Study of Efficacy and Safety of NIS793 in Combination Wit... | NCT04935359 | Trialant
NCT04935359
Sponsor
Novartis Pharmaceuticals
Status
Completed
Last Update Posted
May 19, 2026Actual
Enrollment
511Actual
Phase
Phase 3
Conditions
Metastatic Pancreatic Ductal Adenocarcinoma
Interventions
NIS793
Nab-paclitaxel
Gemcitabine
Placebo
Countries
United States
Australia
Belgium
Brazil
Canada
China
Czechia
Finland
France
Germany
Greece
Hungary
Israel
Italy
Japan
Netherlands
Norway
Russia
Singapore
Slovakia
South Korea
Spain
Sweden
Switzerland
Taiwan
Turkey (Türkiye)
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT04935359
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
CNIS793B12301
Secondary IDs
ID
Type
Description
Link
2021-000591-10
EudraCT Number
Brief Title
Study of Efficacy and Safety of NIS793 in Combination With Standard of Care (SOC) Chemotherapy in First-line Metastatic Pancreatic Ductal Adenocarcinoma (mPDAC) - daNIS-2
Official Title
A Randomized, Double-blind, Phase III Study, Comparing NIS793 in Combination With Gemcitabine and Nab-paclitaxel Versus (vs.) Placebo Combined With Gemcitabine and Nab-paclitaxel for First Line Treatment of Metastatic Pancreatic Ductal Adenocarcinoma (mPDAC) - daNIS-2
Acronym
Not provided
Organization
NovartisINDUSTRY
Status Module
Record Verification Date
Apr 2026
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
Not provided
Start Date
Sep 30, 2021Actual
Primary Completion Date
Aug 13, 2024Actual
Completion Date
Aug 13, 2024Actual
First Submitted Date
Jun 21, 2021
First Submission Date that Met QC Criteria
Jun 21, 2021
First Posted Date
Jun 23, 2021Actual
Results Waived
Not provided
Results First Submitted Date
Aug 11, 2025
Results First Submitted that Met QC Criteria
Apr 27, 2026
Results First Posted Date
May 19, 2026Actual
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
Apr 27, 2026
Last Update Posted Date
May 19, 2026Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Novartis PharmaceuticalsINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
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 purpose of this study was to evaluate the efficacy and safety of NIS793 in combination with gemcitabine/nab-paclitaxel versus gemcitabine/nab-paclitaxel and placebo in first-line metastatic pancreatic ductal adenocarcinoma (mPDAC). This study aimed to explore whether blockade of Transforming Growth Factor β (TGFβ) in combination with gemcitabine/nab-paclitaxel could reduce fibrosis in PDAC, restore chemo-sensitivity and ultimately lead to improvements in overall survival (OS) and other clinically relevant outcomes.
Detailed Description
This was a randomized, double-blind, multicenter, two- group, phase III study that consisted of two parts: a Safety Run-in part and a Randomized part.
The decision to open the randomized part of the study was based on dose confirmation and available safety, relevant PK, and other clinical and laboratory data from the Safety Run-in part.
The open-label Safety Run-in part was conducted to confirm the recommended phase 3 dose (RP3D) of NIS793 in combination with gemcitabine and nab-paclitaxel. The safety run-in part started with one treatment regimen - NIS793 (2100 mg intravenous (i.v.) every 2 weeks (Q2W)) in combination with gemcitabine and nab-paclitaxel during the DLT assessment period. Dose limiting toxicity assessment period is defined as first cycle (i.e. 28 days, or 4 weeks) of dosing of the study treatment.
The Randomized part randomized participants 1:1 to one of the two treatment groups:
Investigational group (Arm A); combination of NIS793, gemcitabine and nab-paclitaxel
Control group (Arm B): combination of placebo, gemcitabine and nab-paclitaxel
Participants were stratified at randomization by Eastern Cooperative Oncology Group Performance Status (ECOG-PS) (0 or 1), presence of liver metastasis (yes vs. no), and region (North America, Europe and Australia vs. other countries).
Cross-over to the other treatment group was not allowed during the study duration.
The study treatment was administered as a 28-day treatment cycle. NIS793 was administered at a flat dose as confirmed in the Safety Run-in part on day 1 and 15 (e.g., 2100 mg i.v. Q2W or 2100 mg i.v. Q4W, if Q2W was considered as not tolerable in Safety Run-in part). Gemcitabine (1000 mg/m² on days 1, 8 and 15) and nab-paclitaxel (125 mg/m² on days 1, 8 and 15) were administered as per label.
As of 7-Jul-2023, the administration of NIS793/placebo was stopped for all participants following the recommendation from Data Monitoring Committee (DMC). Following the recommendation to stop administration of NIS793/placebo, the DMC encouraged to continue administration of gemcitabine/nab-paclitaxel to all participants per investigator's assessment, and the collection of additional follow-up data to better characterize the safety of NIS793 in combination with gemcitabine/nab-paclitaxel.
The study was considered complete when each participant completed at least 12 months of follow-up from randomization date, died, withdrew consent, or was lost to follow-up, whichever occurred first or, in the event of an early study termination. At which time, any study participant continuing with standard of care chemotherapy (gemcitabine + nab-paclitaxel) was transitioned off the study.
Safety run-in part: NIS793 plus (Gemcitabine and Nab-paclitaxel)
Experimental
Participants received a combination of NIS793, Gemcitabine and Nab-paclitaxel :
NIS793 at 2100 mg (Days 1 and 15)
Gemcitabine at 1000 mg/m² (Days 1, 8 and 15)
Nab-paclitaxel at 125 mg/m² (Days 1, 8 and 15)
Note: As of 7-Jul-2023, treatment with NIS793/placebo was stopped. Study participants were allowed to continue with standard of care (SoC) chemotherapy (gemcitabine+ nab-paclitaxel) per investigator assessment.
Drug: NIS793
Drug: Nab-paclitaxel
Drug: Gemcitabine
Randomized part (Arm A): NIS793 plus (Gemcitabine and Nab-paclitaxel)
Experimental
Participants received a combination of NIS793, gemcitabine and nab-paclitaxel:
NIS793 at 2100 mg (Days 1 and 15) assuming this was the confirmed RP3D in the safety run-in part or NIS793 at 2100 mg on Day 1 if dose level -1 was the confirmed RP3D in the safety run-in
Gemcitabine at 1000 mg/m² (Days 1, 8 and 15)
Nab-paclitaxel at 125 mg/m² (Days 1, 8 and 15)
Note: As of 7-Jul-2023, treatment with NIS793/placebo was stopped. Study participants were allowed to continue with standard of care (SoC) chemotherapy (gemcitabine+ nab-paclitaxel) per investigator assessment.
Drug: NIS793
Drug: Nab-paclitaxel
Drug: Gemcitabine
Drug: Placebo
Randomized part (Arm B): Placebo plus (Gemcitabine and Nab-paclitaxel)
Placebo Comparator
Participants received a combination of placebo, gemcitabine and nab-paclitaxel:
Placebo for NIS793 (Days 1 and 15)
Gemcitabine at 1000 mg/m² (Days 1, 8 and 15)
Nab-paclitaxel at 125 mg/m² (Days 1, 8 and 15)
Note: As of 7-Jul-2023, treatment with NIS793/placebo was stopped. Study participants were allowed to continue with standard of care (SoC) chemotherapy (gemcitabine+ nab-paclitaxel) per investigator assessment.
Interventions
Name
Type
Description
Arm Group Labels
Other Names
NIS793
Drug
Concentrate for solution infusion (Liquid in Vial)
Randomized part (Arm A): NIS793 plus (Gemcitabine and Nab-paclitaxel)
Safety run-in part: NIS793 plus (Gemcitabine and Nab-paclitaxel)
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Safety run-in Part: Percentage of Participants With Dose Limiting Toxicities (DLTs) During the First Cycle (4 Weeks) of Treatment.
A dose-limiting toxicity (DLT) was defined as an adverse event or abnormal laboratory value assessed as unrelated to disease, disease progression, inter-current illness, or concomitant medications that occurred within the first cycle (i.e., 28 days or 4 weeks) of the treatment with NIS793 in combination with gemcitabine/nab-paclitaxel. The National Cancer Institute Common Terminology Criteria for Adverse events (NCI CTCAE) version 5 was used for all grading.
Up to 4 weeks
Randomized Part: Overall Survival (OS)
Overall Survival (OS) was defined as the time from date of randomization/start of treatment to date of death due to any cause. If a patient was not known to have died, survival was censored at the date of last known date patient alive.
From randomization up to death, assessed up to approximately 34 months
Secondary Outcomes
Measure
Description
Time Frame
Percentage of Participants With Adverse Events (AEs)
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign [including abnormal laboratory findings], symptom or disease) in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
Treatment emergent Adverse Event (TEAEs) in this study are events that started after the first dose of study treatment and until 30 days after last dose of SOC chemotherapies and up to 90 days after NIS793, whichever is later.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Key Inclusion Criteria:
Applicable for both Safety run-in and Randomized part
Participants aged ≥18 years with histologically or cytologically confirmed (based on local assessment and per local guidelines) mPDAC eligible for treatment in the first line setting and not amenable for potentially curative surgery
Presence of at least one measurable lesion assessed by Computerized Tomography (CT) and/or Magnetic Resonance Imaging (MRI) according to RECIST 1.1
Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
Adequate organ function (assessed by central laboratory for eligibility)
Participants must have recovered from treatment-related toxicities of prior anticancer therapies to grade ≤ 1 (CTCAE v 5.0) at time of screening, except alopecia.
Key Main Exclusion Criteria:
Applicable for both Safety run-in and Randomized part
Previous systemic anti-cancer treatment for metastatic PDAC
Pancreatic neuroendocrine (islet) or acinar tumors
Participants with known status of microsatellite instability-high (MSI-H) or mismatch repair-deficient pancreatic cancer (if status is not already available, testing is not required at screening).
Participant has not recovered from a major surgery performed prior to start of study treatment or has had a major surgery within 4 weeks prior to start of study treatment.
Radiation therapy or brain radiotherapy ≤ 4 weeks prior to start of study treatment (palliative radiotherapy to bone lesions allowed > 2 weeks prior to start of study treatment).
Impaired cardiac function or clinically significant cardio-vascular disease
Use of hematopoietic growth factors or transfusion support ≤ 2 weeks prior to start of study treatment.
Participant has conditions that are considered to have a high risk of clinically significant gastrointestinal tract bleeding or any other condition associated with or history of significant bleeding.
Serious non-healing wounds.
Pregnant or breast-feeding women
Women of childbearing potential, unless willing to use highly effective contraception methods during treatment and after stopping study treatments as indicated
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
Randomized part (Arm A): NIS793 plus (Gemcitabine and Nab-paclitaxel)
Randomized part (Arm B): Placebo plus (Gemcitabine and Nab-paclitaxel)
Safety run-in part: NIS793 plus (Gemcitabine and Nab-paclitaxel)
Gemcitabine
Drug
Per locally approved formulation
Randomized part (Arm A): NIS793 plus (Gemcitabine and Nab-paclitaxel)
Randomized part (Arm B): Placebo plus (Gemcitabine and Nab-paclitaxel)
Safety run-in part: NIS793 plus (Gemcitabine and Nab-paclitaxel)
Placebo
Drug
Dextrose 5% in water (D5W) solution for infusion
Randomized part (Arm A): NIS793 plus (Gemcitabine and Nab-paclitaxel)
Randomized part (Arm B): Placebo plus (Gemcitabine and Nab-paclitaxel)
Up to approximately 32 months
Percentage of Participants With Dose Interruptions and Dose Reductions of NIS793 in Combination With Gemcitabine and Nab-paclitaxel
No dose reductions were allowed for NIS793 in the Randomized part and beyond the first 28 days period of the Safety Run-in part. Increasing the dosing interval from every 2 weeks (Q2W) to every 2 weeks (Q4W) was allowed.
Dose interruption for NIS793 was permitted if adverse drug reaction was suspected to be related to NIS793. If NIS793 was interrupted or delayed for > 8 weeks due to toxicity that was suspected to be related to treatment, study treatment was permanently discontinued.
