Study of Efficacy and Safety of Pembrolizumab Plus Platin... | NCT03631199 | Trialant
NCT03631199
Sponsor
Novartis Pharmaceuticals
Status
Terminated
Last Update Posted
Jun 17, 2026Actual
Enrollment
673Actual
Phase
Phase 3
Conditions
Non-small Cell Lung Cancer
Interventions
canakinumab
canakinumab-matching placebo
pembrolizumab
carboplatin
cisplatin
paclitaxel
nab-paclitaxel
pemetrexed
Countries
United States
Argentina
Australia
Austria
Brazil
Canada
Chile
China
Colombia
Czechia
Denmark
Finland
France
Germany
Greece
Hong Kong
Hungary
Iceland
India
Italy
Japan
Lebanon
Malaysia
Netherlands
Norway
Philippines
Poland
Portugal
Romania
Russia
Singapore
Slovakia
South Korea
Spain
Sweden
Switzerland
Taiwan
Thailand
Turkey (Türkiye)
United Kingdom
Vietnam
Protocol Section
Identification Module
NCT ID
NCT03631199
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
CACZ885U2301
Secondary IDs
ID
Type
Description
Link
2024-511490-29-00
Registry Identifier
EU CT Number
Brief Title
Study of Efficacy and Safety of Pembrolizumab Plus Platinum-based Doublet Chemotherapy With or Without Canakinumab in Previously Untreated Locally Advanced or Metastatic Non-squamous and Squamous NSCLC Subjects
Official Title
A Randomized, Double-blind, Placebo-controlled, Phase III Study Evaluating the Efficacy and Safety of Pembrolizumab Plus Platinum-based Doublet Chemotherapy With or Without Canakinumab as First Line Therapy for Locally Advanced or Metastatic Non-squamous and Squamous Non-small Cell Lung Cancer Subjects (CANOPY-1)
Acronym
CANOPY-1
Organization
NovartisINDUSTRY
Status Module
Record Verification Date
Jun 2026
Overall Recruitment Status or Expanded Access Status
Terminated
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Results of primary analysis showed addition of canakinumab to combination treatment did not improve tumor response or overall survival; the decision to stop the trial was not due to safety concerns
Expanded Access Info
No
Start Date
Dec 21, 2018Actual
Primary Completion Date
Aug 9, 2021Actual
Completion Date
Jan 26, 2026Actual
First Submitted Date
Aug 6, 2018
First Submission Date that Met QC Criteria
Aug 10, 2018
First Posted Date
Aug 15, 2018Actual
Results Waived
Not provided
Results First Submitted Date
Jul 5, 2024
Results First Submitted that Met QC Criteria
Sep 27, 2024
Results First Posted Date
Oct 8, 2024Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Jul 11, 2022
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Oct 8, 2024Actual
Last Update Submitted Date
Jun 16, 2026
Last Update Posted Date
Jun 17, 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
This was a Phase III study of pembrolizumab plus platinum-based doublet chemotherapy with or without canakinumab in previously untreated locally advanced or metastatic non-squamous and squamous NSCLC participants.
Detailed Description
The study primarily assessed the safety and tolerability (safety run-in Part A) of pembrolizumab plus platinum-based doublet chemotherapy with canakinumab, and then, the efficacy (double-blind, randomized, placebo-controlled Part B) of pembrolizumab plus platinum-based doublet chemotherapy with or without canakinumab.
Conditions Module
Conditions
Non-small Cell Lung Cancer
Keywords
ACZ885
canakinumab
pembrolizumab
carboplatin
cisplatin
paclitaxel
nab-paclitaxel
pemetrexed
NSCLC
non-small cell lung cancer
non small cell lung cancer
squamous
non-squamous
hsCRP
IL-1β
PD-L1
CANOPY
CANOPY-1
platinum-based doublet chemotherapy
first line therapy
locally advanced
metastatic
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 3
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
673Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Part 1: Cohort A
Experimental
Safety run-in, canakinumab in combination with pembrolizumab, carboplatin, and pemetrexed.
Drug: canakinumab
Drug: pembrolizumab
Drug: carboplatin
Drug: pemetrexed
Part 1: Cohort B
Experimental
Safety run-in, canakinumab in combination with pembrolizumab, cisplatin, and pemetrexed.
Drug: canakinumab
Drug: pembrolizumab
Drug: cisplatin
Drug: pemetrexed
Part 1: Cohort C
Experimental
Safety run-in, canakinumab in combination with pembrolizumab, carboplatin, and paclitaxel.
Drug: canakinumab
Drug: pembrolizumab
Drug: carboplatin
Drug: paclitaxel
Part 2: Canakinumab+pembro+CTx
Experimental
Double-blind, randomized, placebo-controlled, canakinumab in combination with pembrolizumab and platinum-based doublet chemotherapy.
Drug: canakinumab
Drug: pembrolizumab
Drug: carboplatin
Drug: cisplatin
Drug: paclitaxel
Drug: nab-paclitaxel
Drug: pemetrexed
Part 2: Placebo+pembro+CTx
Other
Interventions
Name
Type
Description
Arm Group Labels
Other Names
canakinumab
Drug
canakinumab 200 mg subcutaneous (s.c.) injection every 3 weeks (squamous and non-squamous)
Part 1: Cohort A
Part 1: Cohort B
Part 1: Cohort C
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Part 1 (Safety Run-in): Number of Participants With Dose-limiting Toxicities (DLTs)
A DLT was defined as an adverse event or abnormal laboratory value assessed as unrelated to disease progression, inter-current illness, or concomitant medications that met certain criteria as defined in the protocol.
During the first 42 days of dosing
Part 2 (Double-blind, Randomized, Placebo-controlled): Progression-free Survival (PFS) Per Investigator Assessment Using RECIST v1.1
Progression free survival was defined as the time from randomization to the date of the first documented radiological progression using RECIST 1.1 (Response evaluation criteria in solid tumor) or death due to any cause.
18 months
Part 2 (Double-blind, Randomized, Placebo-controlled): Overall Survival (OS) Per Investigator Assessment Using RECIST v1.1
Overall survival is defined as the time from date of randomization to date of death due to any cause.
Up to approximately 32 months
Secondary Outcomes
Measure
Description
Time Frame
Part 1 (Safety Run-in): Overall Response Rate (ORR) Per Investigator Assessment Using RECIST v1.1
ORR was defined as the percentage of participants with confirmed best overall response of complete response (CR) or partial response (PR), as per investigator's assessment by RECIST 1.1. CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm; PR= At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Key inclusion criteria:
Histologically confirmed locally advanced stage IIIB or stage IV NSCLC for treatment in the first-line setting
Known PD-L1 status determined by a Novartis designated central laboratory. A newly obtained tissue biopsy or an archival biopsy (block or slides) is required for PD-L1 determination (PD-L1 IHC 22C3 pharmDx assay), prior to study randomization. Note: For the safety run-in part, known PD-L1 status is not required.
Eastern Cooperative oncology group (ECOG) performance status of 0 or 1.
At least 1 measurable lesion by RECIST 1.1
Key exclusion criteria:
Previous immunotherapy (e.g. anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways).
Prior treatment with canakinumab or drugs of a similar mechanism of action (IL-1β inhibitor).
Subjects with epidermal growth factor receptor (EGFR) sensitizing mutations (identified in exons 19, 20, or 21), and/or ALK rearrangement by locally approved laboratory testing.
Previously untreated or symptomatic central nervous system (CNS) metastases or lepto-meningeal disease.
Subject with suspected or proven immune-compromised state or infections.
Subject has prior to starting study drug: received live vaccination ≤3 months, had major surgery ≤4 weeks prior to starting study drug, has thoracic radiotherapy: lung fields ≤ 4 weeks, other anatomic sites ≤ 2 weeks, palliative radiotherapy for bone lesions ≤ 2 weeks.
Tan DSW, Felip E, de Castro G, Solomon BJ, Greystoke A, Cho BC, Cobo M, Kim TM, Ganguly S, Carcereny E, Paz-Ares L, Bennouna J, Garassino MC, Schenker M, Kim SW, Brase JC, Bury-Maynard D, Passos VQ, Deudon S, Dharan B, Song Y, Caparica R, Johnson BE. Canakinumab Versus Placebo in Combination With First-Line Pembrolizumab Plus Chemotherapy for Advanced Non-Small-Cell Lung Cancer: Results From the CANOPY-1 Trial. J Clin Oncol. 2024 Jan 10;42(2):192-204. doi: 10.1200/JCO.23.00980. Epub 2023 Dec 1.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
Plan to Share IPD
Yes
Description
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 expert 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.
Double-blind, randomized, placebo-controlled, canakinumab-matching placebo in combination with pembrolizumab and platinum-based doublet chemotherapy.
Drug: canakinumab-matching placebo
Drug: pembrolizumab
Drug: carboplatin
Drug: cisplatin
Drug: paclitaxel
Drug: nab-paclitaxel
Drug: pemetrexed
Part 2: Canakinumab+pembro+CTx
ACZ885
canakinumab-matching placebo
Drug
canakinumab placebo every 3 weeks (squamous and non-squamous)
Part 2: Placebo+pembro+CTx
pembrolizumab
Drug
200 mg every 3 weeks (squamous and non-squamous)
Part 1: Cohort A
Part 1: Cohort B
Part 1: Cohort C
Part 2: Canakinumab+pembro+CTx
Part 2: Placebo+pembro+CTx
carboplatin
Drug
Area Under the Curve (AUC) 5 mg/mL*min every 3 weeks (non-squamous) or AUC 6 mg/mL*min (squamous)
Part 1: Cohort A
Part 1: Cohort C
Part 2: Canakinumab+pembro+CTx
Part 2: Placebo+pembro+CTx
cisplatin
Drug
75 mg/m^2 every 3 weeks (non-squamous)
Part 1: Cohort B
Part 2: Canakinumab+pembro+CTx
Part 2: Placebo+pembro+CTx
paclitaxel
Drug
200 mg/m^2 every 3 weeks (squamous)
Part 1: Cohort C
Part 2: Canakinumab+pembro+CTx
Part 2: Placebo+pembro+CTx
nab-paclitaxel
Drug
100 mg/m^2 on Days 1, 8, and 15 of every cycle (squamous)
Part 2: Canakinumab+pembro+CTx
Part 2: Placebo+pembro+CTx
pemetrexed
Drug
500 mg/m^2 every 3 weeks (non-squamous)
Part 1: Cohort A
Part 1: Cohort B
Part 2: Canakinumab+pembro+CTx
Part 2: Placebo+pembro+CTx
Up to approximately 14 months
Part 2 (Double-blind, Randomized, Placebo-controlled): Overall Response Rate (ORR) Per Investigator Assessment Using RECIST v1.1
ORR was defined as the percentage of participants with confirmed best overall response of complete response (CR) or partial response (PR), as per investigator's assessment by RECIST 1.1. CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm; PR= At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.
Up to approximately 26 months
Part 1 (Safety run-in): Disease Control Rate (DCR) Per Investigator Assessment Using RECIST v1.1
Disease control rate was defined as the percentage of participants with complete response (CR) or partial response (PR) or participants with stable disease (SD) as per investigator assessment according to RECIST 1.1 criteria. CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm; PR= At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters; SD=Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for progressive disease.
Up to approximately 14 months
Part 2 (Double-blind, Randomized, Placebo-controlled): Disease Control Rate (DCR) Per Investigator Assessment Using RECIST v1.1
Disease control rate was defined as the percentage of participants with complete response (CR) or partial response (PR) or participants with stable disease (SD) as per investigator assessment according to RECIST 1.1 criteria. CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm; PR= At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters; SD=Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for progressive disease.
Up to approximately 26 months
Part 1 (Safety run-in): Duration of Response (DOR) Per Investigator Assessment Using RECIST v1.1
Duration of response was defined as the time from first documented response of CR or PR to date of first documented progression or death due to any cause, according to RECIST 1.1 criteria. DOR only applied to participants whose best overall response was CR or PR based on tumor response data per local review. If a participant did not have an event, DOR was censored at the date of last adequate tumor assessment. CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm; PR= At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.
