A Study to Evaluate the Safety, Tolerability, Pharmacokin... | NCT01449461 | Trialant
NCT01449461
Sponsor
Ariad Pharmaceuticals
Status
Completed
Last Update Posted
Aug 17, 2021Actual
Enrollment
137Actual
Phase
Phase 1Phase 2
Conditions
Lymphoma, Large-Cell, Anaplastic
Carcinoma, Non-Small-Cell Lung
Interventions
Brigatinib
Countries
Not provided
Protocol Section
Identification Module
NCT ID
NCT01449461
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
AP26113-11-101
Secondary IDs
ID
Type
Description
Link
2011-005718-12
EudraCT Number
U1111-1196-8197
Other Identifier
World Health Organization
Brief Title
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-Tumor Activity of the Oral Anaplastic Lymphoma Kinase (ALK)/Epidermal Growth Factor Receptor (EGFR) Inhibitor Brigatinib (AP26113)
Official Title
A Phase 1/2 Study of the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-Tumor Activity of the Oral ALK/EGFR Inhibitor AP26113
Acronym
Not provided
Organization
TakedaINDUSTRY
Status Module
Record Verification Date
Jul 2021
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
Sep 20, 2011Actual
Primary Completion Date
Nov 16, 2015Actual
Completion Date
Feb 18, 2020Actual
First Submitted Date
Sep 30, 2011
First Submission Date that Met QC Criteria
Oct 6, 2011
First Posted Date
Oct 10, 2011Estimated
Results Waived
Not provided
Results First Submitted Date
May 26, 2017
Results First Submitted that Met QC Criteria
May 26, 2017
Results First Posted Date
Jun 21, 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
Jul 26, 2021
Last Update Posted Date
Aug 17, 2021Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Ariad PharmaceuticalsINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The purpose of this study is 2-fold: initially, in the dose escalation phase, the goal is to determine the safety profile of orally administered brigatinib, including: the maximum tolerated dose (MTD), dose limiting toxicities (DLTs), recommended phase 2 dose (RP2D), and pharmacokinetic (PK) profile. Then, once the RP2D is established, an expansion phase will assess the preliminary anti-tumor activity of brigatinib, both in non-small cell lung cancer (NSCLC) with ALK gene rearrangement (including participants with active brain metastases) or mutated EGFR, and in other cancers with abnormal targets against which brigatinib is active.
Detailed Description
The drug being tested in this study is called brigatinib (AP26113). Brigatinib is being tested to treat people with NSCLC. This study will look at the safety, tolerability and efficacy of brigatinib.
The study enrolled 137 patients. Participants were assigned to one of the following treatment groups:
Brigatinib 30 mg once daily (QD)/60 mg QD
Brigatinib 90 mg QD
Brigatinib 120 mg QD/60 mg twice daily (BID)
Brigatinib 90 mg QD-180 mg QD
Brigatinib 180 mg QD/90 mg BID
Brigatinib 240 mg QD/120 mg BID/300 mg QD
This multi-center trial will be conducted worldwide. The overall expected time to participate in this study is approximately 4 years. Participants will make multiple visits to the clinic, and 30 days after the End-of-Treatment visit. Follow-up is intended to continue for at least 2 years after the initial dose.
Conditions Module
Conditions
Lymphoma, Large-Cell, Anaplastic
Carcinoma, Non-Small-Cell Lung
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
137Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Brigatinib 30 mg QD/60 mg QD
Experimental
Brigatinib 30 mg/60 mg, tablets, orally, once daily (QD) in each cycle of 28 days (Approximately up to 7.3 years).
Drug: Brigatinib
Brigatinib 90 mg QD
Experimental
Brigatinib 90 mg, tablets, orally, QD in each cycle of 28 days (Approximately up to 7.3 years).
Drug: Brigatinib
Brigatinib 120 mg QD/60 mg BID
Experimental
Brigatinib 120 mg, once daily or 60 mg, twice daily (BID), tablets, orally, in each cycle of 28 days (Approximately up to 7.3 years).
Drug: Brigatinib
Brigatinib 90 mg QD-180 mg QD
Experimental
Brigatinib 90 mg, tablets, orally, once daily for 7 days followed by brigatinib 180 mg, orally once daily in Cycle 1 of 28 days followed by brigatinib 180 mg, orally once daily in cycle 2 and onward cycles of 28 days.
Drug: Brigatinib
Brigatinib 180 mg QD/90 mg BID
Experimental
Brigatinib 180 mg, once daily or 90 mg, BID, tablets, orally in each cycle of 28 days (Approximately up to 7.3 years).
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Brigatinib
Drug
Brigatinib tablets and capsules.
Brigatinib 120 mg QD/60 mg BID
Brigatinib 180 mg QD/90 mg BID
Brigatinib 240 mg QD/120 mg BID/300 mg QD
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Recommended Phase 2 Dose (RP2D) of Brigatinib
The RP2D is the maximum tolerated dose (MTD) or less. The MTD is defined as the dose range at which ≤ 1 of 6 evaluable participants experience dose limiting toxicities (DLT) within the first 28 days of treatment (end of Cycle 1).
28 days
Objective Response Rate (ORR)
ORR assessed by the investigator, is defined as the percentage of the participants with complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid tumors (RECIST) v1.1 after the initiation of study treatment. CR for target lesion: disappearance of all extranodal lesions and all pathological lymph nodes must have decreased to <10 mm in short axis. CR for non-target lesion: Disappearance of all extranodal non-target lesions, all lymph nodes must be non-pathological in size (<10mm short axis) and normalization of tumor marker level. PR: at least a 30% decrease in the sum of the longest diameters (SLD) of target lesions, taking as reference the baseline sum diameters. Crzb=Crizotinib.
From Screening and at 8-week intervals thereafter up to end of the study (up to 8.4 years)
Secondary Outcomes
Measure
Description
Time Frame
Number of Participants Who Had at Least One Treatment-Emergent Adverse Event (TEAE)
An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
General Eligibility Criteria
All participants must have tumor tissue available for analysis. If sufficient tissue is not available, participants must undergo a biopsy to obtain adequate samples. For participants in expansion cohorts 2, 3 and 5, for whom failure of prior therapy is specified (crizotinib for cohorts 2 and 5, one epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI) for cohort 3), tumor tissue must be available following failure of the prior therapy.
Must have measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST).
Male or female participants ≥ 18 years old.
Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
Minimum life expectancy of 3 months or more.
Adequate renal and hepatic function.
Adequate bone marrow function.
Normal QT interval on screening electrocardiogram (ECG) evaluation.
For females of childbearing potential, a negative pregnancy test must be documented prior to enrollment.
Female participants who are of childbearing potential and fertile male participants must agree to use an effective form of contraception with their sexual partners throughout study participation.
Signed and dated informed consent indicating that the participant has been informed of all pertinent aspects of the study.
Willingness and ability to comply with scheduled visits and study procedures.
Cohort-specific Eligibility Criteria
PART 1: Dose Escalation Phase:
Histologically confirmed advanced malignancies. All histologies except leukemia;
Refractory to available therapies or for whom no standard or available curative treatments exist;
Tumor tissue available for analysis.
PART 2: Expansion cohorts (5 additional cohorts):
1. Expansion cohort 1: Non-small cell lung cancer (NSCLC) participants whose tumors exhibit anaplastic lymphoma kinase (ALK) rearrangements and who have not been treated with previous ALK inhibitors.
i. Histologically or cytologically confirmed NSCLC; ii. Tumor tissue available for analysis (see General Eligibility Criterion 1; iii. History of ALK rearrangement by fluorescence in situ hybridization (FISH); iv. No prior ALK inhibitor therapy; 2. Expansion cohort 2: NSCLC participants whose tumors exhibit ALK rearrangements and who are resistant to crizotinib: i. Histologically or cytologically confirmed NSCLC; ii. Tumor tissue available for analysis (see General Eligibility Criterion 1); iii. History of ALK rearrangement by FISH; iv. Resistant to crizotinib (and have not received any other prior ALK inhibitor therapy); 3. Expansion cohort 3: NSCLC participants whose tumors exhibit an epidermal growth factor receptor EGFR-T790M mutation and who are resistant to 1 prior EGFR TKI: i. Histologically or cytologically confirmed NSCLC ii. Previous treatment with only 1 EGFR TKI for which the last administration was within 30 days of the initiation of brigatinib; iii. Documented evidence of an EGFR-T790M mutation following disease progression on the most recent EGFR TKI therapy; iv. No intervening systemic therapy between cessation of the EGFR TKI and initiating brigatinib; v. Tumor tissue available for analysis (see General Eligibility Criterion 1). 4. Expansion cohort 4: Participants with any cancers with abnormalities in ALK or other brigatinib targets. Examples include, but are not limited to, anaplastic large cell lymphoma (ALCL), diffuse large-cell lymphoma (DLCL), inflammatory myofibroblastic tumors (IMT), and other cancers with ALK abnormalities, or tumors with ROS1 fusions: i. Histologically confirmed lymphomas and other cancers, with the exception of leukemias; ii. Tumor tissue available for analysis (see General Eligibility Criterion 1). 5. Expansion Cohort 5: NSCLC participants whose tumors exhibit ALK rearrangements and who have active, measurable brain metastases: i. Histologically or cytologically confirmed NSCLC: ii. Tumor tissue available for analysis (see General Eligibility Criterion 1); iii. History of ALK rearrangement by FISH; iv. Either crizotinib naive or resistant; v. Have at least one measurable brain lesion (≥ 10 mm by contrast enhanced, T1 weighted magnetic resonance imaging [cMRI]). Previously treated brain lesions by stereotactic radiosurgery (SRS) or surgical resection should not be included as a target or non-target lesion; vi. Previously untreated brain metastases with radiologically documented new or progressing brain lesions. Unequivocal progression of previously treated lesions (non-SRS and non-surgically treated lesions) at least 3 months after the last treatment; vii. Neurologically stable. Participants must be on a stable or deceasing dose of corticosteroids and/or have no requirement for anticonvulsants for 5 days prior to the baseline MRI and for 5 days prior to initiating brigatinib.
Exclusion Criteria:
Received an investigational agent ≤ 14 days prior to initiating brigatinib.
Received systemic anticancer therapy (including monoclonal antibodies and irreversible TKIs such as afatinib or dacomitinib) or radiation therapy ≤ 14 days prior to initiating brigatinib.
a. Except for a reversible TKI (ie, erlotinib or gefitinib) or crizotinib, which are allowed up to 72 hours prior to initiating brigatinib, provided that the participant is free of treatment-related toxicity that might confound the safety evaluation of brigatinib.
Received any prior agents targeted against ALK, with the exception of crizotinib, or received more than 1 prior EGFR TKI.
a. Re-challenge with the same TKI is allowed.
Major surgery within 28 days prior to initiating brigatinib.
Brain metastases that are neurologically unstable or require anticonvulsants or an increasing dose of corticosteroids.
Participants with previously treated brain metastases without evidence of disease or recurrence are allowed for cohorts 1-4.
Participants with evaluable but non-measurable, active brain lesions who otherwise meet the criteria for cohort 5 for CNS disease can be enrolled in other cohorts.
Significant uncontrolled or active cardiovascular disease.
Uncontrolled hypertension (diastolic blood pressure [BP] > 100 mm Hg; systolic > 150 mm Hg).
Prolonged QT interval, or being treated with medications known to cause Torsades de Pointes.
History or presence of pulmonary interstitial disease or drug-related pneumonitis.
Ongoing or active infection. The requirement for intravenous (IV) antibiotics is considered active infection.
Known history of human immunodeficiency virus (HIV). Testing is not required in the absence of history.
Pregnant or breastfeeding.
Malabsorption syndrome or other gastrointestinal illness that could affect oral absorption of brigatinib.
Any condition or illness that, in the opinion of the Investigator, would compromise participant safety or interfere with the evaluation of the safety of the drug.
Leptomeningeal carcinomatosis and spinal cord compression. In the case of suspected meningeal involvement, a negative lumbar puncture prior to study entry is required.
Camidge DR, Kim DW, Tiseo M, Langer CJ, Ahn MJ, Shaw AT, Huber RM, Hochmair MJ, Lee DH, Bazhenova LA, Gold KA, Ou SI, West HL, Reichmann W, Haney J, Clackson T, Kerstein D, Gettinger SN. Exploratory Analysis of Brigatinib Activity in Patients With Anaplastic Lymphoma Kinase-Positive Non-Small-Cell Lung Cancer and Brain Metastases in Two Clinical Trials. J Clin Oncol. 2018 Sep 10;36(26):2693-2701. doi: 10.1200/JCO.2017.77.5841. Epub 2018 May 16.
Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
Types
Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame
Not provided
Access Criteria
IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
Participants with advanced malignancies, all histologies other than leukemia were enrolled in dose-escalation and participants with non-small cell lung cancer (NSCLC) with anaplastic lymphoma kinase (ALK) rearrangements were enrolled in dose expansion phase. Participants received brigatinib 30 mg - 300 mg, tablets, orally once daily or twice daily.
Recruitment Details
Participants took part in the study at 9 investigative sites in the United States and Spain from 20 September 2011 to 18 February 2020.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Brigatinib 30 mg QD/60 mg QD
Brigatinib 30 mg/60 mg, tablets, orally, once daily (QD) in each cycle of 28 days (Approximately up to 7.3 years).
FG001
Brigatinib 90 mg QD
Brigatinib 90 mg, tablets, orally, QD in each cycle of 28 days (Approximately up to 7.3 years).
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Mar 20, 2017
Feb 18, 2021
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Spain
United States
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Non-Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
Drug: Brigatinib
Brigatinib 240 mg QD/120 mg BID/300 mg QD
Experimental
Brigatinib 240 mg, QD or 120 mg, BID or 300 mg once daily, tablets, orally, in each cycle of 28 days (Approximately up to 7.3 years).
Drug: Brigatinib
Brigatinib 30 mg QD/60 mg QD
Brigatinib 90 mg QD
Brigatinib 90 mg QD-180 mg QD
ALUNBRIGâ„¢
AP26113
From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Maximum Tolerated Dose (MTD) Assessed in Dose Escalation Phase of the Study
The MTD is defined as the highest dose at which ≤ 1 of 6 evaluable participants experience a DLT within the first 28 days of treatment (end of Cycle 1).
