LDK378 Versus Chemotherapy in ALK Rearranged (ALK Positiv... | NCT01828112 | Trialant
NCT01828112
Sponsor
Novartis Pharmaceuticals
Status
Completed
Last Update Posted
Feb 7, 2025Actual
Enrollment
231Actual
Phase
Phase 3
Conditions
Non-Small Cell Lung Cancer
Interventions
Ceritinib
Pemetrexed
Docetaxel
Countries
United States
Belgium
Canada
France
Germany
Hong Kong
Ireland
Israel
Italy
Japan
Lebanon
Netherlands
Portugal
Russia
Singapore
South Korea
Spain
Switzerland
Turkey (Türkiye)
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT01828112
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
CLDK378A2303
Secondary IDs
ID
Type
Description
Link
2012-005637-36
EudraCT Number
Brief Title
LDK378 Versus Chemotherapy in ALK Rearranged (ALK Positive) Patients Previously Treated With Chemotherapy (Platinum Doublet) and Crizotinib
Official Title
A Phase III, Multicenter, Randomized, Open-label Study of Oral LDK378 Versus Standard Chemotherapy in Adult Patients With ALK-rearranged (ALK-positive) Advanced Non-small Cell Lung Cancer Who Have Been Treated Previously With Chemotherapy (Platinum Doublet) and Crizotinib
Acronym
Not provided
Organization
NovartisINDUSTRY
Status Module
Record Verification Date
Jan 2025
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Jun 28, 2013Actual
Primary Completion Date
Jan 26, 2016Actual
Completion Date
Nov 10, 2023Actual
First Submitted Date
Apr 2, 2013
First Submission Date that Met QC Criteria
Apr 9, 2013
First Posted Date
Apr 10, 2013Estimated
Results Waived
Not provided
Results First Submitted Date
Jun 24, 2017
Results First Submitted that Met QC Criteria
Jun 27, 2017
Results First Posted Date
Jul 27, 2017Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Jan 16, 2025
Last Update Posted Date
Feb 7, 2025Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Novartis PharmaceuticalsINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The primary purpose of the study was to compare the antitumor activity of LDK378 vs. chemotherapy in patients previously treated with chemotherapy (platinum doublet) and crizotinib. Patients in the chemotherapy arm were given the option to switch to LDK378 after confirmed progressive disease (PD), while also had the choice to continue with pemetrexed treatment.
Detailed Description
A total of 231 patients were randomized to one of the two treatment arms in a 1:1 ratio. Randomization was stratified by World Health Organization (WHO) performance status (0 versus 1-2) and whether the patient had brain metastases at screening. The study was planned to be ended once the final overall survival (OS) analysis was performed (at the earliest of approximately 196 deaths observed or statistical significance reached at earlier OS interim analysis).
Following an agreement between Novartis and European Medicines Agency (EMA) in May 2023 to terminate the trial earlier, this study was completed when the total number of deaths was 190. Patients who had Response Evaluation Criteria In Solid Tumors (RECIST)-defined disease progression as confirmed by the Blinded Independent Review Committee (BIRC), but who, in the opinion of the Investigator, had continued clinical benefit from study treatment on either the chemotherapy arm or the ceritinib arm, continued to receive treatment. These patients continued assessments in the treatment phase. In addition, only patients randomized to the chemotherapy arm were allowed to crossover to receive ceritinib therapy (extension treatment [ET] phase) after BIRC-confirmed, RECIST-defined disease progression, and provided they met the eligibility requirements.
Conditions Module
Conditions
Non-Small Cell Lung Cancer
Keywords
Non-Small Cell Lung Cancer
ALK
LDK378
Non-small cell lung carcinoma (NSCLC)
treatment of lung cancer after first metastasis
lung cancer
lung adenocarcinoma
Non small cell lung carcinoma
Non small cell lung cancer
NSCLC
chemotherapy
ALK-positive
ALK-rearranged advanced non-small cell lung cancer
crizotinib
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
231Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Ceritinib
Experimental
Ceritinib 750 mg
Drug: Ceritinib
Chemotherapy
Active Comparator
Chemotherapy as determined by BIRC
Drug: Pemetrexed
Drug: Docetaxel
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Ceritinib
Drug
Ceritinib was the investigational treatment and was provided as 150 mg hard gelatin capsules for oral use. The dose was 750 mg once daily.
Ceritinib
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Progression Free Survival (PFS) Per Blinded Independent Review Committee (BIRC)
PFS was defined as the time from the date of randomization to the date of the first radiologically documented disease progression or death due to any cause.
From the date of randomization to the date of first radiologically documented disease progression or death due to any cause up to approximately 24 months
Secondary Outcomes
Measure
Description
Time Frame
Overall Survival (OS)
OS was defined as time from date of randomization to date of death due to any cause.
Up to approximately 114 months
Progression Free Survival (PFS) Per Investigator Assessment
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Patient has a histologically or cytologically confirmed diagnosis of non-small cell lung cancer (NSCLC) that is anaplastic lymphoma kinase (ALK) positive as assessed by the FDA approved Abbott FISH Test.
Patient has stage IIIB or IV diagnosis and must have received one or two prior regimens (including platinum- doublet) of cytotoxic chemotherapy for the treatment of locally advanced or metastatic NSCLC.
Patient has at least one measurable lesion as defined by RECIST 1.1. A previously irradiated site lesion may only be counted as a target lesion if there is clear sign of progression since the irradiation
Patients must have received previous treatment with crizotinib for the treatment of locally advanced or metastatic NSCLC.
Exclusion Criteria:
Patient with known hypersensitivity to any of the excipients of LDK378 (microcrystalline cellulose, mannitol, crospovidone, colloidal silicon dioxide and magnesium stearate)
Patient with a history of severe hypersensitivity reaction to pemetrexed or docetaxel or any known excipients of these drugs.
Patient with symptomatic central nervous system (CNS) metastases who is neurologically unstable or has required increasing doses of steroids within the 2 weeks prior to screening to manage CNS symptoms.
Kiura K, Imamura F, Kagamu H, Matsumoto S, Hida T, Nakagawa K, Satouchi M, Okamoto I, Takenoyama M, Fujisaka Y, Kurata T, Ito M, Tokushige K, Hatano B, Nishio M. Phase 3 study of ceritinib vs chemotherapy in ALK-rearranged NSCLC patients previously treated with chemotherapy and crizotinib (ASCEND-5): Japanese subset. Jpn J Clin Oncol. 2018 Apr 1;48(4):367-375. doi: 10.1093/jjco/hyy016.
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
In the treatment phase, patients were randomized 1:1 to one of the treatment arms (ceritinib or chemotherapy). In the extension treatment phase, only patients randomized to the chemotherapy arm were allowed to crossover to receive ceritinib therapy after BIRC-confirmed, RECIST-defined disease progression.
Recruitment Details
Participants were enrolled in the following countries (with number of sites): Belgium (4), Canada (1), France (9), Germany (8), Hong Kong (3), Ireland (2), Israel (2), Italy (10), Japan (12), Republic of Korea (5), Lebanon (1), Netherlands (2), Portugal (1), Russia (3), Singapore (2), Spain (11), Switzerland (2), Turkey (3), United Kingdom (5), United States (13).
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Ceritinib
Ceritinib 750 mg
FG001
Chemotherapy
Chemotherapy as determined by BIRC
Periods
Title
Milestones
Reasons Not Completed
Treatment Phase
Type
Comment
Milestone Data
STARTED
Full Analysis Set: all patients to whom study treatment was assigned by randomization
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
Pemetrexed
Drug
Pemetrexed was one of the chemotherapy treatments. Pemetrexed, a reconstituted solution, was intravenously administered over 10 minutes at 500 mg/m^2 every 21 days.
Chemotherapy
Docetaxel
Drug
Docetaxel was one of the chemotherapy treatments. Docetaxel, a reconstituted solution, was intravenously administered over 1 hour, at 75 mg/m^2 every 21 days.
Chemotherapy
PFS was defined as the time from the date of randomization to the date of the first radiologically documented disease progression or death due to any cause.
Up to approximately 84 months
Overall Response Rate (ORR) Per BIRC
ORR was defined as the percentage of participants with a best overall response defined as complete response (CR) or partial response (PR): (CR+PR) per Response Evaluation Criteria in Solid Tumors (RECIST), v. 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 54 months
Overall Response Rate (ORR) Per Investigator Assessment
ORR was defined as the percentage of participants with a best overall response defined as complete response (CR) or partial response (PR): (CR+PR) per Response Evaluation Criteria in Solid Tumors (RECIST), v. 1.1. CR: Disappearance of all lesions with lymph nodes measuring < 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 93 months
Duration of Response (DOR) Per BIRC
DOR defined as the time from the first documented response (CR or PR) to the first documented progression or death due to underlying cancer. CR: Disappearance of all lesions with lymph nodes measuring < 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 54 months
Duration of Response (DOR) Per Investigator Assessment
DOR defined as the time from the first documented response (CR or PR) to the first documented progression or death due to underlying cancer. CR: Disappearance of all lesions with lymph nodes measuring < 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 93 months
Disease Control Rate (DCR) Per BIRC
DCR was defined as the percentage of participants with best overall response of CR, PR, or stable disease (SD). CR: Disappearance of all lesions with lymph nodes measuring < 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 54 months
Disease Control Rate (DCR) Per Investigator Assessment
DCR was defined as the percentage of participants with best overall response of CR, PR, or stable disease (SD). CR: Disappearance of all lesions with lymph nodes measuring < 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 93 months
Time to Response (TTR) Per BIRC
TTR was defined as the time from date of randomization to date of first documented response (CR or PR). CR: Disappearance of all lesions with lymph nodes measuring < 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 52 weeks
Time to Response (TTR) Per Investigator Assessment
TTR was defined as the time from date of randomization to date of first documented response (CR or PR). CR: Disappearance of all lesions with lymph nodes measuring < 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 45 weeks
Overall Intracranial Response Rate (OIRR) Per BIRC
OIRR was defined as the ORR based on lesions in brain (target, nontarget lesions (and new lesions, if applicable) and calculated as the percentage of patients with a best overall confirmed response of CR or PR in the brain per modified RECIST 1.1 as assessed by BIRC neuroradiologist. CR: Disappearance of all lesions with lymph nodes measuring < 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 18 months
Intracranial Disease Control Rate (IDCR) Per BIRC
IDCR was defined as the DCR based on lesions in brain (target, non-target lesions (and new lesions, if applicable) and calculated as the proportion of patients with a best overall response of CR or PR or SD (or non-CR/nonPD) in the brain per modified RECIST 1.1 as assessed by BIRC neuro-radiologist. CR: Disappearance of all lesions with lymph nodes measuring < 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 18 months
Duration of Intracranial Response (DOIR) Per BIRC
DOIR was defined as the DOR based on lesions in brain (target, non-target lesions (and new lesions, if applicable) and calculated from the time of first documented response of CR or PR to the date of the first documented disease progression in the brain or death due to any cause per modified RECIST 1.1 as assessed by BIRC neuro-radiologist. CR: Disappearance of all lesions with lymph nodes measuring < 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 18 months
Least Squares Mean Scores on the European Organization for Research and Treatment of Cancer's Core Quality of Life Questionnaire (EORTC-QLQC30)
The EORTC QLQ-C30 questionnaire contained 30 items and was composed of both multi-item scales and single item measures. These included five functional scales (physical, role, emotional, cognitive, and social functioning), three symptom scales (fatigue, nausea/vomiting, and pain), six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial impact), and a global health status/quality of life (QoL) scale.
