IRESSAâ„¢ (Gefitinib) With Cisplatin Plus Radiotherapy for... | NCT00229723 | Trialant
NCT00229723
Sponsor
AstraZeneca
Status
Completed
Last Update Posted
Aug 4, 2009Estimated
Enrollment
224Actual
Phase
Phase 2
Conditions
Neoplasms, Squamous Cell
Interventions
gefitinib (Iressa)
cisplatin
radiotherapy
Gefitinib (Iressa)
Countries
United States
Belgium
Czechia
Germany
India
Poland
Serbia
Taiwan
Protocol Section
Identification Module
NCT ID
NCT00229723
Obsolete or Duplicate NCT IDs
NCT00099398
Organization Study
1839IL/0706
Secondary IDs
ID
Type
Description
Link
EudraCT number 2004-000358-21
D7919C00706
Brief Title
IRESSAâ„¢ (Gefitinib) With Cisplatin Plus Radiotherapy for the Treatment of Previously Untreated Unresected Late Stage III/IV Non-Metastatic Head and Neck Squamous Cell Carcinoma
Official Title
A Phase 2 Randomised, Double-Blind, Placebo-Controlled, Multicentre Comparative Study of Gefitinib 250 mg or 500 mg (IRESSAâ„¢) Given Either Continuously or Concomitantly With Cisplatin Plus Radiotherapy for the Treatment of Patients With Previously Untreated Unresected Late Stage III/IV Non-Metastatic Head and Neck Squamous Cell Carcinoma
Acronym
Not provided
Organization
AstraZenecaINDUSTRY
Status Module
Record Verification Date
Jun 2009
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Nov 2004
Primary Completion Date
Not provided
Completion Date
Jun 2008Actual
First Submitted Date
Sep 28, 2005
First Submission Date that Met QC Criteria
Sep 28, 2005
First Posted Date
Sep 30, 2005Estimated
Results Waived
Not provided
Results First Submitted Date
Jun 17, 2009
Results First Submitted that Met QC Criteria
Jun 17, 2009
Results First Posted Date
Aug 4, 2009Estimated
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
Jun 17, 2009
Last Update Posted Date
Aug 4, 2009Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Not provided
Lead Sponsor
AstraZenecaINDUSTRY
Collaborators
Not provided
Oversight Module
No data available
No data is available for this block.
Description Module
Brief Summary
The primary purpose of this study is to assess the effectiveness of ZD1839 250 mg and 500 mg when given either concomitantly or as maintenance to a standard therapy of radiotherapy (X-rays) plus chemotherapy (cisplatin) in terms of local disease control (progression-free) rate at 2 years.
Detailed Description
Not provided
Conditions Module
Conditions
Neoplasms, Squamous Cell
Keywords
Head and Neck Squamous Cell Carcinoma
Head and Neck Squamous Cell Cancer
Squamous Cell Carcinoma
Squamous Cell Cancer
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 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
224Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
1
Placebo Comparator
Radiation + cisplatin; followed by placebo as maintenance therapy
Drug: cisplatin
Radiation: radiotherapy
2
Experimental
250 mg gefitinib + radiation + cisplatin; followed by placebo as maintenance therapy
Drug: gefitinib (Iressa)
Drug: cisplatin
Radiation: radiotherapy
3
Experimental
500 mg gefitinib + radiation + cisplatin; followed by placebo as maintenance therapy
Drug: cisplatin
Radiation: radiotherapy
Drug: Gefitinib (Iressa)
4
Experimental
gefitinib 250 mg + cisplatin + radiotherapy; followed by gefitinib 250 mg as maintenance therapy
Drug: gefitinib (Iressa)
Drug: cisplatin
Radiation: radiotherapy
5
Experimental
gefitinib 500 mg + cisplatin + radiotherapy; followed by gefitinib 500 mg as maintenance therapy
Drug: cisplatin
Radiation: radiotherapy
Drug: Gefitinib (Iressa)
Interventions
Name
Type
Description
Arm Group Labels
Other Names
gefitinib (Iressa)
Drug
250 mg oral tablet
2
4
6
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Local Disease Control Rate at 2 Years
A patient demonstrated local disease control at 2 years if there was no evidence of failure of treatment. Failure was defined as the patient having objective disease progression (as per RECIST) inside the original irradiated area, at an isodose level (between 20% and 95%), or death.
Assessed at 2 yrs. Tumour assessments (clinical & by CT/MRI) were carried out during screening & regularly throughout the study until disease progression (as defined by Response evaluation criteria in solid tumours (RECIST)).
Secondary Outcomes
Measure
Description
Time Frame
Local Disease Control Rate at 1 Year
A patient demonstrated local disease control at 1 year if there was no evidence of failure of treatment. Failure was defined as the patient having objective disease progression (as per RECIST) inside the original irradiated area, at an isodose level (between 20% and 95%), or death.
Assessed after 1 year. Tumour assessments (clinical and by CT/MRI) were carried out during screening & regularly throughout the study until disease progression (as defined by RECIST).
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Histologically or cytologically confirmed stage III or IVA squamous cell carcinoma of the head and neck
No prior surgery or chemotherapy/biological therapy/radiation therapy
Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST)
Life expectancy of more than 12 weeks
Exclusion Criteria:
Cancers of the nasal space, oral cavity and larynx; or certain lung diseases.
Abnormal blood chemistry; uncontrolled respiratory, cardiac, hepatic, or renal disease; or coexisting malignancies.
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
AstraZeneca Oncology Medical Science Director, MD
AstraZeneca
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Research Site
Aurora
Colorado
United States
Research Site
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
Participant Flow Module
Pre-assignment Details
Not provided
Recruitment Details
In total, 226 patients from 26 centres in 8 countries were randomized to receive study medication, the first patient was enrolled into the study on 13 November 2004 and the last patient completed the study on 27 June 2008. Patients were to be followed up for a maximum of two years (± 12 weeks) after randomization.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Placebo/Placebo
Concomitant placebo (plus cisplatin and radiotherapy) followed by placebo as maintenance therapy
FG001
250mg/Placebo
Concomitant gefitinib 250 mg (plus cisplatin and radiotherapy) followed by placebo as maintenance therapy
placebo + cisplatin + radiotherapy; followed by gefitinib 250 mg as maintenance therapy
Drug: gefitinib (Iressa)
Drug: cisplatin
Radiation: radiotherapy
7
Placebo Comparator
placebo + cisplatin + radiotherapy; followed by gefitinib 500 mg as maintenance therapy
Drug: cisplatin
Radiation: radiotherapy
Drug: Gefitinib (Iressa)
ZD1839
IRESSA
cisplatin
Drug
intravenous infusion
1
2
3
4
5
6
7
radiotherapy
Radiation
radiation therapy
1
2
3
4
5
6
7
Gefitinib (Iressa)
Drug
500 mg oral tablet
3
5
7
ZD1839
Iressa
Complete Response
A patient was deemed to be a complete responder if the RECIST criteria for complete response were satisfied at any time during the study.
Assessed at 2 years. Clinical tumour assessments and tumour assessment by CT/MRI were carried out during screening and regularly throughout the study until disease progression.
A patient was deemed to be have a tumour response if the RECIST criteria for complete response or partial response were satisfied at any time during the study.
Assessed at 2 years. Clinical tumour assessments and tumour assessment by CT/MRI were carried out during screening and regularly throughout the study until disease progression
Progression Free Survival
Percentage of participants who are progression free at 2 years (calculated using the Kaplan-Meier method, which allows for censored observations for example those lost to follow-up). A patient is said to have progressed if they have progression of target or non-target lesions or evidence of any new lesions (as defined by RECIST).
Clinical tumour assessments and tumour assessment by CT/MRI were carried out during screening and regularly throughout the study until disease progression (as defined by RECIST)
Overall Survival
Percentage of participants who are alive at 2 years (calculated using the Kaplan-Meier method, which allows for patients who do not have complete follow-up (censored observations)).
