Efficacy and Safety of the Combination Therapy of Dabrafe... | NCT02034110 | Trialant
NCT02034110
Sponsor
Novartis Pharmaceuticals
Status
Completed
Last Update Posted
Aug 21, 2023Actual
Enrollment
206Actual
Phase
Phase 2
Conditions
Cancer
Interventions
Dabrafenib
Trametinib
Countries
United States
Austria
Belgium
Canada
Denmark
France
Germany
Italy
Japan
Netherlands
Norway
South Korea
Spain
Sweden
Protocol Section
Identification Module
NCT ID
NCT02034110
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
117019
Secondary IDs
ID
Type
Description
Link
2013-001705-87
EudraCT Number
CDRB436X2201
Other Identifier
Novartis
BRF117019
Other Identifier
GlaxoSmithKline
Brief Title
Efficacy and Safety of the Combination Therapy of Dabrafenib and Trametinib in Subjects With BRAF V600E- Mutated Rare Cancers
Official Title
A Phase II, Open-label, Study in Subjects With BRAF V600E-Mutated Rare Cancers With Several Histologies to Investigate the Clinical Efficacy and Safety of the Combination Therapy of Dabrafenib and Trametinib
Acronym
Not provided
Organization
NovartisINDUSTRY
Status Module
Record Verification Date
Jul 2023
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Mar 12, 2014Actual
Primary Completion Date
Dec 10, 2021Actual
Completion Date
Dec 10, 2021Actual
First Submitted Date
Dec 5, 2013
First Submission Date that Met QC Criteria
Jan 9, 2014
First Posted Date
Jan 13, 2014Estimated
Results Waived
Not provided
Results First Submitted Date
Jul 4, 2022
Results First Submitted that Met QC Criteria
Jul 24, 2023
Results First Posted Date
Aug 21, 2023Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Jun 8, 2022
Certification/Extension First Submitted that Passed QC Review
Jun 8, 2022
Certification/Extension First Posted Date
Jun 10, 2022Actual
Last Update Submitted Date
Jul 24, 2023
Last Update Posted Date
Aug 21, 2023Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Novartis PharmaceuticalsINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
This was a Phase II, open-label, non-randomized, multi-center study of oral dabrafenib in combination with oral trametinib in subjects with rare cancers harboring the BRAF V600E mutation including anaplastic thyroid cancer (ATC), biliary tract cancer (BTC), gastrointestinal stromal tumor (GIST), low grade (WHO G1/G2) glioma (LGG), high grade (WHO G3/G4) glioma (HGG), non-seminomatous germ cell tumors (NSGCT) / non-germinomatous germ cell tumors (NGGCT), adenocarcinoma of the small intestine (ASI), hairy cell leukemia (HCL) and multiple myeloma (MM).
Detailed Description
This study was designed to determine the overall response rate (ORR) of oral Dabrafenib in combination with oral Trametinib in subjects with rare BRAF V600E mutated cancers. Subjects needed to have a fresh or frozen tumor tissue sample provided to confirm the BRAF V600E mutation status. Only subjects with histologically confirmed advanced disease and no available standard treatment options were eligible for enrollment. Subjects underwent screening assessments within 14 days (up to 35 days for ophthalmology exam, echocardiogram or disease assessments) prior to the start of treatment to determine their eligibility for enrollment in the study. All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, withdrawal of consent or death. Once a subject discontinued treatment, a post-treatment follow-up visit was conducted within 28 days (+ 7 days) after the last dose of study treatment(s). Extended follow-up visits were conducted every 4 weeks (+/- 7 days) for the first 6 months and then every 3 months (+/- 14 days) thereafter. A subject was considered to have discontinued the study if the subject was lost to follow-up or withdrew consent or another reason existed that prevented additional data from being collected on the subject. A subject was considered to have completed the study at the time of death.
For each histology, up to 25 patients were planned to be enrolled in each of the 9 primary analysis cohorts. A cohort could be closed or stopped early (prior to capping at 25 patients) for futility or efficacy. An uncapped expansion cohort was planned when a particular cohort was stopped early for efficacy. All planned histology cohorts enrolled at least one subject, with the exception of the germ cell tumor cohort. Enrolment in the study was closed in July 2018.
Subjects received Dabrafenib 150 mg twice daily orally plus Trametinib 2 mg once daily orally on a continuous basis. Dabrafenib was administered under fasted conditions, either 1 hour (hr) before or 2 hours (hrs) after a meal with approximately 200 mL of water with an interval of 12 hours. Trametinib was administered under fasted conditions, either 1 hr before or 2 hrs after a meal with approximately 200 mL of water. Subjects took their dose of Trametinib concurrently with the morning dose of Dabrafenib. A treatment cycle was 28 days in duration. Subjects continued treatment until an unacceptable toxicity, disease progression, or death occurs.
Drug: Dabrafenib
Drug: Trametinib
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Dabrafenib
Drug
A 150 mg twice daily capsule administered orally on a continuous basis.
Dabrafenib + Trametinib
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Overall Response Rate (ORR) in the Anaplastic Thyroid Cancer (ATC) Cohort
Overall Response Rate (ORR) was defined as the percentage of participants with a tumor response (complete response [CR], partial response [PR]) by investigator assessment as defined by RECIST v1.1. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
From study treatment start date until first documented complete response or partial response, assessed up to 78 months (cut-off date for FDA Submission = 14-Sep-20) and up to 92 months (cut-off date for end of study = 10-Dec-21)
Overall Response Rate (ORR) in the Biliary Tract Cancer (BTC) Cohort
Overall Response Rate (ORR) was defined as the percentage of participants with a tumor response (complete response [CR], partial response [PR]) by investigator assessment as defined by RECIST v1.1. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
From study treatment start date until first documented complete response or partial response, assessed up to 78 months (cut-off date for FDA Submission = 14-Sep-20) and up to 92 months (cut-off date for end of study = 10-Dec-21)
Overall Response Rate (ORR) in the Gastrointestinal Stromal Tumor (GIST) Cohort
Overall Response Rate (ORR) was defined as the percentage of participants with a tumor response (complete response [CR], partial response [PR]) by investigator assessment as defined by RECIST v1.1. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
From study treatment start date until first documented complete response or partial response, assessed up to 78 months (cut-off date for FDA Submission = 14-Sep-20) and up to 92 months (cut-off date for end of study = 10-Dec-21)
Secondary Outcomes
Measure
Description
Time Frame
Duration of Response (DoR) in the Anaplastic Thyroid Cancer (ATC) Cohort
For the subset of subjects who showed a confirmed response as defined for each cohort, Duration of Response (DoR) was defined as the time (in weeks) from first documented evidence of response (the first response prior to confirmation) until time of documented disease progression or death due to any cause, whichever was first. If the subject did not have a documented date of progression or death, DoR was censored at the date of the last adequate assessment.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Signed, written informed consent.
Sex: male or female.
Age: >=18 years of age at the time of providing informed consent.
Eastern Cooperative Oncology Group (ECOG) performance status: 0, 1 or 2.
Must have advanced disease and no standard treatment options as determined by locally/regionally available standards of care and treating physician's discretion
Must have a a BRAF V600E mutation-positive tumor as confirmed by an approved local laboratory or a sponsor designated central reference laboratory. All subjects must provide an archived or fresh tumor sample (for solid tumors) or a fresh BM aspirate and peripheral blood sample (for HCL and MM) for confirmation testing of the BRAF V600E mutation by a sponsor designated central reference laboratory using a sponsor designated assay
Able to swallow and retain orally administered medication. NOTE: Subject should not have any clinically significant gastrointestinal (GI) abnormalities that may alter absorption such as malabsorption syndrome or major resection of the stomach or bowels. For example, subjects should have no more than 50% of the large intestine removed and no sign of malabsorption (i.e., diarrhea).NOTE: If clarification is needed as to whether a condition will significantly affect the absorption of study treatments, contact the GSK Medical Monitor.
Female Subjects of Childbearing Potential: Subjects must have a negative serum pregnancy test within 7 days prior to the first dose of study treatment and agrees to use effective contraception, throughout the treatment period and for 4 months after the last dose of study treatment.
French subjects: In France, a subject will be eligible for inclusion in this study only if either affiliated to or a beneficiary of a social security category
Exclusion Criteria:
Prior treatment with: BRAF and/or MEK inhibitor(s); anti-cancer therapy (e.g., chemotherapy with delayed toxicity, immunotherapy, biologic therapy or chemoradiation) within 21 days or prior nitrosourea or mitomycin C containing therapy within 42 days prior to enrollment and/or prior daily or weekly chemotherapy or biologic therapy without the potential for delayed toxicity within 14 days prior to enrolment or prior nvestigational drug(s) within 30 days or 5 half-lives, whichever is longer, prior to enrollment
History of malignancy with confirmed activating RAS mutation at any time. Prospective RAS testing is not required. However, if the results of previous RAS testing are known, then those results must be used in assessing eligibility.
Prior radiotherapy less than 14 days prior to enrollment, except for WHO Grade 1 4 glioma (radiotherapy is not permitted within 3 months prior to enrollment) and ATC (radiotherapy is not permitted within 7 days prior to enrollment). Treatment-related AEs must have resolved prior to enrollment.
Prior major surgery less than 14 days prior to enrollment. Any surgery-related AE(s) must have resolved prior to enrollment
Prior solid organ transplantation or allogenic stem cell transplantation (ASCT). However, previous autologous BM transplant (ABMT) or autologous peripheral blood stem cell transplant (PBSCT) is permitted.
History of another malignancy. Subjects with another malignancy are eligible if: (a) disease-free for 3 years, or (b) have a history of completely resected non-melanoma skin cancer, and/or (c) have an indolent second malignancy(ies).
Presence of brain metastases (except for subjects in the WHO Grade 1 or 2 or 3 or 4 glioma histology cohorts) that are symptomatic or untreated or not stable for >=3 months (must be documented by imaging) or requiring corticosteroids. Subjects on a stable dose of corticosteroids >14 days and have not required treatment with enzyme-inducing anticonvulsants for >30 days prior to enrollment can be enrolled with approval of the Medical Monitor
Presence of symptomatic or untreated leptomeningeal or spinal cord compression. Subjects who have been previously treated for these conditions and have stable CNS disease (documented by consecutive imaging studies) for >60 days, are asymptomatic and currently not taking corticosteroids, or have been on a stable dose of corticosteroids for at least 30 days prior to enrollment, are permitted
Presence of interstitial lung disease or pneumonitis
Presence of any unresolved >=Grade 2 (per Common Terminology Criteria for Adverse Events [CTCAE] version 4.0) toxicity from previous anti-cancer therapy at the time of enrollment, except alopecia or Grade 2 anemia. Subjects with MM who have ≤Grade 2 peripheral neuropathy (per CTCAE v4.0) are permitted.
Presence of any serious and/or unstable pre-existing medical disorder, psychiatric disorder, or other conditions that could interfere with subject's safety, obtaining informed consent or compliance to the study procedures
History of retinal vein occlusion
Clinically significant GI abnormalities that may alter absorption such as malabsorption syndrome or major resection of the stomach or bowels. For example, subjects should have no more than 50% of the large intestine removed and no sign of malabsorption (i.e., diarrhea)
History or evidence of cardiovascular risk including any of the following: Acute coronary syndromes (including myocardial infarction and unstable angina), coronary angioplasty, or stenting within 6 months prior to enrolment; clinically significant uncontrolled arrhythmias; however, subjects with controlled atrial fibrillation for >30 days prior to enrollment are eligible; class II or higher congestive heart failure as defined by the New York Heart Association (NYHA) criteria; left ventricular ejection fraction (LVEF) below the institutional LLN. If a LLN does not exist at an institution, then use LVEF <50%; abnormal cardiac valve morphology (≥Grade 2) documented by ECHO; however, subjects with Grade 1 abnormalities (i.e., mild regurgitation/stenosis) may be entered on study but subjects with moderate valvular thickening should NOT be enrolled; corrected QT (QTc) interval for heart rate using Bazett-corrected QT interval (QTcB) >=480 msec; intracardiac defibrillator; treatment-refractory hypertension defined as a blood pressure (BP) >140/90 mmHg which may not be controlled by anti-hypertensive medication(s) and/or lifestyle modifications
Presence of hepatitis B surface antigen (HBsAg), positive hepatitis C antibody test result within 3 months prior to first dose of study treatment. Subjects with positive Hepatitis C antibody due to prior exposure can be enrolled, only if a confirmatory negative Hepatitis C RNA polymerase chain reaction (PCR) test is obtained.
Current use of prohibited medication(s) or requirement for prohibited medications during study as per the study protocol. Use of anticoagulants such as warfarin is permitted; however, international normalization ratio (INR) must be monitored according to local institutional practice.
Clinically significant known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to study treatment, or excipients, or to dimethyl sulfoxide (structural component of dabrafenib).
Pregnant, lactating or actively breastfeeding female subjects
Subbiah V, Burris HA 3rd, Kurzrock R. Revolutionizing cancer drug development: Harnessing the potential of basket trials. Cancer. 2024 Jan;130(2):186-200. doi: 10.1002/cncr.35085. Epub 2023 Nov 7.