Up to Cycle 1 (28 days)
Number of Participants With Dose Limiting Toxicities (DLTs) Assessed in Dose Escalation Phase of the Study
DLT include any toxicity that is possibly, probably, or definitely drug-related. Toxicity grades will be defined by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v 4.0. DLTs are defined by the following: A) Non-hematologic toxicities: Any grade ≥3 non-hematologic toxicity, with the exception of self-limiting or medically controllable toxicities (eg, nausea, vomiting, fatigue, electrolyte disturbances, hypersensitivity reactions) lasting < 3 days, and excluding alopecia. B) Hematologic toxicities: Febrile neutropenia not related to underlying disease (fever, > 101°F; ANC<500); Prolonged grade 4 neutropenia (> 7 days); Neutropenic infection: ≥ grade 3 neutropenia with ≥ grade 3 infection; Thrombocytopenia ≥ grade 3 with bleeding or grade 4 lasting ≥ 7 days. C) Missed ≥ 25% of planned doses of brigatinib over 28 days due to treatment-related AEs in the first cycle.
Up to Cycle 1 (28 days)
Cmax: Maximum Observed Plasma Concentration for Brigatinib at Cycle 1 Day 1
Cycle 1 (28-days cycle): Day 1
Cmax: Maximum Observed Plasma Concentration for Brigatinib at Cycle 2 Day 1
Cycle 2 (28-days cycle): Day 1
Tmax: Time to Reach the Maximum Observed Plasma Concentration (Cmax) for Brigatinib at Cycle 1 Day 1
Cycle 1 (28-days cycle): Day 1
Tmax: Time to Reach the Maximum Observed Plasma Concentration (Cmax) for Brigatinib at Cycle 2 Day 1
Cycle 2 (28-days cycle): Day 1
AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours Post-dose for Brigatinib at Cycle 1 Day 1
Cycle 1 (28-days cycle): Day 1 multiple time points (up to 24 hours) post-dose
AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours Post-dose for Brigatinib at Cycle 2 Day 1
Cycle 2 (28-days cycle): Day 1 multiple time points (up to 24 hours) post-dose
T1/2: Terminal Phase Elimination Half-life for Brigatinib at Cycle 2 Day 1
Cycle 2 (28-days cycle): Day 1
Best Overall Response
Best overall response is defined as percentage of participants with CR, PR, stable disease (SD) or progressive disease (PD) as per of RECIST v1.1 as evaluated by investigator. CR for target lesion: disappearance of all extranodal lesions and all pathological lymph nodes must have decreased to <10 mm in short axis. CR for non-target lesion: disappearance of all extranodal non-target lesions, all lymph nodes must be non-pathological in size (<10mm short axis) and normalization of tumor marker level. PR: at least a 30% decrease in the SLD of target lesions, taking as reference the baseline sum diameters. Disease progression for target lesion: SLD increased by at least 20% from smallest value on study and SLD must also demonstrate an absolute increase of at least 5 mm or development of any new lesion. PD for non-target lesion: unequivocal progression of existing non-target lesions. SD for neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.
Screening and at 8-week intervals thereafter up to end of the study (up to 8.4 years)
Duration of Response
Duration of response is defined as time interval from time that measurement criteria are first met for CR/PR (whichever is first recorded) until first date that progressive disease is objectively documented or death due to any cause. Participants who did not progress nor die were censored at last valid response assessment.CR for target lesion: disappearance of all extranodal lesions and all pathological lymph nodes must have decreased to <10 mm in short axis.CR for non-target lesion:disappearance of all extranodal non-target lesions,all lymph nodes must be non-pathological in size(<10mm short axis) and normalization of tumor marker level.PR:at least a 30% decrease in SLD of target lesions.PD for target lesion:SLD increased by at least 20% from smallest value and must also demonstrate an absolute increase of >=5 mm or development of any new lesion.PD for non-target lesion:unequivocal progression of existing non-target lesions.Duration of response calculated by Kaplan-Meier estimation.
Screening and at 8-week intervals thereafter up to end of the study (up to 8.4 years)
Progression Free Survival (PFS)
PFS is defined as the time interval from the date of the first dose of the study treatment until the first date at which disease progression is objectively documented, or death due to any cause, whichever occurs first. Disease progression for target lesion: SLD increased by at least 20% from the smallest value on study (including baseline, if that is the smallest) and SLD must also demonstrate an absolute increase of at least 5 mm or development of any new lesion. Disease progression for non-target lesion: Unequivocal progression of existing non-target lesions. (Subjective judgment by experienced reader).
Screening and at 8-week intervals thereafter up to end of the study (up to 8.4 years)
Overall Survival (OS)
OS is defined as the time interval from the date of the first dose of the study treatment until death due to any cause.
Screening and at 8-week intervals thereafter up to end of the study (up to 8.4 years)
Intracranial Objective Response Rate
Intracranial objective response rate is defined as the percentage of the participants with CR or PR in the intracranial CNS per modification of RECIST v1.1 after the initiation of study drug. CR for target lesion: disappearance of all extranodal lesions. CR for non-target lesion: disappearance of all extranodal non-target lesions and normalization of tumor marker level. PR: at least a 30% decrease in the sum of the longest diameters (SLD) of target lesions, taking as reference the baseline sum diameters.
Screening and at 8-week intervals thereafter (approximately up to 50 months)
Duration of Intracranial Response
Intracranial duration of response is defined as the time interval from the time that the measurement criteria are first met for CR/PR in brain metastases (whichever is first recorded) until the first date that progressive disease is objectively documented or death due to any cause. Participants who did not progress nor die were censored at the last valid response assessment. Duration intracranial of response was calculated by Kaplan-Meier estimation.
Screening and at 8-week intervals thereafter (approximately up to 50 months)
Intracranial Progression Free Survival (PFS)
PFS is defined as the time interval from the date of the first dose of the study treatment until the first date at which disease progression in brain, or death due to any cause, whichever occurs first. Intracranial PFS was calculated by Kaplan-Meier estimation.
Screening and at 8-week intervals thereafter (approximately up to 50 months)
Derived
Gettinger SN, Bazhenova LA, Langer CJ, Salgia R, Gold KA, Rosell R, Shaw AT, Weiss GJ, Tugnait M, Narasimhan NI, Dorer DJ, Kerstein D, Rivera VM, Clackson T, Haluska FG, Camidge DR. Activity and safety of brigatinib in ALK-rearranged non-small-cell lung cancer and other malignancies: a single-arm, open-label, phase 1/2 trial. Lancet Oncol. 2016 Dec;17(12):1683-1696. doi: 10.1016/S1470-2045(16)30392-8. Epub 2016 Nov 8.
Yu HA, Riely GJ. Second-generation epidermal growth factor receptor tyrosine kinase inhibitors in lung cancers. J Natl Compr Canc Netw. 2013 Feb 1;11(2):161-9. doi: 10.6004/jnccn.2013.0024.
FG002
Brigatinib 120 mg QD/60 mg BID
Brigatinib 120 mg, once daily or 60 mg, twice daily (BID), tablets, orally, in each cycle of 28 days (Approximately up to 7.3 years).
FG003
Brigatinib 90 mg QD-180 mg QD
Brigatinib 90 mg, tablets, orally, once daily for 7 days followed by brigatinib 180 mg, orally QD in Cycle 1 of 28 days followed by brigatinib 180 mg, orally QD in cycle 2 and onward cycles of 28 days (Approximately up to 7.3 years).
FG004
Brigatinib 180 mg QD/90 mg BID
Brigatinib 180 mg, once daily or 90 mg, BID, tablets, orally in each cycle of 28 days (Approximately up to 7.3 years).
FG005
Brigatinib 240 mg QD/120 mg BID/300 mg QD
Brigatinib 240 mg, QD or 120 mg, BID or 300 mg once daily, tablets, orally, in each cycle of 28 days (Approximately up to 7.3 years).
FG0006 subjects
FG00118 subjects
FG00218 subjects
FG00332 subjects
FG00448 subjects
FG00515 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
NOT COMPLETED
FG0006 subjects
FG00118 subjects
FG00218 subjects
FG00332 subjects
FG00448 subjects
FG00515 subjects
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0013 subjects
FG0022 subjects
FG0033 subjects
FG0044 subjects
FG0054 subjects
Death
FG0000 subjects
FG0012 subjects
FG0020 subjects
FG0030 subjects
FG004
Physician Decision
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0034 subjects
FG004
Documented Progressive Disease
FG0004 subjects
FG0017 subjects
FG00214 subjects
FG00315 subjects
FG004
Clinical Progressive Disease
FG0002 subjects
FG0012 subjects
FG0020 subjects
FG0033 subjects
FG004
Protocol Violation
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
Site Terminated by Sponsor
FG0000 subjects
FG0011 subjects
FG0022 subjects
FG0033 subjects
FG004
Withdrawal by Subject
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
Reason not Specified
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0033 subjects
FG004
Safety population included all enrolled participants who received at least one dose of study drug.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Brigatinib 30 mg QD/60 mg QD
Brigatinib 30 mg/60 mg, tablets, orally, QD in each cycle of 28 days (Approximately up to 7.3 years).
BG001
Brigatinib 90 mg QD
Brigatinib 90 mg, tablets, orally, QD in each cycle of 28 days (Approximately up to 7.3 years).
BG002
Brigatinib 120 mg QD/60 mg BID
Brigatinib 120 mg, once daily or 60 mg, BID, tablets, orally, in each cycle of 28 days (Approximately up to 7.3 years).
BG003
Brigatinib 90 mg QD-180 mg QD
Brigatinib 90 mg, tablets, orally, once daily for 7 days followed by brigatinib 180 mg, orally QD in Cycle 1 of 28 days followed by brigatinib 180 mg, orally QD in cycle 2 and onward cycles of 28 days (Approximately up to 7.3 years).
BG004
Brigatinib 180 mg QD/90 mg BID
Brigatinib 180 mg, once daily or 90 mg, BID, tablets, orally in each cycle of 28 days (Approximately up to 7.3 years).
BG005
Brigatinib 240 mg QD/120 mg BID/300 mg QD
Brigatinib 240 mg, QD or 120 mg, BID or 300 mg once daily, tablets, orally, in each cycle of 28 days (Approximately up to 7.3 years).
BG006
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0006
BG00118
BG00218
BG00332
BG00448
BG00515
BG006137
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00066.8± 9.30
BG00157.9± 12.93
BG00257.8± 10.91
BG003
Age, Customized
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Adults [18-64 years]
BG0002
BG00111
BG002
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0003
BG00112
BG002
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG002
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0001
BG0010
BG002
Region of Enrollment
Count of Participants
Participants
Title
Denominators
Categories
United States
Title
Measurements
BG0006
BG00118
BG002
Eastern Cooperative Oncology Group (ECOG) Performance Score
ECOG assessed participant's performance status on a 5 point scale: 0 equals (=) fully active/able to carry on all pre-disease activities without restriction; 1=restricted in physically strenuous activity, but ambulatory/able to carry out light or sedentary work; 2=ambulatory (greater than [>] 50 percentage [%] of waking hours [h]), capable of all self care, but unable to carry out any work activities; 3=capable of only limited self care, confined to bed/chair >50% of waking hours; 4= completely disabled, cannot carry on any selfcare, totally confined to bed or chair and 5=Dead.
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
0
BG0000
BG001
Time Since Diagnosis of Cancer
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG0002.48± 3.303
BG0013.33± 2.184
BG002
Participants with Diagnosis of Cancer Type
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
NSCLC
BG0003
BG00116
BG002
Number of Participants with Mutation Types
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Anaplastic Lymphoma Kinase (ALK+)
BG0001
BG00116
BG002
Participants with Prior Chemotherapy Regimen
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
0
BG0000
BG0012
BG002
Participants with Prior Radiotherapy to Brain
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
No
BG0006
BG00113
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
Recommended Phase 2 Dose (RP2D) of Brigatinib
The RP2D is the maximum tolerated dose (MTD) or less. The MTD is defined as the dose range at which ≤ 1 of 6 evaluable participants experience dose limiting toxicities (DLT) within the first 28 days of treatment (end of Cycle 1).
Safety population included all enrolled participants who received at least one dose of study drug.
Posted
Mean
Full Range
mg
28 days
ID
Title
Description
OG000
Brigatinib
All participants who received brigatinib, tablets, orally, once daily in each cycle of 28 days (Approximately up to 7.3 years).
Units
Counts
Participants
OG000137
Title
Denominators
Categories
Title
Measurements
OG000NA(90 to 180)RP2D for this study is a dose range.
Primary
Objective Response Rate (ORR)
ORR assessed by the investigator, is defined as the percentage of the participants with complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid tumors (RECIST) v1.1 after the initiation of study treatment. CR for target lesion: disappearance of all extranodal lesions and all pathological lymph nodes must have decreased to <10 mm in short axis. CR for non-target lesion: Disappearance of all extranodal non-target lesions, all lymph nodes must be non-pathological in size (<10mm short axis) and normalization of tumor marker level. PR: at least a 30% decrease in the sum of the longest diameters (SLD) of target lesions, taking as reference the baseline sum diameters. Crzb=Crizotinib.
Full analysis set (FAS) included all participants who received at least one dose of study drug. Participants with anaplastic lymphoma kinase (ALK) and non-small cell lung cancer (NSCLC) were evaluated for this outcome measure. Number analyzed is the number of participants with data evaluable for specific category.
Posted
Number
95% Confidence Interval
percentage of participants
From Screening and at 8-week intervals thereafter up to end of the study (up to 8.4 years)
ID
Title
Description
OG000
Brigatinib 30 mg QD/60 mg QD
Brigatinib 30 mg/60 mg, tablets, orally, QD in each cycle of 28 days (Approximately up to 7.3 years).
OG001
Brigatinib 90 mg QD
Brigatinib 90 mg, tablets, orally, QD in each cycle of 28 days (Approximately up to 7.3 years).
Secondary
Number of Participants Who Had at Least One Treatment-Emergent Adverse Event (TEAE)
An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.
Safety population included all enrolled participants who received at least one dose of study drug.
Posted
Count of Participants
Participants
From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
ID
Title
Description
OG000
Brigatinib 30 mg QD/60 mg QD
Brigatinib 30 mg/60 mg, tablets, orally, QD in each cycle of 28 days (Approximately up to 7.3 years).
OG001
Brigatinib 90 mg QD
Brigatinib 90 mg, tablets, orally, QD in each cycle of 28 days (Approximately up to 7.3 years).
OG002
Brigatinib 120 mg QD/60 mg BID
Brigatinib 120 mg, once daily or 60 mg, BID, tablets, orally, in each cycle of 28 days (Approximately up to 7.3 years).