Up to approximately 32 months
Dose Intensity of NIS793 in Combination With Gemcitabine and Nab-paclitaxel
Dose intensity was computed as the ratio of actual cumulative dose received and actual duration of exposure.
Up to approximately 32 months
Progression-Free Survival (PFS)
Progression-Free Survival (PFS) was defined as the time from the enrollment (run-in part) or randomization (randomized part) to the date of the first documented disease progression based on local investigator assessment as per RECIST 1.1 or date of death due to any cause, whichever occurs first. PFS was censored if no PFS event was observed before the analysis cut-off date. The censoring date was the date of the last adequate tumor assessment prior to the analysis cut-off.
From enrollment (run-in part) or randomization (randomized part) up to disease progression or death, assessed up to approximately 34 months
Overall Response Rate (ORR)
Overall Response Rate (ORR) was defined as the proportion of participants with a Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR) as per local review. ORR was evaluated according to RECIST 1.1. The BOR was determined from response assessments undertaken while on treatment.
Up to approximately 34 months
Disease Control Rate (DCR)
Disease Control Rate (DCR) was defined as the proportion of participants with Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR), or Stable Disease (SD) or Non-CR/Non-progressive disease as per local review. DCR was evaluated according to RECIST 1.1.
Up to approximately 34 months
Duration of Response (DOR)
Duration of Response (DOR) was defined as the duration of time between the date of first documented response (CR or PR) and the date of first documented progression or death due to any cause.
Up to approximately 34 months
Time to Response (TTR)
Time to Response (TTR) was defined as the duration of time between the date of enrollment (run-in part) or randomization (randomized part) and the date of first documented response of either CR or PR as per local review, which was subsequently confirmed. TTR was evaluated according to RECIST 1.1. Participants without a confirmed CR or PR were censored at the time of PFS event (i.e., disease progression or death due to any cause) for participants with a PFS event (i.e., disease progression or death due to any cause), or at the date of the last adequate tumor assessment for participants without a PFS event.
From enrollment (run-in part) or randomization (randomized part) up to first documented response, assessed up to approximately 34 months
Safety run-in Part: Trough Concentration (Ctrough) of NIS793 in Combination With Gemcitabine and Nab-paclitaxel
Venous whole blood samples were collected for activity-based pharmacokinetics characterization. Ctrough was listed and summarized using descriptive statistics.
Cycles 1 and 3 Day 15 (0 hour (pre-dose)), Cycles 2, 4, 6 and 12 Day 1 (0 hour (pre-dose)). 1 cycle = 28 days.
Safety run-in Part: Maximum Concentration (Cmax) of NIS793 in Combination With Gemcitabine and Nab-paclitaxel
Venous whole blood samples were collected for activity-based pharmacokinetics characterization. Cmax was listed and summarized using descriptive statistics.
Cycles 1 and 3 Day 1: 0 hour (pre-dose) and 1 hour. 1 cycle = 28 days.
Safety run-in Part: Time to Reach Maximum Concentration (Tmax) of NIS793 in Combination With Gemcitabine and Nab-paclitaxel
Venous whole blood samples were collected for activity-based pharmacokinetics characterization. Tmax was listed and summarized using descriptive statistics.
Cycles 1 and 3 Day 1: 0 hour (pre-dose) and 1 hour. 1 cycle = 28 days.
Randomized Part (Chinese Participants With Intensive PK Sampling): Trough Concentration (Ctrough) of NIS793 in Combination With Gemcitabine and Nab-paclitaxel
In the randomized part, participants enrolled for treatment in China were assigned to more intensive PK sampling (taken into account the ability of clinical sites to comply with the instructions in the laboratory manual concerning the preparation of serum samples) to assess PK of NIS793 in Chinese participants. Venous whole blood samples were collected for activity-based pharmacokinetics characterization and Ctrough was summarized using descriptive statistics.
Cycle 1 Day 15, Cycle 3 Day 1, Cycle 3 Day 15, Cycle 4 Day 1 and Cycle 6 Day 1: 0 hour (pre-dose). 1 cycle = 28 days.
Randomized Part (Chinese Participants With Intensive PK Sampling): Maximum Concentration (Cmax) of NIS793 in Combination With Gemcitabine and Nab-paclitaxel
In the randomized part, participants enrolled for treatment in China were assigned to more intensive PK sampling (taken into account the ability of clinical sites to comply with the instructions in the laboratory manual concerning the preparation of serum samples) to assess PK of NIS793 in Chinese participants. Venous whole blood samples were collected for activity-based pharmacokinetics characterization and Cmax was summarized using descriptive statistics.
Cycles 1 and 3 Day 1: 0 hour (pre-dose) and 1 hour. 1 cycle = 28 days.
Randomized Part (Chinese Participants With Intensive PK Sampling): Time to Reach Maximum Concentration (Tmax) of NIS793 in Combination With Gemcitabine and Nab-paclitaxel
In the randomized part, participants enrolled for treatment in China were assigned to more intensive PK sampling (taken into account the ability of clinical sites to comply with the instructions in the laboratory manual concerning the preparation of serum samples) to assess PK of NIS793 in Chinese participants. Venous whole blood samples were collected for activity-based pharmacokinetics characterization and Tmax was summarized using descriptive statistics.
Cycles 1 and 3 Day 1: 0 hour (pre-dose) and 1 hour. 1 cycle = 28 days.
Randomized Part (Chinese Participants With Intensive PK Sampling): Area Under the Curve From Time Zero to the Last Measurable Concentration Sampling Time (AUClast) of NIS793 in Combination With Gemcitabine and Nab-paclitaxel
In the randomized part, participants enrolled for treatment in China were assigned to more intensive PK sampling (taken into account the ability of clinical sites to comply with the instructions in the laboratory manual concerning the preparation of serum samples) to assess PK of NIS793 in Chinese participants. Venous whole blood samples were collected for activity-based pharmacokinetics characterization and AUClast was summarized using descriptive statistics.
Cycles 1 Day 1: 0 hour (pre-dose) and 1 hour. 1 cycle = 28 days.
Randomized Part (Chinese Participants With Intensive PK Sampling): Area Under the Curve Calculated to the End of a Dosing Interval (Tau) at Steady-state (AUCtau) of NIS793 in Combination With Gemcitabine and Nab-paclitaxel
In the randomized part, participants enrolled for treatment in China were assigned to more intensive PK sampling (taken into account the ability of clinical sites to comply with the instructions in the laboratory manual concerning the preparation of serum samples) to assess PK of NIS793 in Chinese participants. Venous whole blood samples were collected and AUCtau was summarized using descriptive statistics.
Cycles 3 Day 1: 0 hour (pre-dose) and 1 hour. 1 cycle = 28 days.
Randomized Part (Participants Without Intensive PK Sampling): Trough Concentration (Ctrough) of NIS793 in Combination With Gemcitabine and Nab-paclitaxel
For participants without intensive PK sampling, venous whole blood samples were collected for activity-based pharmacokinetics characterization. Ctrough was listed and summarized using descriptive statistics.
Cycles 2, 3, 4, 6 and 12 Day 1 (0 hour (pre-dose)). 1 cycle = 28 days.
Randomized Part (Participants Without Intensive PK Sampling): Maximum Concentration (Cmax) of NIS793 in Combination With Gemcitabine and Nab-paclitaxel
For Chinese participants without intensive PK sampling schedule and global participants in the randomized part, for which only sparse PK samples were collected for activity-based pharmacokinetics characterization, Cmax was listed and summarized using descriptive statistics.
Cycles 1 and 3: Day 1 (0 hour (pre-dose)). 1 cycle = 28 days.
Randomized Part (Participants Without Intensive PK Sampling): Time to Reach Maximum Concentration (Tmax) of NIS793 in Combination With Gemcitabine and Nab-paclitaxel
For Chinese participants without intensive PK sampling schedule and global participants in the randomized part, for which only sparse PK samples were collected for activity-based pharmacokinetics characterization, Tmax was listed and summarized using descriptive statistics.
Cycles 1 and 3: Day 1 (0 hour (pre-dose)). 1 cycle = 28 days.
Randomized Part: Anti-drug Antibodies (ADA) Against NIS793 Prevalence at Baseline
Anti-drug antibodies (ADA) against NIS793 prevalence at baseline refers to the proportion of subjects who have developed antibodies against the drug NIS793 before starting treatment. This is calculated by dividing the number of subjects with ADA-positive samples at baseline by the total number of subjects whose baseline samples were tested for ADA.
Baseline
Randomized Part: Anti-drug Antibodies (ADA) Against NIS793 Incidence on Treatment
Anti-drug antibodies (ADA) against NIS793 incidence on treatment refers to the proportion of participants who developed antibodies against the drug NIS793 during the treatment period. This can be categorized into two types:
Treatment-induced ADA positive: Participants who were ADA-negative at baseline but became ADA-positive after starting the treatment.
Treatment-boosted ADA positive: Participants who were ADA-positive at baseline and showed a significant increase in ADA titer during the treatment.