Hicks HM, Pozdeyev N, Sams SB, Pugazhenthi U, Bales ES, Hofmann MC, McKenna LR, Schweppe RE. Fibronectin Contributes to a BRAF Inhibitor-driven Invasive Phenotype in Thyroid Cancer through EGR1, Which Can Be Blocked by Inhibition of ERK1/2. Mol Cancer Res. 2023 Sep 1;21(9):867-880. doi: 10.1158/1541-7786.MCR-22-1031.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
Plan to Share IPD
Yes
Description
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
Subjects were enrolled into cohorts based on the type of histology. For each histology, up to 25 patients were planned to be enrolled. A cohort could be closed or stopped early (prior to capping at 25 patients) for futility or efficacy. An uncapped expansion cohort was planned when a particular cohort was stopped early for efficacy.
Recruitment Details
The study was conducted in 41 centers in 14 countries worldwide.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Anaplastic Thyroid Cancer (ATC)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
FG001
Biliary Tract Cancer (BTC)
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
All enrolled participants were included in the Intent-to-treat (ITT), All-treated subjects (ATS) and ITT/Evaluable populations
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
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
Jun 4, 2020
Jul 4, 2022
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
N/A
Intervention Model
Single Group Assignment
Intervention Model Description
9 indications: anaplastic thyroid cancer (ATC), biliary tract cancer (BTC), gastrointestinal stromal tumor (GIST), low grade (WHO G1/G2) glioma (LGG), high grade (WHO G3/G4) glioma (HGG), non-seminomatous germ cell tumors (NSGCT)/non-germinomatous germ cell tumors (NGGCT), adenocarcinoma of the small intestine (ASI), hairy cell leukemia (HCL) and multiple myeloma (MM).
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
DRB436
GSK2118436
Trametinib
Drug
A 2 mg once daily tablet administered orally on a continuous basis.
Dabrafenib + Trametinib
TMT212
GSK1120212
Overall Response Rate (ORR) in the Adenocarcinoma of the Small Intestine (ASI) Cohort
Overall Response Rate (ORR) was defined as the percentage of participants with a tumor response (complete response [CR], partial response [PR]) by investigator assessment as defined by RECIST v1.1. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
From study treatment start date until first documented complete response or partial response, assessed up to 78 months (cut-off date for FDA Submission = 14-Sep-20) and up to 92 months (cut-off date for end of study = 10-Dec-21)
Overall Response Rate (ORR) in the Low Grade (WHO G1/G2) Glioma (LGG) Cohort
Overall Response Rate (ORR) was defined as the percentage of participants with a tumor response (response assessment criteria (CR, PR, and minor response [MR]) WHO Grade 1 and 2 Glioma) by investigator assessment as defined by response assessment for neuro-oncology (RANO). Specifically, ORR = number of subjects with a confirmed overall response divided by the total number of subjects in the corresponding analysis population.
From study treatment start date until first documented complete response or partial response, assessed up to 78 months (cut-off date for FDA Submission = 14-Sep-20) and up to 92 months (cut-off date for end of study = 10-Dec-21)
Overall Response Rate (ORR) in the High Grade (WHO G3/G4) Glioma (HGG) Cohort
Overall Response Rate (ORR) was defined as the percentage of participants with a tumor response (updated response assessment criteria (CR, PR) WHO Grade 3 and 4 Glioma) by investigator assessment as defined by modified response assessment for neuro-oncology (RANO). Specifically, ORR = number of subjects with a confirmed overall response divided by the total number of subjects in the corresponding analysis population.
From study treatment start date until first documented complete response or partial response, assessed up to 78 months (cut-off date for FDA Submission = 14-Sep-20) and up to 92 months (cut-off date for end of study = 10-Dec-21)
Overall Response Rate (ORR) in the Hairy Cell Leukemia (HCL) Cohort
Overall Response Rate (ORR) was defined as the percentage of participants with CR +/- minimal residual disease [MRD], PR by investigator assessment as defined by the Consensus Resolution Criteria adapted from the National Comprehensive Cancer Network (NCCN) guidelines. Specifically, ORR = number of subjects with a confirmed overall response divided by the total number of subjects in the corresponding analysis population.
From study treatment start date until first documented complete response or partial response, assessed up to 78 months (cut-off date for FDA Submission = 14-Sep-20) and up to 92 months (cut-off date for end of study = 10-Dec-21)
Overall Response Rate (ORR) in the Multiple Myeloma (MM) Cohort
Overall Response Rate (ORR) was defined as the percentage of participants with stringent complete response (sCR), CR, PR, very good partial response (VGPR) by investigator assessment as defined by the International Myeloma Working Group (IMWG) Uniform Response Criteria for Multiple Myeloma. Specifically, ORR = number of subjects with a confirmed overall response divided by the total number of subjects in the corresponding analysis population.
From study treatment start date until first documented complete response or partial response, assessed up to 78 months (cut-off date for FDA Submission = 14-Sep-20) and up to 92 months (cut-off date for end of study = 10-Dec-21)
From first documented evidence of response (the first response prior to confirmation) until time of documented disease progression or death due to any cause, whichever comes first, assessed up to 92 months (cut-off date for end of study = 10-Dec-21)
Duration of Response (DoR) in the Biliary Tract Cancer (BTC) Cohort
For the subset of subjects who showed a confirmed response as defined for each cohort, Duration of Response (DoR) was defined as the time (in weeks) from first documented evidence of response (the first response prior to confirmation) until time of documented disease progression or death due to any cause, whichever was first. If the subject did not have a documented date of progression or death, DoR was censored at the date of the last adequate assessment.
From first documented evidence of response (the first response prior to confirmation) until time of documented disease progression or death due to any cause, whichever comes first, assessed up to 92 months (cut-off date for end of study = 10-Dec-21)
Duration of Response (DoR) in the Adenocarcinoma of the Small Intestine (ASI) Cohort
For the subset of subjects who showed a confirmed response as defined for each cohort, Duration of Response (DoR) was defined as the time (in weeks) from first documented evidence of response (the first response prior to confirmation) until time of documented disease progression or death due to any cause, whichever was first. If the subject did not have a documented date of progression or death, DoR was censored at the date of the last adequate assessment.
From first documented evidence of response (the first response prior to confirmation) until time of documented disease progression or death due to any cause, whichever comes first, assessed up to 92 months (cut-off date for end of study = 10-Dec-21)
Duration of Response (DoR) in the Low Grade (WHO G1/G2) Glioma (LGG) Cohort
For the subset of subjects who showed a confirmed response as defined for each cohort, Duration of Response (DoR) was defined as the time (in weeks) from first documented evidence of response (the first response prior to confirmation) until time of documented disease progression or death due to any cause, whichever was first. If the subject did not have a documented date of progression or death, DoR was censored at the date of the last adequate assessment.
From first documented evidence of response (the first response prior to confirmation) until time of documented disease progression or death due to any cause, whichever comes first, assessed up to 92 months (cut-off date for end of study = 10-Dec-21)
Duration of Response (DoR) in the High Grade (WHO G3/G4) Glioma (HGG) Cohort
For the subset of subjects who showed a confirmed response as defined for each cohort, Duration of Response (DoR) was defined as the time (in weeks) from first documented evidence of response (the first response prior to confirmation) until time of documented disease progression or death due to any cause, whichever was first. If the subject did not have a documented date of progression or death, DoR was censored at the date of the last adequate assessment.
From first documented evidence of response (the first response prior to confirmation) until time of documented disease progression or death due to any cause, whichever comes first, assessed up to 92 months (cut-off date for end of study = 10-Dec-21)
Duration of Response (DoR) in the Hairy Cell Leukemia (HCL) Cohort
For the subset of subjects who showed a confirmed response as defined for each cohort, Duration of Response (DoR) was defined as the time (in weeks) from first documented evidence of response (the first response prior to confirmation) until time of documented disease progression or death due to any cause, whichever was first. If the subject did not have a documented date of progression or death, DoR was censored at the date of the last adequate assessment.
From first documented evidence of response (the first response prior to confirmation) until time of documented disease progression or death due to any cause, whichever comes first, assessed up to 92 months (cut-off date for end of study = 10-Dec-21)
Duration of Response (DoR) in the Multiple Myeloma (MM) Cohort
For the subset of subjects who showed a confirmed response as defined for each cohort, Duration of Response (DoR) was defined as the time (in weeks) from first documented evidence of response (the first response prior to confirmation) until time of documented disease progression or death due to any cause, whichever was first. If the subject did not have a documented date of progression or death, DoR was censored at the date of the last adequate assessment.
From first documented evidence of response (the first response prior to confirmation) until time of documented disease progression or death due to any cause, whichever comes first, assessed up to 92 months (cut-off date for end of study = 10-Dec-21)
Progression Free Survival (PFS) in the Anaplastic Thyroid Cancer (ATC) Cohort
Progression Free Survival (PFS) was defined as the interval between the first dose of study treatment and earlier date of first radiologically documented progression or death due to any cause. If the subject did not have a documented date of progression or death, PFS was censored at the date of the last adequate assessment. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started.
From study treatment start date until date of radiographic progression or date of death from any cause, whichever comes first, assessed up to 92 months (cut-off date for end of study = 10-Dec-21)
Progression Free Survival (PFS) in the Biliary Tract Cancer (BTC) Cohort
Progression Free Survival (PFS) was defined as the interval between the first dose of study treatment and earlier date of first radiologically documented progression or death due to any cause. If the subject did not have a documented date of progression or death, PFS was censored at the date of the last adequate assessment. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started.
From study treatment start date until date of radiographic progression or date of death from any cause, whichever comes first, assessed up to 92 months (cut-off date for end of study = 10-Dec-21)
Progression Free Survival (PFS) in the Adenocarcinoma of the Small Intestine (ASI) Cohort
Progression Free Survival (PFS) was defined as the interval between the first dose of study treatment and earlier date of first radiologically documented progression or death due to any cause. If the subject did not have a documented date of progression or death, PFS was censored at the date of the last adequate assessment. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started.
From study treatment start date until date of radiographic progression or date of death from any cause, whichever comes first, assessed up to 92 months (cut-off date for end of study = 10-Dec-21)
Progression Free Survival (PFS) in the Low Grade (WHO G1/G2) Glioma (LGG) Cohort
Progression Free Survival (PFS) was defined as the interval between the first dose of study treatment and earlier date of first radiologically documented progression or death due to any cause. If the subject did not have a documented date of progression or death, PFS was censored at the date of the last adequate assessment.
From study treatment start date until date of radiographic progression or date of death from any cause, whichever comes first, assessed up to 92 months (cut-off date for end of study = 10-Dec-21)
Progression Free Survival (PFS) in the High Grade (WHO G3/G4) Glioma (HGG) Cohort
Progression Free Survival (PFS) was defined as the interval between the first dose of study treatment and earlier date of first radiologically documented progression or death due to any cause. If the subject did not have a documented date of progression or death, PFS was censored at the date of the last adequate assessment.
From study treatment start date until date of radiographic progression or date of death from any cause, whichever comes first, assessed up to 92 months (cut-off date for end of study = 10-Dec-21)
Progression Free Survival (PFS) in the Hairy Cell Leukemia (HCL) Cohort
Progression Free Survival (PFS) was defined as the interval between the first dose of study treatment and earlier date of first radiologically documented progression or death due to any cause. If the subject did not have a documented date of progression or death, PFS was censored at the date of the last adequate assessment.
From study treatment start date until date of radiographic progression or date of death from any cause, whichever comes first, assessed up to 92 months (cut-off date for end of study = 10-Dec-21)
Progression Free Survival (PFS) in the Multiple Myeloma (MM) Cohort
Progression Free Survival (PFS) was defined as the interval between the first dose of study treatment and earlier date of first radiologically documented progression or death due to any cause. If the subject did not have a documented date of progression or death, PFS was censored at the date of the last adequate assessment.
From study treatment start date until date of radiographic progression or date of death from any cause, whichever comes first, assessed up to 92 months (cut-off date for end of study = 10-Dec-21)
Overall Survival (OS) in the Anaplastic Thyroid Cancer (ATC) Cohort
Overall Survival (OS) was defined as the time from first dose until death due to any cause. Censoring was performed using the date of last known contact for those who were alive at the time of analysis.
From study treatment start date until date of death from any cause, assessed up to 92 months (cut-off date for end of study = 10-Dec-21)
Overall Survival (OS) in the Biliary Tract Cancer (BTC) Cohort
Overall Survival (OS) was defined as the time from first dose until death due to any cause. Censoring was performed using the date of last known contact for those who were alive at the time of analysis.
From study treatment start date until date of death from any cause, assessed up to 92 months (cut-off date for end of study = 10-Dec-21)
Overall Survival (OS) in the Adenocarcinoma of the Small Intestine (ASI) Cohort
Overall Survival (OS) was defined as the time from first dose until death due to any cause. Censoring was performed using the date of last known contact for those who were alive at the time of analysis.