Secondary
Maximum Tolerated Dose (MTD) Assessed in Dose Escalation Phase of the Study
The MTD is defined as the highest dose at which ≤ 1 of 6 evaluable participants experience a DLT within the first 28 days of treatment (end of Cycle 1).
Safety population included all enrolled participants who received at least one dose of study drug. Participants enrolled in the dose escalation phase were included in the analysis.
Posted
Number
mg
Up to Cycle 1 (28 days)
ID
Title
Description
OG000
Brigatinib
All participants received brigatinib tablets, orally, once daily (QD) starting at 30 mg in each cycle of 28 days.
Units
Counts
Participants
OG000
Secondary
Number of Participants With Dose Limiting Toxicities (DLTs) Assessed in Dose Escalation Phase of the Study
DLT include any toxicity that is possibly, probably, or definitely drug-related. Toxicity grades will be defined by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v 4.0. DLTs are defined by the following: A) Non-hematologic toxicities: Any grade ≥3 non-hematologic toxicity, with the exception of self-limiting or medically controllable toxicities (eg, nausea, vomiting, fatigue, electrolyte disturbances, hypersensitivity reactions) lasting < 3 days, and excluding alopecia. B) Hematologic toxicities: Febrile neutropenia not related to underlying disease (fever, > 101°F; ANC<500); Prolonged grade 4 neutropenia (> 7 days); Neutropenic infection: ≥ grade 3 neutropenia with ≥ grade 3 infection; Thrombocytopenia ≥ grade 3 with bleeding or grade 4 lasting ≥ 7 days. C) Missed ≥ 25% of planned doses of brigatinib over 28 days due to treatment-related AEs in the first cycle.
DLT-evaluable population included participants who received ≥75% of planned study drug doses during Cycle 1.
Posted
Number
participants
Up to Cycle 1 (28 days)
ID
Title
Description
OG000
Brigatinib 30 mg
Brigatinib 30 mg, tablets, orally, once daily (QD) in each cycle of 28 days (Approximately up to 7.3 years).
OG001
Brigatinib 60 mg
Brigatinib 60 mg, tablets, orally, once daily (QD) in each cycle of 28 days (Approximately up to 7.3 years).
Secondary
Cmax: Maximum Observed Plasma Concentration for Brigatinib at Cycle 1 Day 1
Analysis was performed on all enrolled participants in the study who received at least one dose of brigatinib. Here number of participants analyzed is the participants who were evaluable for this outcome measure. Participants of brigatinib 90 mg QD-180 mg QD arm were included as per treatment received at each time point.
Posted
Mean
Standard Deviation
ng/mL
Cycle 1 (28-days cycle): Day 1
ID
Title
Description
OG000
Brigatinib 30 mg
Brigatinib 30 mg, tablets, orally, once daily (QD) in each cycle of 28 days (Approximately up to 7.3 years).
OG001
Brigatinib 60 mg
Brigatinib 60 mg, tablets, orally, once daily (QD) in each cycle of 28 days (Approximately up to 7.3 years).
OG002
Brigatinib 90 mg
Brigatinib 90 mg, tablets, orally, once daily or twice daily in each cycle of 28 days (Approximately up to 7.3 years).
OG003
Brigatinib 120 mg
Brigatinib 120 mg, tablets, orally, once daily in each cycle of 28 days (Approximately up to 7.3 years).
Secondary
Cmax: Maximum Observed Plasma Concentration for Brigatinib at Cycle 2 Day 1
Analysis was performed on all enrolled participants in the study who received at least one dose of brigatinib. Here number of participants analyzed is the participants with data available for analysis for this outcome measure. Participants of brigatinib 90 mg QD-180 mg QD arm were included as per treatment received at each time point.
Posted
Mean
Standard Deviation
ng/mL
Cycle 2 (28-days cycle): Day 1
ID
Title
Description
OG000
Brigatinib 30 mg
Brigatinib 30 mg, tablets, orally, once daily (QD) in each cycle of 28 days (Approximately up to 7.3 years).
OG001
Brigatinib 60 mg
Brigatinib 60 mg, tablets, orally, once daily (QD) in each cycle of 28 days (Approximately up to 7.3 years).
OG002
Brigatinib 90 mg
Brigatinib 90 mg, tablets, orally, once daily or twice daily in each cycle of 28 days (Approximately up to 7.3 years).
OG003
Brigatinib 120 mg
Brigatinib 120 mg, tablets, orally, once daily in each cycle of 28 days (Approximately up to 7.3 years).
Secondary
Tmax: Time to Reach the Maximum Observed Plasma Concentration (Cmax) for Brigatinib at Cycle 1 Day 1
Analysis was performed on all enrolled participants in the study who received at least one dose of brigatinib. Here, number of participants analyzed is the participants who were evaluable for this outcome measure. Participants of brigatinib 90 mg QD-180 mg QD arm were included as per treatment received at each time point.
Posted
Median
Full Range
hours
Cycle 1 (28-days cycle): Day 1
ID
Title
Description
OG000
Brigatinib 30 mg
Brigatinib 30 mg, tablets, orally, once daily (QD) in each cycle of 28 days (Approximately up to 7.3 years).
OG001
Brigatinib 60 mg
Brigatinib 60 mg, tablets, orally, once daily (QD) in each cycle of 28 days (Approximately up to 7.3 years).
OG002
Brigatinib 90 mg
Brigatinib 90 mg, tablets, orally, once daily or twice daily in each cycle of 28 days (Approximately up to 7.3 years).
OG003
Brigatinib 120 mg
Brigatinib 120 mg, tablets, orally, once daily in each cycle of 28 days (Approximately up to 7.3 years).
Secondary
Tmax: Time to Reach the Maximum Observed Plasma Concentration (Cmax) for Brigatinib at Cycle 2 Day 1
Analysis was performed on all enrolled participants in the study who received at least one dose of brigatinib. Here, number of participants analyzed is the participants with data available for analyses for this outcome measure. Participants of brigatinib 90 mg QD-180 mg QD arm were included as per treatment received at each time point.
Posted
Median
Full Range
hours
Cycle 2 (28-days cycle): Day 1
ID
Title
Description
OG000
Brigatinib 30 mg
Brigatinib 30 mg, tablets, orally, once daily (QD) in each cycle of 28 days (Approximately up to 7.3 years).
OG001
Brigatinib 60 mg
Brigatinib 60 mg, tablets, orally, once daily (QD) in each cycle of 28 days (Approximately up to 7.3 years).
OG002
Brigatinib 90 mg
Brigatinib 90 mg, tablets, orally, once daily or twice daily in each cycle of 28 days (Approximately up to 7.3 years).
OG003
Brigatinib 120 mg
Brigatinib 120 mg, tablets, orally, once daily in each cycle of 28 days (Approximately up to 7.3 years).
Secondary
AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours Post-dose for Brigatinib at Cycle 1 Day 1
Analysis was performed on all enrolled participants in the study who received at least one dose of brigatinib. Here, number of participants analyzed is the participants who were evaluable for this outcome measure. Participants of brigatinib 90 mg QD-180 mg QD arm were included as per treatment received at each time point.
Posted
Mean
Standard Deviation
h*ng/mL
Cycle 1 (28-days cycle): Day 1 multiple time points (up to 24 hours) post-dose
ID
Title
Description
OG000
Brigatinib 30 mg
Brigatinib 30 mg, tablets, orally, once daily (QD) in each cycle of 28 days (Approximately up to 7.3 years).
OG001
Brigatinib 60 mg
Brigatinib 60 mg, tablets, orally, once daily (QD) in each cycle of 28 days (Approximately up to 7.3 years).
OG002
Brigatinib 90 mg
Brigatinib 90 mg, tablets, orally, once daily or twice daily in each cycle of 28 days (Approximately up to 7.3 years).
OG003
Brigatinib 120 mg
Secondary
AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours Post-dose for Brigatinib at Cycle 2 Day 1
Analysis was performed on all enrolled participants in the study who received at least one dose of brigatinib. Here, number of participants analyzed is the participants with data available for analyses for this outcome measure. Participants of brigatinib 90 mg QD-180 mg QD arm were included as per treatment received at each time point.
Posted
Mean
Standard Deviation
h*ng/mL
Cycle 2 (28-days cycle): Day 1 multiple time points (up to 24 hours) post-dose
ID
Title
Description
OG000
Brigatinib 30 mg
Brigatinib 30 mg, tablets, orally, once daily (QD) in each cycle of 28 days (Approximately up to 7.3 years).
OG001
Brigatinib 60 mg
Brigatinib 60 mg, tablets, orally, once daily (QD) in each cycle of 28 days (Approximately up to 7.3 years).
OG002
Brigatinib 90 mg
Brigatinib 90 mg, tablets, orally, once daily or twice daily in each cycle of 28 days (Approximately up to 7.3 years).
OG003
Brigatinib 120 mg
Secondary
T1/2: Terminal Phase Elimination Half-life for Brigatinib at Cycle 2 Day 1
Analysis was performed on all enrolled participants in the study who received at least one dose of brigatinib. Here, number of participants analyzed is the participants with data available for analyses for this outcome measure. Participants of brigatinib 90 mg QD-180 mg QD arm were included as per treatment received at each time point.
Posted
Mean
Standard Deviation
hours
Cycle 2 (28-days cycle): Day 1
ID
Title
Description
OG000
Brigatinib 30 mg
Brigatinib 30 mg, tablets, orally, once daily (QD) in each cycle of 28 days (Approximately up to 7.3 years).
OG001
Brigatinib 60 mg
Brigatinib 60 mg, tablets, orally, once daily (QD) in each cycle of 28 days (Approximately up to 7.3 years).
OG002
Brigatinib 90 mg
Brigatinib 90 mg, tablets, orally, once daily or twice daily in each cycle of 28 days (Approximately up to 7.3 years).
OG003
Brigatinib 120 mg
Brigatinib 120 mg, tablets, orally, once daily in each cycle of 28 days (Approximately up to 7.3 years).
Secondary
Best Overall Response
Best overall response is defined as percentage of participants with CR, PR, stable disease (SD) or progressive disease (PD) as per of RECIST v1.1 as evaluated by investigator. CR for target lesion: disappearance of all extranodal lesions and all pathological lymph nodes must have decreased to <10 mm in short axis. CR for non-target lesion: disappearance of all extranodal non-target lesions, all lymph nodes must be non-pathological in size (<10mm short axis) and normalization of tumor marker level. PR: at least a 30% decrease in the SLD of target lesions, taking as reference the baseline sum diameters. Disease progression for target lesion: SLD increased by at least 20% from smallest value on study and SLD must also demonstrate an absolute increase of at least 5 mm or development of any new lesion. PD for non-target lesion: unequivocal progression of existing non-target lesions. SD for neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.
Full analysis set included all participants who received at least one dose of study drug. Participants with ALK and NSCLC were evaluated for this outcome measure. Number analyzed is the number of participants with data evaluable for specific category.
Posted
Number
95% Confidence Interval
percentage of participants
Screening and at 8-week intervals thereafter up to end of the study (up to 8.4 years)
ID
Title
Description
OG000
Brigatinib 30 mg QD/60 mg QD
Brigatinib 30 mg/60 mg, tablets, orally, QD in each cycle of 28 days (Approximately up to 7.3 years).
OG001
Secondary
Duration of Response
Duration of response is defined as time interval from time that measurement criteria are first met for CR/PR (whichever is first recorded) until first date that progressive disease is objectively documented or death due to any cause. Participants who did not progress nor die were censored at last valid response assessment.CR for target lesion: disappearance of all extranodal lesions and all pathological lymph nodes must have decreased to <10 mm in short axis.CR for non-target lesion:disappearance of all extranodal non-target lesions,all lymph nodes must be non-pathological in size(<10mm short axis) and normalization of tumor marker level.PR:at least a 30% decrease in SLD of target lesions.PD for target lesion:SLD increased by at least 20% from smallest value and must also demonstrate an absolute increase of >=5 mm or development of any new lesion.PD for non-target lesion:unequivocal progression of existing non-target lesions.Duration of response calculated by Kaplan-Meier estimation.
Full analysis set included all participants who received at least one dose of study drug. Participants who were responders among those who had ALK and NSCLC were evaluated for this outcome measure. Number analyzed is the number of participants with data evaluable for specific category.
Posted
Median
95% Confidence Interval
months
Screening and at 8-week intervals thereafter up to end of the study (up to 8.4 years)
ID
Title
Description
OG000
Brigatinib 30 mg QD/60 mg QD
Brigatinib 30 mg/60 mg, tablets, orally, QD in each cycle of 28 days (Approximately up to 7.3 years).
OG001
Secondary
Progression Free Survival (PFS)
PFS is defined as the time interval from the date of the first dose of the study treatment until the first date at which disease progression is objectively documented, or death due to any cause, whichever occurs first. Disease progression for target lesion: SLD increased by at least 20% from the smallest value on study (including baseline, if that is the smallest) and SLD must also demonstrate an absolute increase of at least 5 mm or development of any new lesion. Disease progression for non-target lesion: Unequivocal progression of existing non-target lesions. (Subjective judgment by experienced reader).
Analysis was performed on all enrolled participants in the study who received at least one dose of brigatinib. Here, overall number of participants analyzed is the participants who were evaluable for this outcome measure.
Posted
Median
95% Confidence Interval
months
Screening and at 8-week intervals thereafter up to end of the study (up to 8.4 years)
ID
Title
Description
OG000
Brigatinib 30 mg QD/60 mg QD
Brigatinib 30 mg/60 mg, tablets, orally, QD in each cycle of 28 days (Approximately up to 7.3 years).
OG001
Brigatinib 90 mg QD
Brigatinib 90 mg, tablets, orally, QD in each cycle of 28 days (Approximately up to 7.3 years).
OG002
Brigatinib 120 mg QD/60 mg BID
Secondary
Overall Survival (OS)
OS is defined as the time interval from the date of the first dose of the study treatment until death due to any cause.
Analysis was performed on all enrolled participants in the study who received at least one dose of brigatinib. Here, overall number of participants analyzed is the participants who were evaluable for this outcome measure.
Posted
Median
95% Confidence Interval
months
Screening and at 8-week intervals thereafter up to end of the study (up to 8.4 years)
ID
Title
Description
OG000
Brigatinib 30 mg QD/60 mg QD
Brigatinib 30 mg/60 mg, tablets, orally, QD in each cycle of 28 days (Approximately up to 7.3 years).
