risk
EG0060 events0 affected70 at risk
0 events
0 affected
8 at risk
EG0040 events0 affected62 at risk
EG0051 events1 affected38 at risk
EG0060 events0 affected70 at risk
0 events
0 affected
8 at risk
EG0040 events0 affected62 at risk
EG0051 events1 affected38 at risk
EG0061 events1 affected70 at risk
0 events
0 affected
8 at risk
EG0040 events0 affected62 at risk
EG0051 events1 affected38 at risk
EG0060 events0 affected70 at risk
0 events
0 affected
8 at risk
EG0040 events0 affected62 at risk
EG0051 events1 affected38 at risk
EG0060 events0 affected70 at risk
0 events
0 affected
8 at risk
EG0041 events1 affected62 at risk
EG0052 events2 affected38 at risk
EG0064 events3 affected70 at risk
1 events
1 affected
8 at risk
EG0040 events0 affected62 at risk
EG0050 events0 affected38 at risk
EG0060 events0 affected70 at risk
0 events
0 affected
8 at risk
EG0040 events0 affected62 at risk
EG0051 events1 affected38 at risk
EG0060 events0 affected70 at risk
0 events
0 affected
8 at risk
EG0040 events0 affected62 at risk
EG0050 events0 affected38 at risk
EG0060 events0 affected70 at risk
0 events
0 affected
8 at risk
EG0040 events0 affected62 at risk
EG0050 events0 affected38 at risk
EG0061 events1 affected70 at risk
0 events
0 affected
8 at risk
EG0041 events1 affected62 at risk
EG0051 events1 affected38 at risk
EG0062 events2 affected70 at risk
2 events
2 affected
8 at risk
EG0042 events1 affected62 at risk
EG0052 events2 affected38 at risk
EG0063 events3 affected70 at risk
1 events
1 affected
8 at risk
EG00413 events12 affected62 at risk
EG0057 events6 affected38 at risk
EG00616 events13 affected70 at risk
1 events
1 affected
8 at risk
EG0045 events5 affected62 at risk
EG0054 events4 affected38 at risk
EG0065 events5 affected70 at risk
0 events
0 affected
8 at risk
EG0040 events0 affected62 at risk
EG0050 events0 affected38 at risk
EG0061 events1 affected70 at risk
0 events
0 affected
8 at risk
EG0041 events1 affected62 at risk
EG0050 events0 affected38 at risk
EG0061 events1 affected70 at risk
0 events
0 affected
8 at risk
EG0040 events0 affected62 at risk
EG0050 events0 affected38 at risk
EG0061 events1 affected70 at risk
1 events
1 affected
8 at risk
EG0042 events2 affected62 at risk
EG0053 events3 affected38 at risk
EG0063 events3 affected70 at risk
0 events
0 affected
8 at risk
EG0041 events1 affected62 at risk
EG0050 events0 affected38 at risk
EG0062 events2 affected70 at risk
2 events
2 affected
8 at risk
EG00413 events10 affected62 at risk
EG00521 events15 affected38 at risk
EG00628 events18 affected70 at risk
0 events
0 affected
8 at risk
EG0041 events1 affected62 at risk
EG0050 events0 affected38 at risk
EG0061 events1 affected70 at risk
6 events
5 affected
8 at risk
EG00426 events18 affected62 at risk
EG00529 events14 affected38 at risk
EG00663 events36 affected70 at risk
0 events
0 affected
8 at risk
EG0043 events3 affected62 at risk
EG0052 events2 affected38 at risk
EG0064 events4 affected70 at risk
0 events
0 affected
8 at risk
EG0042 events2 affected62 at risk
EG0054 events4 affected38 at risk
EG0067 events7 affected70 at risk
0 events
0 affected
8 at risk
EG0040 events0 affected62 at risk
EG0051 events1 affected38 at risk
EG0061 events1 affected70 at risk
0 events
0 affected
8 at risk
EG0040 events0 affected62 at risk
EG0050 events0 affected38 at risk
EG0063 events3 affected70 at risk
2 events
2 affected
8 at risk
EG0041 events1 affected62 at risk
EG0050 events0 affected38 at risk
EG0062 events2 affected70 at risk
0 events
0 affected
8 at risk
EG0041 events1 affected62 at risk
EG0050 events0 affected38 at risk
EG0060 events0 affected70 at risk
0 events
0 affected
8 at risk
EG0041 events1 affected62 at risk
EG0050 events0 affected38 at risk
EG0060 events0 affected70 at risk
0 events
0 affected
8 at risk
EG0040 events0 affected62 at risk
EG0050 events0 affected38 at risk
EG0061 events1 affected70 at risk
0 events
0 affected
8 at risk
EG0041 events1 affected62 at risk
EG0053 events2 affected38 at risk
EG0068 events3 affected70 at risk
0 events
0 affected
8 at risk