From study treatment start date until date of death from any cause, assessed up to 92 months (cut-off date for end of study = 10-Dec-21)
Overall Survival (OS) in the Low Grade (WHO G1/G2) Glioma (LGG) Cohort
Overall Survival (OS) was defined as the time from first dose until death due to any cause. Censoring was performed using the date of last known contact for those who were alive at the time of analysis.
From study treatment start date until date of death from any cause, assessed up to 92 months (cut-off date for end of study = 10-Dec-21)
Overall Survival (OS) in the High Grade (WHO G3/G4) Glioma (HGG) Cohort
Overall Survival (OS) was defined as the time from first dose until death due to any cause. Censoring was performed using the date of last known contact for those who were alive at the time of analysis.
From study treatment start date until date of death from any cause, assessed up to 92 months (cut-off date for end of study = 10-Dec-21)
Overall Survival (OS) in the Hairy Cell Leukemia (HCL) Cohort
Overall Survival (OS) was defined as the time from first dose until death due to any cause. Censoring was performed using the date of last known contact for those who were alive at the time of analysis.
From study treatment start date until date of death from any cause, assessed up to 92 months (cut-off date for end of study = 10-Dec-21)
Overall Survival (OS) in the Multiple Myeloma (MM) Cohort
Overall Survival (OS) was defined as the time from first dose until death due to any cause. Censoring was performed using the date of last known contact for those who were alive at the time of analysis.
From study treatment start date until date of death from any cause, assessed up to 92 months (cut-off date for end of study = 10-Dec-21)
Number of Participants With Adverse Events (AEs)
The distribution of adverse events (AE) was done via the analysis of frequencies for treatment emergent Adverse Event (TEAEs) and Serious Adverse Event (TESAEs) through the monitoring of relevant clinical and laboratory safety parameters.
From study treatment start date till 30 days safety follow-up, assessed up to 92 months (cut-off date for end of study = 10-Dec-21)
Subbiah V, Kreitman RJ, Wainberg ZA, Gazzah A, Lassen U, Stein A, Wen PY, Dietrich S, de Jonge MJA, Blay JY, Italiano A, Yonemori K, Cho DC, de Vos FYFL, Moreau P, Fernandez EE, Schellens JHM, Zielinski CC, Redhu S, Boran A, Passos VQ, Ilankumaran P, Bang YJ. Dabrafenib plus trametinib in BRAFV600E-mutated rare cancers: the phase 2 ROAR trial. Nat Med. 2023 May;29(5):1103-1112. doi: 10.1038/s41591-023-02321-8. Epub 2023 Apr 14.
Kreitman RJ, Moreau P, Ravandi F, Hutchings M, Gazzah A, Michallet AS, Wainberg ZA, Stein A, Dietrich S, de Jonge MJA, Willenbacher W, De Greve J, Arons E, Ilankumaran P, Burgess P, Gasal E, Subbiah V. Dabrafenib plus trametinib in patients with relapsed/refractory BRAF V600E mutation-positive hairy cell leukemia. Blood. 2023 Mar 2;141(9):996-1006. doi: 10.1182/blood.2021013658.
Wen PY, Stein A, van den Bent M, De Greve J, Wick A, de Vos FYFL, von Bubnoff N, van Linde ME, Lai A, Prager GW, Campone M, Fasolo A, Lopez-Martin JA, Kim TM, Mason WP, Hofheinz RD, Blay JY, Cho DC, Gazzah A, Pouessel D, Yachnin J, Boran A, Burgess P, Ilankumaran P, Gasal E, Subbiah V. Dabrafenib plus trametinib in patients with BRAFV600E-mutant low-grade and high-grade glioma (ROAR): a multicentre, open-label, single-arm, phase 2, basket trial. Lancet Oncol. 2022 Jan;23(1):53-64. doi: 10.1016/S1470-2045(21)00578-7. Epub 2021 Nov 24.
Subbiah V, Lassen U, Elez E, Italiano A, Curigliano G, Javle M, de Braud F, Prager GW, Greil R, Stein A, Fasolo A, Schellens JHM, Wen PY, Viele K, Boran AD, Gasal E, Burgess P, Ilankumaran P, Wainberg ZA. Dabrafenib plus trametinib in patients with BRAFV600E-mutated biliary tract cancer (ROAR): a phase 2, open-label, single-arm, multicentre basket trial. Lancet Oncol. 2020 Sep;21(9):1234-1243. doi: 10.1016/S1470-2045(20)30321-1. Epub 2020 Aug 17.
Lee EQ, Ruland S, LeBoeuf NR, Wen PY, Santagata S. Successful Treatment of a Progressive BRAF V600E-Mutated Anaplastic Pleomorphic Xanthoastrocytoma With Vemurafenib Monotherapy. J Clin Oncol. 2016 Apr 1;34(10):e87-9. doi: 10.1200/JCO.2013.51.1766. Epub 2014 Aug 4. No abstract available.
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
FG002
Gastrointestinal Stromal Tumor (GIST)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
FG003
Low Grade (WHO G1/G2) Glioma (LGG)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
FG004
High Grade (WHO G3/G4) Glioma (HGG)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
FG005
Adenocarcinoma of the Small Intestine (ASI)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
FG006
Hairy Cell Leukemia (HCL)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
FG007
Multiple Myeloma (MM)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
FG00036 subjects
FG00143 subjects
FG0021 subjects
FG00313 subjects
FG00445 subjects
FG0053 subjects
FG00655 subjects
FG00710 subjects
Primary Analysis Cohort
FG00015 subjects
FG00118 subjects
FG0021 subjects
FG00313 subjects
FG00424 subjects
FG0053 subjects
FG00624 subjects
FG00710 subjects
Expansion Cohort
FG00021 subjects
FG00125 subjects
FG0020 subjects
FG0030 subjects
FG00421 subjects
FG0050 subjects
FG00631 subjects
FG0070 subjects
COMPLETED
FG00024 subjects
FG00134 subjects
FG0021 subjects
FG0034 subjects
FG00428 subjects
FG0053 subjects
FG0068 subjects
FG0079 subjects
NOT COMPLETED
FG00012 subjects
FG0019 subjects
FG0020 subjects
FG0039 subjects
FG00417 subjects
FG0050 subjects
FG00647 subjects
FG0071 subjects
Type
Comment
Reasons
Physician Decision
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0042 subjects
FG0050 subjects
FG0061 subjects
FG0070 subjects
Lost to Follow-up
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Withdrawal by Subject
FG0005 subjects
FG0017 subjects
FG0020 subjects
FG0033 subjects
FG004
Study closed by sponsor
FG0006 subjects
FG0012 subjects
FG0020 subjects
FG0036 subjects
FG004
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Anaplastic Thyroid Cancer (ATC)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
BG001
Biliary Tract Cancer (BTC)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
BG002
Gastrointestinal Stromal Tumor (GIST)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
BG003
Low Grade (WHO G1/G2) Glioma (LGG)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
BG004
High Grade (WHO G3/G4) Glioma (HGG)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
BG005
Adenocarcinoma of the Small Intestine (ASI)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
BG006
Hairy Cell Leukemia (HCL)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
BG007
Multiple Myeloma (MM)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
BG008
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00036
BG00143
BG0021
BG00313
BG00445
BG0053
BG00655
BG00710
BG008206
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
BG00069.6± 9.53
BG00157.0± 11.88
BG00277.0± NAOnly one participant analyzed
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00020
BG00124
BG002
Race/Ethnicity, Customized
Number
Participants
Title
Denominators
Categories
African American/African Heritage
Title
Measurements
BG0000
BG0010
BG002
ECOG Performance Status
The Eastern Cooperative Oncology Group Performance Status (ECOG PS) score classifies participants according to their functional impairment, with scores ranging from 0 (fully active) to 5 (dead). ECOG PS: 0 = Fully active, able to carry on all pre-disease performance without restriction; 1 = Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work; 2 = ambulatory and capable of all self-care but unable to carry out any work activities, up and about more than 50% of waking hours
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Grade 0
BG0004
BG001
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
Overall Response Rate (ORR) in the Anaplastic Thyroid Cancer (ATC) Cohort
Overall Response Rate (ORR) was defined as the percentage of participants with a tumor response (complete response [CR], partial response [PR]) by investigator assessment as defined by RECIST v1.1. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
ITT/Evaluable population - Primary and expansion cohort combined
Posted
Number
95% Confidence Interval
Percentage of Participants
From study treatment start date until first documented complete response or partial response, assessed up to 78 months (cut-off date for FDA Submission = 14-Sep-20) and up to 92 months (cut-off date for end of study = 10-Dec-21)
ID
Title
Description
OG000
Anaplastic Thyroid Cancer (ATC)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
Units
Counts
Participants
OG00036
Title
Denominators
Categories
Investigator assessment @ up to 78 months
Title
Measurements
OG00056(38.1 to 72.1)
Investigator assessment @ up to 92 months
Title
Measurements
OG00056(38.1 to 72.1)
Independent radiology review @ up to 78 months
Primary
Overall Response Rate (ORR) in the Biliary Tract Cancer (BTC) Cohort
Overall Response Rate (ORR) was defined as the percentage of participants with a tumor response (complete response [CR], partial response [PR]) by investigator assessment as defined by RECIST v1.1. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
ITT/Evaluable population - Primary and expansion cohort combined
Posted
Number
95% Confidence Interval
Percentage of Participants
From study treatment start date until first documented complete response or partial response, assessed up to 78 months (cut-off date for FDA Submission = 14-Sep-20) and up to 92 months (cut-off date for end of study = 10-Dec-21)
ID
Title
Description
OG000
Biliary Tract Cancer (BTC)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
Units
Counts
Participants
Primary
Overall Response Rate (ORR) in the Gastrointestinal Stromal Tumor (GIST) Cohort
Overall Response Rate (ORR) was defined as the percentage of participants with a tumor response (complete response [CR], partial response [PR]) by investigator assessment as defined by RECIST v1.1. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
ITT/Evaluable population - Primary and expansion cohort combined
Posted
Number
95% Confidence Interval
Percentage of Participants
From study treatment start date until first documented complete response or partial response, assessed up to 78 months (cut-off date for FDA Submission = 14-Sep-20) and up to 92 months (cut-off date for end of study = 10-Dec-21)
ID
Title
Description
OG000
Gastrointestinal Stromal Tumor (GIST)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
Units
Counts
Participants
Primary
Overall Response Rate (ORR) in the Adenocarcinoma of the Small Intestine (ASI) Cohort
Overall Response Rate (ORR) was defined as the percentage of participants with a tumor response (complete response [CR], partial response [PR]) by investigator assessment as defined by RECIST v1.1. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
ITT/Evaluable population - Primary and expansion cohort combined
Posted
Number
95% Confidence Interval
Percentage of Participants
From study treatment start date until first documented complete response or partial response, assessed up to 78 months (cut-off date for FDA Submission = 14-Sep-20) and up to 92 months (cut-off date for end of study = 10-Dec-21)
ID
Title
Description
OG000
Adenocarcinoma of the Small Intestine (ASI)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
Units
Counts
Participants
Primary
Overall Response Rate (ORR) in the Low Grade (WHO G1/G2) Glioma (LGG) Cohort
Overall Response Rate (ORR) was defined as the percentage of participants with a tumor response (response assessment criteria (CR, PR, and minor response [MR]) WHO Grade 1 and 2 Glioma) by investigator assessment as defined by response assessment for neuro-oncology (RANO). Specifically, ORR = number of subjects with a confirmed overall response divided by the total number of subjects in the corresponding analysis population.
ITT/Evaluable population - Primary analysis cohort
Posted
Number
95% Confidence Interval
Percentage of Participants
From study treatment start date until first documented complete response or partial response, assessed up to 78 months (cut-off date for FDA Submission = 14-Sep-20) and up to 92 months (cut-off date for end of study = 10-Dec-21)
ID
Title
Description
OG000
Low Grade (WHO G1/G2) Glioma (LGG)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
Units
Counts
Participants
OG000
Primary
Overall Response Rate (ORR) in the High Grade (WHO G3/G4) Glioma (HGG) Cohort
Overall Response Rate (ORR) was defined as the percentage of participants with a tumor response (updated response assessment criteria (CR, PR) WHO Grade 3 and 4 Glioma) by investigator assessment as defined by modified response assessment for neuro-oncology (RANO). Specifically, ORR = number of subjects with a confirmed overall response divided by the total number of subjects in the corresponding analysis population.
ITT/Evaluable population - Primary and expansion cohort combined
Posted
Number
95% Confidence Interval
Percentage of Participants
From study treatment start date until first documented complete response or partial response, assessed up to 78 months (cut-off date for FDA Submission = 14-Sep-20) and up to 92 months (cut-off date for end of study = 10-Dec-21)
ID
Title
Description
OG000
High Grade (WHO G3/G4) Glioma (HGG)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
Units
Counts
Participants
OG000
Primary
Overall Response Rate (ORR) in the Hairy Cell Leukemia (HCL) Cohort
Overall Response Rate (ORR) was defined as the percentage of participants with CR +/- minimal residual disease [MRD], PR by investigator assessment as defined by the Consensus Resolution Criteria adapted from the National Comprehensive Cancer Network (NCCN) guidelines. Specifically, ORR = number of subjects with a confirmed overall response divided by the total number of subjects in the corresponding analysis population.