Up to approximately 25 months
Part 2 (Double-blind, Randomized, Placebo-controlled): Duration of Response (DOR) Per Investigator Assessment Using RECIST v1.1
Duration of response was defined as the time from first documented response of CR or PR to date of first documented progression or death due to any cause, according to RECIST 1.1 criteria. DOR only applied to participants whose best overall response was CR or PR based on tumor response data per local review. If a participant did not have an event, DOR was censored at the date of last adequate tumor assessment. CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm; PR= At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.
Up to approximately 26 months
Part 2 (Double-blind, Randomized, Placebo-controlled): Time to Response (TTR) Per Investigator Assessment Using RECIST v1.1
Time to response (TTR) was defined as duration of time between the date of randomization and the date of first documented response of either CR or PR, according to RECIST 1.1 criteria. Duration of response was defined as the time from first documented response of CR or PR to date of first documented progression or death due to any cause, according to RECIST 1.1 criteria. CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm; PR= At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.
Up to approximately 26 months
Part 1 (Safety Run-in): Antidrug Antibodies (ADA) of Canakinumab
Participants with at least one ADA-positive sample.
Predose (0 hours (h)) on Day 1 of Cycles 1, 4, 8, 12, 16 (Cycle length =21 days), at end of treatment & then at 26, 78 and 130 days after last dose
Part 2 (Double-blind, Randomized, Placebo-controlled): Number of Participants With Antidrug Antibodies (ADA) of Canakinumab
Participants with at least one ADA-positive sample.
Up to approximately 26 months
Part 1 (Safety run-in): Antidrug Antibodies (ADAs) of Pembrolizumab
Participants with at least one ADA-positive sample.
Predose (0 h) on Day 1 of Cycles 1, 2, 4, 8, 12, 16 (Cycle length =21 days), at end of treatment & then at 26 days after last dose
Part 2 (Double-blind, Randomized, Placebo-controlled): Antidrug Antibodies (ADA) of Pembrolizumab
Participants with at least one ADA-positive sample.
Up to approximately 26 months
Part 1 (Safety Run-in): Serum Canakinumab Concentration
Predose (0 h) on Day 1 of Cycles 1-6, 8, 12, 16, Postdose on day 2, 8, 15 of Cycle 1, Post dose on Cycle 5 day 8, at end of treatment & then at 26, 78 and 130 days after last dose (Cycle length =21 days)
Part 2 (Double-blind, Randomized, Placebo-controlled): Serum Canakinumab Concentration
Predose (0 h) on Day 1 of Cycles 1-6, 8, 12, 16, Postdose on day 2, 8, 15 of Cycle 1, Post dose on Cycle 5 day 8, at end of treatment & then at 26, 78 and 130 days after last dose (Cycle length =21 days)
Part 1 (Safety Run-in): Serum Pembrolizumab Concentration
Predose (0 h) on Day 1 of Cycles 1-6, 8, 12, 16, Postdose on day 2, 8, 15 of Cycle 1, at end of treatment & then at 26 days after last dose (Cycle length =21 days)
Part 2 (Double-blind, Randomized, Placebo-controlled): Serum Pembrolizumab Concentration
Predose (0 h) on Day 1 of Cycles 1-6, 8, 12, 16, Postdose on day 2, 8, 15 of Cycle 1, at end of treatment & then at 26 days after last dose (Cycle length =21 days)
Part 1 (Safety Run-in): Plasma Pemetrexed Concentration
Predose (0 h) and end of infusion on Cycle 1 and 2; 1, 4, 8 h post infusion on Cycle 1; 1, 2, 4, 8h post infusion on Cycle 2 (Cycle length =21 days)
Part 2 (Double-blind, Randomized, Placebo-controlled): Plasma Pemetrexed Concentration
Predose (0 h) and end of infusion on Cycle 1 and 2; 1, 4, 8 h post infusion on Cycle 1; 1, 2, 4, 8h post infusion on Cycle 2 (Cycle length =21 days)
Part 1 (Safety Run-in): Plasma Cisplatin Concentration
Predose (0 h) and end of infusion on Cycle 1 and 2; 2, 4, 8 h post infusion on Cycle 1; 1.5, 2, 4, 8 h post infusion on Cycle 2 (Cycle length =21 days)
Part 2 (Double-blind, Randomized, Placebo-controlled): Plasma Cisplatin Concentration
Predose (0 h) and end of infusion on Cycle 1 and 2; 2, 4, 8 h post infusion on Cycle 1; 1.5, 2, 4, 8 h post infusion on Cycle 2 (Cycle length = 21 days)
Part 1 (Safety Run-in): Plasma Carboplatin Concentration
Predose (0 h), end of infusion, 1, 2, 4, 8 h post infusion on Cycles 1 and 2 (Cycle length =21 days)
Part 2 (Double-blind, Randomized, Placebo-controlled): Plasma Carboplatin Concentration
Predose (0 h), end of infusion, 1, 2, 4, 8 h post infusion on Cycles 1 and 2 (Cycle length =21 days)
Part 1 (Safety Run-in): Plasma Paclitaxel Concentration
Predose (0 h) and end of infusion on Cycle 1 and 2; 4, 8, 12 h post infusion on Cycle 1; 4, 6, 8, 12 h post infusion on Cycle 2 (Cycle length =21 days)
Part 2 (Double-blind, Randomized, Placebo-controlled): Plasma Paclitaxel Concentration
Predose (0 h) and end of infusion on Cycle 1 and 2; 4, 8, 12 h post infusion on Cycle 1; 4, 6, 8, 12 h post infusion on Cycle 2 (Cycle length =21 days)
Part 2 (Double-blind, Randomized, Placebo-controlled): Plasma Nab-paclitaxel Concentration
Predose (0 h) and end of infusion on Cy 1 and 2, 4, 8, 12 h post infusion on Cy 1, 4, 6, 8, 12 h post infusion on Cy 2 (Cy length =21 days)
Part 2 (Double-blind, Randomized, Placebo-controlled): Time to Definitive 10-point Deterioration (TTDD) Symptom Scores of Pain, Cough and Dyspnea Per EORTC QLQ-LC13 Questionnaire
The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13) comprises both multi-item and single-item measures of lung cancer-associated symptoms (ie, coughing, dyspnea, and chest pain). Scores for each scale and single-item range from 0 to 100, with higher scores indicating higher level of symptoms. TTDD for chest pain, cough and dyspnea was defined as the time from randomization to the date of event, which was defined as at least 10 points absolute worsening from baseline of the corresponding scale score, with no later change below this threshold ie.<10 points was observed, or if this worsening was observed at the last assessment for the subject, or death due to any cause (whichever occurred earlier). If a subject did not have an event, TTDD was censored at the last adequate assessment.
Up to approximately 25 months
Part 2 (Double-blind, Randomized, Placebo-controlled): Time to Definitive Deterioration in Global Health Status/Quality of Life, Shortness of Breath and Pain Per EORTC QLQ-C30 Questionnaire
The European Organization for Research and Treatment of Cancer quality of life (EORTC QLQ-C30) is a questionnaire developed to assess the health-related quality of life of cancer participants. It assesses 15 domains consisting of 5 functional domains (physical, role, emotional, cognitive, social) and 9 symptom domains (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties) and a global health status/QoL scale. All domain scores range from 0 to 100. A high score for the functional or global health status scales indicates a high level of functioning or QoL; a high score for a symptom scale indicates a high level of symptoms.
Up to approximately 25 months
Part 2 (Double-blind, Randomized, Placebo-controlled): Change From Baseline in Score as Per the EuroQol 5 Dimension 5 Level (EQ-5D-5L) Questionnaire
The EQ-5D-5L questionnaire is a standardized measure of health status developed by the EuroQol Group in order to provide a simple, generic measure of health for clinical and economic appraisal. The EQ-5D-5L measures 5 items on mobility, self-care, usual activities, pain/discomfort, anxiety/depression, measured on 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. A utility index can be computed from the EQ 5D-5L descriptive system with utility scores ranging from -0.281 (worst imaginable health state) to 1 (best imaginable health state), with -0.281 representing an "unconscious" health state. A single index value is analyzed for the EQ-5D-5L score. An increase from baseline in the EQ-ED-5L utility index is indicative of an improvement.). CFB = change from baseline
Assessed every 3 weeks from Week 3 through Week 108, at follow-up visits 1, 2, 3, 4, and 5 (follow-up visits occurred every 26 days from week 108), and at 7 and 28 days post-disease progression, all up to a maximum of 3.5 years
Part 2 (Double-blind, Randomized, Placebo-controlled): Change From Baseline in Score as Per the EuroQol 5 Dimension 5 Level (EQ-5D-5L) Questionnaire - Visual Analog Scale (VAS)
The EQ-5D-5L is a standardized questionnaire used to assess health-related quality of life, and it includes a Visual Analog Scale (VAS). The VAS score is obtained by asking the individual to rate their current health status on a scale from 0 to 100, where 0 represents the worst possible health state and 100 represents the best possible health state.