From date of first study drug intake up to approximately 34 months
Los Angeles
California
90095
United States
AdventHealth
Orlando
Florida
32804
United States
Fort Wayne Medical Oncology Hematology Inc
Fort Wayne
Indiana
46815
United States
NYU Clinical Cancer Center
New York
New York
10016
United States
US Oncology Research Dallas
Dallas
Texas
75204
United States
Houston Methodist Hospital
Houston
Texas
77030
United States
Huntsman Cancer Institute
Salt Lake City
Utah
84112
United States
Seattle Cancer Care Alliance
Seattle
Washington
98109
United States
Novartis Investigative Site
Adelaide
South Australia
5000
Australia
Novartis Investigative Site
Perth
Western Australia
6009
Australia
Novartis Investigative Site
Bonheiden
2820
Belgium
Novartis Investigative Site
Brussels
1200
Belgium
Novartis Investigative Site
Edegem
2650
Belgium
Novartis Investigative Site
Leuven
3000
Belgium
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Brasília
Federal District
70200-730
Brazil
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Ijuí
Rio Grande do Sul
98700-000
Brazil
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Porto Alegre
Rio Grande do Sul
90560-032
Brazil
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São Paulo
São Paulo
04014-002
Brazil
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Brampton
Ontario
L6R 3J7
Canada
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Cambridge
Ontario
N1R 3G2
Canada
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Toronto
Ontario
M4N 3M5
Canada
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Guangzhou
Guangdong
510000
China
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Harbin
Heilongjiang
150081
China
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Nanjing
Jiangsu
210029
China
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Dalian
Liaoning
116001
China
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Jining
Shandong
272000
China
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Xian
Shanxi
710061
China
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Chengdu
Sichuan
610041
China
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Hangzhou
Zhejiang
310022
China
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Beijing
100021
China
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Beijing
100036
China
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Beijing
100730
China
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Shanghai
200025
China
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Shanghai
200032
China
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Shanghai
200127
China
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Shanghai
200433
China
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Tianjin
300480
China
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Brno
656 53
Czechia
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Hradec Králové
500 05
Czechia
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Nový Jičín
741 01
Czechia
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Prague
140 59
Czechia
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Helsinki
00290
Finland
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Tampere
FIN-33521
Finland
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Nice
Alpes Maritimes
06189
France
Novartis Investigative Site
Avignon
84082
France
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Besançon
25030
France
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Créteil
94010
France
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Lyon 08
69373
France
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Marseille
13273
France
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Montpellier
34295
France
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Nantes
44093
France
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Paris
75015
France
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Frankfurt am Main
Hesse
60488
Germany
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Halle
Saxony-Anhalt
06120
Germany
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Berlin
13353
Germany
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Bochum
44791
Germany
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Essen
45147
Germany
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Hamburg
20249
Germany
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Ulm
89081
Germany
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Thessaloniki
540 07
Greece
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Thessaloniki
570 01
Greece
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Debrecen
Hajdu Bihar Megye
4032
Hungary
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Budapest
H 1122
Hungary
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Budapest
H-1097
Hungary
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Jerusalem
9112001
Israel
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Ramat Gan
5265601
Israel
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Tel Aviv
6423906
Israel
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Florence
FI
50134
Italy
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Milan
MI
20133
Italy
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Milan
MI
20162
Italy
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Verona
VR
37134
Italy
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Nagoya
Aichi-ken
4648681
Japan
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Kashiwa
Chiba
277-8577
Japan
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Yokohama
Kanagawa
241-8515
Japan
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Osaka
Osaka
5418567
Japan
Novartis Investigative Site
Chuo Ku
Tokyo
1040045
Japan
Novartis Investigative Site
Koto Ku
Tokyo
1358550
Japan
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Utrecht
3543 AZ
Netherlands
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Nordbyhagen
Oslo
1478
Norway
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Oslo
NO-0407
Norway
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Omsk
644013
Russia
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Saint Petersburg
196603
Russia
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Singapore
168583
Singapore
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Banská Bystrica
975 17
Slovakia
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Bratislava
83310
Slovakia
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Košice
041 91
Slovakia
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Seoul
03080
South Korea
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Seoul
05505
South Korea
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Seoul
06591
South Korea
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Santiago Compostela
A Coruna
15706
Spain
Novartis Investigative Site
L'Hospitalet de Llobregat
Barcelona
08907
Spain
Novartis Investigative Site
Barcelona
08035
Spain
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Madrid
28009
Spain
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Madrid
28034
Spain
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Madrid
28040
Spain
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Malmö
SE-205 02
Sweden
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Umeå
901 85
Sweden
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Bellinzona
6500
Switzerland
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Geneva
1211
Switzerland
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Sankt Gallen
9007
Switzerland
Novartis Investigative Site
Taipei
10002
Taiwan
Novartis Investigative Site
Taipei
11217
Taiwan
Novartis Investigative Site
Taoyuan
33305
Taiwan
Novartis Investigative Site
Istanbul
Kadikoy
34722
Turkey (Türkiye)
Novartis Investigative Site
Ankara
Sihhiye-Altindag
06230
Turkey (Türkiye)
Novartis Investigative Site
Adana
Yuregir
01250
Turkey (Türkiye)
Novartis Investigative Site
Izmir
35100
Turkey (Türkiye)
Novartis Investigative Site
Sutton
Surrey
SM2 5PT
United Kingdom
Novartis Investigative Site
Cambridge
CB2 0QQ
United Kingdom
Novartis Investigative Site
Liverpool
CH63 4JY
United Kingdom
Novartis Investigative Site
London
EC1A 7BE
United Kingdom
Novartis Investigative Site
Oxford
OX3 7LE
United Kingdom
Randomized Part (Arm A): NIS793 Plus (Gemcitabine and Nab-paclitaxel)
Participants received a combination of NIS793, Gemcitabine and Nab-paclitaxel:
NIS793 at 2100 mg (Days 1 and 15)
Gemcitabine at 1000 mg/m² (Days 1, 8 and 15)
Nab-paclitaxel at 125 mg/m² (Days 1, 8 and 15)
FG002
Randomized Part (Arm B): Placebo Plus (Gemcitabine and Nab-paclitaxel)
Participants received a combination of placebo, gemcitabine and nab-paclitaxel:
Placebo for NIS793 (Days 1 and 15)
Gemcitabine at 1000 mg/m² (Days 1, 8 and 15)
Nab-paclitaxel at 125 mg/m² (Days 1, 8 and 15)
FG00021 subjects
FG001245 subjects
FG002245 subjects
Entered Post Treatment Follow-up
FG00018 subjectsOne safety run-in participant lost to follow-up was later confirmed (via public records) to have died \>30 days post-treatment and was only included for all-cause mortality.
FG001192 subjects
FG002200 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
NOT COMPLETED
FG00021 subjects
FG001245 subjects
FG002245 subjects
Type
Comment
Reasons
Progressive disease
FG00017 subjects
FG001148 subjects
FG002149 subjects
Physician Decision
FG0002 subjects
FG00120 subjects
FG00224 subjects
Adverse Event
FG0001 subjects
FG00125 subjects
FG00224 subjects
Lost to Follow-up
FG0001 subjects
FG0010 subjects
FG0020 subjects
Death
FG0000 subjects
FG00116 subjects
FG0028 subjects
Guardian decision
FG0000 subjects
FG0011 subjects
FG0020 subjects
Sponsor decision
FG0000 subjects
FG0019 subjects
FG00216 subjects
Participant decision
FG0000 subjects
FG00125 subjects
FG00224 subjects
Participants not treated due to Protocol deviation
FG0000 subjects
FG0011 subjects
FG0020 subjects
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Safety run-in Part: NIS793 Plus (Gemcitabine and Nab-paclitaxel)
Participants received a combination of NIS793, Gemcitabine and Nab-paclitaxel :
NIS793 at 2100 mg (Days 1 and 15)
Gemcitabine at 1000 mg/m² (Days 1, 8 and 15)
Nab-paclitaxel at 125 mg/m² (Days 1, 8 and 15)
BG001
Randomized Part (Arm A): NIS793 Plus (Gemcitabine and Nab-paclitaxel)
Participants received a combination of NIS793, Gemcitabine and Nab-paclitaxel:
NIS793 at 2100 mg (Days 1 and 15)
Gemcitabine at 1000 mg/m² (Days 1, 8 and 15)
Nab-paclitaxel at 125 mg/m² (Days 1, 8 and 15)
BG002
Randomized Part (Arm B): Placebo Plus (Gemcitabine and Nab-paclitaxel)
Participants received a combination of placebo, gemcitabine and nab-paclitaxel:
Placebo for NIS793 (Days 1 and 15)
Gemcitabine at 1000 mg/m² (Days 1, 8 and 15)
Nab-paclitaxel at 125 mg/m² (Days 1, 8 and 15)
BG003
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00021
BG001245
BG002245
BG003511
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Customized
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
<= 65 years
BG00013
BG001130
BG002125
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0006
BG001109
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0013
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Safety run-in Part: Percentage of Participants With Dose Limiting Toxicities (DLTs) During the First Cycle (4 Weeks) of Treatment.
A dose-limiting toxicity (DLT) was defined as an adverse event or abnormal laboratory value assessed as unrelated to disease, disease progression, inter-current illness, or concomitant medications that occurred within the first cycle (i.e., 28 days or 4 weeks) of the treatment with NIS793 in combination with gemcitabine/nab-paclitaxel. The National Cancer Institute Common Terminology Criteria for Adverse events (NCI CTCAE) version 5 was used for all grading.
Dose-Determining Set (DDS) - The DDS consisted of all participants in the safety run-in part who met the minimum exposure criterion and had sufficient safety evaluations after 4 weeks of treatment or experienced a DLT during the first 4 weeks of treatment.
Posted
Count of Participants
Participants
Up to 4 weeks
ID
Title
Description
OG000
Safety run-in Part: NIS793 Plus (Gemcitabine and Nab-paclitaxel)
Participants received a combination of NIS793, Gemcitabine and Nab-paclitaxel :
NIS793 at 2100 mg (Days 1 and 15)
Gemcitabine at 1000 mg/m² (Days 1, 8 and 15)
Nab-paclitaxel at 125 mg/m² (Days 1, 8 and 15)
Units
Counts
Participants
OG00018
Title
Denominators
Categories
Title
Measurements
OG0000
Primary
Randomized Part: Overall Survival (OS)
Overall Survival (OS) was defined as the time from date of randomization/start of treatment to date of death due to any cause. If a patient was not known to have died, survival was censored at the date of last known date patient alive.
The Full Analysis Set (FAS) in the Randomized Part included all participants assigned study treatment by randomization and were analyzed according to the treatment they were assigned during the randomization procedure.
Posted
Median
95% Confidence Interval
Months
From randomization up to death, assessed up to approximately 34 months
ID
Title
Description
OG000
Randomized Part (Arm A): NIS793 Plus (Gemcitabine and Nab-paclitaxel)
Participants received a combination of NIS793, Gemcitabine and Nab-paclitaxel:
NIS793 at 2100 mg (Days 1 and 15)
Gemcitabine at 1000 mg/m² (Days 1, 8 and 15)
Nab-paclitaxel at 125 mg/m² (Days 1, 8 and 15)
OG001
Randomized Part (Arm B): Placebo Plus (Gemcitabine and Nab-paclitaxel)
Participants received a combination of placebo, gemcitabine and nab-paclitaxel:
Placebo for NIS793 (Days 1 and 15)
Gemcitabine at 1000 mg/m² (Days 1, 8 and 15)
Nab-paclitaxel at 125 mg/m² (Days 1, 8 and 15)
Secondary
Percentage of Participants With Adverse Events (AEs)
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign [including abnormal laboratory findings], symptom or disease) in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
Treatment emergent Adverse Event (TEAEs) in this study are events that started after the first dose of study treatment and until 30 days after last dose of SOC chemotherapies and up to 90 days after NIS793, whichever is later.
The Safety Set (SAF) in the Run-in part included all participants who received at least one dose of study treatment, including incomplete infusions, and were analyzed according to the treatment(s) they received. In the Randomized Part, the SAF included all participants who received at least one dose of study treatment, including incomplete infusions, and were analyzed according to the treatment they received, either the randomized treatment assigned or the first treatment received.
Posted
Count of Participants
Participants
Up to approximately 32 months
ID
Title
Description
OG000
Safety run-in Part: NIS793 Plus (Gemcitabine and Nab-paclitaxel)
Participants received a combination of NIS793, gemcitabine and nab-paclitaxel.
Note: As of 7-Jul-2023, treatment with NIS793/placebo was stopped. Study participants were allowed to continue with standard of care (SoC) chemotherapy (gemcitabine+ nab-paclitaxel) per investigator assessment.
Secondary
Percentage of Participants With Dose Interruptions and Dose Reductions of NIS793 in Combination With Gemcitabine and Nab-paclitaxel
No dose reductions were allowed for NIS793 in the Randomized part and beyond the first 28 days period of the Safety Run-in part. Increasing the dosing interval from every 2 weeks (Q2W) to every 2 weeks (Q4W) was allowed.
Dose interruption for NIS793 was permitted if adverse drug reaction was suspected to be related to NIS793. If NIS793 was interrupted or delayed for > 8 weeks due to toxicity that was suspected to be related to treatment, study treatment was permanently discontinued.
The Safety Set (SAF) in the Run-in part included all participants who received at least one dose of study treatment, including incomplete infusions, and were analyzed according to the treatment(s) they received. In the Randomized Part, the SAF included all participants who received at least one dose of study treatment, including incomplete infusions, and were analyzed according to the treatment they received, either the randomized treatment assigned or the first treatment received.
Posted
Count of Participants
Participants
Up to approximately 32 months
ID
Title
Description
OG000
Safety run-in Part: NIS793 Plus (Gemcitabine and Nab-paclitaxel)
Participants received a combination of NIS793, gemcitabine and nab-paclitaxel.
Note: As of 7-Jul-2023, treatment with NIS793/placebo was stopped. Study participants were allowed to continue with standard of care (SoC) chemotherapy (gemcitabine+ nab-paclitaxel) per investigator assessment.
OG001
Secondary
Dose Intensity of NIS793 in Combination With Gemcitabine and Nab-paclitaxel
Dose intensity was computed as the ratio of actual cumulative dose received and actual duration of exposure.
The Safety Set (SAF) in the Run-in part included all participants who received at least one dose of study treatment, including incomplete infusions, and were analyzed according to the treatment(s) they received. In the Randomized Part, the SAF included all participants who received at least one dose of study treatment, including incomplete infusions, and were analyzed according to the treatment they received, either the randomized treatment assigned or the first treatment received.
Posted
Mean
Standard Deviation
mg/cycle
Up to approximately 32 months
ID
Title
Description
OG000
Safety run-in Part: NIS793 Plus (Gemcitabine and Nab-paclitaxel)
Participants received a combination of NIS793, gemcitabine and nab-paclitaxel.
Note: As of 7-Jul-2023, treatment with NIS793/placebo was stopped. Study participants were allowed to continue with standard of care (SoC) chemotherapy (gemcitabine+ nab-paclitaxel) per investigator assessment.