ITT/Evaluable population - Primary and expansion cohort combined
Posted
Number
95% Confidence Interval
Percentage of Participants
From study treatment start date until first documented complete response or partial response, assessed up to 78 months (cut-off date for FDA Submission = 14-Sep-20) and up to 92 months (cut-off date for end of study = 10-Dec-21)
ID
Title
Description
OG000
Hairy Cell Leukemia (HCL)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
Units
Counts
Participants
OG000
Primary
Overall Response Rate (ORR) in the Multiple Myeloma (MM) Cohort
Overall Response Rate (ORR) was defined as the percentage of participants with stringent complete response (sCR), CR, PR, very good partial response (VGPR) by investigator assessment as defined by the International Myeloma Working Group (IMWG) Uniform Response Criteria for Multiple Myeloma. Specifically, ORR = number of subjects with a confirmed overall response divided by the total number of subjects in the corresponding analysis population.
ITT/Evaluable population - Primary analysis cohort
Posted
Number
95% Confidence Interval
Percentage of Participants
From study treatment start date until first documented complete response or partial response, assessed up to 78 months (cut-off date for FDA Submission = 14-Sep-20) and up to 92 months (cut-off date for end of study = 10-Dec-21)
ID
Title
Description
OG000
Multiple Myeloma (MM)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
Units
Counts
Participants
OG000
Secondary
Duration of Response (DoR) in the Anaplastic Thyroid Cancer (ATC) Cohort
For the subset of subjects who showed a confirmed response as defined for each cohort, Duration of Response (DoR) was defined as the time (in weeks) from first documented evidence of response (the first response prior to confirmation) until time of documented disease progression or death due to any cause, whichever was first. If the subject did not have a documented date of progression or death, DoR was censored at the date of the last adequate assessment.
ITT/Evaluable population - Primary and expansion cohorts combined. Only responders were included in the analysis.
Posted
Median
95% Confidence Interval
Weeks
From first documented evidence of response (the first response prior to confirmation) until time of documented disease progression or death due to any cause, whichever comes first, assessed up to 92 months (cut-off date for end of study = 10-Dec-21)
ID
Title
Description
OG000
Anaplastic Thyroid Cancer (ATC)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
Units
Counts
Participants
Secondary
Duration of Response (DoR) in the Biliary Tract Cancer (BTC) Cohort
For the subset of subjects who showed a confirmed response as defined for each cohort, Duration of Response (DoR) was defined as the time (in weeks) from first documented evidence of response (the first response prior to confirmation) until time of documented disease progression or death due to any cause, whichever was first. If the subject did not have a documented date of progression or death, DoR was censored at the date of the last adequate assessment.
ITT/Evaluable population - Primary and expansion cohorts combined. Only responders were included in the analysis.
Posted
Median
95% Confidence Interval
Weeks
From first documented evidence of response (the first response prior to confirmation) until time of documented disease progression or death due to any cause, whichever comes first, assessed up to 92 months (cut-off date for end of study = 10-Dec-21)
ID
Title
Description
OG000
Biliary Tract Cancer (BTC)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
Units
Counts
Participants
Secondary
Duration of Response (DoR) in the Adenocarcinoma of the Small Intestine (ASI) Cohort
For the subset of subjects who showed a confirmed response as defined for each cohort, Duration of Response (DoR) was defined as the time (in weeks) from first documented evidence of response (the first response prior to confirmation) until time of documented disease progression or death due to any cause, whichever was first. If the subject did not have a documented date of progression or death, DoR was censored at the date of the last adequate assessment.
ITT/Evaluable population - Primary analysis cohort. Only responders were included in the analysis.
Posted
Median
95% Confidence Interval
Weeks
From first documented evidence of response (the first response prior to confirmation) until time of documented disease progression or death due to any cause, whichever comes first, assessed up to 92 months (cut-off date for end of study = 10-Dec-21)
ID
Title
Description
OG000
Adenocarcinoma of the Small Intestine (ASI)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
Units
Counts
Participants
Secondary
Duration of Response (DoR) in the Low Grade (WHO G1/G2) Glioma (LGG) Cohort
For the subset of subjects who showed a confirmed response as defined for each cohort, Duration of Response (DoR) was defined as the time (in weeks) from first documented evidence of response (the first response prior to confirmation) until time of documented disease progression or death due to any cause, whichever was first. If the subject did not have a documented date of progression or death, DoR was censored at the date of the last adequate assessment.
ITT/Evaluable population - Primary analysis cohort. Only responders were included in the analysis.
Posted
Median
95% Confidence Interval
Weeks
From first documented evidence of response (the first response prior to confirmation) until time of documented disease progression or death due to any cause, whichever comes first, assessed up to 92 months (cut-off date for end of study = 10-Dec-21)
ID
Title
Description
OG000
Low Grade (WHO G1/G2) Glioma (LGG)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
Units
Counts
Participants
Secondary
Duration of Response (DoR) in the High Grade (WHO G3/G4) Glioma (HGG) Cohort
For the subset of subjects who showed a confirmed response as defined for each cohort, Duration of Response (DoR) was defined as the time (in weeks) from first documented evidence of response (the first response prior to confirmation) until time of documented disease progression or death due to any cause, whichever was first. If the subject did not have a documented date of progression or death, DoR was censored at the date of the last adequate assessment.
ITT/Evaluable population - Primary and expansion cohorts combined. Only responders were included in the analysis.
Posted
Median
95% Confidence Interval
Weeks
From first documented evidence of response (the first response prior to confirmation) until time of documented disease progression or death due to any cause, whichever comes first, assessed up to 92 months (cut-off date for end of study = 10-Dec-21)
ID
Title
Description
OG000
High Grade (WHO G3/G4) Glioma (HGG)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
Units
Counts
Participants
Secondary
Duration of Response (DoR) in the Hairy Cell Leukemia (HCL) Cohort
For the subset of subjects who showed a confirmed response as defined for each cohort, Duration of Response (DoR) was defined as the time (in weeks) from first documented evidence of response (the first response prior to confirmation) until time of documented disease progression or death due to any cause, whichever was first. If the subject did not have a documented date of progression or death, DoR was censored at the date of the last adequate assessment.
ITT/Evaluable population - Primary and expansion cohorts combined. Only responders were included in the analysis.
Posted
Median
95% Confidence Interval
Weeks
From first documented evidence of response (the first response prior to confirmation) until time of documented disease progression or death due to any cause, whichever comes first, assessed up to 92 months (cut-off date for end of study = 10-Dec-21)
ID
Title
Description
OG000
Hairy Cell Leukemia (HCL)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
Units
Counts
Participants
Secondary
Duration of Response (DoR) in the Multiple Myeloma (MM) Cohort
For the subset of subjects who showed a confirmed response as defined for each cohort, Duration of Response (DoR) was defined as the time (in weeks) from first documented evidence of response (the first response prior to confirmation) until time of documented disease progression or death due to any cause, whichever was first. If the subject did not have a documented date of progression or death, DoR was censored at the date of the last adequate assessment.
ITT/Evaluable population - Primary analysis cohort. Only responders were included in the analysis.
Posted
Median
95% Confidence Interval
Weeks
From first documented evidence of response (the first response prior to confirmation) until time of documented disease progression or death due to any cause, whichever comes first, assessed up to 92 months (cut-off date for end of study = 10-Dec-21)
ID
Title
Description
OG000
Multiple Myeloma (MM)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
Units
Counts
Participants
Secondary
Progression Free Survival (PFS) in the Anaplastic Thyroid Cancer (ATC) Cohort
Progression Free Survival (PFS) was defined as the interval between the first dose of study treatment and earlier date of first radiologically documented progression or death due to any cause. If the subject did not have a documented date of progression or death, PFS was censored at the date of the last adequate assessment. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started.
ITT/Evaluable population - Primary and expansion cohort combined
Posted
Median
95% Confidence Interval
Weeks
From study treatment start date until date of radiographic progression or date of death from any cause, whichever comes first, assessed up to 92 months (cut-off date for end of study = 10-Dec-21)
ID
Title
Description
OG000
Anaplastic Thyroid Cancer (ATC)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
Units
Counts
Participants
Secondary
Progression Free Survival (PFS) in the Biliary Tract Cancer (BTC) Cohort
Progression Free Survival (PFS) was defined as the interval between the first dose of study treatment and earlier date of first radiologically documented progression or death due to any cause. If the subject did not have a documented date of progression or death, PFS was censored at the date of the last adequate assessment. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started.
ITT/Evaluable population - Primary and expansion cohort combined
Posted
Median
95% Confidence Interval
Weeks
From study treatment start date until date of radiographic progression or date of death from any cause, whichever comes first, assessed up to 92 months (cut-off date for end of study = 10-Dec-21)
ID
Title
Description
OG000
Biliary Tract Cancer (BTC)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
Units
Counts
Participants
Secondary
Progression Free Survival (PFS) in the Adenocarcinoma of the Small Intestine (ASI) Cohort
Progression Free Survival (PFS) was defined as the interval between the first dose of study treatment and earlier date of first radiologically documented progression or death due to any cause. If the subject did not have a documented date of progression or death, PFS was censored at the date of the last adequate assessment. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started.
ITT/Evaluable population - Primary analysis cohort.
Posted
Median
95% Confidence Interval
Weeks
From study treatment start date until date of radiographic progression or date of death from any cause, whichever comes first, assessed up to 92 months (cut-off date for end of study = 10-Dec-21)
ID
Title
Description
OG000
Adenocarcinoma of the Small Intestine (ASI)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
Units
Counts
Participants
Secondary
Progression Free Survival (PFS) in the Low Grade (WHO G1/G2) Glioma (LGG) Cohort
Progression Free Survival (PFS) was defined as the interval between the first dose of study treatment and earlier date of first radiologically documented progression or death due to any cause. If the subject did not have a documented date of progression or death, PFS was censored at the date of the last adequate assessment.
ITT/Evaluable population - Primary analysis cohort.
Posted
Median
95% Confidence Interval
Weeks
From study treatment start date until date of radiographic progression or date of death from any cause, whichever comes first, assessed up to 92 months (cut-off date for end of study = 10-Dec-21)
ID
Title
Description
OG000
Low Grade (WHO G1/G2) Glioma (LGG)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
Units
Counts
Participants
OG000
Secondary
Progression Free Survival (PFS) in the High Grade (WHO G3/G4) Glioma (HGG) Cohort
Progression Free Survival (PFS) was defined as the interval between the first dose of study treatment and earlier date of first radiologically documented progression or death due to any cause. If the subject did not have a documented date of progression or death, PFS was censored at the date of the last adequate assessment.
ITT/Evaluable population - Primary and expansion cohort combined
Posted
Median
95% Confidence Interval
Weeks
From study treatment start date until date of radiographic progression or date of death from any cause, whichever comes first, assessed up to 92 months (cut-off date for end of study = 10-Dec-21)
ID
Title
Description
OG000
High Grade (WHO G3/G4) Glioma (HGG)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
Units
Counts
Participants
OG000
Secondary
Progression Free Survival (PFS) in the Hairy Cell Leukemia (HCL) Cohort
Progression Free Survival (PFS) was defined as the interval between the first dose of study treatment and earlier date of first radiologically documented progression or death due to any cause. If the subject did not have a documented date of progression or death, PFS was censored at the date of the last adequate assessment.
ITT/Evaluable population - Primary and expansion cohort combined
Posted
Median
95% Confidence Interval
Weeks
From study treatment start date until date of radiographic progression or date of death from any cause, whichever comes first, assessed up to 92 months (cut-off date for end of study = 10-Dec-21)
ID
Title
Description
OG000
Hairy Cell Leukemia (HCL)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
Units
Counts
Participants
OG000
Secondary
Progression Free Survival (PFS) in the Multiple Myeloma (MM) Cohort
Progression Free Survival (PFS) was defined as the interval between the first dose of study treatment and earlier date of first radiologically documented progression or death due to any cause. If the subject did not have a documented date of progression or death, PFS was censored at the date of the last adequate assessment.
ITT/Evaluable population - primary analysis cohort
Posted
Median
95% Confidence Interval
Weeks
From study treatment start date until date of radiographic progression or date of death from any cause, whichever comes first, assessed up to 92 months (cut-off date for end of study = 10-Dec-21)
ID
Title
Description
OG000
Multiple Myeloma (MM)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
Units
Counts
Participants
OG000
Secondary
Overall Survival (OS) in the Anaplastic Thyroid Cancer (ATC) Cohort
Overall Survival (OS) was defined as the time from first dose until death due to any cause. Censoring was performed using the date of last known contact for those who were alive at the time of analysis.