EG0041 events1 affected62 at risk
EG0051 events1 affected38 at risk
EG0062 events2 affected70 at risk
0 events
0 affected
8 at risk
EG0040 events0 affected62 at risk
EG0051 events1 affected38 at risk
EG0060 events0 affected70 at risk
0 events
0 affected
8 at risk
EG0040 events0 affected62 at risk
EG0050 events0 affected38 at risk
EG0061 events1 affected70 at risk
0 events
0 affected
8 at risk
EG0040 events0 affected62 at risk
EG0051 events1 affected38 at risk
EG0060 events0 affected70 at risk
0 events
0 affected
8 at risk
EG0041 events1 affected62 at risk
EG0050 events0 affected38 at risk
EG0060 events0 affected70 at risk
0 events
0 affected
8 at risk
EG0040 events0 affected62 at risk
EG0050 events0 affected38 at risk
EG0061 events1 affected70 at risk
0 events
0 affected
8 at risk
EG0041 events1 affected62 at risk
EG0050 events0 affected38 at risk
EG0060 events0 affected70 at risk
0 events
0 affected
8 at risk
EG0040 events0 affected62 at risk
EG0050 events0 affected38 at risk
EG0061 events1 affected70 at risk
0 events
0 affected
8 at risk
EG0041 events1 affected62 at risk
EG0050 events0 affected38 at risk
EG0060 events0 affected70 at risk
0 events
0 affected
8 at risk
EG0040 events0 affected62 at risk
EG0050 events0 affected38 at risk
EG0062 events2 affected70 at risk
5 events
4 affected
8 at risk
EG00434 events26 affected62 at risk
EG00570 events26 affected38 at risk
EG00649 events41 affected70 at risk
0 events
0 affected
8 at risk
EG0041 events1 affected62 at risk
EG0050 events0 affected38 at risk
EG0060 events0 affected70 at risk
0 events
0 affected
8 at risk
EG0040 events0 affected62 at risk
EG0051 events1 affected38 at risk
EG0060 events0 affected70 at risk
0 events
0 affected
8 at risk
EG0041 events1 affected62 at risk
EG0050 events0 affected38 at risk
EG0060 events0 affected70 at risk
0 events
0 affected
8 at risk
EG0042 events2 affected62 at risk
EG0050 events0 affected38 at risk
EG0062 events2 affected70 at risk
0 events
0 affected
8 at risk
EG0041 events1 affected62 at risk
EG0050 events0 affected38 at risk
EG0060 events0 affected70 at risk
0 events
0 affected
8 at risk
EG0040 events0 affected62 at risk
EG0050 events0 affected38 at risk
EG0061 events1 affected70 at risk
0 events
0 affected
8 at risk
EG0040 events0 affected62 at risk
EG0051 events1 affected38 at risk
EG0060 events0 affected70 at risk
0 events
0 affected
8 at risk
EG0040 events0 affected62 at risk
EG0050 events0 affected38 at risk
EG0061 events1 affected70 at risk
3 events
3 affected
8 at risk
EG0045 events5 affected62 at risk
EG0055 events3 affected38 at risk
EG0067 events7 affected70 at risk
0 events
0 affected
8 at risk
EG0040 events0 affected62 at risk
EG0050 events0 affected38 at risk
EG0061 events1 affected70 at risk
0 events
0 affected
8 at risk
EG0040 events0 affected62 at risk
EG0051 events1 affected38 at risk
EG0061 events1 affected70 at risk
3 events
3 affected
8 at risk
EG00421 events15 affected62 at risk
EG00518 events12 affected38 at risk
EG00623 events16 affected70 at risk
0
0
1
0
1
0
1
1
1
1
2
3
1
1
0
0
0
2
3
2
2
1
1
2
1
2
0
0
1
1
1
1
1
OG0041
OG0050
1
OG0040
OG0050
0
OG0041
OG0050
0
OG0040
OG0050
2
OG0040
2
OG0040
0
OG0040
0
OG0040
734.6
± 41.01
OG004704.4± 30.28
OG005725.9± 34.69
Participants
OG004
27
ParticipantsOG00557
Title
Measurements
OG000128.6± 10.00
OG001211.5± 73.40
OG002134.3± 141.5
OG003368.9± 2.461
OG004164.8± 324.1
OG005226.8± 70.41
Participants
OG004
25
ParticipantsOG00557
Title
Measurements
OG000NA± NAPer sponsor convention three observations \> Lower Limit of Quantification were required as a minimum for a plasma concentration to be summarized. Otherwise, the statistics were not calculated at the time point.
OG001870.3± 21.86
OG002571.1± 15.75
OG0031181± 24.97
OG004893.0± 30.66
OG005894.4± 39.22
Participants
OG004
20
ParticipantsOG00545
Title
Measurements
OG000NA± NAPer sponsor convention three observations \> Lower Limit of Quantification were required as a minimum for a plasma concentration to be summarized. Otherwise, the statistics were not calculated at the time point.
