A Phase Ib/II Study of BYL719 and Cetuximab in Recurrent... | NCT01602315 | Trialant
NCT01602315
Sponsor
Novartis Pharmaceuticals
Status
Terminated
Last Update Posted
Dec 29, 2020Actual
Enrollment
179Actual
Phase
Phase 1Phase 2
Conditions
Recurrent Head and Neck Squamous Cell Carcinoma
Metastatic Head and Neck Squamous Cell Carcinoma
Interventions
BYL719 as film-coated (FC) whole tablets
BYL719 as dispersible tablets (DT)
cetuximab
BYL719 drink suspension
Countries
United States
Australia
Canada
France
Hong Kong
Netherlands
Singapore
South Korea
Taiwan
Protocol Section
Identification Module
NCT ID
NCT01602315
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
CBYL719X2104
Secondary IDs
ID
Type
Description
Link
2011-006017-34
EudraCT Number
Brief Title
A Phase Ib/II Study of BYL719 and Cetuximab in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
Official Title
A Phase Ib Dose Escalation/Randomized Phase II, Multicenter, Open-label Study of BYL719 in Combination With Cetuximab in Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
Acronym
Not provided
Organization
NovartisINDUSTRY
Status Module
Record Verification Date
Apr 2018
Overall Recruitment Status or Expanded Access Status
Terminated
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
early termination due to Sponsor decision (slow recruitment)
Expanded Access Info
No
Start Date
Nov 12, 2012Actual
Primary Completion Date
Sep 16, 2016Actual
Completion Date
Sep 16, 2016Actual
First Submitted Date
May 16, 2012
First Submission Date that Met QC Criteria
May 17, 2012
First Posted Date
May 18, 2012Estimated
Results Waived
Not provided
Results First Submitted Date
May 8, 2017
Results First Submitted that Met QC Criteria
Apr 19, 2018
Results First Posted Date
May 21, 2018Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Dec 6, 2020
Last Update Posted Date
Dec 29, 2020Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Novartis PharmaceuticalsINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
This was a multi-center, open-label, Phase Ib dose escalation /Phase II study in recurrent or metastatic head and neck squamous cell carcinoma (RM HNSCC) patients considered to be resistant, ineligible or intolerant to platinum-based chemotherapy. The Phase Ib included three arms. Three different methods of administration and two different BYL719 formulations were studied to determine the MTD and/or RP2D of BYL719 in combination with cetuximab:
Arm A - film-coated whole tablets were orally administered to patients who were able to swallow the tablets; Arm B - a drinkable suspension prepared from crushed film-coated tablets was administered orally to patients with swallowing dysfunction Arm C - a suspension from a dispersible tablet administered via G-tube, in patients with swallowing dysfunction. Arm C was used to investigate the pharmacokinetics (PK), compared to Arm A (film coated tablet), and safety of the dispersible tablet of the dispersible tablet formulation of BYL719.
The Phase II investigated the clinical efficacy of BYL719 and consisted of an open label, randomized Phase II part investigating BYL719 in combination with cetuximab compared to cetuximab alone in patients resistant or intolerant to platinum and naïve to cetuximab (Scheme 1: Arm 1 and Arm 2), and a non-randomized Phase II part Scheme 2: Arm 3. In addition, patients who experienced disease progression in Arm 2 (cetuximab) were allowed to switch to the combination regimen (cross-over, Arm 2B). The safety of the BYL719 in combination with cetuximab was also further characterized in Arms 1, 2B and 3.
Patients were treated until progression of disease), unacceptable toxicity, or withdrawal of informed consent, whichever occurred first (except for phase II Arm 2 had the opportunity to crossover to the combination treatment (Arm 2B). In the follow-up period all patients had to complete the safety follow-up assessments within 30 days after the last dose of the study treatment. Patients who did not have disease progression at the time of discontinuation of study treatment were radiologically followed for disease status until disease progression, initiation of subsequent anticancer therapies, or death, whichever occurred first. In addition, all patients enrolled in Phase II were followed for survival.
Detailed Description
Not provided
Conditions Module
Conditions
Recurrent Head and Neck Squamous Cell Carcinoma
Metastatic Head and Neck Squamous Cell Carcinoma
Keywords
BYL719
PI3K inhibitor
PIK3CA
cetuximab
EGFR
HNSCC
RM HNSCC
platinum-based chemotherapy
(RM HNSCC) patients
resistant or ineligible/intolerant to platinum-based chemotherapy
swallowing dysfunction
G-tube
alpelisib
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
179Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Phase Ib: A-BYL719 FC whole tab+cetux
Experimental
Oral film-coated tablets without swallowing dysfunction.
Drug: BYL719 as film-coated (FC) whole tablets
Biological: cetuximab
Phase II: 2-Cetuximab
Experimental
Cetuximab in patients naive to cetuximab (phase ll)
Biological: cetuximab
Phase Ib: B-BYL719 FC drink sus+cetux
Experimental
Crushed film-coated (FC) tablets as an oral suspension with swallowing dysfunction.
Biological: cetuximab
Drug: BYL719 drink suspension
Phase II: 3-BYL719 + Cetuximab
Experimental
BYL719 + cetuximab in patients resistant to cetuximab. BYL719 can be administered as FC whole/crushed only or DT via G-tube in addition, depending on the Phase Ib results
Drug: BYL719 as film-coated (FC) whole tablets
Biological: cetuximab
Drug: BYL719 drink suspension
Phase II: 1-BYL719 + Cetuximab
Experimental
BYL719 + Cetuximab in Patients naive to cetuximab. BYL719 can be administered as FC whole/crushed only or DT via G-tube in addition, depending on the Phase Ib results
Interventions
Name
Type
Description
Arm Group Labels
Other Names
BYL719 as film-coated (FC) whole tablets
Drug
Oral alpha-specific PI3K inhibitor
Phase II: 1-BYL719 + Cetuximab
Phase II: 3-BYL719 + Cetuximab
Phase II: Cross over
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Phase Ib Arms A: Probability That Dose Limiting Toxicities (DLTs) Rate is in the Recommended Phase 2 Dose in Cycle 1 (Cycle 1=28 Days)
Maximum Tolerated Doses (MTDs) and/or recommended Phase II doses (RP2Ds) of BYL719 in combination with cetuximab in patients with recurrent or metastatic head and neck squamous cell carcinoma (RM HNSCC) in arm A (BYL719 administered as a whole tablet in patients able to swallow the tablets). Dose recommendation was based on posterior summaries including the mean, median, standard deviation, 95%-credibility interval, and the probability that the true DLT rate for each dose combination lies in one of the following categories: (0%, 16%) under-dosing; (16%, 35%) targeted toxicity; (35%, 100%) excessive toxicity. The combination treatment was considered superior to cetuximab alone if the posterior probability (HR > 1) < 10%, and the posterior median HR < 0.7.
until disease progression or intolerable toxicity (approximately 6 months)
Phase Ib Arm B: Probability That Distribution of Dose Limiting Toxicities (DLTs) is in the Recommended Phase 2 Dose in Cycle 1 (Cycle 1=28 Days)
Maximum Tolerated Doses (MTDs) and/or recommended Phase II doses (RP2Ds) of BYL719 in combination with cetuximab in patients with recurrent or metastatic head and neck squamous cell carcinoma (RM HNSCC) in arm B (crushed film-coated tablets as an oral suspension with swallowing dysfunction). Dose recommendation was based on posterior summaries including the mean, median, standard deviation, 95%-credibility interval, and the probability that the true DLT rate for each dose combination lies in one of the following categories: (0%, 16%) under-dosing; (16%, 35%) targeted toxicity; (35%, 100%) excessive toxicity. The combination treatment was considered superior to cetuximab alone if the posterior probability (HR > 1) < 10%, and the posterior median HR < 0.7.
until disease progression or intolerable toxicity (approximately 6 months)
For Phase Ib: Incidence of Dose Limiting Toxicities (DLTs) in Cycle 1 (28 Days)
Estimation of Maximum Tolerated Doses (MTDs) and/or recommended Phase II doses (RP2Ds) of BYL719 in combination with cetuximab in patients with recurrent or metastatic head and neck squamous cell carcinoma (RM HNSCC) in arm A (BYL719 administered as a whole tablet in patients able to swallow the tablets) and arm B (BYL719 administered as a drinkable suspension in patients with swallowing dysfunction).
6 months is an approximate timeframe.
Secondary Outcomes
Measure
Description
Time Frame
Phase II: Progression Free Survival (PFS) as Per RECIST v 1.1
Phase II, Scheme 1 (Arm 2B): To further assess the anti-tumor activity of BYL719 + cetuximab in the setting of resistance to single agent cetuximab
approximately 6 months
Phase Ib: Progression Free Survival (PFS) as Per RECIST v1.1
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Age ≥ 18 years
Patients with histologically/cytologically-confirmed HNSCC
Patients must be resistant to platinum-based chemotherapy, or be ineligible (due to medical comorbidities) or intolerant to platinum-based therapy per medical history
For Phase Ib, there is no restriction on the number of prior therapies for recurrent or metastatic disease
For Phase II, patients may have received a maximum of 1 prior line of therapy for recurrent or metastatic disease
For Phase Ib, prior cetuximab or other EGFR-targeted antibody therapy is allowed regardless of the prior treatment settings.
For Phase II, Arms 1 and 2, prior cetuximab or other EGFR-targeted antibody therapy is allowed only if administered in the induction setting, or concurrently with radiation in the curative setting, with the last dose of cetuximab administered at least 12 months prior to starting the study treatment. For Arm 3, prior cetuximab must have been administered in the curative, recurrent or metastatic disease setting and disease progression documented within 9 months of the last dose of cetuximab administered in that setting. This regimen (including both platinum and cetuximab) must be the most recent anti-neoplastic treatment regimen administered.
Patients with swallowing dysfunction who are unable to swallow BYL719 whole tablets and are not using feeding tubes for study drug administration can participate in the Phase Ib Arm B. For the Phase II, these patients with swallowing dysfunction may participate if able to drink the suspension and results of Arm B confirm the use of this method. Patients with swallowing dysfunction requiring G tube (G/PEG tube) for study drug administration may participate in Phase II if Arm C confirms dispersible tablet via G tube administration is permitted if the administration of drinkable suspension of BYL719 is allowed to be used in Phase II.
Availability of a representative tumor specimen. Patients enrolled in Arm 3 of Phase II must have disease sites amenable to biopsy unless prior agreement between Novartis and the Investigator.
At least one measurable or non-measurable lesion as per RECIST 1.1 criteria for patients in Phase Ib; Measurable disease as determined by RECIST v1.1 for Phase II patients
World Health Organization (WHO) Performance Status (PS) ≤ 2
Adequate organ function
Negative serum pregnancy test.
Exclusion Criteria:
Prior treatment with PI3K-inhibitors
Patients with a prior serious infusion reaction to cetuximab
Patients with uncontrolled CNS tumor metastatic involvement
Clinically significant cardiac disease or impaired cardiac function
Patients with diabetes mellitus
Impaired GI function or GI disease
History of another malignancy within 2 years prior to starting study treatment
Razak ARA, Wang HM, Chang JY, Ahn MJ, Munster P, Blumenschein G Jr, Solomon B, Lim DW, Hong RL, Pfister D, Saba NF, Lee SH, van Herpen C, Quadt C, Bootle D, Blumenstein L, Demanse D, Delord JP. A Phase 1b/2 Study of Alpelisib in Combination with Cetuximab in Patients with Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma. Target Oncol. 2023 Nov;18(6):853-868. doi: 10.1007/s11523-023-00997-z. Epub 2023 Oct 25.
See Also Links
Label
URL
Results for CBYL719X2104 can be found on the Novartis Clinical Trial Results Website
One patient was prematurely randomized at the site but was never treated.
Recruitment Details
45 patients enrolled in Phase Ib, 106 cetuximab naïve patients in Phase II were randomized to either BYL719+cet (N=71) or cet monotherapy (N=35). Of the 35 patients, 16 crossed over to BYL719+cet combo treatment. 29 patients enrolled in the non-randomized combo treatment arm (cet resistant patients). All patients have completed the trial.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Arm A - 300mg BYL719+Cetuximab
300 mg BYL719 as film-coated (FC) whole tablets with cetuximab.
FG001
Arm A - 400mg BYL719+Cetuximab
400 mg BYL719 as FC whole tablets with cetuximab
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Argentina
Brazil
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
Drug: BYL719 as film-coated (FC) whole tablets
Biological: cetuximab
Drug: BYL719 drink suspension
Phase Ib: C-BYL719 DT+cetux
Experimental
Dispersible tablet with swallowing dysfunction administered via a gastrostomy tube (G-tube)
Drug: BYL719 as dispersible tablets (DT)
Biological: cetuximab
Phase II: Cross over
Experimental
patients received BYL719 at RP2D in combination with cetuximab.
Drug: BYL719 as film-coated (FC) whole tablets
Biological: cetuximab
Phase Ib: A-BYL719 FC whole tab+cetux
NVP-BYL719
alpelisib
BYL719 as dispersible tablets (DT)
Drug
New formulation of the oral alpha-specific PI3K inhibitor
Phase Ib: C-BYL719 DT+cetux
NVP-BYL719
cetuximab
Biological
Recombinant chimeric monoclonal antibody driven against EGFR
Phase II: 1-BYL719 + Cetuximab
Phase II: 2-Cetuximab
Phase II: 3-BYL719 + Cetuximab
Phase II: Cross over
Phase Ib: A-BYL719 FC whole tab+cetux
Phase Ib: B-BYL719 FC drink sus+cetux
Phase Ib: C-BYL719 DT+cetux
erbitux
BYL719 drink suspension
Drug
Oral alpha-specific PI3K inhibitor
Phase II: 1-BYL719 + Cetuximab
Phase II: 3-BYL719 + Cetuximab
Phase Ib: B-BYL719 FC drink sus+cetux
NVP-BYL719
until disease progression or intolerable toxicity (approximately 6 months)
Phase II Arms 1 and 2: Progression Free Survival (PFS) as Per RECIST v1.1 by Central Radiology Review
Assessment of the anti-tumor activity of BYL719 in combination with cetuximab vs. cetuximab as single-agent in RM HNSCC patients naive to cetuximab.