ITT/Evaluable population - Primary and expansion cohort combined
Posted
Median
95% Confidence Interval
Weeks
From study treatment start date until date of death from any cause, assessed up to 92 months (cut-off date for end of study = 10-Dec-21)
ID
Title
Description
OG000
Anaplastic Thyroid Cancer (ATC)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
Units
Counts
Participants
OG000
Secondary
Overall Survival (OS) in the Biliary Tract Cancer (BTC) Cohort
Overall Survival (OS) was defined as the time from first dose until death due to any cause. Censoring was performed using the date of last known contact for those who were alive at the time of analysis.
ITT/Evaluable population - Primary and expansion cohort combined
Posted
Median
95% Confidence Interval
Weeks
From study treatment start date until date of death from any cause, assessed up to 92 months (cut-off date for end of study = 10-Dec-21)
ID
Title
Description
OG000
Biliary Tract Cancer (BTC)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
Units
Counts
Participants
OG000
Secondary
Overall Survival (OS) in the Adenocarcinoma of the Small Intestine (ASI) Cohort
Overall Survival (OS) was defined as the time from first dose until death due to any cause. Censoring was performed using the date of last known contact for those who were alive at the time of analysis.
ITT/Evaluable population - Primary analysis cohort
Posted
Median
95% Confidence Interval
Weeks
From study treatment start date until date of death from any cause, assessed up to 92 months (cut-off date for end of study = 10-Dec-21)
ID
Title
Description
OG000
Adenocarcinoma of the Small Intestine (ASI)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
Units
Counts
Participants
OG000
Secondary
Overall Survival (OS) in the Low Grade (WHO G1/G2) Glioma (LGG) Cohort
Overall Survival (OS) was defined as the time from first dose until death due to any cause. Censoring was performed using the date of last known contact for those who were alive at the time of analysis.
ITT/Evaluable population - Primary analysis cohort
Posted
Median
95% Confidence Interval
Weeks
From study treatment start date until date of death from any cause, assessed up to 92 months (cut-off date for end of study = 10-Dec-21)
ID
Title
Description
OG000
Low Grade (WHO G1/G2) Glioma (LGG)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
Units
Counts
Participants
OG000
Secondary
Overall Survival (OS) in the High Grade (WHO G3/G4) Glioma (HGG) Cohort
Overall Survival (OS) was defined as the time from first dose until death due to any cause. Censoring was performed using the date of last known contact for those who were alive at the time of analysis.
ITT/Evaluable population - Primary and expansion cohort combined.
Posted
Median
95% Confidence Interval
Weeks
From study treatment start date until date of death from any cause, assessed up to 92 months (cut-off date for end of study = 10-Dec-21)
ID
Title
Description
OG000
High Grade (WHO G3/G4) Glioma (HGG)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
Units
Counts
Participants
OG000
Secondary
Overall Survival (OS) in the Hairy Cell Leukemia (HCL) Cohort
Overall Survival (OS) was defined as the time from first dose until death due to any cause. Censoring was performed using the date of last known contact for those who were alive at the time of analysis.
ITT/Evaluable population - Primary and expansion cohort combined
Posted
Median
95% Confidence Interval
Weeks
From study treatment start date until date of death from any cause, assessed up to 92 months (cut-off date for end of study = 10-Dec-21)
ID
Title
Description
OG000
Hairy Cell Leukemia (HCL)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
Units
Counts
Participants
OG000
Secondary
Overall Survival (OS) in the Multiple Myeloma (MM) Cohort
Overall Survival (OS) was defined as the time from first dose until death due to any cause. Censoring was performed using the date of last known contact for those who were alive at the time of analysis.
ITT/Evaluable population - Primary analysis cohort
Posted
Median
95% Confidence Interval
Weeks
From study treatment start date until date of death from any cause, assessed up to 92 months (cut-off date for end of study = 10-Dec-21)
ID
Title
Description
OG000
Multiple Myeloma (MM)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
Units
Counts
Participants
OG000
Secondary
Number of Participants With Adverse Events (AEs)
The distribution of adverse events (AE) was done via the analysis of frequencies for treatment emergent Adverse Event (TEAEs) and Serious Adverse Event (TESAEs) through the monitoring of relevant clinical and laboratory safety parameters.
All-treated Subjects (ATS) population - Primary and expansion cohort combined
Posted
Count of Participants
Participants
From study treatment start date till 30 days safety follow-up, assessed up to 92 months (cut-off date for end of study = 10-Dec-21)
ID
Title
Description
OG000
Anaplastic Thyroid Cancer (ATC)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
OG001
Biliary Tract Cancer (BTC)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
OG002
Gastrointestinal Stromal Tumor (GIST)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
Post-Hoc
All Collected Deaths
On-treatment deaths were collected from first dose of study medication to 30 days after study drug discontinuation, for a maximum duration of 85 months. Post-treatment survival follow-up deaths were collected from day 31 after last dose of first dose of study medication, up to 92 months. All deaths refer to the sum of on-treatment deaths and post-treatment survival follow-up deaths.
All-treated Subjects (ATS) population - Primary and expansion cohort combined
Posted
Number
Participants
On-treatment deaths: Up to 85 months. Post-treatment survival follow-up deaths: Up to 92 months.
ID
Title
Description
OG000
Anaplastic Thyroid Cancer (ATC)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
OG001
Biliary Tract Cancer (BTC)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
OG002
Gastrointestinal Stromal Tumor (GIST)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
Time Frame
Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 85 months. Deaths were collected in the post treatment survival follow up period from 31 days after last dose of study medication until the end of the study, up to approximately 92 months. These are not considered Adverse Events.
Description
Any sign or symptom that occurred during the conduct of the trial and safety follow-up.
Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post treatment survival follow-up period includes patients that entered the post treatment survival follow-up period.
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
Anaplastic Thyroid Cancer (ATC) (On-Treatment)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
6
36
20
36
36
36
EG001
Biliary Tract Cancer (BTC) (On-Treatment)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
0
1
1
1
1
1
EG003
Low Grade (WHO G1/G2) Glioma (LGG) (On-Treatment)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
1
13
3
13
12
13
EG004
High Grade (WHO G3/G4) Glioma (HGG) (On-Treatment)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
2
45
16
45
42
45
EG005
Adenocarcinoma of the Small Intestine (ASI) (On-Treatment)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
0
3
0
3
3
3
EG006
Hairy Cell Leukemia (HCL) (On-Treatment)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
4
55
32
55
55
55
EG007
Multiple Myeloma (MM) (On-Treatment)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
1
10
4
10
9
10
EG008
Anaplastic Thyroid Cancer (ATC) (Post-treatment Survival Follow-up)
Deaths collected in the post- treatment survival follow-up period (starting from day 31 post- treatment). No AEs were collected during this period.
18
30
0
0
0
0
EG009
Biliary Tract Cancer (BTC) (Post-treatment Survival Follow-up)
Deaths collected in the post- treatment survival follow-up period (starting from day 31 post- treatment). No AEs were collected during this period.
Deaths collected in the post- treatment survival follow-up period (starting from day 31 post- treatment). No AEs were collected during this period.
8
9
0
0
0
0
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA (24.1)
Systematic Assessment
EG0001 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG0031 affected13 at risk
EG0040 affected45 at risk
EG0050 affected3 at risk
EG0060 affected55 at risk
EG0070 affected10 at risk
EG0080 at risk
EG0090 at risk
EG0100 at risk
EG0110 at risk
EG0120 at risk
EG0130 at risk
EG0140 at risk
EG0150 at risk
Autoimmune haemolytic anaemia
Blood and lymphatic system disorders
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Febrile neutropenia
Blood and lymphatic system disorders
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0011 affected43 at risk
EG0020 affected1 at risk
EG003
Haemolytic uraemic syndrome
Blood and lymphatic system disorders
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Leukopenia
Blood and lymphatic system disorders
MedDRA (24.1)
Systematic Assessment
EG0002 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA (24.1)
Systematic Assessment
EG0001 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0011 affected43 at risk
EG0020 affected1 at risk
EG003
Atrioventricular block
Cardiac disorders
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Cardiac ventricular thrombosis
Cardiac disorders
MedDRA (24.1)
Systematic Assessment
EG0001 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Conduction disorder
Cardiac disorders
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Myocardial infarction
Cardiac disorders
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Myocardial ischaemia
Cardiac disorders
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Myocarditis
Cardiac disorders
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Stress cardiomyopathy
Cardiac disorders
MedDRA (24.1)
Systematic Assessment
EG0001 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Adrenocortical insufficiency acute
Endocrine disorders
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Amaurosis fugax
Eye disorders
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Diplopia
Eye disorders
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Retinal detachment
Eye disorders
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0011 affected43 at risk
EG0020 affected1 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA (24.1)
Systematic Assessment
EG0001 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Haematochezia
Gastrointestinal disorders
MedDRA (24.1)
Systematic Assessment
EG0002 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Intestinal obstruction
Gastrointestinal disorders
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0010 affected43 at risk
EG0021 affected1 at risk
EG003
Large intestinal haemorrhage
Gastrointestinal disorders
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Oesophageal stenosis
Gastrointestinal disorders
MedDRA (24.1)
Systematic Assessment
EG0001 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Rectal haemorrhage
Gastrointestinal disorders
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0011 affected43 at risk
EG0020 affected1 at risk
EG003
Small intestinal obstruction
Gastrointestinal disorders
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0011 affected43 at risk
EG0020 affected1 at risk
EG003
Chills
General disorders
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Fat necrosis
General disorders
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Fatigue
General disorders
MedDRA (24.1)
Systematic Assessment
EG0001 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
General physical health deterioration
General disorders
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Pyrexia
General disorders
MedDRA (24.1)
Systematic Assessment
EG0001 affected36 at risk
EG0019 affected43 at risk
EG0020 affected1 at risk
EG003
Cholangitis
Hepatobiliary disorders
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0013 affected43 at risk
EG0020 affected1 at risk
EG003
Hepatic cytolysis
Hepatobiliary disorders
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Hepatotoxicity
Hepatobiliary disorders
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Haemophagocytic lymphohistiocytosis
Immune system disorders
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Bacteraemia
Infections and infestations
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Bacterial diarrhoea
Infections and infestations
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Cellulitis
Infections and infestations
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Cervicitis human papilloma virus
Infections and infestations
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Clostridium difficile infection
Infections and infestations
MedDRA (24.1)
Systematic Assessment
EG0001 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Device related infection
Infections and infestations
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0011 affected43 at risk
EG0020 affected1 at risk
EG003
Diverticulitis
Infections and infestations
MedDRA (24.1)
Systematic Assessment
EG0001 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Enterobacter infection
Infections and infestations
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Gastroenteritis pseudomonas
Infections and infestations
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Infection
Infections and infestations
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Influenza
Infections and infestations
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Lymph node tuberculosis
Infections and infestations
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Otitis media acute
Infections and infestations
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Parotitis
Infections and infestations
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Pelvic infection
Infections and infestations
MedDRA (24.1)
Systematic Assessment
EG0001 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Pneumonia
Infections and infestations
MedDRA (24.1)
Systematic Assessment
EG0008 affected36 at risk
EG0011 affected43 at risk
EG0020 affected1 at risk
EG003
Pneumonia aspiration
Infections and infestations
MedDRA (24.1)
Systematic Assessment
EG0001 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Pneumonia necrotising
Infections and infestations
MedDRA (24.1)
Systematic Assessment
EG0001 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Pulmonary sepsis
Infections and infestations
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Pyelonephritis acute
Infections and infestations
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Respiratory tract infection
Infections and infestations
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0011 affected43 at risk
EG0020 affected1 at risk
EG003
Sepsis
Infections and infestations
MedDRA (24.1)
Systematic Assessment
EG0001 affected36 at risk
EG0013 affected43 at risk
EG0020 affected1 at risk
EG003
Staphylococcal infection
Infections and infestations
MedDRA (24.1)
Systematic Assessment
EG0001 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA (24.1)
Systematic Assessment
EG0002 affected36 at risk
EG0011 affected43 at risk
EG0020 affected1 at risk
EG003
Urinary tract infection bacterial
Infections and infestations
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Viral infection
Infections and infestations
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Wound infection
Infections and infestations
MedDRA (24.1)
Systematic Assessment
EG0001 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Clavicle fracture
Injury, poisoning and procedural complications
MedDRA (24.1)
Systematic Assessment
EG0001 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0011 affected43 at risk
EG0020 affected1 at risk
EG003
Femoral neck fracture
Injury, poisoning and procedural complications
MedDRA (24.1)
Systematic Assessment
