Trial Outcomes & Findings for IRESSA™ (Gefitinib) With Cisplatin Plus Radiotherapy for the Treatment of Previously Untreated Unresected Late Stage III/IV Non-Metastatic Head and Neck Squamous Cell Carcinoma (NCT NCT00229723)
NCT ID: NCT00229723
Last Updated: 2009-08-04
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
224 participants
Primary outcome timeframe
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)).
Results posted on
2009-08-04
Participant Flow
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.
Participant milestones
| Measure |
Placebo/Placebo
Concomitant placebo (plus cisplatin and radiotherapy) followed by placebo as maintenance therapy
|
250mg/Placebo
Concomitant gefitinib 250 mg (plus cisplatin and radiotherapy) followed by placebo as maintenance therapy
|
500mg/Placebo
Concomitant gefitinib 500 mg (plus cisplatin and radiotherapy) followed by placebo as maintenance therapy
|
250mg/250mg
Concomitant gefitinib 250 mg (plus cisplatin and radiotherapy) followed by gefitinib 250 mg as maintenance therapy
|
500mg/500mg
Concomitant gefitinib 500 mg (plus cisplatin and radiotherapy) followed by gefitinib 500 mg as maintenance therapy
|
Placebo/250mg
Concomitant placebo (plus cisplatin and radiotherapy) followed by gefitinib 250 mg as maintenance therapy
|
Placebo/500mg
Concomitant placebo (plus cisplatin and radiotherapy) followed by gefitinib 500 mg as maintenance therapy
|
|---|---|---|---|---|---|---|---|
|
Concomitant Phase
STARTED
|
60
|
24
|
31
|
31
|
24
|
34
|
22
|
|
Concomitant Phase
COMPLETED
|
50
|
19
|
25
|
26
|
22
|
31
|
19
|
|
Concomitant Phase
NOT COMPLETED
|
10
|
5
|
6
|
5
|
2
|
3
|
3
|
|
Maintenance Phase
STARTED
|
50
|
19
|
25
|
26
|
22
|
31
|
19
|
|
Maintenance Phase
COMPLETED
|
25
|
5
|
16
|
9
|
7
|
12
|
9
|
|
Maintenance Phase
NOT COMPLETED
|
25
|
14
|
9
|
17
|
15
|
19
|
10
|
Reasons for withdrawal
| Measure |
Placebo/Placebo
Concomitant placebo (plus cisplatin and radiotherapy) followed by placebo as maintenance therapy
|
250mg/Placebo
Concomitant gefitinib 250 mg (plus cisplatin and radiotherapy) followed by placebo as maintenance therapy
|
500mg/Placebo
Concomitant gefitinib 500 mg (plus cisplatin and radiotherapy) followed by placebo as maintenance therapy
|
250mg/250mg
Concomitant gefitinib 250 mg (plus cisplatin and radiotherapy) followed by gefitinib 250 mg as maintenance therapy
|
500mg/500mg
Concomitant gefitinib 500 mg (plus cisplatin and radiotherapy) followed by gefitinib 500 mg as maintenance therapy
|
Placebo/250mg
Concomitant placebo (plus cisplatin and radiotherapy) followed by gefitinib 250 mg as maintenance therapy
|
Placebo/500mg
Concomitant placebo (plus cisplatin and radiotherapy) followed by gefitinib 500 mg as maintenance therapy
|
|---|---|---|---|---|---|---|---|
|
Concomitant Phase
Adverse Event
|
4
|
2
|
5
|
2
|
0
|
1
|
2
|
|
Concomitant Phase
Objective disease progression
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Concomitant Phase
Clinical progression
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Concomitant Phase
Lost to Follow-up
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Concomitant Phase
Informed consent withdrawn
|
3
|
2
|
0
|
2
|
0
|
0
|
0
|
|
Concomitant Phase
Severe non-compliance
|
0
|
1
|
0
|
0
|
1
|
0
|
0
|
|
Concomitant Phase
Other
|
3
|
0
|
1
|
1
|
0
|
2
|
0
|
|
Maintenance Phase
Adverse Event
|
7
|
2
|
1
|
4
|
7
|
5
|
2
|
|
Maintenance Phase
Objective disease progression
|
5
|
5
|
3
|
6
|
2
|
9
|
5
|
|
Maintenance Phase
Clinical progression
|
4
|
1
|
2
|
2
|
1
|
1
|
1
|
|
Maintenance Phase
Lost to Follow-up
|
0
|
1
|
2
|
2
|
0
|
0
|
1
|
|
Maintenance Phase
Informed consent withdrawn
|
1
|
0
|
0
|
1
|
1
|
1
|
0
|
|
Maintenance Phase
Severe non-compliance
|
3
|
1
|
0
|
0
|
1
|
0
|
0
|
|
Maintenance Phase
Other
|
5
|
4
|
1
|
2
|
3
|
3
|
1
|
Baseline Characteristics
IRESSA™ (Gefitinib) With Cisplatin Plus Radiotherapy for the Treatment of Previously Untreated Unresected Late Stage III/IV Non-Metastatic Head and Neck Squamous Cell Carcinoma
Baseline characteristics by cohort
| Measure |
Placebo/Placebo
n=60 Participants
Concomitant placebo (plus cisplatin and radiotherapy) followed by placebo as maintenance therapy
|
250mg/Placebo
n=24 Participants
Concomitant gefitinib 250 mg (plus cisplatin and radiotherapy) followed by placebo as maintenance therapy
|
500mg/Placebo
n=31 Participants