6 months is an approximate timeframe.
approximately 6 months
Phase II Arm 3: Progression Free Survival (PFS) as Per RECIST V1.1
Assessment of the anti-tumor activity of BYL719 in combination with cetuximab in patients resistant to platinum-based therapy and cetuximab.
approximately 6 months
Phase Ib: Area Under Curve (AUC) 0-24 for BYL719 by Treatment
Comparison of single-dose exposure of BYL719 dispersible tablet via G-tube in combination with cetuximab in RM HNSCC to that of Arm A (film-coated tables)
6 months
Assessment of the preliminary anti-tumor activity of BYL719 in combination with cetuximab in arm A, B and C.
approximately 6 months
Phase II: Randomized Best Overall Response as Per RECIST v1.1
Scheme 1 (Arms 1 and 2): Further assessment of the anti-tumor activity of BYL719 in combination with cetuximab vs. cetuximab as single-agent in RM HNSCC patients naive to cetuximab
approximately 6 months
Phase II: Non-Randomized Best Overall Response as Per RECIST v1.1
Scheme 1 (Arm 3): Further assessment of the anti-tumor activity of BYL719 in combination with cetuximab vs. cetuximab as single-agent in RM HNSCC patients naive to cetuximab
approximately 6 months
Phase II: Randomized Overall Response Rate (ORR) and Disease Control Rate (DCR) as Per RECIST v1.1
Assessment of the preliminary anti-tumor activity of BYL719 in combination with cetuximab in arms 1 and 2.
approximately 6 months
Phase II: Non-Randomized Overall Response Rate (ORR) and Disease Control Rate (DCR) as Per RECIST v1.1
Scheme 1 (arm 3): Assessment of the preliminary anti-tumor activity of BYL719 in combination with cetuximab in arm 3 (non-randomized arm)
approximately 6 months
Phase II: Randomized Overall Survival (OS) by Treatment
Scheme 1 (Arms 1 and 2): Further assessment of the anti-tumor activity of BYL719 in combination with cetuximab vs. cetuximab as single-agent in RM HNSCC patients naive to cetuximab
approximately 1 year
Phase II: Non-Randomized Overall Survival (OS) by Treatment
Scheme 1 (Arm 3): Further assessment of the anti-tumor activity of BYL719 in combination with cetuximab vs. cetuximab as single-agent in RM HNSCC patients naive to cetuximab
approximately 1 year
For Phase Ib: Overall Response Rate (ORR) and Disease Control Rate (DCR) as Per RECIST v1.1
Assessment of the preliminary anti-tumor activity of BYL719 in combination with cetuximab in arm A, B and C
CR=complete response PR=partial response
approximately 6 months
Phase II, Scheme 1 (Arm 2B): Overall Response Rate (ORR) and Disease Control Rate (DCR) as Per RECIST v1.1
Phase II: Scheme 1 (Arm 2B): To further assess the anti-tumor activity of BYL719 + cetuximab in the setting of resistance to single agent cetuximab.
Phase II, Scheme 2 (Arm 2B): Overall Survival (OS) for the Cross-over
Phase II, Scheme 1 (Arm 2B): To further assess the anti-tumor activity of BYL719 + cetuximab in the setting of resistance to single agent cetuximab.
approximately 1 year
Phase Ib: Primary Plasma Pharmacokinetic Parameters for BYL719 by Treatment
Non compartmental PK parameters derived after single dose at Cycle 1 Day 1
1 to 24 hours post dose (Day 1 Cycle 1)
Phase Ib: Cmax for BYL719 by Treatment
Non compartmental Cmax derived after single dose at Cycle 1 Day 1
Day 1 Cycle 1
Phase Ib: Tmax for BYL719 by Treatment
Non compartmental Cmax derived after single dose at Cycle 1 Day 1
Day 1 Cycle 1
Phase Ib: Plasma Pharmacokinetic Parameters for BYL719 After Continuous Dose Administration (Steady State)
Non compartmental PK parameters derived after single dose at Cycle 1 Day 1
Day 1 Cycle 1
Phase Ib: Cmax for BYL719 After Continuous Dose Administration (Steady State)
Non compartmental PK parameters derived after single dose at Cycle 1 Day 1
Day 1 Cycle 1
Phase Ib: Tmax for BYL719 After Continuous Dose Administration (Steady State)
Non compartmental PK parameters derived after single dose at Cycle 1 Day 1
Day 1 Cycle 1
Phase Ib: Notable Abnormal Vital Signs by Treatment
Characterization of the safety and tolerability of BYL719 in combination with cetuximab in arm A, B and C.
approximately 6 months
Phase Ib: Number of Patients With Notable Electrocardiogram (ECG) Abnormalities
Characterization of the safety and tolerability of BYL719 in combination with cetuximab in arm A, B and C.
baseline, post baseline
For Phase II: Notable Abnormal Vital Signs by Treatment
Characterization of the safety and tolerability of BYL719 in combination with cetuximab in arm 1, 2 and 2B.
approximately 6 months
For Phase II: Number of Patients With Notable Electrocardiogram (ECG) Abnormalities
Characterization of the safety and tolerability of BYL719 in combination with cetuximab in arm 1, 2 and 2B.
baseline, post baseline during the entire study period (approximately 1 year)
Phase II: Progression Free Survival (PFS) Based on Investigator's Assessment With Treatment
Assessment of the anti-tumor activity of BYL719 in combination with cetuximab vs. cetuximab as single-agent in RM HNSCC patients naive to cetuximab
approximately 6 months
San Francisco
California
94101
United States
Novartis Investigative Site
Aurora
Colorado
80045
United States
Novartis Investigative Site
Jacksonville
Florida
32224
United States
Novartis Investigative Site
Orlando
Florida
32806
United States
Novartis Investigative Site
Atlanta
Georgia
30322
United States
Novartis Investigative Site
Boston
Massachusetts
02114
United States
Novartis Investigative Site
St Louis
Missouri
63110
United States
Novartis Investigative Site
New York
New York
10017
United States
Novartis Investigative Site
New York
New York
10029
United States
Novartis Investigative Site
Philadelphia
Pennsylvania
19104
United States
Novartis Investigative Site
Charleston
South Carolina
29425
United States
Novartis Investigative Site
Nashville
Tennessee
37232
United States
Novartis Investigative Site
Houston
Texas
77030
United States
Novartis Investigative Site
Melbourne
Victoria
3000
Australia
Novartis Investigative Site
Murdoch
Western Australia
6150
Australia
Novartis Investigative Site
Toronto
Ontario
M5G 2M9
Canada
Novartis Investigative Site
Lyon
69373
France
Novartis Investigative Site
Toulouse
31059
France
Novartis Investigative Site
Shatin, New Territories
Hong Kong
Hong Kong
Novartis Investigative Site
Maastricht
5800
Netherlands
Novartis Investigative Site
Nijmegen
6500 HB
Netherlands
Novartis Investigative Site
Singapore
169610
Singapore
Novartis Investigative Site
Seoul
Korea
03080
South Korea
Novartis Investigative Site
Seoul
Korea
06351
South Korea
Novartis Investigative Site
Seoul
03722
South Korea
Novartis Investigative Site
Tainan
Taiwan ROC
70421
Taiwan
Novartis Investigative Site
Kuei-Shan Chiang
Taoyuan/ Taiwan ROC
33305
Taiwan
Novartis Investigative Site
Taipei
10048
Taiwan
FG002
Arm B - BYL719 + Cetuximab, Oral Suspension
300mg BYL719 as crushed FC tablets with cetuxumab in patients with swallowing dysfunction
FG003
Arm C - BYL719+Cetuximab, Dispersible Tablets
300mg BYL719 dispersible tablets with cetuxumab in patients with swallowing dysfunction administered via G-tube
FG004
Arm 1 - BYL719+Cetuximab (Randomized)
300mg BYL719 with cetuxumab (Phase II) in patients resistant to or intolerant/ineligible for platinum-based chemotherapy.
FG005
Arm 2 - Monotherapy Cetuximab (Randomized)
Cetuximab in Phase II in patients resistant to or intolerant/ineligible for platinum-based chemotherapy.
FG006
Arm 3 - BYL719+Cetuximab (Non-randomized)
300mg BYL719 with cetuximab in Phase II in patients resistant to platinum-based therapy and cetuximab
FG00016 subjects
FG0015 subjects
FG00218 subjects
FG0036 subjects
FG00471 subjects
FG00535 subjects
FG00629 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
NOT COMPLETED
FG00016 subjects
FG0015 subjects
FG00218 subjects
FG0036 subjects
FG00471 subjects
FG00535 subjects
FG00629 subjects
Type
Comment
Reasons
Protocol Violation
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0051 subjects
FG0060 subjects
Physician Decision
FG0002 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Disease progression
FG0006 subjects
FG0013 subjects
FG00210 subjects
FG0031 subjects
FG004
Death
FG0001 subjects
FG0011 subjects
FG0021 subjects
FG0031 subjects
FG004
Withdrawal by Subject
FG0002 subjects
FG0010 subjects
FG0022 subjects
FG0030 subjects
FG004
Adverse Event
FG0005 subjects
FG0011 subjects
FG0025 subjects
FG0034 subjects
FG004
Subject/guardian decision
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Cross-over patients to combo treatment
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Full Analysis Set (FAS) consisted of all patients who received at least one dose of either BYL719 or Cetuximab in Phase Ib and Phase II Arm 3, and all randomized patients in Phase II Scheme 1, Arm 1 and Arm 2.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Arm A - 300mg BYL719+Cetuximab
300 mg BYL719 as film-coated (FC) whole tablets with cetuximab.
BG001
Arm A - 400mg BYL719+Cetuximab
400 mg BYL719 as FC whole tablets with cetuximab
BG002
Arm B - BYL719 + Cetuximab, Oral Suspension
300mg BYL719 as crushed FC tablets with cetuxumab in patients with swallowing dysfunction
BG003
Arm C - BYL719+Cetuximab, Dispersible Tablets
300mg BYL719 dispersible tablets with cetuxumab in patients with swallowing dysfunction administered via G-tube
BG004
Arm 1 - BYL719+Cetuximab (Randomized)
300mg BYL719 with cetuxumab (Phase II) in patients resistant to or intolerant/ineligible for platinum-based chemotherapy.
BG005
Arm 2 - Monotherapy Cetuximab (Randomized)
Cetuximab in Phase II in patients resistant to or intolerant/ineligible for platinum-based chemotherapy.
BG006
Arm 3 - BYL719+Cetuximab (Non-randomized)
300mg BYL719 with cetuximab in Phase II in patients resistant to platinum-based therapy and cetuximab
BG007
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00016
BG0015
BG00218
BG0036
BG00471
BG00535
BG00629
BG007180
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
BG00052.8± 13.40
BG00162.6± 7.99
BG00256.7± 10.20
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0007
BG0011
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Phase Ib Arms A: Probability That Dose Limiting Toxicities (DLTs) Rate is in the Recommended Phase 2 Dose in Cycle 1 (Cycle 1=28 Days)
Maximum Tolerated Doses (MTDs) and/or recommended Phase II doses (RP2Ds) of BYL719 in combination with cetuximab in patients with recurrent or metastatic head and neck squamous cell carcinoma (RM HNSCC) in arm A (BYL719 administered as a whole tablet in patients able to swallow the tablets). Dose recommendation was based on posterior summaries including the mean, median, standard deviation, 95%-credibility interval, and the probability that the true DLT rate for each dose combination lies in one of the following categories: (0%, 16%) under-dosing; (16%, 35%) targeted toxicity; (35%, 100%) excessive toxicity. The combination treatment was considered superior to cetuximab alone if the posterior probability (HR > 1) < 10%, and the posterior median HR < 0.7.
Dose Determining Analysis Set (DDS) consisted of all patients from the SAS who met the requirements for minimum safety evaluation and minimum exposure or experienced DLT during Cycle 1. This analysis set was defined only for the Phase Ib patients.
Posted
Number
Probability of DLT rate
until disease progression or intolerable toxicity (approximately 6 months)
ID
Title
Description
OG000
Arm A - 300mg BYL719+Cetuximab
OG001
Arm A - 400mg BYL719+Cetuximab
Units
Counts
Participants
OG00011
OG0013
Title
Denominators
Categories
Posterior probabilities that Pr(DLT) in 0-0.16
Title
Measurements
OG0000.764
OG0010.086
Posterior probabilities that Pr (DLT) in 0.16-0.35
Title
Measurements
OG000
Primary
Phase Ib Arm B: Probability That Distribution of Dose Limiting Toxicities (DLTs) is in the Recommended Phase 2 Dose in Cycle 1 (Cycle 1=28 Days)
Maximum Tolerated Doses (MTDs) and/or recommended Phase II doses (RP2Ds) of BYL719 in combination with cetuximab in patients with recurrent or metastatic head and neck squamous cell carcinoma (RM HNSCC) in arm B (crushed film-coated tablets as an oral suspension with swallowing dysfunction). Dose recommendation was based on posterior summaries including the mean, median, standard deviation, 95%-credibility interval, and the probability that the true DLT rate for each dose combination lies in one of the following categories: (0%, 16%) under-dosing; (16%, 35%) targeted toxicity; (35%, 100%) excessive toxicity. The combination treatment was considered superior to cetuximab alone if the posterior probability (HR > 1) < 10%, and the posterior median HR < 0.7.
Dose Determining Analysis Set (DDS) consisted of all patients from the SAS who met the requirements for minimum safety evaluation and minimum exposure or experienced DLT during Cycle 1. This analysis set was defined only for the Phase Ib patients.
Posted
Number
Probability of DLT rate
until disease progression or intolerable toxicity (approximately 6 months)
ID
Title
Description
OG000
Arm B- 300mg BYL719+Cetuximab
Units
Counts
Participants
Primary
For Phase Ib: Incidence of Dose Limiting Toxicities (DLTs) in Cycle 1 (28 Days)
Estimation of Maximum Tolerated Doses (MTDs) and/or recommended Phase II doses (RP2Ds) of BYL719 in combination with cetuximab in patients with recurrent or metastatic head and neck squamous cell carcinoma (RM HNSCC) in arm A (BYL719 administered as a whole tablet in patients able to swallow the tablets) and arm B (BYL719 administered as a drinkable suspension in patients with swallowing dysfunction).
6 months is an approximate timeframe.
Dose Determining Analysis Set (DDS) consisted of all patients from the SAS who met the requirements for minimum safety evaluation and minimum exposure or experienced DLT during Cycle 1. This analysis set was defined only for the Phase Ib patients.
Posted
Number
Participants
until disease progression or intolerable toxicity (approximately 6 months)
ID
Title
Description
OG000
Arm A - 300mg BYL719+Cetuximab
300 mg BYL719 as film-coated (FC) whole tablets with cetuximab.
OG001
Arm A - 400mg BYL719+Cetuximab
400 mg BYL719 as FC whole tablets with cetuximab
OG002
Arm B - BYL719 + Cetuximab, Oral Suspension
300mg BYL719 as crushed FC tablets with cetuxumab in patients with swallowing dysfunction
Primary
Phase II Arms 1 and 2: Progression Free Survival (PFS) as Per RECIST v1.1 by Central Radiology Review
Assessment of the anti-tumor activity of BYL719 in combination with cetuximab vs. cetuximab as single-agent in RM HNSCC patients naive to cetuximab.