EG0001 affected36 at risk
EG0011 affected43 at risk
EG0020 affected1 at risk
EG003
Post procedural discomfort
Injury, poisoning and procedural complications
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Rib fracture
Injury, poisoning and procedural complications
MedDRA (24.1)
Systematic Assessment
EG0001 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Ejection fraction decreased
Investigations
MedDRA (24.1)
Systematic Assessment
EG0001 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA (24.1)
Systematic Assessment
EG0002 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Transaminases increased
Investigations
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0011 affected43 at risk
EG0020 affected1 at risk
EG003
White blood cell count decreased
Investigations
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0011 affected43 at risk
EG0020 affected1 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA (24.1)
Systematic Assessment
EG0001 affected36 at risk
EG0011 affected43 at risk
EG0020 affected1 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Hyperglycaemic hyperosmolar nonketotic syndrome
Metabolism and nutrition disorders
MedDRA (24.1)
Systematic Assessment
EG0001 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA (24.1)
Systematic Assessment
EG0001 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0011 affected43 at risk
EG0020 affected1 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0011 affected43 at risk
EG0020 affected1 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Rhabdomyolysis
Musculoskeletal and connective tissue disorders
MedDRA (24.1)
Systematic Assessment
EG0001 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Spinal pain
Musculoskeletal and connective tissue disorders
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0011 affected43 at risk
EG0020 affected1 at risk
EG003
Adenocarcinoma of the cervix
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Adenocarcinoma pancreas
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Basal cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Bladder neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Bladder transitional cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (24.1)
Systematic Assessment
EG0001 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Bowen's disease
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Chronic lymphocytic leukaemia
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Gastrointestinal stromal tumour
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Hodgkin's disease
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Invasive breast carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Metastases to bone
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Metastatic squamous cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Prostate cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Squamous cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Squamous cell carcinoma of skin
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Amnesia
Nervous system disorders
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Aphasia
Nervous system disorders
MedDRA (24.1)
Systematic Assessment
EG0001 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Ataxia
Nervous system disorders
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Brain oedema
Nervous system disorders
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Central nervous system lesion
Nervous system disorders
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Cerebral cyst
Nervous system disorders
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Cerebral thrombosis
Nervous system disorders
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Dizziness
Nervous system disorders
MedDRA (24.1)
Systematic Assessment
EG0001 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Epilepsy
Nervous system disorders
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Facial nerve disorder
Nervous system disorders
MedDRA (24.1)
Systematic Assessment
EG0001 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Guillain-Barre syndrome
Nervous system disorders
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Haemorrhagic stroke
Nervous system disorders
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Headache
Nervous system disorders
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Hydrocephalus
Nervous system disorders
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Paralysis recurrent laryngeal nerve
Nervous system disorders
MedDRA (24.1)
Systematic Assessment
EG0001 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Seizure
Nervous system disorders
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Syncope
Nervous system disorders
MedDRA (24.1)
Systematic Assessment
EG0001 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Device failure
Product Issues
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Hallucination
Psychiatric disorders
MedDRA (24.1)
Systematic Assessment
EG0001 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA (24.1)
Systematic Assessment
EG0002 affected36 at risk
EG0011 affected43 at risk
EG0020 affected1 at risk
EG003
Calculus urinary
Renal and urinary disorders
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA (24.1)
Systematic Assessment
EG0001 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Renal colic
Renal and urinary disorders
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Urinary retention
Renal and urinary disorders
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Aspiration
Respiratory, thoracic and mediastinal disorders
MedDRA (24.1)
Systematic Assessment
EG0001 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA (24.1)
Systematic Assessment
EG0001 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA (24.1)
Systematic Assessment
EG0003 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Pneumothorax
Respiratory, thoracic and mediastinal disorders
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA (24.1)
Systematic Assessment
EG0001 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Pulmonary granuloma
Respiratory, thoracic and mediastinal disorders
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Pulmonary haematoma
Respiratory, thoracic and mediastinal disorders
MedDRA (24.1)
Systematic Assessment
EG0001 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Erythema nodosum
Skin and subcutaneous tissue disorders
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Skin ulcer
Skin and subcutaneous tissue disorders
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Aortic thrombosis
Vascular disorders
MedDRA (24.1)
Systematic Assessment
EG0001 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Hypotension
Vascular disorders
MedDRA (24.1)
Systematic Assessment
EG0001 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Thrombophlebitis
Vascular disorders
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0011 affected43 at risk
EG0020 affected1 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA (24.1)
Systematic Assessment
EG00012 affected36 at risk
EG00110 affected43 at risk
EG0020 affected1 at risk
EG0034 affected13 at risk
EG0049 affected45 at risk
EG0050 affected3 at risk
EG00610 affected55 at risk
EG0073 affected10 at risk
EG0080 at risk
EG0090 at risk
EG0100 at risk
EG0110 at risk
EG0120 at risk
EG0130 at risk
EG0140 at risk
EG0150 at risk
Leukopenia
Blood and lymphatic system disorders
MedDRA (24.1)
Systematic Assessment
EG0002 affected36 at risk
EG0012 affected43 at risk
EG0020 affected1 at risk
EG003
Lymphopenia
Blood and lymphatic system disorders
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Microcytic anaemia
Blood and lymphatic system disorders
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA (24.1)
Systematic Assessment
EG0002 affected36 at risk
EG0013 affected43 at risk
EG0020 affected1 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA (24.1)
Systematic Assessment
EG0002 affected36 at risk
EG0017 affected43 at risk
EG0020 affected1 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA (24.1)
Systematic Assessment
EG0002 affected36 at risk
EG0011 affected43 at risk
EG0020 affected1 at risk
EG003
Atrioventricular block first degree
Cardiac disorders
MedDRA (24.1)
Systematic Assessment
EG0001 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Bradycardia
Cardiac disorders
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Sinus bradycardia
Cardiac disorders
MedDRA (24.1)
Systematic Assessment
EG0001 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA (24.1)
Systematic Assessment
EG0002 affected36 at risk
EG0011 affected43 at risk
EG0020 affected1 at risk
EG003
Ear pain
Ear and labyrinth disorders
MedDRA (24.1)
Systematic Assessment
EG0002 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Hypoacusis
Ear and labyrinth disorders
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Tinnitus
Ear and labyrinth disorders
MedDRA (24.1)
Systematic Assessment
EG0001 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Hypothyroidism
Endocrine disorders
MedDRA (24.1)
Systematic Assessment
EG0004 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Cataract
Eye disorders
MedDRA (24.1)
Systematic Assessment
EG0001 affected36 at risk
EG0011 affected43 at risk
EG0020 affected1 at risk
EG003
Diplopia
Eye disorders
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Dry eye
Eye disorders
MedDRA (24.1)
Systematic Assessment
EG0001 affected36 at risk
EG0012 affected43 at risk
EG0020 affected1 at risk
EG003
Eye pain
Eye disorders
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0011 affected43 at risk
EG0020 affected1 at risk
EG003
Eyelid oedema
Eye disorders
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Iritis
Eye disorders
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Lacrimation increased
Eye disorders
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Macular oedema
Eye disorders
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Papilloedema
Eye disorders
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Photophobia
Eye disorders
MedDRA (24.1)
Systematic Assessment
EG0001 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Saccadic eye movement
Eye disorders
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Uveitis
Eye disorders
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Vision blurred
Eye disorders
MedDRA (24.1)
Systematic Assessment
EG0001 affected36 at risk
EG0011 affected43 at risk
EG0020 affected1 at risk
EG003
Visual impairment
Eye disorders
MedDRA (24.1)
Systematic Assessment
EG0004 affected36 at risk
EG0011 affected43 at risk
EG0020 affected1 at risk
EG003
Vitreous floaters
Eye disorders
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Abdominal discomfort
Gastrointestinal disorders
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0011 affected43 at risk
EG0020 affected1 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA (24.1)
Systematic Assessment
EG0001 affected36 at risk
EG0011 affected43 at risk
EG0020 affected1 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA (24.1)
Systematic Assessment
EG0002 affected36 at risk
EG0015 affected43 at risk
EG0020 affected1 at risk
EG003
Abdominal pain lower
Gastrointestinal disorders
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA (24.1)
Systematic Assessment
EG0002 affected36 at risk
EG0017 affected43 at risk
EG0020 affected1 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA (24.1)
Systematic Assessment
EG0008 affected36 at risk
EG0019 affected43 at risk
EG0021 affected1 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA (24.1)
Systematic Assessment
EG0007 affected36 at risk
EG00114 affected43 at risk
EG0020 affected1 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA (24.1)
Systematic Assessment
EG0005 affected36 at risk
EG0018 affected43 at risk
EG0020 affected1 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA (24.1)
Systematic Assessment
EG0001 affected36 at risk
EG0013 affected43 at risk
EG0021 affected1 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA (24.1)
Systematic Assessment
EG0006 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Flatulence
Gastrointestinal disorders
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA (24.1)
Systematic Assessment
EG0003 affected36 at risk
EG0012 affected43 at risk
EG0020 affected1 at risk
EG003
Gingival bleeding
Gastrointestinal disorders
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0011 affected43 at risk
EG0020 affected1 at risk
EG003
Hyperaesthesia teeth
Gastrointestinal disorders
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA (24.1)
Systematic Assessment
EG00012 affected36 at risk
EG00118 affected43 at risk
EG0021 affected1 at risk
EG003
Noninfective gingivitis
Gastrointestinal disorders
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Oral pain
Gastrointestinal disorders
MedDRA (24.1)
Systematic Assessment
EG0001 affected36 at risk
EG0011 affected43 at risk
EG0020 affected1 at risk
EG003
Retching
Gastrointestinal disorders
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Salivary gland mass
Gastrointestinal disorders
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA (24.1)
Systematic Assessment
EG0002 affected36 at risk
EG0013 affected43 at risk
EG0021 affected1 at risk
EG003
Toothache
Gastrointestinal disorders
MedDRA (24.1)
Systematic Assessment
EG0001 affected36 at risk
EG0012 affected43 at risk
EG0020 affected1 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA (24.1)
Systematic Assessment
EG0007 affected36 at risk
EG00115 affected43 at risk
EG0021 affected1 at risk
EG003
Asthenia
General disorders
MedDRA (24.1)
Systematic Assessment
EG0003 affected36 at risk
EG0017 affected43 at risk
EG0021 affected1 at risk
EG003
Chills
General disorders
MedDRA (24.1)
Systematic Assessment
EG0008 affected36 at risk
EG00112 affected43 at risk
EG0020 affected1 at risk
EG003
Fatigue
General disorders
MedDRA (24.1)
Systematic Assessment
EG00013 affected36 at risk
EG00114 affected43 at risk
EG0020 affected1 at risk
EG003
Feeling cold
General disorders
MedDRA (24.1)
Systematic Assessment
EG0002 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Gait disturbance
General disorders
MedDRA (24.1)
Systematic Assessment
EG0001 affected36 at risk
EG0011 affected43 at risk
EG0020 affected1 at risk
EG003
Influenza like illness
General disorders
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0013 affected43 at risk
EG0020 affected1 at risk
EG003
Injection site reaction
General disorders
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Malaise
General disorders
MedDRA (24.1)
Systematic Assessment
EG0001 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Mucosal inflammation
General disorders
MedDRA (24.1)
Systematic Assessment
EG0003 affected36 at risk
EG0013 affected43 at risk
EG0020 affected1 at risk
EG003
Nodule
General disorders
MedDRA (24.1)
Systematic Assessment
EG0001 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA (24.1)
Systematic Assessment
EG0002 affected36 at risk
EG0011 affected43 at risk
EG0020 affected1 at risk
EG003
Oedema
General disorders
MedDRA (24.1)
Systematic Assessment
EG0001 affected36 at risk
EG0013 affected43 at risk
EG0020 affected1 at risk
EG003
Oedema peripheral
General disorders
MedDRA (24.1)
Systematic Assessment
EG0005 affected36 at risk
EG0014 affected43 at risk
EG0020 affected1 at risk
EG003
Pain
General disorders
MedDRA (24.1)
Systematic Assessment
EG0002 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Peripheral swelling
General disorders
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Pyrexia
General disorders
MedDRA (24.1)
Systematic Assessment
EG00017 affected36 at risk
EG00125 affected43 at risk
EG0021 affected1 at risk
EG003
Thirst
General disorders
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Xerosis
General disorders
MedDRA (24.1)
Systematic Assessment
EG0001 affected36 at risk
EG0011 affected43 at risk
EG0020 affected1 at risk
EG003
Hypersensitivity