OG001
Brigatinib 90 mg QD
Brigatinib 90 mg, tablets, orally, QD in each cycle of 28 days (Approximately up to 7.3 years).
OG002
Brigatinib 120 mg QD/60 mg BID
Brigatinib 120 mg, once daily or 60 mg, BID, tablets, orally, in each cycle of 28 days (Approximately up to 7.3 years).
OG003
Brigatinib 90 mg QD-180 mg QD
Secondary
Intracranial Objective Response Rate
Intracranial objective response rate is defined as the percentage of the participants with CR or PR in the intracranial CNS per modification of RECIST v1.1 after the initiation of study drug. CR for target lesion: disappearance of all extranodal lesions. CR for non-target lesion: disappearance of all extranodal non-target lesions and normalization of tumor marker level. PR: at least a 30% decrease in the sum of the longest diameters (SLD) of target lesions, taking as reference the baseline sum diameters.
Full analysis set. ALK+ NSCLC participants with measurable and non-measurable brain metastases at baseline were evaluated for this outcome measure. Here, number analyzed is the number of participants who were evaluable for specific category.
Posted
Number
95% Confidence Interval
percentage of participants
Screening and at 8-week intervals thereafter (approximately up to 50 months)
ID
Title
Description
OG000
Brigatinib 30 mg QD/60 mg QD
Brigatinib 30 mg/60 mg, tablets, orally, QD in each cycle of 28 days (Approximately up to 7.3 years).
OG001
Brigatinib 90 mg QD
Brigatinib 90 mg, tablets, orally, QD in each cycle of 28 days (Approximately up to 7.3 years).
OG002
Brigatinib 120 mg QD/60 mg BID
Secondary
Duration of Intracranial Response
Intracranial duration of response is defined as the time interval from the time that the measurement criteria are first met for CR/PR in brain metastases (whichever is first recorded) until the first date that progressive disease is objectively documented or death due to any cause. Participants who did not progress nor die were censored at the last valid response assessment. Duration intracranial of response was calculated by Kaplan-Meier estimation.
Full analysis set. ALK+ NSCLC participants with measurable and non-measurable brain metastases at baseline were evaluated for this outcome measure.
Posted
Median
95% Confidence Interval
months
Screening and at 8-week intervals thereafter (approximately up to 50 months)
ID
Title
Description
OG000
Brigatinib 30 mg QD/60 mg QD
Brigatinib 30 mg/60 mg, tablets, orally, QD in each cycle of 28 days (Approximately up to 7.3 years).
OG001
Brigatinib 90 mg QD
Brigatinib 90 mg, tablets, orally, QD in each cycle of 28 days (Approximately up to 7.3 years).
OG002
Brigatinib 120 mg QD/60 mg BID
Brigatinib 120 mg, once daily or 60 mg, BID, tablets, orally, in each cycle of 28 days (Approximately up to 7.3 years).
Secondary
Intracranial Progression Free Survival (PFS)
PFS is defined as the time interval from the date of the first dose of the study treatment until the first date at which disease progression in brain, or death due to any cause, whichever occurs first. Intracranial PFS was calculated by Kaplan-Meier estimation.
Full analysis set. ALK+ NSCLC participants with measurable and non-measurable brain metastases at baseline were evaluated for this outcome measure.
Posted
Median
95% Confidence Interval
months
Screening and at 8-week intervals thereafter (approximately up to 50 months)
ID
Title
Description
OG000
Brigatinib 30 mg QD/60 mg QD
Brigatinib 30 mg/60 mg, tablets, orally, QD in each cycle of 28 days (Approximately up to 7.3 years).
OG001
Brigatinib 90 mg QD
Brigatinib 90 mg, tablets, orally, QD in each cycle of 28 days (Approximately up to 7.3 years).
OG002
Brigatinib 120 mg QD/60 mg BID
Brigatinib 120 mg, once daily or 60 mg, BID, tablets, orally, in each cycle of 28 days (Approximately up to 7.3 years).
OG003
Brigatinib 90 mg QD-180 mg QD
Time Frame
All-Cause Mortality: From first dose up to the End of the Study (Up to 8.4 years). Serious and other adverse events: From first dose of study drug up to 30 days following the last dose of the study treatment or the investigator/participant decision to discontinue treatment, whichever occurs first (approximately up to 7.4 years)
Description
Not provided
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
Brigatinib 30 mg QD/60 mg QD
Brigatinib 30 mg/60 mg, tablets, orally, QD in each cycle of 28 days (Approximately up to 7.3 years).
6
6
1
6
6
6
EG001
Brigatinib 90 mg QD
Brigatinib 90 mg, tablets, orally, QD in each cycle of 28 days (Approximately up to 7.3 years).
11
18
10
18
17
18
EG002
Brigatinib 120 mg QD/60 mg BID
Brigatinib 120 mg, once daily or 60 mg, BID, tablets, orally, in each cycle of 28 days (Approximately up to 7.3 years).
12
18
10
18
17
18
EG003
Brigatinib 90 mg QD-180 mg QD
Brigatinib 90 mg, tablets, orally, once daily for 7 days followed by brigatinib 180 mg, orally QD in Cycle 1 of 28 days followed by brigatinib 180 mg, orally QD in cycle 2 and onward cycles of 28 days (Approximately up to 7.3 years).
17
32
14
32
31
32
EG004
Brigatinib 180 mg QD/90 mg BID
Brigatinib 180 mg, once daily or 90 mg, BID, tablets, orally in each cycle of 28 days (Approximately up to 7.3 years).
25
48
30
48
45
48
EG005
Brigatinib 240 mg QD/120 mg BID/300 mg QD
Brigatinib 240 mg, QD or 120 mg, BID or 300 mg once daily, tablets, orally, in each cycle of 28 days (Approximately up to 7.3 years).
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0014 affected18 at risk
EG0021 affected18 at risk
EG003
Pericardial effusion malignant
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0020 affected18 at risk
EG003
Metastases to central nervous system
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.0
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected18 at risk
EG0020 affected18 at risk
EG003
Cancer pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0020 affected18 at risk
EG003
Intracranial tumour haemorrhage
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0020 affected18 at risk
EG003
Malignant ascites
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected18 at risk
EG0020 affected18 at risk
EG003
Metastatic malignant melanoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0020 affected18 at risk
EG003
Basal cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0020 affected18 at risk
EG003
Seizure
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected18 at risk
EG0021 affected18 at risk
EG003
Syncope
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected18 at risk
EG0020 affected18 at risk
EG003
Central nervous system haemorrhage
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0020 affected18 at risk
EG003
Cerebral haemorrhage
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0020 affected18 at risk
EG003
Cognitive disorder
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0020 affected18 at risk
EG003
Embolic stroke
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0020 affected18 at risk
EG003
Haemorrhage intracranial
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0020 affected18 at risk
EG003
Haemorrhagic stroke
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected18 at risk
EG0020 affected18 at risk
EG003
Headache
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0020 affected18 at risk
EG003
Ischaemic stroke
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0020 affected18 at risk
EG003
Nervous system disorder
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0020 affected18 at risk
EG003
Transient ischaemic attack
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected18 at risk
EG0020 affected18 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0020 affected18 at risk
EG003
Pyrexia
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0020 affected18 at risk
EG003
Death
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected18 at risk
EG0020 affected18 at risk
EG003
Influenza like illness
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0020 affected18 at risk
EG003
Sudden death
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0020 affected18 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected18 at risk
EG0020 affected18 at risk
EG003
Supraventricular tachycardia
Cardiac disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0020 affected18 at risk
EG003
Cardiac failure congestive
Cardiac disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected18 at risk
EG0020 affected18 at risk
EG003
Cardiac tamponade
Cardiac disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0020 affected18 at risk
EG003
Angina unstable
Cardiac disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0020 affected18 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0020 affected18 at risk
EG003
Pancreatitis
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0020 affected18 at risk
EG003
Abdominal wall haematoma
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0020 affected18 at risk
EG003
Bezoar
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0020 affected18 at risk
EG003
Colitis
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0020 affected18 at risk
EG003
Gastric ulcer haemorrhage
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0020 affected18 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0021 affected18 at risk
EG003
Oesophageal compression
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0020 affected18 at risk
EG003
Rectal ulcer
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected18 at risk
EG0020 affected18 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0020 affected18 at risk
EG003
Bone pain
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0020 affected18 at risk
EG003
Intervertebral disc protrusion
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0020 affected18 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0020 affected18 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected18 at risk
EG0020 affected18 at risk
EG003
Failure to thrive
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected18 at risk
EG0020 affected18 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0020 affected18 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0020 affected18 at risk
EG003
Insulin resistance
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected18 at risk
EG0020 affected18 at risk
EG003
Mental status changes
Psychiatric disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0021 affected18 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0020 affected18 at risk
EG003
Suicidal ideation
Psychiatric disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0020 affected18 at risk
EG003
Post procedural haemorrhage
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0020 affected18 at risk
EG003
Radiation necrosis
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0020 affected18 at risk
EG003
Radiation pneumonitis
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0020 affected18 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0020 affected18 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0020 affected18 at risk
EG003
Eczema
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0021 affected18 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0020 affected18 at risk
EG003
Haematoma
Vascular disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0020 affected18 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected18 at risk
EG0020 affected18 at risk
EG003
Food allergy
Immune system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected18 at risk
EG0020 affected18 at risk
EG003
Dyspnoea exertional
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0020 affected18 at risk
EG003
Pleuritic pain
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0020 affected18 at risk
EG003
Chronic myeloid leukaemia recurrent
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected18 at risk
EG0020 affected18 at risk
EG003
Malignant pleural effusion
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0020 affected18 at risk
EG003
Metastases to meninges
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0020 affected18 at risk
EG003
Penile squamous cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0020 affected18 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0020 affected18 at risk
EG003
Respiratory tract infection
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0020 affected18 at risk
EG003
Ataxia
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0020 affected18 at risk
EG003
Central nervous system lesion
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0020 affected18 at risk
EG003
Cerebral ischaemia
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0020 affected18 at risk
EG003
Dysarthria
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0020 affected18 at risk
EG003
Hydrocephalus
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0020 affected18 at risk
EG003
Presyncope
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0020 affected18 at risk
EG003
Status epilepticus
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0020 affected18 at risk
EG003
Cardio-respiratory arrest
Cardiac disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0020 affected18 at risk
EG003
Pericardial effusion
Cardiac disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0020 affected18 at risk
EG003
Intestinal obstruction
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0020 affected18 at risk
EG003
Femur fracture
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0020 affected18 at risk
EG003
Radiation associated cardiac failure
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0020 affected18 at risk
EG003
Road traffic accident
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0020 affected18 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0020 affected18 at risk
EG003
Blindness
Eye disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0020 affected18 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Nausea
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0003 affected6 at risk
EG0018 affected18 at risk
EG0029 affected18 at risk
EG00316 affected32 at risk
EG00433 affected48 at risk
EG0058 affected15 at risk
Diarrhoea
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected6 at risk
EG0018 affected18 at risk
EG0027 affected18 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected6 at risk
EG0016 affected18 at risk
EG0025 affected18 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected6 at risk
EG0011 affected18 at risk
EG0025 affected18 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0003 affected6 at risk
EG0011 affected18 at risk
EG0022 affected18 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0013 affected18 at risk
EG0020 affected18 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0014 affected18 at risk
EG0021 affected18 at risk
EG003
Abdominal discomfort
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected18 at risk
EG0021 affected18 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected18 at risk
EG0020 affected18 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0014 affected18 at risk
EG0021 affected18 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0021 affected18 at risk
EG003
Aphthous ulcer
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0013 affected18 at risk
EG0020 affected18 at risk
EG003
Flatulence
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0020 affected18 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0012 affected18 at risk
EG0022 affected18 at risk
EG003
Cheilitis
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0021 affected18 at risk
EG003
Mouth ulceration
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0021 affected18 at risk
EG003
Abdominal rigidity
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0021 affected18 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected18 at risk
EG0021 affected18 at risk
EG003
Lip dry
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected18 at risk
EG0020 affected18 at risk
EG003
Lip swelling
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected18 at risk
EG0020 affected18 at risk
EG003
Oesophageal irritation
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0021 affected18 at risk
EG003
Oesophageal pain
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0020 affected18 at risk
EG003
Toothache
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected18 at risk
EG0020 affected18 at risk
EG003
Hypoaesthesia oral
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0020 affected18 at risk
EG003
Fatigue
General disorders
MedDRA 23.0
Systematic Assessment
EG0002 affected6 at risk
EG0019 affected18 at risk
EG0029 affected18 at risk
EG003
Oedema peripheral
General disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected6 at risk
EG0011 affected18 at risk
EG0024 affected18 at risk
EG003
Pyrexia
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0013 affected18 at risk
EG0022 affected18 at risk
EG003
Pain
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0013 affected18 at risk
EG0022 affected18 at risk
EG003
Chest discomfort
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0013 affected18 at risk
EG0020 affected18 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected18 at risk
EG0022 affected18 at risk
EG003
Influenza like illness
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected18 at risk
EG0022 affected18 at risk
EG003
Asthenia
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected18 at risk
EG0021 affected18 at risk
EG003
Chills
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0013 affected18 at risk
EG0020 affected18 at risk
EG003
Gait disturbance
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected18 at risk
EG0020 affected18 at risk
EG003
Peripheral swelling
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0012 affected18 at risk
EG0020 affected18 at risk
EG003
Chest pain
General disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected18 at risk
EG0020 affected18 at risk
EG003
Thirst
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected18 at risk
EG0020 affected18 at risk
EG003
Axillary pain
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected18 at risk
EG0020 affected18 at risk
EG003
Exercise tolerance decreased
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected18 at risk
EG0020 affected18 at risk
EG003
Feeling abnormal
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0021 affected18 at risk
EG003
Feeling jittery
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0021 affected18 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected6 at risk
EG0017 affected18 at risk