All of the scales and single items ranged from 0 to 100. A high scale score represented a higher response level. Thus, a high score for a functional scale indicated a high/healthy level of functioning, a high score for the QoL indicated high QoL, but a high score for a symptom scale/single item indicated a high level of symptomatology/problems. Data from all collected time points were combined and presented using a repeated measures model for longitudinal data.
Screening and treatment phase up to 92 months
EORTC QLQ-LC13 Time to Definitive Deterioration
The Lung Cancer module of the EORTC's quality of life questionnaire (EORTC QLQ-LC13) was used in conjunction with the EORTC QLQ-C30 and provided information on an additional 13 items specifically related to lung cancer. The lung cancer module incorporated one multi-item scale to assess dyspnea, and 9 single items assessing pain, coughing, sore mouth, dysphagia, peripheral neuropathy, alopecia, and hemoptysis. All of the domain scores ranged from 0 to 100. A high score indicated a high level of symptoms. QLQ-LC13 time to definitive deterioration was defined as the time from randomization to the earliest date a patient shows a 10 point or higher increase from baseline in any of the ALCLC13 scores related to pain in chest, cough, or dyspnea (with no later change below this threshold), or death due to any cause. Each cycle was 21 days.
Screening and treatment phase up to 92 months
Least Squares Mean Scores on the Lung Cancer Symptom Scale (LCSS)
The LCSS patient scale uses a 24-hour recall period and contains nine items: six measuring major symptoms for lung cancer (appetite loss, fatigue, cough, dyspnea, hemoptysis, pain), and three summary items related to total symptom distress, normal activity status, and overall quality of life. The total scale used is a 100 mm visual analog scale to measure the intensity of patient responses, with zero corresponding to the lowest rating (best status) and 100 representing the highest rating (worst status). The total score was calculated as the mean of the 9 items. Data from all collected time points were combined and presented using a repeated measures model for longitudinal data.
Screening and treatment phase up to 92 months
Least Squares Mean Scores on the EQ-5D-5L Index
The EQ-5D descriptive classification consists of five dimensions of health: mobility, self-care, usual activities, anxiety/depression and pain/discomfort. Patients are requested to select the statement which best describes their condition on that day for each dimension. EQ-5D-5L index scores can range from -0.59 to 1, where 1 is the best possible health state. Data from all collected time points were combined and presented using a repeated measures model for longitudinal data.
Screening and treatment phase up to 92 months
Least Squares Mean Scores on the EQ-5D Visual Analogue Scale (VAS)
The EQ-5D descriptive classification consists of five dimensions of health: mobility, self-care, usual activities, anxiety/depression and pain/discomfort. Patients are requested to select the statement which best describes their condition on that day for each dimension. EQ VAS scores can range from 0 to 100, where 100 is the best possible health state. Data from all collected time points were combined and presented using a repeated measures model for longitudinal data.
Screening and treatment phase up to 92 months
Cmax for Ceritinib
The observed maximum plasma concentration following administration
Cycle 1, Day 1 and Cycle 2, Day 1: pre-dose and 1, 2, 4, 6, 8, and 24 hours post-dose. Each cycle was 21 days.
Tmax for Ceritinib
The time to reach peak or maximum concentration
Cycle 1, Day 1 and Cycle 2, Day 1: pre-dose and 1, 2, 4, 6, 8, and 24 hours post-dose. Each cycle was 21 days.
Tlast for Ceritinib
The time to last quantifiable concentration
Cycle 1, Day 1 and Cycle 2, Day 1: pre-dose and 1, 2, 4, 6, 8, and 24 hours post-dose. Each cycle was 21 days.
AUC0-24h for Ceritinib
The area under the plasma concentration-time curve calculated from time zero to 24 hours
Cycle 1, Day 1 and Cycle 2, Day 1: pre-dose and 1, 2, 4, 6, 8, and 24 hours post-dose. Each cycle was 21 days.
Mean Accumulation Ratio (Racc) for Ceritinib
Accumulation ratio calculated using AUC0-24 values obtained from a dosing interval at steady-state (Cycle 2, Day 1) divided by AUC0-24 on Cycle 1, Day 1.
Cycle 1, Day 1 and Cycle 2, Day 1: pre-dose and 1, 2, 4, 6, 8, and 24 hours post-dose. Each cycle was 21 days.
Clearance Rate at Steady State (CLss/F) for Ceritinib
The apparent total body clearance from plasma. CLss/F is calculated from AUC0-24 assuming steady state (CLss/F=Dose/AUC0-24).
Cycle 1, Day 1 and Cycle 2, Day 1: pre-dose and 1, 2, 4, 6, 8, and 24 hours post-dose. Each cycle was 21 days.
Post-Hoc: All Collected Deaths
Pre-treatment deaths: from day of patient's informed consent to the day before first dose of study treatment. On-treatment deaths: from first dose of study treatment to 30 days following the last dose of study treatment at the end of treatment phase. For crossover patients, from first dose of ceritinib at the extension treatment phase to 30 days following the last dose. Survival Follow-up deaths: from Day 31 after last dose of study treatment to the data cut-off date.
Pre-treatment and on-treatment deaths: Up to approximately 8 years. Post-treatment survival follow-up deaths: Up to an additional 2.5 years.
Hollywood
Florida
33021
United States
Cancer Specialists of North Florida
Jacksonville
Florida
32256
United States
University Of Miami
Miami
Florida
33136
United States
Loyola University Medical Center
Marywood
Illinois
60153
United States
Uni Of Iowa Hospitals And Clinics
Iowa City
Iowa
52242
United States
Massachusetts General Hospital
Boston
Massachusetts
02114
United States
Oklahoma Cancer Specialists and Research Institute
Tulsa
Oklahoma
74136
United States
Sarah Cannon Research Institute
Nashville
Tennessee
37203
United States
Texas Oncology-Sugarland
Sugar Land
Texas
77479
United States
Texas Oncology Cancer Care and Research Center
Waco
Texas
76712
United States
Virginia Cancer Specialists
Fairfax
Virginia
22031
United States
Swedish Cancer Institute
Seattle
Washington
98104
United States
Novartis Investigative Site
Brussels
1000
Belgium
Novartis Investigative Site
Brussels
1200
Belgium
Novartis Investigative Site
Edegem
2650
Belgium
Novartis Investigative Site
Leuven
3000
Belgium
Novartis Investigative Site
Toronto
Ontario
M5G 2M9
Canada
Novartis Investigative Site
Marseille
Bouches Du Rhone
13915
France
Novartis Investigative Site
Besançon
25030
France
Novartis Investigative Site
Brest
29609
France
Novartis Investigative Site
Caen
14021
France
Novartis Investigative Site
Le Mans
72000
France
Novartis Investigative Site
Mulhouse
68070
France
Novartis Investigative Site
Paris
75970
France
Novartis Investigative Site
Strasbourg
F 67085
France
Novartis Investigative Site
Suresnes
92150
France
Novartis Investigative Site
Bad Berka
99438
Germany
Novartis Investigative Site
Cologne
51109
Germany
Novartis Investigative Site
Essen
45147
Germany
Novartis Investigative Site
Esslingen am Neckar
73730
Germany
Novartis Investigative Site
Frankfurt
60590
Germany
Novartis Investigative Site
Heidelberg
69120
Germany
Novartis Investigative Site
Tübingen
72076
Germany
Novartis Investigative Site
Ulm
89081
Germany
Novartis Investigative Site
Hong Kong
Hong Kong
Novartis Investigative Site
Pokfulam
Hong Kong
Novartis Investigative Site
Limerick
Co Limerick
V94 YX29
Ireland
Novartis Investigative Site
Dublin
DO4
Ireland
Novartis Investigative Site
Kfar Saba
44281
Israel
Novartis Investigative Site
Ramat Gan
52621
Israel
Novartis Investigative Site
Avellino
AV
83100
Italy
Novartis Investigative Site
Monza
MB
20900
Italy
Novartis Investigative Site
Milan
MI
20132
Italy
Novartis Investigative Site
Perugia
PG
06129
Italy
Novartis Investigative Site
Pisa
PI
56124
Italy
Novartis Investigative Site
Aviano
PN
33081
Italy
Novartis Investigative Site
Reggio Emilia
RE
42123
Italy
Novartis Investigative Site
Roma
RM
00189
Italy
Novartis Investigative Site
Orbassano
TO
10043
Italy
Novartis Investigative Site
Verona
VR
37126
Italy
Novartis Investigative Site
Nagoya
Aichi-ken
464 8681
Japan
Novartis Investigative Site
Kashiwa
Chiba
277 8577
Japan
Novartis Investigative Site
Fukuoka
Fukuoka
811-1395
Japan
Novartis Investigative Site
Fukuoka
Fukuoka
812-8582
Japan
Novartis Investigative Site
Akashi
Hyōgo
673-8558
Japan
Novartis Investigative Site
Okayama
Okayama-ken
700-8558
Japan
Novartis Investigative Site
Hirakata
Osaka
573-1191
Japan
Novartis Investigative Site
Osaka
Osaka
541-8567
Japan
Novartis Investigative Site
Ōsaka-sayama
Osaka
589 8511
Japan
Novartis Investigative Site
Takatsuki
Osaka
569-8686
Japan
Novartis Investigative Site
Koto Ku
Tokyo
135 8550
Japan
Novartis Investigative Site
Niigata
951 8520
Japan
Novartis Investigative Site
El Achrafiyé
166830
Lebanon
Novartis Investigative Site
Groningen
9713 GZ
Netherlands
Novartis Investigative Site
Lisbon
1649 035
Portugal
Novartis Investigative Site
Moscow
115478
Russia
Novartis Investigative Site
Moscow Region Istra Village
143423
Russia
Novartis Investigative Site
Saint Petersburg
197022
Russia
Novartis Investigative Site
Singapore
119074
Singapore
Novartis Investigative Site
Singapore
168583
Singapore
Novartis Investigative Site
Seoul
Seocho Gu
06591
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
06351
South Korea
Novartis Investigative Site
Seville
Andalusia
41009
Spain
Novartis Investigative Site
Seville
Andalusia
41013
Spain
Novartis Investigative Site
Barcelona
Catalonia
08028
Spain
Novartis Investigative Site
Barcelona
Catalonia
08035
Spain
Novartis Investigative Site
A Coruña
Galicia
15006
Spain
Novartis Investigative Site
Santiago de Compostela
Galicia
15706
Spain
Novartis Investigative Site
Valencia
Valencia
46010
Spain
Novartis Investigative Site
Madrid
28034
Spain
Novartis Investigative Site
Madrid
28041
Spain
Novartis Investigative Site
Madrid
28046
Spain
Novartis Investigative Site
Madrid
28222
Spain
Novartis Investigative Site
Lucerne
6000
Switzerland
Novartis Investigative Site
Sankt Gallen
9007
Switzerland
Novartis Investigative Site
Pendik Istanbul
Turkey
34899
Turkey (Türkiye)
Novartis Investigative Site
Istanbul
TUR
34098
Turkey (Türkiye)
Novartis Investigative Site
Ankara
06230
Turkey (Türkiye)
Novartis Investigative Site
Cheltenham
Gloucestershire
GL53 7AN
United Kingdom
Novartis Investigative Site
Aberdeen
Grampian Region
AB25 2ZN
United Kingdom
Novartis Investigative Site
Leicester
LE1 5WW
United Kingdom
Novartis Investigative Site
London
SE1 9RT
United Kingdom
Novartis Investigative Site
Southampton
SO30 3JB
United Kingdom
Derived
Shaw AT, Kim TM, Crino L, Gridelli C, Kiura K, Liu G, Novello S, Bearz A, Gautschi O, Mok T, Nishio M, Scagliotti G, Spigel DR, Deudon S, Zheng C, Pantano S, Urban P, Massacesi C, Viraswami-Appanna K, Felip E. Ceritinib versus chemotherapy in patients with ALK-rearranged non-small-cell lung cancer previously given chemotherapy and crizotinib (ASCEND-5): a randomised, controlled, open-label, phase 3 trial. Lancet Oncol. 2017 Jul;18(7):874-886. doi: 10.1016/S1470-2045(17)30339-X. Epub 2017 Jun 9.