Immune system disorders
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0011 affected43 at risk
EG0020 affected1 at risk
EG003
Sarcoidosis
Immune system disorders
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Abdominal abscess
Infections and infestations
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Abscess limb
Infections and infestations
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Bronchitis
Infections and infestations
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
COVID-19
Infections and infestations
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Conjunctivitis
Infections and infestations
MedDRA (24.1)
Systematic Assessment
EG0001 affected36 at risk
EG0011 affected43 at risk
EG0020 affected1 at risk
EG003
Folliculitis
Infections and infestations
MedDRA (24.1)
Systematic Assessment
EG0001 affected36 at risk
EG0012 affected43 at risk
EG0020 affected1 at risk
EG003
Fungal infection
Infections and infestations
MedDRA (24.1)
Systematic Assessment
EG0002 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0011 affected43 at risk
EG0020 affected1 at risk
EG003
Gingivitis
Infections and infestations
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0013 affected43 at risk
EG0020 affected1 at risk
EG003
Infection
Infections and infestations
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA (24.1)
Systematic Assessment
EG0002 affected36 at risk
EG0011 affected43 at risk
EG0020 affected1 at risk
EG003
Onychomycosis
Infections and infestations
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Oral candidiasis
Infections and infestations
MedDRA (24.1)
Systematic Assessment
EG0001 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Oral herpes
Infections and infestations
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Oropharyngeal candidiasis
Infections and infestations
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Paronychia
Infections and infestations
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0011 affected43 at risk
EG0020 affected1 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Pneumonia
Infections and infestations
MedDRA (24.1)
Systematic Assessment
EG0001 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Rash pustular
Infections and infestations
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0011 affected43 at risk
EG0020 affected1 at risk
EG003
Rhinitis
Infections and infestations
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0011 affected43 at risk
EG0020 affected1 at risk
EG003
Sinusitis
Infections and infestations
MedDRA (24.1)
Systematic Assessment
EG0002 affected36 at risk
EG0011 affected43 at risk
EG0020 affected1 at risk
EG003
Skin candida
Infections and infestations
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Skin infection
Infections and infestations
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Streptococcal infection
Infections and infestations
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Subcutaneous abscess
Infections and infestations
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Tooth abscess
Infections and infestations
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0011 affected43 at risk
EG0020 affected1 at risk
EG003
Tooth infection
Infections and infestations
MedDRA (24.1)
Systematic Assessment
EG0001 affected36 at risk
EG0011 affected43 at risk
EG0020 affected1 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA (24.1)
Systematic Assessment
EG0003 affected36 at risk
EG0011 affected43 at risk
EG0020 affected1 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA (24.1)
Systematic Assessment
EG0002 affected36 at risk
EG0012 affected43 at risk
EG0020 affected1 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0012 affected43 at risk
EG0020 affected1 at risk
EG003
Procedural pain
Injury, poisoning and procedural complications
MedDRA (24.1)
Systematic Assessment
EG0001 affected36 at risk
EG0011 affected43 at risk
EG0020 affected1 at risk
EG003
Radiation associated pain
Injury, poisoning and procedural complications
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Skin laceration
Injury, poisoning and procedural complications
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Thermal burn
Injury, poisoning and procedural complications
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA (24.1)
Systematic Assessment
EG0004 affected36 at risk
EG0017 affected43 at risk
EG0020 affected1 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA (24.1)
Systematic Assessment
EG0005 affected36 at risk
EG00111 affected43 at risk
EG0020 affected1 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA (24.1)
Systematic Assessment
EG0006 affected36 at risk
EG0019 affected43 at risk
EG0020 affected1 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0013 affected43 at risk
EG0020 affected1 at risk
EG003
Blood creatine phosphokinase increased
Investigations
MedDRA (24.1)
Systematic Assessment
EG0001 affected36 at risk
EG0012 affected43 at risk
EG0020 affected1 at risk
EG003
Blood creatinine increased
Investigations
MedDRA (24.1)
Systematic Assessment
EG0002 affected36 at risk
EG0015 affected43 at risk
EG0020 affected1 at risk
EG003
Blood glucose increased
Investigations
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Blood lactate dehydrogenase increased
Investigations
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0011 affected43 at risk
EG0020 affected1 at risk
EG003
Blood oestrogen decreased
Investigations
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Blood testosterone decreased
Investigations
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Blood urea increased
Investigations
MedDRA (24.1)
Systematic Assessment
EG0002 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Blood uric acid increased
Investigations
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0011 affected43 at risk
EG0020 affected1 at risk
EG003
C-reactive protein increased
Investigations
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0011 affected43 at risk
EG0020 affected1 at risk
EG003
Ejection fraction decreased
Investigations
MedDRA (24.1)
Systematic Assessment
EG0003 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Electrocardiogram QT prolonged
Investigations
MedDRA (24.1)
Systematic Assessment
EG0003 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Gamma-glutamyltransferase increased
Investigations
MedDRA (24.1)
Systematic Assessment
EG0003 affected36 at risk
EG00112 affected43 at risk
EG0020 affected1 at risk
EG003
Glycosylated haemoglobin increased
Investigations
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0013 affected43 at risk
EG0020 affected1 at risk
EG003
Lipase increased
Investigations
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Liver function test increased
Investigations
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Lymphocyte count decreased
Investigations
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0012 affected43 at risk
EG0020 affected1 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA (24.1)
Systematic Assessment
EG0003 affected36 at risk
EG0014 affected43 at risk
EG0020 affected1 at risk
EG003
Neutrophil count increased
Investigations
MedDRA (24.1)
Systematic Assessment
EG0002 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Platelet count decreased
Investigations
MedDRA (24.1)
Systematic Assessment
EG0001 affected36 at risk
EG0015 affected43 at risk
EG0020 affected1 at risk
EG003
Urine output decreased
Investigations
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Weight decreased
Investigations
MedDRA (24.1)
Systematic Assessment
EG0004 affected36 at risk
EG0013 affected43 at risk
EG0020 affected1 at risk
EG003
Weight increased
Investigations
MedDRA (24.1)
Systematic Assessment
EG0001 affected36 at risk
EG0014 affected43 at risk
EG0020 affected1 at risk
EG003
White blood cell count decreased
Investigations
MedDRA (24.1)
Systematic Assessment
EG0005 affected36 at risk
EG00110 affected43 at risk
EG0020 affected1 at risk
EG003
Cachexia
Metabolism and nutrition disorders
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA (24.1)
Systematic Assessment
EG00012 affected36 at risk
EG00110 affected43 at risk
EG0020 affected1 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA (24.1)
Systematic Assessment
EG0001 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Diabetes mellitus
Metabolism and nutrition disorders
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA (24.1)
Systematic Assessment
EG0003 affected36 at risk
EG0011 affected43 at risk
EG0020 affected1 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA (24.1)
Systematic Assessment
EG0005 affected36 at risk
EG0018 affected43 at risk
EG0020 affected1 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA (24.1)
Systematic Assessment
EG0001 affected36 at risk
EG0011 affected43 at risk
EG0020 affected1 at risk
EG003
Hyperuricaemia
Metabolism and nutrition disorders
MedDRA (24.1)
Systematic Assessment
EG0002 affected36 at risk
EG0012 affected43 at risk
EG0020 affected1 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRA (24.1)
Systematic Assessment
EG0007 affected36 at risk
EG0013 affected43 at risk
EG0020 affected1 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
MedDRA (24.1)
Systematic Assessment
EG0005 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0012 affected43 at risk
EG0020 affected1 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA (24.1)
Systematic Assessment
EG0004 affected36 at risk
EG0014 affected43 at risk
EG0020 affected1 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA (24.1)
Systematic Assessment
EG0002 affected36 at risk
EG0015 affected43 at risk
EG0020 affected1 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA (24.1)
Systematic Assessment
EG0007 affected36 at risk
EG0015 affected43 at risk
EG0020 affected1 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
MedDRA (24.1)
Systematic Assessment
EG0001 affected36 at risk
EG0012 affected43 at risk
EG0020 affected1 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA (24.1)
Systematic Assessment
EG0005 affected36 at risk
EG0016 affected43 at risk
EG0020 affected1 at risk
EG003
Arthritis
Musculoskeletal and connective tissue disorders
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA (24.1)
Systematic Assessment
EG0006 affected36 at risk
EG0014 affected43 at risk
EG0020 affected1 at risk
EG003
Bone pain
Musculoskeletal and connective tissue disorders
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Flank pain
Musculoskeletal and connective tissue disorders
MedDRA (24.1)
Systematic Assessment
EG0001 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Foot deformity
Musculoskeletal and connective tissue disorders
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Joint range of motion decreased
Musculoskeletal and connective tissue disorders
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Joint stiffness
Musculoskeletal and connective tissue disorders
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Joint swelling
Musculoskeletal and connective tissue disorders
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0012 affected43 at risk
EG0020 affected1 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0012 affected43 at risk
EG0020 affected1 at risk
EG003
Muscle twitching
Musculoskeletal and connective tissue disorders
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA (24.1)
Systematic Assessment
EG0001 affected36 at risk
EG0011 affected43 at risk
EG0020 affected1 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA (24.1)
Systematic Assessment
EG0001 affected36 at risk
EG0011 affected43 at risk
EG0020 affected1 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0013 affected43 at risk
EG0020 affected1 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA (24.1)
Systematic Assessment
EG0002 affected36 at risk
EG0018 affected43 at risk
EG0020 affected1 at risk
EG003
Myopathy
Musculoskeletal and connective tissue disorders
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Neck mass
Musculoskeletal and connective tissue disorders
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA (24.1)
Systematic Assessment
EG0003 affected36 at risk
EG0011 affected43 at risk
EG0020 affected1 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA (24.1)
Systematic Assessment
EG0001 affected36 at risk
EG0013 affected43 at risk
EG0020 affected1 at risk
EG003
Pain in jaw
Musculoskeletal and connective tissue disorders
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0011 affected43 at risk
EG0020 affected1 at risk
EG003
Spinal pain
Musculoskeletal and connective tissue disorders
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Synovial cyst
Musculoskeletal and connective tissue disorders
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Basal cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0011 affected43 at risk
EG0020 affected1 at risk
EG003
Fibroma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Lipoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Melanocytic naevus
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Seborrhoeic keratosis
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (24.1)
Systematic Assessment
EG0002 affected36 at risk
EG0011 affected43 at risk
EG0020 affected1 at risk
EG003
Skin papilloma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Aphasia
Nervous system disorders
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Balance disorder
Nervous system disorders
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Dizziness
Nervous system disorders
MedDRA (24.1)
Systematic Assessment
EG0007 affected36 at risk
EG0011 affected43 at risk
EG0020 affected1 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0011 affected43 at risk
EG0020 affected1 at risk
EG003
Epilepsy
Nervous system disorders
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0011 affected43 at risk
EG0020 affected1 at risk
EG003
Facial paralysis
Nervous system disorders
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Facial paresis
Nervous system disorders
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Head discomfort
Nervous system disorders
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Headache
Nervous system disorders
MedDRA (24.1)
Systematic Assessment
EG0008 affected36 at risk
EG00110 affected43 at risk
EG0020 affected1 at risk
EG003
Hemiparesis
Nervous system disorders
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Hydrocephalus
Nervous system disorders
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Hypoaesthesia
Nervous system disorders
MedDRA (24.1)
Systematic Assessment
EG0001 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
IIIrd nerve disorder
Nervous system disorders
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Intercostal neuralgia
Nervous system disorders
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Memory impairment
Nervous system disorders
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Neuralgia
Nervous system disorders
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Neuropathy peripheral
Nervous system disorders
MedDRA (24.1)
Systematic Assessment
EG0002 affected36 at risk
EG0012 affected43 at risk
EG0020 affected1 at risk
EG003
Nystagmus
Nervous system disorders
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Palatal palsy
Nervous system disorders
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA (24.1)
Systematic Assessment
EG0001 affected36 at risk
EG0011 affected43 at risk
EG0020 affected1 at risk
EG003
Peripheral motor neuropathy
Nervous system disorders
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Peripheral sensory neuropathy
Nervous system disorders
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0011 affected43 at risk
EG0020 affected1 at risk
EG003
Polyneuropathy
Nervous system disorders
MedDRA (24.1)
Systematic Assessment
EG0002 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Pyramidal tract syndrome
Nervous system disorders
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Sciatica