The change from baseline in EQ-5D-5L VAS score was calculated. A positive change from baseline indicates improvement in the health status. CFB = change from baseline
Assessed every 3 weeks from Week 3 through Week 108, at follow-up visits 1, 2, 3, 4, and 5 (follow-up visits occurred every 26 days from week 108), and at 7 and 28 days post-disease progression, all up to a maximum of 3.5 years
Los Angeles
California
90033
United States
AdventHealth
Orlando
Florida
32804
United States
Dana Farber Cancer Institute
Boston
Massachusetts
02215
United States
Novartis Investigative Site
Caba
Buenos Aires
C1426ANZ
Argentina
Novartis Investigative Site
Caba
C1431FWO
Argentina
Novartis Investigative Site
Westmead
New South Wales
2145
Australia
Novartis Investigative Site
Wooloongabba
Queensland
4102
Australia
Novartis Investigative Site
Melbourne
Victoria
3000
Australia
Novartis Investigative Site
Murdoch
Western Australia
6150
Australia
Novartis Investigative Site
Linz
Upper Austria
4020
Austria
Novartis Investigative Site
Salzburg
5020
Austria
Novartis Investigative Site
Barretos
São Paulo
14784 400
Brazil
Novartis Investigative Site
São Paulo
São Paulo
01246 000
Brazil
Novartis Investigative Site
São Paulo
São Paulo
04014-002
Brazil
Novartis Investigative Site
Edmonton
Alberta
T6G 1Z2
Canada
Novartis Investigative Site
Brampton
Ontario
L6R 3J7
Canada
Novartis Investigative Site
Toronto
Ontario
M5G 2M9
Canada
Novartis Investigative Site
Temuco
Araucania
4810469
Chile
Novartis Investigative Site
Santiago
8420383
Chile
Novartis Investigative Site
Harbin
Heilongjiang
150081
China
Novartis Investigative Site
Wuhan
Hubei
430022
China
Novartis Investigative Site
Wuhan
Hubei
430030
China
Novartis Investigative Site
Changsha
Hunan
410013
China
Novartis Investigative Site
Changchun
Jilin
130012
China
Novartis Investigative Site
Xi’an
Shanxi
710038
China
Novartis Investigative Site
Hangzhou
Zhejiang
310022
China
Novartis Investigative Site
Beijing
100036
China
Novartis Investigative Site
Valledupar
Cesar Department
200001
Colombia
Novartis Investigative Site
Ostrava
Vitkovice
703 84
Czechia
Novartis Investigative Site
Brno
625 00
Czechia
Novartis Investigative Site
Brno
656 53
Czechia
Novartis Investigative Site
Prague
128 08
Czechia
Novartis Investigative Site
Herning
7400
Denmark
Novartis Investigative Site
Oulu
FIN-90220
Finland
Novartis Investigative Site
Marseille
Bouches Du Rhone
13915
France
Novartis Investigative Site
Lyon
69373
France
Novartis Investigative Site
Montpellier
34070
France
Novartis Investigative Site
Nantes
44093
France
Novartis Investigative Site
Paris
75231
France
Novartis Investigative Site
Munich
Bavaria
81377
Germany
Novartis Investigative Site
Göttingen
Lower Saxony
37075
Germany
Novartis Investigative Site
Cologne
North Rhine-Westphalia
50937
Germany
Novartis Investigative Site
Cologne
North Rhine-Westphalia
51109
Germany
Novartis Investigative Site
Dresden
Saxony
01307
Germany
Novartis Investigative Site
Leipzig
Saxony
04347
Germany
Novartis Investigative Site
Halle
Saxony-Anhalt
06120
Germany
Novartis Investigative Site
Berlin
13125
Germany
Novartis Investigative Site
Essen
45147
Germany
Novartis Investigative Site
Georgsmarienhütte
49124
Germany
Novartis Investigative Site
Gerlingen
70839
Germany
Novartis Investigative Site
Heidelberg
69120
Germany
Novartis Investigative Site
Athens
GR
115 27
Greece
Novartis Investigative Site
Athens
185 47
Greece
Novartis Investigative Site
Kowloon
999077
Hong Kong
Novartis Investigative Site
Veszprém
8200
Hungary
Novartis Investigative Site
Reykjavik
101
Iceland
Novartis Investigative Site
Hyderabad
Andhra Pradesh
500034
India
Novartis Investigative Site
Gurgaon
Haryana
122 001
India
Novartis Investigative Site
Pune
Maharashtra
411013
India
Novartis Investigative Site
Jaipur
Rajasthan
302017
India
Novartis Investigative Site
Hyderabad
Telangana
500082
India
Novartis Investigative Site
Kolkata
West Bengal
700160
India
Novartis Investigative Site
Avellino
AV
83100
Italy
Novartis Investigative Site
Genova
GE
16132
Italy
Novartis Investigative Site
Milan
MI
20132
Italy
Novartis Investigative Site
Milan
MI
20133
Italy
Novartis Investigative Site
Rozzano
MI
20089
Italy
Novartis Investigative Site
Modena
MO
41124
Italy
Novartis Investigative Site
Padova
PD
35128
Italy
Novartis Investigative Site
Perugia
PG
06129
Italy
Novartis Investigative Site
Parma
PR
43126
Italy
Novartis Investigative Site
Orbassano
TO
10043
Italy
Novartis Investigative Site
Milan
20141
Italy
Novartis Investigative Site
Nagoya
Aichi-ken
4648681
Japan
Novartis Investigative Site
Sapporo
Hokkaido
060-8648
Japan
Novartis Investigative Site
Himeji
Hyōgo
670-8520
Japan
Novartis Investigative Site
Yokohama
Kanagawa
241-8515
Japan
Novartis Investigative Site
Sakai
Osaka
591-8555
Japan
Novartis Investigative Site
Sunto Gun
Shizuoka
4118777
Japan
Novartis Investigative Site
Chuo Ku
Tokyo
1040045
Japan
Novartis Investigative Site
Ube
Yamaguchi
755-0241
Japan
Novartis Investigative Site
Osaka
5458586
Japan
Novartis Investigative Site
Beirut
1100 2070
Lebanon
Novartis Investigative Site
Saida
652
Lebanon
Novartis Investigative Site
Kuala Lumpur
Kuala Lumpur
50586
Malaysia
Novartis Investigative Site
Kuantan
Pahang
25100
Malaysia
Novartis Investigative Site
Kuching
Sarawak
93586
Malaysia
Novartis Investigative Site
Kuala Lumpur
59100
Malaysia
Novartis Investigative Site
Groningen
9713 GZ
Netherlands
Novartis Investigative Site
Groningen
9728 NZ
Netherlands
Novartis Investigative Site
Drammen
3004
Norway
Novartis Investigative Site
City of Taguig
National Capital Region
1634
Philippines
Novartis Investigative Site
Makati City
1229
Philippines
Novartis Investigative Site
Quezon
1102
Philippines
Novartis Investigative Site
San Juan City
1502
Philippines
Novartis Investigative Site
Gliwice
44 101
Poland
Novartis Investigative Site
Poznan
60 569
Poland
Novartis Investigative Site
Tomaszw Mazowiecki
97-200
Poland
Novartis Investigative Site
Lisbon
1769 001
Portugal
Novartis Investigative Site
Porto
4200-072
Portugal
Novartis Investigative Site
Cluj-Napoca
Cluj
400015
Romania
Novartis Investigative Site
Craiova
Dolj
200347
Romania
Novartis Investigative Site
Arkhangelsk
163045
Russia
Novartis Investigative Site
Omsk
644013
Russia
Novartis Investigative Site
Saint Petersburg
192148
Russia
Novartis Investigative Site
Saint Petersburg
196603
Russia
Novartis Investigative Site
Saint Petersburg
197022
Russia
Novartis Investigative Site
Singapore
119228
Singapore
Novartis Investigative Site
Singapore
168583
Singapore
Novartis Investigative Site
Singapore
S308433
Singapore
Novartis Investigative Site
Bratislava
83310
Slovakia
Novartis Investigative Site
Kosice-Saca
958 01
Slovakia
Novartis Investigative Site
Gyeonggi-do
Korea
10408
South Korea
Novartis Investigative Site
Seoul
03080
South Korea
Novartis Investigative Site
Seoul
03722
South Korea
Novartis Investigative Site
Seoul
05505
South Korea
Novartis Investigative Site
Seoul
06591
South Korea
Novartis Investigative Site
Granada
Andalusia
18014
Spain
Novartis Investigative Site
Badalona
Barcelona
08916
Spain
Novartis Investigative Site
Donostia / San Sebastian
Gipuzkoa
20014
Spain
Novartis Investigative Site
Las Palmas de Gran C
Las Palmas
35016
Spain
Novartis Investigative Site
Barcelona
08035
Spain
Novartis Investigative Site
Barcelona
08036
Spain
Novartis Investigative Site
Madrid
28009
Spain
Novartis Investigative Site
Madrid
28040
Spain
Novartis Investigative Site
Madrid
28041
Spain
Novartis Investigative Site
Madrid
28046
Spain
Novartis Investigative Site
Málaga
29010
Spain
Novartis Investigative Site
Valencia
46026
Spain
Novartis Investigative Site
Zaragoza
50009
Spain
Novartis Investigative Site
Stockholm
171 76
Sweden
Novartis Investigative Site
Basel
4031
Switzerland
Novartis Investigative Site
Kaohsiung City
83301
Taiwan
Novartis Investigative Site
Tainan
704
Taiwan
Novartis Investigative Site
Taipei
10002
Taiwan
Novartis Investigative Site
Taipei
11217
Taiwan
Novartis Investigative Site
Taoyuan
333
Taiwan
Novartis Investigative Site
Songkhla
Hat Yai
90110
Thailand
Novartis Investigative Site
Khon Kaen
THA
40002
Thailand
Novartis Investigative Site
Bangkok
10330
Thailand
Novartis Investigative Site
Bangkok
10400
Thailand
Novartis Investigative Site
Bangkok
10700
Thailand
Novartis Investigative Site
Istanbul
Bagcilar
34214
Turkey (Türkiye)
Novartis Investigative Site
Ankara
Bilkent Cankaya
06800
Turkey (Türkiye)
Novartis Investigative Site
Edirne
Merkez
22030
Turkey (Türkiye)
Novartis Investigative Site
Ankara
Sihhiye-Altindag
06230
Turkey (Türkiye)
Novartis Investigative Site
High Heaton
Newcastle Upon Tyne
NE7 7DN
United Kingdom
Novartis Investigative Site
London
NW3 2QG
United Kingdom
Novartis Investigative Site
Manchester
M20 2BX
United Kingdom
Novartis Investigative Site
Plymouth
PL6 8DH
United Kingdom
Novartis Investigative Site
Hanoi
100000
Vietnam
FG002
Part 1: Cohort C
Safety run-in, canakinumab in combination with pembrolizumab, carboplatin, and paclitaxel.
FG003
Part 2: Canakinumab+Pembro+CTx
Double-blind, randomized, placebo-controlled, canakinumab in combination with pembrolizumab and platinum-based doublet chemotherapy.
FG004
Part 2: Placebo+Pembro+CTx
Double-blind, randomized, placebo-controlled, canakinumab-matching placebo in combination with pembrolizumab and platinum-based doublet chemotherapy.
FG00010 subjects
FG00111 subjects
FG0029 subjects
FG003320 subjects
FG004323 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
NOT COMPLETED
FG00010 subjects
FG00111 subjects
FG0029 subjects
FG003320 subjects
FG004323 subjects
Type
Comment
Reasons
Progressive disease
FG0009 subjects
FG0015 subjects
FG0025 subjects
FG003149 subjects
FG004148 subjects
Physician Decision
FG0000 subjects
FG0012 subjects
FG0023 subjects
FG00319 subjects
FG004
Adverse Event
FG0001 subjects
FG0011 subjects
FG0020 subjects
FG00328 subjects
FG004
Death
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG00335 subjects
FG004
Subject decision
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG00312 subjects
FG004
No treated
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Treatment ongoing
FG0000 subjects
FG0011 subjects
FG0021 subjects
FG00376 subjects
FG004
Guardian decision
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Part 1: Cohort A
Safety run-in, canakinumab in combination with pembrolizumab, carboplatin, and pemetrexed.
BG001
Part 1: Cohort B
Safety run-in, canakinumab in combination with pembrolizumab, cisplatin, and pemetrexed.
BG002
Part 1: Cohort C
Safety run-in, canakinumab in combination with pembrolizumab, carboplatin, and paclitaxel.
BG003
Part 2: Canakinumab+Pembro+CTx
Double-blind, randomized, placebo-controlled, canakinumab in combination with pembrolizumab and platinum-based doublet chemotherapy.
BG004
Part 2: Placebo+Pembro+CTx
Double-blind, randomized, placebo-controlled, canakinumab-matching placebo in combination with pembrolizumab and platinum-based doublet chemotherapy.
BG005
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00010
BG00111
BG0029
BG003320
BG004323
BG005673
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00064.5± 6.57
BG00157.9± 13.03
BG00263.1± 7.18
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0000
BG0015
BG002
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
White
Title
Measurements
BG0005
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
Part 1 (Safety Run-in): Number of Participants With Dose-limiting Toxicities (DLTs)
A DLT was defined as an adverse event or abnormal laboratory value assessed as unrelated to disease progression, inter-current illness, or concomitant medications that met certain criteria as defined in the protocol.
The dose-determining set (DDS) included all participants from the safety set who met the minimum exposure criterion and had sufficient safety evaluations, or experienced a dose-limiting toxicity (DLT) during the first 42 days (6 weeks) of dosing. Data are reported for Part 1 only.
Posted
Count of Participants
Participants
During the first 42 days of dosing
ID
Title
Description
OG000
Part 1: Cohort A
Safety run-in, canakinumab in combination with pembrolizumab, carboplatin, and pemetrexed.
OG001
Part 1: Cohort B
Safety run-in, canakinumab in combination with pembrolizumab, cisplatin, and pemetrexed.
OG002
Part 1: Cohort C
Safety run-in, canakinumab in combination with pembrolizumab, carboplatin, and paclitaxel.
Units
Counts
Participants
OG00010
OG00110
OG0029
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0021
Primary
Part 2 (Double-blind, Randomized, Placebo-controlled): Progression-free Survival (PFS) Per Investigator Assessment Using RECIST v1.1
Progression free survival was defined as the time from randomization to the date of the first documented radiological progression using RECIST 1.1 (Response evaluation criteria in solid tumor) or death due to any cause.
The full analysis set (FAS) comprised all participants to whom study treatment was assigned and who received at least one dose of the study treatment. Data are reported for Part 2 only.