6 months is an approximate timeframe.
Full Analysis Set (FAS) consisted of all patients who received at least one dose of either BYL719 or Cetuximab in Phase Ib and Phase II Arm 3, and all randomized patients in Phase II Scheme 1, Arm 1 and Arm 2.
Posted
Number
participants
approximately 6 months
ID
Title
Description
OG000
BYL719+ Cetuximab (Randomized)
300mg BYL719 with cetuximab (Phase II) in patients resistant to or intolerant/ineligible for platinum-based chemotherapy.
OG001
Monotherapy Cetuximab (Randomized)
Cetuximab in Phase II in patients resistant to or intolerant/ineligible for platinum-based chemotherapy.
Units
Counts
Participants
OG000
Primary
Phase II Arm 3: Progression Free Survival (PFS) as Per RECIST V1.1
Assessment of the anti-tumor activity of BYL719 in combination with cetuximab in patients resistant to platinum-based therapy and cetuximab.
Full Analysis Set (FAS) consisted of all patients who received at least one dose of either BYL719 or Cetuximab in Phase Ib and Phase II Arm 3, and all randomized patients in Phase II Scheme 1, Arm 1 and Arm 2.
Posted
Median
95% Confidence Interval
months
approximately 6 months
ID
Title
Description
OG000
BYL719+ Cetuximab (Non-randomized)
300mg BYL719 with cetuximab in patients resistant to platinum-based therapy and cetuximab in Phase II
Units
Counts
Participants
OG000
Primary
Phase Ib: Area Under Curve (AUC) 0-24 for BYL719 by Treatment
Comparison of single-dose exposure of BYL719 dispersible tablet via G-tube in combination with cetuximab in RM HNSCC to that of Arm A (film-coated tables)
Pharmacokinetic Analysis Set (PAS) consisted of all patients who had at least one blood sample providing evaluable PK data. The PAS was used for summaries of PK data as well as for listings of derived parameters.
Posted
Median
Full Range
hr*ng/mL
6 months
ID
Title
Description
OG000
Arm A - 300mg BYL719+Cetuximab
300 mg BYL719 as film-coated (FC) whole tablets with cetuximab.
OG001
Arm C: BYL719+Cetixumab, Dispersible Tablets
300mg BYL719 dispersible tablets with cetuxumab in patients with swallowing dysfunction administered via G-tube
OG002
Arm A: 400mg BYL719 + Cetuximab
400 mg BYL719 as FC whole tablets with cetuximab
OG003
Arm B: 300mg BYL719 + Cetuximab
300mg BYL719 in oral suspension with cetuximab
Secondary
Phase II: Progression Free Survival (PFS) as Per RECIST v 1.1
Phase II, Scheme 1 (Arm 2B): To further assess the anti-tumor activity of BYL719 + cetuximab in the setting of resistance to single agent cetuximab
Full analysis Set (FAS) consisted of those patients who, after crossing over had received at least one dose of BYL719.
Posted
Number
Participants
approximately 6 months
ID
Title
Description
OG000
Arm 2B - BYL719+Cetuximab
300mg BYL719 with cetuximab in Phase II in patients resistant to platinum-based therapy and cetuximab
Units
Counts
Participants
OG000
Secondary
Phase Ib: Progression Free Survival (PFS) as Per RECIST v1.1
Assessment of the preliminary anti-tumor activity of BYL719 in combination with cetuximab in arm A, B and C.
Full Analysis Set (FAS) consisted of all patients who received at least one dose of either BYL719 or Cetuximab in Phase Ib and Phase II Arm 3, and all randomized patients in Phase II Scheme 1, Arm 1 and Arm 2.
Posted
Number
Participants
approximately 6 months
ID
Title
Description
OG000
Arm A - 300mg BYL719+Cetuximab
300 mg BYL719 as film-coated (FC) whole tablets with cetuximab.
OG001
Arm A - 400mg BYL719+Cetuximab
400 mg BYL719 as FC whole tablets with cetuximab
OG002
Arm B - BYL719 + Cetuximab, Oral Suspension
300mg BYL719 as crushed FC tablets with cetuxumab in patients with swallowing dysfunction
OG003
Arm C - BYL719+Cetuximab, Dispersible Tablets
300mg BYL719 dispersible tablets with cetuxumab in patients with swallowing dysfunction administered via G-tube
Secondary
Phase II: Randomized Best Overall Response as Per RECIST v1.1
Scheme 1 (Arms 1 and 2): Further assessment of the anti-tumor activity of BYL719 in combination with cetuximab vs. cetuximab as single-agent in RM HNSCC patients naive to cetuximab
Full Analysis Set (FAS) consisted of all patients who received at least one dose of either BYL719 or Cetuximab in Phase Ib and Phase II Arm 3, and all randomized patients in Phase II Scheme 1, Arm 1 and Arm 2.
Posted
Number
Participants
approximately 6 months
ID
Title
Description
OG000
Arm 1 - BYL719+Cetuximab (Randomized)
300mg BYL719 with cetuxumab (Phase II) in patients resistant to or intolerant/ineligible for platinum-based chemotherapy.
OG001
Arm 2 - Monotherapy Cetuximab (Randomized)
Cetuximab in Phase II in patients resistant to or intolerant/ineligible for platinum-based chemotherapy.
OG002
All Patients
Units
Counts
Participants
Secondary
Phase II: Non-Randomized Best Overall Response as Per RECIST v1.1
Scheme 1 (Arm 3): Further assessment of the anti-tumor activity of BYL719 in combination with cetuximab vs. cetuximab as single-agent in RM HNSCC patients naive to cetuximab
Full Analysis Set (FAS) consisted of all patients who received at least one dose of either BYL719 or Cetuximab in Phase Ib and Phase II Arm 3, and all randomized patients in Phase II Scheme 1, Arm 1 and Arm 2.
Posted
Number
Participants
approximately 6 months
ID
Title
Description
OG000
Arm 3 - BYL719+Cetuximab
300mg BYL719 with cetuximab in Phase II in patients resistant to platinum-based therapy and cetuximab
Units
Counts
Participants
OG000
Secondary
Phase II: Randomized Overall Response Rate (ORR) and Disease Control Rate (DCR) as Per RECIST v1.1
Assessment of the preliminary anti-tumor activity of BYL719 in combination with cetuximab in arms 1 and 2.
Full Analysis Set (FAS) consisted of all patients who received at least one dose of either BYL719 or Cetuximab in Phase Ib and Phase II Arm 3, and all randomized patients in Phase II Scheme 1, Arm 1 and Arm 2.
Posted
Number
95% Confidence Interval
Percentages
approximately 6 months
ID
Title
Description
OG000
Arm 1 - BYL719+Cetuximab (Randomized)
300mg BYL719 with cetuxumab (Phase II) in patients resistant to or intolerant/ineligible for platinum-based chemotherapy.
OG001
Arm 2 - Monotherapy Cetuximab (Randomized)
Cetuximab in Phase II in patients resistant to or intolerant/ineligible for platinum-based chemotherapy.
OG002
All Patients (Phase II)
Units
Counts
Participants
Secondary
Phase II: Non-Randomized Overall Response Rate (ORR) and Disease Control Rate (DCR) as Per RECIST v1.1
Scheme 1 (arm 3): Assessment of the preliminary anti-tumor activity of BYL719 in combination with cetuximab in arm 3 (non-randomized arm)
Full Analysis Set (FAS) consisted of all patients who received at least one dose of either BYL719 or Cetuximab in Phase Ib and Phase II Arm 3, and all randomized patients in Phase II Scheme 1, Arm 1 and Arm 2.
Posted
Number
95% Confidence Interval
Percentages
approximately 6 months
ID
Title
Description
OG000
Arm 3 - BYL719+Cetuximab
300mg BYL719 with cetuximab in Phase II in patients resistant to platinum-based therapy and cetuximab
Units
Counts
Participants
OG000
Secondary
Phase II: Randomized Overall Survival (OS) by Treatment
Scheme 1 (Arms 1 and 2): Further assessment of the anti-tumor activity of BYL719 in combination with cetuximab vs. cetuximab as single-agent in RM HNSCC patients naive to cetuximab
Full Analysis Set (FAS) consisted of all patients who received at least one dose of either BYL719 or Cetuximab in Phase Ib and Phase II Arm 3, and all randomized patients in Phase II Scheme 1, Arm 1 and Arm 2.
Posted
Number
Patients
approximately 1 year
ID
Title
Description
OG000
Arm 1 - BYL719+Cetuximab (Randomized)
300mg BYL719 with cetuxumab (Phase II) in patients resistant to or intolerant/ineligible for platinum-based chemotherapy.
OG001
Arm 2 - Monotherapy Cetuximab (Randomized)
Cetuximab in Phase II in patients resistant to or intolerant/ineligible for platinum-based chemotherapy.
Units
Counts
Participants
OG000
Secondary
Phase II: Non-Randomized Overall Survival (OS) by Treatment
Scheme 1 (Arm 3): Further assessment of the anti-tumor activity of BYL719 in combination with cetuximab vs. cetuximab as single-agent in RM HNSCC patients naive to cetuximab
Full Analysis Set (FAS) consisted of all patients who received at least one dose of either BYL719 or Cetuximab in Phase Ib and Phase II Arm 3, and all randomized patients in Phase II Scheme 1, Arm 1 and Arm 2.
Posted
Number
Patients
approximately 1 year
ID
Title
Description
OG000
Arm 3 - BYL719+Cetuximab
300mg BYL719 with cetuximab in Phase II in patients resistant to platinum-based therapy and cetuximab
Units
Counts
Participants
OG000
Secondary
For Phase Ib: Overall Response Rate (ORR) and Disease Control Rate (DCR) as Per RECIST v1.1
Assessment of the preliminary anti-tumor activity of BYL719 in combination with cetuximab in arm A, B and C
CR=complete response PR=partial response
Safety Analysis Set (SAS) consisted of all patients from the FAS who received at least one dose of BYL719 or the standard cetuximab therapy and had at least one post -baseline safety assessment.
Posted
Number
95% Confidence Interval
Percentages
approximately 6 months
ID
Title
Description
OG000
Arm A - 300mg BYL719+Cetuximab
300 mg BYL719 as film-coated (FC) whole tablets with cetuximab.
OG001
Arm A - 400mg BYL719+Cetuximab
400 mg BYL719 as FC whole tablets with cetuximab
OG002
Arm B - BYL719 + Cetuximab, Oral Suspension
300mg BYL719 as crushed FC tablets with cetuxumab in patients with swallowing dysfunction
OG003
Arm C - BYL719+Cetuximab, Dispersible Tablets
300mg BYL719 dispersible tablets with cetuxumab in patients with swallowing dysfunction administered via G-tube
Secondary
Phase II, Scheme 1 (Arm 2B): Overall Response Rate (ORR) and Disease Control Rate (DCR) as Per RECIST v1.1
Phase II: Scheme 1 (Arm 2B): To further assess the anti-tumor activity of BYL719 + cetuximab in the setting of resistance to single agent cetuximab.
Safety Analysis Set (SAS) consisted of all patients from the FAS who received at least one dose of BYL719 or the standard cetuximab therapy and had at least one post -baseline safety assessment.
Posted
Number
95% Confidence Interval
Rate
Approximately 6 months
ID
Title
Description
OG000
Arm 2B - BYL719+Cetuximab
300mg BYL719 with cetuximab in Phase II in patients resistant to platinum-based therapy and cetuximab
Units
Counts
Participants
OG000
Secondary
Phase II, Scheme 2 (Arm 2B): Overall Survival (OS) for the Cross-over
Phase II, Scheme 1 (Arm 2B): To further assess the anti-tumor activity of BYL719 + cetuximab in the setting of resistance to single agent cetuximab.
Safety Analysis Set (SAS) consisted of all patients from the FAS who received at least one dose of BYL719 or the standard cetuximab therapy and had at least one post -baseline safety assessment.
Posted
Median
95% Confidence Interval
Days
approximately 1 year
ID
Title
Description
OG000
Arm 2B - BYL719+Cetuximab
300mg BYL719 with cetuximab in Phase II in patients resistant to platinum-based therapy and cetuximab
Units
Counts
Participants
OG000
Secondary
Phase Ib: Primary Plasma Pharmacokinetic Parameters for BYL719 by Treatment
Non compartmental PK parameters derived after single dose at Cycle 1 Day 1
Pharmacokinetic Analysis Set (PAS) consisted of all patients who had at least one blood sample providing evaluable PK data. The PAS was used for summaries of PK data as well as for listings of derived parameters.
Posted
Median
Full Range
hr*ng/mL
1 to 24 hours post dose (Day 1 Cycle 1)
ID
Title
Description
OG000
Arm A - 300mg BYL719+Cetuximab
300 mg BYL719 as film-coated (FC) whole tablets with cetuximab.
OG001
Arm B: BYL719 + Cetuximab, Oral Suspension
300mg BYL719 as crushed FC tablets with cetuxumab in patients with swallowing dysfunction
OG002
Arm C: BYL719+Cetixumab, Dispersible Tablets
300mg BYL719 dispersible tablets with cetuxumab in patients with swallowing dysfunction administered via G-tube
OG003
Arm A: 400mg BYL719 + Cetuximab
400 mg BYL719 as FC whole tablets with cetuximab
Secondary
Phase Ib: Cmax for BYL719 by Treatment
Non compartmental Cmax derived after single dose at Cycle 1 Day 1
Pharmacokinetic Analysis Set (PAS) consisted of all patients who had at least one blood sample providing evaluable PK data. The PAS was used for summaries of PK data as well as for listings of derived parameters.
Posted
Median
Full Range
ng/mL
Day 1 Cycle 1
ID
Title
Description
OG000
Arm A - 300mg BYL719+Cetuximab
300 mg BYL719 as film-coated (FC) whole tablets with cetuximab.
OG001
Arm B: BYL719 + Cetuximab, Oral Suspension
300mg BYL719 as crushed FC tablets with cetuxumab in patients with swallowing dysfunction
OG002
Arm C: BYL719+Cetixumab, Dispersible Tablets
300mg BYL719 dispersible tablets with cetuxumab in patients with swallowing dysfunction administered via G-tube
OG003
Arm A: 400mg BYL719 + Cetuximab
400 mg BYL719 as FC whole tablets with cetuximab
Secondary
Phase Ib: Tmax for BYL719 by Treatment
Non compartmental Cmax derived after single dose at Cycle 1 Day 1
Pharmacokinetic Analysis Set (PAS) consisted of all patients who had at least one blood sample providing evaluable PK data. The PAS was used for summaries of PK data as well as for listings of derived parameters.