Concomitant gefitinib 500 mg (plus cisplatin and radiotherapy) followed by placebo as maintenance therapy
FG003
250mg/250mg
Concomitant gefitinib 250 mg (plus cisplatin and radiotherapy) followed by gefitinib 250 mg as maintenance therapy
FG004
500mg/500mg
Concomitant gefitinib 500 mg (plus cisplatin and radiotherapy) followed by gefitinib 500 mg as maintenance therapy
FG005
Placebo/250mg
Concomitant placebo (plus cisplatin and radiotherapy) followed by gefitinib 250 mg as maintenance therapy
FG006
Placebo/500mg
Concomitant placebo (plus cisplatin and radiotherapy) followed by gefitinib 500 mg as maintenance therapy
FG00060 subjectsReceived randomized treatment
FG00124 subjectsReceived randomized treatment
FG00231 subjectsReceived randomized treatment
FG00331 subjectsReceived randomized treatment
FG00424 subjectsReceived randomized treatment
FG00534 subjectsReceived randomized treatment
FG00622 subjectsReceived randomized treatment
COMPLETED
FG00050 subjects
FG00119 subjects
FG00225 subjects
FG00326 subjects
FG00422 subjects
FG00531 subjects
FG00619 subjects
NOT COMPLETED
FG00010 subjects
FG0015 subjects
FG0026 subjects
FG0035 subjects
FG0042 subjects
FG0053 subjects
FG0063 subjects
Type
Comment
Reasons
Adverse Event
FG0004 subjects
FG0012 subjects
FG0025 subjects
FG0032 subjects
FG0040 subjects
FG0051 subjects
FG0062 subjects
Objective disease progression
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Clinical progression
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Informed consent withdrawn
FG0003 subjects
FG0012 subjects
FG0020 subjects
FG0032 subjects
FG004
Severe non-compliance
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
Other
FG0003 subjects
FG0010 subjects
FG0021 subjects
FG0031 subjects
FG004
Maintenance Phase
Type
Comment
Milestone Data
STARTED
FG00050 subjects
FG00119 subjects
FG00225 subjects
FG00326 subjects
FG00422 subjects
FG00531 subjects
FG00619 subjects
COMPLETED
FG00025 subjectsCompleted study on randomized treatment
FG0015 subjectsCompleted study on randomized treatment
FG00216 subjectsCompleted study on randomized treatment
FG003
NOT COMPLETED
FG00025 subjects
FG00114 subjects
FG0029 subjects
FG00317 subjects
FG004
Type
Comment
Reasons
Adverse Event
FG0007 subjects
FG0012 subjects
FG0021 subjects
FG003
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Placebo/Placebo
Concomitant placebo (plus cisplatin and radiotherapy) followed by placebo as maintenance therapy
BG001
250mg/Placebo
Concomitant gefitinib 250 mg (plus cisplatin and radiotherapy) followed by placebo as maintenance therapy
BG002
500mg/Placebo
Concomitant gefitinib 500 mg (plus cisplatin and radiotherapy) followed by placebo as maintenance therapy
BG003
250mg/250mg
Concomitant gefitinib 250 mg (plus cisplatin and radiotherapy) followed by gefitinib 250 mg as maintenance therapy
BG004
500mg/500mg
Concomitant gefitinib 500 mg (plus cisplatin and radiotherapy) followed by gefitinib 500 mg as maintenance therapy
BG005
Placebo/250mg
Concomitant placebo (plus cisplatin and radiotherapy) followed by gefitinib 250 mg as maintenance therapy
BG006
Placebo/500mg
Concomitant placebo (plus cisplatin and radiotherapy) followed by gefitinib 500 mg as maintenance therapy
BG007
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00060
BG00124
BG00231
BG00331
BG00424
BG00534
BG00622
BG007226
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age Continuous
Mean
Full Range
Years
Title
Denominators
Categories
Title
Measurements
BG00053.1(29 to 67)
BG00152.5(21 to 73)
BG00253.4(30 to 74)
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0008
BG0013
BG002
Race/Ethnicity, Customized
Number
Participants
Title
Denominators
Categories
Caucasian (includes Indian)
Title
Measurements
BG00056
BG00122
BG002
Original site of primary cancer
Number
Participants
Title
Denominators
Categories
Oral cavity
Title
Measurements
BG0004
BG0010
BG002
Stage of disease at entry to study
Number
Participants
Title
Denominators
Categories
Stage III
Title
Measurements
BG00010
BG0017
BG002
WHO Performance Status
Number
Participants
Title
Denominators
Categories
0 (Normal activity)
Title
Measurements
BG00041
BG00114
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
Local Disease Control Rate at 2 Years
A patient demonstrated local disease control at 2 years if there was no evidence of failure of treatment. Failure was defined as the patient having objective disease progression (as per RECIST) inside the original irradiated area, at an isodose level (between 20% and 95%), or death.
Posted
Number
Participants
Assessed at 2 yrs. Tumour assessments (clinical & by CT/MRI) were carried out during screening & regularly throughout the study until disease progression (as defined by Response evaluation criteria in solid tumours (RECIST)).
ID
Title
Description
OG000
Placebo/Placebo
Concomitant placebo (plus cisplatin and radiotherapy) followed by placebo as maintenance therapy
OG001
250mg/Placebo
Concomitant gefitinib 250 mg (plus cisplatin and radiotherapy) followed by placebo as maintenance therapy
OG002
500mg/Placebo
Concomitant gefitinib 500 mg (plus cisplatin and radiotherapy) followed by placebo as maintenance therapy
OG003
250mg/250mg
Concomitant gefitinib 250 mg (plus cisplatin and radiotherapy) followed by gefitinib 250 mg as maintenance therapy
OG004
500mg/500mg
Concomitant gefitinib 500 mg (plus cisplatin and radiotherapy) followed by gefitinib 500 mg as maintenance therapy
OG005
Placebo/250mg
Concomitant placebo (plus cisplatin and radiotherapy) followed by gefitinib 250 mg as maintenance therapy
OG006
Placebo/500mg
Concomitant placebo (plus cisplatin and radiotherapy) followed by gefitinib 500 mg as maintenance therapy
Units
Counts
Participants
OG00060
OG00124
OG00231
OG003
Title
Denominators
Categories
Title
Measurements
OG00021
OG0017
OG00215
OG003
Secondary
Local Disease Control Rate at 1 Year
A patient demonstrated local disease control at 1 year if there was no evidence of failure of treatment. Failure was defined as the patient having objective disease progression (as per RECIST) inside the original irradiated area, at an isodose level (between 20% and 95%), or death.
Posted
Number
Participants
Assessed after 1 year. Tumour assessments (clinical and by CT/MRI) were carried out during screening & regularly throughout the study until disease progression (as defined by RECIST).
ID
Title
Description
OG000
Placebo/Placebo
Concomitant placebo (plus cisplatin and radiotherapy) followed by placebo as maintenance therapy
OG001
250mg/Placebo
Concomitant gefitinib 250 mg (plus cisplatin and radiotherapy) followed by placebo as maintenance therapy
OG002
500mg/Placebo
Concomitant gefitinib 500 mg (plus cisplatin and radiotherapy) followed by placebo as maintenance therapy
OG003
250mg/250mg
Concomitant gefitinib 250 mg (plus cisplatin and radiotherapy) followed by gefitinib 250 mg as maintenance therapy
Secondary
Complete Response
A patient was deemed to be a complete responder if the RECIST criteria for complete response were satisfied at any time during the study.
Posted
Number
Participants
Assessed at 2 years. Clinical tumour assessments and tumour assessment by CT/MRI were carried out during screening and regularly throughout the study until disease progression.
ID
Title
Description
OG000
Placebo/Placebo
Concomitant placebo (plus cisplatin and radiotherapy) followed by placebo as maintenance therapy
OG001
250mg/Placebo
Concomitant gefitinib 250 mg (plus cisplatin and radiotherapy) followed by placebo as maintenance therapy
OG002
500mg/Placebo
Concomitant gefitinib 500 mg (plus cisplatin and radiotherapy) followed by placebo as maintenance therapy
OG003
250mg/250mg
Concomitant gefitinib 250 mg (plus cisplatin and radiotherapy) followed by gefitinib 250 mg as maintenance therapy
A patient was deemed to be have a tumour response if the RECIST criteria for complete response or partial response were satisfied at any time during the study.
Posted
Number
Participants
Assessed at 2 years. Clinical tumour assessments and tumour assessment by CT/MRI were carried out during screening and regularly throughout the study until disease progression
ID
Title
Description
OG000
Placebo/Placebo
Concomitant placebo (plus cisplatin and radiotherapy) followed by placebo as maintenance therapy
OG001
250mg/Placebo
Concomitant gefitinib 250 mg (plus cisplatin and radiotherapy) followed by placebo as maintenance therapy
OG002
500mg/Placebo
Concomitant gefitinib 500 mg (plus cisplatin and radiotherapy) followed by placebo as maintenance therapy
OG003
250mg/250mg
Concomitant gefitinib 250 mg (plus cisplatin and radiotherapy) followed by gefitinib 250 mg as maintenance therapy
Secondary
Progression Free Survival
Percentage of participants who are progression free at 2 years (calculated using the Kaplan-Meier method, which allows for censored observations for example those lost to follow-up). A patient is said to have progressed if they have progression of target or non-target lesions or evidence of any new lesions (as defined by RECIST).