Concomitant gefitinib 500 mg (plus cisplatin and radiotherapy) followed by placebo as maintenance therapy
|
250mg/250mg
n=31 Participants
Concomitant gefitinib 250 mg (plus cisplatin and radiotherapy) followed by gefitinib 250 mg as maintenance therapy
|
500mg/500mg
n=24 Participants
Concomitant gefitinib 500 mg (plus cisplatin and radiotherapy) followed by gefitinib 500 mg as maintenance therapy
|
Placebo/250mg
n=34 Participants
Concomitant placebo (plus cisplatin and radiotherapy) followed by gefitinib 250 mg as maintenance therapy
|
Placebo/500mg
n=22 Participants
Concomitant placebo (plus cisplatin and radiotherapy) followed by gefitinib 500 mg as maintenance therapy
|
Total
n=226 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age Continuous
|
53.1 Years
n=5 Participants
|
52.5 Years
n=7 Participants
|
53.4 Years
n=5 Participants
|
54.3 Years
n=4 Participants
|
50.8 Years
n=21 Participants
|
53.4 Years
n=10 Participants
|
54.9 Years
n=115 Participants
|
53.2 Years
n=24 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
4 Participants
n=115 Participants
|
28 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
52 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
27 Participants
n=4 Participants
|
19 Participants
n=21 Participants
|
33 Participants
n=10 Participants
|
18 Participants
n=115 Participants
|
198 Participants
n=24 Participants
|
|
Race/Ethnicity, Customized
Caucasian (includes Indian)
|
56 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
29 Participants
n=4 Participants
|
22 Participants
n=21 Participants
|
32 Participants
n=10 Participants
|
20 Participants
n=115 Participants
|
210 Participants
n=24 Participants
|
|
Race/Ethnicity, Customized
Oriental
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
16 Participants
n=24 Participants
|
|
Original site of primary cancer
Oral cavity
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
15 Participants
n=24 Participants
|
|
Original site of primary cancer
Oropharynx
|
26 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
15 Participants
n=10 Participants
|
10 Participants
n=115 Participants
|
109 Participants
n=24 Participants
|
|
Original site of primary cancer
Hypopharynx
|
19 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
12 Participants
n=10 Participants
|
4 Participants
n=115 Participants
|
67 Participants
n=24 Participants
|
|
Original site of primary cancer
Larynx
|
10 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
4 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
27 Participants
n=24 Participants
|
|
Original site of primary cancer
Oropharynx / Hypopharynx
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
1 Participants
n=24 Participants
|
|
Original site of primary cancer
Other
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
7 Participants
n=24 Participants
|
|
Stage of disease at entry to study
Stage III
|
10 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
6 Participants
n=10 Participants
|
8 Participants
n=115 Participants
|
49 Participants
n=24 Participants
|
|
Stage of disease at entry to study
Stage IV (All these patients had Stage IVa cancer)
|
50 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
20 Participants
n=21 Participants
|
28 Participants
n=10 Participants
|
14 Participants
n=115 Participants
|
177 Participants
n=24 Participants
|
|
WHO Performance Status
0 (Normal activity)
|
41 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
17 Participants
n=21 Participants
|
24 Participants
n=10 Participants
|
16 Participants
n=115 Participants
|
160 Participants
n=24 Participants
|
|
WHO Performance Status
1 (Restricted activity)
|
13 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
6 Participants
n=10 Participants
|
5 Participants
n=115 Participants
|
48 Participants
n=24 Participants
|
|
WHO Performance Status
2 (in bed ≤ 50% of the time)
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
|
WHO Performance Status
3 (in bed > 50% of the time)
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
|
WHO Performance Status
4 (100% Bed ridden)
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
|
WHO Performance Status
Not recorded
|
6 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
4 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
18 Participants
n=24 Participants
|
PRIMARY outcome
Timeframe: 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)).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.