FG002
Chemotherapy/Ceritinib
Patients randomized to chemotherapy who crossed over to ceritinib at the extension treatment phase
FG000115 subjects
FG001116 subjects
FG0020 subjects
Safety Set
All patients who received at least one dose of study drug
FG000115 subjects
FG001113 subjects
FG0020 subjects
COMPLETED
Patients who did not discontinue treatment at the end of the treatment phase
FG0000 subjects
FG0010 subjects
FG0020 subjects
NOT COMPLETED
FG000115 subjects
FG001116 subjects
FG0020 subjects
Type
Comment
Reasons
Adverse Event
FG0007 subjects
FG0018 subjects
FG0020 subjects
Death
FG0009 subjects
FG0015 subjects
FG0020 subjects
No longer required treatment
FG0000 subjects
FG0011 subjects
FG0020 subjects
Physician Decision
FG0006 subjects
FG0017 subjects
FG0020 subjects
Pregnancy
FG0001 subjects
FG0010 subjects
FG0020 subjects
Progressive disease
FG00079 subjects
FG00187 subjects
FG0020 subjects
Study terminated by sponsor
FG0001 subjects
FG0010 subjects
FG0020 subjects
Subject/guardian decision
FG00012 subjects
FG0018 subjects
FG0020 subjects
Extension Treatment Phase
Type
Comment
Milestone Data
STARTED
Patients randomized to chemotherapy who crossed over to the ceritinib arm
FG0000 subjects
FG0010 subjects
FG00279 subjects
Crossover Analysis Set
Patients who crossed over to the ceritinib arm and received at least one dose of ceritinib
FG0000 subjects
FG0010 subjects
FG00278 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG00279 subjects
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0010 subjects
FG0026 subjects
Death
FG000
The Full Analysis Set (FAS) consisted of all patients to whom study treatment had been assigned by randomization.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Ceritinib
Ceritinib 750 mg
BG001
Chemotherapy
Chemotherapy as determined by BIRC
BG002
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000115
BG001116
BG002231
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
BG00053.1± 11.96
BG00154.4± 11.61
BG00253.7± 11.78
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00068
BG00161
BG002
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Asian
BG00030
BG00138
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
Progression Free Survival (PFS) Per Blinded Independent Review Committee (BIRC)
PFS was defined as the time from the date of randomization to the date of the first radiologically documented disease progression or death due to any cause.
The Full Analysis Set (FAS) consisted of all patients to whom study treatment had been assigned by randomization.
Posted
Median
95% Confidence Interval
months
From the date of randomization to the date of first radiologically documented disease progression or death due to any cause up to approximately 24 months
ID
Title
Description
OG000
Ceritinib
Ceritinib 750 mg
OG001
Chemotherapy
Chemotherapy as determined by BIRC
Units
Counts
Participants
OG000115
OG001116
Title
Denominators
Categories
Title
Measurements
OG0005.4(4.1 to 6.9)
OG0011.6(1.4 to 2.8)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Log Rank
<0.001
Hazard Ratio (HR)
0.49
2-Sided
95
0.36
0.67
Superiority or Other (legacy)
Secondary
Overall Survival (OS)
OS was defined as time from date of randomization to date of death due to any cause.
The Full Analysis Set (FAS) consisted of all patients to whom study treatment had been assigned by randomization.
Posted
Median
95% Confidence Interval
months
Up to approximately 114 months
ID
Title
Description
OG000
Ceritinib
Ceritinib 750 mg
OG001
Chemotherapy
Chemotherapy as determined by BIRC
Units
Counts
Participants
OG000
Secondary
Progression Free Survival (PFS) Per Investigator Assessment
PFS was defined as the time from the date of randomization to the date of the first radiologically documented disease progression or death due to any cause.
The Full Analysis Set (FAS) consisted of all patients to whom study treatment had been assigned by randomization.
Posted
Median
95% Confidence Interval
months
Up to approximately 84 months
ID
Title
Description
OG000
Ceritinib
Ceritinib 750 mg
OG001
Chemotherapy
Chemotherapy as determined by BIRC
Units
Counts
Participants
OG000
Secondary
Overall Response Rate (ORR) Per BIRC
ORR was defined as the percentage of participants with a best overall response defined as complete response (CR) or partial response (PR): (CR+PR) per Response Evaluation Criteria in Solid Tumors (RECIST), v. 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) consisted of all patients to whom study treatment had been assigned by randomization.
Posted
Number
95% Confidence Interval
percentage of participants
Up to approximately 54 months
ID
Title
Description
OG000
Ceritinib
Ceritinib 750 mg
OG001
Chemotherapy
Chemotherapy as determined by BIRC
Units
Counts
Participants
OG000
Secondary
Overall Response Rate (ORR) Per Investigator Assessment
ORR was defined as the percentage of participants with a best overall response defined as complete response (CR) or partial response (PR): (CR+PR) per Response Evaluation Criteria in Solid Tumors (RECIST), v. 1.1. CR: Disappearance of all lesions with lymph nodes measuring < 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) consisted of all patients to whom study treatment had been assigned by randomization.
Posted
Number
95% Confidence Interval
percentage of participants
Up to approximately 93 months
ID
Title
Description
OG000
Ceritinib
Ceritinib 750 mg
OG001
Chemotherapy
Chemotherapy as determined by BIRC
Units
Counts
Participants
OG000
Secondary
Duration of Response (DOR) Per BIRC
DOR defined as the time from the first documented response (CR or PR) to the first documented progression or death due to underlying cancer. CR: Disappearance of all lesions with lymph nodes measuring < 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) consisted of all patients to whom study treatment had been assigned by randomization. Patients with confirmed CR or PR.
Posted
Median
95% Confidence Interval
months
Up to approximately 54 months
ID
Title
Description
OG000
Ceritinib
Ceritinib 750 mg
OG001
Chemotherapy
Chemotherapy as determined by BIRC
Units
Counts
Participants
OG000
Secondary
Duration of Response (DOR) Per Investigator Assessment
DOR defined as the time from the first documented response (CR or PR) to the first documented progression or death due to underlying cancer. CR: Disappearance of all lesions with lymph nodes measuring < 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) consisted of all patients to whom study treatment had been assigned by randomization. Data are reported for responders only. Patients with confirmed CR or PR.
Posted
Median
95% Confidence Interval
months
Up to approximately 93 months
ID
Title
Description
OG000
Ceritinib
Ceritinib 750 mg
OG001
Chemotherapy
Chemotherapy as determined by BIRC
Units
Counts
Participants
OG000
Secondary
Disease Control Rate (DCR) Per BIRC
DCR was defined as the percentage of participants with best overall response of CR, PR, or stable disease (SD). CR: Disappearance of all lesions with lymph nodes measuring < 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) consisted of all patients to whom study treatment had been assigned by randomization.
Posted
Number
95% Confidence Interval
percentage of participants
Up to approximately 54 months
ID
Title
Description
OG000
Ceritinib
Ceritinib 750 mg
OG001
Chemotherapy
Chemotherapy as determined by BIRC
Units
Counts
Participants
OG000
Secondary
Disease Control Rate (DCR) Per Investigator Assessment
DCR was defined as the percentage of participants with best overall response of CR, PR, or stable disease (SD). CR: Disappearance of all lesions with lymph nodes measuring < 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) consisted of all patients to whom study treatment had been assigned by randomization.
Posted
Number
95% Confidence Interval
percentage of participants
Up to approximately 93 months
ID
Title
Description
OG000
Ceritinib
Ceritinib 750 mg
OG001
Chemotherapy
Chemotherapy as determined by BIRC
Units
Counts
Participants
OG000
Secondary
Time to Response (TTR) Per BIRC
TTR was defined as the time from date of randomization to date of first documented response (CR or PR). CR: Disappearance of all lesions with lymph nodes measuring < 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) consisted of all patients to whom study treatment had been assigned by randomization. Patients with confirmed CR or PR.
Posted
Median
Full Range
weeks
Up to approximately 52 weeks
ID
Title
Description
OG000
Ceritinib
Ceritinib 750 mg
OG001
Chemotherapy
Chemotherapy as determined by BIRC
Units
Counts
Participants
OG000
Secondary
Time to Response (TTR) Per Investigator Assessment
TTR was defined as the time from date of randomization to date of first documented response (CR or PR). CR: Disappearance of all lesions with lymph nodes measuring < 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) consisted of all patients to whom study treatment had been assigned by randomization. Patients with confirmed CR or PR.