Posted
Number
Percentage of participants
Clinical tumour assessments and tumour assessment by CT/MRI were carried out during screening and regularly throughout the study until disease progression (as defined by RECIST)
ID
Title
Description
OG000
Placebo/Placebo
Concomitant placebo (plus cisplatin and radiotherapy) followed by placebo as maintenance therapy
OG001
250mg/Placebo
Concomitant gefitinib 250 mg (plus cisplatin and radiotherapy) followed by placebo as maintenance therapy
OG002
500mg/Placebo
Concomitant gefitinib 500 mg (plus cisplatin and radiotherapy) followed by placebo as maintenance therapy
OG003
250mg/250mg
Secondary
Overall Survival
Percentage of participants who are alive at 2 years (calculated using the Kaplan-Meier method, which allows for patients who do not have complete follow-up (censored observations)).
Posted
Number
Percentage of participants
Overall survival assessed at 2 years
ID
Title
Description
OG000
Placebo/Placebo
Concomitant placebo (plus cisplatin and radiotherapy) followed by placebo as maintenance therapy
OG001
250mg/Placebo
Concomitant gefitinib 250 mg (plus cisplatin and radiotherapy) followed by placebo as maintenance therapy
OG002
500mg/Placebo
Concomitant gefitinib 500 mg (plus cisplatin and radiotherapy) followed by placebo as maintenance therapy
OG003
250mg/250mg
Concomitant gefitinib 250 mg (plus cisplatin and radiotherapy) followed by gefitinib 250 mg as maintenance therapy
OG004
500mg/500mg
Secondary
Safety and Tolerability
Not Posted
Assessed over two years
Time Frame
Not provided
Description
Not provided
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Placebo/Placebo
Concomitant placebo (plus cisplatin and radiotherapy) followed by placebo as maintenance therapy
23
58
EG001
250mg/Placebo
Concomitant gefitinib 250 mg (plus cisplatin and radiotherapy) followed by placebo as maintenance therapy
9
23
EG002
500mg/Placebo
Concomitant gefitinib 500 mg (plus cisplatin and radiotherapy) followed by placebo as maintenance therapy
21
30
EG003
250mg/250mg
Concomitant gefitinib 250 mg (plus cisplatin and radiotherapy) followed by gefitinib 250 mg as maintenance therapy
15
30
EG004
500mg/500mg
Concomitant gefitinib 500 mg (plus cisplatin and radiotherapy) followed by gefitinib 500 mg as maintenance therapy
14
23
EG005
Placebo/250mg
Concomitant placebo (plus cisplatin and radiotherapy) followed by gefitinib 250 mg as maintenance therapy
16
32
EG006
Placebo/500mg
Concomitant placebo (plus cisplatin and radiotherapy) followed by gefitinib 500 mg as maintenance therapy
11
21
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 11.0
Systematic Assessment
EG0001 affected60 at risk
EG0010 affected24 at risk
EG0020 affected31 at risk
EG0030 affected31 at risk
EG0040 affected24 at risk
EG0051 affected34 at risk
EG0060 affected22 at risk
Febrile Neutropenia
Blood and lymphatic system disorders
MedDRA 11.0
Systematic Assessment
EG0000 affected60 at risk
EG0010 affected24 at risk
EG0020 affected31 at risk
EG003
Leukopenia
Blood and lymphatic system disorders
MedDRA 11.0
Systematic Assessment
EG0000 affected60 at risk
EG0010 affected24 at risk
EG0020 affected31 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA 11.0
Systematic Assessment
EG0000 affected60 at risk
EG0010 affected24 at risk
EG0020 affected31 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 11.0
Systematic Assessment
EG0000 affected60 at risk
EG0010 affected24 at risk
EG0020 affected31 at risk
EG003
Cardiac Arrest
Cardiac disorders
MedDRA 11.0
Systematic Assessment
EG0003 affected60 at risk
EG0010 affected24 at risk
EG0020 affected31 at risk
EG003
Cardiac Failure
Cardiac disorders
MedDRA 11.0
Systematic Assessment
EG0000 affected60 at risk
EG0010 affected24 at risk
EG0021 affected31 at risk
EG003
Cardiopulmonary Failure
Cardiac disorders
MedDRA 11.0
Systematic Assessment
EG0001 affected60 at risk
EG0010 affected24 at risk
EG0020 affected31 at risk
EG003
Cardio-Respiratory Arrest
Cardiac disorders
MedDRA 11.0
Systematic Assessment
EG0000 affected60 at risk
EG0010 affected24 at risk
EG0022 affected31 at risk
EG003
Myocardial Infarction
Cardiac disorders
MedDRA 11.0
Systematic Assessment
EG0001 affected60 at risk
EG0010 affected24 at risk
EG0021 affected31 at risk
EG003
Deafness Bilateral
Ear and labyrinth disorders
MedDRA 11.0
Systematic Assessment
EG0000 affected60 at risk
EG0010 affected24 at risk
EG0021 affected31 at risk
EG003
Hypoacusis
Ear and labyrinth disorders
MedDRA 11.0
Systematic Assessment
EG0000 affected60 at risk
EG0010 affected24 at risk
EG0021 affected31 at risk
EG003
Visual Disturbance
Eye disorders
MedDRA 11.0
Systematic Assessment
EG0000 affected60 at risk
EG0010 affected24 at risk
EG0020 affected31 at risk
EG003
Abdominal Pain Upper
Gastrointestinal disorders
MedDRA 11.0
Systematic Assessment
EG0000 affected60 at risk
EG0010 affected24 at risk
EG0020 affected31 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 11.0
Systematic Assessment
EG0000 affected60 at risk
EG0010 affected24 at risk
EG0023 affected31 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA 11.0
Systematic Assessment
EG0002 affected60 at risk
EG0010 affected24 at risk
EG0020 affected31 at risk
EG003
Gastric Ulcer
Gastrointestinal disorders
MedDRA 11.0
Systematic Assessment
EG0000 affected60 at risk
EG0010 affected24 at risk
EG0020 affected31 at risk
EG003
Gastric Ulcer Perforation
Gastrointestinal disorders
MedDRA 11.0
Systematic Assessment
EG0001 affected60 at risk
EG0010 affected24 at risk
EG0021 affected31 at risk
EG003
Gastrointestinal Disorder
Gastrointestinal disorders
MedDRA 11.0
Systematic Assessment
EG0001 affected60 at risk
EG0010 affected24 at risk
EG0020 affected31 at risk
EG003
Haematemesis
Gastrointestinal disorders
MedDRA 11.0
Systematic Assessment
EG0000 affected60 at risk
EG0010 affected24 at risk
EG0020 affected31 at risk
EG003
Intestinal Ischaemia
Gastrointestinal disorders
MedDRA 11.0
Systematic Assessment
EG0000 affected60 at risk
EG0010 affected24 at risk
EG0020 affected31 at risk
EG003
Mouth Haemorrhage
Gastrointestinal disorders
MedDRA 11.0
Systematic Assessment
EG0001 affected60 at risk
EG0010 affected24 at risk
EG0020 affected31 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 11.0
Systematic Assessment
EG0001 affected60 at risk
EG0010 affected24 at risk
EG0020 affected31 at risk
EG003
Oesophagitis
Gastrointestinal disorders
MedDRA 11.0
Systematic Assessment
EG0001 affected60 at risk
EG0010 affected24 at risk
EG0020 affected31 at risk
EG003
Peptic Ulcer
Gastrointestinal disorders
MedDRA 11.0
Systematic Assessment
EG0000 affected60 at risk
EG0010 affected24 at risk
EG0020 affected31 at risk
EG003
Pneumoperitoneum
Gastrointestinal disorders
MedDRA 11.0
Systematic Assessment
EG0000 affected60 at risk
EG0010 affected24 at risk
EG0020 affected31 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA 11.0
Systematic Assessment
EG0000 affected60 at risk
EG0010 affected24 at risk
EG0020 affected31 at risk
EG003
Upper Gastrointestinal Haemorrhage
Gastrointestinal disorders
MedDRA 11.0
Systematic Assessment
EG0001 affected60 at risk
EG0011 affected24 at risk
EG0020 affected31 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 11.0
Systematic Assessment
EG0001 affected60 at risk
EG0011 affected24 at risk
EG0020 affected31 at risk
EG003
Death
General disorders
MedDRA 11.0
Systematic Assessment
EG0002 affected60 at risk
EG0011 affected24 at risk
EG0020 affected31 at risk
EG003
Facial Pain
General disorders
MedDRA 11.0
Systematic Assessment
EG0000 affected60 at risk
EG0010 affected24 at risk
EG0020 affected31 at risk
EG003
Fatigue
General disorders
MedDRA 11.0
Systematic Assessment
EG0001 affected60 at risk
EG0011 affected24 at risk
EG0021 affected31 at risk