Posted
Median
Full Range
hr
Day 1 Cycle 1
ID
Title
Description
OG000
Arm A - 300mg BYL719+Cetuximab
300 mg BYL719 as film-coated (FC) whole tablets with cetuximab.
OG001
Arm B: BYL719 + Cetuximab, Oral Suspension
300mg BYL719 as crushed FC tablets with cetuxumab in patients with swallowing dysfunction
OG002
Arm C: BYL719+Cetixumab, Dispersible Tablets
300mg BYL719 dispersible tablets with cetuxumab in patients with swallowing dysfunction administered via G-tube
OG003
Arm A: 400mg BYL719 + Cetuximab
400 mg BYL719 as FC whole tablets with cetuximab
Secondary
Phase Ib: Plasma Pharmacokinetic Parameters for BYL719 After Continuous Dose Administration (Steady State)
Non compartmental PK parameters derived after single dose at Cycle 1 Day 1
Pharmacokinetic Analysis Set (PAS) consisted of all patients who had at least one blood sample providing evaluable PK data. The PAS was used for summaries of PK data as well as for listings of derived parameters.
Posted
Median
Full Range
hr*ng/mL
Day 1 Cycle 1
ID
Title
Description
OG000
Arm A - 300mg BYL719+Cetuximab
300 mg BYL719 as film-coated (FC) whole tablets with cetuximab.
OG001
Arm B: BYL719 + Cetuximab, Oral Suspension
300mg BYL719 as crushed FC tablets with cetuxumab in patients with swallowing dysfunction
OG002
Arm C: BYL719+Cetixumab, Dispersible Tablets
300mg BYL719 dispersible tablets with cetuxumab in patients with swallowing dysfunction administered via G-tube
Units
Counts
Secondary
Phase Ib: Cmax for BYL719 After Continuous Dose Administration (Steady State)
Non compartmental PK parameters derived after single dose at Cycle 1 Day 1
Pharmacokinetic Analysis Set (PAS) consisted of all patients who had at least one blood sample providing evaluable PK data. The PAS was used for summaries of PK data as well as for listings of derived parameters.
Posted
Median
Full Range
ng/mL
Day 1 Cycle 1
ID
Title
Description
OG000
Arm A - 300mg BYL719+Cetuximab
300 mg BYL719 as film-coated (FC) whole tablets with cetuximab.
OG001
Arm B: BYL719 + Cetuximab, Oral Suspension
300mg BYL719 as crushed FC tablets with cetuxumab in patients with swallowing dysfunction
OG002
Arm C: BYL719+Cetixumab, Dispersible Tablets
300mg BYL719 dispersible tablets with cetuxumab in patients with swallowing dysfunction administered via G-tube
Units
Counts
Secondary
Phase Ib: Tmax for BYL719 After Continuous Dose Administration (Steady State)
Non compartmental PK parameters derived after single dose at Cycle 1 Day 1
Pharmacokinetic Analysis Set (PAS) consisted of all patients who had at least one blood sample providing evaluable PK data. The PAS was used for summaries of PK data as well as for listings of derived parameters.
Posted
Median
Full Range
hr
Day 1 Cycle 1
ID
Title
Description
OG000
Arm A - 300mg BYL719+Cetuximab
300 mg BYL719 as film-coated (FC) whole tablets with cetuximab.
OG001
Arm B: BYL719 + Cetuximab, Oral Suspension
300mg BYL719 as crushed FC tablets with cetuxumab in patients with swallowing dysfunction
OG002
Arm C: BYL719+Cetixumab, Dispersible Tablets
300mg BYL719 dispersible tablets with cetuxumab in patients with swallowing dysfunction administered via G-tube
Units
Counts
Participants
Secondary
Phase Ib: Notable Abnormal Vital Signs by Treatment
Characterization of the safety and tolerability of BYL719 in combination with cetuximab in arm A, B and C.
Safety Analysis Set (SAS) consisted of all patients from the FAS who received at least one dose of BYL719 or the standard cetuximab therapy and had at least one post -baseline safety assessment.
Posted
Number
Participants
approximately 6 months
ID
Title
Description
OG000
Arm A - 300mg BYL719+Cetuximab
300 mg BYL719 as film-coated (FC) whole tablets with cetuximab.
OG001
Arm A - 400mg BYL719+Cetuximab
400 mg BYL719 as FC whole tablets with cetuximab
OG002
Arm B - BYL719 + Cetuximab, Oral Suspension
300mg BYL719 as crushed FC tablets with cetuxumab in patients with swallowing dysfunction
OG003
Arm C - BYL719+Cetuximab, Dispersible Tablets
300mg BYL719 dispersible tablets with cetuxumab in patients with swallowing dysfunction administered via G-tube
Secondary
Phase Ib: Number of Patients With Notable Electrocardiogram (ECG) Abnormalities
Characterization of the safety and tolerability of BYL719 in combination with cetuximab in arm A, B and C.
Safety Analysis Set (SAS) consisted of all patients from the FAS who received at least one dose of BYL719 or the standard cetuximab therapy and had at least one post -baseline safety assessment.
Posted
Number
Participants
baseline, post baseline
ID
Title
Description
OG000
Arm A - 300mg BYL719+Cetuximab
300 mg BYL719 as film-coated (FC) whole tablets with cetuximab.
OG001
Arm A - 400mg BYL719+Cetuximab
400 mg BYL719 as FC whole tablets with cetuximab
OG002
Arm B - BYL719 + Cetuximab, Oral Suspension
300mg BYL719 as crushed FC tablets with cetuxumab in patients with swallowing dysfunction
OG003
Arm C - BYL719+Cetuximab, Dispersible Tablets
300mg BYL719 dispersible tablets with cetuxumab in patients with swallowing dysfunction administered via G-tube
Secondary
For Phase II: Notable Abnormal Vital Signs by Treatment
Characterization of the safety and tolerability of BYL719 in combination with cetuximab in arm 1, 2 and 2B.
Safety Analysis Set (SAS) consisted of all patients from the FAS who received at least one dose of BYL719 or the standard cetuximab therapy and had at least one post -baseline safety assessment.
Posted
Number
Participants
approximately 6 months
ID
Title
Description
OG000
Arm 1 - BYL719+Cetuximab (Randomized)
300mg BYL719 with cetuxumab (Phase II) in patients resistant to or intolerant/ineligible for platinum-based chemotherapy.
OG001
Arm 2 - Monotherapy Cetuximab (Randomized)
Cetuximab in Phase II in patients resistant to or intolerant/ineligible for platinum-based chemotherapy.
OG002
Arm 2B - BYL719+Cetuximab
300mg BYL719 with cetuximab in Phase II in patients resistant to platinum-based therapy and cetuximab
Units
Counts
Secondary
For Phase II: Number of Patients With Notable Electrocardiogram (ECG) Abnormalities
Characterization of the safety and tolerability of BYL719 in combination with cetuximab in arm 1, 2 and 2B.
Safety Analysis Set (SAS) consisted of all patients from the FAS who received at least one dose of BYL719 or the standard cetuximab therapy and had at least one post -baseline safety assessment.
Posted
Number
Participants
baseline, post baseline during the entire study period (approximately 1 year)
ID
Title
Description
OG000
Arm 1 - BYL719+Cetuximab (Randomized)
300mg BYL719 with cetuxumab (Phase II) in patients resistant to or intolerant/ineligible for platinum-based chemotherapy.
OG001
Arm 2 - Monotherapy Cetuximab (Randomized)
Cetuximab in Phase II in patients resistant to or intolerant/ineligible for platinum-based chemotherapy.
OG002
Arm 2B - BYL719+Cetuximab
300mg BYL719 with cetuximab in Phase II in patients resistant to platinum-based therapy and cetuximab
Secondary
Phase II: Progression Free Survival (PFS) Based on Investigator's Assessment With Treatment
Assessment of the anti-tumor activity of BYL719 in combination with cetuximab vs. cetuximab as single-agent in RM HNSCC patients naive to cetuximab
Full Analysis Set (FAS) consisted of all patients who received at least one dose of either BYL719 or Cetuximab in Phase Ib and Phase II Arm 3, and all randomized patients in Phase II Scheme 1, Arm 1 and Arm 2.
Posted
Median
95% Confidence Interval
Days
approximately 6 months
ID
Title
Description
OG000
BYL719+ Cetuximab (Randomized)
300mg BYL719 with cetuximab (Phase II) in patients resistant to or intolerant/ineligible for platinum-based chemotherapy.
OG001
Monotherapy Cetuximab (Randomized)
Cetuximab in Phase II in patients resistant to or intolerant/ineligible for platinum-based chemotherapy.
OG002
BYL719=Cetuximab (Non-randomized)
300mg BYL719with cetuximab in patients resistant to platinum-based therapy and cetuximab in Phase II
Time Frame
Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Treatment until Last Patient Last Visit.
Description
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious AEs field "number of deaths resulting from AEs" all those deaths, resulting from serious AEs that are deemed to be causally related to treatment by the investigator. Safety set excluded 2 patients who were randomized but died before starting study treatment.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Arm A - 300mg BYL719+Cetuximab
300 mg BYL719 as film-coated (FC) whole tablets with cetuximab
9
15
15
15
EG001
Arm A: 400 mg BYL719 + Cetuximab
400 mg BYL719 as FC whole tablets with cetuximab
4
5
5
5
EG002
Arm B - BYL719 + Cetuximab Oral Suspension
300mg BYL719 as crushed FC tablets with cetuximab in patients with swallowing dysfunction
12
18
18
18
EG003
Arm C - BYL719+Cetuximab Dispersible Tablets
300mg BYL719 dispersible tablets with cetuximab in patients with swallowing dysfunction administered via G-tube
4
6
6
6
EG004
Arm 1 - BYL719+Cetuximab (Randomized)
300mg BYL719 with cetuximab (Phase II) in patients resistant to or intolerant/ineligible for platinum-based chemotherapy.
40
69
69
69
EG005
Arm 2 - Monotherapy Cetuximab (Randomized)
Cetuximab in Phase II in patients resistant to or intolerant/ineligible for platinum-based chemotherapy
15
35
35
35
EG006
Arm 3 - BYL719+Cetuximab (Non-randomized)
300mg BYL719 with cetuximab in Phase II in patients resistant to Platinum-based therapy and cetuximab.