Posted
Median
Full Range
weeks
Up to approximately 45 weeks
ID
Title
Description
OG000
Ceritinib
Ceritinib 750 mg
OG001
Chemotherapy
Chemotherapy as determined by BIRC
Units
Counts
Participants
OG000
Secondary
Overall Intracranial Response Rate (OIRR) Per BIRC
OIRR was defined as the ORR based on lesions in brain (target, nontarget lesions (and new lesions, if applicable) and calculated as the percentage of patients with a best overall confirmed response of CR or PR in the brain per modified RECIST 1.1 as assessed by BIRC neuroradiologist. CR: Disappearance of all lesions with lymph nodes measuring < 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) consisted of all patients to whom study treatment had been assigned by randomization. Patients with measurable and/or nonmeasurable disease in the brain at baseline as per BIRC neuroradiology review.
Posted
Number
95% Confidence Interval
percentage of participants
Up to approximately 18 months
ID
Title
Description
OG000
Ceritinib
Ceritinib 750 mg
OG001
Chemotherapy
Chemotherapy as determined by BIRC
Units
Counts
Participants
Secondary
Intracranial Disease Control Rate (IDCR) Per BIRC
IDCR was defined as the DCR based on lesions in brain (target, non-target lesions (and new lesions, if applicable) and calculated as the proportion of patients with a best overall response of CR or PR or SD (or non-CR/nonPD) in the brain per modified RECIST 1.1 as assessed by BIRC neuro-radiologist. CR: Disappearance of all lesions with lymph nodes measuring < 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) consisted of all patients to whom study treatment had been assigned by randomization. Patients with measurable and/or nonmeasurable disease in the brain at baseline as per BIRC neuroradiology review.
Posted
Number
95% Confidence Interval
percentage of participants
Up to approximately 18 months
ID
Title
Description
OG000
Ceritinib
Ceritinib 750 mg
OG001
Chemotherapy
Chemotherapy as determined by BIRC
Units
Counts
Secondary
Duration of Intracranial Response (DOIR) Per BIRC
DOIR was defined as the DOR based on lesions in brain (target, non-target lesions (and new lesions, if applicable) and calculated from the time of first documented response of CR or PR to the date of the first documented disease progression in the brain or death due to any cause per modified RECIST 1.1 as assessed by BIRC neuro-radiologist. CR: Disappearance of all lesions with lymph nodes measuring < 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) consisted of all patients to whom study treatment had been assigned by randomization. Patients with measurable and/or nonmeasurable disease in the brain at baseline as per BIRC neuroradiology review. patients with measurable and/or non-measurable disease in the brain at baseline as per BIRC neuro-radiology review, and with confirmed intracranial CR or PR.
Posted
Median
95% Confidence Interval
months
Up to approximately 18 months
ID
Title
Description
OG000
Ceritinib
Ceritinib 750 mg
OG001
Chemotherapy
Chemotherapy as determined by BIRC
Units
Counts
Secondary
Least Squares Mean Scores on the European Organization for Research and Treatment of Cancer's Core Quality of Life Questionnaire (EORTC-QLQC30)
The EORTC QLQ-C30 questionnaire contained 30 items and was composed of both multi-item scales and single item measures. These included five functional scales (physical, role, emotional, cognitive, and social functioning), three symptom scales (fatigue, nausea/vomiting, and pain), six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial impact), and a global health status/quality of life (QoL) scale.
All of the scales and single items ranged from 0 to 100. A high scale score represented a higher response level. Thus, a high score for a functional scale indicated a high/healthy level of functioning, a high score for the QoL indicated high QoL, but a high score for a symptom scale/single item indicated a high level of symptomatology/problems. Data from all collected time points were combined and presented using a repeated measures model for longitudinal data.
The Full Analysis Set (FAS) consisted of all patients to whom study treatment had been assigned by randomization.
Posted
Least Squares Mean
Standard Error
score on a scale
Screening and treatment phase up to 92 months
ID
Title
Description
OG000
Ceritinib
Ceritinib 750 mg
OG001
Chemotherapy
Chemotherapy as determined by BIRC
Secondary
EORTC QLQ-LC13 Time to Definitive Deterioration
The Lung Cancer module of the EORTC's quality of life questionnaire (EORTC QLQ-LC13) was used in conjunction with the EORTC QLQ-C30 and provided information on an additional 13 items specifically related to lung cancer. The lung cancer module incorporated one multi-item scale to assess dyspnea, and 9 single items assessing pain, coughing, sore mouth, dysphagia, peripheral neuropathy, alopecia, and hemoptysis. All of the domain scores ranged from 0 to 100. A high score indicated a high level of symptoms. QLQ-LC13 time to definitive deterioration was defined as the time from randomization to the earliest date a patient shows a 10 point or higher increase from baseline in any of the ALCLC13 scores related to pain in chest, cough, or dyspnea (with no later change below this threshold), or death due to any cause. Each cycle was 21 days.
The Full Analysis Set (FAS) consisted of all patients to whom study treatment had been assigned by randomization.
Posted
Median
95% Confidence Interval
months
Screening and treatment phase up to 92 months
ID
Title
Description
OG000
Ceritinib
Ceritinib 750 mg
OG001
Chemotherapy
Chemotherapy as determined by BIRC
Secondary
Least Squares Mean Scores on the Lung Cancer Symptom Scale (LCSS)
The LCSS patient scale uses a 24-hour recall period and contains nine items: six measuring major symptoms for lung cancer (appetite loss, fatigue, cough, dyspnea, hemoptysis, pain), and three summary items related to total symptom distress, normal activity status, and overall quality of life. The total scale used is a 100 mm visual analog scale to measure the intensity of patient responses, with zero corresponding to the lowest rating (best status) and 100 representing the highest rating (worst status). The total score was calculated as the mean of the 9 items. Data from all collected time points were combined and presented using a repeated measures model for longitudinal data.
The Full Analysis Set (FAS) consisted of all patients to whom study treatment had been assigned by randomization.
Posted
Least Squares Mean
Standard Error
millimeters
Screening and treatment phase up to 92 months
ID
Title
Description
OG000
Ceritinib
Ceritinib 750 mg
OG001
Chemotherapy
Chemotherapy as determined by BIRC
Units
Counts
Participants
Secondary
Least Squares Mean Scores on the EQ-5D-5L Index
The EQ-5D descriptive classification consists of five dimensions of health: mobility, self-care, usual activities, anxiety/depression and pain/discomfort. Patients are requested to select the statement which best describes their condition on that day for each dimension. EQ-5D-5L index scores can range from -0.59 to 1, where 1 is the best possible health state. Data from all collected time points were combined and presented using a repeated measures model for longitudinal data.
The Full Analysis Set (FAS) consisted of all patients to whom study treatment had been assigned by randomization.
Posted
Least Squares Mean
Standard Error
score on a scale
Screening and treatment phase up to 92 months
ID
Title
Description
OG000
Ceritinib
Ceritinib 750 mg
OG001
Chemotherapy
Chemotherapy as determined by BIRC
Units
Counts
Participants
OG000
Secondary
Least Squares Mean Scores on the EQ-5D Visual Analogue Scale (VAS)
The EQ-5D descriptive classification consists of five dimensions of health: mobility, self-care, usual activities, anxiety/depression and pain/discomfort. Patients are requested to select the statement which best describes their condition on that day for each dimension. EQ VAS scores can range from 0 to 100, where 100 is the best possible health state. Data from all collected time points were combined and presented using a repeated measures model for longitudinal data.
The Full Analysis Set (FAS) consisted of all patients to whom study treatment had been assigned by randomization.
Posted
Least Squares Mean
Standard Error
score on a scale
Screening and treatment phase up to 92 months
ID
Title
Description
OG000
Ceritinib
Ceritinib 750 mg
OG001
Chemotherapy
Chemotherapy as determined by BIRC
Units
Counts
Participants
OG000
Secondary
Cmax for Ceritinib
The observed maximum plasma concentration following administration
Participants in the pharmacokinetic (PK) analysis set who had extensive PK collection.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng/mL
Cycle 1, Day 1 and Cycle 2, Day 1: pre-dose and 1, 2, 4, 6, 8, and 24 hours post-dose. Each cycle was 21 days.
ID
Title
Description
OG000
Ceritinib
Ceritinib 750 mg
OG001
Chemotherapy
Chemotherapy as determined by BIRC
Units
Counts
Participants
OG000
Secondary
Tmax for Ceritinib
The time to reach peak or maximum concentration
Participants in the pharmacokinetic (PK) analysis set who had extensive PK collection.
Posted
Median
Full Range
hours
Cycle 1, Day 1 and Cycle 2, Day 1: pre-dose and 1, 2, 4, 6, 8, and 24 hours post-dose. Each cycle was 21 days.
ID
Title
Description
OG000
Ceritinib
Ceritinib 750 mg
OG001
Chemotherapy
Chemotherapy as determined by BIRC
Units
Counts
Participants
OG000
Secondary
Tlast for Ceritinib
The time to last quantifiable concentration
Participants in the pharmacokinetic (PK) analysis set who had extensive PK collection.
Posted
Median
Full Range
hours
Cycle 1, Day 1 and Cycle 2, Day 1: pre-dose and 1, 2, 4, 6, 8, and 24 hours post-dose. Each cycle was 21 days.
ID
Title
Description
OG000
Ceritinib
Ceritinib 750 mg
OG001
Chemotherapy
Chemotherapy as determined by BIRC
Units
Counts
Participants
OG000
Secondary
AUC0-24h for Ceritinib
The area under the plasma concentration-time curve calculated from time zero to 24 hours
Participants in the pharmacokinetic (PK) analysis set who had extensive PK collection.
Posted
Geometric Mean
Geometric Coefficient of Variation
h*ng/mL
Cycle 1, Day 1 and Cycle 2, Day 1: pre-dose and 1, 2, 4, 6, 8, and 24 hours post-dose. Each cycle was 21 days.
ID
Title
Description
OG000
Ceritinib
Ceritinib 750 mg
OG001
Chemotherapy
Chemotherapy as determined by BIRC
Units
Counts
Participants
OG000
Secondary
Mean Accumulation Ratio (Racc) for Ceritinib
Accumulation ratio calculated using AUC0-24 values obtained from a dosing interval at steady-state (Cycle 2, Day 1) divided by AUC0-24 on Cycle 1, Day 1.
Participants in the pharmacokinetic (PK) analysis set who had extensive PK collection.
Posted
Geometric Mean
Geometric Coefficient of Variation
ratio
Cycle 1, Day 1 and Cycle 2, Day 1: pre-dose and 1, 2, 4, 6, 8, and 24 hours post-dose. Each cycle was 21 days.
ID
Title
Description
OG000
Ceritinib
Ceritinib 750 mg
OG001
Chemotherapy
Chemotherapy as determined by BIRC
Units
Counts
Participants
OG000
Secondary
Clearance Rate at Steady State (CLss/F) for Ceritinib
The apparent total body clearance from plasma. CLss/F is calculated from AUC0-24 assuming steady state (CLss/F=Dose/AUC0-24).