EG0026 affected18 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0014 affected18 at risk
EG0025 affected18 at risk
EG003
Dyspnoea exertional
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected18 at risk
EG0022 affected18 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0012 affected18 at risk
EG0021 affected18 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0012 affected18 at risk
EG0020 affected18 at risk
EG003
Productive cough
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0012 affected18 at risk
EG0021 affected18 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0012 affected18 at risk
EG0023 affected18 at risk
EG003
Haemoptysis
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected18 at risk
EG0020 affected18 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0021 affected18 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected18 at risk
EG0020 affected18 at risk
EG003
Sinus congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected6 at risk
EG0011 affected18 at risk
EG0020 affected18 at risk
EG003
Dysphonia
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected18 at risk
EG0020 affected18 at risk
EG003
Rhinitis allergic
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected18 at risk
EG0021 affected18 at risk
EG003
Sputum discoloured
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected18 at risk
EG0021 affected18 at risk
EG003
Dry throat
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0020 affected18 at risk
EG003
Hiccups
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0021 affected18 at risk
EG003
Laryngeal inflammation
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0020 affected18 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0020 affected18 at risk
EG003
Pleuritic pain
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0020 affected18 at risk
EG003
Throat irritation
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected18 at risk
EG0020 affected18 at risk
EG003
Wheezing
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0020 affected18 at risk
EG003
Nasal dryness
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0020 affected18 at risk
EG003
Pleurisy
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0020 affected18 at risk
EG003
Pneumothorax
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0020 affected18 at risk
EG003
Pulmonary hypertension
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0020 affected18 at risk
EG003
Respiratory tract irritation
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected18 at risk
EG0020 affected18 at risk
EG003
Sneezing
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0020 affected18 at risk
EG003
Upper-airway cough syndrome
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0021 affected18 at risk
EG003
Seasonal allergy
Immune system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0021 affected18 at risk
EG003
Contrast media allergy
Immune system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0021 affected18 at risk
EG003
Pericardial effusion malignant
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0020 affected18 at risk
EG003
Melanocytic naevus
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0021 affected18 at risk
EG003
Skin papilloma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0020 affected18 at risk
EG003
Tumour pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0020 affected18 at risk
EG003
Vulvovaginal dryness
Reproductive system and breast disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected18 at risk
EG0020 affected18 at risk
EG003
Nipple pain
Reproductive system and breast disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected18 at risk
EG0020 affected18 at risk
EG003
Hypothyroidism
Endocrine disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected18 at risk
EG0020 affected18 at risk
EG003
Tinnitus
Ear and labyrinth disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0012 affected18 at risk
EG0020 affected18 at risk
EG003
Deafness unilateral
Ear and labyrinth disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected18 at risk
EG0020 affected18 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected18 at risk
EG0020 affected18 at risk
EG003
Sinus tachycardia
Cardiac disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected18 at risk
EG0020 affected18 at risk
EG003
Palpitations
Cardiac disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0012 affected18 at risk
EG0021 affected18 at risk
EG003
Sinus bradycardia
Cardiac disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0021 affected18 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected18 at risk
EG0020 affected18 at risk
EG003
Atrial flutter
Cardiac disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected18 at risk
EG0020 affected18 at risk
EG003
Cardiac failure congestive
Cardiac disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected18 at risk
EG0020 affected18 at risk
EG003
Anaemia
Blood and lymphatic system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected18 at risk
EG0023 affected18 at risk
EG003
Increased tendency to bruise
Blood and lymphatic system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0020 affected18 at risk
EG003
Skin Laceration
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected18 at risk
EG0020 affected18 at risk
EG003
Rib fracture
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected18 at risk
EG0020 affected18 at risk
EG003
Procedural pain
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0020 affected18 at risk
EG003
Radiation neuropathy
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0021 affected18 at risk
EG003
Radiation pneumonitis
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0020 affected18 at risk
EG003
Pollakiuria
Renal and urinary disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected18 at risk
EG0021 affected18 at risk
EG003
Proteinuria
Renal and urinary disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0020 affected18 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected18 at risk
EG0021 affected18 at risk
EG003
Dysuria
Renal and urinary disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0020 affected18 at risk
EG003
Renal failure
Renal and urinary disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected18 at risk
EG0020 affected18 at risk
EG003
Urinary retention
Renal and urinary disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected18 at risk
EG0020 affected18 at risk
EG003
Hypertension
Vascular disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0012 affected18 at risk
EG0026 affected18 at risk
EG003
Hypotension
Vascular disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected18 at risk
EG0020 affected18 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected18 at risk
EG0020 affected18 at risk
EG003
Vascular pain
Vascular disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected18 at risk
EG0020 affected18 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected18 at risk
EG0021 affected18 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected18 at risk
EG0020 affected18 at risk
EG003
Depression
Psychiatric disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected18 at risk
EG0020 affected18 at risk
EG003
Bruxism
Psychiatric disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected18 at risk
EG0020 affected18 at risk
EG003
Anticipatory anxiety
Psychiatric disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0021 affected18 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected18 at risk
EG0020 affected18 at risk
EG003
Disorientation
Psychiatric disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected18 at risk
EG0020 affected18 at risk
EG003
Nervousness
Psychiatric disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected18 at risk
EG0020 affected18 at risk
EG003
Stress
Psychiatric disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected18 at risk
EG0020 affected18 at risk
EG003
Vision blurred
Eye disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected18 at risk
EG0022 affected18 at risk
EG003
Dry eye
Eye disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected18 at risk
EG0020 affected18 at risk
EG003
Visual impairment
Eye disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected18 at risk
EG0020 affected18 at risk
EG003
Blepharospasm
Eye disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected18 at risk
EG0020 affected18 at risk
EG003
Lacrimation increased
Eye disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected18 at risk
EG0020 affected18 at risk
EG003
Photopsia
Eye disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected6 at risk
EG0011 affected18 at risk
EG0020 affected18 at risk
EG003
Vitreous floaters
Eye disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0020 affected18 at risk
EG003
Asthenopia
Eye disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0020 affected18 at risk
EG003
Cataract
Eye disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected18 at risk
EG0020 affected18 at risk
EG003
Eye pain
Eye disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected18 at risk
EG0020 affected18 at risk
EG003
Eyelid margin crusting
Eye disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected18 at risk
EG0020 affected18 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected18 at risk
EG0023 affected18 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected18 at risk
EG0024 affected18 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0013 affected18 at risk
EG0020 affected18 at risk
EG003
Sinusitis
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0020 affected18 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected18 at risk
EG0022 affected18 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0012 affected18 at risk
EG0020 affected18 at risk
EG003
Influenza
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected18 at risk
EG0020 affected18 at risk
EG003
Oral candidiasis
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected18 at risk
EG0020 affected18 at risk
EG003
Viral infection
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected18 at risk
EG0020 affected18 at risk
EG003
Vulvovaginal mycotic infection
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected18 at risk
EG0020 affected18 at risk
EG003
Conjunctivitis viral
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0020 affected18 at risk
EG003
Diarrhoea infectious
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0020 affected18 at risk
EG003
Folliculitis
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0020 affected18 at risk
EG003
Fungal skin infection
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected18 at risk
EG0020 affected18 at risk
EG003
Infectious pleural effusion
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0021 affected18 at risk
EG003
Laryngitis viral
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0020 affected18 at risk
EG003
Nail infection
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected18 at risk
EG0020 affected18 at risk
EG003
Nasal herpes
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected18 at risk
EG0020 affected18 at risk
EG003
Onychomycosis
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected18 at risk
EG0020 affected18 at risk
EG003
Otitis externa
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0020 affected18 at risk
EG003
Paronychia
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected18 at risk
EG0020 affected18 at risk
EG003
Skin candida
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0021 affected18 at risk
EG003
Vaginal infection
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected18 at risk
EG0020 affected18 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0012 affected18 at risk
EG0020 affected18 at risk
EG003
Photosensitivity reaction
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0024 affected18 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0012 affected18 at risk
EG0021 affected18 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected18 at risk
EG0022 affected18 at risk
EG003
Night sweats
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0012 affected18 at risk
EG0021 affected18 at risk
EG003
Dermatitis acneiform
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0012 affected18 at risk
EG0021 affected18 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0012 affected18 at risk
EG0020 affected18 at risk
EG003
Hyperhidrosis
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected18 at risk
EG0020 affected18 at risk
EG003
Onychoclasis
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0013 affected18 at risk
EG0020 affected18 at risk
EG003
Rash pruritic
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected18 at risk
EG0020 affected18 at risk
EG003
Dermatitis contact
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0021 affected18 at risk
EG003
Eczema
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected18 at risk
EG0020 affected18 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected18 at risk
EG0020 affected18 at risk
EG003
Pain of skin
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected18 at risk
EG0020 affected18 at risk
EG003
Skin disorder
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0021 affected18 at risk
EG003
Dermal cyst
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0021 affected18 at risk
EG003
Dermatitis
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0020 affected18 at risk
EG003
Dermatitis atopic
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0020 affected18 at risk
EG003
Nail disorder
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0021 affected18 at risk
EG003
Petechiae
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected18 at risk
EG0020 affected18 at risk
EG003
Skin hyperpigmentation
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0021 affected18 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected18 at risk
EG0020 affected18 at risk
EG003
Nail growth abnormal
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected18 at risk
EG0020 affected18 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0015 affected18 at risk
EG0021 affected18 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0022 affected18 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0023 affected18 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0013 affected18 at risk
EG0021 affected18 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected18 at risk
EG0020 affected18 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0021 affected18 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected18 at risk
EG0020 affected18 at risk
EG003
Increased appetite
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected18 at risk
EG0020 affected18 at risk
EG003
Hyperlipidaemia
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected18 at risk
EG0020 affected18 at risk
EG003
Amylase increased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0015 affected18 at risk
EG0025 affected18 at risk
EG003
Lipase increased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0015 affected18 at risk
EG0024 affected18 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0013 affected18 at risk
EG0027 affected18 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0013 affected18 at risk
EG0023 affected18 at risk
EG003
Blood insulin increased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0014 affected18 at risk
EG0022 affected18 at risk
EG003
Weight decreased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0012 affected18 at risk
EG0020 affected18 at risk
EG003
Blood creatine phosphokinase increased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0012 affected18 at risk
EG0022 affected18 at risk
EG003
Lymphocyte count decreased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected18 at risk
EG0020 affected18 at risk
EG003
Weight increased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected18 at risk
EG0022 affected18 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0012 affected18 at risk
EG0021 affected18 at risk
EG003
Blood testosterone decreased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0020 affected18 at risk
EG003
Blood thyroid stimulating hormone decreased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0012 affected18 at risk
EG0021 affected18 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0021 affected18 at risk
EG003
Blood lactate dehydrogenase increased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected18 at risk
EG0020 affected18 at risk
EG003
Blood thyroid stimulating hormone increased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected18 at risk
EG0021 affected18 at risk
EG003
Activated partial thromboplastin time prolonged
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected18 at risk
EG0020 affected18 at risk
EG003
Electrocardiogram QT prolonged
Investigations
MedDRA 23.0
Systematic Assessment
EG0002 affected6 at risk
EG0011 affected18 at risk
EG0020 affected18 at risk
EG003
Bacterial test positive
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0020 affected18 at risk
EG003
Ejection fraction decreased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected18 at risk
EG0020 affected18 at risk
EG003
Heart rate increased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected18 at risk
EG0020 affected18 at risk
EG003
Urinary sediment present
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0020 affected18 at risk
EG003
Urine leukocyte esterase positive
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0020 affected18 at risk
EG003
White blood cells urine positive
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0021 affected18 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected6 at risk
EG0011 affected18 at risk
EG0024 affected18 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected6 at risk
EG0013 affected18 at risk
EG0025 affected18 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0012 affected18 at risk
EG0021 affected18 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected6 at risk
EG0014 affected18 at risk
EG0021 affected18 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected6 at risk
EG0013 affected18 at risk
EG0023 affected18 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0002 affected6 at risk
EG0011 affected18 at risk
EG0021 affected18 at risk
EG003
Joint swelling
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected18 at risk
EG0020 affected18 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0014 affected18 at risk