OG001
Randomized Part (Arm A): NIS793 Plus (Gemcitabine and Nab-paclitaxel)
Participants received a combination of NIS793, Gemcitabine and Nab-paclitaxel:
NIS793 at 2100 mg (Days 1 and 15)
Gemcitabine at 1000 mg/m² (Days 1, 8 and 15)
Nab-paclitaxel at 125 mg/m² (Days 1, 8 and 15)
Secondary
Progression-Free Survival (PFS)
Progression-Free Survival (PFS) was defined as the time from the enrollment (run-in part) or randomization (randomized part) to the date of the first documented disease progression based on local investigator assessment as per RECIST 1.1 or date of death due to any cause, whichever occurs first. PFS was censored if no PFS event was observed before the analysis cut-off date. The censoring date was the date of the last adequate tumor assessment prior to the analysis cut-off.
The Full Analysis Set (FAS) in the Safety Run-in Part included all participants who received any study drug and were analyzed according to the treatment(s) received, following the intent-to-treat (ITT) principle. In the Randomized Part, the FAS included all participants assigned study treatment by randomization and were analyzed according to the treatment they were assigned during the randomization procedure.
Posted
Median
95% Confidence Interval
Months
From enrollment (run-in part) or randomization (randomized part) up to disease progression or death, assessed up to approximately 34 months
ID
Title
Description
OG000
Safety run-in Part: NIS793 Plus (Gemcitabine and Nab-paclitaxel)
Participants received a combination of NIS793, gemcitabine and nab-paclitaxel.
Note: As of 7-Jul-2023, treatment with NIS793/placebo was stopped. Study participants were allowed to continue with standard of care (SoC) chemotherapy (gemcitabine+ nab-paclitaxel) per investigator assessment.
OG001
Randomized Part (Arm A): NIS793 Plus (Gemcitabine and Nab-paclitaxel)
Secondary
Overall Response Rate (ORR)
Overall Response Rate (ORR) was defined as the proportion of participants with a Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR) as per local review. ORR was evaluated according to RECIST 1.1. The BOR was determined from response assessments undertaken while on treatment.
The Full Analysis Set (FAS) in the Safety Run-in Part included all participants who received any study drug and were analyzed according to the treatment(s) received, following the intent-to-treat (ITT) principle. In the Randomized Part, the FAS included all participants assigned study treatment by randomization and were analyzed according to the treatment they were assigned during the randomization procedure.
Posted
Number
95% Confidence Interval
Percentage of participants
Up to approximately 34 months
ID
Title
Description
OG000
Safety run-in Part: NIS793 Plus (Gemcitabine and Nab-paclitaxel)
Participants received a combination of NIS793, gemcitabine and nab-paclitaxel.
Note: As of 7-Jul-2023, treatment with NIS793/placebo was stopped. Study participants were allowed to continue with standard of care (SoC) chemotherapy (gemcitabine+ nab-paclitaxel) per investigator assessment.
OG001
Randomized Part (Arm A): NIS793 Plus (Gemcitabine and Nab-paclitaxel)
Participants received a combination of NIS793, Gemcitabine and Nab-paclitaxel:
NIS793 at 2100 mg (Days 1 and 15)
Gemcitabine at 1000 mg/m² (Days 1, 8 and 15)
Nab-paclitaxel at 125 mg/m² (Days 1, 8 and 15)
Secondary
Disease Control Rate (DCR)
Disease Control Rate (DCR) was defined as the proportion of participants with Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR), or Stable Disease (SD) or Non-CR/Non-progressive disease as per local review. DCR was evaluated according to RECIST 1.1.
The Full Analysis Set (FAS) in the Safety Run-in Part included all participants who received any study drug and were analyzed according to the treatment(s) received, following the intent-to-treat (ITT) principle. In the Randomized Part, the FAS included all participants assigned study treatment by randomization and were analyzed according to the treatment they were assigned during the randomization procedure.
Posted
Number
95% Confidence Interval
Percentage of participants
Up to approximately 34 months
ID
Title
Description
OG000
Safety run-in Part: NIS793 Plus (Gemcitabine and Nab-paclitaxel)
Participants received a combination of NIS793, gemcitabine and nab-paclitaxel.
Note: As of 7-Jul-2023, treatment with NIS793/placebo was stopped. Study participants were allowed to continue with standard of care (SoC) chemotherapy (gemcitabine+ nab-paclitaxel) per investigator assessment.
OG001
Randomized Part (Arm A): NIS793 Plus (Gemcitabine and Nab-paclitaxel)
Participants received a combination of NIS793, Gemcitabine and Nab-paclitaxel:
NIS793 at 2100 mg (Days 1 and 15)
Gemcitabine at 1000 mg/m² (Days 1, 8 and 15)
Nab-paclitaxel at 125 mg/m² (Days 1, 8 and 15)
Secondary
Duration of Response (DOR)
Duration of Response (DOR) was defined as the duration of time between the date of first documented response (CR or PR) and the date of first documented progression or death due to any cause.
Full Analysis Set (FAS) - Only participants with first documented response (CR or PR) included
Posted
Median
95% Confidence Interval
Months
Up to approximately 34 months
ID
Title
Description
OG000
Safety run-in Part: NIS793 Plus (Gemcitabine and Nab-paclitaxel)
Participants received a combination of NIS793, gemcitabine and nab-paclitaxel.
Note: As of 7-Jul-2023, treatment with NIS793/placebo was stopped. Study participants were allowed to continue with standard of care (SoC) chemotherapy (gemcitabine+ nab-paclitaxel) per investigator assessment.
OG001
Randomized Part (Arm A): NIS793 Plus (Gemcitabine and Nab-paclitaxel)
Participants received a combination of NIS793, Gemcitabine and Nab-paclitaxel:
NIS793 at 2100 mg (Days 1 and 15)
Gemcitabine at 1000 mg/m² (Days 1, 8 and 15)
Nab-paclitaxel at 125 mg/m² (Days 1, 8 and 15)
OG002
Randomized Part (Arm B): Placebo Plus (Gemcitabine and Nab-paclitaxel)
Participants received a combination of placebo, gemcitabine and nab-paclitaxel:
Placebo for NIS793 (Days 1 and 15)
Gemcitabine at 1000 mg/m² (Days 1, 8 and 15)
Nab-paclitaxel at 125 mg/m² (Days 1, 8 and 15)
Secondary
Time to Response (TTR)
Time to Response (TTR) was defined as the duration of time between the date of enrollment (run-in part) or randomization (randomized part) and the date of first documented response of either CR or PR as per local review, which was subsequently confirmed. TTR was evaluated according to RECIST 1.1. Participants without a confirmed CR or PR were censored at the time of PFS event (i.e., disease progression or death due to any cause) for participants with a PFS event (i.e., disease progression or death due to any cause), or at the date of the last adequate tumor assessment for participants without a PFS event.
The Full Analysis Set (FAS) in the Safety Run-in Part included all participants who received any study drug and were analyzed according to the treatment(s) received, following the intent-to-treat (ITT) principle. In the Randomized Part, the FAS included all participants assigned study treatment by randomization and were analyzed according to the treatment they were assigned during the randomization procedure.
Posted
Median
95% Confidence Interval
Months
From enrollment (run-in part) or randomization (randomized part) up to first documented response, assessed up to approximately 34 months
ID
Title
Description
OG000
Safety run-in Part: NIS793 Plus (Gemcitabine and Nab-paclitaxel)
Participants received a combination of NIS793, gemcitabine and nab-paclitaxel.
Note: As of 7-Jul-2023, treatment with NIS793/placebo was stopped. Study participants were allowed to continue with standard of care (SoC) chemotherapy (gemcitabine+ nab-paclitaxel) per investigator assessment.
Secondary
Safety run-in Part: Trough Concentration (Ctrough) of NIS793 in Combination With Gemcitabine and Nab-paclitaxel
Venous whole blood samples were collected for activity-based pharmacokinetics characterization. Ctrough was listed and summarized using descriptive statistics.
Pharmacokinetic Analysis Set - Participants with corresponding evaluable PK parameters at the indicated timepoint were analyzed
Posted
Mean
Standard Deviation
ng/mL
Cycles 1 and 3 Day 15 (0 hour (pre-dose)), Cycles 2, 4, 6 and 12 Day 1 (0 hour (pre-dose)). 1 cycle = 28 days.
ID
Title
Description
OG000
Safety run-in Part: NIS793 Plus (Gemcitabine and Nab-paclitaxel)
Participants received a combination of NIS793, Gemcitabine and Nab-paclitaxel :
NIS793 at 2100 mg (Days 1 and 15)
Gemcitabine at 1000 mg/m² (Days 1, 8 and 15)
Nab-paclitaxel at 125 mg/m² (Days 1, 8 and 15)
Units
Counts
Participants
OG000
Secondary
Safety run-in Part: Maximum Concentration (Cmax) of NIS793 in Combination With Gemcitabine and Nab-paclitaxel
Venous whole blood samples were collected for activity-based pharmacokinetics characterization. Cmax was listed and summarized using descriptive statistics.
Pharmacokinetic Analysis Set - Participants with corresponding evaluable PK parameters at the indicated timepoint were analyzed
Posted
Mean
Standard Deviation
ng/mL
Cycles 1 and 3 Day 1: 0 hour (pre-dose) and 1 hour. 1 cycle = 28 days.
ID
Title
Description
OG000
Safety run-in Part: NIS793 Plus (Gemcitabine and Nab-paclitaxel)
Participants received a combination of NIS793, Gemcitabine and Nab-paclitaxel :
NIS793 at 2100 mg (Days 1 and 15)
Gemcitabine at 1000 mg/m² (Days 1, 8 and 15)
Nab-paclitaxel at 125 mg/m² (Days 1, 8 and 15)
Units
Counts
Participants
OG000
Secondary
Safety run-in Part: Time to Reach Maximum Concentration (Tmax) of NIS793 in Combination With Gemcitabine and Nab-paclitaxel
Venous whole blood samples were collected for activity-based pharmacokinetics characterization. Tmax was listed and summarized using descriptive statistics.
Pharmacokinetic Analysis Set - Participants with corresponding evaluable PK parameters at the indicated timepoint were analyzed
Posted
Median
Full Range
Hour
Cycles 1 and 3 Day 1: 0 hour (pre-dose) and 1 hour. 1 cycle = 28 days.
ID
Title
Description
OG000
Safety run-in Part: NIS793 Plus (Gemcitabine and Nab-paclitaxel)
Participants received a combination of NIS793, Gemcitabine and Nab-paclitaxel :
NIS793 at 2100 mg (Days 1 and 15)
Gemcitabine at 1000 mg/m² (Days 1, 8 and 15)
Nab-paclitaxel at 125 mg/m² (Days 1, 8 and 15)
Units
Counts
Participants
OG000
Secondary
Randomized Part (Chinese Participants With Intensive PK Sampling): Trough Concentration (Ctrough) of NIS793 in Combination With Gemcitabine and Nab-paclitaxel
In the randomized part, participants enrolled for treatment in China were assigned to more intensive PK sampling (taken into account the ability of clinical sites to comply with the instructions in the laboratory manual concerning the preparation of serum samples) to assess PK of NIS793 in Chinese participants. Venous whole blood samples were collected for activity-based pharmacokinetics characterization and Ctrough was summarized using descriptive statistics.
Pharmacokinetic Analysis Set - Chinese participants with intensive PK sampling with corresponding evaluable PK parameters at the indicated timepoint were analyzed
Posted
Mean
Standard Deviation
ng/mL
Cycle 1 Day 15, Cycle 3 Day 1, Cycle 3 Day 15, Cycle 4 Day 1 and Cycle 6 Day 1: 0 hour (pre-dose). 1 cycle = 28 days.
ID
Title
Description
OG000
Randomized Part (Arm A): NIS793 Plus (Gemcitabine and Nab-paclitaxel)
Participants received a combination of NIS793, Gemcitabine and Nab-paclitaxel:
NIS793 at 2100 mg (Days 1 and 15)
Gemcitabine at 1000 mg/m² (Days 1, 8 and 15)
Nab-paclitaxel at 125 mg/m² (Days 1, 8 and 15)
Units
Counts
Participants
Secondary
Randomized Part (Chinese Participants With Intensive PK Sampling): Maximum Concentration (Cmax) of NIS793 in Combination With Gemcitabine and Nab-paclitaxel
In the randomized part, participants enrolled for treatment in China were assigned to more intensive PK sampling (taken into account the ability of clinical sites to comply with the instructions in the laboratory manual concerning the preparation of serum samples) to assess PK of NIS793 in Chinese participants. Venous whole blood samples were collected for activity-based pharmacokinetics characterization and Cmax was summarized using descriptive statistics.