Participants in the pharmacokinetic (PK) analysis set who had extensive PK collection.
Posted
Geometric Mean
Geometric Coefficient of Variation
L/h
Cycle 1, Day 1 and Cycle 2, Day 1: pre-dose and 1, 2, 4, 6, 8, and 24 hours post-dose. Each cycle was 21 days.
ID
Title
Description
OG000
Ceritinib
Ceritinib 750 mg
OG001
Chemotherapy
Chemotherapy as determined by BIRC
Units
Counts
Participants
OG000
Secondary
Post-Hoc: All Collected Deaths
Pre-treatment deaths: from day of patient's informed consent to the day before first dose of study treatment. On-treatment deaths: from first dose of study treatment to 30 days following the last dose of study treatment at the end of treatment phase. For crossover patients, from first dose of ceritinib at the extension treatment phase to 30 days following the last dose. Survival Follow-up deaths: from Day 31 after last dose of study treatment to the data cut-off date.
The analysis included patients who received at least one dose of study drug. For the Chemotherapy/Ceritinib group, the analysis included patients randomized to the chemotherapy arm who crossed over to receive at least one dose of ceritinib in the extension-treatment phase. For pre-treatment deaths, all randomized patients are included.
Posted
Count of Participants
Participants
Pre-treatment and on-treatment deaths: Up to approximately 8 years. Post-treatment survival follow-up deaths: Up to an additional 2.5 years.
ID
Title
Description
OG000
Ceritinib
Ceritinib 750 mg
OG001
Chemotherapy
Chemotherapy as determined by BIRC
OG002
Chemotherapy/Ceritinib
Patients randomized to chemotherapy who crossed over to ceritinib at the extension treatment phase
Time Frame
From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
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 participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
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
Ceritinib (Pre-treatment)
Ceritinib 750 mg
0
115
0
0
0
0
EG001
Chemotherapy (Pre-treatment)
Chemotherapy as determined by BIRC
2
116
0
0
0
0
EG002
Chemotherapy/Ceritinib (Pre-treatment)
Patients randomized to chemotherapy who crossed over to ceritinib at the extension treatment phase
0
0
0
0
0
0
EG003
Ceritinib (On-treatment)
Ceritinib 750 mg
16
115
57
115
114
115
EG004
Chemotherapy (On-treatment)
Chemotherapy as determined by BIRC
5
113
35
113
111
113
EG005
Chemotherapy/Ceritinib (On-treatment)
Patients randomized to chemotherapy who crossed over to ceritinib at the extension treatment phase
19
78
45
78
76
78
EG006
Ceritinib (Survival Follow-up)
Ceritinib 750 mg
86
93
0
0
0
0
EG007
Chemotherapy (Survival Follow-up)
Chemotherapy as determined by BIRC
18
23
0
0
0
0
EG008
Chemotherapy/Ceritinib (Survival Follow-up)
Patients randomized to chemotherapy who crossed over to ceritinib at the extension treatment phase
44
55
0
0
0
0
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA (26.1)
Systematic Assessment
EG0000 at risk
EG0010 at risk
EG0020 at risk
EG0030 affected115 at risk
EG0041 affected113 at risk
EG0050 affected78 at risk
EG0060 at risk
EG0070 at risk
EG0080 at risk
Febrile neutropenia
Blood and lymphatic system disorders
MedDRA (26.1)
Systematic Assessment
EG0000 at risk
EG0010 at risk
EG0020 at risk
EG003
Acute coronary syndrome
Cardiac disorders
MedDRA (26.1)
Systematic Assessment
EG0000 at risk
EG0010 at risk
EG0020 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA (26.1)
Systematic Assessment
EG0000 at risk
EG0010 at risk
EG0020 at risk
EG003
Atrial flutter
Cardiac disorders
MedDRA (26.1)
Systematic Assessment
EG0000 at risk
EG0010 at risk
EG0020 at risk
EG003
Cardiac arrest
Cardiac disorders
MedDRA (26.1)
Systematic Assessment
EG0000 at risk
EG0010 at risk
EG0020 at risk
EG003
Myocardial ischaemia
Cardiac disorders
MedDRA (26.1)
Systematic Assessment
EG0000 at risk
EG0010 at risk
EG0020 at risk
EG003
Pericardial effusion
Cardiac disorders
MedDRA (26.1)
Systematic Assessment
EG0000 at risk
EG0010 at risk
EG0020 at risk
EG003
Pericarditis
Cardiac disorders
MedDRA (26.1)
Systematic Assessment
EG0000 at risk
EG0010 at risk
EG0020 at risk
EG003
Ventricular extrasystoles
Cardiac disorders
MedDRA (26.1)
Systematic Assessment
EG0000 at risk
EG0010 at risk
EG0020 at risk
EG003
Lenticular opacities
Eye disorders
MedDRA (26.1)
Systematic Assessment
EG0000 at risk
EG0010 at risk
EG0020 at risk
EG003
Visual field defect
Eye disorders
MedDRA (26.1)
Systematic Assessment
EG0000 at risk
EG0010 at risk
EG0020 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA (26.1)
Systematic Assessment
EG0000 at risk
EG0010 at risk
EG0020 at risk
EG003
Colitis
Gastrointestinal disorders
MedDRA (26.1)
Systematic Assessment
EG0000 at risk
EG0010 at risk
EG0020 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA (26.1)
Systematic Assessment
EG0000 at risk
EG0010 at risk
EG0020 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA (26.1)
Systematic Assessment
EG0000 at risk
EG0010 at risk
EG0020 at risk
EG003
Faecaloma
Gastrointestinal disorders
MedDRA (26.1)
Systematic Assessment
EG0000 at risk
EG0010 at risk
EG0020 at risk
EG003
Gastric perforation
Gastrointestinal disorders
MedDRA (26.1)
Systematic Assessment
EG0000 at risk
EG0010 at risk
EG0020 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA (26.1)
Systematic Assessment
EG0000 at risk
EG0010 at risk
EG0020 at risk
EG003
Gastrointestinal obstruction
Gastrointestinal disorders
MedDRA (26.1)
Systematic Assessment
EG0000 at risk
EG0010 at risk
EG0020 at risk
EG003
Gastrointestinal perforation
Gastrointestinal disorders
MedDRA (26.1)
Systematic Assessment
EG0000 at risk
EG0010 at risk
EG0020 at risk
EG003
Gastrointestinal toxicity
Gastrointestinal disorders
MedDRA (26.1)
Systematic Assessment
EG0000 at risk
EG0010 at risk
EG0020 at risk
EG003
Haematemesis
Gastrointestinal disorders
MedDRA (26.1)
Systematic Assessment
EG0000 at risk
EG0010 at risk
EG0020 at risk
EG003
Large intestine perforation
Gastrointestinal disorders
MedDRA (26.1)
Systematic Assessment
EG0000 at risk
EG0010 at risk
EG0020 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA (26.1)
Systematic Assessment
EG0000 at risk
EG0010 at risk
EG0020 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA (26.1)
Systematic Assessment
EG0000 at risk
EG0010 at risk
EG0020 at risk
EG003
Asthenia
General disorders
MedDRA (26.1)
Systematic Assessment
EG0000 at risk
EG0010 at risk
EG0020 at risk
EG003
Chest pain
General disorders
MedDRA (26.1)
Systematic Assessment
EG0000 at risk
EG0010 at risk
EG0020 at risk
EG003
Condition aggravated
General disorders
MedDRA (26.1)
Systematic Assessment
EG0000 at risk
EG0010 at risk
EG0020 at risk
EG003
Fatigue
General disorders
MedDRA (26.1)
Systematic Assessment
EG0000 at risk
EG0010 at risk
EG0020 at risk
EG003
General physical health deterioration
General disorders
MedDRA (26.1)
Systematic Assessment
EG0000 at risk
EG0010 at risk
EG0020 at risk
EG003
Multiple organ dysfunction syndrome
General disorders
MedDRA (26.1)
Systematic Assessment
EG0000 at risk
EG0010 at risk
EG0020 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA (26.1)
Systematic Assessment
EG0000 at risk
EG0010 at risk
EG0020 at risk
EG003
Pain
General disorders
MedDRA (26.1)
Systematic Assessment
EG0000 at risk
EG0010 at risk
EG0020 at risk
EG003
Pyrexia
General disorders
MedDRA (26.1)
Systematic Assessment
EG0000 at risk
EG0010 at risk
EG0020 at risk
EG003
Sudden death
General disorders
MedDRA (26.1)
Systematic Assessment
EG0000 at risk
EG0010 at risk
EG0020 at risk
EG003
Acute hepatic failure
Hepatobiliary disorders
MedDRA (26.1)
Systematic Assessment
EG0000 at risk
EG0010 at risk
EG0020 at risk
EG003
Hepatic failure
Hepatobiliary disorders
MedDRA (26.1)
Systematic Assessment
EG0000 at risk
EG0010 at risk
EG0020 at risk
EG003
Hepatic lesion
Hepatobiliary disorders
MedDRA (26.1)
Systematic Assessment
EG0000 at risk
EG0010 at risk
EG0020 at risk
EG003
Jaundice
Hepatobiliary disorders
MedDRA (26.1)
Systematic Assessment
EG0000 at risk
EG0010 at risk
EG0020 at risk
EG003
Bacteraemia
Infections and infestations
MedDRA (26.1)
Systematic Assessment
EG0000 at risk
EG0010 at risk
EG0020 at risk
EG003
Bacterial pyelonephritis
Infections and infestations
MedDRA (26.1)
Systematic Assessment
EG0000 at risk
EG0010 at risk
EG0020 at risk
EG003
Biliary tract infection
Infections and infestations
MedDRA (26.1)
Systematic Assessment
EG0000 at risk
EG0010 at risk
EG0020 at risk
EG003
Bronchitis
Infections and infestations
MedDRA (26.1)
Systematic Assessment
EG0000 at risk
EG0010 at risk
EG0020 at risk
EG003
Hepatic infection
Infections and infestations
MedDRA (26.1)
Systematic Assessment
EG0000 at risk
EG0010 at risk
EG0020 at risk
EG003
Infection
Infections and infestations
MedDRA (26.1)
Systematic Assessment
EG0000 at risk
EG0010 at risk
EG0020 at risk
EG003
Localised infection
Infections and infestations
MedDRA (26.1)
Systematic Assessment
EG0000 at risk
EG0010 at risk
EG0020 at risk
EG003
Lower respiratory tract infection
Infections and infestations
MedDRA (26.1)
Systematic Assessment
EG0000 at risk
EG0010 at risk
EG0020 at risk
EG003
Mucosal infection
Infections and infestations
MedDRA (26.1)
Systematic Assessment
EG0000 at risk
EG0010 at risk
EG0020 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA (26.1)
Systematic Assessment
EG0000 at risk
EG0010 at risk
EG0020 at risk
EG003
Neutropenic sepsis
Infections and infestations
MedDRA (26.1)
Systematic Assessment
EG0000 at risk
EG0010 at risk
EG0020 at risk
EG003
Oral herpes
Infections and infestations
MedDRA (26.1)
Systematic Assessment
EG0000 at risk
EG0010 at risk
EG0020 at risk
EG003
Oropharyngeal candidiasis
Infections and infestations
MedDRA (26.1)
Systematic Assessment
EG0000 at risk
EG0010 at risk