Posted
Median
95% Confidence Interval
months
18 months
ID
Title
Description
OG000
Part 2: Canakinumab+Pembro+CTx
Double-blind, randomized, placebo-controlled, canakinumab in combination with pembrolizumab and platinum-based doublet chemotherapy.
OG001
Part 2: Placebo+Pembro+CTx
Double-blind, randomized, placebo-controlled, canakinumab-matching placebo in combination with pembrolizumab and platinum-based doublet chemotherapy.
Units
Counts
Participants
Primary
Part 2 (Double-blind, Randomized, Placebo-controlled): Overall Survival (OS) Per Investigator Assessment Using RECIST v1.1
Overall survival is defined as the time from date of randomization to date of death due to any cause.
The full analysis set (FAS) comprised all participants to whom study treatment was assigned and who received at least one dose of the study treatment. Data are reported for Part 2 only.
Posted
Median
95% Confidence Interval
months
Up to approximately 32 months
ID
Title
Description
OG000
Part 2: Canakinumab+Pembro+CTx
Double-blind, randomized, placebo-controlled, canakinumab in combination with pembrolizumab and platinum-based doublet chemotherapy.
OG001
Part 2: Placebo+Pembro+CTx
Double-blind, randomized, placebo-controlled, canakinumab-matching placebo in combination with pembrolizumab and platinum-based doublet chemotherapy.
Units
Counts
Participants
OG000
Secondary
Part 1 (Safety Run-in): Overall Response Rate (ORR) Per Investigator Assessment Using RECIST v1.1
ORR was defined as the percentage of participants with confirmed best overall response of complete response (CR) or partial response (PR), as per investigator's assessment by RECIST 1.1. CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm; PR= At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.
The full analysis set (FAS) comprised all participants to whom study treatment was assigned and who received at least one dose of the study treatment. Data are reported for Part 1 only.
Posted
Number
95% Confidence Interval
percentage of participants
Up to approximately 14 months
ID
Title
Description
OG000
Part 1: Cohort A
Safety run-in, canakinumab in combination with pembrolizumab, carboplatin, and pemetrexed.
OG001
Part 1: Cohort B
Safety run-in, canakinumab in combination with pembrolizumab, cisplatin, and pemetrexed.
OG002
Part 1: Cohort C
Safety run-in, canakinumab in combination with pembrolizumab, carboplatin, and paclitaxel.
Secondary
Part 2 (Double-blind, Randomized, Placebo-controlled): Overall Response Rate (ORR) Per Investigator Assessment Using RECIST v1.1
ORR was defined as the percentage of participants with confirmed best overall response of complete response (CR) or partial response (PR), as per investigator's assessment by RECIST 1.1. CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm; PR= At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.
The full analysis set (FAS) comprised all participants to whom study treatment was assigned and who received at least one dose of the study treatment. Data are reported for Part 2 only.
Posted
Number
95% Confidence Interval
percentage of participants
Up to approximately 26 months
ID
Title
Description
OG000
Part 2: Canakinumab+Pembro+CTx
Double-blind, randomized, placebo-controlled, canakinumab in combination with pembrolizumab and platinum-based doublet chemotherapy.
OG001
Part 2: Placebo+Pembro+CTx
Double-blind, randomized, placebo-controlled, canakinumab-matching placebo in combination with pembrolizumab and platinum-based doublet chemotherapy.
Secondary
Part 1 (Safety run-in): Disease Control Rate (DCR) Per Investigator Assessment Using RECIST v1.1
Disease control rate was defined as the percentage of participants with complete response (CR) or partial response (PR) or participants with stable disease (SD) as per investigator assessment according to RECIST 1.1 criteria. CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm; PR= At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters; SD=Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for progressive disease.
The full analysis set (FAS) comprised all participants to whom study treatment was assigned and who received at least one dose of the study treatment. Data are reported for Part 1 only.
Posted
Number
95% Confidence Interval
percentage of participants
Up to approximately 14 months
ID
Title
Description
OG000
Part 1: Cohort A
Safety run-in, canakinumab in combination with pembrolizumab, carboplatin, and pemetrexed.
OG001
Part 1: Cohort B
Safety run-in, canakinumab in combination with pembrolizumab, cisplatin, and pemetrexed.
OG002
Part 1: Cohort C
Secondary
Part 2 (Double-blind, Randomized, Placebo-controlled): Disease Control Rate (DCR) Per Investigator Assessment Using RECIST v1.1
Disease control rate was defined as the percentage of participants with complete response (CR) or partial response (PR) or participants with stable disease (SD) as per investigator assessment according to RECIST 1.1 criteria. CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm; PR= At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters; SD=Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for progressive disease.
The full analysis set (FAS) comprised all participants to whom study treatment was assigned and who received at least one dose of the study treatment. Data are reported for Part 2 only.
Posted
Number
95% Confidence Interval
percentage of participants
Up to approximately 26 months
ID
Title
Description
OG000
Part 2: Canakinumab+Pembro+CTx
Double-blind, randomized, placebo-controlled, canakinumab in combination with pembrolizumab and platinum-based doublet chemotherapy.
OG001
Part 2: Placebo+Pembro+CTx
Double-blind, randomized, placebo-controlled, canakinumab-matching placebo in combination with pembrolizumab and platinum-based doublet chemotherapy.
Secondary
Part 1 (Safety run-in): Duration of Response (DOR) Per Investigator Assessment Using RECIST v1.1
Duration of response was defined as the time from first documented response of CR or PR to date of first documented progression or death due to any cause, according to RECIST 1.1 criteria. DOR only applied to participants whose best overall response was CR or PR based on tumor response data per local review. If a participant did not have an event, DOR was censored at the date of last adequate tumor assessment. CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm; PR= At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.
The full analysis set (FAS) comprised all participants to whom study treatment was assigned and who received at least one dose of the study treatment. Participants who never achieved a best overall response of CR or PR were excluded from the analysis. Data are reported for responders in Part 1 only.
Posted
Median
95% Confidence Interval
months
Up to approximately 25 months
ID
Title
Description
OG000
Part 1: Cohort A
Safety run-in, canakinumab in combination with pembrolizumab, carboplatin, and pemetrexed.
OG001
Part 1: Cohort B
Safety run-in, canakinumab in combination with pembrolizumab, cisplatin, and pemetrexed.
Secondary
Part 2 (Double-blind, Randomized, Placebo-controlled): Duration of Response (DOR) Per Investigator Assessment Using RECIST v1.1
Duration of response was defined as the time from first documented response of CR or PR to date of first documented progression or death due to any cause, according to RECIST 1.1 criteria. DOR only applied to participants whose best overall response was CR or PR based on tumor response data per local review. If a participant did not have an event, DOR was censored at the date of last adequate tumor assessment. CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm; PR= At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.
The full analysis set (FAS) comprised all participants to whom study treatment was assigned and who received at least one dose of the study treatment. Participants who never achieved a best overall response of CR or PR were excluded from the analysis. Data are reported for responders in Part 2 only.
Posted
Median
95% Confidence Interval
months
Up to approximately 26 months
ID
Title
Description
OG000
Part 2: Canakinumab+Pembro+CTx
Double-blind, randomized, placebo-controlled, canakinumab in combination with pembrolizumab and platinum-based doublet chemotherapy.
OG001
Part 2: Placebo+Pembro+CTx
Double-blind, randomized, placebo-controlled, canakinumab-matching placebo in combination with pembrolizumab and platinum-based doublet chemotherapy.
Secondary
Part 2 (Double-blind, Randomized, Placebo-controlled): Time to Response (TTR) Per Investigator Assessment Using RECIST v1.1
Time to response (TTR) was defined as duration of time between the date of randomization and the date of first documented response of either CR or PR, according to RECIST 1.1 criteria. Duration of response was defined as the time from first documented response of CR or PR to date of first documented progression or death due to any cause, according to RECIST 1.1 criteria. CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm; PR= At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.
The full analysis set (FAS) comprised all participants to whom study treatment was assigned and who received at least one dose of the study treatment. Data are reported for responders in Part 2 only.
Posted
Median
95% Confidence Interval
months
Up to approximately 26 months
ID
Title
Description
OG000
Part 2: Canakinumab+Pembro+CTx
Double-blind, randomized, placebo-controlled, canakinumab in combination with pembrolizumab and platinum-based doublet chemotherapy.
OG001
Part 2: Placebo+Pembro+CTx
Double-blind, randomized, placebo-controlled, canakinumab-matching placebo in combination with pembrolizumab and platinum-based doublet chemotherapy.
Secondary
Part 1 (Safety Run-in): Antidrug Antibodies (ADA) of Canakinumab
Participants with at least one ADA-positive sample.
Not Posted
Jun 2028
Predose (0 hours (h)) on Day 1 of Cycles 1, 4, 8, 12, 16 (Cycle length =21 days), at end of treatment & then at 26, 78 and 130 days after last dose
Participants
Secondary
Part 2 (Double-blind, Randomized, Placebo-controlled): Number of Participants With Antidrug Antibodies (ADA) of Canakinumab
Participants with at least one ADA-positive sample.
The safety set comprised all participants to whom study treatment was assigned and who received at least one dose of the study treatment. The data analysis applied to the Part 2 Canakinumab+pembro+CTx arm only.
Posted
Count of Participants
Participants
Up to approximately 26 months
ID
Title
Description
OG000
Part 2: Canakinumab+Pembro+CTx
Double-blind, randomized, placebo-controlled, canakinumab in combination with pembrolizumab and platinum-based doublet chemotherapy.
Units
Counts
Participants
OG000
Secondary
Part 1 (Safety run-in): Antidrug Antibodies (ADAs) of Pembrolizumab
Participants with at least one ADA-positive sample.
Not Posted
Jun 2028
Predose (0 h) on Day 1 of Cycles 1, 2, 4, 8, 12, 16 (Cycle length =21 days), at end of treatment & then at 26 days after last dose
Participants
Secondary
Part 2 (Double-blind, Randomized, Placebo-controlled): Antidrug Antibodies (ADA) of Pembrolizumab
Participants with at least one ADA-positive sample.
The safety set comprised all participants to whom study treatment was assigned and who received at least one dose of the study treatment. Data are reported for Part 2 only.
Posted
Count of Participants
Participants
Up to approximately 26 months
ID
Title
Description
OG000
Part 2: Canakinumab+Pembro+CTx
Double-blind, randomized, placebo-controlled, canakinumab in combination with pembrolizumab and platinum-based doublet chemotherapy.
OG001
Part 2: Placebo+Pembro+CTx
Double-blind, randomized, placebo-controlled, canakinumab-matching placebo in combination with pembrolizumab and platinum-based doublet chemotherapy.
Units
Counts
Participants
OG000
Secondary
Part 1 (Safety Run-in): Serum Canakinumab Concentration
The pharmacokinetic (PK) analysis set - canakinumab included all participants who received at least one dose of canakinumab and had at least one evaluable PK sample for canakinumab. Data are reported for Part 1 only.
Posted
Geometric Mean
Geometric Coefficient of Variation
μg/mL
Predose (0 h) on Day 1 of Cycles 1-6, 8, 12, 16, Postdose on day 2, 8, 15 of Cycle 1, Post dose on Cycle 5 day 8, at end of treatment & then at 26, 78 and 130 days after last dose (Cycle length =21 days)
ID
Title
Description
OG000
Part 1: Cohort A
Safety run-in, canakinumab in combination with pembrolizumab, carboplatin, and pemetrexed.
OG001
Part 1: Cohort B
Safety run-in, canakinumab in combination with pembrolizumab, cisplatin, and pemetrexed.
OG002
Part 1: Cohort C
Safety run-in, canakinumab in combination with pembrolizumab, carboplatin, and paclitaxel.
Units
Counts
Secondary
Part 2 (Double-blind, Randomized, Placebo-controlled): Serum Canakinumab Concentration
The pharmacokinetic (PK) analysis set - canakinumab included all participants who received at least one dose of canakinumab and had at least one evaluable PK sample for canakinumab. Data are reported for the Part 2 Canakinumab+pembro+CTx arm only.