Pharmacokinetic Analysis Set - Chinese participants with intensive PK sampling with corresponding evaluable PK parameters at the indicated timepoint were analyzed
Posted
Mean
Standard Deviation
ng/mL
Cycles 1 and 3 Day 1: 0 hour (pre-dose) and 1 hour. 1 cycle = 28 days.
ID
Title
Description
OG000
Randomized Part (Arm A): NIS793 Plus (Gemcitabine and Nab-paclitaxel)
Participants received a combination of NIS793, Gemcitabine and Nab-paclitaxel:
NIS793 at 2100 mg (Days 1 and 15)
Gemcitabine at 1000 mg/m² (Days 1, 8 and 15)
Nab-paclitaxel at 125 mg/m² (Days 1, 8 and 15)
Units
Counts
Participants
Secondary
Randomized Part (Chinese Participants With Intensive PK Sampling): Time to Reach Maximum Concentration (Tmax) of NIS793 in Combination With Gemcitabine and Nab-paclitaxel
In the randomized part, participants enrolled for treatment in China were assigned to more intensive PK sampling (taken into account the ability of clinical sites to comply with the instructions in the laboratory manual concerning the preparation of serum samples) to assess PK of NIS793 in Chinese participants. Venous whole blood samples were collected for activity-based pharmacokinetics characterization and Tmax was summarized using descriptive statistics.
Pharmacokinetic Analysis Set - Chinese participants with intensive PK sampling with corresponding evaluable PK parameters at the indicated timepoint were analyzed
Posted
Median
Full Range
Hour
Cycles 1 and 3 Day 1: 0 hour (pre-dose) and 1 hour. 1 cycle = 28 days.
ID
Title
Description
OG000
Randomized Part (Arm A): NIS793 Plus (Gemcitabine and Nab-paclitaxel)
Participants received a combination of NIS793, Gemcitabine and Nab-paclitaxel:
NIS793 at 2100 mg (Days 1 and 15)
Gemcitabine at 1000 mg/m² (Days 1, 8 and 15)
Nab-paclitaxel at 125 mg/m² (Days 1, 8 and 15)
Units
Counts
Participants
Secondary
Randomized Part (Chinese Participants With Intensive PK Sampling): Area Under the Curve From Time Zero to the Last Measurable Concentration Sampling Time (AUClast) of NIS793 in Combination With Gemcitabine and Nab-paclitaxel
In the randomized part, participants enrolled for treatment in China were assigned to more intensive PK sampling (taken into account the ability of clinical sites to comply with the instructions in the laboratory manual concerning the preparation of serum samples) to assess PK of NIS793 in Chinese participants. Venous whole blood samples were collected for activity-based pharmacokinetics characterization and AUClast was summarized using descriptive statistics.
Pharmacokinetic Analysis Set - Chinese participants with intensive PK sampling with corresponding evaluable PK parameters
Posted
Geometric Mean
Geometric Coefficient of Variation
h*ng/mL
Cycles 1 Day 1: 0 hour (pre-dose) and 1 hour. 1 cycle = 28 days.
ID
Title
Description
OG000
Randomized Part (Arm A): NIS793 Plus (Gemcitabine and Nab-paclitaxel)
Participants received a combination of NIS793, Gemcitabine and Nab-paclitaxel:
NIS793 at 2100 mg (Days 1 and 15)
Gemcitabine at 1000 mg/m² (Days 1, 8 and 15)
Nab-paclitaxel at 125 mg/m² (Days 1, 8 and 15)
Units
Counts
Participants
Secondary
Randomized Part (Chinese Participants With Intensive PK Sampling): Area Under the Curve Calculated to the End of a Dosing Interval (Tau) at Steady-state (AUCtau) of NIS793 in Combination With Gemcitabine and Nab-paclitaxel
In the randomized part, participants enrolled for treatment in China were assigned to more intensive PK sampling (taken into account the ability of clinical sites to comply with the instructions in the laboratory manual concerning the preparation of serum samples) to assess PK of NIS793 in Chinese participants. Venous whole blood samples were collected and AUCtau was summarized using descriptive statistics.
Pharmacokinetic Analysis Set - Chinese participants with intensive PK sampling with corresponding evaluable PK parameters
Posted
Geometric Mean
Geometric Coefficient of Variation
h*ng/mL
Cycles 3 Day 1: 0 hour (pre-dose) and 1 hour. 1 cycle = 28 days.
ID
Title
Description
OG000
Randomized Part (Arm A): NIS793 Plus (Gemcitabine and Nab-paclitaxel)
Participants received a combination of NIS793, Gemcitabine and Nab-paclitaxel:
NIS793 at 2100 mg (Days 1 and 15)
Gemcitabine at 1000 mg/m² (Days 1, 8 and 15)
Nab-paclitaxel at 125 mg/m² (Days 1, 8 and 15)
Units
Counts
Participants
Secondary
Randomized Part (Participants Without Intensive PK Sampling): Trough Concentration (Ctrough) of NIS793 in Combination With Gemcitabine and Nab-paclitaxel
For participants without intensive PK sampling, venous whole blood samples were collected for activity-based pharmacokinetics characterization. Ctrough was listed and summarized using descriptive statistics.
Pharmacokinetic Analysis Set - Participants without intensive PK sampling with corresponding evaluable PK parameters at the indicated timepoint were analyzed
Posted
Mean
Standard Deviation
ng/mL
Cycles 2, 3, 4, 6 and 12 Day 1 (0 hour (pre-dose)). 1 cycle = 28 days.
ID
Title
Description
OG000
Randomized Part (Arm A): NIS793 Plus (Gemcitabine and Nab-paclitaxel)
Participants received a combination of NIS793, Gemcitabine and Nab-paclitaxel:
NIS793 at 2100 mg (Days 1 and 15)
Gemcitabine at 1000 mg/m² (Days 1, 8 and 15)
Nab-paclitaxel at 125 mg/m² (Days 1, 8 and 15)
Units
Counts
Participants
OG000
Secondary
Randomized Part (Participants Without Intensive PK Sampling): Maximum Concentration (Cmax) of NIS793 in Combination With Gemcitabine and Nab-paclitaxel
For Chinese participants without intensive PK sampling schedule and global participants in the randomized part, for which only sparse PK samples were collected for activity-based pharmacokinetics characterization, Cmax was listed and summarized using descriptive statistics.
Pharmacokinetic Analysis Set - Participants without intensive PK sampling with corresponding evaluable PK parameters at the indicated timepoint were analyzed
Posted
Mean
Standard Deviation
ng/mL
Cycles 1 and 3: Day 1 (0 hour (pre-dose)). 1 cycle = 28 days.
ID
Title
Description
OG000
Randomized Part (Arm A): NIS793 Plus (Gemcitabine and Nab-paclitaxel)
Participants received a combination of NIS793, Gemcitabine and Nab-paclitaxel:
NIS793 at 2100 mg (Days 1 and 15)
Gemcitabine at 1000 mg/m² (Days 1, 8 and 15)
Nab-paclitaxel at 125 mg/m² (Days 1, 8 and 15)
Units
Counts
Participants
OG000
Secondary
Randomized Part (Participants Without Intensive PK Sampling): Time to Reach Maximum Concentration (Tmax) of NIS793 in Combination With Gemcitabine and Nab-paclitaxel
For Chinese participants without intensive PK sampling schedule and global participants in the randomized part, for which only sparse PK samples were collected for activity-based pharmacokinetics characterization, Tmax was listed and summarized using descriptive statistics.
Pharmacokinetic Analysis Set - Participants without intensive PK sampling with corresponding evaluable PK parameters at the indicated timepoint were analyzed
Posted
Median
Full Range
Hour
Cycles 1 and 3: Day 1 (0 hour (pre-dose)). 1 cycle = 28 days.
ID
Title
Description
OG000
Randomized Part (Arm A): NIS793 Plus (Gemcitabine and Nab-paclitaxel)
Participants received a combination of NIS793, Gemcitabine and Nab-paclitaxel:
NIS793 at 2100 mg (Days 1 and 15)
Gemcitabine at 1000 mg/m² (Days 1, 8 and 15)
Nab-paclitaxel at 125 mg/m² (Days 1, 8 and 15)
Units
Counts
Participants
OG000
Secondary
Randomized Part: Anti-drug Antibodies (ADA) Against NIS793 Prevalence at Baseline
Anti-drug antibodies (ADA) against NIS793 prevalence at baseline refers to the proportion of subjects who have developed antibodies against the drug NIS793 before starting treatment. This is calculated by dividing the number of subjects with ADA-positive samples at baseline by the total number of subjects whose baseline samples were tested for ADA.
For the randomized part, the immunogenicity (IG) incidence set included all participants in the IG prevalence set with a determinant baseline IG sample.
Posted
Count of Participants
Participants
Baseline
ID
Title
Description
OG000
Randomized Part (Arm A): NIS793 Plus (Gemcitabine and Nab-paclitaxel)
Participants received a combination of NIS793, Gemcitabine and Nab-paclitaxel:
NIS793 at 2100 mg (Days 1 and 15)
Gemcitabine at 1000 mg/m² (Days 1, 8 and 15)
Nab-paclitaxel at 125 mg/m² (Days 1, 8 and 15)
Units
Counts
Participants
OG000
Secondary
Randomized Part: Anti-drug Antibodies (ADA) Against NIS793 Incidence on Treatment
Anti-drug antibodies (ADA) against NIS793 incidence on treatment refers to the proportion of participants who developed antibodies against the drug NIS793 during the treatment period. This can be categorized into two types:
Treatment-induced ADA positive: Participants who were ADA-negative at baseline but became ADA-positive after starting the treatment.
Treatment-boosted ADA positive: Participants who were ADA-positive at baseline and showed a significant increase in ADA titer during the treatment.
For the randomized part, the immunogenicity (IG) incidence set included all participants in the IG prevalence set with a determinant baseline IG sample and at least one determinant post-baseline IG sample.
Posted
Count of Participants
Participants
From date of first study drug intake up to approximately 34 months
ID
Title
Description
OG000
Randomized Part (Arm A): NIS793 Plus (Gemcitabine and Nab-paclitaxel)
Participants received a combination of NIS793, Gemcitabine and Nab-paclitaxel:
NIS793 at 2100 mg (Days 1 and 15)
Gemcitabine at 1000 mg/m² (Days 1, 8 and 15)
Nab-paclitaxel at 125 mg/m² (Days 1, 8 and 15)
Units
Counts
Participants
Time Frame
Adverse events were collected from the first dose through the end of the extended follow-up period (end of study), up to approximately 34 months. Deaths were recorded from study start through the end of post-treatment follow-up (end of study). On-treatment adverse events (up to 30 days after the last dose) and post-treatment follow-up events are reported separately.
Description
All enrolled participants were included in the assessment of all-cause mortality. One safety run-in participant lost to follow-up was later confirmed (via public records) to have died >30 days post-treatment and was only included for all-cause mortality. Serious adverse events and other adverse events were assessed only in participants who received at least one dose of the investigational product. Participants entering post-treatment follow-up (efficacy or survival) were considered at risk.