EG0020 at risk
EG003
Pneumonia
Infections and infestations
MedDRA (26.1)
Systematic Assessment
EG0000 at risk
EG0010 at risk
EG0020 at risk
EG003
Pseudomembranous colitis
Infections and infestations
MedDRA (26.1)
Systematic Assessment
EG0000 at risk
EG0010 at risk
EG0020 at risk
EG003
Respiratory tract infection
Infections and infestations
MedDRA (26.1)
Systematic Assessment
EG0000 at risk
EG0010 at risk
EG0020 at risk
EG003
Typhoid fever
Infections and infestations
MedDRA (26.1)
Systematic Assessment
EG0000 at risk
EG0010 at risk
EG0020 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA (26.1)
Systematic Assessment
EG0000 at risk
EG0010 at risk
EG0020 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA (26.1)
Systematic Assessment
EG0000 at risk
EG0010 at risk
EG0020 at risk
EG003
Urosepsis
Infections and infestations
MedDRA (26.1)
Systematic Assessment
EG0000 at risk
EG0010 at risk
EG0020 at risk
EG003
Viral infection
Infections and infestations
MedDRA (26.1)
Systematic Assessment
EG0000 at risk
EG0010 at risk
EG0020 at risk
EG003
Hip fracture
Injury, poisoning and procedural complications
MedDRA (26.1)
Systematic Assessment
EG0000 at risk
EG0010 at risk
EG0020 at risk
EG003
Radius fracture
Injury, poisoning and procedural complications
MedDRA (26.1)
Systematic Assessment
EG0000 at risk
EG0010 at risk
EG0020 at risk
EG003
Tracheal obstruction
Injury, poisoning and procedural complications
MedDRA (26.1)
Systematic Assessment
EG0000 at risk
EG0010 at risk
EG0020 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA (26.1)
Systematic Assessment
EG0000 at risk
EG0010 at risk
EG0020 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA (26.1)
Systematic Assessment
EG0000 at risk
EG0010 at risk
EG0020 at risk
EG003
C-reactive protein increased
Investigations
MedDRA (26.1)
Systematic Assessment
EG0000 at risk
EG0010 at risk
EG0020 at risk
EG003
Electrocardiogram QT prolonged
Investigations
MedDRA (26.1)
Systematic Assessment
EG0000 at risk
EG0010 at risk
EG0020 at risk
EG003
Electrocardiogram T wave inversion
Investigations
MedDRA (26.1)
Systematic Assessment
EG0000 at risk
EG0010 at risk
EG0020 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA (26.1)
Systematic Assessment
EG0000 at risk
EG0010 at risk
EG0020 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA (26.1)
Systematic Assessment
EG0000 at risk
EG0010 at risk
EG0020 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA (26.1)
Systematic Assessment
EG0000 at risk
EG0010 at risk
EG0020 at risk
EG003
Diabetes mellitus inadequate control
Metabolism and nutrition disorders
MedDRA (26.1)
Systematic Assessment
EG0000 at risk
EG0010 at risk
EG0020 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA (26.1)
Systematic Assessment
EG0000 at risk
EG0010 at risk
EG0020 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA (26.1)
Systematic Assessment
EG0000 at risk
EG0010 at risk
EG0020 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA (26.1)
Systematic Assessment
EG0000 at risk
EG0010 at risk
EG0020 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA (26.1)
Systematic Assessment
EG0000 at risk
EG0010 at risk
EG0020 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA (26.1)
Systematic Assessment
EG0000 at risk
EG0010 at risk
EG0020 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA (26.1)
Systematic Assessment
EG0000 at risk
EG0010 at risk
EG0020 at risk
EG003
Mobility decreased
Musculoskeletal and connective tissue disorders
MedDRA (26.1)
Systematic Assessment
EG0000 at risk
EG0010 at risk
EG0020 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA (26.1)
Systematic Assessment
EG0000 at risk
EG0010 at risk
EG0020 at risk
EG003
Pathological fracture
Musculoskeletal and connective tissue disorders
MedDRA (26.1)
Systematic Assessment
EG0000 at risk
EG0010 at risk
EG0020 at risk
EG003
Bladder neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (26.1)
Systematic Assessment
EG0000 at risk
EG0010 at risk
EG0020 at risk
EG003
Metastases to central nervous system
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (26.1)
Systematic Assessment
EG0000 at risk
EG0010 at risk
EG0020 at risk
EG003
Metastases to meninges
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (26.1)
Systematic Assessment
EG0000 at risk
EG0010 at risk
EG0020 at risk
EG003
Tumour flare
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (26.1)
Systematic Assessment
EG0000 at risk
EG0010 at risk
EG0020 at risk
EG003
Aphasia
Nervous system disorders
MedDRA (26.1)
Systematic Assessment
EG0000 at risk
EG0010 at risk
EG0020 at risk
EG003
Brain oedema
Nervous system disorders
MedDRA (26.1)
Systematic Assessment
EG0000 at risk
EG0010 at risk
EG0020 at risk
EG003
Cerebellar infarction
Nervous system disorders
MedDRA (26.1)
Systematic Assessment
EG0000 at risk
EG0010 at risk
EG0020 at risk
EG003
Cerebrovascular accident
Nervous system disorders
MedDRA (26.1)
Systematic Assessment
EG0000 at risk
EG0010 at risk
EG0020 at risk
EG003
Cognitive disorder
Nervous system disorders
MedDRA (26.1)
Systematic Assessment
EG0000 at risk
EG0010 at risk
EG0020 at risk
EG003
Coordination abnormal
Nervous system disorders
MedDRA (26.1)
Systematic Assessment
EG0000 at risk
EG0010 at risk
EG0020 at risk
EG003
Depressed level of consciousness
Nervous system disorders
MedDRA (26.1)
Systematic Assessment
EG0000 at risk
EG0010 at risk
EG0020 at risk
EG003
Dizziness
Nervous system disorders
MedDRA (26.1)
Systematic Assessment
EG0000 at risk
EG0010 at risk
EG0020 at risk
EG003
Epilepsy
Nervous system disorders
MedDRA (26.1)
Systematic Assessment
EG0000 at risk
EG0010 at risk
EG0020 at risk
EG003
Headache
Nervous system disorders
MedDRA (26.1)
Systematic Assessment
EG0000 at risk
EG0010 at risk
EG0020 at risk
EG003
Intracranial mass
Nervous system disorders
MedDRA (26.1)
Systematic Assessment
EG0000 at risk
EG0010 at risk
EG0020 at risk
EG003
Loss of consciousness
Nervous system disorders
MedDRA (26.1)
Systematic Assessment
EG0000 at risk
EG0010 at risk
EG0020 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA (26.1)
Systematic Assessment
EG0000 at risk
EG0010 at risk
EG0020 at risk
EG003
Paraparesis
Nervous system disorders
MedDRA (26.1)
Systematic Assessment
EG0000 at risk
EG0010 at risk
EG0020 at risk
EG003
Parkinsonism
Nervous system disorders
MedDRA (26.1)
Systematic Assessment
EG0000 at risk
EG0010 at risk
EG0020 at risk
EG003
Partial seizures
Nervous system disorders
MedDRA (26.1)
Systematic Assessment
EG0000 at risk
EG0010 at risk
EG0020 at risk
EG003
Petit mal epilepsy
Nervous system disorders
MedDRA (26.1)
Systematic Assessment
EG0000 at risk
EG0010 at risk
EG0020 at risk
EG003
Presyncope
Nervous system disorders
MedDRA (26.1)
Systematic Assessment
EG0000 at risk
EG0010 at risk
EG0020 at risk
EG003
Seizure
Nervous system disorders
MedDRA (26.1)
Systematic Assessment
EG0000 at risk
EG0010 at risk
EG0020 at risk
EG003
Syncope
Nervous system disorders
MedDRA (26.1)
Systematic Assessment
EG0000 at risk
EG0010 at risk
EG0020 at risk
EG003
Device failure
Product Issues
MedDRA (26.1)
Systematic Assessment
EG0000 at risk
EG0010 at risk
EG0020 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA (26.1)
Systematic Assessment
EG0000 at risk
EG0010 at risk
EG0020 at risk
EG003
Anxiety disorder
Psychiatric disorders
MedDRA (26.1)
Systematic Assessment
EG0000 at risk
EG0010 at risk
EG0020 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA (26.1)
Systematic Assessment
EG0000 at risk
EG0010 at risk
EG0020 at risk
EG003
Hallucination
Psychiatric disorders
MedDRA (26.1)
Systematic Assessment
EG0000 at risk
EG0010 at risk
EG0020 at risk
EG003
Mental status changes
Psychiatric disorders
MedDRA (26.1)
Systematic Assessment
EG0000 at risk
EG0010 at risk
EG0020 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA (26.1)
Systematic Assessment
EG0000 at risk
EG0010 at risk
EG0020 at risk
EG003
Renal failure
Renal and urinary disorders
MedDRA (26.1)
Systematic Assessment
EG0000 at risk
EG0010 at risk
EG0020 at risk
EG003
Urinary bladder rupture
Renal and urinary disorders
MedDRA (26.1)
Systematic Assessment
EG0000 at risk
EG0010 at risk
EG0020 at risk
EG003
Urinary retention
Renal and urinary disorders
MedDRA (26.1)
Systematic Assessment
EG0000 at risk
EG0010 at risk
EG0020 at risk
EG003
Acute respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA (26.1)
Systematic Assessment
EG0000 at risk
EG0010 at risk
EG0020 at risk
EG003
Chronic obstructive pulmonary disease
Respiratory, thoracic and mediastinal disorders
MedDRA (26.1)
Systematic Assessment
EG0000 at risk
EG0010 at risk
EG0020 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA (26.1)
Systematic Assessment
EG0000 at risk
EG0010 at risk
EG0020 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA (26.1)
Systematic Assessment
EG0000 at risk
EG0010 at risk
EG0020 at risk
EG003
Interstitial lung disease
Respiratory, thoracic and mediastinal disorders
MedDRA (26.1)
Systematic Assessment
EG0000 at risk
EG0010 at risk
EG0020 at risk
EG003
Lung infiltration
Respiratory, thoracic and mediastinal disorders
MedDRA (26.1)
Systematic Assessment
EG0000 at risk
EG0010 at risk
EG0020 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA (26.1)
Systematic Assessment
EG0000 at risk
EG0010 at risk
EG0020 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
MedDRA (26.1)
Systematic Assessment
EG0000 at risk
EG0010 at risk
EG0020 at risk
EG003
Pneumothorax
Respiratory, thoracic and mediastinal disorders
MedDRA (26.1)
Systematic Assessment
EG0000 at risk
EG0010 at risk
EG0020 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA (26.1)
Systematic Assessment
EG0000 at risk
EG0010 at risk
EG0020 at risk
EG003
Respiratory distress
Respiratory, thoracic and mediastinal disorders