EG003
General Physical Health Deterioration
General disorders
MedDRA 11.0
Systematic Assessment
EG0001 affected60 at risk
EG0010 affected24 at risk
EG0020 affected31 at risk
EG003
Localised Oedema
General disorders
MedDRA 11.0
Systematic Assessment
EG0000 affected60 at risk
EG0010 affected24 at risk
EG0020 affected31 at risk
EG003
Pyrexia
General disorders
MedDRA 11.0
Systematic Assessment
EG0001 affected60 at risk
EG0010 affected24 at risk
EG0024 affected31 at risk
EG003
Sudden Death
General disorders
MedDRA 11.0
Systematic Assessment
EG0000 affected60 at risk
EG0011 affected24 at risk
EG0020 affected31 at risk
EG003
Hepatic Failure
Hepatobiliary disorders
MedDRA 11.0
Systematic Assessment
EG0000 affected60 at risk
EG0010 affected24 at risk
EG0020 affected31 at risk
EG003
Hypersensitivity
Immune system disorders
MedDRA 11.0
Systematic Assessment
EG0000 affected60 at risk
EG0010 affected24 at risk
EG0020 affected31 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 11.0
Systematic Assessment
EG0000 affected60 at risk
EG0011 affected24 at risk
EG0020 affected31 at risk
EG003
Bronchopneumonia
Infections and infestations
MedDRA 11.0
Systematic Assessment
EG0000 affected60 at risk
EG0010 affected24 at risk
EG0020 affected31 at risk
EG003
Implant Site Infection
Infections and infestations
MedDRA 11.0
Systematic Assessment
EG0000 affected60 at risk
EG0010 affected24 at risk
EG0020 affected31 at risk
EG003
Laryngitis
Infections and infestations
MedDRA 11.0
Systematic Assessment
EG0000 affected60 at risk
EG0010 affected24 at risk
EG0020 affected31 at risk
EG003
Lobar Pneumonia
Infections and infestations
MedDRA 11.0
Systematic Assessment
EG0000 affected60 at risk
EG0010 affected24 at risk
EG0021 affected31 at risk
EG003
Lower Respiratory Tract Infection
Infections and infestations
MedDRA 11.0
Systematic Assessment
EG0000 affected60 at risk
EG0010 affected24 at risk
EG0021 affected31 at risk
EG003
Lymph Gland Infection
Infections and infestations
MedDRA 11.0
Systematic Assessment
EG0000 affected60 at risk
EG0010 affected24 at risk
EG0021 affected31 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA 11.0
Systematic Assessment
EG0001 affected60 at risk
EG0011 affected24 at risk
EG0020 affected31 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 11.0
Systematic Assessment
EG0004 affected60 at risk
EG0011 affected24 at risk
EG0021 affected31 at risk
EG003
Pneumonia Fungal
Infections and infestations
MedDRA 11.0
Systematic Assessment
EG0000 affected60 at risk
EG0010 affected24 at risk
EG0020 affected31 at risk
EG003
Sepsis
Infections and infestations
MedDRA 11.0
Systematic Assessment
EG0000 affected60 at risk
EG0011 affected24 at risk
EG0020 affected31 at risk
EG003
Septic Shock
Infections and infestations
MedDRA 11.0
Systematic Assessment
EG0000 affected60 at risk
EG0011 affected24 at risk
EG0020 affected31 at risk
EG003
Soft Tissue Infection
Infections and infestations
MedDRA 11.0
Systematic Assessment
EG0000 affected60 at risk
EG0010 affected24 at risk
EG0021 affected31 at risk
EG003
Urinary Tract Infection
Infections and infestations
MedDRA 11.0
Systematic Assessment
EG0000 affected60 at risk
EG0010 affected24 at risk
EG0020 affected31 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 11.0
Systematic Assessment
EG0000 affected60 at risk
EG0010 affected24 at risk
EG0021 affected31 at risk
EG003
Femur Fracture
Injury, poisoning and procedural complications
MedDRA 11.0
Systematic Assessment
EG0000 affected60 at risk
EG0010 affected24 at risk
EG0020 affected31 at risk
EG003
Post Procedural Haemorrhage
Injury, poisoning and procedural complications
MedDRA 11.0
Systematic Assessment
EG0001 affected60 at risk
EG0010 affected24 at risk
EG0020 affected31 at risk
EG003
Radiation Mucositis
Injury, poisoning and procedural complications
MedDRA 11.0
Systematic Assessment
EG0000 affected60 at risk
EG0010 affected24 at risk
EG0020 affected31 at risk
EG003
Tibia Fracture
Injury, poisoning and procedural complications
MedDRA 11.0
Systematic Assessment
EG0000 affected60 at risk
EG0010 affected24 at risk
EG0020 affected31 at risk
EG003
Tracheal Obstruction
Injury, poisoning and procedural complications
MedDRA 11.0
Systematic Assessment
EG0001 affected60 at risk
EG0010 affected24 at risk
EG0020 affected31 at risk
EG003
Traumatic Brain Injury
Injury, poisoning and procedural complications
MedDRA 11.0
Systematic Assessment
EG0000 affected60 at risk
EG0010 affected24 at risk
EG0020 affected31 at risk
EG003
Blood Creatinine Increased
Injury, poisoning and procedural complications
MedDRA 11.0
Systematic Assessment
EG0000 affected60 at risk
EG0010 affected24 at risk
EG0020 affected31 at risk
EG003
Blood Potassium Increased
Injury, poisoning and procedural complications
MedDRA 11.0
Systematic Assessment
EG0000 affected60 at risk
EG0010 affected24 at risk
EG0020 affected31 at risk
EG003
Fibrin D Dimer Increased
Injury, poisoning and procedural complications
MedDRA 11.0
Systematic Assessment
EG0001 affected60 at risk
EG0010 affected24 at risk
EG0020 affected31 at risk
EG003
Renal Function Test Abnormal
Injury, poisoning and procedural complications
MedDRA 11.0
Systematic Assessment
EG0000 affected60 at risk
EG0010 affected24 at risk
EG0021 affected31 at risk
EG003
Anorexia
Metabolism and nutrition disorders
MedDRA 11.0
Systematic Assessment
EG0001 affected60 at risk
EG0010 affected24 at risk
EG0020 affected31 at risk
EG003
Cachexia
Metabolism and nutrition disorders
MedDRA 11.0
Systematic Assessment
EG0000 affected60 at risk
EG0011 affected24 at risk
EG0020 affected31 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 11.0
Systematic Assessment
EG0002 affected60 at risk
EG0011 affected24 at risk
EG0022 affected31 at risk
EG003
Electrolyte Imbalance
Metabolism and nutrition disorders
MedDRA 11.0
Systematic Assessment
EG0000 affected60 at risk
EG0010 affected24 at risk
EG0021 affected31 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRA 11.0
Systematic Assessment
EG0000 affected60 at risk
EG0010 affected24 at risk
EG0020 affected31 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA 11.0
Systematic Assessment
EG0000 affected60 at risk
EG0010 affected24 at risk
EG0021 affected31 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 11.0
Systematic Assessment
EG0000 affected60 at risk
EG0010 affected24 at risk
EG0020 affected31 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 11.0
Systematic Assessment
EG0002 affected60 at risk
EG0010 affected24 at risk
EG0021 affected31 at risk
EG003
Neck Mass
Musculoskeletal and connective tissue disorders
MedDRA 11.0
Systematic Assessment
EG0000 affected60 at risk
EG0010 affected24 at risk
EG0020 affected31 at risk
EG003
Neck Pain
Musculoskeletal and connective tissue disorders
MedDRA 11.0
Systematic Assessment
EG0000 affected60 at risk
EG0010 affected24 at risk
EG0021 affected31 at risk
EG003
Osteonecrosis
Musculoskeletal and connective tissue disorders
MedDRA 11.0
Systematic Assessment
EG0001 affected60 at risk
EG0010 affected24 at risk
EG0020 affected31 at risk
EG003
Degeneration Of Uterine Fibroid
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 11.0
Systematic Assessment
EG0000 affected60 at risk
EG0010 affected24 at risk
EG0020 affected31 at risk
EG003
Oropharyngeal Neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 11.0
Systematic Assessment
EG0000 affected60 at risk
EG0010 affected24 at risk
EG0020 affected31 at risk
EG003
Cerebral Artery Embolism
Nervous system disorders
MedDRA 11.0
Systematic Assessment
EG0000 affected60 at risk
EG0010 affected24 at risk
EG0020 affected31 at risk
EG003
Cerebral Haematoma
Nervous system disorders
MedDRA 11.0
Systematic Assessment
EG0000 affected60 at risk
EG0010 affected24 at risk