Posted
Geometric Mean
Geometric Coefficient of Variation
μg/mL
Predose (0 h) on Day 1 of Cycles 1-6, 8, 12, 16, Postdose on day 2, 8, 15 of Cycle 1, Post dose on Cycle 5 day 8, at end of treatment & then at 26, 78 and 130 days after last dose (Cycle length =21 days)
ID
Title
Description
OG000
Part 2: Canakinumab+Pembro+CTx
Double-blind, randomized, placebo-controlled, canakinumab in combination with pembrolizumab and platinum-based doublet chemotherapy.
Units
Counts
Participants
OG000
Secondary
Part 1 (Safety Run-in): Serum Pembrolizumab Concentration
The pharmacokinetic (PK) analysis set -pembrolizumab included all participants who received at least one dose of pembrolizumab and had at least one evaluable PK sample for pembrolizumab. Data are reported for Part 1 only.
Posted
Geometric Mean
Geometric Coefficient of Variation
μg/mL
Predose (0 h) on Day 1 of Cycles 1-6, 8, 12, 16, Postdose on day 2, 8, 15 of Cycle 1, at end of treatment & then at 26 days after last dose (Cycle length =21 days)
ID
Title
Description
OG000
Part 1: Cohort A
Safety run-in, canakinumab in combination with pembrolizumab, carboplatin, and pemetrexed.
OG001
Part 1: Cohort B
Safety run-in, canakinumab in combination with pembrolizumab, cisplatin, and pemetrexed.
OG002
Part 1: Cohort C
Safety run-in, canakinumab in combination with pembrolizumab, carboplatin, and paclitaxel.
Units
Counts
Participants
Secondary
Part 2 (Double-blind, Randomized, Placebo-controlled): Serum Pembrolizumab Concentration
The pharmacokinetic (PK) analysis set -pembrolizumab included all participants who received at least one dose of pembrolizumab and had at least one evaluable PK sample for pembrolizumab. Data are reported for Part 2 only.
Posted
Geometric Mean
Geometric Coefficient of Variation
μg/mL
Predose (0 h) on Day 1 of Cycles 1-6, 8, 12, 16, Postdose on day 2, 8, 15 of Cycle 1, at end of treatment & then at 26 days after last dose (Cycle length =21 days)
ID
Title
Description
OG000
Part 2: Canakinumab+Pembro+CTx
Double-blind, randomized, placebo-controlled, canakinumab in combination with pembrolizumab and platinum-based doublet chemotherapy.
OG001
Part 2: Placebo+Pembro+CTx
Double-blind, randomized, placebo-controlled, canakinumab-matching placebo in combination with pembrolizumab and platinum-based doublet chemotherapy.
Units
Counts
Participants
OG000
Secondary
Part 1 (Safety Run-in): Plasma Pemetrexed Concentration
The pharmacokinetic (PK) analysis set -pemetrexed included all participants who received at least one dose of pemetrexed and had at least one evaluable PK sample for pemetrexed. Data are reported for the Part 1 Cohorts A and B arms only.
Posted
Geometric Mean
Geometric Coefficient of Variation
μg/mL
Predose (0 h) and end of infusion on Cycle 1 and 2; 1, 4, 8 h post infusion on Cycle 1; 1, 2, 4, 8h post infusion on Cycle 2 (Cycle length =21 days)
ID
Title
Description
OG000
Part 1: Cohort A
Safety run-in, canakinumab in combination with pembrolizumab, carboplatin, and pemetrexed.
OG001
Part 1: Cohort B
Safety run-in, canakinumab in combination with pembrolizumab, cisplatin, and pemetrexed.
Units
Counts
Participants
OG000
Secondary
Part 2 (Double-blind, Randomized, Placebo-controlled): Plasma Pemetrexed Concentration
The pharmacokinetic (PK) analysis set -pemetrexed included all participants who received at least one dose of pemetrexed and had at least one evaluable PK sample for pemetrexed. Data are reported for Part 2 only.
Posted
Geometric Mean
Geometric Coefficient of Variation
μg/mL
Predose (0 h) and end of infusion on Cycle 1 and 2; 1, 4, 8 h post infusion on Cycle 1; 1, 2, 4, 8h post infusion on Cycle 2 (Cycle length =21 days)
ID
Title
Description
OG000
Part 2: Canakinumab+Pembro+CTx
Double-blind, randomized, placebo-controlled, canakinumab in combination with pembrolizumab and platinum-based doublet chemotherapy.
OG001
Part 2: Placebo+Pembro+CTx
Double-blind, randomized, placebo-controlled, canakinumab-matching placebo in combination with pembrolizumab and platinum-based doublet chemotherapy.
Units
Counts
Participants
OG000
Secondary
Part 1 (Safety Run-in): Plasma Cisplatin Concentration
The pharmacokinetic (PK) analysis set -cisplatin included all participants who received at least one dose of cisplatin and had at least one evaluable PK sample for cisplatin. Data are reported for the Part 1 Cohort B arm only.
Posted
Geometric Mean
Geometric Coefficient of Variation
μg/mL
Predose (0 h) and end of infusion on Cycle 1 and 2; 2, 4, 8 h post infusion on Cycle 1; 1.5, 2, 4, 8 h post infusion on Cycle 2 (Cycle length =21 days)
ID
Title
Description
OG000
Part 1: Cohort B
Safety run-in, canakinumab in combination with pembrolizumab, cisplatin, and pemetrexed.
Units
Counts
Participants
OG000
Secondary
Part 2 (Double-blind, Randomized, Placebo-controlled): Plasma Cisplatin Concentration
The pharmacokinetic (PK) analysis set -cisplatin included all participants who received at least one dose of cisplatin and had at least one evaluable PK sample for cisplatin. Data are reported for Part 2 only.
Posted
Geometric Mean
Geometric Coefficient of Variation
μg/mL
Predose (0 h) and end of infusion on Cycle 1 and 2; 2, 4, 8 h post infusion on Cycle 1; 1.5, 2, 4, 8 h post infusion on Cycle 2 (Cycle length = 21 days)
ID
Title
Description
OG000
Part 2: Canakinumab+Pembro+CTx
Double-blind, randomized, placebo-controlled, canakinumab in combination with pembrolizumab and platinum-based doublet chemotherapy.
OG001
Part 2: Placebo+Pembro+CTx
Double-blind, randomized, placebo-controlled, canakinumab-matching placebo in combination with pembrolizumab and platinum-based doublet chemotherapy.
Units
Counts
Participants
OG000
Secondary
Part 1 (Safety Run-in): Plasma Carboplatin Concentration
The pharmacokinetic (PK) analysis set -carboplatin included all participants who received at least one dose of carboplatin and had at least one evaluable PK sample for carboplatin. Data are reported for the Part 1 Cohorts A and C arms only.
Posted
Geometric Mean
Geometric Coefficient of Variation
μg/mL
Predose (0 h), end of infusion, 1, 2, 4, 8 h post infusion on Cycles 1 and 2 (Cycle length =21 days)
ID
Title
Description
OG000
Part 1: Cohort A
Safety run-in, canakinumab in combination with pembrolizumab, carboplatin, and pemetrexed.
OG001
Part 1: Cohort C
Safety run-in, canakinumab in combination with pembrolizumab, carboplatin, and paclitaxel.
Units
Counts
Participants
OG000
Secondary
Part 2 (Double-blind, Randomized, Placebo-controlled): Plasma Carboplatin Concentration
The pharmacokinetic (PK) analysis set -carboplatin included all participants who received at least one dose of carboplatin and had at least one evaluable PK sample for carboplatin. Data are reported for Part 2 only.
Posted
Geometric Mean
Geometric Coefficient of Variation
μg/mL
Predose (0 h), end of infusion, 1, 2, 4, 8 h post infusion on Cycles 1 and 2 (Cycle length =21 days)
ID
Title
Description
OG000
Part 2: Canakinumab+Pembro+CTx
Double-blind, randomized, placebo-controlled, canakinumab in combination with pembrolizumab and platinum-based doublet chemotherapy.
OG001
Part 2: Placebo+Pembro+CTx
Double-blind, randomized, placebo-controlled, canakinumab-matching placebo in combination with pembrolizumab and platinum-based doublet chemotherapy.
Units
Counts
Participants
OG000
Secondary
Part 1 (Safety Run-in): Plasma Paclitaxel Concentration
The pharmacokinetic (PK) analysis set -paclitaxel included all participants who received at least one dose of paclitaxel and had at least one evaluable PK sample for paclitaxel. Data are reported for the Part 1 Cohort C arm only.
Posted
Geometric Mean
Geometric Coefficient of Variation
μg/mL
Predose (0 h) and end of infusion on Cycle 1 and 2; 4, 8, 12 h post infusion on Cycle 1; 4, 6, 8, 12 h post infusion on Cycle 2 (Cycle length =21 days)
ID
Title
Description
OG000
Part 1: Cohort C
Safety run-in, canakinumab in combination with pembrolizumab, carboplatin, and paclitaxel.
Units
Counts
Participants
OG000
Secondary
Part 2 (Double-blind, Randomized, Placebo-controlled): Plasma Paclitaxel Concentration
The pharmacokinetic (PK) analysis set -paclitaxel included all participants who received at least one dose of paclitaxel and had at least one evaluable PK sample for paclitaxel. Data are reported for Part 2 only.
Posted
Geometric Mean
Geometric Coefficient of Variation
μg/mL
Predose (0 h) and end of infusion on Cycle 1 and 2; 4, 8, 12 h post infusion on Cycle 1; 4, 6, 8, 12 h post infusion on Cycle 2 (Cycle length =21 days)
ID
Title
Description
OG000
Part 2: Canakinumab+Pembro+CTx
Double-blind, randomized, placebo-controlled, canakinumab in combination with pembrolizumab and platinum-based doublet chemotherapy.
OG001
Part 2: Placebo+Pembro+CTx
Double-blind, randomized, placebo-controlled, canakinumab-matching placebo in combination with pembrolizumab and platinum-based doublet chemotherapy.
Units
Counts
Participants
OG000
Secondary
Part 2 (Double-blind, Randomized, Placebo-controlled): Plasma Nab-paclitaxel Concentration
The pharmacokinetic (PK) analysis set -nab-paclitaxel included all participants who received at least one dose of nab-paclitaxel and had at least one evaluable PK sample for nab-paclitaxel. Data are reported for Part 2 only.
Posted
Geometric Mean
Geometric Coefficient of Variation
μg/mL
Predose (0 h) and end of infusion on Cy 1 and 2, 4, 8, 12 h post infusion on Cy 1, 4, 6, 8, 12 h post infusion on Cy 2 (Cy length =21 days)
ID
Title
Description
OG000
Part 2: Canakinumab+Pembro+CTx
Double-blind, randomized, placebo-controlled, canakinumab in combination with pembrolizumab and platinum-based doublet chemotherapy.
OG001
Part 2: Placebo+Pembro+CTx
Double-blind, randomized, placebo-controlled, canakinumab-matching placebo in combination with pembrolizumab and platinum-based doublet chemotherapy.
Units
Counts
Participants
OG000
Secondary
Part 2 (Double-blind, Randomized, Placebo-controlled): Time to Definitive 10-point Deterioration (TTDD) Symptom Scores of Pain, Cough and Dyspnea Per EORTC QLQ-LC13 Questionnaire
The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13) comprises both multi-item and single-item measures of lung cancer-associated symptoms (ie, coughing, dyspnea, and chest pain). Scores for each scale and single-item range from 0 to 100, with higher scores indicating higher level of symptoms. TTDD for chest pain, cough and dyspnea was defined as the time from randomization to the date of event, which was defined as at least 10 points absolute worsening from baseline of the corresponding scale score, with no later change below this threshold ie.<10 points was observed, or if this worsening was observed at the last assessment for the subject, or death due to any cause (whichever occurred earlier). If a subject did not have an event, TTDD was censored at the last adequate assessment.