Nervous system disorders
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0011 affected43 at risk
EG0020 affected1 at risk
EG003
Tremor
Nervous system disorders
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
VIth nerve disorder
Nervous system disorders
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Agitation
Psychiatric disorders
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA (24.1)
Systematic Assessment
EG0001 affected36 at risk
EG0013 affected43 at risk
EG0020 affected1 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Depressed mood
Psychiatric disorders
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Depression
Psychiatric disorders
MedDRA (24.1)
Systematic Assessment
EG0001 affected36 at risk
EG0011 affected43 at risk
EG0020 affected1 at risk
EG003
Emotional disorder
Psychiatric disorders
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA (24.1)
Systematic Assessment
EG0005 affected36 at risk
EG0016 affected43 at risk
EG0020 affected1 at risk
EG003
Libido decreased
Psychiatric disorders
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Mood swings
Psychiatric disorders
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Sleep disorder
Psychiatric disorders
MedDRA (24.1)
Systematic Assessment
EG0001 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0013 affected43 at risk
EG0020 affected1 at risk
EG003
Chromaturia
Renal and urinary disorders
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA (24.1)
Systematic Assessment
EG0002 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Pollakiuria
Renal and urinary disorders
MedDRA (24.1)
Systematic Assessment
EG0001 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Proteinuria
Renal and urinary disorders
MedDRA (24.1)
Systematic Assessment
EG0002 affected36 at risk
EG0011 affected43 at risk
EG0020 affected1 at risk
EG003
Renal failure
Renal and urinary disorders
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0011 affected43 at risk
EG0020 affected1 at risk
EG003
Urinary retention
Renal and urinary disorders
MedDRA (24.1)
Systematic Assessment
EG0001 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Benign prostatic hyperplasia
Reproductive system and breast disorders
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA (24.1)
Systematic Assessment
EG0004 affected36 at risk
EG00110 affected43 at risk
EG0020 affected1 at risk
EG003
Dysphonia
Respiratory, thoracic and mediastinal disorders
MedDRA (24.1)
Systematic Assessment
EG0001 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA (24.1)
Systematic Assessment
EG0008 affected36 at risk
EG0017 affected43 at risk
EG0020 affected1 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA (24.1)
Systematic Assessment
EG0001 affected36 at risk
EG0012 affected43 at risk
EG0020 affected1 at risk
EG003
Haemoptysis
Respiratory, thoracic and mediastinal disorders
MedDRA (24.1)
Systematic Assessment
EG0004 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Hiccups
Respiratory, thoracic and mediastinal disorders
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Lung disorder
Respiratory, thoracic and mediastinal disorders
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA (24.1)
Systematic Assessment
EG0002 affected36 at risk
EG0011 affected43 at risk
EG0020 affected1 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0012 affected43 at risk
EG0020 affected1 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA (24.1)
Systematic Assessment
EG0002 affected36 at risk
EG0011 affected43 at risk
EG0020 affected1 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
MedDRA (24.1)
Systematic Assessment
EG0002 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Productive cough
Respiratory, thoracic and mediastinal disorders
MedDRA (24.1)
Systematic Assessment
EG0003 affected36 at risk
EG0011 affected43 at risk
EG0020 affected1 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA (24.1)
Systematic Assessment
EG0002 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Rhinitis allergic
Respiratory, thoracic and mediastinal disorders
MedDRA (24.1)
Systematic Assessment
EG0002 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA (24.1)
Systematic Assessment
EG0002 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Upper-airway cough syndrome
Respiratory, thoracic and mediastinal disorders
MedDRA (24.1)
Systematic Assessment
EG0001 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Wheezing
Respiratory, thoracic and mediastinal disorders
MedDRA (24.1)
Systematic Assessment
EG0001 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Acne
Skin and subcutaneous tissue disorders
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0012 affected43 at risk
EG0020 affected1 at risk
EG003
Actinic keratosis
Skin and subcutaneous tissue disorders
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA (24.1)
Systematic Assessment
EG0001 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Dermatitis acneiform
Skin and subcutaneous tissue disorders
MedDRA (24.1)
Systematic Assessment
EG0001 affected36 at risk
EG0014 affected43 at risk
EG0020 affected1 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA (24.1)
Systematic Assessment
EG0004 affected36 at risk
EG0014 affected43 at risk
EG0020 affected1 at risk
EG003
Eczema
Skin and subcutaneous tissue disorders
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0015 affected43 at risk
EG0020 affected1 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA (24.1)
Systematic Assessment
EG0001 affected36 at risk
EG0015 affected43 at risk
EG0020 affected1 at risk
EG003
Erythema nodosum
Skin and subcutaneous tissue disorders
MedDRA (24.1)
Systematic Assessment
EG0001 affected36 at risk
EG0012 affected43 at risk
EG0020 affected1 at risk
EG003
Hidradenitis
Skin and subcutaneous tissue disorders
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Hyperhidrosis
Skin and subcutaneous tissue disorders
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Hyperkeratosis
Skin and subcutaneous tissue disorders
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0012 affected43 at risk
EG0020 affected1 at risk
EG003
Ingrowing nail
Skin and subcutaneous tissue disorders
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Nail discolouration
Skin and subcutaneous tissue disorders
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0011 affected43 at risk
EG0020 affected1 at risk
EG003
Night sweats
Skin and subcutaneous tissue disorders
MedDRA (24.1)
Systematic Assessment
EG0003 affected36 at risk
EG0013 affected43 at risk
EG0020 affected1 at risk
EG003
Palmar-plantar erythrodysaesthesia syndrome
Skin and subcutaneous tissue disorders
MedDRA (24.1)
Systematic Assessment
EG0002 affected36 at risk
EG0011 affected43 at risk
EG0020 affected1 at risk
EG003
Papule
Skin and subcutaneous tissue disorders
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Photosensitivity reaction
Skin and subcutaneous tissue disorders
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0011 affected43 at risk
EG0020 affected1 at risk
EG003
Piloerection
Skin and subcutaneous tissue disorders
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA (24.1)
Systematic Assessment
EG0004 affected36 at risk
EG0015 affected43 at risk
EG0020 affected1 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA (24.1)
Systematic Assessment
EG00010 affected36 at risk
EG00112 affected43 at risk
EG0020 affected1 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA (24.1)
Systematic Assessment
EG0003 affected36 at risk
EG0014 affected43 at risk
EG0020 affected1 at risk
EG003
Seborrhoeic dermatitis
Skin and subcutaneous tissue disorders
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Skin atrophy
Skin and subcutaneous tissue disorders
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Skin hyperpigmentation
Skin and subcutaneous tissue disorders
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Skin lesion
Skin and subcutaneous tissue disorders
MedDRA (24.1)
Systematic Assessment
EG0002 affected36 at risk
EG0012 affected43 at risk
EG0020 affected1 at risk
EG003
Skin mass
Skin and subcutaneous tissue disorders
MedDRA (24.1)
Systematic Assessment
EG0001 affected36 at risk
EG0011 affected43 at risk
EG0020 affected1 at risk
EG003
Skin plaque
Skin and subcutaneous tissue disorders
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Skin striae
Skin and subcutaneous tissue disorders
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Xeroderma
Skin and subcutaneous tissue disorders
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Flushing
Vascular disorders
MedDRA (24.1)
Systematic Assessment
EG0001 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Hot flush
Vascular disorders
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0011 affected43 at risk
EG0020 affected1 at risk
EG003
Hypertension
Vascular disorders
MedDRA (24.1)
Systematic Assessment
EG0001 affected36 at risk
EG0016 affected43 at risk
EG0020 affected1 at risk
EG003
Hypotension
Vascular disorders
MedDRA (24.1)
Systematic Assessment
EG0005 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Lymphoedema
Vascular disorders
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Varicose vein
Vascular disorders
MedDRA (24.1)
Systematic Assessment
EG0000 affected36 at risk
EG0010 affected43 at risk
EG0020 affected1 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
OG0000(NA to NA)95% Confidence Interval not determined as there are an insufficient number of participants with events.
Investigator assessment @ 92 months
Title
Measurements
OG0000(NA to NA)95% Confidence Interval not determined as there are an insufficient number of participants with events.
OG0003
Title
Denominators
Categories
Investigator assessment @ up to 78 months
Title
Measurements
OG00067(9.4 to 99.2)
Investigator assessment @ up to 92 months
Title
Measurements
OG00067(9.4 to 99.2)
13
Title
Denominators
Categories
Investigator assessment/Response rate @ up to 78 months
Title
Measurements
OG00069(38.6 to 90.9)
Investigator assessment/Response rate @ up to 92 months
Title
Measurements
OG00069(38.6 to 90.9)
Independent radiology review/Response rate @ up to 78 months
Title
Measurements
OG00069(38.6 to 90.9)
Independent radiology review/Response rate @ up to 92 months
Title
Measurements
OG00062(31.6 to 86.1)
45
Title
Denominators
Categories
Investigator assessment @ up to 78 months
Title
Measurements
OG00033(20.0 to 49.0)
Investigator assessment @ up to 92 months
Title
Measurements
OG00033(20.0 to 49.0)
Independent radiology review @ up to 78 months
Title
Measurements
OG00031(18.2 to 46.6)
Independent radiology review @ up to 92 months
Title
Measurements
OG00031(18.2 to 46.6)
55
Title
Denominators
Categories
Investigator assessment @ up to 78 months
Title
Measurements
OG00089(77.8 to 95.9)
Investigator assessment @ up to 92 months
Title
Measurements
OG00089(77.8 to 95.9)
10
Title
Denominators
Categories
Investigator assessment @ up to 78 months
Title
Measurements
OG00050(18.7 to 81.3)
Investigator assessment @ up to 92 months
Title
Measurements
OG00050(18.7 to 81.3)
OG00020
Title
Denominators
Categories
Investigator assessment
Title
Measurements
OG00062.4(32.1 to NA)Not estimable due to insufficient events observed.
Independent radiology review
Title
Measurements
OG00059.1(16.6 to 171.4)
OG00023
Title
Denominators
Categories
Investigator assessment
Title
Measurements
OG00038.9(24.3 to 59.4)
Independent radiology review
Title
Measurements
OG00045.4(20.1 to 64.9)
OG0002
Title
Denominators
Categories
Investigator assessment
Title
Measurements
OG00033.4(NA to NA)Not estimable due to insufficient events observed.
Independent radiology review
Title
Measurements
OG00032.8(32.1 to NA)Not estimable due to insufficient events observed.
OG0009
Title
Denominators
Categories
Investigator assessment
Title
Measurements
OG000NA(24.1 to NA)Not estimable due to insufficient events observed
Independent radiology review
Title
Measurements
OG00084.3(16.4 to NA)Not estimable due to insufficient events observed
OG00015
Title
Denominators
Categories
Investigator assessment
Title
Measurements
OG000135.7(32.0 to 192.0)
Independent radiology review
Title
Measurements
OG00059.3(20.1 to 116.0)
OG00049
Title
Denominators
Categories
Title
Measurements
OG000NA(NA to NA)Not estimable due to insufficient events observed
OG000
5
Title
Denominators
Categories
Title
Measurements
OG00048.1(24.3 to NA)Not estimable due to insufficient events observed
OG00036
Title
Denominators
Categories
Investigator assessment
Title
Measurements
OG00029.1(20.3 to 59.9)
Independent radiology review
Title
Measurements
OG00024.1(16.1 to 56.0)
OG00043
Title
Denominators
Categories
Investigator assessment
Title
Measurements
OG00039.0(24.1 to 41.0)
Independent radiology review
Title
Measurements
OG00032.6(23.6 to 56.0)
OG0003
Title
Denominators
Categories
Investigator assessment
Title
Measurements
OG00041.3(NA to NA)Not estimable due to insufficient events observed
Independent radiology review
Title
Measurements
OG00040.1(4.1 to NA)Not estimable due to insufficient events observed
13
Title
Denominators
Categories
Investigator assessment
Title
Measurements
OG000NA(32.1 to NA)Not estimable due to insufficient events observed
Independent radiology review
Title
Measurements
OG00040.1(20.3 to 143.7)
45
Title
Denominators
Categories
Investigator assessment
Title
Measurements
OG00024.0(8.0 to 59.4)
Independent radiology review
Title
Measurements
OG00019.7(8.0 to 32.1)
55
Title
Denominators
Categories
Title
Measurements
OG000NA(NA to NA)Not estimable due to insufficient events observed
10
Title
Denominators
Categories
Title
Measurements
OG00027.5(10.0 to 55.9)
36
Title
Denominators
Categories
Title
Measurements
OG00062.9(29.6 to 100.9)
43
Title
Denominators
Categories
Title
Measurements
OG00058.9(45.4 to 76.6)
3
Title
Denominators
Categories
Title
Measurements
OG00094.6(14.9 to NA)Not estimable due to insufficient events observed
13
Title
Denominators
Categories
Title
Measurements
OG000NA(50.4 to NA)Not estimable due to insufficient events observed
45
Title
Denominators
Categories
Title
Measurements
OG00076.4(41.1 to 139.9)
55
Title
Denominators
Categories
Title
Measurements
OG000NA(NA to NA)Not estimable due to insufficient events observed
10
Title
Denominators
Categories
Title
Measurements
OG000147.3(12.4 to 194.0)
OG003
Low Grade (WHO G1/G2) Glioma (LGG)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
OG004
High Grade (WHO G3/G4) Glioma (HGG)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
OG005
Adenocarcinoma of the Small Intestine (ASI)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
OG006
Hairy Cell Leukemia (HCL)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
OG007
Multiple Myeloma (MM)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
Units
Counts
Participants
OG00036
OG00143
OG0021
OG00313
OG00445
OG0053
OG00655
OG00710
Title
Denominators
Categories
Any AE
Title
Measurements
OG00036
OG00143
OG0021
OG00312
OG00442
OG0053
OG00655
OG0079
AEs related to study treatment
Title
Measurements
OG00027
OG00142
OG0021
OG003
AEs leading to permanent discontinuation of any study treatment
Title
Measurements
OG0006
OG0011
OG0020
OG003
AEs leading to dose reduction
Title
Measurements
OG00017
OG00115
OG0021
OG003
AEs leading to dose interruption/delay
Title
Measurements
OG00019
OG00124
OG0021
OG003
Any SAE
Title
Measurements
OG00020
OG00117
OG0021
OG003
SAEs related to study treatment
Title
Measurements
OG0007
OG0019
OG0020
OG003
Fatal SAEs
Title
Measurements
OG0003
OG0012
OG0020
OG003
OG003
Low Grade (WHO G1/G2) Glioma (LGG)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
OG004
High Grade (WHO G3/G4) Glioma (HGG)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
OG005
Adenocarcinoma of the Small Intestine (ASI)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
OG006
Hairy Cell Leukemia (HCL)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
OG007
Multiple Myeloma (MM)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.