EG0021 affected18 at risk
EG003
Bone pain
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected18 at risk
EG0020 affected18 at risk
EG003
Musculoskeletal discomfort
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0022 affected18 at risk
EG003
Flank pain
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0012 affected18 at risk
EG0022 affected18 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0021 affected18 at risk
EG003
Pain in jaw
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected18 at risk
EG0020 affected18 at risk
EG003
Arthritis
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected18 at risk
EG0020 affected18 at risk
EG003
Fracture pain
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0020 affected18 at risk
EG003
Limb discomfort
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected18 at risk
EG0020 affected18 at risk
EG003
Musculoskeletal stiffness
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected18 at risk
EG0021 affected18 at risk
EG003
Groin pain
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected18 at risk
EG0020 affected18 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0020 affected18 at risk
EG003
Osteopenia
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected18 at risk
EG0020 affected18 at risk
EG003
Headache
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0018 affected18 at risk
EG0027 affected18 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0015 affected18 at risk
EG0021 affected18 at risk
EG003
Peripheral sensory neuropathy
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected18 at risk
EG0022 affected18 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected6 at risk
EG0012 affected18 at risk
EG0021 affected18 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0020 affected18 at risk
EG003
Tremor
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected18 at risk
EG0021 affected18 at risk
EG003
Amnesia
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected18 at risk
EG0020 affected18 at risk
EG003
Balance disorder
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0012 affected18 at risk
EG0020 affected18 at risk
EG003
Hypoaesthesia
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected18 at risk
EG0020 affected18 at risk
EG003
Visual field defect
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0020 affected18 at risk
EG003
Seizure
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected18 at risk
EG0021 affected18 at risk
EG003
Aphasia
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected18 at risk
EG0020 affected18 at risk
EG003
Disturbance in attention
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected18 at risk
EG0020 affected18 at risk
EG003
Dysarthria
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0012 affected18 at risk
EG0020 affected18 at risk
EG003
Memory impairment
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected6 at risk
EG0011 affected18 at risk
EG0020 affected18 at risk
EG003
Sinus headache
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0020 affected18 at risk
EG003
Somnolence
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected18 at risk
EG0021 affected18 at risk
EG003
Syncope
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0020 affected18 at risk
EG003
Burning sensation
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected18 at risk
EG0020 affected18 at risk
EG003
Cognitive disorder
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected18 at risk
EG0020 affected18 at risk
EG003
Neuralgia
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected18 at risk
EG0020 affected18 at risk
EG003
Parosmia
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0021 affected18 at risk
EG003
Peripheral motor neuropathy
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected18 at risk
EG0020 affected18 at risk
EG003
Hyperaesthesia teeth
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected18 at risk
EG0020 affected18 at risk
EG003
Abdominal pain lower
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected18 at risk
EG0020 affected18 at risk
EG003
Eructation
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected18 at risk
EG0020 affected18 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0012 affected18 at risk
EG0020 affected18 at risk
EG003
Abnormal faeces
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected18 at risk
EG0020 affected18 at risk
EG003
Enterocolitis
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected18 at risk
EG0020 affected18 at risk
EG003
Haematochezia
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0021 affected18 at risk
EG003
Swelling face
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0020 affected18 at risk
EG003
Mucosal inflammation
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected18 at risk
EG0020 affected18 at risk
EG003
Swelling
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0021 affected18 at risk
EG003
Temperature intolerance
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected18 at risk
EG0020 affected18 at risk
EG003
Bursitis
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected18 at risk
EG0021 affected18 at risk
EG003
Tendonitis
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0021 affected18 at risk
EG003
Taste disorder
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0012 affected18 at risk
EG0021 affected18 at risk
EG003
Neuropathy peripheral
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0021 affected18 at risk
EG003
Presyncope
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0020 affected18 at risk
EG003
Dizziness postural
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected18 at risk
EG0020 affected18 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected18 at risk
EG0020 affected18 at risk
EG003
Gout
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0021 affected18 at risk
EG003
Hyperuricaemia
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected18 at risk
EG0020 affected18 at risk
EG003
Blood creatinine increased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0012 affected18 at risk
EG0022 affected18 at risk
EG003
Blood alkaline phosphatase decreased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0020 affected18 at risk
EG003
Blood magnesium decreased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0020 affected18 at risk
EG003
Blood phosphorus decreased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0021 affected18 at risk
EG003
Blood sodium increased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0021 affected18 at risk
EG003
Electrocardiogram T wave abnormal
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0020 affected18 at risk
EG003
Haematocrit decreased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0021 affected18 at risk
EG003
Haemoglobin decreased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0021 affected18 at risk
EG003
Rash erythematous
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0012 affected18 at risk
EG0022 affected18 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected18 at risk
EG0020 affected18 at risk
EG003
Actinic keratosis
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0021 affected18 at risk
EG003
Rash papular
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0020 affected18 at risk
EG003
Eczema nummular
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected18 at risk
EG0020 affected18 at risk
EG003
Ingrowing nail
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected18 at risk
EG0020 affected18 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected18 at risk
EG0020 affected18 at risk
EG003
Gastroenteritis viral
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0021 affected18 at risk
EG003
Rhinitis
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0020 affected18 at risk
EG003
Ear infection bacterial
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0021 affected18 at risk
EG003
Kidney infection
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0020 affected18 at risk
EG003
Oral herpes
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected18 at risk
EG0020 affected18 at risk
EG003
Vulvovaginal candidiasis
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected18 at risk
EG0020 affected18 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0020 affected18 at risk
EG003
Hot flush
Vascular disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0020 affected18 at risk
EG003
Eyelid oedema
Eye disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected18 at risk
EG0020 affected18 at risk
EG003
Dyschromatopsia
Eye disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected18 at risk
EG0020 affected18 at risk
EG003
Eye swelling
Eye disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected18 at risk
EG0020 affected18 at risk
EG003
Urinary tract pain
Renal and urinary disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected18 at risk
EG0020 affected18 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0020 affected18 at risk
EG003
Arthropod bite
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected18 at risk
EG0020 affected18 at risk
EG003
Corneal abrasion
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0020 affected18 at risk
EG003
Foot fracture
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected18 at risk
EG0020 affected18 at risk
EG003
Joint dislocation
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected18 at risk
EG0020 affected18 at risk
EG003
Ear discomfort
Ear and labyrinth disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected18 at risk
EG0020 affected18 at risk
EG003
Ear pain
Ear and labyrinth disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected18 at risk
EG0020 affected18 at risk
EG003
Hyperthyroidism
Endocrine disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected18 at risk
EG0020 affected18 at risk
EG003
Basal cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0021 affected18 at risk
EG003
Dysplastic naevus
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected18 at risk
EG0020 affected18 at risk
EG003
Squamous cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0021 affected18 at risk
EG003
Metrorrhagia
Reproductive system and breast disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected18 at risk
EG0020 affected18 at risk
EG003
Breast pain
Reproductive system and breast disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0020 affected18 at risk
EG003
Cataract cortical
Eye disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0020 affected18 at risk
EG003
White blood cell count increased.
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected18 at risk
EG0020 affected18 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 first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
Brigatinib 120 mg, once daily or 60 mg, BID, tablets, orally, in each cycle of 28 days (Approximately up to 7.3 years).
OG003
Brigatinib 90 mg QD-180 mg QD
Brigatinib 90 mg, tablets, orally, once daily for 7 days followed by brigatinib 180 mg, orally QD in Cycle 1 of 28 days followed by brigatinib 180 mg, orally QD in cycle 2 and onward cycles of 28 days (Approximately up to 7.3 years).
OG004
Brigatinib 180 mg QD/90 mg BID
Brigatinib 180 mg, once daily or 90 mg, BID, tablets, orally in each cycle of 28 days (Approximately up to 7.3 years).
OG005
Brigatinib 240 mg QD/120 mg BID/300 mg QD
Brigatinib 240 mg, QD or 120 mg, BID or 300 mg once daily, tablets, orally, in each cycle of 28 days (Approximately up to 7.3 years).
Units
Counts
Participants
OG0001
OG00114
OG0026
OG00328
OG00425
OG0055
Title
Denominators
Categories
With Prior Treatment with Crizotinib
ParticipantsOG0001
ParticipantsOG00113
ParticipantsOG0025
ParticipantsOG00325
ParticipantsOG00423
ParticipantsOG0054
Title
Measurements
OG0000(0 to 0)
OG00153.8(25.1 to 80.8)
OG00260.0(14.7 to 94.7)
OG003
Without Prior Treatment with Crizotinib
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0021
ParticipantsOG0033
OG003
Brigatinib 90 mg QD-180 mg QD
Brigatinib 90 mg, tablets, orally, once daily for 7 days followed by brigatinib 180 mg, orally QD in Cycle 1 of 28 days followed by brigatinib 180 mg, orally QD in cycle 2 and onward cycles of 28 days (Approximately up to 7.3 years).
OG004
Brigatinib 180 mg QD/90 mg BID
Brigatinib 180 mg, once daily or 90 mg, BID, tablets, orally in each cycle of 28 days (Approximately up to 7.3 years).
OG005
Brigatinib 240 mg QD/120 mg BID/300 mg QD
Brigatinib 240 mg, QD or 120 mg, BID or 300 mg once daily, tablets, orally, in each cycle of 28 days (Approximately up to 7.3 years).
Units
Counts
Participants
OG0006
OG00118
OG00218
OG00332
OG00448
OG00515
Title
Denominators
Categories
Title
Measurements
OG0006
OG00118
OG00218
OG00332
OG00448
OG00515
66
Title
Denominators
Categories
Title
Measurements
OG000NAMTD criteria was not met.
OG002
Brigatinib 90 mg
Brigatinib 90 mg, tablets, orally, once daily or twice daily in each cycle of 28 days (Approximately up to 7.3 years).
OG003
Brigatinib 120 mg
Brigatinib 120 mg, tablets, orally, once daily in each cycle of 28 days (Approximately up to 7.3 years).
OG004
Brigatinib 180 mg
Brigatinib 180 mg, tablets, orally once daily in each cycle of 28 days (Approximately up to 7.3 years).
OG005
Brigatinib 240 mg
Brigatinib 240 mg, tablets, orally, once daily in each cycle of 28 days (Approximately up to 7.3 years).
OG006
Brigatinib 300 mg
Brigatinib 300 mg, tablets, orally, once daily in each cycle of 28 days (Approximately up to 7.3 years).
Units
Counts
Participants
OG0003
OG0013
OG0025
OG0033
OG0043
OG0056
OG0062
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0051
OG0061
OG004
Brigatinib 180 mg
Brigatinib 180 mg, tablets, orally once daily in each cycle of 28 days (Approximately up to 7.3 years).
OG005
Brigatinib 240 mg
Brigatinib 240 mg, tablets, orally, once daily in each cycle of 28 days (Approximately up to 7.3 years).
OG006
Brigatinib 300 mg
Brigatinib 300 mg, tablets, orally, once daily in each cycle of 28 days (Approximately up to 7.3 years).
Units
Counts
Participants
OG0003
OG0013
OG00250
OG00311
OG00444
OG00510
OG0062
Title
Denominators
Categories
Title
Measurements
OG000125.6± 41.07
OG001406.3± 102
OG002493± 289.5
OG003793.7± 828.7
OG0041185± 607.6
OG0051515± 637.9
OG006895± 487.9
OG004
Brigatinib 180 mg
Brigatinib 180 mg, tablets, orally once daily in each cycle of 28 days (Approximately up to 7.3 years).
OG005
Brigatinib 240 mg
Brigatinib 240 mg, tablets, orally, once daily in each cycle of 28 days (Approximately up to 7.3 years).
OG006
Brigatinib 300 mg
Brigatinib 300 mg, tablets, orally, once daily in each cycle of 28 days (Approximately up to 7.3 years).
Units
Counts
Participants
OG0002
OG0013
OG00215
OG00310
OG00463
OG0057
OG0060
Title
Denominators
Categories
Title
Measurements
OG000249.50± 167.58
OG001491.67± 223.95
OG002634.07± 310.05
OG003942.30± 472.33
OG0041694.3± 1014.3
OG0052280.0± 1308.5
OG004
Brigatinib 180 mg
Brigatinib 180 mg, tablets, orally once daily in each cycle of 28 days (Approximately up to 7.3 years).
OG005
Brigatinib 240 mg
Brigatinib 240 mg, tablets, orally, once daily in each cycle of 28 days (Approximately up to 7.3 years).
OG006
Brigatinib 300 mg
Brigatinib 300 mg, tablets, orally, once daily in each cycle of 28 days (Approximately up to 7.3 years).
Units
Counts
Participants
OG0003
OG0013
OG00250
OG00311
OG00444
OG00510
OG0062
Title
Denominators
Categories
Title
Measurements
OG0003.9(3.8 to 4.0)
OG0011.0(0.48 to 4.0)
OG0022.0(0.48 to 24)
OG0032.0(0.98 to 6.0)
OG0042.0(0.60 to 25)
OG0052.0(1.0 to 4.0)
OG0064.05(4 to 4.1)
OG004
Brigatinib 180 mg
Brigatinib 180 mg, tablets, orally once daily in each cycle of 28 days (Approximately up to 7.3 years).
OG005
Brigatinib 240 mg
Brigatinib 240 mg, tablets, orally, once daily in each cycle of 28 days (Approximately up to 7.3 years).
OG006
Brigatinib 300 mg
Brigatinib 300 mg, tablets, orally, once daily in each cycle of 28 days (Approximately up to 7.3 years).
Units
Counts
Participants
OG0002
OG0013
OG00215
OG00310
OG00463
OG0057
OG0060
Title
Denominators
Categories
Title
Measurements
OG0002.49(0.98 to 4.0)
OG0011.00(0.50 to 1.8)
OG0022.00(0.98 to 8.0)
OG0033.00(0.50 to 6.1)
OG0042.10(0.50 to 6.2)
OG0052.00(1.0 to 4.0)
Brigatinib 120 mg, tablets, orally, once daily in each cycle of 28 days (Approximately up to 7.3 years).
OG004
Brigatinib 180 mg
Brigatinib 180 mg, tablets, orally once daily in each cycle of 28 days (Approximately up to 7.3 years).
OG005
Brigatinib 240 mg
Brigatinib 240 mg, tablets, orally, once daily in each cycle of 28 days (Approximately up to 7.3 years).
OG006
Brigatinib 300 mg
Brigatinib 300 mg, tablets, orally, once daily in each cycle of 28 days (Approximately up to 7.3 years).
Units
Counts
Participants
OG0003
OG0013
OG00215
OG00311
OG00463
OG0057
OG0062
Title
Denominators
Categories
Title
Measurements
OG0001320.9± 576.29
OG0013900± 430.31
OG0025710.1± 3268.4
OG0039895.5± 11772
OG00413204± 6306.9
OG00516800± 7571.1
OG00612356± 5869
Brigatinib 120 mg, tablets, orally, once daily in each cycle of 28 days (Approximately up to 7.3 years).
OG004
Brigatinib 180 mg
Brigatinib 180 mg, tablets, orally once daily in each cycle of 28 days (Approximately up to 7.3 years).
OG005
Brigatinib 240 mg
Brigatinib 240 mg, tablets, orally, once daily in each cycle of 28 days (Approximately up to 7.3 years).
OG006
Brigatinib 300 mg
Brigatinib 300 mg, tablets, orally, once daily in each cycle of 28 days (Approximately up to 7.3 years).
Units
Counts
Participants
OG0002
OG0013
OG00215
OG00310
OG00463
OG0057
OG0060
Title
Denominators
Categories
Title
Measurements
OG0002689.0± 1145.5
OG0015069.0± 1664.7
OG0029142.1± 4076.7
OG00313888± 7011.4
OG00423478± 14463
OG00530117± 19921
OG004
Brigatinib 180 mg
Brigatinib 180 mg, tablets, orally once daily in each cycle of 28 days (Approximately up to 7.3 years).
OG005
Brigatinib 240 mg
Brigatinib 240 mg, tablets, orally, once daily in each cycle of 28 days (Approximately up to 7.3 years).
OG006
Brigatinib 300 mg
Brigatinib 300 mg, tablets, orally, once daily in each cycle of 28 days (Approximately up to 7.3 years).
Units
Counts
Participants
OG0002
OG0013
OG00215
OG00310
OG00463
OG0057
OG0060
Title
Denominators
Categories
Title
Measurements
OG00031.55± 2.758
OG00130.93± 5.873
OG00228.69± 10.06
OG00325.52± 7.958
OG00424.90± 7.437
OG00521.77± 4.007
Brigatinib 90 mg QD
Brigatinib 90 mg, tablets, orally, QD in each cycle of 28 days (Approximately up to 7.3 years).
OG002
Brigatinib 120 mg QD/60 mg BID
Brigatinib 120 mg, once daily or 60 mg, BID, tablets, orally, in each cycle of 28 days (Approximately up to 7.3 years).