The full analysis set (FAS) comprised all participants to whom study treatment was assigned and who received at least one dose of the study treatment. Data are reported for Part 2 only.
Posted
Median
95% Confidence Interval
months
Up to approximately 25 months
ID
Title
Description
OG000
Part 2: Canakinumab+Pembro+CTx
Double-blind, randomized, placebo-controlled, canakinumab in combination with pembrolizumab and platinum-based doublet chemotherapy.
OG001
Part 2: Placebo+Pembro+CTx
Secondary
Part 2 (Double-blind, Randomized, Placebo-controlled): Time to Definitive Deterioration in Global Health Status/Quality of Life, Shortness of Breath and Pain Per EORTC QLQ-C30 Questionnaire
The European Organization for Research and Treatment of Cancer quality of life (EORTC QLQ-C30) is a questionnaire developed to assess the health-related quality of life of cancer participants. It assesses 15 domains consisting of 5 functional domains (physical, role, emotional, cognitive, social) and 9 symptom domains (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties) and a global health status/QoL scale. All domain scores range from 0 to 100. A high score for the functional or global health status scales indicates a high level of functioning or QoL; a high score for a symptom scale indicates a high level of symptoms.
The full analysis set (FAS) comprised all participants to whom study treatment was assigned and who received at least one dose of the study treatment. Data are reported for Part 2 only.
Posted
Median
95% Confidence Interval
months
Up to approximately 25 months
ID
Title
Description
OG000
Part 2: Canakinumab+Pembro+CTx
Double-blind, randomized, placebo-controlled, canakinumab in combination with pembrolizumab and platinum-based doublet chemotherapy.
OG001
Part 2: Placebo+Pembro+CTx
Double-blind, randomized, placebo-controlled, canakinumab-matching placebo in combination with pembrolizumab and platinum-based doublet chemotherapy.
Secondary
Part 2 (Double-blind, Randomized, Placebo-controlled): Change From Baseline in Score as Per the EuroQol 5 Dimension 5 Level (EQ-5D-5L) Questionnaire
The EQ-5D-5L questionnaire is a standardized measure of health status developed by the EuroQol Group in order to provide a simple, generic measure of health for clinical and economic appraisal. The EQ-5D-5L measures 5 items on mobility, self-care, usual activities, pain/discomfort, anxiety/depression, measured on 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. A utility index can be computed from the EQ 5D-5L descriptive system with utility scores ranging from -0.281 (worst imaginable health state) to 1 (best imaginable health state), with -0.281 representing an "unconscious" health state. A single index value is analyzed for the EQ-5D-5L score. An increase from baseline in the EQ-ED-5L utility index is indicative of an improvement.). CFB = change from baseline
The full analysis set (FAS) comprised all participants to whom study treatment was assigned and who received at least one dose of the study treatment. Data are reported for Part 2 only.
Posted
Mean
Standard Deviation
score on a scale
Assessed every 3 weeks from Week 3 through Week 108, at follow-up visits 1, 2, 3, 4, and 5 (follow-up visits occurred every 26 days from week 108), and at 7 and 28 days post-disease progression, all up to a maximum of 3.5 years
ID
Title
Description
OG000
Part 2: Canakinumab+Pembro+CTx
Double-blind, randomized, placebo-controlled, canakinumab in combination with pembrolizumab and platinum-based doublet chemotherapy.
Secondary
Part 2 (Double-blind, Randomized, Placebo-controlled): Change From Baseline in Score as Per the EuroQol 5 Dimension 5 Level (EQ-5D-5L) Questionnaire - Visual Analog Scale (VAS)
The EQ-5D-5L is a standardized questionnaire used to assess health-related quality of life, and it includes a Visual Analog Scale (VAS). The VAS score is obtained by asking the individual to rate their current health status on a scale from 0 to 100, where 0 represents the worst possible health state and 100 represents the best possible health state.
The change from baseline in EQ-5D-5L VAS score was calculated. A positive change from baseline indicates improvement in the health status. CFB = change from baseline
The full analysis set (FAS) comprised all participants to whom study treatment was assigned and who received at least one dose of the study treatment. Data are reported for Part 2 only.
Posted
Mean
Standard Deviation
score on a scale
Assessed every 3 weeks from Week 3 through Week 108, at follow-up visits 1, 2, 3, 4, and 5 (follow-up visits occurred every 26 days from week 108), and at 7 and 28 days post-disease progression, all up to a maximum of 3.5 years
ID
Title
Description
OG000
Part 2: Canakinumab+Pembro+CTx
Double-blind, randomized, placebo-controlled, canakinumab in combination with pembrolizumab and platinum-based doublet chemotherapy.
OG001
Part 2: Placebo+Pembro+CTx
Double-blind, randomized, placebo-controlled, canakinumab-matching placebo in combination with pembrolizumab and platinum-based doublet chemotherapy.
Post-Hoc
All Collected Deaths
On-treatment deaths due to any cause were collected from first dose of study medication to 30 days after the last dose of study treatment. Post-treatment survival follow-up deaths were collected from Day 31 after last dose of study medication to the data cut-off date.
The full analysis set (FAS) comprised all participants to whom study treatment was assigned and who received at least one dose of the study treatment.
Posted
Count of Participants
Participants
On-treatment deaths: Up to approximately 29 months in Part 1 or approximately 25 months in Part 2. Post-treatment survival follow-up deaths: Up to an additional 130 days.
ID
Title
Description
OG000
Part 1: Cohort A
Safety run-in, canakinumab in combination with pembrolizumab, carboplatin, and pemetrexed.
OG001
Part 1: Cohort B
Safety run-in, canakinumab in combination with pembrolizumab, cisplatin, and pemetrexed.
OG002
Part 1: Cohort C
Safety run-in, canakinumab in combination with pembrolizumab, carboplatin, and paclitaxel.
OG003
Part 2: Canakinumab+Pembro+CTx
Time Frame
Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months.
Description
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients that entered the post-treatment survival follow-up period. All-cause Mortality was assessed on the Full analysis set (FAS). SAEs and AEs were assessed on the Safety Set (participants who received at least one dose of the study treatment).
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Part 1: Cohort A (On-treatment)
AEs during the on-treatment period (up to 30 days post-treatment)
4
10
4
10
10
10
EG001
Part 1: Cohort B (On-treatment)
AEs during the on-treatment period (up to 30 days post-treatment)
1
11
3
11
11
11
EG002
Part 1: Cohort C (On-treatment)
AEs during the on-treatment period (up to 30 days post-treatment)
4
9
4
9
9
9
EG003
Part 2: Canakinumab+Pembro+CTx (On-treatment)
AEs during the on-treatment period (up to 30 days post-treatment)
97
320
174
320
309
320
EG004
Part 2: Placebo+Pembro+CTx (On-treatment)
AEs during the on-treatment period (up to 30 days post-treatment)
102
323
167
322
310
322
EG005
Part 1: Cohort A (Post-treatment Survival Follow-up)
Deaths collected in the post-treatment survival follow-up period (starting from Day 31 post-treatment). No AEs were collected during this period.
2
6
0
0
0
0
EG006
Part 1: Cohort B (Post-treatment Survival Follow-up)
Deaths collected in the post-treatment survival follow-up period (starting from Day 31 post-treatment). No AEs were collected during this period.
5
10
0
0
0
0
EG007
Part 1: Cohort C (Post-treatment Survival Follow-up)
Deaths collected in the post-treatment survival follow-up period (starting from Day 31 post-treatment). No AEs were collected during this period.
3
5
0
0
0
0
EG008
Part 2: Canakinumab+Pembro+CTx (Post-treatment Survival Follow-up)
Deaths collected in the post-treatment survival follow-up period (starting from Day 31 post-treatment). No AEs were collected during this period.
50
223
0
0
0
0
EG009
Part 2: Placebo+Pembro+CTx (Post-treatment Survival Follow-up)
Deaths collected in the post-treatment survival follow-up period (starting from Day 31 post-treatment). No AEs were collected during this period.
57
220
0
0
0
0
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG00310 affected320 at risk
EG00411 affected322 at risk
EG0050 at risk
EG0060 at risk
EG0070 at risk
EG0080 at risk
EG0090 at risk
Bicytopenia
Blood and lymphatic system disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Coagulopathy
Blood and lymphatic system disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Disseminated intravascular coagulation
Blood and lymphatic system disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Febrile neutropenia
Blood and lymphatic system disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Granulocytopenia
Blood and lymphatic system disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Immune-mediated cytopenia
Blood and lymphatic system disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Leukopenia
Blood and lymphatic system disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Pancytopenia
Blood and lymphatic system disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Acute myocardial infarction
Cardiac disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Angina pectoris
Cardiac disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Arrhythmia
Cardiac disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0021 affected9 at risk
EG003
Atrial flutter
Cardiac disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0021 affected9 at risk
EG003
Atrioventricular block complete
Cardiac disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Bradycardia
Cardiac disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Cardiac arrest
Cardiac disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Cardiac failure
Cardiac disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Cardiac tamponade
Cardiac disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0011 affected11 at risk
EG0020 affected9 at risk
EG003
Cardio-respiratory arrest
Cardiac disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Cardiogenic shock
Cardiac disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Cardiovascular disorder
Cardiac disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Coronary artery stenosis
Cardiac disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Myocardial infarction
Cardiac disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Myocarditis
Cardiac disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Pericardial effusion
Cardiac disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Sinus bradycardia
Cardiac disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Supraventricular tachycardia
Cardiac disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Ventricular arrhythmia
Cardiac disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Adrenal disorder
Endocrine disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Adrenal insufficiency
Endocrine disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Glucocorticoid deficiency
Endocrine disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Hypercalcaemia of malignancy
Endocrine disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Hyperthyroidism
Endocrine disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Hypophysitis
Endocrine disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Hypothyroidism
Endocrine disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Diplopia
Eye disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Autoimmune colitis
Gastrointestinal disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Colitis
Gastrointestinal disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0021 affected9 at risk
EG003
Diarrhoea haemorrhagic
Gastrointestinal disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Enterocolitis
Gastrointestinal disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Immune-mediated enterocolitis
Gastrointestinal disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Intestinal ischaemia
Gastrointestinal disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Large intestine perforation
Gastrointestinal disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Mesenteric artery thrombosis
Gastrointestinal disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA (24.0)
Systematic Assessment
EG0002 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Odynophagia
Gastrointestinal disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0011 affected11 at risk
EG0020 affected9 at risk
EG003
Oesophageal haemorrhage
Gastrointestinal disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Pancreatitis
Gastrointestinal disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Rectal haemorrhage
Gastrointestinal disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA (24.0)
Systematic Assessment
EG0001 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Asthenia
General disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Chest pain
General disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Condition aggravated
General disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Face oedema
General disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Fatigue
General disorders
MedDRA (24.0)
Systematic Assessment
EG0001 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Feeling abnormal
General disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
General physical health deterioration
General disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Generalised oedema
General disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Implant site pain
General disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Localised oedema
General disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Malaise
General disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Oedema peripheral
General disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Pain
General disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Performance status decreased
General disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Pyrexia
General disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0021 affected9 at risk
EG003
Sudden death
General disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Cholecystitis
Hepatobiliary disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Cholestasis
Hepatobiliary disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Hepatic cytolysis
Hepatobiliary disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Hepatic failure
Hepatobiliary disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Hepatic function abnormal
Hepatobiliary disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Hepatitis
Hepatobiliary disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0021 affected9 at risk
EG003
Hepatitis acute
Hepatobiliary disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0011 affected11 at risk
EG0020 affected9 at risk
EG003
Immune-mediated hepatitis
Hepatobiliary disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Anaphylactic reaction
Immune system disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Anaphylactic shock
Immune system disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Hypersensitivity
Immune system disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Abdominal infection
Infections and infestations
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Abscess limb
Infections and infestations
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Asymptomatic COVID-19
Infections and infestations
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Atypical pneumonia
Infections and infestations
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Bacteraemia
Infections and infestations
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Bacterial sepsis
Infections and infestations
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Biliary sepsis
Infections and infestations
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
COVID-19
Infections and infestations
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
COVID-19 pneumonia
Infections and infestations
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Cellulitis
Infections and infestations
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Dengue fever
Infections and infestations