MedDRA (26.1)
Systematic Assessment
EG0000 at risk
EG0010 at risk
EG0020 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA (26.1)
Systematic Assessment
EG0000 at risk
EG0010 at risk
EG0020 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA (26.1)
Systematic Assessment
EG0000 at risk
EG0010 at risk
EG0020 at risk
EG003
Lymphoedema
Vascular disorders
MedDRA (26.1)
Systematic Assessment
EG0000 at risk
EG0010 at risk
EG0020 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA (26.1)
Systematic Assessment
EG0000 at risk
EG0010 at risk
EG0020 at risk
EG0037 affected115 at risk
EG00420 affected113 at risk
EG0058 affected78 at risk
EG0060 at risk
EG0070 at risk
EG0080 at risk
Febrile neutropenia
Blood and lymphatic system disorders
MedDRA (26.1)
Systematic Assessment
EG0000 at risk
EG0010 at risk
EG0020 at risk
EG003
Leukopenia
Blood and lymphatic system disorders
MedDRA (26.1)
Systematic Assessment
EG0000 at risk
EG0010 at risk
EG0020 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA (26.1)
Systematic Assessment
EG0000 at risk
EG0010 at risk
EG0020 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA (26.1)
Systematic Assessment
EG0000 at risk
EG0010 at risk
EG0020 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA (26.1)
Systematic Assessment
EG0000 at risk
EG0010 at risk
EG0020 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA (26.1)
Systematic Assessment
EG0000 at risk
EG0010 at risk
EG0020 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA (26.1)
Systematic Assessment
EG0000 at risk
EG0010 at risk
EG0020 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA (26.1)
Systematic Assessment
EG0000 at risk
EG0010 at risk
EG0020 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA (26.1)
Systematic Assessment
EG0000 at risk
EG0010 at risk
EG0020 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA (26.1)
Systematic Assessment
EG0000 at risk
EG0010 at risk
EG0020 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA (26.1)
Systematic Assessment
EG0000 at risk
EG0010 at risk
EG0020 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA (26.1)
Systematic Assessment
EG0000 at risk
EG0010 at risk
EG0020 at risk
EG003
Asthenia
General disorders
MedDRA (26.1)
Systematic Assessment
EG0000 at risk
EG0010 at risk
EG0020 at risk
EG003
Fatigue
General disorders
MedDRA (26.1)
Systematic Assessment
EG0000 at risk
EG0010 at risk
EG0020 at risk
EG003
Malaise
General disorders
MedDRA (26.1)
Systematic Assessment
EG0000 at risk
EG0010 at risk
EG0020 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA (26.1)
Systematic Assessment
EG0000 at risk
EG0010 at risk
EG0020 at risk
EG003
Oedema peripheral
General disorders
MedDRA (26.1)
Systematic Assessment
EG0000 at risk
EG0010 at risk
EG0020 at risk
EG003
Pain
General disorders
MedDRA (26.1)
Systematic Assessment
EG0000 at risk
EG0010 at risk
EG0020 at risk
EG003
Pyrexia
General disorders
MedDRA (26.1)
Systematic Assessment
EG0000 at risk
EG0010 at risk
EG0020 at risk
EG003
Bronchitis
Infections and infestations
MedDRA (26.1)
Systematic Assessment
EG0000 at risk
EG0010 at risk
EG0020 at risk
EG003
Cystitis
Infections and infestations
MedDRA (26.1)
Systematic Assessment
EG0000 at risk
EG0010 at risk
EG0020 at risk
EG003
Influenza
Infections and infestations
MedDRA (26.1)
Systematic Assessment
EG0000 at risk
EG0010 at risk
EG0020 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA (26.1)
Systematic Assessment
EG0000 at risk
EG0010 at risk
EG0020 at risk
EG003
Oral candidiasis
Infections and infestations
MedDRA (26.1)
Systematic Assessment
EG0000 at risk
EG0010 at risk
EG0020 at risk
EG003
Pneumonia
Infections and infestations
MedDRA (26.1)
Systematic Assessment
EG0000 at risk
EG0010 at risk
EG0020 at risk
EG003
Respiratory tract infection
Infections and infestations
MedDRA (26.1)
Systematic Assessment
EG0000 at risk
EG0010 at risk
EG0020 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA (26.1)
Systematic Assessment
EG0000 at risk
EG0010 at risk
EG0020 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA (26.1)
Systematic Assessment
EG0000 at risk
EG0010 at risk
EG0020 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA (26.1)
Systematic Assessment
EG0000 at risk
EG0010 at risk
EG0020 at risk
EG003
Amylase increased
Investigations
MedDRA (26.1)
Systematic Assessment
EG0000 at risk
EG0010 at risk
EG0020 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA (26.1)
Systematic Assessment
EG0000 at risk
EG0010 at risk
EG0020 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA (26.1)
Systematic Assessment
EG0000 at risk
EG0010 at risk
EG0020 at risk
EG003
Blood creatinine increased
Investigations
MedDRA (26.1)
Systematic Assessment
EG0000 at risk
EG0010 at risk
EG0020 at risk
EG003
Electrocardiogram QT prolonged
Investigations
MedDRA (26.1)
Systematic Assessment
EG0000 at risk
EG0010 at risk
EG0020 at risk
EG003
Gamma-glutamyltransferase increased
Investigations
MedDRA (26.1)
Systematic Assessment
EG0000 at risk
EG0010 at risk
EG0020 at risk
EG003
Lipase increased
Investigations
MedDRA (26.1)
Systematic Assessment
EG0000 at risk
EG0010 at risk
EG0020 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA (26.1)
Systematic Assessment
EG0000 at risk
EG0010 at risk
EG0020 at risk
EG003
Weight decreased
Investigations
MedDRA (26.1)
Systematic Assessment
EG0000 at risk
EG0010 at risk
EG0020 at risk
EG003
White blood cell count decreased
Investigations
MedDRA (26.1)
Systematic Assessment
EG0000 at risk
EG0010 at risk
EG0020 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA (26.1)
Systematic Assessment
EG0000 at risk
EG0010 at risk
EG0020 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA (26.1)
Systematic Assessment
EG0000 at risk
EG0010 at risk
EG0020 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRA (26.1)
Systematic Assessment
EG0000 at risk
EG0010 at risk
EG0020 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA (26.1)
Systematic Assessment
EG0000 at risk
EG0010 at risk
EG0020 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA (26.1)
Systematic Assessment
EG0000 at risk
EG0010 at risk
EG0020 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA (26.1)
Systematic Assessment
EG0000 at risk
EG0010 at risk
EG0020 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA (26.1)
Systematic Assessment
EG0000 at risk
EG0010 at risk
EG0020 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA (26.1)
Systematic Assessment
EG0000 at risk
EG0010 at risk
EG0020 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA (26.1)
Systematic Assessment
EG0000 at risk
EG0010 at risk
EG0020 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA (26.1)
Systematic Assessment
EG0000 at risk
EG0010 at risk
EG0020 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA (26.1)
Systematic Assessment
EG0000 at risk
EG0010 at risk
EG0020 at risk
EG003
Dizziness
Nervous system disorders
MedDRA (26.1)
Systematic Assessment
EG0000 at risk
EG0010 at risk
EG0020 at risk
EG003
Headache
Nervous system disorders
MedDRA (26.1)
Systematic Assessment
EG0000 at risk
EG0010 at risk
EG0020 at risk
EG003
Neuropathy peripheral
Nervous system disorders
MedDRA (26.1)
Systematic Assessment
EG0000 at risk
EG0010 at risk
EG0020 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA (26.1)
Systematic Assessment
EG0000 at risk
EG0010 at risk
EG0020 at risk
EG003
Somnolence
Nervous system disorders
MedDRA (26.1)
Systematic Assessment
EG0000 at risk
EG0010 at risk
EG0020 at risk
EG003
Tremor
Nervous system disorders
MedDRA (26.1)
Systematic Assessment
EG0000 at risk
EG0010 at risk
EG0020 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA (26.1)
Systematic Assessment
EG0000 at risk
EG0010 at risk
EG0020 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA (26.1)
Systematic Assessment
EG0000 at risk
EG0010 at risk
EG0020 at risk
EG003
Pollakiuria
Renal and urinary disorders
MedDRA (26.1)
Systematic Assessment
EG0000 at risk
EG0010 at risk
EG0020 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA (26.1)
Systematic Assessment
EG0000 at risk
EG0010 at risk
EG0020 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA (26.1)
Systematic Assessment
EG0000 at risk
EG0010 at risk
EG0020 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA (26.1)
Systematic Assessment
EG0000 at risk
EG0010 at risk
EG0020 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA (26.1)
Systematic Assessment
EG0000 at risk
EG0010 at risk
EG0020 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA (26.1)
Systematic Assessment
EG0000 at risk
EG0010 at risk
EG0020 at risk
EG003
Productive cough
Respiratory, thoracic and mediastinal disorders
MedDRA (26.1)
Systematic Assessment
EG0000 at risk
EG0010 at risk
EG0020 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA (26.1)
Systematic Assessment
EG0000 at risk
EG0010 at risk
EG0020 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA (26.1)
Systematic Assessment
EG0000 at risk
EG0010 at risk
EG0020 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA (26.1)
Systematic Assessment
EG0000 at risk
EG0010 at risk
EG0020 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA (26.1)
Systematic Assessment
EG0000 at risk
EG0010 at risk
EG0020 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA (26.1)
Systematic Assessment
EG0000 at risk
EG0010 at risk
EG0020 at risk
EG003
Hypertension
Vascular disorders
MedDRA (26.1)
Systematic Assessment
EG0000 at risk
EG0010 at risk
EG0020 at risk
EG003
Although 116 patients were randomized to the Chemotherapy arm, 3 did not receive study drug and were excluded from the Safety set.
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 pooled data (i.e.,data from all sites) in clinical trial or disclosure of trial results in their entirety.