OG003
Brigatinib 90 mg QD-180 mg QD
Brigatinib 90 mg, tablets, orally, once daily for 7 days followed by brigatinib 180 mg, orally QD in Cycle 1 of 28 days followed by brigatinib 180 mg, orally QD in cycle 2 and onward cycles of 28 days (Approximately up to 7.3 years).
OG004
Brigatinib 180 mg QD/90 mg BID
Brigatinib 180 mg, once daily or 90 mg, BID, tablets, orally in each cycle of 28 days (Approximately up to 7.3 years).
OG005
Brigatinib 240 mg QD/120 mg BID/300 mg QD
Brigatinib 240 mg, QD or 120 mg, BID or 300 mg once daily, tablets, orally, in each cycle of 28 days (Approximately up to 7.3 years).
Units
Counts
Participants
OG0001
OG00114
OG0026
OG00328
OG00425
OG0055
Title
Denominators
Categories
With Prior Treatment with Crizotinib: Complete Response
ParticipantsOG0001
ParticipantsOG00113
ParticipantsOG0025
ParticipantsOG00325
ParticipantsOG00423
ParticipantsOG0054
Title
Measurements
OG0000.0(0.0 to 0.0)
OG0010.0(0.0 to 0.0)
OG0020.0(0.0 to 0.0)
OG003
Without Prior Treatment with Crizotinib: Complete Response
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0021
ParticipantsOG003
With Prior Treatment with Crizotinib: Partial Response
ParticipantsOG0001
ParticipantsOG00113
ParticipantsOG0025
ParticipantsOG003
Without Prior Treatment with Crizotinib: Partial Response
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0021
ParticipantsOG003
With Prior Treatment with Crizotinib: Stable Disease
ParticipantsOG0001
ParticipantsOG00113
ParticipantsOG0025
ParticipantsOG003
Without Prior Treatment with Crizotinib: Stable Disease
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0021
ParticipantsOG003
With Prior Treatment with Crizotinib: Progressive Disease
ParticipantsOG0001
ParticipantsOG00113
ParticipantsOG0025
ParticipantsOG003
Without Prior Treatment with Crizotinib: Progressive Disease
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0021
ParticipantsOG003
Brigatinib 90 mg QD
Brigatinib 90 mg, tablets, orally, QD in each cycle of 28 days (Approximately up to 7.3 years).
OG002
Brigatinib 120 mg QD/60 mg BID
Brigatinib 120 mg, once daily or 60 mg, BID, tablets, orally, in each cycle of 28 days (Approximately up to 7.3 years).
OG003
Brigatinib 90 mg QD-180 mg QD
Brigatinib 90 mg, tablets, orally, once daily for 7 days followed by brigatinib 180 mg, orally QD in Cycle 1 of 28 days followed by brigatinib 180 mg, orally QD in cycle 2 and onward cycles of 28 days (Approximately up to 7.3 years).
OG004
Brigatinib 180 mg QD/90 mg BID
Brigatinib 180 mg, once daily or 90 mg, BID, tablets, orally in each cycle of 28 days (Approximately up to 7.3 years).
OG005
Brigatinib 240 mg QD/120 mg BID/300 mg QD
Brigatinib 240 mg, QD or 120 mg, BID or 300 mg once daily, tablets, orally, in each cycle of 28 days (Approximately up to 7.3 years).
Units
Counts
Participants
OG0000
OG0018
OG0024
OG00322
OG00417
OG0052
Title
Denominators
Categories
With Prior Treatment with Crizotinib
ParticipantsOG0000
ParticipantsOG0017
ParticipantsOG0023
ParticipantsOG00319
ParticipantsOG00415
ParticipantsOG0051
Title
Measurements
OG00111.1(3.8 to 16.7)
OG0024.0(3.7 to 29.5)
OG00314.8(7.9 to 25.1)
OG004
Without Prior Treatment with Crizotinib
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0021
ParticipantsOG0033
Brigatinib 120 mg, once daily or 60 mg, BID, tablets, orally, in each cycle of 28 days (Approximately up to 7.3 years).
OG003
Brigatinib 90 mg QD-180 mg QD
Brigatinib 90 mg, tablets, orally, once daily for 7 days followed by brigatinib 180 mg, orally QD in Cycle 1 of 28 days followed by brigatinib 180 mg, orally QD in cycle 2 and onward cycles of 28 days (Approximately up to 7.3 years).
OG004
Brigatinib 180 mg QD/90 mg BID
Brigatinib 180 mg, once daily or 90 mg, BID, tablets, orally in each cycle of 28 days (Approximately up to 7.3 years).
OG005
Brigatinib 240 mg QD/120 mg BID/300 mg QD
Brigatinib 240 mg, QD or 120 mg, BID or 300 mg once daily, tablets, orally, in each cycle of 28 days (Approximately up to 7.3 years).
Units
Counts
Participants
OG0005
OG00115
OG00217
OG00321
OG00440
OG0057
Title
Denominators
Categories
Title
Measurements
OG0001.8(1.0 to 5.5)
OG00112.6(0.9 to 47.9)
OG0025.4(0.8 to 63.9)
OG00311.0(0.5 to 53.6)
OG0045.4(0.1 to 69.9)
OG0055.4(1.8 to 31.5)
Brigatinib 90 mg, tablets, orally, once daily for 7 days followed by brigatinib 180 mg, orally QD in Cycle 1 of 28 days followed by brigatinib 180 mg, orally QD in cycle 2 and onward cycles of 28 days (Approximately up to 7.3 years).
OG004
Brigatinib 180 mg QD/90 mg BID
Brigatinib 180 mg, once daily or 90 mg, BID, tablets, orally in each cycle of 28 days (Approximately up to 7.3 years).
OG005
Brigatinib 240 mg QD/120 mg BID/300 mg QD
Brigatinib 240 mg, QD or 120 mg, BID or 300 mg once daily, tablets, orally, in each cycle of 28 days (Approximately up to 7.3 years).
Units
Counts
Participants
OG0006
OG00111
OG00212
OG00317
OG00425
OG00511
Title
Denominators
Categories
Title
Measurements
OG0005.3(2.3 to 12.6)
OG00111.6(4.0 to 47.6)
OG0027.3(0.5 to 28.6)
OG00317.9(1.4 to 35.0)
OG0047.3(0.1 to 55.0)
OG0058.3(3.3 to 22.3)
Brigatinib 120 mg, once daily or 60 mg, BID, tablets, orally, in each cycle of 28 days (Approximately up to 7.3 years).
OG003
Brigatinib 90 mg QD-180 mg QD
Brigatinib 90 mg, tablets, orally, once daily for 7 days followed by brigatinib 180 mg, orally QD in Cycle 1 of 28 days followed by brigatinib 180 mg, orally QD in cycle 2 and onward cycles of 28 days (Approximately up to 7.3 years).
OG004
Brigatinib 180 mg QD/90 mg BID
Brigatinib 180 mg, once daily or 90 mg, BID, tablets, orally in each cycle of 28 days (Approximately up to 7.3 years).
OG005
Brigatinib 240 mg QD/120 mg BID/300 mg QD
Brigatinib 240 mg, QD or 120 mg, BID or 300 mg once daily, tablets, orally, in each cycle of 28 days (Approximately up to 7.3 years).
Units
Counts
Participants
OG0000
OG0018
OG0021
OG00318
OG00416
OG0053
Title
Denominators
Categories
Measurable Brain Metastases
ParticipantsOG0000
ParticipantsOG0012
ParticipantsOG0020
ParticipantsOG0035
ParticipantsOG0047
ParticipantsOG0051
Title
Measurements
OG001100(15.8 to 100)
OG00380(28.4 to 99.5)
OG00442.9(9.9 to 81.6)
OG005
Only Non-Measurable Brain Metastases
ParticipantsOG0000
ParticipantsOG0016
ParticipantsOG0021
ParticipantsOG00313
OG003
Brigatinib 90 mg QD-180 mg QD
Brigatinib 90 mg, tablets, orally, once daily for 7 days followed by brigatinib 180 mg, orally QD in Cycle 1 of 28 days followed by brigatinib 180 mg, orally QD in cycle 2 and onward cycles of 28 days (Approximately up to 7.3 years).
OG004
Brigatinib 180 mg QD/90 mg BID
Brigatinib 180 mg, once daily or 90 mg, BID, tablets, orally in each cycle of 28 days (Approximately up to 7.3 years).
OG005
Brigatinib 240 mg QD/120 mg BID/300 mg QD
Brigatinib 240 mg, QD or 120 mg, BID or 300 mg once daily, tablets, orally, in each cycle of 28 days (Approximately up to 7.3 years).
Units
Counts
Participants
OG0000
OG0018
OG0021
OG00318
OG00416
OG0053
Title
Denominators
Categories
Title
Measurements
OG00112.9(NA to NA)Upper and lower limit of duration of intracranial response was not reached due to low number of participants with events.
OG0025.0(NA to NA)Upper and lower limit of duration of intracranial response was not reached due to low number of participants with events.
OG00311.4(7.5 to 11.4)
OG00429.2(5.5 to 29.2)
OG00511.3(3.6 to 18.9)
Brigatinib 90 mg, tablets, orally, once daily for 7 days followed by brigatinib 180 mg, orally QD in Cycle 1 of 28 days followed by brigatinib 180 mg, orally QD in cycle 2 and onward cycles of 28 days (Approximately up to 7.3 years).
OG004
Brigatinib 180 mg QD/90 mg BID
Brigatinib 180 mg, once daily or 90 mg, BID, tablets, orally in each cycle of 28 days (Approximately up to 7.3 years).
OG005
Brigatinib 240 mg QD/120 mg BID/300 mg QD
Brigatinib 240 mg, QD or 120 mg, BID or 300 mg once daily, tablets, orally, in each cycle of 28 days (Approximately up to 7.3 years).
Units
Counts
Participants
OG0000
OG0018
OG0021
OG00318
OG00416
OG0053
Title
Denominators
Categories
Title
Measurements
OG00136.8(5.5 to 36.8)
OG0026.7(NA to NA)Upper limit of 95% CI was not reached due to low number of participants with events.
OG003NA(9.4 to NA)Progression-free survival was not reached due to low number of participants with events.