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Empyema
Infections and infestations
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Escherichia bacteraemia
Infections and infestations
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Gastroenteritis clostridial
Infections and infestations
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Gastrointestinal infection
Infections and infestations
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Gastrointestinal protozoal infection
Infections and infestations
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Herpes virus infection
Infections and infestations
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Infection
Infections and infestations
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Infectious pleural effusion
Infections and infestations
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Infective exacerbation of chronic obstructive airways disease
Infections and infestations
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Influenza
Infections and infestations
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Klebsiella sepsis
Infections and infestations
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Lower respiratory tract infection
Infections and infestations
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0011 affected11 at risk
EG0020 affected9 at risk
EG003
Lung abscess
Infections and infestations
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Meningitis aseptic
Infections and infestations
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Neutropenic sepsis
Infections and infestations
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Nosocomial infection
Infections and infestations
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Peritonitis
Infections and infestations
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Pneumonia
Infections and infestations
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0011 affected11 at risk
EG0020 affected9 at risk
EG003
Pneumonia bacterial
Infections and infestations
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Pneumonia cytomegaloviral
Infections and infestations
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Pneumonia pseudomonal
Infections and infestations
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Pulmonary sepsis
Infections and infestations
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Respiratory tract infection
Infections and infestations
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Sepsis
Infections and infestations
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Septic shock
Infections and infestations
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Skin infection
Infections and infestations
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Tracheobronchitis
Infections and infestations
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Urinary tract infection bacterial
Infections and infestations
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Urosepsis
Infections and infestations
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Vascular device infection
Infections and infestations
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Wound infection
Infections and infestations
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Femoral neck fracture
Injury, poisoning and procedural complications
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Hip fracture
Injury, poisoning and procedural complications
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Infusion related reaction
Injury, poisoning and procedural complications
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Periprosthetic fracture
Injury, poisoning and procedural complications
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Post procedural complication
Injury, poisoning and procedural complications
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Thoracic vertebral fracture
Injury, poisoning and procedural complications
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Transfusion-related circulatory overload
Injury, poisoning and procedural complications
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Wrist fracture
Injury, poisoning and procedural complications
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Blood creatine phosphokinase increased
Investigations
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Blood creatinine increased
Investigations
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Cortisol decreased
Investigations
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Eastern Cooperative Oncology Group performance status worsened
Investigations
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Gamma-glutamyltransferase increased
Investigations
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Lipase increased
Investigations
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Lymphocyte count decreased
Investigations
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Platelet count decreased
Investigations
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Transaminases increased
Investigations
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Troponin I increased
Investigations
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
White blood cell count decreased
Investigations
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Diabetic ketoacidosis
Metabolism and nutrition disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Hyperglycaemic hyperosmolar nonketotic syndrome
Metabolism and nutrition disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Hypophagia
Metabolism and nutrition disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Malnutrition
Metabolism and nutrition disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Type 1 diabetes mellitus
Metabolism and nutrition disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Bone pain
Musculoskeletal and connective tissue disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Necrotising myositis
Musculoskeletal and connective tissue disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Pathological fracture
Musculoskeletal and connective tissue disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Spinal pain
Musculoskeletal and connective tissue disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Bladder neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Blast crisis in myelogenous leukaemia
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Malignant melanoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Malignant neoplasm progression
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0021 affected9 at risk
EG003
Metastases to meninges
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Squamous cell carcinoma of skin
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Transitional cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Tumour pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Altered state of consciousness
Nervous system disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Brain oedema
Nervous system disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Cerebellar infarction
Nervous system disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Cerebrovascular accident
Nervous system disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Cognitive disorder
Nervous system disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Diabetic neuropathy
Nervous system disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Diplegia
Nervous system disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Dizziness
Nervous system disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Epilepsy
Nervous system disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Haemorrhage intracranial
Nervous system disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Hemianopia
Nervous system disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Hemiparesis
Nervous system disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Hypoaesthesia
Nervous system disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Ischaemic stroke
Nervous system disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Neuropathy peripheral
Nervous system disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Polyneuropathy
Nervous system disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0021 affected9 at risk
EG003
Presyncope
Nervous system disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Spinal cord compression
Nervous system disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Syncope
Nervous system disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Delirium
Psychiatric disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Schizophrenia
Psychiatric disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Chronic kidney disease
Renal and urinary disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Nephritis
Renal and urinary disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Renal failure
Renal and urinary disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Renal impairment
Renal and urinary disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Tubulointerstitial nephritis
Renal and urinary disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Ureteric obstruction
Renal and urinary disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Urinary retention
Renal and urinary disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Benign prostatic hyperplasia
Reproductive system and breast disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Postmenopausal haemorrhage
Reproductive system and breast disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Acute respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Atelectasis
Respiratory, thoracic and mediastinal disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Bronchial fistula
Respiratory, thoracic and mediastinal disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Chronic obstructive pulmonary disease
Respiratory, thoracic and mediastinal disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA (24.0)
Systematic Assessment
EG0001 affected10 at risk
EG0010 affected11 at risk
EG0021 affected9 at risk
EG003
Dyspnoea paroxysmal nocturnal
Respiratory, thoracic and mediastinal disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Haemoptysis
Respiratory, thoracic and mediastinal disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Immune-mediated lung disease
Respiratory, thoracic and mediastinal disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Interstitial lung disease
Respiratory, thoracic and mediastinal disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Laryngeal obstruction
Respiratory, thoracic and mediastinal disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Lung disorder
Respiratory, thoracic and mediastinal disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Pleuritic pain
Respiratory, thoracic and mediastinal disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Pneumonia aspiration
Respiratory, thoracic and mediastinal disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0011 affected11 at risk
EG0020 affected9 at risk
EG003
Pneumothorax
Respiratory, thoracic and mediastinal disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0021 affected9 at risk
EG003
Pulmonary haemorrhage
Respiratory, thoracic and mediastinal disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Pulmonary oedema
Respiratory, thoracic and mediastinal disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Angioedema
Skin and subcutaneous tissue disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Immune-mediated dermatitis
Skin and subcutaneous tissue disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Panniculitis
Skin and subcutaneous tissue disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Arteriosclerosis
Vascular disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Extremity necrosis
Vascular disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Hypertension
Vascular disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Hypotension
Vascular disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Jugular vein thrombosis
Vascular disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Peripheral arterial occlusive disease
Vascular disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Thrombosis
Vascular disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Venous thrombosis
Vascular disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA (24.0)
Systematic Assessment
EG0003 affected10 at risk
EG0013 affected11 at risk
EG0023 affected9 at risk
EG003153 affected320 at risk
EG004148 affected322 at risk
EG0050 at risk
EG0060 at risk
EG0070 at risk
EG0080 at risk
EG0090 at risk
Leukopenia
Blood and lymphatic system disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA (24.0)
Systematic Assessment
EG0001 affected10 at risk
EG0011 affected11 at risk
EG0021 affected9 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA (24.0)
Systematic Assessment
EG0001 affected10 at risk
EG0011 affected11 at risk
EG0020 affected9 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0011 affected11 at risk
EG0020 affected9 at risk
EG003
Cardiac failure
Cardiac disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0021 affected9 at risk
EG003
Palpitations
Cardiac disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0011 affected11 at risk
EG0021 affected9 at risk
EG003
Pericardial effusion
Cardiac disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0011 affected11 at risk
EG0020 affected9 at risk
EG003
Hypoacusis
Ear and labyrinth disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0022 affected9 at risk
EG003
Tinnitus
Ear and labyrinth disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0011 affected11 at risk
EG0020 affected9 at risk
EG003
Hyperthyroidism
Endocrine disorders
MedDRA (24.0)
Systematic Assessment
EG0001 affected10 at risk
EG0010 affected11 at risk
EG0022 affected9 at risk
EG003
Hypothyroidism
Endocrine disorders
MedDRA (24.0)
Systematic Assessment
EG0001 affected10 at risk
EG0012 affected11 at risk
EG0021 affected9 at risk
EG003
Conjunctivitis allergic
Eye disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0011 affected11 at risk
EG0020 affected9 at risk
EG003
Dry eye
Eye disorders
MedDRA (24.0)
Systematic Assessment
EG0001 affected10 at risk
EG0011 affected11 at risk
EG0020 affected9 at risk
EG003
Endocrine ophthalmopathy
Eye disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0021 affected9 at risk
EG003
Glaucoma
Eye disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0021 affected9 at risk
EG003
Lacrimation increased
Eye disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0013 affected11 at risk
EG0020 affected9 at risk
EG003
Vision blurred
Eye disorders
MedDRA (24.0)
Systematic Assessment
EG0001 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Visual impairment
Eye disorders
MedDRA (24.0)
Systematic Assessment
EG0001 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Xerophthalmia
Eye disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0011 affected11 at risk
EG0020 affected9 at risk
EG003
Abdominal discomfort
Gastrointestinal disorders
MedDRA (24.0)
Systematic Assessment
EG0001 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0011 affected11 at risk
EG0020 affected9 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0013 affected11 at risk
EG0021 affected9 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA (24.0)
Systematic Assessment
EG0002 affected10 at risk
EG0012 affected11 at risk
EG0020 affected9 at risk
EG003
Anal incontinence
Gastrointestinal disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0011 affected11 at risk
EG0020 affected9 at risk
EG003
Anal inflammation
Gastrointestinal disorders
MedDRA (24.0)
Systematic Assessment
EG0001 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA (24.0)
Systematic Assessment
EG0006 affected10 at risk
EG0013 affected11 at risk
EG0022 affected9 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA (24.0)
Systematic Assessment
EG0003 affected10 at risk
EG0011 affected11 at risk
EG0022 affected9 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA (24.0)
Systematic Assessment
EG0001 affected10 at risk
EG0011 affected11 at risk
EG0020 affected9 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0011 affected11 at risk