15
29
29
29
EG007
All Patients
All patients
99
178
177
178
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected5 at risk
EG0020 affected18 at risk
EG0030 affected6 at risk
EG0041 affected69 at risk
EG0050 affected35 at risk
EG0061 affected29 at risk
EG0072 affected178 at risk
Neutropenia
Blood and lymphatic system disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected5 at risk
EG0020 affected18 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected5 at risk
EG0020 affected18 at risk
EG003
Myocardial infarction
Cardiac disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected5 at risk
EG0020 affected18 at risk
EG003
Myocardial ischaemia
Cardiac disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected15 at risk
EG0011 affected5 at risk
EG0020 affected18 at risk
EG003
Pulseless electrical activity
Cardiac disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected5 at risk
EG0020 affected18 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected5 at risk
EG0020 affected18 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected5 at risk
EG0021 affected18 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected5 at risk
EG0021 affected18 at risk
EG003
Enterocolitis
Gastrointestinal disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected5 at risk
EG0020 affected18 at risk
EG003
Large intestine perforation
Gastrointestinal disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected5 at risk
EG0020 affected18 at risk
EG003
Mouth haemorrhage
Gastrointestinal disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected5 at risk
EG0020 affected18 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected5 at risk
EG0020 affected18 at risk
EG003
Oesophageal fistula
Gastrointestinal disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected5 at risk
EG0021 affected18 at risk
EG003
Oesophageal haemorrhage
Gastrointestinal disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected5 at risk
EG0021 affected18 at risk
EG003
Oesophageal ulcer
Gastrointestinal disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected15 at risk
EG0011 affected5 at risk
EG0020 affected18 at risk
EG003
Oesophagitis
Gastrointestinal disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected5 at risk
EG0020 affected18 at risk
EG003
Upper gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected5 at risk
EG0020 affected18 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected5 at risk
EG0020 affected18 at risk
EG003
Asthenia
General disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected5 at risk
EG0020 affected18 at risk
EG003
Chills
General disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected5 at risk
EG0020 affected18 at risk
EG003
Fatigue
General disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected5 at risk
EG0020 affected18 at risk
EG003
General physical health deterioration
General disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected5 at risk
EG0020 affected18 at risk
EG003
Pain
General disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected5 at risk
EG0020 affected18 at risk
EG003
Pyrexia
General disorders
MedDRA (18.1)
Systematic Assessment
EG0001 affected15 at risk
EG0010 affected5 at risk
EG0021 affected18 at risk
EG003
Anaphylactic reaction
Immune system disorders
MedDRA (18.1)
Systematic Assessment
EG0001 affected15 at risk
EG0010 affected5 at risk
EG0020 affected18 at risk
EG003
Drug hypersensitivity
Immune system disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected5 at risk
EG0020 affected18 at risk
EG003
Abdominal infection
Infections and infestations
MedDRA (18.1)
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected5 at risk
EG0020 affected18 at risk
EG003
Brain abscess
Infections and infestations
MedDRA (18.1)
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected5 at risk
EG0020 affected18 at risk
EG003
Cellulitis
Infections and infestations
MedDRA (18.1)
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected5 at risk
EG0020 affected18 at risk
EG003
Device related infection
Infections and infestations
MedDRA (18.1)
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected5 at risk
EG0020 affected18 at risk
EG003
Diarrhoea infectious
Infections and infestations
MedDRA (18.1)
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected5 at risk
EG0020 affected18 at risk
EG003
Diverticulitis
Infections and infestations
MedDRA (18.1)
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected5 at risk
EG0020 affected18 at risk
EG003
Epiglottitis
Infections and infestations
MedDRA (18.1)
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected5 at risk
EG0020 affected18 at risk
EG003
Lower respiratory tract infection
Infections and infestations
MedDRA (18.1)
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected5 at risk
EG0020 affected18 at risk
EG003
Lung infection
Infections and infestations
MedDRA (18.1)
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected5 at risk
EG0020 affected18 at risk
EG003
Osteomyelitis
Infections and infestations
MedDRA (18.1)
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected5 at risk
EG0020 affected18 at risk
EG003
Pneumonia
Infections and infestations
MedDRA (18.1)
Systematic Assessment
EG0002 affected15 at risk
EG0010 affected5 at risk
EG0024 affected18 at risk
EG003
Post procedural infection
Infections and infestations
MedDRA (18.1)
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected5 at risk
EG0021 affected18 at risk
EG003
Purulent discharge
Infections and infestations
MedDRA (18.1)
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected5 at risk
EG0021 affected18 at risk
EG003
Sepsis
Infections and infestations
MedDRA (18.1)
Systematic Assessment
EG0001 affected15 at risk
EG0010 affected5 at risk
EG0020 affected18 at risk
EG003
Septic shock
Infections and infestations
MedDRA (18.1)
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected5 at risk
EG0021 affected18 at risk
EG003
Superinfection
Infections and infestations
MedDRA (18.1)
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected5 at risk
EG0020 affected18 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA (18.1)
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected5 at risk
EG0020 affected18 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA (18.1)
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected5 at risk
EG0020 affected18 at risk
EG003
Wound infection
Infections and infestations
MedDRA (18.1)
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected5 at risk
EG0021 affected18 at risk
EG003
Feeding tube complication
Injury, poisoning and procedural complications
MedDRA (18.1)
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected5 at risk
EG0020 affected18 at risk
EG003
Pneumocephalus
Injury, poisoning and procedural complications
MedDRA (18.1)
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected5 at risk
EG0020 affected18 at risk
EG003
Spinal fracture
Injury, poisoning and procedural complications
MedDRA (18.1)
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected5 at risk
EG0020 affected18 at risk
EG003
Tracheal obstruction
Injury, poisoning and procedural complications
MedDRA (18.1)
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected5 at risk
EG0021 affected18 at risk
EG003
Wound secretion
Injury, poisoning and procedural complications
MedDRA (18.1)
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected5 at risk
EG0020 affected18 at risk
EG003
Blood creatine phosphokinase increased
Investigations
MedDRA (18.1)
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected5 at risk
EG0020 affected18 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected5 at risk
EG0020 affected18 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected5 at risk
EG0020 affected18 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected5 at risk
EG0020 affected18 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA (18.1)
Systematic Assessment
EG0001 affected15 at risk
EG0010 affected5 at risk
EG0020 affected18 at risk
EG003
Hypernatraemia
Metabolism and nutrition disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected5 at risk
EG0020 affected18 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected5 at risk
EG0020 affected18 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected5 at risk
EG0020 affected18 at risk
EG003
Tumour lysis syndrome
Metabolism and nutrition disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected15 at risk
EG0011 affected5 at risk
EG0020 affected18 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected5 at risk
EG0020 affected18 at risk
EG003
Bone pain
Musculoskeletal and connective tissue disorders
MedDRA (18.1)
Systematic Assessment
EG0001 affected15 at risk
EG0010 affected5 at risk
EG0020 affected18 at risk
EG003
Fistula
Musculoskeletal and connective tissue disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected5 at risk
EG0020 affected18 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected15 at risk
EG0011 affected5 at risk
EG0020 affected18 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected5 at risk
EG0020 affected18 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected5 at risk
EG0020 affected18 at risk
EG003
Trismus
Musculoskeletal and connective tissue disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected5 at risk
EG0020 affected18 at risk
EG003
Tumour haemorrhage
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (18.1)
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected5 at risk
EG0020 affected18 at risk
EG003
Tumour necrosis
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (18.1)
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected5 at risk
EG0020 affected18 at risk
EG003
Tumour pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (18.1)
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected5 at risk
EG0020 affected18 at risk
EG003
Carotid artery perforation
Nervous system disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected5 at risk
EG0020 affected18 at risk
EG003
Cerebrovascular accident
Nervous system disorders
MedDRA (18.1)
Systematic Assessment
EG0001 affected15 at risk
EG0010 affected5 at risk
EG0020 affected18 at risk
EG003
Embolic cerebral infarction
Nervous system disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected5 at risk
EG0020 affected18 at risk
EG003
Somnolence
Nervous system disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected5 at risk
EG0020 affected18 at risk
EG003
Device dislocation
Product Issues
MedDRA (18.1)
Systematic Assessment
EG0000 affected15 at risk
EG0011 affected5 at risk
EG0020 affected18 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected5 at risk
EG0021 affected18 at risk
EG003
Ketonuria
Renal and urinary disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected5 at risk
EG0020 affected18 at risk
EG003
Renal injury
Renal and urinary disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected5 at risk
EG0020 affected18 at risk
EG003
Aspiration
Respiratory, thoracic and mediastinal disorders
MedDRA (18.1)
Systematic Assessment
EG0001 affected15 at risk
EG0010 affected5 at risk
EG0020 affected18 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected15 at risk
EG0011 affected5 at risk
EG0020 affected18 at risk
EG003
Interstitial lung disease
Respiratory, thoracic and mediastinal disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected5 at risk
EG0020 affected18 at risk
EG003
Laryngeal oedema
Respiratory, thoracic and mediastinal disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected5 at risk
EG0020 affected18 at risk
EG003
Lung infiltration
Respiratory, thoracic and mediastinal disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected5 at risk
EG0020 affected18 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected5 at risk
EG0020 affected18 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected5 at risk
EG0021 affected18 at risk
EG003
Pneumonia aspiration
Respiratory, thoracic and mediastinal disorders
MedDRA (18.1)
Systematic Assessment
EG0002 affected15 at risk
EG0010 affected5 at risk
EG0020 affected18 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
MedDRA (18.1)
Systematic Assessment
EG0001 affected15 at risk
EG0010 affected5 at risk
EG0020 affected18 at risk
EG003
Pneumothorax
Respiratory, thoracic and mediastinal disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected5 at risk
EG0020 affected18 at risk
EG003
Productive cough
Respiratory, thoracic and mediastinal disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected5 at risk
EG0020 affected18 at risk
EG003
Pulmonary air leakage
Respiratory, thoracic and mediastinal disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected5 at risk
EG0020 affected18 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected5 at risk
EG0020 affected18 at risk
EG003
Pulmonary haemorrhage
Respiratory, thoracic and mediastinal disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected5 at risk
EG0020 affected18 at risk
EG003
Respiratory distress
Respiratory, thoracic and mediastinal disorders
MedDRA (18.1)
Systematic Assessment
EG0001 affected15 at risk
EG0010 affected5 at risk
EG0020 affected18 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected5 at risk
EG0020 affected18 at risk
EG003
Stridor
Respiratory, thoracic and mediastinal disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected5 at risk
EG0020 affected18 at risk
EG003
Erythema nodosum
Skin and subcutaneous tissue disorders
MedDRA (18.1)
Systematic Assessment
EG0001 affected15 at risk
EG0010 affected5 at risk
EG0020 affected18 at risk
EG003
Swelling face
Skin and subcutaneous tissue disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected5 at risk
EG0021 affected18 at risk
EG003
Gastrostomy
Surgical and medical procedures
MedDRA (18.1)
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected5 at risk
EG0020 affected18 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected5 at risk
EG0020 affected18 at risk
EG003
Embolism
Vascular disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected5 at risk
EG0020 affected18 at risk
EG003
Hypertension
Vascular disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected5 at risk
EG0021 affected18 at risk
EG003
Hypotension
Vascular disorders
MedDRA (18.1)
Systematic Assessment
EG0001 affected15 at risk
EG0010 affected5 at risk
EG0020 affected18 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected5 at risk
EG0021 affected18 at risk
EG0032 affected6 at risk
EG0049 affected69 at risk
EG0056 affected35 at risk
EG0067 affected29 at risk
EG00725 affected178 at risk
Lymph node pain
Blood and lymphatic system disorders
MedDRA (18.1)
Systematic Assessment
EG0001 affected15 at risk
EG0010 affected5 at risk
EG0020 affected18 at risk
EG003
Lymphadenopathy
Blood and lymphatic system disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected5 at risk
EG0021 affected18 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected5 at risk
EG0020 affected18 at risk
EG003
Angina pectoris
Cardiac disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected5 at risk
EG0021 affected18 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected5 at risk
EG0021 affected18 at risk
EG003
Cardiac arrest
Cardiac disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected5 at risk
EG0021 affected18 at risk
EG003
Cardiomegaly
Cardiac disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected5 at risk
EG0021 affected18 at risk
EG003
Palpitations
Cardiac disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected5 at risk
EG0021 affected18 at risk
EG003
Pericardial effusion
Cardiac disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected5 at risk
EG0020 affected18 at risk
EG003
Sinus bradycardia
Cardiac disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected5 at risk
EG0021 affected18 at risk
EG003
Sinus tachycardia
Cardiac disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected5 at risk
EG0021 affected18 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected5 at risk
EG0021 affected18 at risk
EG003
Tympanic membrane perforation
Ear and labyrinth disorders
MedDRA (18.1)
Systematic Assessment
EG0001 affected15 at risk
EG0010 affected5 at risk
EG0020 affected18 at risk
EG003
Conjunctival hyperaemia
Eye disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected5 at risk
EG0021 affected18 at risk
EG003
Diplopia
Eye disorders
MedDRA (18.1)
Systematic Assessment
EG0001 affected15 at risk
EG0010 affected5 at risk
EG0020 affected18 at risk
EG003
Dry eye
Eye disorders
MedDRA (18.1)
Systematic Assessment
EG0003 affected15 at risk
EG0010 affected5 at risk
EG0020 affected18 at risk
EG003
Eye irritation
Eye disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected5 at risk
EG0020 affected18 at risk
EG003
Eye pain
Eye disorders
MedDRA (18.1)
Systematic Assessment
EG0002 affected15 at risk
EG0011 affected5 at risk
EG0020 affected18 at risk
EG003
Ocular hyperaemia
Eye disorders
MedDRA (18.1)
Systematic Assessment
EG0001 affected15 at risk
EG0010 affected5 at risk
EG0020 affected18 at risk
EG003
Vision blurred
Eye disorders
MedDRA (18.1)
Systematic Assessment
EG0001 affected15 at risk
EG0011 affected5 at risk
EG0020 affected18 at risk
EG003
Abdominal discomfort