Safety run-in (NIS793 + gemcitabine/nab-paclitaxel): Events in the post-treatment follow-up phase
19
19
2
18
6
18
EG002
Randomized Arm A (NIS793 + Gemcitabine/Nab-Paclitaxel): On-treatment
Randomized Arm A (NIS793 + gemcitabine/nab-paclitaxel): Events up to 30 days safety follow-up
24
239
144
239
228
239
EG003
Randomized Arm A (NIS793 + Gemcitabine/Nab-Paclitaxel): Post-treatment
Randomized Arm A (NIS793 + gemcitabine/nab-paclitaxel): Events in the post-treatment follow-up phase
135
192
21
192
29
192
EG004
Randomized Arm B (Placebo + Gemcitabine/Nab-Paclitaxel): On-Treatment
Randomized Arm B (Placebo + gemcitabine/nab-paclitaxel): Events up to 30 days safety follow-up
16
241
110
241
236
241
EG005
Randomized Arm B (Placebo + Gemcitabine/Nab-Paclitaxel): Post-Treatment
Randomized Arm B (Placebo + gemcitabine/nab-paclitaxel): Events in the post-treatment follow-up phase
132
200
28
200
36
200
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA (20.1)
Systematic Assessment
EG0001 affected21 at risk
EG0010 affected18 at risk
EG00213 affected239 at risk
EG0031 affected192 at risk
EG0043 affected241 at risk
EG0050 affected200 at risk
Atypical haemolytic uraemic syndrome
Blood and lymphatic system disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected18 at risk
EG0021 affected239 at risk
EG003
Blood loss anaemia
Blood and lymphatic system disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0011 affected18 at risk
EG0020 affected239 at risk
EG003
Coagulopathy
Blood and lymphatic system disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected18 at risk
EG0020 affected239 at risk
EG003
Disseminated intravascular coagulation
Blood and lymphatic system disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected18 at risk
EG0020 affected239 at risk
EG003
Febrile neutropenia
Blood and lymphatic system disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected18 at risk
EG0024 affected239 at risk
EG003
Leukocytosis
Blood and lymphatic system disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected18 at risk
EG0021 affected239 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected18 at risk
EG0021 affected239 at risk
EG003
Pancytopenia
Blood and lymphatic system disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected18 at risk
EG0021 affected239 at risk
EG003
Thrombotic microangiopathy
Blood and lymphatic system disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected18 at risk
EG0021 affected239 at risk
EG003
Acute myocardial infarction
Cardiac disorders
MedDRA (20.1)
Systematic Assessment
EG0001 affected21 at risk
EG0010 affected18 at risk
EG0020 affected239 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected18 at risk
EG0021 affected239 at risk
EG003
Cardiac arrest
Cardiac disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected18 at risk
EG0020 affected239 at risk
EG003
Cardiac disorder
Cardiac disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected18 at risk
EG0021 affected239 at risk
EG003
Cardiac failure
Cardiac disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected18 at risk
EG0020 affected239 at risk
EG003
Cardiac valve disease
Cardiac disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected18 at risk
EG0020 affected239 at risk
EG003
Cardiopulmonary failure
Cardiac disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected18 at risk
EG0020 affected239 at risk
EG003
Coronary artery disease
Cardiac disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected18 at risk
EG0020 affected239 at risk
EG003
Heart failure with preserved ejection fraction
Cardiac disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected18 at risk
EG0020 affected239 at risk
EG003
Myocardial infarction
Cardiac disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected18 at risk
EG0021 affected239 at risk
EG003
Palpitations
Cardiac disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected18 at risk
EG0021 affected239 at risk
EG003
Ventricular fibrillation
Cardiac disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected18 at risk
EG0021 affected239 at risk
EG003
Papilloedema
Eye disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected18 at risk
EG0020 affected239 at risk
EG003
Retinal ischaemia
Eye disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected18 at risk
EG0021 affected239 at risk
EG003
Retinal vasculitis
Eye disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected18 at risk
EG0020 affected239 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected18 at risk
EG0021 affected239 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected18 at risk
EG0023 affected239 at risk
EG003
Abdominal pain lower
Gastrointestinal disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected18 at risk
EG0021 affected239 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected18 at risk
EG0020 affected239 at risk
EG003
Acute abdomen
Gastrointestinal disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected18 at risk
EG0021 affected239 at risk
EG003
Ascites
Gastrointestinal disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected18 at risk
EG0020 affected239 at risk
EG003
Colitis
Gastrointestinal disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected18 at risk
EG0020 affected239 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected18 at risk
EG0020 affected239 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected18 at risk
EG0023 affected239 at risk
EG003
Duodenal obstruction
Gastrointestinal disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected18 at risk
EG0021 affected239 at risk
EG003
Duodenal stenosis
Gastrointestinal disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected18 at risk
EG0021 affected239 at risk
EG003
Duodenal ulcer
Gastrointestinal disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected18 at risk
EG0022 affected239 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected18 at risk
EG0020 affected239 at risk
EG003
Gastric haemorrhage
Gastrointestinal disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected18 at risk
EG0023 affected239 at risk
EG003
Gastric perforation
Gastrointestinal disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected18 at risk
EG0020 affected239 at risk
EG003
Gastric stenosis
Gastrointestinal disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected18 at risk
EG0020 affected239 at risk
EG003
Gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA (20.1)
Systematic Assessment
EG0001 affected21 at risk
EG0010 affected18 at risk
EG0024 affected239 at risk
EG003
Gastrointestinal inflammation
Gastrointestinal disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected18 at risk
EG0020 affected239 at risk
EG003
Gastrointestinal toxicity
Gastrointestinal disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected18 at risk
EG0021 affected239 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected18 at risk
EG0021 affected239 at risk
EG003
Haematemesis
Gastrointestinal disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected18 at risk
EG0023 affected239 at risk
EG003
Haematochezia
Gastrointestinal disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected18 at risk
EG0021 affected239 at risk
EG003
Haemorrhoidal haemorrhage
Gastrointestinal disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected18 at risk
EG0021 affected239 at risk
EG003
Ileus
Gastrointestinal disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected18 at risk
EG0022 affected239 at risk
EG003
Impaired gastric emptying
Gastrointestinal disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected18 at risk
EG0021 affected239 at risk
EG003
Intestinal obstruction
Gastrointestinal disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected18 at risk
EG0024 affected239 at risk
EG003
Ischaemic enteritis
Gastrointestinal disorders
MedDRA (20.1)
Systematic Assessment
EG0001 affected21 at risk
EG0010 affected18 at risk
EG0020 affected239 at risk
EG003
Large intestinal obstruction
Gastrointestinal disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected18 at risk
EG0021 affected239 at risk
EG003
Lower gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected18 at risk
EG0022 affected239 at risk
EG003
Malignant ascites
Gastrointestinal disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected18 at risk
EG0020 affected239 at risk
EG003
Malignant gastrointestinal obstruction
Gastrointestinal disorders
MedDRA (20.1)
Systematic Assessment
EG0001 affected21 at risk
EG0010 affected18 at risk
EG0020 affected239 at risk
EG003
Melaena
Gastrointestinal disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected18 at risk
EG0023 affected239 at risk
EG003
Obstruction gastric
Gastrointestinal disorders
MedDRA (20.1)
Systematic Assessment
EG0001 affected21 at risk
EG0010 affected18 at risk
EG0020 affected239 at risk
EG003
Pancreatitis
Gastrointestinal disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected18 at risk
EG0022 affected239 at risk
EG003
Pancreatitis acute
Gastrointestinal disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected18 at risk
EG0022 affected239 at risk
EG003
Portal hypertensive gastropathy
Gastrointestinal disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected18 at risk
EG0021 affected239 at risk
EG003
Rectal haemorrhage
Gastrointestinal disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected18 at risk
EG0022 affected239 at risk
EG003
Small intestinal haemorrhage
Gastrointestinal disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected18 at risk
EG0021 affected239 at risk
EG003
Small intestinal obstruction
Gastrointestinal disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected18 at risk
EG0021 affected239 at risk
EG003
Small intestinal perforation
Gastrointestinal disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected18 at risk
EG0021 affected239 at risk
EG003
Upper gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA (20.1)
Systematic Assessment
EG0001 affected21 at risk
EG0010 affected18 at risk
EG0028 affected239 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA (20.1)
Systematic Assessment
EG0002 affected21 at risk
EG0010 affected18 at risk
EG0025 affected239 at risk
EG003
Asthenia
General disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected18 at risk
EG0022 affected239 at risk
EG003
Condition aggravated
General disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected18 at risk
EG0020 affected239 at risk
EG003
Death
General disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected18 at risk
EG0021 affected239 at risk
EG003
Fatigue
General disorders
MedDRA (20.1)
Systematic Assessment
EG0001 affected21 at risk
EG0010 affected18 at risk
EG0023 affected239 at risk
EG003
General physical health deterioration
General disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected18 at risk
EG0026 affected239 at risk
EG003
Generalised oedema
General disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected18 at risk
EG0020 affected239 at risk
EG003
Malaise
General disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected18 at risk
EG0020 affected239 at risk
EG003
Oedema peripheral
General disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected18 at risk
EG0021 affected239 at risk
EG003
Pain
General disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected18 at risk
EG0022 affected239 at risk
EG003
Pyrexia
General disorders
MedDRA (20.1)
Systematic Assessment
EG0001 affected21 at risk
EG0010 affected18 at risk
EG00211 affected239 at risk
EG003
Autoimmune hepatitis
Hepatobiliary disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected18 at risk
EG0020 affected239 at risk
EG003
Bile duct stenosis
Hepatobiliary disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected18 at risk
EG0021 affected239 at risk
EG003
Biliary obstruction
Hepatobiliary disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected18 at risk
EG0024 affected239 at risk
EG003
Cholangitis
Hepatobiliary disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected18 at risk
EG0027 affected239 at risk
EG003
Cholangitis acute
Hepatobiliary disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected18 at risk
EG0021 affected239 at risk
EG003
Cholecystitis
Hepatobiliary disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected18 at risk
EG0022 affected239 at risk
EG003
Cholecystitis acute
Hepatobiliary disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected18 at risk
EG0020 affected239 at risk
EG003
Gallbladder fistula
Hepatobiliary disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected18 at risk
EG0020 affected239 at risk
EG003
Hepatic function abnormal
Hepatobiliary disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected18 at risk
EG0020 affected239 at risk
EG003
Hepatobiliary disease
Hepatobiliary disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected18 at risk
EG0021 affected239 at risk
EG003
Jaundice
Hepatobiliary disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected18 at risk
EG0021 affected239 at risk
EG003
Jaundice cholestatic
Hepatobiliary disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected18 at risk
EG0022 affected239 at risk
EG003
Liver disorder
Hepatobiliary disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected18 at risk
EG0020 affected239 at risk
EG003
Malignant biliary obstruction
Hepatobiliary disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected18 at risk
EG0020 affected239 at risk
EG003
Portal vein thrombosis
Hepatobiliary disorders
MedDRA (20.1)
Systematic Assessment
EG0001 affected21 at risk
EG0010 affected18 at risk
EG0020 affected239 at risk
EG003
Abdominal abscess
Infections and infestations
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected18 at risk
EG0021 affected239 at risk
EG003
Abdominal infection
Infections and infestations
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected18 at risk
EG0021 affected239 at risk
EG003
Anal abscess
Infections and infestations
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected18 at risk
EG0021 affected239 at risk
EG003
Appendicitis
Infections and infestations
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected18 at risk
EG0020 affected239 at risk
EG003
Bacteraemia
Infections and infestations
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected18 at risk
EG0022 affected239 at risk
EG003
Bacterial infection
Infections and infestations
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected18 at risk
EG0020 affected239 at risk
EG003
Biliary tract infection
Infections and infestations
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected18 at risk
EG0021 affected239 at risk
EG003
COVID-19
Infections and infestations
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected18 at risk
EG0021 affected239 at risk
EG003
COVID-19 pneumonia
Infections and infestations