OG00173.19± 130.2
OG003235.7± 27.68
OG00485.99± 192.0
OG005116.4± 54.0
Participants
OG004
20
ParticipantsOG00545
Title
Measurements
OG000NA± NAPer sponsor convention three observations \> Lower Limit of Quantification were required as a minimum for a plasma concentration to be summarized. Otherwise, the statistics were not calculated at the time point.
OG001948.3± 44.90
OG0031057± 14.88
OG004852.8± 24.77
OG005753.2± 41.32
380.7
± 56.89
OG004345.8± 324.2
Participants
OG004
61
Title
Measurements
OG00035.97± 51.44
OG00114.39± 5129
OG00250.52± 57.30
OG00359.97± 176.7
OG00486.20± 97.95
Participants
OG004
45
Title
Measurements
OG000NA± NAPer sponsor convention three observations \> Lower Limit of Quantification were required as a minimum for a plasma concentration to be summarized. Otherwise, the statistics were not calculated at the time point.
OG00174.52± 28.32
OG003175.9± 43.50
OG004137.9± 48.85
Participants
OG004
44
Title
Measurements
OG000NA± NAPer sponsor convention three observations \> Lower Limit of Quantification were required as a minimum for a plasma concentration to be summarized. Otherwise, the statistics were not calculated at the time point.
OG001522.1± 46.72
OG003664.5± 28.14
OG004597.9± 23.40
3315
± 135.4
OG0044086± 148.9
ParticipantsOG00450
Title
Measurements
OG000NA± NAPer sponsor convention three observations \> Lower Limit of Quantification were required as a minimum for a plasma concentration to be summarized. Otherwise, the statistics were not calculated at the time point.
OG001NA± NAPer sponsor convention three observations \> Lower Limit of Quantification were required as a minimum for a plasma concentration to be summarized. Otherwise, the statistics were not calculated at the time point.
OG002NA± NAPer sponsor convention three observations \> Lower Limit of Quantification were required as a minimum for a plasma concentration to be summarized. Otherwise, the statistics were not calculated at the time point.
OG003NA± NAPer sponsor convention three observations \> Lower Limit of Quantification were required as a minimum for a plasma concentration to be summarized. Otherwise, the statistics were not calculated at the time point.
OG004NA± NAPer sponsor convention three observations \> Lower Limit of Quantification were required as a minimum for a plasma concentration to be summarized. Otherwise, the statistics were not calculated at the time point.
ParticipantsOG00449
Title
Measurements
OG000NA± NAPer sponsor convention three observations \> Lower Limit of Quantification were required as a minimum for a plasma concentration to be summarized. Otherwise, the statistics were not calculated at the time point.
OG0013530± 48.11
OG0021748± 236.5
OG0031431± 446.3
OG0042998± 151.3
ParticipantsOG00465
Title
Measurements
OG00033700± 14.70
OG00132160± 17.67
OG00229510± 113.4
OG00332350± 17.10
OG00426300± 163.9
ParticipantsOG00450
Title
Measurements
OG000NA± NAPer sponsor convention three observations \> Lower Limit of Quantification were required as a minimum for a plasma concentration to be summarized. Otherwise, the statistics were not calculated at the time point.
OG001434.6± 344.7
OG002245.1± 361.5
OG003149.9± 147.0
OG004177.5± 170.0
ParticipantsOG00449
Title
Measurements
OG000NA± NAPer sponsor convention three observations \> Lower Limit of Quantification were required as a minimum for a plasma concentration to be summarized. Otherwise, the statistics were not calculated at the time point.
OG00134550± 35.37
OG00223900± 189.1
OG00321970± 130.3
OG00427260± 43.07
2711
± 81.67
OG0042611± 142.0
ParticipantsOG00447
Title
Measurements
OG000NA± NAPer sponsor convention three observations \> Lower Limit of Quantification were required as a minimum for a plasma concentration to be summarized. Otherwise, the statistics were not calculated at the time point.
OG001NA± NAPer sponsor convention three observations \> Lower Limit of Quantification were required as a minimum for a plasma concentration to be summarized. Otherwise, the statistics were not calculated at the time point.
OG002NA± NAPer sponsor convention three observations \> Lower Limit of Quantification were required as a minimum for a plasma concentration to be summarized. Otherwise, the statistics were not calculated at the time point.
OG003NA± NAPer sponsor convention three observations \> Lower Limit of Quantification were required as a minimum for a plasma concentration to be summarized. Otherwise, the statistics were not calculated at the time point.
OG004NA± NAPer sponsor convention three observations \> Lower Limit of Quantification were required as a minimum for a plasma concentration to be summarized. Otherwise, the statistics were not calculated at the time point.
Participants
OG004
48
Title
Measurements
OG000NA± NAPer sponsor convention three observations \> Lower Limit of Quantification were required as a minimum for a plasma concentration to be summarized. Otherwise, the statistics were not calculated at the time point.