EG0020 affected31 at risk
EG003
Convulsion
Nervous system disorders
MedDRA 11.0
Systematic Assessment
EG0000 affected60 at risk
EG0010 affected24 at risk
EG0021 affected31 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 11.0
Systematic Assessment
EG0000 affected60 at risk
EG0010 affected24 at risk
EG0020 affected31 at risk
EG003
Epilepsy
Nervous system disorders
MedDRA 11.0
Systematic Assessment
EG0000 affected60 at risk
EG0010 affected24 at risk
EG0020 affected31 at risk
EG003
Hypoxic Encephalopathy
Nervous system disorders
MedDRA 11.0
Systematic Assessment
EG0001 affected60 at risk
EG0010 affected24 at risk
EG0020 affected31 at risk
EG003
Depression
Psychiatric disorders
MedDRA 11.0
Systematic Assessment
EG0000 affected60 at risk
EG0011 affected24 at risk
EG0020 affected31 at risk
EG003
Acute Prerenal Failure
Renal and urinary disorders
MedDRA 11.0
Systematic Assessment
EG0000 affected60 at risk
EG0010 affected24 at risk
EG0021 affected31 at risk
EG003
Azotaemia
Renal and urinary disorders
MedDRA 11.0
Systematic Assessment
EG0000 affected60 at risk
EG0010 affected24 at risk
EG0020 affected31 at risk
EG003
Renal Failure
Renal and urinary disorders
MedDRA 11.0
Systematic Assessment
EG0001 affected60 at risk
EG0010 affected24 at risk
EG0021 affected31 at risk
EG003
Renal Failure Acute
Renal and urinary disorders
MedDRA 11.0
Systematic Assessment
EG0003 affected60 at risk
EG0010 affected24 at risk
EG0020 affected31 at risk
EG003
Renal Impairment
Renal and urinary disorders
MedDRA 11.0
Systematic Assessment
EG0000 affected60 at risk
EG0010 affected24 at risk
EG0020 affected31 at risk
EG003
Choking
Respiratory, thoracic and mediastinal disorders
MedDRA 11.0
Systematic Assessment
EG0000 affected60 at risk
EG0010 affected24 at risk
EG0020 affected31 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 11.0
Systematic Assessment
EG0002 affected60 at risk
EG0011 affected24 at risk
EG0021 affected31 at risk
EG003
Laryngeal Oedema
Respiratory, thoracic and mediastinal disorders
MedDRA 11.0
Systematic Assessment
EG0001 affected60 at risk
EG0011 affected24 at risk
EG0021 affected31 at risk
EG003
Pharyngeal Haemorrhage
Respiratory, thoracic and mediastinal disorders
MedDRA 11.0
Systematic Assessment
EG0000 affected60 at risk
EG0010 affected24 at risk
EG0020 affected31 at risk
EG003
Pharyngeal Inflammation
Respiratory, thoracic and mediastinal disorders
MedDRA 11.0
Systematic Assessment
EG0000 affected60 at risk
EG0010 affected24 at risk
EG0020 affected31 at risk
EG003
Pleurisy
Respiratory, thoracic and mediastinal disorders
MedDRA 11.0
Systematic Assessment
EG0000 affected60 at risk
EG0010 affected24 at risk
EG0020 affected31 at risk
EG003
Pulmonary Embolism
Respiratory, thoracic and mediastinal disorders
MedDRA 11.0
Systematic Assessment
EG0001 affected60 at risk
EG0010 affected24 at risk
EG0020 affected31 at risk
EG003
Respiratory Distress
Respiratory, thoracic and mediastinal disorders
MedDRA 11.0
Systematic Assessment
EG0001 affected60 at risk
EG0010 affected24 at risk
EG0020 affected31 at risk
EG003
Respiratory Failure
Respiratory, thoracic and mediastinal disorders
MedDRA 11.0
Systematic Assessment
EG0000 affected60 at risk
EG0010 affected24 at risk
EG0020 affected31 at risk
EG003
Stridor
Respiratory, thoracic and mediastinal disorders
MedDRA 11.0
Systematic Assessment
EG0000 affected60 at risk
EG0010 affected24 at risk
EG0020 affected31 at risk
EG003
Livedo Reticularis
Skin and subcutaneous tissue disorders
MedDRA 11.0
Systematic Assessment
EG0000 affected60 at risk
EG0011 affected24 at risk
EG0020 affected31 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 11.0
Systematic Assessment
EG0000 affected60 at risk
EG0010 affected24 at risk
EG0020 affected31 at risk
EG003
Aortic Thrombosis
Vascular disorders
MedDRA 11.0
Systematic Assessment
EG0001 affected60 at risk
EG0010 affected24 at risk
EG0020 affected31 at risk
EG003
Arterial Thrombosis Limb
Vascular disorders
MedDRA 11.0
Systematic Assessment
EG0000 affected60 at risk
EG0011 affected24 at risk
EG0020 affected31 at risk
EG003
Arteriosclerosis Obliterans
Vascular disorders
MedDRA 11.0
Systematic Assessment
EG0000 affected60 at risk
EG0010 affected24 at risk
EG0020 affected31 at risk
EG003
Circulatory Collapse
Vascular disorders
MedDRA 11.0
Systematic Assessment
EG0000 affected60 at risk
EG0010 affected24 at risk
EG0020 affected31 at risk
EG003
Hypertension
Vascular disorders
MedDRA 11.0
Systematic Assessment
EG0001 affected60 at risk
EG0010 affected24 at risk
EG0020 affected31 at risk
EG003
Hypotension
Vascular disorders
MedDRA 11.0
Systematic Assessment
EG0000 affected60 at risk
EG0010 affected24 at risk
EG0020 affected31 at risk
EG003
Subclavian Artery Stenosis
Vascular disorders
MedDRA 11.0
Systematic Assessment
EG0000 affected60 at risk
EG0010 affected24 at risk
EG0020 affected31 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 11.0
Systematic Assessment
EG0009 affected60 at risk
EG0016 affected24 at risk
EG0027 affected31 at risk
EG00310 affected31 at risk
EG0046 affected24 at risk
EG0058 affected34 at risk
EG0062 affected22 at risk
Leukopenia
Blood and lymphatic system disorders
MedDRA 11.0
Systematic Assessment
EG0008 affected60 at risk
EG0015 affected24 at risk
EG0025 affected31 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA 11.0
Systematic Assessment
EG0008 affected60 at risk
EG0014 affected24 at risk
EG0026 affected31 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 11.0
Systematic Assessment
EG0002 affected60 at risk
EG0010 affected24 at risk
EG0023 affected31 at risk
EG003
Atrial Fibrillation
Cardiac disorders
MedDRA 11.0
Systematic Assessment
EG0003 affected60 at risk
EG0010 affected24 at risk
EG0020 affected31 at risk
EG003
Deafness
Ear and labyrinth disorders
MedDRA 11.0
Systematic Assessment
EG0002 affected60 at risk
EG0010 affected24 at risk
EG0020 affected31 at risk
EG003
Ear Pain
Ear and labyrinth disorders
MedDRA 11.0
Systematic Assessment
EG0006 affected60 at risk
EG0012 affected24 at risk
EG0020 affected31 at risk
EG003
Hypoacusis
Ear and labyrinth disorders
MedDRA 11.0
Systematic Assessment
EG0000 affected60 at risk
EG0010 affected24 at risk
EG0020 affected31 at risk
EG003
Tinnitus
Ear and labyrinth disorders
MedDRA 11.0
Systematic Assessment
EG0001 affected60 at risk
EG0010 affected24 at risk
EG0022 affected31 at risk
EG003
Hypothyroidism
Endocrine disorders
MedDRA 11.0
Systematic Assessment
EG0000 affected60 at risk
EG0010 affected24 at risk
EG0022 affected31 at risk
EG003
Abdominal Pain
Gastrointestinal disorders
MedDRA 11.0
Systematic Assessment
EG0001 affected60 at risk
EG0010 affected24 at risk
EG0022 affected31 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 11.0
Systematic Assessment
EG00016 affected60 at risk
EG0014 affected24 at risk
EG0028 affected31 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 11.0
Systematic Assessment
EG0009 affected60 at risk
EG0014 affected24 at risk
EG00218 affected31 at risk
EG003
Dry Mouth
Gastrointestinal disorders
MedDRA 11.0
Systematic Assessment
EG00025 affected60 at risk
EG00112 affected24 at risk
EG00214 affected31 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 11.0
Systematic Assessment
EG0001 affected60 at risk
EG0010 affected24 at risk
EG0021 affected31 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA 11.0
Systematic Assessment
EG00021 affected60 at risk
EG0014 affected24 at risk
EG00213 affected31 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA 11.0
Systematic Assessment
EG0001 affected60 at risk
EG0010 affected24 at risk
EG0025 affected31 at risk
EG003
Glossodynia
Gastrointestinal disorders
MedDRA 11.0
Systematic Assessment
EG0000 affected60 at risk
EG0010 affected24 at risk