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected18 at risk
EG0020 affected239 at risk
EG003
Cellulitis
Infections and infestations
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected18 at risk
EG0021 affected239 at risk
EG003
Cholangitis infective
Infections and infestations
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected18 at risk
EG0020 affected239 at risk
EG003
Clostridium difficile colitis
Infections and infestations
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected18 at risk
EG0021 affected239 at risk
EG003
Clostridium difficile infection
Infections and infestations
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected18 at risk
EG0020 affected239 at risk
EG003
Device related infection
Infections and infestations
MedDRA (20.1)
Systematic Assessment
EG0001 affected21 at risk
EG0010 affected18 at risk
EG0023 affected239 at risk
EG003
Device related sepsis
Infections and infestations
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected18 at risk
EG0021 affected239 at risk
EG003
Erysipelas
Infections and infestations
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected18 at risk
EG0020 affected239 at risk
EG003
Escherichia infection
Infections and infestations
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected18 at risk
EG0021 affected239 at risk
EG003
Escherichia sepsis
Infections and infestations
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected18 at risk
EG0020 affected239 at risk
EG003
Escherichia urinary tract infection
Infections and infestations
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0011 affected18 at risk
EG0020 affected239 at risk
EG003
Eye infection
Infections and infestations
MedDRA (20.1)
Systematic Assessment
EG0001 affected21 at risk
EG0010 affected18 at risk
EG0020 affected239 at risk
EG003
Febrile infection
Infections and infestations
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected18 at risk
EG0020 affected239 at risk
EG003
Focal peritonitis
Infections and infestations
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected18 at risk
EG0020 affected239 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA (20.1)
Systematic Assessment
EG0001 affected21 at risk
EG0010 affected18 at risk
EG0020 affected239 at risk
EG003
Giardiasis
Infections and infestations
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected18 at risk
EG0020 affected239 at risk
EG003
Hepatic infection
Infections and infestations
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected18 at risk
EG0020 affected239 at risk
EG003
Infection
Infections and infestations
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected18 at risk
EG0020 affected239 at risk
EG003
Liver abscess
Infections and infestations
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected18 at risk
EG0021 affected239 at risk
EG003
Lower respiratory tract infection
Infections and infestations
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected18 at risk
EG0020 affected239 at risk
EG003
Nail infection
Infections and infestations
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected18 at risk
EG0020 affected239 at risk
EG003
Oesophageal candidiasis
Infections and infestations
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected18 at risk
EG0020 affected239 at risk
EG003
Oral candidiasis
Infections and infestations
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected18 at risk
EG0020 affected239 at risk
EG003
Oropharyngitis fungal
Infections and infestations
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected18 at risk
EG0020 affected239 at risk
EG003
Pancreas infection
Infections and infestations
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected18 at risk
EG0021 affected239 at risk
EG003
Penile infection
Infections and infestations
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected18 at risk
EG0020 affected239 at risk
EG003
Peritonitis
Infections and infestations
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected18 at risk
EG0023 affected239 at risk
EG003
Pneumococcal infection
Infections and infestations
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected18 at risk
EG0021 affected239 at risk
EG003
Pneumonia
Infections and infestations
MedDRA (20.1)
Systematic Assessment
EG0001 affected21 at risk
EG0010 affected18 at risk
EG0027 affected239 at risk
EG003
Pneumonia bacterial
Infections and infestations
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected18 at risk
EG0021 affected239 at risk
EG003
Pyelonephritis
Infections and infestations
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected18 at risk
EG0021 affected239 at risk
EG003
Rhinovirus infection
Infections and infestations
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected18 at risk
EG0020 affected239 at risk
EG003
Sepsis
Infections and infestations
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected18 at risk
EG0025 affected239 at risk
EG003
Septic shock
Infections and infestations
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected18 at risk
EG0025 affected239 at risk
EG003
Sinusitis
Infections and infestations
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected18 at risk
EG0021 affected239 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected18 at risk
EG0024 affected239 at risk
EG003
Urosepsis
Infections and infestations
MedDRA (20.1)
Systematic Assessment
EG0001 affected21 at risk
EG0010 affected18 at risk
EG0022 affected239 at risk
EG003
Anastomotic ulcer
Injury, poisoning and procedural complications
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected18 at risk
EG0021 affected239 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected18 at risk
EG0020 affected239 at risk
EG003
Femur fracture
Injury, poisoning and procedural complications
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected18 at risk
EG0020 affected239 at risk
EG003
Fractured sacrum
Injury, poisoning and procedural complications
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected18 at risk
EG0021 affected239 at risk
EG003
Hepatic rupture
Injury, poisoning and procedural complications
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected18 at risk
EG0021 affected239 at risk
EG003
Hip fracture
Injury, poisoning and procedural complications
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected18 at risk
EG0022 affected239 at risk
EG003
Infusion related reaction
Injury, poisoning and procedural complications
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected18 at risk
EG0021 affected239 at risk
EG003
Spinal fracture
Injury, poisoning and procedural complications
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected18 at risk
EG0020 affected239 at risk
EG003
Vascular pseudoaneurysm ruptured
Injury, poisoning and procedural complications
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected18 at risk
EG0020 affected239 at risk
EG003
Wound dehiscence
Injury, poisoning and procedural complications
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected18 at risk
EG0021 affected239 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected18 at risk
EG0021 affected239 at risk
EG003
Amylase increased
Investigations
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected18 at risk
EG0021 affected239 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected18 at risk
EG0021 affected239 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected18 at risk
EG0021 affected239 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected18 at risk
EG0020 affected239 at risk
EG003
Blood creatinine increased
Investigations
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected18 at risk
EG0021 affected239 at risk
EG003
Lipase increased
Investigations
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected18 at risk
EG0021 affected239 at risk
EG003
Platelet count decreased
Investigations
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected18 at risk
EG0021 affected239 at risk
EG003
Troponin increased
Investigations
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected18 at risk
EG0020 affected239 at risk
EG003
Weight decreased
Investigations
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected18 at risk
EG0020 affected239 at risk
EG003
White blood cell count decreased
Investigations
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected18 at risk
EG0021 affected239 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected18 at risk
EG0024 affected239 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected18 at risk
EG0021 affected239 at risk
EG003
Diabetic ketoacidosis
Metabolism and nutrition disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected18 at risk
EG0021 affected239 at risk
EG003
Failure to thrive
Metabolism and nutrition disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected18 at risk
EG0020 affected239 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected18 at risk
EG0020 affected239 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected18 at risk
EG0021 affected239 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected18 at risk
EG0021 affected239 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected18 at risk
EG0022 affected239 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected18 at risk
EG0021 affected239 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected18 at risk
EG0021 affected239 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected18 at risk
EG0023 affected239 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected18 at risk
EG0021 affected239 at risk
EG003
Malnutrition
Metabolism and nutrition disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected18 at risk
EG0020 affected239 at risk
EG003
Metabolic acidosis
Metabolism and nutrition disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected18 at risk
EG0021 affected239 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA (20.1)
Systematic Assessment
EG0001 affected21 at risk
EG0010 affected18 at risk
EG0024 affected239 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected18 at risk
EG0022 affected239 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected18 at risk
EG0021 affected239 at risk
EG003
Osteoporotic fracture
Musculoskeletal and connective tissue disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected18 at risk
EG0021 affected239 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA (20.1)
Systematic Assessment
EG0001 affected21 at risk
EG0010 affected18 at risk
EG0020 affected239 at risk
EG003
Pathological fracture
Musculoskeletal and connective tissue disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected18 at risk
EG0021 affected239 at risk
EG003
Sarcopenia
Musculoskeletal and connective tissue disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected18 at risk
EG0020 affected239 at risk
EG003
Oesophageal adenocarcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (20.1)
Systematic Assessment
EG0001 affected21 at risk
EG0010 affected18 at risk
EG0020 affected239 at risk
EG003
Transitional cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected18 at risk
EG0021 affected239 at risk
EG003
Tumour associated fever
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected18 at risk
EG0021 affected239 at risk
EG003
Tumour haemorrhage
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (20.1)
Systematic Assessment
EG0001 affected21 at risk
EG0010 affected18 at risk
EG0022 affected239 at risk
EG003
Cerebral haemorrhage
Nervous system disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected18 at risk
EG0021 affected239 at risk
EG003
Cerebral infarction
Nervous system disorders
MedDRA (20.1)
Systematic Assessment
EG0001 affected21 at risk
EG0010 affected18 at risk
EG0022 affected239 at risk
EG003
Cerebrovascular accident
Nervous system disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected18 at risk
EG0020 affected239 at risk
EG003
Coma
Nervous system disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected18 at risk
EG0020 affected239 at risk
EG003
Dizziness
Nervous system disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected18 at risk
EG0021 affected239 at risk
EG003
Dysstasia
Nervous system disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected18 at risk
EG0020 affected239 at risk
EG003
Encephalopathy
Nervous system disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected18 at risk
EG0021 affected239 at risk
EG003
Facial paralysis
Nervous system disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected18 at risk
EG0020 affected239 at risk
EG003
Haemorrhage intracranial
Nervous system disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected18 at risk
EG0021 affected239 at risk
EG003
Headache
Nervous system disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected18 at risk
EG0020 affected239 at risk
EG003
Ischaemic stroke
Nervous system disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected18 at risk
EG0022 affected239 at risk
EG003
Metabolic encephalopathy
Nervous system disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected18 at risk
EG0021 affected239 at risk
EG003
Motor dysfunction
Nervous system disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected18 at risk
EG0020 affected239 at risk
EG003
Neuropathy peripheral
Nervous system disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected18 at risk
EG0021 affected239 at risk
EG003
Neurotoxicity
Nervous system disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected18 at risk
EG0021 affected239 at risk
EG003
Putamen haemorrhage
Nervous system disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected18 at risk
EG0021 affected239 at risk
EG003
Seizure
Nervous system disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected18 at risk
EG0020 affected239 at risk
EG003
Syncope
Nervous system disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected18 at risk
EG0021 affected239 at risk
EG003
Transient ischaemic attack
Nervous system disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected18 at risk
EG0020 affected239 at risk
EG003
Device dislocation
Product Issues
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected18 at risk
EG0021 affected239 at risk
EG003
Device occlusion
Product Issues
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected18 at risk
EG0023 affected239 at risk
EG003
Stent malfunction
Product Issues
MedDRA (20.1)
Systematic Assessment
EG0001 affected21 at risk
EG0010 affected18 at risk
EG0020 affected239 at risk
EG003
Delirium
Psychiatric disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected18 at risk
EG0020 affected239 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected18 at risk
EG0024 affected239 at risk
EG003
Calculus urinary
Renal and urinary disorders
MedDRA (20.1)
Systematic Assessment
EG0001 affected21 at risk
EG0010 affected18 at risk
EG0020 affected239 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA (20.1)