Gastrointestinal disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected5 at risk
EG0021 affected18 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA (18.1)
Systematic Assessment
EG0001 affected15 at risk
EG0010 affected5 at risk
EG0020 affected18 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA (18.1)
Systematic Assessment
EG0001 affected15 at risk
EG0010 affected5 at risk
EG0020 affected18 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected5 at risk
EG0021 affected18 at risk
EG003
Anal incontinence
Gastrointestinal disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected5 at risk
EG0020 affected18 at risk
EG003
Ascites
Gastrointestinal disorders
MedDRA (18.1)
Systematic Assessment
EG0001 affected15 at risk
EG0010 affected5 at risk
EG0020 affected18 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA (18.1)
Systematic Assessment
EG0002 affected15 at risk
EG0010 affected5 at risk
EG0024 affected18 at risk
EG003
Dental caries
Gastrointestinal disorders
MedDRA (18.1)
Systematic Assessment
EG0001 affected15 at risk
EG0010 affected5 at risk
EG0020 affected18 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA (18.1)
Systematic Assessment
EG0007 affected15 at risk
EG0012 affected5 at risk
EG00210 affected18 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA (18.1)
Systematic Assessment
EG0001 affected15 at risk
EG0010 affected5 at risk
EG0020 affected18 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected5 at risk
EG0021 affected18 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA (18.1)
Systematic Assessment
EG0003 affected15 at risk
EG0011 affected5 at risk
EG0021 affected18 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA (18.1)
Systematic Assessment
EG0001 affected15 at risk
EG0010 affected5 at risk
EG0020 affected18 at risk
EG003
Gastritis erosive
Gastrointestinal disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected15 at risk
EG0011 affected5 at risk
EG0020 affected18 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA (18.1)
Systematic Assessment
EG0002 affected15 at risk
EG0010 affected5 at risk
EG0020 affected18 at risk
EG003
Glossodynia
Gastrointestinal disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected5 at risk
EG0020 affected18 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
MedDRA (18.1)
Systematic Assessment
EG0001 affected15 at risk
EG0010 affected5 at risk
EG0020 affected18 at risk
EG003
Melaena
Gastrointestinal disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected5 at risk
EG0020 affected18 at risk
EG003
Mouth haemorrhage
Gastrointestinal disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected15 at risk
EG0011 affected5 at risk
EG0020 affected18 at risk
EG003
Mouth ulceration
Gastrointestinal disorders
MedDRA (18.1)
Systematic Assessment
EG0002 affected15 at risk
EG0010 affected5 at risk
EG0021 affected18 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA (18.1)
Systematic Assessment
EG0006 affected15 at risk
EG0011 affected5 at risk
EG0024 affected18 at risk
EG003
Odynophagia
Gastrointestinal disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected5 at risk
EG0020 affected18 at risk
EG003
Oesophageal fistula
Gastrointestinal disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected5 at risk
EG0022 affected18 at risk
EG003
Oesophageal ulcer
Gastrointestinal disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected15 at risk
EG0011 affected5 at risk
EG0020 affected18 at risk
EG003
Oesophagitis
Gastrointestinal disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected15 at risk
EG0011 affected5 at risk
EG0020 affected18 at risk
EG003
Oral pain
Gastrointestinal disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected15 at risk
EG0011 affected5 at risk
EG0021 affected18 at risk
EG003
Salivary gland mucocoele
Gastrointestinal disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected5 at risk
EG0021 affected18 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA (18.1)
Systematic Assessment
EG0007 affected15 at risk
EG0012 affected5 at risk
EG0028 affected18 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA (18.1)
Systematic Assessment
EG0003 affected15 at risk
EG0011 affected5 at risk
EG0023 affected18 at risk
EG003
Asthenia
General disorders
MedDRA (18.1)
Systematic Assessment
EG0001 affected15 at risk
EG0010 affected5 at risk
EG0021 affected18 at risk
EG003
Chills
General disorders
MedDRA (18.1)
Systematic Assessment
EG0001 affected15 at risk
EG0010 affected5 at risk
EG0021 affected18 at risk
EG003
Cyst rupture
General disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected15 at risk
EG0011 affected5 at risk
EG0020 affected18 at risk
EG003
Face oedema
General disorders
MedDRA (18.1)
Systematic Assessment
EG0001 affected15 at risk
EG0011 affected5 at risk
EG0020 affected18 at risk
EG003
Facial pain
General disorders
MedDRA (18.1)
Systematic Assessment
EG0001 affected15 at risk
EG0010 affected5 at risk
EG0020 affected18 at risk
EG003
Fatigue
General disorders
MedDRA (18.1)
Systematic Assessment
EG0005 affected15 at risk
EG0012 affected5 at risk
EG0025 affected18 at risk
EG003
Gait disturbance
General disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected5 at risk
EG0020 affected18 at risk
EG003
General physical health deterioration
General disorders
MedDRA (18.1)
Systematic Assessment
EG0001 affected15 at risk
EG0010 affected5 at risk
EG0020 affected18 at risk
EG003
Localised oedema
General disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected15 at risk
EG0011 affected5 at risk
EG0021 affected18 at risk
EG003
Malaise
General disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected5 at risk
EG0020 affected18 at risk
EG003
Mucosal dryness
General disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected5 at risk
EG0020 affected18 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected5 at risk
EG0021 affected18 at risk
EG003
Oedema peripheral
General disorders
MedDRA (18.1)
Systematic Assessment
EG0002 affected15 at risk
EG0011 affected5 at risk
EG0020 affected18 at risk
EG003
Pyrexia
General disorders
MedDRA (18.1)
Systematic Assessment
EG0003 affected15 at risk
EG0010 affected5 at risk
EG0025 affected18 at risk
EG003
Secretion discharge
General disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected5 at risk
EG0021 affected18 at risk
EG003
Submandibular mass
General disorders
MedDRA (18.1)
Systematic Assessment
EG0001 affected15 at risk
EG0010 affected5 at risk
EG0020 affected18 at risk
EG003
Drug hypersensitivity
Immune system disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected5 at risk
EG0021 affected18 at risk
EG003
Candida infection
Infections and infestations
MedDRA (18.1)
Systematic Assessment
EG0001 affected15 at risk
EG0010 affected5 at risk
EG0020 affected18 at risk
EG003
Cellulitis
Infections and infestations
MedDRA (18.1)
Systematic Assessment
EG0001 affected15 at risk
EG0010 affected5 at risk
EG0020 affected18 at risk
EG003
Conjunctivitis
Infections and infestations
MedDRA (18.1)
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected5 at risk
EG0021 affected18 at risk
EG003
Ear infection
Infections and infestations
MedDRA (18.1)
Systematic Assessment
EG0001 affected15 at risk
EG0010 affected5 at risk
EG0020 affected18 at risk
EG003
Folliculitis
Infections and infestations
MedDRA (18.1)
Systematic Assessment
EG0001 affected15 at risk
EG0010 affected5 at risk
EG0021 affected18 at risk
EG003
Herpes virus infection
Infections and infestations
MedDRA (18.1)
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected5 at risk
EG0020 affected18 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA (18.1)
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected5 at risk
EG0020 affected18 at risk
EG003
Klebsiella sepsis
Infections and infestations
MedDRA (18.1)
Systematic Assessment
EG0000 affected15 at risk
EG0011 affected5 at risk
EG0020 affected18 at risk
EG003
Lung infection
Infections and infestations
MedDRA (18.1)
Systematic Assessment
EG0001 affected15 at risk
EG0010 affected5 at risk
EG0021 affected18 at risk
EG003
Nail infection
Infections and infestations
MedDRA (18.1)
Systematic Assessment
EG0001 affected15 at risk
EG0010 affected5 at risk
EG0020 affected18 at risk
EG003
Oral candidiasis
Infections and infestations
MedDRA (18.1)
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected5 at risk
EG0020 affected18 at risk
EG003
Paronychia
Infections and infestations
MedDRA (18.1)
Systematic Assessment
EG0006 affected15 at risk
EG0011 affected5 at risk
EG0025 affected18 at risk
EG003
Rash pustular
Infections and infestations
MedDRA (18.1)
Systematic Assessment
EG0001 affected15 at risk
EG0010 affected5 at risk
EG0021 affected18 at risk
EG003
Rhinitis
Infections and infestations
MedDRA (18.1)
Systematic Assessment
EG0000 affected15 at risk
EG0011 affected5 at risk
EG0021 affected18 at risk
EG003
Sinusitis
Infections and infestations
MedDRA (18.1)
Systematic Assessment
EG0001 affected15 at risk
EG0010 affected5 at risk
EG0020 affected18 at risk
EG003
Skin infection
Infections and infestations
MedDRA (18.1)
Systematic Assessment
EG0002 affected15 at risk
EG0010 affected5 at risk
EG0020 affected18 at risk
EG003
Stoma site infection
Infections and infestations
MedDRA (18.1)
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected5 at risk
EG0021 affected18 at risk
EG003
Tooth infection
Infections and infestations
MedDRA (18.1)
Systematic Assessment
EG0001 affected15 at risk
EG0010 affected5 at risk
EG0020 affected18 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA (18.1)
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected5 at risk
EG0020 affected18 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA (18.1)
Systematic Assessment
EG0001 affected15 at risk
EG0010 affected5 at risk
EG0020 affected18 at risk
EG003
Viral infection
Infections and infestations
MedDRA (18.1)
Systematic Assessment
EG0001 affected15 at risk
EG0010 affected5 at risk
EG0020 affected18 at risk
EG003
Wound infection
Infections and infestations
MedDRA (18.1)
Systematic Assessment
EG0001 affected15 at risk
EG0010 affected5 at risk
EG0020 affected18 at risk
EG003
Feeding tube complication
Injury, poisoning and procedural complications
MedDRA (18.1)
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected5 at risk
EG0020 affected18 at risk
EG003
Gastrointestinal stoma complication
Injury, poisoning and procedural complications
MedDRA (18.1)
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected5 at risk
EG0020 affected18 at risk
EG003
Infusion related reaction
Injury, poisoning and procedural complications
MedDRA (18.1)
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected5 at risk
EG0020 affected18 at risk
EG003
Limb injury
Injury, poisoning and procedural complications
MedDRA (18.1)
Systematic Assessment
EG0001 affected15 at risk
EG0010 affected5 at risk
EG0020 affected18 at risk
EG003
Procedural pain
Injury, poisoning and procedural complications
MedDRA (18.1)
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected5 at risk
EG0020 affected18 at risk
EG003
Skin abrasion
Injury, poisoning and procedural complications
MedDRA (18.1)
Systematic Assessment
EG0002 affected15 at risk
EG0010 affected5 at risk
EG0020 affected18 at risk
EG003
Stoma site erythema
Injury, poisoning and procedural complications
MedDRA (18.1)
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected5 at risk
EG0020 affected18 at risk
EG003
Stoma site ulcer
Injury, poisoning and procedural complications
MedDRA (18.1)
Systematic Assessment
EG0001 affected15 at risk
EG0010 affected5 at risk
EG0020 affected18 at risk
EG003
Tracheal obstruction
Injury, poisoning and procedural complications
MedDRA (18.1)
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected5 at risk
EG0021 affected18 at risk
EG003
Wound
Injury, poisoning and procedural complications
MedDRA (18.1)
Systematic Assessment
EG0000 affected15 at risk
EG0011 affected5 at risk
EG0020 affected18 at risk
EG003
Wound secretion
Injury, poisoning and procedural complications
MedDRA (18.1)
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected5 at risk
EG0020 affected18 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA (18.1)
Systematic Assessment
EG0001 affected15 at risk
EG0010 affected5 at risk
EG0020 affected18 at risk
EG003
Amylase increased
Investigations
MedDRA (18.1)
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected5 at risk
EG0020 affected18 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA (18.1)
Systematic Assessment
EG0002 affected15 at risk
EG0010 affected5 at risk
EG0020 affected18 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA (18.1)
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected5 at risk
EG0021 affected18 at risk
EG003
Blood creatine phosphokinase increased
Investigations
MedDRA (18.1)
Systematic Assessment
EG0001 affected15 at risk
EG0012 affected5 at risk
EG0020 affected18 at risk
EG003
Blood creatinine increased
Investigations
MedDRA (18.1)
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected5 at risk
EG0022 affected18 at risk
EG003
Blood glucose increased
Investigations
MedDRA (18.1)
Systematic Assessment
EG0001 affected15 at risk
EG0010 affected5 at risk
EG0020 affected18 at risk
EG003
Blood testosterone decreased
Investigations
MedDRA (18.1)
Systematic Assessment
EG0002 affected15 at risk
EG0010 affected5 at risk
EG0020 affected18 at risk
EG003
Electrocardiogram QT prolonged
Investigations
MedDRA (18.1)
Systematic Assessment
EG0001 affected15 at risk
EG0010 affected5 at risk
EG0021 affected18 at risk
EG003
Electrocardiogram T wave abnormal
Investigations
MedDRA (18.1)
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected5 at risk
EG0021 affected18 at risk
EG003
Electrocardiogram T wave inversion
Investigations
MedDRA (18.1)
Systematic Assessment
EG0000 affected15 at risk
EG0011 affected5 at risk
EG0020 affected18 at risk
EG003
Gamma-glutamyltransferase increased
Investigations
MedDRA (18.1)
Systematic Assessment
EG0001 affected15 at risk
EG0010 affected5 at risk
EG0020 affected18 at risk
EG003
Glycosylated haemoglobin increased
Investigations
MedDRA (18.1)
Systematic Assessment
EG0001 affected15 at risk
EG0010 affected5 at risk
EG0020 affected18 at risk
EG003
Lipase increased
Investigations
MedDRA (18.1)
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected5 at risk
EG0021 affected18 at risk
EG003
Lymphocyte count decreased
Investigations
MedDRA (18.1)
Systematic Assessment
EG0000 affected15 at risk
EG0011 affected5 at risk
EG0021 affected18 at risk
EG003
Troponin increased
Investigations
MedDRA (18.1)
Systematic Assessment
EG0000 affected15 at risk
EG0011 affected5 at risk
EG0020 affected18 at risk
EG003
Weight decreased
Investigations
MedDRA (18.1)
Systematic Assessment
EG0006 affected15 at risk
EG0012 affected5 at risk
EG0026 affected18 at risk
EG003
Weight increased
Investigations
MedDRA (18.1)
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected5 at risk
EG0020 affected18 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA (18.1)
Systematic Assessment
EG0006 affected15 at risk
EG0011 affected5 at risk
EG0024 affected18 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected15 at risk
EG0011 affected5 at risk
EG0020 affected18 at risk
EG003
Glucose tolerance impaired
Metabolism and nutrition disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected15 at risk
EG0011 affected5 at risk
EG0020 affected18 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA (18.1)
Systematic Assessment
EG0001 affected15 at risk
EG0011 affected5 at risk
EG0023 affected18 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA (18.1)
Systematic Assessment
EG0008 affected15 at risk
EG0012 affected5 at risk
EG00210 affected18 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected5 at risk
EG0021 affected18 at risk
EG003
Hypermagnesaemia
Metabolism and nutrition disorders
MedDRA (18.1)
Systematic Assessment
EG0001 affected15 at risk
EG0010 affected5 at risk
EG0020 affected18 at risk
EG003
Hypernatraemia
Metabolism and nutrition disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected5 at risk
EG0021 affected18 at risk
EG003
Hyperosmolar state
Metabolism and nutrition disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected5 at risk
EG0020 affected18 at risk
EG003
Hypertriglyceridaemia
Metabolism and nutrition disorders
MedDRA (18.1)
Systematic Assessment
EG0001 affected15 at risk
EG0010 affected5 at risk
EG0020 affected18 at risk
EG003
Hyperuricaemia
Metabolism and nutrition disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected5 at risk
EG0021 affected18 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRA (18.1)
Systematic Assessment
EG0002 affected15 at risk
EG0011 affected5 at risk
EG0021 affected18 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
MedDRA (18.1)
Systematic Assessment
EG0001 affected15 at risk
EG0010 affected5 at risk
EG0021 affected18 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA (18.1)
Systematic Assessment
EG0001 affected15 at risk
EG0010 affected5 at risk
EG0020 affected18 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA (18.1)
Systematic Assessment
EG0005 affected15 at risk
EG0010 affected5 at risk
EG0024 affected18 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA (18.1)
Systematic Assessment
EG0008 affected15 at risk