EG0020 affected31 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 11.0
Systematic Assessment
EG00028 affected60 at risk
EG00112 affected24 at risk
EG00215 affected31 at risk
EG003
Odynophagia
Gastrointestinal disorders
MedDRA 11.0
Systematic Assessment
EG0003 affected60 at risk
EG0010 affected24 at risk
EG0024 affected31 at risk
EG003
Oral Discomfort
Gastrointestinal disorders
MedDRA 11.0
Systematic Assessment
EG0001 affected60 at risk
EG0011 affected24 at risk
EG0020 affected31 at risk
EG003
Oral Pain
Gastrointestinal disorders
MedDRA 11.0
Systematic Assessment
EG0006 affected60 at risk
EG0013 affected24 at risk
EG0024 affected31 at risk
EG003
Saliva Altered
Gastrointestinal disorders
MedDRA 11.0
Systematic Assessment
EG0003 affected60 at risk
EG0010 affected24 at risk
EG0021 affected31 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA 11.0
Systematic Assessment
EG00021 affected60 at risk
EG0018 affected24 at risk
EG00212 affected31 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 11.0
Systematic Assessment
EG00030 affected60 at risk
EG0019 affected24 at risk
EG00218 affected31 at risk
EG003
Asthenia
General disorders
MedDRA 11.0
Systematic Assessment
EG0004 affected60 at risk
EG0012 affected24 at risk
EG0021 affected31 at risk
EG003
Chest Pain
General disorders
MedDRA 11.0
Systematic Assessment
EG0001 affected60 at risk
EG0011 affected24 at risk
EG0022 affected31 at risk
EG003
Chills
General disorders
MedDRA 11.0
Systematic Assessment
EG0000 affected60 at risk
EG0010 affected24 at risk
EG0021 affected31 at risk
EG003
Face Oedema
General disorders
MedDRA 11.0
Systematic Assessment
EG0000 affected60 at risk
EG0012 affected24 at risk
EG0020 affected31 at risk
EG003
Fatigue
General disorders
MedDRA 11.0
Systematic Assessment
EG0007 affected60 at risk
EG0013 affected24 at risk
EG0028 affected31 at risk
EG003
Localised Oedema
General disorders
MedDRA 11.0
Systematic Assessment
EG0001 affected60 at risk
EG0010 affected24 at risk
EG0020 affected31 at risk
EG003
Oedema Peripheral
General disorders
MedDRA 11.0
Systematic Assessment
EG0002 affected60 at risk
EG0012 affected24 at risk
EG0022 affected31 at risk
EG003
Pain
General disorders
MedDRA 11.0
Systematic Assessment
EG0000 affected60 at risk
EG0012 affected24 at risk
EG0021 affected31 at risk
EG003
Pyrexia
General disorders
MedDRA 11.0
Systematic Assessment
EG00012 affected60 at risk
EG0015 affected24 at risk
EG0028 affected31 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 11.0
Non-systematic Assessment
EG0000 affected60 at risk
EG0012 affected24 at risk
EG0020 affected0 at risk
EG003
Candidiasis
Infections and infestations
MedDRA 11.0
Systematic Assessment
EG0000 affected60 at risk
EG0010 affected24 at risk
EG0022 affected31 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 11.0
Systematic Assessment
EG0000 affected60 at risk
EG0010 affected24 at risk
EG0020 affected31 at risk
EG003
Folliculitis
Infections and infestations
MedDRA 11.0
Systematic Assessment
EG0000 affected60 at risk
EG0010 affected24 at risk
EG0021 affected31 at risk
EG003
Furuncle
Infections and infestations
MedDRA 11.0
Systematic Assessment
EG0000 affected60 at risk
EG0010 affected24 at risk
EG0020 affected31 at risk
EG003
Implant Site Infection
Infections and infestations
MedDRA 11.0
Systematic Assessment
EG0000 affected60 at risk
EG0010 affected24 at risk
EG0022 affected31 at risk
EG003
Laryngitis
Infections and infestations
MedDRA 11.0
Systematic Assessment
EG0001 affected60 at risk
EG0010 affected24 at risk
EG0021 affected31 at risk
EG003
Lung Infection
Infections and infestations
MedDRA 11.0
Systematic Assessment
EG0000 affected60 at risk
EG0011 affected24 at risk
EG0020 affected31 at risk
EG003
Oral Candidiasis
Infections and infestations
MedDRA 11.0
Systematic Assessment
EG0002 affected60 at risk
EG0011 affected24 at risk
EG0021 affected31 at risk
EG003
Oral Fungal Infection
Infections and infestations
MedDRA 11.0
Systematic Assessment
EG0000 affected60 at risk
EG0010 affected24 at risk
EG0022 affected31 at risk
EG003
Oral Infection
Infections and infestations
MedDRA 11.0
Systematic Assessment
EG0000 affected60 at risk
EG0010 affected24 at risk
EG0021 affected31 at risk
EG003
Oropharyngitis Fungal
Infections and infestations
MedDRA 11.0
Systematic Assessment
EG0001 affected60 at risk
EG0011 affected24 at risk
EG0020 affected31 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA 11.0
Systematic Assessment
EG0007 affected60 at risk
EG0011 affected24 at risk
EG0026 affected31 at risk
EG003
Rash Pustular
Infections and infestations
MedDRA 11.0
Systematic Assessment
EG0000 affected60 at risk
EG0011 affected24 at risk
EG0021 affected31 at risk
EG003
Respiratory Tract Infection
Infections and infestations
MedDRA 11.0
Systematic Assessment
EG0002 affected60 at risk
EG0011 affected24 at risk
EG0022 affected31 at risk
EG003
Rhinitis
Infections and infestations
MedDRA 11.0
Systematic Assessment
EG0001 affected60 at risk
EG0012 affected24 at risk
EG0022 affected31 at risk
EG003
Tracheostomy Infection
Infections and infestations
MedDRA 11.0
Systematic Assessment
EG0001 affected60 at risk
EG0011 affected24 at risk
EG0020 affected31 at risk
EG003
Procedural Pain
Injury, poisoning and procedural complications
MedDRA 11.0
Systematic Assessment
EG0001 affected60 at risk
EG0012 affected24 at risk
EG0020 affected31 at risk
EG003
Radiation Associated Pain
Injury, poisoning and procedural complications
MedDRA 11.0
Systematic Assessment
EG0003 affected60 at risk
EG0011 affected24 at risk
EG0020 affected31 at risk
EG003
Radiation Dysphagia
Injury, poisoning and procedural complications
MedDRA 11.0
Systematic Assessment
EG0003 affected60 at risk
EG0014 affected24 at risk
EG0020 affected31 at risk
EG003
Radiation Mucositis
Injury, poisoning and procedural complications
MedDRA 11.0
Systematic Assessment
EG00021 affected60 at risk
EG00112 affected24 at risk
EG00212 affected31 at risk
EG003
Radiation Skin Injury
Injury, poisoning and procedural complications
MedDRA 11.0
Systematic Assessment
EG00013 affected60 at risk
EG0018 affected24 at risk
EG0028 affected31 at risk
EG003
Aspartate Aminotransferase Increased
Injury, poisoning and procedural complications
MedDRA 11.0
Systematic Assessment
EG0002 affected60 at risk
EG0010 affected24 at risk
EG0020 affected31 at risk
EG003
Blood Creatinine Increased
Injury, poisoning and procedural complications
MedDRA 11.0
Systematic Assessment
EG0001 affected60 at risk
EG0011 affected24 at risk
EG0022 affected31 at risk
EG003
Creatinine Renal Clearance Decreased
Injury, poisoning and procedural complications
MedDRA 11.0
Systematic Assessment
EG0003 affected60 at risk
EG0010 affected24 at risk
EG0021 affected31 at risk
EG003
Hepatic Enzyme Increased
Injury, poisoning and procedural complications
MedDRA 11.0
Systematic Assessment
EG0000 affected60 at risk
EG0010 affected24 at risk
EG0020 affected31 at risk
EG003
Weight Decreased
Injury, poisoning and procedural complications
MedDRA 11.0
Systematic Assessment
EG00013 affected60 at risk
EG0018 affected24 at risk
EG0029 affected31 at risk
EG003
Anorexia
Metabolism and nutrition disorders
MedDRA 11.0
Systematic Assessment
EG0009 affected60 at risk
EG0012 affected24 at risk
EG0022 affected31 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 11.0
Systematic Assessment
EG0004 affected60 at risk
EG0011 affected24 at risk
EG0024 affected31 at risk
EG003
Electrolyte Imbalance
Metabolism and nutrition disorders
MedDRA 11.0
Systematic Assessment
EG0001 affected60 at risk
EG0012 affected24 at risk
EG0020 affected31 at risk
EG003
Hypercreatininaemia
Metabolism and nutrition disorders
MedDRA 11.0
Systematic Assessment
EG0000 affected60 at risk
EG0010 affected24 at risk
EG0022 affected31 at risk
EG003