Systematic Assessment
EG0001 affected21 at risk
EG0010 affected18 at risk
EG0021 affected239 at risk
EG003
Hydronephrosis
Renal and urinary disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected18 at risk
EG0021 affected239 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected18 at risk
EG0021 affected239 at risk
EG003
Renal failure
Renal and urinary disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected18 at risk
EG0020 affected239 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected18 at risk
EG0021 affected239 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected18 at risk
EG0023 affected239 at risk
EG003
Haemoptysis
Respiratory, thoracic and mediastinal disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected18 at risk
EG0021 affected239 at risk
EG003
Hiccups
Respiratory, thoracic and mediastinal disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected18 at risk
EG0021 affected239 at risk
EG003
Hydrothorax
Respiratory, thoracic and mediastinal disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected18 at risk
EG0020 affected239 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected18 at risk
EG0020 affected239 at risk
EG003
Interstitial lung disease
Respiratory, thoracic and mediastinal disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected18 at risk
EG0021 affected239 at risk
EG003
Non-cardiogenic pulmonary oedema
Respiratory, thoracic and mediastinal disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected18 at risk
EG0020 affected239 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected18 at risk
EG0021 affected239 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected18 at risk
EG0022 affected239 at risk
EG003
Pneumothorax
Respiratory, thoracic and mediastinal disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected18 at risk
EG0022 affected239 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA (20.1)
Systematic Assessment
EG0001 affected21 at risk
EG0010 affected18 at risk
EG0024 affected239 at risk
EG003
Respiratory distress
Respiratory, thoracic and mediastinal disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected18 at risk
EG0021 affected239 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected18 at risk
EG0021 affected239 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected18 at risk
EG0022 affected239 at risk
EG003
Aortic dissection
Vascular disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected18 at risk
EG0020 affected239 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected18 at risk
EG0020 affected239 at risk
EG003
Distributive shock
Vascular disorders
MedDRA (20.1)
Systematic Assessment
EG0001 affected21 at risk
EG0010 affected18 at risk
EG0020 affected239 at risk
EG003
Embolism
Vascular disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0011 affected18 at risk
EG0020 affected239 at risk
EG003
Hypotension
Vascular disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected18 at risk
EG0023 affected239 at risk
EG003
Orthostatic hypotension
Vascular disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected18 at risk
EG0021 affected239 at risk
EG003
Peripheral vein thrombosis
Vascular disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected18 at risk
EG0020 affected239 at risk
EG003
Shock haemorrhagic
Vascular disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected18 at risk
EG0021 affected239 at risk
EG003
Thrombophlebitis
Vascular disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected18 at risk
EG0020 affected239 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA (20.1)
Systematic Assessment
EG00014 affected21 at risk
EG0010 affected18 at risk
EG002165 affected239 at risk
EG00316 affected192 at risk
EG004143 affected241 at risk
EG00510 affected200 at risk
Leukopenia
Blood and lymphatic system disorders
MedDRA (20.1)
Systematic Assessment
EG0002 affected21 at risk
EG0010 affected18 at risk
EG00215 affected239 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA (20.1)
Systematic Assessment
EG0005 affected21 at risk
EG0010 affected18 at risk
EG00249 affected239 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA (20.1)
Systematic Assessment
EG0003 affected21 at risk
EG0010 affected18 at risk
EG00236 affected239 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA (20.1)
Systematic Assessment
EG0002 affected21 at risk
EG0010 affected18 at risk
EG0029 affected239 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA (20.1)
Systematic Assessment
EG0008 affected21 at risk
EG0011 affected18 at risk
EG00225 affected239 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA (20.1)
Systematic Assessment
EG0001 affected21 at risk
EG0010 affected18 at risk
EG00213 affected239 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA (20.1)
Systematic Assessment
EG0007 affected21 at risk
EG0010 affected18 at risk
EG00247 affected239 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA (20.1)
Systematic Assessment
EG0009 affected21 at risk
EG0011 affected18 at risk
EG00270 affected239 at risk
EG003
Gingival bleeding
Gastrointestinal disorders
MedDRA (20.1)
Systematic Assessment
EG0003 affected21 at risk
EG0010 affected18 at risk
EG0029 affected239 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
MedDRA (20.1)
Systematic Assessment
EG0001 affected21 at risk
EG0010 affected18 at risk
EG00214 affected239 at risk
EG003
Mouth ulceration
Gastrointestinal disorders
MedDRA (20.1)
Systematic Assessment
EG0002 affected21 at risk
EG0010 affected18 at risk
EG0025 affected239 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA (20.1)
Systematic Assessment
EG00012 affected21 at risk
EG0010 affected18 at risk
EG00289 affected239 at risk
EG003
Rectal haemorrhage
Gastrointestinal disorders
MedDRA (20.1)
Systematic Assessment
EG0002 affected21 at risk
EG0010 affected18 at risk
EG0028 affected239 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected18 at risk
EG00225 affected239 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA (20.1)
Systematic Assessment
EG0004 affected21 at risk
EG0010 affected18 at risk
EG00257 affected239 at risk
EG003
Asthenia
General disorders
MedDRA (20.1)
Systematic Assessment
EG0002 affected21 at risk
EG0010 affected18 at risk
EG00239 affected239 at risk
EG003
Chills
General disorders
MedDRA (20.1)
Systematic Assessment
EG0001 affected21 at risk
EG0010 affected18 at risk
EG00213 affected239 at risk
EG003
Fatigue
General disorders
MedDRA (20.1)
Systematic Assessment
EG00012 affected21 at risk
EG0010 affected18 at risk
EG00276 affected239 at risk
EG003
Malaise
General disorders
MedDRA (20.1)
Systematic Assessment
EG0001 affected21 at risk
EG0010 affected18 at risk
EG00221 affected239 at risk
EG003
Mucosal inflammation
General disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected18 at risk
EG00211 affected239 at risk
EG003
Oedema peripheral
General disorders
MedDRA (20.1)
Systematic Assessment
EG0004 affected21 at risk
EG0010 affected18 at risk
EG00236 affected239 at risk
EG003
Pyrexia
General disorders
MedDRA (20.1)
Systematic Assessment
EG0005 affected21 at risk
EG0011 affected18 at risk
EG00275 affected239 at risk
EG003
COVID-19
Infections and infestations
MedDRA (20.1)
Systematic Assessment
EG0001 affected21 at risk
EG0010 affected18 at risk
EG00220 affected239 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA (20.1)
Systematic Assessment
EG0003 affected21 at risk
EG0010 affected18 at risk
EG00228 affected239 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA (20.1)
Systematic Assessment
EG0004 affected21 at risk
EG0010 affected18 at risk
EG00259 affected239 at risk
EG003
Amylase increased
Investigations
MedDRA (20.1)
Systematic Assessment
EG0002 affected21 at risk
EG0010 affected18 at risk
EG0029 affected239 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA (20.1)
Systematic Assessment
EG0004 affected21 at risk
EG0010 affected18 at risk
EG00254 affected239 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA (20.1)
Systematic Assessment
EG0003 affected21 at risk
EG0010 affected18 at risk
EG00220 affected239 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected18 at risk
EG00219 affected239 at risk
EG003
Blood lactate dehydrogenase increased
Investigations
MedDRA (20.1)
Systematic Assessment
EG0002 affected21 at risk
EG0010 affected18 at risk
EG0026 affected239 at risk
EG003
Gamma-glutamyltransferase increased
Investigations
MedDRA (20.1)
Systematic Assessment
EG0003 affected21 at risk
EG0010 affected18 at risk
EG00227 affected239 at risk
EG003
Lipase increased
Investigations
MedDRA (20.1)
Systematic Assessment
EG0003 affected21 at risk
EG0010 affected18 at risk
EG00215 affected239 at risk
EG003
Lymphocyte count decreased
Investigations
MedDRA (20.1)
Systematic Assessment
EG0002 affected21 at risk
EG0010 affected18 at risk
EG00217 affected239 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA (20.1)
Systematic Assessment
EG0003 affected21 at risk
EG0010 affected18 at risk
EG00263 affected239 at risk
EG003
Platelet count decreased
Investigations
MedDRA (20.1)
Systematic Assessment
EG0004 affected21 at risk
EG0010 affected18 at risk
EG00252 affected239 at risk
EG003
Weight decreased
Investigations
MedDRA (20.1)
Systematic Assessment
EG0006 affected21 at risk
EG0011 affected18 at risk
EG00244 affected239 at risk
EG003
White blood cell count decreased
Investigations
MedDRA (20.1)
Systematic Assessment
EG0002 affected21 at risk
EG0010 affected18 at risk
EG00248 affected239 at risk
EG003
White blood cell count increased
Investigations
MedDRA (20.1)
Systematic Assessment
EG0003 affected21 at risk
EG0010 affected18 at risk
EG0023 affected239 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA (20.1)
Systematic Assessment
EG0008 affected21 at risk
EG0010 affected18 at risk
EG00266 affected239 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA (20.1)
Systematic Assessment
EG0001 affected21 at risk
EG0010 affected18 at risk
EG00212 affected239 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRA (20.1)
Systematic Assessment
EG0001 affected21 at risk
EG0010 affected18 at risk
EG00239 affected239 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
MedDRA (20.1)
Systematic Assessment
EG0002 affected21 at risk
EG0010 affected18 at risk
EG00230 affected239 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA (20.1)
Systematic Assessment
EG0004 affected21 at risk
EG0010 affected18 at risk
EG00228 affected239 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected18 at risk
EG00212 affected239 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected18 at risk
EG00226 affected239 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
MedDRA (20.1)
Systematic Assessment
EG0003 affected21 at risk
EG0010 affected18 at risk
EG00235 affected239 at risk
EG003
Iron deficiency
Metabolism and nutrition disorders
MedDRA (20.1)
Systematic Assessment
EG0004 affected21 at risk
EG0010 affected18 at risk
EG0025 affected239 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected18 at risk
EG00216 affected239 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA (20.1)
Systematic Assessment
EG0004 affected21 at risk
EG0013 affected18 at risk
EG00218 affected239 at risk
EG003
Joint swelling
Musculoskeletal and connective tissue disorders
MedDRA (20.1)
Systematic Assessment
EG0003 affected21 at risk
EG0010 affected18 at risk
EG0021 affected239 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected18 at risk
EG00217 affected239 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA (20.1)
Systematic Assessment
EG0001 affected21 at risk
EG0010 affected18 at risk
EG00218 affected239 at risk
EG003
Dizziness
Nervous system disorders
MedDRA (20.1)
Systematic Assessment
EG0002 affected21 at risk
EG0010 affected18 at risk
EG00215 affected239 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA (20.1)
Systematic Assessment
EG0002 affected21 at risk
EG0010 affected18 at risk
EG00220 affected239 at risk
EG003
Headache
Nervous system disorders
MedDRA (20.1)
Systematic Assessment
EG0004 affected21 at risk
EG0010 affected18 at risk
EG00217 affected239 at risk
EG003
Neuropathy peripheral
Nervous system disorders
MedDRA (20.1)
Systematic Assessment
EG0001 affected21 at risk
EG0010 affected18 at risk
EG00231 affected239 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA (20.1)
Systematic Assessment
EG0002 affected21 at risk
EG0010 affected18 at risk
EG00210 affected239 at risk
EG003
Peripheral sensory neuropathy
Nervous system disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected21 at risk
EG0010 affected18 at risk
EG00222 affected239 at risk
EG003
Delirium
Psychiatric disorders
MedDRA (20.1)
Systematic Assessment
EG0002 affected21 at risk
EG0010 affected18 at risk
EG0020 affected239 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA (20.1)
Systematic Assessment
EG0003 affected21 at risk
EG0010 affected18 at risk
EG00218 affected239 at risk
EG003
Dysuria
Renal and urinary disorders
MedDRA (20.1)
Systematic Assessment
EG0002 affected21 at risk
EG0010 affected18 at risk
EG0024 affected239 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA (20.1)
Systematic Assessment
EG0001 affected21 at risk
EG0010 affected18 at risk
EG00214 affected239 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA (20.1)
Systematic Assessment
EG0002 affected21 at risk
EG0010 affected18 at risk
EG00223 affected239 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA (20.1)
Systematic Assessment
EG0001 affected21 at risk
EG0010 affected18 at risk
EG00218 affected239 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA (20.1)
Systematic Assessment
EG0007 affected21 at risk
EG0010 affected18 at risk
EG00266 affected239 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA (20.1)
Systematic Assessment
EG0009 affected21 at risk
EG0010 affected18 at risk
EG00283 affected239 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA (20.1)
Systematic Assessment
EG0002 affected21 at risk
EG0011 affected18 at risk
EG00228 affected239 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA (20.1)
Systematic Assessment
EG0006 affected21 at risk
EG0010 affected18 at risk
EG00267 affected239 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA (20.1)
Systematic Assessment
EG0001 affected21 at risk
EG0010 affected18 at risk
EG00213 affected239 at risk
EG003
Rash papular
Skin and subcutaneous tissue disorders
MedDRA (20.1)
Systematic Assessment
EG0002 affected21 at risk
EG0010 affected18 at risk
EG0021 affected239 at risk
EG003
Hypertension
Vascular disorders
MedDRA (20.1)
Systematic Assessment
EG0001 affected21 at risk
EG0010 affected18 at risk
EG00211 affected239 at risk
EG003
Hypotension
Vascular disorders
MedDRA (20.1)
Systematic Assessment
EG0002 affected21 at risk
EG0010 affected18 at risk
EG00212 affected239 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.