EG0012 affected5 at risk
EG0026 affected18 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA (18.1)
Systematic Assessment
EG0001 affected15 at risk
EG0011 affected5 at risk
EG0020 affected18 at risk
EG003
Hypophagia
Metabolism and nutrition disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected5 at risk
EG0021 affected18 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
MedDRA (18.1)
Systematic Assessment
EG0002 affected15 at risk
EG0011 affected5 at risk
EG0024 affected18 at risk
EG003
Malnutrition
Metabolism and nutrition disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected5 at risk
EG0021 affected18 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA (18.1)
Systematic Assessment
EG0002 affected15 at risk
EG0011 affected5 at risk
EG0022 affected18 at risk
EG003
Bone pain
Musculoskeletal and connective tissue disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected5 at risk
EG0021 affected18 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected15 at risk
EG0011 affected5 at risk
EG0020 affected18 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected5 at risk
EG0020 affected18 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected15 at risk
EG0011 affected5 at risk
EG0020 affected18 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected5 at risk
EG0020 affected18 at risk
EG003
Musculoskeletal stiffness
Musculoskeletal and connective tissue disorders
MedDRA (18.1)
Systematic Assessment
EG0001 affected15 at risk
EG0010 affected5 at risk
EG0020 affected18 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected15 at risk
EG0011 affected5 at risk
EG0022 affected18 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected5 at risk
EG0021 affected18 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA (18.1)
Systematic Assessment
EG0001 affected15 at risk
EG0010 affected5 at risk
EG0020 affected18 at risk
EG003
Trismus
Musculoskeletal and connective tissue disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected5 at risk
EG0020 affected18 at risk
EG003
Cancer pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (18.1)
Systematic Assessment
EG0001 affected15 at risk
EG0010 affected5 at risk
EG0020 affected18 at risk
EG003
Tumour haemorrhage
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (18.1)
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected5 at risk
EG0020 affected18 at risk
EG003
Tumour necrosis
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (18.1)
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected5 at risk
EG0021 affected18 at risk
EG003
Tumour pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (18.1)
Systematic Assessment
EG0000 affected15 at risk
EG0011 affected5 at risk
EG0021 affected18 at risk
EG003
Aphasia
Nervous system disorders
MedDRA (18.1)
Systematic Assessment
EG0001 affected15 at risk
EG0010 affected5 at risk
EG0020 affected18 at risk
EG003
Dizziness
Nervous system disorders
MedDRA (18.1)
Systematic Assessment
EG0002 affected15 at risk
EG0010 affected5 at risk
EG0022 affected18 at risk
EG003
Dysaesthesia
Nervous system disorders
MedDRA (18.1)
Systematic Assessment
EG0001 affected15 at risk
EG0010 affected5 at risk
EG0020 affected18 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA (18.1)
Systematic Assessment
EG0002 affected15 at risk
EG0010 affected5 at risk
EG0022 affected18 at risk
EG003
Headache
Nervous system disorders
MedDRA (18.1)
Systematic Assessment
EG0002 affected15 at risk
EG0010 affected5 at risk
EG0024 affected18 at risk
EG003
Hemiparesis
Nervous system disorders
MedDRA (18.1)
Systematic Assessment
EG0001 affected15 at risk
EG0010 affected5 at risk
EG0020 affected18 at risk
EG003
Lethargy
Nervous system disorders
MedDRA (18.1)
Systematic Assessment
EG0001 affected15 at risk
EG0010 affected5 at risk
EG0020 affected18 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected5 at risk
EG0021 affected18 at risk
EG003
Parosmia
Nervous system disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected5 at risk
EG0020 affected18 at risk
EG003
Peripheral motor neuropathy
Nervous system disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected5 at risk
EG0021 affected18 at risk
EG003
Peripheral sensory neuropathy
Nervous system disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected5 at risk
EG0021 affected18 at risk
EG003
Presyncope
Nervous system disorders
MedDRA (18.1)
Systematic Assessment
EG0001 affected15 at risk
EG0010 affected5 at risk
EG0020 affected18 at risk
EG003
Somnolence
Nervous system disorders
MedDRA (18.1)
Systematic Assessment
EG0001 affected15 at risk
EG0011 affected5 at risk
EG0020 affected18 at risk
EG003
Agitation
Psychiatric disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected15 at risk
EG0011 affected5 at risk
EG0020 affected18 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA (18.1)
Systematic Assessment
EG0001 affected15 at risk
EG0010 affected5 at risk
EG0021 affected18 at risk
EG003
Depression
Psychiatric disorders
MedDRA (18.1)
Systematic Assessment
EG0002 affected15 at risk
EG0010 affected5 at risk
EG0021 affected18 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected5 at risk
EG0021 affected18 at risk
EG003
Irritability
Psychiatric disorders
MedDRA (18.1)
Systematic Assessment
EG0001 affected15 at risk
EG0010 affected5 at risk
EG0020 affected18 at risk
EG003
Sleep disorder
Psychiatric disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected5 at risk
EG0020 affected18 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected15 at risk
EG0011 affected5 at risk
EG0020 affected18 at risk
EG003
Dysuria
Renal and urinary disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected5 at risk
EG0020 affected18 at risk
EG003
Pollakiuria
Renal and urinary disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected5 at risk
EG0020 affected18 at risk
EG003
Renal failure
Renal and urinary disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected5 at risk
EG0020 affected18 at risk
EG003
Urinary incontinence
Renal and urinary disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected5 at risk
EG0020 affected18 at risk
EG003
Urinary retention
Renal and urinary disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected5 at risk
EG0020 affected18 at risk
EG003
Pelvic pain
Reproductive system and breast disorders
MedDRA (18.1)
Systematic Assessment
EG0001 affected15 at risk
EG0010 affected5 at risk
EG0020 affected18 at risk
EG003
Aspiration
Respiratory, thoracic and mediastinal disorders
MedDRA (18.1)
Systematic Assessment
EG0001 affected15 at risk
EG0010 affected5 at risk
EG0020 affected18 at risk
EG003
Atelectasis
Respiratory, thoracic and mediastinal disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected5 at risk
EG0021 affected18 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA (18.1)
Systematic Assessment
EG0002 affected15 at risk
EG0011 affected5 at risk
EG0024 affected18 at risk
EG003
Dysphonia
Respiratory, thoracic and mediastinal disorders
MedDRA (18.1)
Systematic Assessment
EG0001 affected15 at risk
EG0011 affected5 at risk
EG0021 affected18 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA (18.1)
Systematic Assessment
EG0001 affected15 at risk
EG0012 affected5 at risk
EG0023 affected18 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected15 at risk
EG0011 affected5 at risk
EG0021 affected18 at risk
EG003
Haemoptysis
Respiratory, thoracic and mediastinal disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected5 at risk
EG0021 affected18 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA (18.1)
Systematic Assessment
EG0001 affected15 at risk
EG0010 affected5 at risk
EG0020 affected18 at risk
EG003
Lung disorder
Respiratory, thoracic and mediastinal disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected5 at risk
EG0020 affected18 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected5 at risk
EG0021 affected18 at risk
EG003
Nasal dryness
Respiratory, thoracic and mediastinal disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected5 at risk
EG0021 affected18 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA (18.1)
Systematic Assessment
EG0001 affected15 at risk
EG0010 affected5 at risk
EG0024 affected18 at risk
EG003
Pharyngeal inflammation
Respiratory, thoracic and mediastinal disorders
MedDRA (18.1)
Systematic Assessment
EG0001 affected15 at risk
EG0010 affected5 at risk
EG0020 affected18 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected5 at risk
EG0022 affected18 at risk
EG003
Pneumonia aspiration
Respiratory, thoracic and mediastinal disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected5 at risk
EG0021 affected18 at risk
EG003
Productive cough
Respiratory, thoracic and mediastinal disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected5 at risk
EG0021 affected18 at risk
EG003
Pulmonary mass
Respiratory, thoracic and mediastinal disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected5 at risk
EG0021 affected18 at risk
EG003
Pulmonary oedema
Respiratory, thoracic and mediastinal disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected5 at risk
EG0021 affected18 at risk
EG003
Respiratory distress
Respiratory, thoracic and mediastinal disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected5 at risk
EG0021 affected18 at risk
EG003
Rhinitis allergic
Respiratory, thoracic and mediastinal disorders
MedDRA (18.1)
Systematic Assessment
EG0001 affected15 at risk
EG0010 affected5 at risk
EG0020 affected18 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA (18.1)
Systematic Assessment
EG0001 affected15 at risk
EG0010 affected5 at risk
EG0020 affected18 at risk
EG003
Cold sweat
Skin and subcutaneous tissue disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected5 at risk
EG0021 affected18 at risk
EG003
Decubitus ulcer
Skin and subcutaneous tissue disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected5 at risk
EG0020 affected18 at risk
EG003
Dermal cyst
Skin and subcutaneous tissue disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected15 at risk
EG0011 affected5 at risk
EG0020 affected18 at risk
EG003
Dermatitis
Skin and subcutaneous tissue disorders
MedDRA (18.1)
Systematic Assessment
EG0001 affected15 at risk
EG0010 affected5 at risk
EG0020 affected18 at risk
EG003
Dermatitis acneiform
Skin and subcutaneous tissue disorders
MedDRA (18.1)
Systematic Assessment
EG0007 affected15 at risk
EG0012 affected5 at risk
EG0024 affected18 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA (18.1)
Systematic Assessment
EG0004 affected15 at risk
EG0012 affected5 at risk
EG0022 affected18 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected5 at risk
EG0020 affected18 at risk
EG003
Erythema nodosum
Skin and subcutaneous tissue disorders
MedDRA (18.1)
Systematic Assessment
EG0001 affected15 at risk
EG0010 affected5 at risk
EG0020 affected18 at risk
EG003
Palmar-plantar erythrodysaesthesia syndrome
Skin and subcutaneous tissue disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected5 at risk
EG0020 affected18 at risk
EG003
Papule
Skin and subcutaneous tissue disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected5 at risk
EG0020 affected18 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA (18.1)
Systematic Assessment
EG0001 affected15 at risk
EG0011 affected5 at risk
EG0021 affected18 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA (18.1)
Systematic Assessment
EG0007 affected15 at risk
EG0010 affected5 at risk
EG0024 affected18 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA (18.1)
Systematic Assessment
EG0003 affected15 at risk
EG0010 affected5 at risk
EG0022 affected18 at risk
EG003
Rash papular
Skin and subcutaneous tissue disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected5 at risk
EG0021 affected18 at risk
EG003
Skin discolouration
Skin and subcutaneous tissue disorders
MedDRA (18.1)
Systematic Assessment
EG0001 affected15 at risk
EG0010 affected5 at risk
EG0020 affected18 at risk
EG003
Skin fissures
Skin and subcutaneous tissue disorders
MedDRA (18.1)
Systematic Assessment
EG0004 affected15 at risk
EG0011 affected5 at risk
EG0022 affected18 at risk
EG003
Skin striae
Skin and subcutaneous tissue disorders
MedDRA (18.1)
Systematic Assessment
EG0001 affected15 at risk
EG0010 affected5 at risk
EG0020 affected18 at risk
EG003
Skin toxicity
Skin and subcutaneous tissue disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected5 at risk
EG0020 affected18 at risk
EG003
Skin ulcer
Skin and subcutaneous tissue disorders
MedDRA (18.1)
Systematic Assessment
EG0003 affected15 at risk
EG0010 affected5 at risk
EG0021 affected18 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected5 at risk
EG0020 affected18 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA (18.1)
Systematic Assessment
EG0001 affected15 at risk
EG0010 affected5 at risk
EG0020 affected18 at risk
EG003
Embolism
Vascular disorders
MedDRA (18.1)
Systematic Assessment
EG0001 affected15 at risk
EG0010 affected5 at risk
EG0020 affected18 at risk
EG003
Flushing
Vascular disorders
MedDRA (18.1)
Systematic Assessment
EG0001 affected15 at risk
EG0010 affected5 at risk
EG0020 affected18 at risk
EG003
Haematoma
Vascular disorders
MedDRA (18.1)
Systematic Assessment
EG0001 affected15 at risk
EG0010 affected5 at risk
EG0020 affected18 at risk
EG003
Hypertension
Vascular disorders
MedDRA (18.1)
Systematic Assessment
EG0003 affected15 at risk
EG0011 affected5 at risk
EG0022 affected18 at risk
EG003
Hypotension
Vascular disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected15 at risk
EG0010 affected5 at risk
EG0021 affected18 at risk
EG003
Lymphoedema
Vascular disorders
MedDRA (18.1)
Systematic Assessment
EG0001 affected15 at risk
EG0010 affected5 at risk
EG0020 affected18 at risk
EG003
Recruitment of new patients who were resistant to both platinum & cetuximab into Arm 3 was halted due to slow enrollment. The study was terminated early and health authorities were informed.
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. 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 all sites) in the clinical trial.
Point of Contact
Title
Organization
Phone
Extension
Email
Study Director
Novartis Pharmaceuticals
862-778-8300
ID
Term
D000077195
Squamous Cell Carcinoma of Head and Neck
D009477
Hereditary Sensory and Autonomic Neuropathies
Ancestor Terms
ID
Term
D002294
Carcinoma, Squamous Cell
D002277
Carcinoma
D009375
Neoplasms, Glandular and Epithelial
D009370
Neoplasms by Histologic Type
D009369
Neoplasms
D006258
Head and Neck Neoplasms
D009371
Neoplasms by Site
D009421
Nervous System Malformations
D009422
Nervous System Diseases
D020271
Heredodegenerative Disorders, Nervous System
D019636
Neurodegenerative Diseases
D011115
Polyneuropathies
D010523
Peripheral Nervous System Diseases
D009468
Neuromuscular Diseases
D000013
Congenital Abnormalities
D009358
Congenital, Hereditary, and Neonatal Diseases and Abnormalities
D030342
Genetic Diseases, Inborn
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
C585539
Alpelisib
D000068818
Cetuximab
Ancestor Terms
ID
Term
D061067
Antibodies, Monoclonal, Humanized
D000911
Antibodies, Monoclonal
D000906
Antibodies
D007136
Immunoglobulins
D007162
Immunoproteins
D001798
Blood Proteins
D011506
Proteins
D000602
Amino Acids, Peptides, and Proteins
D012712
Serum Globulins
D005916
Globulins
Browse Leaves
Not provided
Browse Branches
Not provided
2 subjects
FG0051 subjects
FG0061 subjects
41 subjects
FG00512 subjects
FG00615 subjects
7 subjects
FG0052 subjects
FG0062 subjects
6 subjects
FG0050 subjects
FG0061 subjects
15 subjects
FG0053 subjects
FG0069 subjects
0 subjects
FG0050 subjects
FG0061 subjects
0 subjects
FG00516 subjects
FG0060 subjects
60.5
± 14.10
BG00457.2± 9.66
BG00557.1± 10.37
BG00656.9± 8.25
BG00757.0± 10.16
4
BG0032
BG00416
BG0054
BG00610
BG00744
Male
BG0009
BG0014
BG00214
BG0034
BG00455
BG00531
BG00619
BG007136
0.222
OG0010.376
Posterior probabilities that Pr (DLT) in 0.35-1
Title
Measurements
OG0000.015
OG0010.538
OG00013
Title
Denominators
Categories
Posterior probabilities that Pr(DLT) in 0-0.16
Title
Measurements
OG0000.267
Posterior probabilities that Pr (DLT) in 0.16-0.35
Title
Measurements
OG0000.664
Posterior probabilities that Pr (DLT) in 0.35-1
Title
Measurements
OG0000.069
OG003
Arm C - BYL719+Cetuximab, Dispersible Tablets
300mg BYL719 dispersible tablets with cetuxumab in patients with swallowing dysfunction administered via G-tube
OG004
All Patients
All patients in Phase Ib
Units
Counts
Participants
OG00011
OG0013
OG00213
OG0033
OG00430
Title
Denominators
Categories
Title
Measurements
OG0001
OG0012
OG0024
OG0032
OG0049
71
OG00135
Title
Denominators
Categories
Number of PFS events
Title
Measurements
OG00046(0.643 to 1.529)
OG00127
Progression
Title
Measurements
OG00033
OG00125
Number of censored
Title
Measurements
OG00025
OG0018
Death
Title
Measurements
OG00013
OG0012
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
The hazard ratio was estimated using the Bayesian Cox proportional hazard (PH) model.
median HR
0.990
Superiority or Other (legacy)
OG000
OG001
Regression, Cox
0.643
Hazard Ratio (HR)
1.12
2-Sided
95
0.69
1.82
Superiority or Other (legacy)
OG000
OG001
Adjusted on Covariates: treatment, sum of longest diameters from central data [SLD (C)], Hemaglobin (Hgb) and White Blood Cells (WBC).