EG0020 affected9 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0021 affected9 at risk
EG003
Glossodynia
Gastrointestinal disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0021 affected9 at risk
EG003
Haemorrhoidal haemorrhage
Gastrointestinal disorders
MedDRA (24.0)
Systematic Assessment
EG0001 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA (24.0)
Systematic Assessment
EG0003 affected10 at risk
EG0015 affected11 at risk
EG0025 affected9 at risk
EG003
Odynophagia
Gastrointestinal disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0012 affected11 at risk
EG0020 affected9 at risk
EG003
Oesophageal pain
Gastrointestinal disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0011 affected11 at risk
EG0020 affected9 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA (24.0)
Systematic Assessment
EG0001 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA (24.0)
Systematic Assessment
EG0003 affected10 at risk
EG0015 affected11 at risk
EG0022 affected9 at risk
EG003
Asthenia
General disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0013 affected11 at risk
EG0021 affected9 at risk
EG003
Chest discomfort
General disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0011 affected11 at risk
EG0020 affected9 at risk
EG003
Chest pain
General disorders
MedDRA (24.0)
Systematic Assessment
EG0001 affected10 at risk
EG0012 affected11 at risk
EG0021 affected9 at risk
EG003
Chills
General disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0011 affected11 at risk
EG0020 affected9 at risk
EG003
Effusion
General disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0021 affected9 at risk
EG003
Fatigue
General disorders
MedDRA (24.0)
Systematic Assessment
EG0002 affected10 at risk
EG0015 affected11 at risk
EG0023 affected9 at risk
EG003
Generalised oedema
General disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0011 affected11 at risk
EG0020 affected9 at risk
EG003
Injection site pain
General disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0021 affected9 at risk
EG003
Injection site reaction
General disorders
MedDRA (24.0)
Systematic Assessment
EG0001 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Malaise
General disorders
MedDRA (24.0)
Systematic Assessment
EG0001 affected10 at risk
EG0011 affected11 at risk
EG0021 affected9 at risk
EG003
Mucosal inflammation
General disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0011 affected11 at risk
EG0021 affected9 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0021 affected9 at risk
EG003
Oedema peripheral
General disorders
MedDRA (24.0)
Systematic Assessment
EG0001 affected10 at risk
EG0011 affected11 at risk
EG0021 affected9 at risk
EG003
Pain
General disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0011 affected11 at risk
EG0020 affected9 at risk
EG003
Peripheral swelling
General disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0011 affected11 at risk
EG0020 affected9 at risk
EG003
Pyrexia
General disorders
MedDRA (24.0)
Systematic Assessment
EG0002 affected10 at risk
EG0012 affected11 at risk
EG0021 affected9 at risk
EG003
Swelling
General disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0011 affected11 at risk
EG0020 affected9 at risk
EG003
Swelling face
General disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0011 affected11 at risk
EG0020 affected9 at risk
EG003
Allergic reaction to excipient
Immune system disorders
MedDRA (24.0)
Systematic Assessment
EG0001 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Anal abscess
Infections and infestations
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0021 affected9 at risk
EG003
Borrelia infection
Infections and infestations
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0011 affected11 at risk
EG0020 affected9 at risk
EG003
Candida infection
Infections and infestations
MedDRA (24.0)
Systematic Assessment
EG0001 affected10 at risk
EG0011 affected11 at risk
EG0020 affected9 at risk
EG003
Conjunctivitis
Infections and infestations
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0011 affected11 at risk
EG0020 affected9 at risk
EG003
Eye infection
Infections and infestations
MedDRA (24.0)
Systematic Assessment
EG0001 affected10 at risk
EG0010 affected11 at risk
EG0021 affected9 at risk
EG003
Fungal skin infection
Infections and infestations
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0021 affected9 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0011 affected11 at risk
EG0022 affected9 at risk
EG003
Oral candidiasis
Infections and infestations
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0012 affected11 at risk
EG0020 affected9 at risk
EG003
Oral herpes
Infections and infestations
MedDRA (24.0)
Systematic Assessment
EG0001 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0021 affected9 at risk
EG003
Pneumonia
Infections and infestations
MedDRA (24.0)
Systematic Assessment
EG0002 affected10 at risk
EG0012 affected11 at risk
EG0021 affected9 at risk
EG003
Sinusitis
Infections and infestations
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0011 affected11 at risk
EG0020 affected9 at risk
EG003
Skin infection
Infections and infestations
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0021 affected9 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA (24.0)
Systematic Assessment
EG0002 affected10 at risk
EG0013 affected11 at risk
EG0021 affected9 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0011 affected11 at risk
EG0021 affected9 at risk
EG003
Vaginal infection
Infections and infestations
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0011 affected11 at risk
EG0020 affected9 at risk
EG003
Viral rhinitis
Infections and infestations
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0011 affected11 at risk
EG0020 affected9 at risk
EG003
Infusion related reaction
Injury, poisoning and procedural complications
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0021 affected9 at risk
EG003
Ligament sprain
Injury, poisoning and procedural complications
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0011 affected11 at risk
EG0020 affected9 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0012 affected11 at risk
EG0020 affected9 at risk
EG003
Amylase increased
Investigations
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA (24.0)
Systematic Assessment
EG0001 affected10 at risk
EG0012 affected11 at risk
EG0020 affected9 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Blood cholesterol increased
Investigations
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0011 affected11 at risk
EG0020 affected9 at risk
EG003
Blood creatinine increased
Investigations
MedDRA (24.0)
Systematic Assessment
EG0001 affected10 at risk
EG0011 affected11 at risk
EG0020 affected9 at risk
EG003
Gamma-glutamyltransferase increased
Investigations
MedDRA (24.0)
Systematic Assessment
EG0001 affected10 at risk
EG0011 affected11 at risk
EG0020 affected9 at risk
EG003
Lipase increased
Investigations
MedDRA (24.0)
Systematic Assessment
EG0002 affected10 at risk
EG0011 affected11 at risk
EG0020 affected9 at risk
EG003
Lymphocyte count decreased
Investigations
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA (24.0)
Systematic Assessment
EG0003 affected10 at risk
EG0013 affected11 at risk
EG0021 affected9 at risk
EG003
Platelet count decreased
Investigations
MedDRA (24.0)
Systematic Assessment
EG0002 affected10 at risk
EG0011 affected11 at risk
EG0020 affected9 at risk
EG003
SARS-CoV-2 test negative
Investigations
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0011 affected11 at risk
EG0020 affected9 at risk
EG003
Weight decreased
Investigations
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0012 affected11 at risk
EG0020 affected9 at risk
EG003
White blood cell count decreased
Investigations
MedDRA (24.0)
Systematic Assessment
EG0002 affected10 at risk
EG0012 affected11 at risk
EG0020 affected9 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA (24.0)
Systematic Assessment
EG0003 affected10 at risk
EG0015 affected11 at risk
EG0021 affected9 at risk
EG003
Diabetes mellitus inadequate control
Metabolism and nutrition disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0011 affected11 at risk
EG0020 affected9 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0021 affected9 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA (24.0)
Systematic Assessment
EG0001 affected10 at risk
EG0012 affected11 at risk
EG0022 affected9 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0011 affected11 at risk
EG0021 affected9 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0011 affected11 at risk
EG0020 affected9 at risk
EG003
Polydipsia
Metabolism and nutrition disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0021 affected9 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA (24.0)
Systematic Assessment
EG0001 affected10 at risk
EG0014 affected11 at risk
EG0022 affected9 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA (24.0)
Systematic Assessment
EG0001 affected10 at risk
EG0011 affected11 at risk
EG0021 affected9 at risk
EG003
Bone pain
Musculoskeletal and connective tissue disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0021 affected9 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0011 affected11 at risk
EG0020 affected9 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0022 affected9 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0011 affected11 at risk
EG0020 affected9 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0013 affected11 at risk
EG0023 affected9 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA (24.0)
Systematic Assessment
EG0003 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0012 affected11 at risk
EG0023 affected9 at risk
EG003
Sjogren's syndrome
Musculoskeletal and connective tissue disorders
MedDRA (24.0)
Systematic Assessment
EG0001 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Cancer pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0011 affected11 at risk
EG0020 affected9 at risk
EG003
Metastases to skin
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (24.0)
Systematic Assessment
EG0001 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Dizziness
Nervous system disorders
MedDRA (24.0)
Systematic Assessment
EG0001 affected10 at risk
EG0011 affected11 at risk
EG0021 affected9 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA (24.0)
Systematic Assessment
EG0001 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Headache
Nervous system disorders
MedDRA (24.0)
Systematic Assessment
EG0001 affected10 at risk
EG0011 affected11 at risk
EG0020 affected9 at risk
EG003
Hypoaesthesia
Nervous system disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0012 affected11 at risk
EG0020 affected9 at risk
EG003
Neuropathy peripheral
Nervous system disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0024 affected9 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0012 affected11 at risk
EG0023 affected9 at risk
EG003
Peripheral sensory neuropathy
Nervous system disorders
MedDRA (24.0)
Systematic Assessment
EG0001 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Polyneuropathy
Nervous system disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0011 affected11 at risk
EG0020 affected9 at risk
EG003
Presyncope
Nervous system disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0021 affected9 at risk
EG003
Taste disorder
Nervous system disorders
MedDRA (24.0)
Systematic Assessment
EG0001 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA (24.0)
Systematic Assessment
EG0001 affected10 at risk
EG0010 affected11 at risk
EG0021 affected9 at risk
EG003
Delirium
Psychiatric disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0021 affected9 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA (24.0)
Systematic Assessment
EG0002 affected10 at risk
EG0011 affected11 at risk
EG0022 affected9 at risk
EG003
Sleep disorder
Psychiatric disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0021 affected9 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0011 affected11 at risk
EG0020 affected9 at risk
EG003
Dysuria
Renal and urinary disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0011 affected11 at risk
EG0020 affected9 at risk
EG003
Nocturia
Renal and urinary disorders
MedDRA (24.0)
Systematic Assessment
EG0001 affected10 at risk
EG0010 affected11 at risk
EG0020 affected9 at risk
EG003
Polyuria
Renal and urinary disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0021 affected9 at risk
EG003
Urinary retention
Renal and urinary disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0021 affected9 at risk
EG003
Heavy menstrual bleeding
Reproductive system and breast disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0011 affected11 at risk
EG0020 affected9 at risk
EG003
Asthma
Respiratory, thoracic and mediastinal disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0011 affected11 at risk
EG0020 affected9 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA (24.0)
Systematic Assessment
EG0004 affected10 at risk
EG0013 affected11 at risk
EG0020 affected9 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA (24.0)
Systematic Assessment
EG0003 affected10 at risk
EG0014 affected11 at risk
EG0023 affected9 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0021 affected9 at risk
EG003
Haemoptysis
Respiratory, thoracic and mediastinal disorders
MedDRA (24.0)
Systematic Assessment
EG0001 affected10 at risk
EG0010 affected11 at risk
EG0021 affected9 at risk
EG003
Interstitial lung disease
Respiratory, thoracic and mediastinal disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0011 affected11 at risk
EG0020 affected9 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0011 affected11 at risk
EG0020 affected9 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0011 affected11 at risk
EG0021 affected9 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0011 affected11 at risk
EG0020 affected9 at risk
EG003
Productive cough
Respiratory, thoracic and mediastinal disorders
MedDRA (24.0)
Systematic Assessment
EG0001 affected10 at risk
EG0011 affected11 at risk
EG0020 affected9 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA (24.0)
Systematic Assessment
EG0001 affected10 at risk
EG0011 affected11 at risk
EG0020 affected9 at risk
EG003
Tonsillar ulcer
Respiratory, thoracic and mediastinal disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0011 affected11 at risk
EG0020 affected9 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0022 affected9 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0011 affected11 at risk
EG0020 affected9 at risk
EG003
Eczema
Skin and subcutaneous tissue disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0011 affected11 at risk
EG0020 affected9 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0011 affected11 at risk
EG0020 affected9 at risk
EG003
Ingrowing nail
Skin and subcutaneous tissue disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0011 affected11 at risk
EG0020 affected9 at risk
EG003
Night sweats
Skin and subcutaneous tissue disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0011 affected11 at risk
EG0020 affected9 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0011 affected11 at risk
EG0021 affected9 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0015 affected11 at risk
EG0022 affected9 at risk
EG003
Rash erythematous
Skin and subcutaneous tissue disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0011 affected11 at risk
EG0020 affected9 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0021 affected9 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0011 affected11 at risk
EG0020 affected9 at risk
EG003
Embolism
Vascular disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0021 affected9 at risk
EG003
Haematoma
Vascular disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0021 affected9 at risk
EG003
Hot flush
Vascular disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected11 at risk
EG0021 affected9 at risk
EG003
Hypertension
Vascular disorders
MedDRA (24.0)
Systematic Assessment
EG0001 affected10 at risk
EG0012 affected11 at risk
EG0021 affected9 at risk
EG003
Hypotension
Vascular disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0011 affected11 at risk
EG0020 affected9 at risk
EG003
Subclavian vein thrombosis
Vascular disorders
MedDRA (24.0)
Systematic Assessment
EG0000 affected10 at risk
EG0011 affected11 at risk
EG0020 affected9 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 (ie, data from all sites) in the clinical trial.