Hyperuricaemia
Metabolism and nutrition disorders
MedDRA 11.0
Systematic Assessment
EG0000 affected60 at risk
EG0010 affected24 at risk
EG0023 affected31 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRA 11.0
Systematic Assessment
EG0004 affected60 at risk
EG0011 affected24 at risk
EG0023 affected31 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
MedDRA 11.0
Systematic Assessment
EG0000 affected60 at risk
EG0010 affected24 at risk
EG0022 affected31 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 11.0
Systematic Assessment
EG0005 affected60 at risk
EG0014 affected24 at risk
EG0025 affected31 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA 11.0
Systematic Assessment
EG0003 affected60 at risk
EG0012 affected24 at risk
EG0024 affected31 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 11.0
Systematic Assessment
EG0003 affected60 at risk
EG0010 affected24 at risk
EG0022 affected31 at risk
EG003
Back Pain
Musculoskeletal and connective tissue disorders
MedDRA 11.0
Systematic Assessment
EG0000 affected60 at risk
EG0012 affected24 at risk
EG0022 affected31 at risk
EG003
Musculoskeletal Pain
Musculoskeletal and connective tissue disorders
MedDRA 11.0
Systematic Assessment
EG0002 affected60 at risk
EG0010 affected24 at risk
EG0021 affected31 at risk
EG003
Neck Pain
Musculoskeletal and connective tissue disorders
MedDRA 11.0
Systematic Assessment
EG0001 affected60 at risk
EG0013 affected24 at risk
EG0021 affected31 at risk
EG003
Tumour Pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 11.0
Systematic Assessment
EG0001 affected60 at risk
EG0011 affected24 at risk
EG0020 affected31 at risk
EG003
Ageusia
Nervous system disorders
MedDRA 11.0
Systematic Assessment
EG0002 affected60 at risk
EG0011 affected24 at risk
EG0022 affected31 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 11.0
Systematic Assessment
EG0001 affected60 at risk
EG0012 affected24 at risk
EG0023 affected31 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA 11.0
Systematic Assessment
EG0005 affected60 at risk
EG0011 affected24 at risk
EG0024 affected31 at risk
EG003
Headache
Nervous system disorders
MedDRA 11.0
Systematic Assessment
EG0004 affected60 at risk
EG0013 affected24 at risk
EG0022 affected31 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA 11.0
Systematic Assessment
EG0005 affected60 at risk
EG0013 affected24 at risk
EG0020 affected31 at risk
EG003
Confusional State
Psychiatric disorders
MedDRA 11.0
Systematic Assessment
EG0000 affected60 at risk
EG0010 affected24 at risk
EG0022 affected31 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 11.0
Systematic Assessment
EG00010 affected60 at risk
EG0014 affected24 at risk
EG0023 affected31 at risk
EG003
Oliguria
Renal and urinary disorders
MedDRA 11.0
Systematic Assessment
EG0000 affected60 at risk
EG0010 affected24 at risk
EG0021 affected31 at risk
EG003
Renal Failure
Renal and urinary disorders
MedDRA 11.0
Systematic Assessment
EG0004 affected60 at risk
EG0013 affected24 at risk
EG0021 affected31 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 11.0
Systematic Assessment
EG00010 affected60 at risk
EG0013 affected24 at risk
EG0027 affected31 at risk
EG003
Dysphonia
Respiratory, thoracic and mediastinal disorders
MedDRA 11.0
Systematic Assessment
EG0005 affected60 at risk
EG0011 affected24 at risk
EG0023 affected31 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 11.0
Systematic Assessment
EG0006 affected60 at risk
EG0011 affected24 at risk
EG0022 affected31 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA 11.0
Systematic Assessment
EG0000 affected60 at risk
EG0011 affected24 at risk
EG0021 affected31 at risk
EG003
Laryngeal Oedema
Respiratory, thoracic and mediastinal disorders
MedDRA 11.0
Systematic Assessment
EG0005 affected60 at risk
EG0011 affected24 at risk
EG0023 affected31 at risk
EG003
Pharyngeal Inflammation
Respiratory, thoracic and mediastinal disorders
MedDRA 11.0
Systematic Assessment
EG00010 affected60 at risk
EG0011 affected24 at risk
EG0026 affected31 at risk
EG003
Pharyngolaryngeal Pain
Respiratory, thoracic and mediastinal disorders
MedDRA 11.0
Systematic Assessment
EG00018 affected60 at risk
EG0013 affected24 at risk
EG0029 affected31 at risk
EG003
Productive Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 11.0
Systematic Assessment
EG0006 affected60 at risk
EG0012 affected24 at risk
EG0023 affected31 at risk
EG003
Acne
Skin and subcutaneous tissue disorders
MedDRA 11.0
Systematic Assessment
EG0001 affected60 at risk
EG0010 affected24 at risk
EG0022 affected31 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA 11.0
Systematic Assessment
EG0006 affected60 at risk
EG0013 affected24 at risk
EG0023 affected31 at risk
EG003
Dermatitis
Skin and subcutaneous tissue disorders
MedDRA 11.0
Systematic Assessment
EG0008 affected60 at risk
EG0014 affected24 at risk
EG0027 affected31 at risk
EG003
Dermatitis Acneiform
Skin and subcutaneous tissue disorders
MedDRA 11.0
Systematic Assessment
EG0001 affected60 at risk
EG0010 affected24 at risk
EG0022 affected31 at risk
EG003
Dermatitis Allergic
Skin and subcutaneous tissue disorders
MedDRA 11.0
Systematic Assessment
EG0000 affected60 at risk
EG0010 affected24 at risk
EG0020 affected31 at risk
EG003
Dry Skin
Skin and subcutaneous tissue disorders
MedDRA 11.0
Systematic Assessment
EG0001 affected60 at risk
EG0010 affected24 at risk
EG0020 affected31 at risk
EG003
Hyperhidrosis
Skin and subcutaneous tissue disorders
MedDRA 11.0
Systematic Assessment
EG0000 affected60 at risk
EG0010 affected24 at risk
EG0020 affected31 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 11.0
Systematic Assessment
EG0001 affected60 at risk
EG0010 affected24 at risk
EG0024 affected31 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 11.0
Systematic Assessment
EG0003 affected60 at risk
EG0012 affected24 at risk
EG00211 affected31 at risk
EG003
Rash Pruritic
Skin and subcutaneous tissue disorders
MedDRA 11.0
Systematic Assessment
EG0000 affected60 at risk
EG0010 affected24 at risk
EG0022 affected31 at risk
EG003
Skin Exfoliation
Skin and subcutaneous tissue disorders
MedDRA 11.0
Systematic Assessment
EG0001 affected60 at risk
EG0012 affected24 at risk
EG0020 affected31 at risk
EG003
Skin Fibrosis
Skin and subcutaneous tissue disorders
MedDRA 11.0
Systematic Assessment
EG0003 affected60 at risk
EG0011 affected24 at risk
EG0023 affected31 at risk
EG003
Skin Hyperpigmentation
Skin and subcutaneous tissue disorders
MedDRA 11.0
Systematic Assessment
EG0003 affected60 at risk
EG0011 affected24 at risk
EG0022 affected31 at risk
EG003
Skin Reaction
Skin and subcutaneous tissue disorders
MedDRA 11.0
Systematic Assessment
EG0006 affected60 at risk
EG0011 affected24 at risk
EG0022 affected31 at risk
EG003
Skin Ulcer
Skin and subcutaneous tissue disorders
MedDRA 11.0
Systematic Assessment
EG0000 affected60 at risk
EG0010 affected24 at risk
EG0020 affected31 at risk
EG003
Hypertension
Vascular disorders
MedDRA 11.0
Systematic Assessment
EG0005 affected60 at risk
EG0013 affected24 at risk
EG0021 affected31 at risk
EG003
Hypotension
Vascular disorders
MedDRA 11.0
Systematic Assessment
EG0002 affected60 at risk
EG0010 affected24 at risk
EG0022 affected31 at risk
EG003
Lymphoedema
Vascular disorders
MedDRA 11.0
Systematic Assessment
EG0001 affected60 at risk
EG0010 affected24 at risk
EG0020 affected31 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
The Principal Investigator (PI) agrees to collaborate on the contents and formation of any publication and to pay due consideration to comments and opinions offered. AstraZeneca have 30 days for final manuscript review and may require that submission for publication be delayed in order to file patent applications.