Point of Contact
Title
Organization
Phone
Extension
Email
Study Director
Novartis Pharmaceuticals
862-778-8300
Novartis.email@Novartis.com
ID
Term
D002289
Carcinoma, Non-Small-Cell Lung
D008175
Lung Neoplasms
D000077192
Adenocarcinoma of Lung
Ancestor Terms
ID
Term
D002283
Carcinoma, Bronchogenic
D001984
Bronchial Neoplasms
D012142
Respiratory Tract Neoplasms
D013899
Thoracic Neoplasms
D009371
Neoplasms by Site
D009369
Neoplasms
D008171
Lung Diseases
D012140
Respiratory Tract Diseases
D000230
Adenocarcinoma
D002277
Carcinoma
D009375
Neoplasms, Glandular and Epithelial
D009370
Neoplasms by Histologic Type
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
C586847
ceritinib
D000068437
Pemetrexed
D000077143
Docetaxel
Ancestor Terms
ID
Term
D006147
Guanine
D007042
Hypoxanthines
D011688
Purinones
D011687
Purines
D006574
Heterocyclic Compounds, 2-Ring
D000072471
Heterocyclic Compounds, Fused-Ring
D006571
Heterocyclic Compounds
D005971
Glutamates
D024342
Amino Acids, Acidic
D000596
Amino Acids
D000602
Amino Acids, Peptides, and Proteins
D000600
Amino Acids, Dicarboxylic
D043823
Taxoids
D043822
Cyclodecanes
D003516
Cycloparaffins
D006840
Hydrocarbons, Alicyclic
D006844
Hydrocarbons, Cyclic
D006838
Hydrocarbons
D009930
Organic Chemicals
D004224
Diterpenes
D013729
Terpenes
Browse Leaves
Not provided
Browse Branches
Not provided
0 subjects
FG0010 subjects
FG00217 subjects
Physician Decision
FG0000 subjects
FG0010 subjects
FG0025 subjects
Progressive disease
FG0000 subjects
FG0010 subjects
FG00246 subjects
Study terminated by sponsor
FG0000 subjects
FG0010 subjects
FG0021 subjects
Subject/guardian decision
FG0000 subjects
FG0010 subjects
FG0024 subjects
129
Male
BG00047
BG00155
BG002102
68
Black
BG0000
BG0011
BG0021
Caucasian
BG00081
BG00168
BG002149
Other
BG0002
BG0014
BG0026
Unknown
BG0002
BG0015
BG0027
115
OG001116
Title
Denominators
Categories
Title
Measurements
OG00017.7(14.2 to 23.7)
OG00120.1(11.9 to 31.2)
115
OG001116
Title
Denominators
Categories
Title
Measurements
OG0006.2(4.4 to 7.9)
OG0011.6(1.4 to 2.6)
115
OG001116
Title
Denominators
Categories
Title
Measurements
OG00040.9(31.8 to 50.4)
OG0016.9(3.0 to 13.1)
115
OG001116
Title
Denominators
Categories
Title
Measurements
OG00044.3(35.1 to 53.9)
OG0016.9(3.0 to 13.1)
47
OG0018
Title
Denominators
Categories
Title
Measurements
OG0007.6(5.4 to 8.3)
OG00110.4(3.5 to NA)The upper limit of 95% CI was not estimable due to an insufficient number of participants with events.
51
OG0018
Title
Denominators
Categories
Title
Measurements
OG0006.7(5.5 to 8.3)
OG0018.3(2.8 to 69.9)
115
OG001116
Title
Denominators
Categories
Title
Measurements
OG00076.5(67.7 to 83.9)
OG00137.9(29.1 to 47.4)
115
OG001116
Title
Denominators
Categories
Title
Measurements
OG00080.0(71.5 to 86.9)
OG00139.7(30.7 to 49.2)
47
OG0018
Title
Denominators
Categories
Title
Measurements
OG0006.71(4.9 to 52.3)
OG0019.64(5.4 to 43.3)
47
OG0018
Title
Denominators
Categories
Title
Measurements
OG0006.43(4.9 to 45.4)
OG00114.71(6.3 to 36.4)
OG00066
OG00167
Title
Denominators
Categories
Title
Measurements
OG00010.6(4.4 to 20.6)
OG0013.0(0.4 to 10.4)
Participants
OG00066
OG00167
Title
Denominators
Categories
Title
Measurements
OG00071.2(58.7 to 81.7)
OG00153.7(41.1 to 66.0)
Participants
OG0006
OG0011
Title
Denominators
Categories
Title
Measurements
OG0008.3(2.7 to NA)The upper limit of 95% CI was not estimable due to an insufficient number of participants with events.
OG00116.7(NA to NA)The lower and upper limits of 95% CI were not estimable due to the single data point.
Units
Counts
Participants
OG000107
OG00186
Title
Denominators
Categories
Global Health Status/QoL n=106,85
ParticipantsOG000106
ParticipantsOG00185
Title
Measurements
OG00062.9± 1.13
OG00163.2± 1.74
Physical Functioning n=107,86
ParticipantsOG000107
ParticipantsOG00186
Title
Measurements
OG00080.5± 1.04
OG001
Emotional Functioning n=106,86
ParticipantsOG000106
ParticipantsOG00186
Title
Measurements
OG00082.4± 1.01
OG001
Social Functioning n=106,86
ParticipantsOG000106
ParticipantsOG00186
Title
Measurements
OG00076.7± 1.56
OG001
Cognitive Functioning n=106,86
ParticipantsOG000106
ParticipantsOG00186
Title
Measurements
OG00086.7± 0.91
OG001
Role Functioning n=107,86
ParticipantsOG000107
ParticipantsOG00186
Title
Measurements
OG00072.6± 1.30
OG001
Fatigue n=107,86
ParticipantsOG000107
ParticipantsOG00186
Title
Measurements
OG00031.1± 1.10
OG001
Nausea and Vomiting n=107,86
ParticipantsOG000107
ParticipantsOG00186
Title
Measurements
OG00017.2± 1.08
OG001
Pain n=107,86
ParticipantsOG000107
ParticipantsOG00186
Title
Measurements
OG00021.4± 1.22
OG001
Dyspnea n=107,86
ParticipantsOG000107
ParticipantsOG00186
Title
Measurements
OG00017.4± 1.03
OG001
Insomnia n=107,86
ParticipantsOG000107
ParticipantsOG00186
Title
Measurements
OG00018.9± 1.33
OG001
Appetite Loss n=107,86
ParticipantsOG000107
ParticipantsOG00186
Title
Measurements
OG00021.2± 1.33
OG001
Constipation n=107,86
ParticipantsOG000107
ParticipantsOG00186
Title
Measurements
OG00015.0± 1.31
OG001
Diarrhea n=106,86
ParticipantsOG000106
ParticipantsOG00186
Title
Measurements
OG00029.3± 1.29
OG001
Financial Difficulties n=104,85
ParticipantsOG000104
ParticipantsOG00185
Title
Measurements
OG00015.5± 1.41
OG001
Units
Counts
Participants
OG000115
OG001116
Title
Denominators
Categories
Title
Measurements
OG00013.4(8.4 to 16.7)
OG0012.8(1.0 to 5.6)
OG000107
OG00185
Title
Denominators
Categories
LCSS Total Score n=106,82
ParticipantsOG000106
ParticipantsOG00182
Title
Measurements
OG00022.0± 0.87
OG00126.3± 1.33
Appetite Loss n=107,85
ParticipantsOG000107
ParticipantsOG00185
Title
Measurements
OG00028.0± 1.26
OG001
Fatigue n=107,84
ParticipantsOG000107
ParticipantsOG00184
Title
Measurements
OG00034.6± 1.33
OG001
Cough n=107,84
ParticipantsOG000107
ParticipantsOG00184
Title
Measurements
OG00011.5± 1.01
OG001
Shortness of Breath n=107,85
ParticipantsOG000107
ParticipantsOG00185
Title
Measurements
OG00018.2± 0.99
OG001
Hemoptysis n=107,85
ParticipantsOG000107
ParticipantsOG00185
Title
Measurements
OG0001.8± 0.34
OG001
Pain n=107,85
ParticipantsOG000107
ParticipantsOG00185
Title
Measurements
OG00018.2± 1.25
OG001
Total Symptom Distress n=107,85
ParticipantsOG000107
ParticipantsOG00185
Title
Measurements
OG00020.7± 1.26
OG001
Normal Activity Status n=107,85
ParticipantsOG000107
ParticipantsOG00185
Title
Measurements
OG00031.3± 1.47
OG001
Overall Quality of Life n=106,84
ParticipantsOG000106
ParticipantsOG00184
Title
Measurements
OG00033.1± 1.27
OG001
LCSS Average Symptom Burden Index n=107,83
ParticipantsOG000107
ParticipantsOG00183
Title
Measurements
OG00018.8± 0.77
OG001
107
OG00188
Title
Denominators
Categories
Title
Measurements
OG0000.7837± 0.01039
OG0010.7108± 0.01533
106
OG00186
Title
Denominators
Categories
Title
Measurements
OG00071.8± 0.98
OG00169.0± 1.45
4
OG0010
Title
Denominators
Categories
Cycle 1, Day 1 n=4,0
ParticipantsOG0004
ParticipantsOG0010
Title
Measurements
OG00090.4± 49.8
Cycle 2, Day 1 n=2,0
ParticipantsOG0002
ParticipantsOG0010
Title
Measurements
OG0001170± 17.7
4
OG0010
Title
Denominators
Categories
Cycle 1, Day 1 n=4,0
ParticipantsOG0004
ParticipantsOG0010
Title
Measurements
OG0006.03(4.17 to 23.6)
Cycle 2, Day 1 n=2,0
ParticipantsOG0002
ParticipantsOG0010
Title
Measurements
OG0007.15(6.17 to 8.13)
4
OG0010
Title
Denominators
Categories
Cycle 1, Day 1 n=4,0
ParticipantsOG0004
ParticipantsOG0010
Title
Measurements
OG00024(23.6 to 24.1)
Cycle 2, Day 1 n=2,0
ParticipantsOG0002
ParticipantsOG0010
Title
Measurements
OG00023.9(23.7 to 24.2)
4
OG0010
Title
Denominators
Categories
Cycle 1, Day 1 n=4,0
ParticipantsOG0004
ParticipantsOG0010
Title
Measurements
OG0001470± 65.1
Cycle 2, Day 1 n=2,0
ParticipantsOG0002
ParticipantsOG0010
Title
Measurements
OG00025000± 19.0
1
OG0010
Title
Denominators
Categories
Cycle 1, Day 1 n=0,0
ParticipantsOG0000
ParticipantsOG0010
Cycle 2, Day 1 n=1,0
ParticipantsOG0001
ParticipantsOG0010
Title
Measurements
OG00015.5± NAThe geometric coefficient of variation was not estimable due to the single data point.