OG00414.4(7.3 to 31.1)
OG0057.3(3.1 to 22.3)
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1 affected
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1 affected
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0 affected
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0 affected
32 at risk
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0 affected
32 at risk
EG0040 affected48 at risk
EG0050 affected15 at risk
6 affected
32 at risk
EG0045 affected48 at risk
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1 affected
32 at risk
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1 affected
32 at risk
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1 affected
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1 affected
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0 affected
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12 affected
32 at risk
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5 affected
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EG0040 affected48 at risk
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32 at risk
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32 at risk
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32 at risk
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32 at risk
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0 affected
32 at risk
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1 affected
32 at risk
EG0040 affected48 at risk
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0 affected
32 at risk
EG0041 affected48 at risk
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0 affected
32 at risk
EG0040 affected48 at risk
EG0050 affected15 at risk
0 affected
32 at risk
EG0040 affected48 at risk
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0 affected
32 at risk
EG0040 affected48 at risk
EG0050 affected15 at risk
3 affected
32 at risk
EG0043 affected48 at risk
EG0050 affected15 at risk
3 affected
32 at risk
EG0045 affected48 at risk
EG0050 affected15 at risk
7 affected
32 at risk
EG0043 affected48 at risk
EG0050 affected15 at risk
4 affected
32 at risk
EG0043 affected48 at risk
EG0050 affected15 at risk
0 affected
32 at risk
EG0044 affected48 at risk
EG0050 affected15 at risk
3 affected
32 at risk
EG0041 affected48 at risk
EG0050 affected15 at risk
0 affected
32 at risk
EG0045 affected48 at risk
EG0051 affected15 at risk
2 affected
32 at risk
EG0043 affected48 at risk
EG0051 affected15 at risk
0 affected
32 at risk
EG0042 affected48 at risk
EG0050 affected15 at risk
3 affected
32 at risk
EG0041 affected48 at risk
EG0050 affected15 at risk
0 affected
32 at risk
EG0042 affected48 at risk
EG0050 affected15 at risk
0 affected
32 at risk
EG0041 affected48 at risk
EG0051 affected15 at risk
2 affected
32 at risk
EG0042 affected48 at risk
EG0050 affected15 at risk
1 affected
32 at risk
EG0041 affected48 at risk
EG0050 affected15 at risk
0 affected
32 at risk
EG0041 affected48 at risk
EG0050 affected15 at risk
1 affected
32 at risk
EG0040 affected48 at risk
EG0050 affected15 at risk
0 affected
32 at risk
EG0041 affected48 at risk
EG0051 affected15 at risk
0 affected
32 at risk
EG0041 affected48 at risk
EG0051 affected15 at risk
1 affected
32 at risk
EG0040 affected48 at risk
EG0050 affected15 at risk
1 affected
32 at risk
EG0040 affected48 at risk
EG0050 affected15 at risk
0 affected
32 at risk
EG0041 affected48 at risk
EG0051 affected15 at risk
0 affected
32 at risk
EG0041 affected48 at risk
EG0051 affected15 at risk
0 affected
32 at risk
EG0040 affected48 at risk
EG0050 affected15 at risk
10 affected
32 at risk
EG00412 affected48 at risk
EG0055 affected15 at risk
7 affected
32 at risk
EG0044 affected48 at risk
EG0051 affected15 at risk
4 affected
32 at risk
EG0042 affected48 at risk
EG0053 affected15 at risk
5 affected
32 at risk
EG0045 affected48 at risk
EG0053 affected15 at risk
4 affected
32 at risk
EG0043 affected48 at risk
EG0051 affected15 at risk
1 affected
32 at risk
EG0042 affected48 at risk
EG0051 affected15 at risk
2 affected
32 at risk
EG0042 affected48 at risk
EG0050 affected15 at risk
0 affected
32 at risk
EG0041 affected48 at risk
EG0050 affected15 at risk
0 affected
32 at risk
EG0040 affected48 at risk
EG0050 affected15 at risk
10 affected
32 at risk
EG0049 affected48 at risk
EG0053 affected15 at risk
12 affected
32 at risk
EG0046 affected48 at risk
EG0053 affected15 at risk
10 affected
32 at risk
EG0049 affected48 at risk
EG0052 affected15 at risk
6 affected
32 at risk
EG0045 affected48 at risk
EG0051 affected15 at risk
4 affected
32 at risk
EG0045 affected48 at risk
EG0050 affected15 at risk
5 affected
32 at risk
EG0046 affected48 at risk
EG0052 affected15 at risk
4 affected
32 at risk
EG0044 affected48 at risk
EG0051 affected15 at risk
2 affected
32 at risk
EG0042 affected48 at risk
EG0051 affected15 at risk
1 affected
32 at risk
EG0044 affected48 at risk
EG0051 affected15 at risk
1 affected
32 at risk
EG0042 affected48 at risk
EG0051 affected15 at risk
2 affected
32 at risk
EG0044 affected48 at risk
EG0051 affected15 at risk
0 affected
32 at risk
EG0041 affected48 at risk
EG0050 affected15 at risk
2 affected
32 at risk
EG0040 affected48 at risk
EG0050 affected15 at risk
2 affected
32 at risk
EG0041 affected48 at risk
EG0051 affected15 at risk
1 affected
32 at risk
EG0043 affected48 at risk
EG0050 affected15 at risk
1 affected
32 at risk
EG0041 affected48 at risk
EG0050 affected15 at risk
1 affected
32 at risk
EG0042 affected48 at risk
EG0051 affected15 at risk
0 affected
32 at risk
EG0040 affected48 at risk
EG0051 affected15 at risk
0 affected
32 at risk
EG0040 affected48 at risk
EG0050 affected15 at risk
0 affected
32 at risk
EG0041 affected48 at risk
EG0050 affected15 at risk
0 affected
32 at risk
EG0040 affected48 at risk
EG0051 affected15 at risk
0 affected
32 at risk
EG0040 affected48 at risk
EG0051 affected15 at risk
0 affected
32 at risk
EG0040 affected48 at risk
EG0051 affected15 at risk
8 affected
32 at risk
EG00413 affected48 at risk
EG0053 affected15 at risk
11 affected
32 at risk
EG00410 affected48 at risk
EG0051 affected15 at risk
3 affected
32 at risk
EG0048 affected48 at risk
EG0053 affected15 at risk
10 affected
32 at risk
EG00410 affected48 at risk
EG0050 affected15 at risk
2 affected
32 at risk
EG0043 affected48 at risk
EG0052 affected15 at risk
4 affected
32 at risk
EG0043 affected48 at risk
EG0051 affected15 at risk
5 affected
32 at risk
EG0042 affected48 at risk
EG0050 affected15 at risk
6 affected
32 at risk
EG0043 affected48 at risk
EG0051 affected15 at risk
1 affected
32 at risk
EG0046 affected48 at risk
EG0050 affected15 at risk
3 affected
32 at risk
EG0042 affected48 at risk
EG0050 affected15 at risk
3 affected
32 at risk
EG0040 affected48 at risk
EG0050 affected15 at risk
5 affected
32 at risk
EG0041 affected48 at risk
EG0050 affected15 at risk
1 affected
32 at risk
EG0040 affected48 at risk
EG0052 affected15 at risk
0 affected
32 at risk
EG0042 affected48 at risk
EG0050 affected15 at risk
2 affected
32 at risk
EG0040 affected48 at risk
EG0050 affected15 at risk
1 affected
32 at risk
EG0040 affected48 at risk
EG0050 affected15 at risk
0 affected
32 at risk
EG0040 affected48 at risk
EG0050 affected15 at risk
0 affected
32 at risk
EG0040 affected48 at risk
EG0050 affected15 at risk
2 affected
32 at risk
EG0040 affected48 at risk
EG0052 affected15 at risk
0 affected
32 at risk
EG0040 affected48 at risk
EG0050 affected15 at risk
14 affected
32 at risk
EG00418 affected48 at risk
EG0056 affected15 at risk
5 affected
32 at risk
EG0043 affected48 at risk
EG0051 affected15 at risk
6 affected
32 at risk
EG0043 affected48 at risk
EG0050 affected15 at risk
2 affected
32 at risk
EG0043 affected48 at risk
EG0051 affected15 at risk
1 affected
32 at risk
EG0043 affected48 at risk
EG0051 affected15 at risk
3 affected
32 at risk
EG0043 affected48 at risk
EG0051 affected15 at risk
2 affected
32 at risk
EG0043 affected48 at risk
EG0050 affected15 at risk
2 affected
32 at risk
EG0045 affected48 at risk
EG0050 affected15 at risk
1 affected
32 at risk
EG0044 affected48 at risk
EG0051 affected15 at risk
0 affected
32 at risk
EG0045 affected48 at risk
EG0051 affected15 at risk
1 affected
32 at risk
EG0041 affected48 at risk
EG0052 affected15 at risk
1 affected
32 at risk
EG0043 affected48 at risk
EG0051 affected15 at risk
2 affected
32 at risk
EG0042 affected48 at risk
EG0050 affected15 at risk
0 affected
32 at risk
EG0042 affected48 at risk
EG0050 affected15 at risk
2 affected
32 at risk
EG0041 affected48 at risk
EG0050 affected15 at risk
2 affected
32 at risk
EG0040 affected48 at risk
EG0050 affected15 at risk
1 affected
32 at risk
EG0040 affected48 at risk
EG0050 affected15 at risk
1 affected
32 at risk
EG0040 affected48 at risk
EG0051 affected15 at risk
0 affected
32 at risk
EG0040 affected48 at risk
EG0050 affected15 at risk
0 affected
32 at risk
EG0041 affected48 at risk
EG0050 affected15 at risk
0 affected
32 at risk
EG0040 affected48 at risk
EG0050 affected15 at risk
0 affected
32 at risk
EG0040 affected48 at risk
EG0050 affected15 at risk
0 affected
32 at risk
EG0040 affected48 at risk
EG0050 affected15 at risk
1 affected
32 at risk
EG0041 affected48 at risk
EG0051 affected15 at risk
1 affected
32 at risk
EG0041 affected48 at risk
EG0050 affected15 at risk
1 affected
32 at risk
EG0041 affected48 at risk
EG0050 affected15 at risk
1 affected
32 at risk
EG0040 affected48 at risk
EG0050 affected15 at risk
1 affected
32 at risk
EG0040 affected48 at risk
EG0050 affected15 at risk
0 affected
32 at risk
EG0041 affected48 at risk
EG0050 affected15 at risk
0 affected
32 at risk
EG0040 affected48 at risk
EG0050 affected15 at risk
1 affected
32 at risk
EG0041 affected48 at risk
EG0051 affected15 at risk
0 affected
32 at risk
EG0040 affected48 at risk
EG0050 affected15 at risk
0 affected
32 at risk
EG0040 affected48 at risk
EG0050 affected15 at risk
0 affected
32 at risk
EG0040 affected48 at risk
EG0050 affected15 at risk
0 affected
32 at risk
EG0040 affected48 at risk
EG0050 affected15 at risk
0 affected
32 at risk
EG0040 affected48 at risk
EG0050 affected15 at risk
1 affected
32 at risk
EG0041 affected48 at risk
EG0051 affected15 at risk
0 affected
32 at risk
EG0041 affected48 at risk
EG0050 affected15 at risk
2 affected
32 at risk
EG0040 affected48 at risk
EG0050 affected15 at risk
0 affected
32 at risk
EG0040 affected48 at risk
EG0050 affected15 at risk
2 affected
32 at risk
EG0041 affected48 at risk
EG0050 affected15 at risk
0 affected
32 at risk
EG0041 affected48 at risk
EG0050 affected15 at risk
1 affected
32 at risk
EG0040 affected48 at risk
EG0050 affected15 at risk
4 affected
32 at risk
EG0043 affected48 at risk
EG0051 affected15 at risk
2 affected
32 at risk
EG0040 affected48 at risk
EG0050 affected15 at risk
0 affected
32 at risk
EG0041 affected48 at risk
EG0051 affected15 at risk
0 affected
32 at risk
EG0040 affected48 at risk
EG0051 affected15 at risk
0 affected
32 at risk
EG0040 affected48 at risk
EG0050 affected15 at risk
0 affected
32 at risk
EG0040 affected48 at risk
EG0051 affected15 at risk
0 affected
32 at risk
EG0040 affected48 at risk
EG0050 affected15 at risk
0 affected
32 at risk
EG0040 affected48 at risk
EG0050 affected15 at risk
0 affected
32 at risk
EG0044 affected48 at risk
EG0050 affected15 at risk
1 affected
32 at risk
EG0041 affected48 at risk
EG0051 affected15 at risk
1 affected
32 at risk
EG0040 affected48 at risk
EG0050 affected15 at risk
2 affected
32 at risk
EG0040 affected48 at risk
EG0050 affected15 at risk
0 affected
32 at risk
EG0040 affected48 at risk
EG0050 affected15 at risk
0 affected
32 at risk
EG0040 affected48 at risk
EG0050 affected15 at risk
1 affected
32 at risk
EG0042 affected48 at risk
EG0050 affected15 at risk
2 affected
32 at risk
EG0040 affected48 at risk
EG0051 affected15 at risk
0 affected
32 at risk
EG0041 affected48 at risk
EG0051 affected15 at risk
0 affected
32 at risk
EG0040 affected48 at risk
EG0050 affected15 at risk
0 affected
32 at risk
EG0040 affected48 at risk
EG0051 affected15 at risk
0 affected
32 at risk
EG0040 affected48 at risk
EG0050 affected15 at risk
0 affected
32 at risk
EG0040 affected48 at risk
EG0050 affected15 at risk
2 affected
32 at risk
EG0042 affected48 at risk
EG0050 affected15 at risk
2 affected
32 at risk
EG0042 affected48 at risk
EG0050 affected15 at risk
0 affected
32 at risk
EG0041 affected48 at risk
EG0050 affected15 at risk
0 affected
32 at risk
EG0040 affected48 at risk
EG0050 affected15 at risk
0 affected
32 at risk
EG0040 affected48 at risk
EG0050 affected15 at risk
0 affected
32 at risk
EG0040 affected48 at risk
EG0050 affected15 at risk
4 affected
32 at risk
EG0042 affected48 at risk
EG0051 affected15 at risk
1 affected
32 at risk
EG0041 affected48 at risk
EG0050 affected15 at risk
2 affected
32 at risk
EG0040 affected48 at risk
EG0050 affected15 at risk
1 affected
32 at risk
EG0040 affected48 at risk
EG0050 affected15 at risk
0 affected
32 at risk
EG0040 affected48 at risk
EG0050 affected15 at risk
0 affected
32 at risk
EG0040 affected48 at risk
EG0050 affected15 at risk
0 affected
32 at risk
EG0040 affected48 at risk
EG0050 affected15 at risk
0 affected
32 at risk
EG0041 affected48 at risk
EG0050 affected15 at risk
1 affected
32 at risk
EG0040 affected48 at risk
EG0050 affected15 at risk
0 affected
32 at risk
EG0040 affected48 at risk
EG0050 affected15 at risk
0 affected
32 at risk
EG0040 affected48 at risk
EG0050 affected15 at risk
1 affected
32 at risk
EG0040 affected48 at risk
EG0050 affected15 at risk
0 affected
32 at risk
EG0041 affected48 at risk
EG0051 affected15 at risk
0 affected
32 at risk
EG0040 affected48 at risk
EG0051 affected15 at risk
0 affected
32 at risk
EG0040 affected48 at risk
EG0050 affected15 at risk
76.0
(54.9 to 90.6)
OG00465.2(42.7 to 83.6)
OG00525.0(0.6 to 80.6)
ParticipantsOG0042
ParticipantsOG0051
Title
Measurements
OG001100.0(2.5 to 100.0)
OG002100.0(2.5 to 100.0)
OG003100.0(29.2 to 100.0)
OG004100.0(15.8 to 100.0)
OG005100.0(2.5 to 100.0)
12.0
(2.5 to 31.2)
OG0048.7(1.1 to 28.0)
OG0050.0(0.0 to 0.0)
3
ParticipantsOG0042
ParticipantsOG0051
Title
Measurements
OG0010.0(0.0 to 0.0)
OG002100.0(2.5 to 100.0)
OG00333.3(0.8 to 90.6)
OG0040.0(0.0 to 0.0)
OG005100.0(2.5 to 100.0)
25
ParticipantsOG00423
ParticipantsOG0054
Title
Measurements
OG0000.0(0.0 to 0.0)
OG00153.8(25.1 to 80.8)
OG00260.0(14.7 to 94.7)
OG00364.0(42.5 to 82.0)
OG00456.5(34.5 to 76.8)
OG00525.0(0.6 to 80.6)
3
ParticipantsOG0042
ParticipantsOG0051
Title
Measurements
OG001100.0(2.5 to 100.0)
OG0020.0(0.0 to 0.0)
OG00366.7(9.4 to 99.2)
OG004100.0(15.8 to 100.0)
OG0050.0(0.0 to 0.0)
25
ParticipantsOG00423
ParticipantsOG0054
Title
Measurements
OG000100.0(2.5 to 100.0)
OG00123.1(5.0 to 53.8)
OG0020.0(0.0 to 0.0)
OG00312.0(2.5 to 31.2)
OG00413.0(2.8 to 33.6)
OG00575.0(19.4 to 99.4)
3
ParticipantsOG0042
ParticipantsOG0051
Title
Measurements
OG0010.0(0.0 to 0.0)
OG0020.0(0.0 to 0.0)
OG0030.0(0.0 to 0.0)
OG0040.0(0.0 to 0.0)
OG0050.0(0.0 to 0.0)
25
ParticipantsOG00423
ParticipantsOG0054
Title
Measurements
OG0000.0(0.0 to 0.0)
OG0010.0(0.0 to 0.0)
OG0020.0(0.0 to 0.0)
OG0038.0(1.0 to 26.0)
OG00421.7(7.5 to 43.7)
OG0050.0(0.0 to 0.0)
3
ParticipantsOG0042
ParticipantsOG0051
Title
Measurements
OG0010.0(0.0 to 0.0)
OG0020.0(0.0 to 0.0)
OG0030.0(0.0 to 0.0)
OG0040.0(0.0 to 0.0)
OG0050.0(0.0 to 0.0)
20.4
(7.5 to 51.6)
OG00529.7(NA to NA)95% CI was not estimable due to low number of participants with events.
ParticipantsOG0042
ParticipantsOG0051
Title
Measurements
OG00130.4(NA to NA)95% CI was not estimable due to low number of participants with events.
OG00260.3(NA to NA)95% CI was not estimable due to low number of participants with events.
OG00352.0(5.6 to 52.0)
OG00420.8(9.2 to 32.4)
OG005NA(NA to NA)Duration of response was not estimable due to low number of participants with events.