Point of Contact
Title
Organization
Phone
Extension
Email
Gerard Lynch
AstraZeneca
AZTrial_Results_Posting@astrazeneca.com
ID
Term
D018307
Neoplasms, Squamous Cell
D000077195
Squamous Cell Carcinoma of Head and Neck
D002294
Carcinoma, Squamous Cell
Ancestor Terms
ID
Term
D009375
Neoplasms, Glandular and Epithelial
D009370
Neoplasms by Histologic Type
D009369
Neoplasms
D002277
Carcinoma
D006258
Head and Neck Neoplasms
D009371
Neoplasms by Site
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
D000077156
Gefitinib
D002945
Cisplatin
D011878
Radiotherapy
Ancestor Terms
ID
Term
D011799
Quinazolines
D006574
Heterocyclic Compounds, 2-Ring
D000072471
Heterocyclic Compounds, Fused-Ring
D006571
Heterocyclic Compounds
D017606
Chlorine Compounds
D007287
Inorganic Chemicals
D017672
Nitrogen Compounds
D017671
Platinum Compounds
D013812
Therapeutics
Browse Leaves
Not provided
Browse Branches
Not provided
0 subjects
FG0050 subjects
FG0060 subjects
0 subjects
FG0050 subjects
FG0061 subjects
1 subjects
FG0050 subjects
FG0060 subjects
0 subjects
FG0050 subjects
FG0060 subjects
1 subjects
FG0050 subjects
FG0060 subjects
0 subjects
FG0052 subjects
FG0060 subjects
9 subjects
Completed study on randomized treatment
FG0047 subjectsCompleted study on randomized treatment
FG00512 subjectsCompleted study on randomized treatment
FG0069 subjectsCompleted study on randomized treatment
15 subjects
FG00519 subjects
FG00610 subjects
4 subjects
FG0047 subjects
FG0055 subjects
FG0062 subjects
Objective disease progression
FG0005 subjects
FG0015 subjects
FG0023 subjects
FG0036 subjects
FG0042 subjects
FG0059 subjects
FG0065 subjects
Clinical progression
FG0004 subjects
FG0011 subjects
FG0022 subjects
FG0032 subjects
FG0041 subjects
FG0051 subjects
FG0061 subjects
Lost to Follow-up
FG0000 subjects
FG0011 subjects
FG0022 subjects
FG0032 subjects
FG0040 subjects
FG0050 subjects
FG0061 subjects
Informed consent withdrawn
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG0041 subjects
FG0051 subjects
FG0060 subjects
Severe non-compliance
FG0003 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG0041 subjects
FG0050 subjects
FG0060 subjects
Other
FG0005 subjects
FG0014 subjects
FG0021 subjects
FG0032 subjects
FG0043 subjects
FG0053 subjects
FG0061 subjects
54.3
(33 to 69)
BG00450.8(33 to 72)
BG00553.4(45 to 70)
BG00654.9(31 to 73)
BG00753.2(21 to 74)
3
BG0034
BG0045
BG0051
BG0064
BG00728
Male
BG00052
BG00121
BG00228
BG00327
BG00419
BG00533
BG00618
BG007198
29
BG00329
BG00422
BG00532
BG00620
BG007210
Oriental
Title
Measurements
BG0004
BG0012
BG0022
BG0032
BG0042
BG0052
BG0062
BG00716
2
BG0031
BG0043
BG0052
BG0063
BG00715
Oropharynx
Title
Measurements
BG00026
BG00112
BG00215
BG00318
BG00413
BG00515
BG00610
BG007109
Hypopharynx
Title
Measurements
BG00019
BG0019
BG0029
BG00310
BG0044
BG00512
BG0064
BG00767
Larynx
Title
Measurements
BG00010
BG0012
BG0024
BG0031
BG0043
BG0054
BG0063
BG00727
Oropharynx / Hypopharynx
Title
Measurements
BG0000
BG0010
BG0020
BG0031
BG0040
BG0050
BG0060
BG0071
Other
Title
Measurements
BG0001
BG0011
BG0021
BG0030
BG0041
BG0051
BG0062
BG0077
7
BG0037
BG0044
BG0056
BG0068
BG00749
Stage IV (All these patients had Stage IVa cancer)
Title
Measurements
BG00050
BG00117
BG00224
BG00324
BG00420
BG00528
BG00614
BG007177
24
BG00324
BG00417
BG00524
BG00616
BG007160
1 (Restricted activity)
Title
Measurements
BG00013
BG0018
BG0026
BG0034
BG0046
BG0056
BG0065
BG00748
2 (in bed ≤ 50% of the time)
Title
Measurements
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
3 (in bed > 50% of the time)
Title
Measurements
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
4 (100% Bed ridden)
Title
Measurements
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
Not recorded
Title
Measurements
BG0006
BG0012
BG0021
BG0033
BG0041
BG0054
BG0061
BG00718
31
OG00424
OG00534
OG00622
7
OG0047
OG0059
OG0069
OG004
500mg/500mg
Concomitant gefitinib 500 mg (plus cisplatin and radiotherapy) followed by gefitinib 500 mg as maintenance therapy
OG005
Placebo/250mg
Concomitant placebo (plus cisplatin and radiotherapy) followed by gefitinib 250 mg as maintenance therapy
OG006
Placebo/500mg
Concomitant placebo (plus cisplatin and radiotherapy) followed by gefitinib 500 mg as maintenance therapy
Units
Counts
Participants
OG00060
OG00124
OG00231
OG00331
OG00424
OG00534
OG00622
Title
Denominators
Categories
Title
Measurements
OG00027
OG0018
OG00216
OG00313
OG00410
OG00514
OG00610
OG004
500mg/500mg
Concomitant gefitinib 500 mg (plus cisplatin and radiotherapy) followed by gefitinib 500 mg as maintenance therapy
OG005
Placebo/250mg
Concomitant placebo (plus cisplatin and radiotherapy) followed by gefitinib 250 mg as maintenance therapy
OG006
Placebo/500mg
Concomitant placebo (plus cisplatin and radiotherapy) followed by gefitinib 500 mg as maintenance therapy
Units
Counts
Participants
OG00060
OG00124
OG00231
OG00331
OG00424
OG00534
OG00622
Title
Denominators
Categories
Title
Measurements
OG00028
OG0017
OG00211
OG00313
OG0046
OG00514
OG00611
OG004
500mg/500mg
Concomitant gefitinib 500 mg (plus cisplatin and radiotherapy) followed by gefitinib 500 mg as maintenance therapy
OG005
Placebo/250mg
Concomitant placebo (plus cisplatin and radiotherapy) followed by gefitinib 250 mg as maintenance therapy
OG006
Placebo/500mg
Concomitant placebo (plus cisplatin and radiotherapy) followed by gefitinib 500 mg as maintenance therapy
Units
Counts
Participants
OG00060
OG00124
OG00231
OG00331
OG00424
OG00534
OG00622
Title
Denominators
Categories
Title
Measurements
OG00034
OG00111
OG00217
OG00318
OG00411
OG00522
OG00614
Concomitant gefitinib 250 mg (plus cisplatin and radiotherapy) followed by gefitinib 250 mg as maintenance therapy
OG004
500mg/500mg
Concomitant gefitinib 500 mg (plus cisplatin and radiotherapy) followed by gefitinib 500 mg as maintenance therapy
OG005
Placebo/250mg
Concomitant placebo (plus cisplatin and radiotherapy) followed by gefitinib 250 mg as maintenance therapy
OG006
Placebo/500mg
Concomitant placebo (plus cisplatin and radiotherapy) followed by gefitinib 500 mg as maintenance therapy
Units
Counts
Participants
OG00060
OG00124
OG00231
OG00331
OG00424
OG00534
OG00622
Title
Denominators
Categories
Title
Measurements
OG00041.9
OG00143.1
OG00258.1
OG00331.2
OG00443.1
OG00530.0
OG00642.9
Concomitant gefitinib 500 mg (plus cisplatin and radiotherapy) followed by gefitinib 500 mg as maintenance therapy
OG005
Placebo/250mg
Concomitant placebo (plus cisplatin and radiotherapy) followed by gefitinib 250 mg as maintenance therapy
OG006
Placebo/500mg
Concomitant placebo (plus cisplatin and radiotherapy) followed by gefitinib 500 mg as maintenance therapy