Regression, Cox
0.039
Hazard Ratio (HR)
0.54
2-Sided
95
0.30
0.97
Superiority or Other (legacy)
29
Title
Denominators
Categories
Title
Measurements
OG0003.896(2.868 to 5.241)
Units
Counts
Participants
OG00015
OG0016
OG0025
OG00317
Title
Denominators
Categories
AUCinf
Title
Measurements
OG00022600(16600 to 48500)
OG00124100(9290 to 33200)
OG00227800(17200 to 60100)
OG00327300(15700 to 47400)
AUC0_24
Title
Measurements
OG00018800(5590 to 43400)
OG00119400(7580 to 32100)
OG00226300(16000 to 56100)
OG003
AUClast
Title
Measurements
OG00019200(5830 to 42700)
OG00122100(4390 to 31800)
OG00226200(15800 to 55600)
OG003
16
Title
Denominators
Categories
Number of PFS
Title
Measurements
OG00012
Progression
Title
Measurements
OG0009
Death
Title
Measurements
OG0003
Number of Censored
Title
Measurements
OG0004
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
Kaplan-Meier method (median)
43.0
2-Sided
95
27.0
88.0
days
Superiority or Other (legacy)
Units
Counts
Participants
OG00016
OG0015
OG00218
OG0036
Title
Denominators
Categories
PFS event (Progression)
Title
Measurements
OG0005
OG0012
OG00210
OG0032
PFS event (Death)
Title
Measurements
OG0002
OG0012
OG0021
OG003
Number of Censored
Title
Measurements
OG0009
OG0011
OG0027
OG003
OG00071
OG00135
OG002106
Title
Denominators
Categories
Complete Response
Title
Measurements
OG0001
OG0010
OG0021
Partial Response
Title
Measurements
OG0006
OG0012
OG0028
Stable Disease
Title
Measurements
OG00024
OG0018
OG00232
Progressive Disease
Title
Measurements
OG00017
OG00112
OG00229
Non-CR/Non-PD (NCRNPD)
Title
Measurements
OG0006
OG00110
OG00216
Unknown
Title
Measurements
OG00017
OG0013
OG00220
29
Title
Denominators
Categories
Complete Response (CR)
Title
Measurements
OG0001
Partial Response (PR)
Title
Measurements
OG0002
Stable Disease (SD)
Title
Measurements
OG0008
Progressive Disease (PD)
Title
Measurements
OG0005
Non-CR/Non-PD (NCRNPD)
Title
Measurements
OG0006
Unknown
Title
Measurements
OG0007
OG00071
OG00135
OG002106
Title
Denominators
Categories
Overall response rate (ORR) (CR or PR)
Title
Measurements
OG0009.9(4.1 to 19.3)
OG0015.7(0.7 to 19.2)
OG0028.5(4.0 to 15.5)
Disease control rate 1 (DCR 1) (CR or PR or SD)
Title
Measurements
OG00043.7(31.9 to 56.0)
OG00128.6(14.6 to 46.3)
OG00238.7(29.4 to 48.6)
DCR 2 (CR or PR or SD or Non-CR/Non-PD)
Title
Measurements
OG00052.1(39.9 to 64.1)
OG00157.1(39.4 to 73.7)
OG00253.8(43.8 to 63.5)
29
Title
Denominators
Categories
Overall response rate (ORR) (CR or PR)
Title
Measurements
OG00010.3(2.2 to 27.4)
Disease control rate 1 (DCR 1) (CR or PR or SD)
Title
Measurements
OG00037.9(20.7 to 57.7)
DCR 2 (CR or PR or SD or Non-CR/Non-PD)
Title
Measurements
OG00058.6(38.9 to 76.5)
71
OG00135
Title
Denominators
Categories
Number of deaths
Title
Measurements
OG00051
OG00126
Number of censored
Title
Measurements
OG00020
OG0019
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Regression, Cox
0.313
Hazard Ratio (HR)
1.28
2-Sided
95
0.79
2.05
Superiority or Other (legacy)
29
Title
Denominators
Categories
Number of deaths
Title
Measurements
OG00013
Number of censored
Title
Measurements
OG00010
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
Kaplan-Meier (median)
294.0
2-Sided
95
172.0
463.0
Superiority or Other (legacy)
OG004
All Patients
BYL719 + Cetuximab in Phase II (non-randomized) in patients resistant to or intolerant/ineligible for platinum-based
Units
Counts
Participants
OG00016
OG0015
OG00218
OG0036
OG00445
Title
Denominators
Categories
ORR (CR) or PR)
Title
Measurements
OG00025.5(7.3 to 52.4)
OG0010.0(0.0 to 52.2)
OG0020.0(0.0 to 18.5)
OG0030.0(0.0 to 45.9)
OG0048.9(2.5 to 21.2)
DCR (CR or PR or Stable Disease or non-CR/Non-PD)
Title
Measurements
OG00075.0(47.6 to 92.7)
OG00120.0(0.5 to 71.6)
OG00250.0(26.0 to 74.0)
OG003
16
Title
Denominators
Categories
Overall Response (ORR) - CR or PR
Title
Measurements
OG0000(NA to NA)none of the patients achieved complete response and partial response.
Disease Control Rate (DCR) - CR, PR, or SD
Title
Measurements
OG00025.0(7.27 to 52.38)
16
Title
Denominators
Categories
Title
Measurements
OG00096.0(87.0 to 148.0)
Units
Counts
Participants
OG00015
OG00117
OG0026
OG0035
Title
Denominators
Categories
AUCinf
Title
Measurements
OG00022600(16600 to 48500)
OG00127300(15700 to 47400)
OG00224100(9290 to 33200)
OG00327800(17200 to 60100)
AUC0_24
Title
Measurements
OG00018800(5590 to 43400)
OG00125600(14600 to 42100)
OG00219400(7580 to 32100)
OG003
AUClast
Title
Measurements
OG00019200(5830 to 42700)
OG0012370(1330 to 3710)
OG00222100(4390 to 31800)
OG003
Units
Counts
Participants
OG00015
OG00117
OG0026
OG0035
Title
Denominators
Categories
Title
Measurements
OG0002130(303 to 4280)
OG0012370(1330 to 3710)
OG0022010(682 to 2980)
OG0032520(1800 to 6240)
Units
Counts
Participants
OG00015
OG00117
OG0026
OG0035
Title
Denominators
Categories
Title
Measurements
OG0002.02(1 to 24.8)
OG0012.97(1 to 5.87)
OG0023(0.767 to 6)
OG0032.23(1.58 to 3.02)
Participants
OG00015
OG00117
OG0026
Title
Denominators
Categories
AUC (0-24)
Title
Measurements
OG00024600(17900 to 44400)
OG00128500(12700 to 53900)
OG00230500(30500 to 30500)
AUClast
Title
Measurements
OG00024500(18000 to 76100)
OG0012370(1330 to 3710)
OG00222100(4390 to 31800)
Participants
OG00015
OG00117
OG0026
Title
Denominators
Categories
Title
Measurements
OG0002200(1710 to 6520)
OG0012820(373 to 4710)
OG0022750(2750 to 2750)
OG00015
OG00117
OG0026
Title
Denominators
Categories
Title
Measurements
OG0003.15(1.5 to 7.13)
OG0013.15(1.03 to 8)
OG0021(1 to 1)
Units
Counts
Participants
OG00015
OG0015
OG00218
OG0036
Title
Denominators
Categories
Sitting Pulse rate (bpm): High only
Title
Measurements
OG0000
OG0010
OG0024
OG0034
Sitting Pulse rate (bpm): Low only
Title
Measurements
OG0000
OG0010
OG0020
OG003
Sitting Pulse rate (bpm): High and low
Title
Measurements
OG0000
OG0010
OG0020
OG003
Sitting systolic B.P. (mmHg): High only
Title
Measurements
OG0001
OG0010
OG0021
OG003
Sitting systolic B.P. (mmHg): Low only
Title
Measurements
OG0001
OG0010
OG0020
OG003
Sitting systolic B.P. (mmHg): High and low
Title
Measurements
OG0000
OG0010
OG0021
OG003
Sitting diastolic B.P. (mmHg): High only
Title
Measurements
OG0000
OG0010
OG0021
OG003
Sitting diastolic B.P. (mmHg): Low only
Title
Measurements
OG0001
OG0010
OG0022
OG003
Sitting diastolic B.P. (mmHg): High and low
Title
Measurements
OG0000
OG0010
OG0020
OG003
Body Temperature (Celsius): High only
Title
Measurements
OG0000
OG0010
OG0020
OG003
Body Temperature (Celsius): Low only
Title
Measurements
OG0000
OG0010
OG0020
OG003
Body Temperature (Celsius): High and low
Title
Measurements
OG0000
OG0010
OG0020
OG003
Weight (kg): High only
Title
Measurements
OG0000
OG0010
OG0020
OG003
Weight (kg): Low only
Title
Measurements
OG0007
OG0011
OG0023
OG003
Weight (kg): High and low
Title
Measurements
OG0000
OG0010
OG0020
OG003
Respiratory Rate (bpm): High only
Title
Measurements
OG0000
OG0010
OG0022
OG003
Respiratory Rate (bpm): Low only
Title
Measurements
OG0000
OG0010
OG0020
OG003
Respiratory Rate (bpm): High and low
Title
Measurements
OG0000
OG0010
OG0020
OG003
Units
Counts
Participants
OG00015
OG0015
OG00218
OG0036
Title
Denominators
Categories
QTcF (msec): Increase from baseline > 30
ParticipantsOG00014
ParticipantsOG0015
ParticipantsOG00218
ParticipantsOG0036
Title
Measurements
OG0009
OG0014
OG00210
OG003
QTcF (msec): Increase from baseline > 60
ParticipantsOG00014
ParticipantsOG0015
ParticipantsOG00218
ParticipantsOG0036
QTcB (msec): Increase from baseline > 30
ParticipantsOG00014
ParticipantsOG0015
ParticipantsOG00218
ParticipantsOG0036
QTcB (msec): Increase from baseline > 60
ParticipantsOG00014
ParticipantsOG0015
ParticipantsOG00218
ParticipantsOG0036
QT (msec): Increase from baseline > 30
ParticipantsOG00014
ParticipantsOG0015
ParticipantsOG00218
ParticipantsOG0036
QT (msec): Increase from baseline > 60
ParticipantsOG00014
ParticipantsOG0015
ParticipantsOG00218
ParticipantsOG0036
VR (bpm): RR decrease > 25% & to a VR > 100
ParticipantsOG00014
ParticipantsOG0015
ParticipantsOG00218
ParticipantsOG0036
VR (bpm): RR decrease > 25% & to a VR < 50
ParticipantsOG00014
ParticipantsOG0015
ParticipantsOG00218
ParticipantsOG0036
PR (msec): increase > 25% & to a VR > 200
ParticipantsOG00014
ParticipantsOG0015
ParticipantsOG00218
ParticipantsOG0036
QRS (msec): increase > 25% & to a VR > 110
ParticipantsOG00014
ParticipantsOG0015
ParticipantsOG00218
ParticipantsOG0036
Participants
OG00069
OG00135
OG00229
Title
Denominators
Categories
Sitting Pulse rate (bpm): High only
Title
Measurements
OG0004
OG0013
OG0025
Sitting Pulse rate (bpm): Low only
Title
Measurements
OG0001
OG0010
OG0021
Sitting Pulse rate (bpm): High and low
Title
Measurements
OG0000
OG0010
OG0020
Sitting systolic B.P. (mmHg): High only
Title
Measurements
OG0000
OG0011
OG0020
Sitting systolic B.P. (mmHg): Low only
Title
Measurements
OG00011
OG0013
OG0021
Sitting systolic B.P. (mmHg): High and low
Title
Measurements
OG0001
OG0010
OG0020
Sitting diastolic B.P. (mmHg): High only
Title
Measurements
OG0001
OG0012
OG0020
Sitting diastolic B.P. (mmHg): Low only
Title
Measurements
OG0004
OG0013
OG0022
Sitting diastolic B.P. (mmHg): High and low
Title
Measurements
OG0001
OG0010
OG0020
Body Temperature (Celsius): High only
Title
Measurements
OG0001
OG0010
OG0020
Body Temperature (Celsius): Low only
Title
Measurements
OG0003
OG0011
OG0022
Body Temperature (Celsius): High and low
Title
Measurements
OG0000
OG0010
OG0020
Weight (kg): High only
Title
Measurements
OG0001
OG0014
OG0020
Weight (kg): Low only
Title
Measurements
OG00031
OG0013
OG0029
Weight (kg): High and low
Title
Measurements
OG0000
OG0010
OG0020
Respiratory Rate (bpm): High only
Title
Measurements
OG0002
OG0010
OG0021
Respiratory Rate (bpm): Low only
Title
Measurements
OG0002
OG0011
OG0024
Respiratory Rate (bpm): High and low
Title
Measurements
OG0000
OG0010
OG0020
Units
Counts
Participants
OG00069
OG00135
OG00229
Title
Denominators
Categories
QTcF (msec): Increase from baseline > 30
ParticipantsOG00068
ParticipantsOG00132
ParticipantsOG00228
Title
Measurements
OG00035
OG0014
OG00215
QTcF (msec): Increase from baseline > 60
ParticipantsOG00068
ParticipantsOG00132
ParticipantsOG00228
Title
Measurements
OG000
QTcB (msec): Increase from baseline > 30
ParticipantsOG00068
ParticipantsOG00132
ParticipantsOG00228
Title
Measurements
OG000
QTcB (msec): Increase from baseline > 60
ParticipantsOG00068
ParticipantsOG00132
ParticipantsOG00228
Title
Measurements
OG000
QT (msec): Increase from baseline > 30
ParticipantsOG00068
ParticipantsOG00132
ParticipantsOG00228
Title
Measurements
OG000
QT (msec): Increase from baseline > 60
ParticipantsOG00068
ParticipantsOG00132
ParticipantsOG00228
Title
Measurements
OG000
VR (bpm): RR decrease > 25% & to a VR > 100
ParticipantsOG00068
ParticipantsOG00132
ParticipantsOG00228
Title
Measurements
OG000
VR (bpm): RR decrease > 25% & to a VR < 50
ParticipantsOG00069
ParticipantsOG00132
ParticipantsOG00228
Title
Measurements
OG000
PR (msec): increase > 25% & to a VR > 200
ParticipantsOG00068
ParticipantsOG00131
ParticipantsOG00227
Title
Measurements
OG000
QRS (msec): increase > 25% & to a VR > 110
ParticipantsOG00068
ParticipantsOG00132
ParticipantsOG00228
Title
Measurements
OG000
Units
Counts
Participants
OG00071
OG00135
OG00229
Title
Denominators
Categories
Title
Measurements
OG00094.0(58.0 to 135.0)
OG00185.0(49.0 to 127.0)
OG002117.0(50.0 to 184.0)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Regression, Cox
0.235
Hazard Ratio (HR)
0.76
2-Sided
95
0.49
1.19
Superiority or Other (legacy)
OG000
OG001
Adjusted on Covariates: treatment, sum of longest diameters from local data [SLD (L)], Hemaglobin (Hgb) and White Blood Cells (WBC).