Outcome measures
| Measure |
Placebo/Placebo
n=60 Participants
Concomitant placebo (plus cisplatin and radiotherapy) followed by placebo as maintenance therapy
|
250mg/Placebo
n=24 Participants
Concomitant gefitinib 250 mg (plus cisplatin and radiotherapy) followed by placebo as maintenance therapy
|
500mg/Placebo
n=31 Participants
Concomitant gefitinib 500 mg (plus cisplatin and radiotherapy) followed by placebo as maintenance therapy
|
250mg/250mg
n=31 Participants
Concomitant gefitinib 250 mg (plus cisplatin and radiotherapy) followed by gefitinib 250 mg as maintenance therapy
|
500mg/500mg
n=24 Participants
Concomitant gefitinib 500 mg (plus cisplatin and radiotherapy) followed by gefitinib 500 mg as maintenance therapy
|
Placebo/250mg
n=34 Participants
Concomitant placebo (plus cisplatin and radiotherapy) followed by gefitinib 250 mg as maintenance therapy
|
Placebo/500mg
n=22 Participants
Concomitant placebo (plus cisplatin and radiotherapy) followed by gefitinib 500 mg as maintenance therapy
|
|---|---|---|---|---|---|---|---|
|
Local Disease Control Rate at 2 Years
|
21 Participants
|
7 Participants
|
15 Participants
|
7 Participants
|
7 Participants
|
9 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: 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).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.
Outcome measures
| Measure |
Placebo/Placebo
n=60 Participants
Concomitant placebo (plus cisplatin and radiotherapy) followed by placebo as maintenance therapy
|
250mg/Placebo
n=24 Participants
Concomitant gefitinib 250 mg (plus cisplatin and radiotherapy) followed by placebo as maintenance therapy
|
500mg/Placebo
n=31 Participants
Concomitant gefitinib 500 mg (plus cisplatin and radiotherapy) followed by placebo as maintenance therapy
|
250mg/250mg
n=31 Participants
Concomitant gefitinib 250 mg (plus cisplatin and radiotherapy) followed by gefitinib 250 mg as maintenance therapy
|
500mg/500mg
n=24 Participants
Concomitant gefitinib 500 mg (plus cisplatin and radiotherapy) followed by gefitinib 500 mg as maintenance therapy
|
Placebo/250mg
n=34 Participants
Concomitant placebo (plus cisplatin and radiotherapy) followed by gefitinib 250 mg as maintenance therapy
|
Placebo/500mg
n=22 Participants
Concomitant placebo (plus cisplatin and radiotherapy) followed by gefitinib 500 mg as maintenance therapy
|
|---|---|---|---|---|---|---|---|
|
Local Disease Control Rate at 1 Year
|
27 Participants
|
8 Participants
|
16 Participants
|
13 Participants
|
10 Participants
|
14 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: 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 a complete responder if the RECIST criteria for complete response were satisfied at any time during the study.
Outcome measures
| Measure |
Placebo/Placebo
n=60 Participants
Concomitant placebo (plus cisplatin and radiotherapy) followed by placebo as maintenance therapy
|
250mg/Placebo
n=24 Participants
Concomitant gefitinib 250 mg (plus cisplatin and radiotherapy) followed by placebo as maintenance therapy
|
500mg/Placebo
n=31 Participants
Concomitant gefitinib 500 mg (plus cisplatin and radiotherapy) followed by placebo as maintenance therapy
|
250mg/250mg
n=31 Participants
Concomitant gefitinib 250 mg (plus cisplatin and radiotherapy) followed by gefitinib 250 mg as maintenance therapy
|
500mg/500mg
n=24 Participants
Concomitant gefitinib 500 mg (plus cisplatin and radiotherapy) followed by gefitinib 500 mg as maintenance therapy
|
Placebo/250mg
n=34 Participants
Concomitant placebo (plus cisplatin and radiotherapy) followed by gefitinib 250 mg as maintenance therapy
|
Placebo/500mg
n=22 Participants
Concomitant placebo (plus cisplatin and radiotherapy) followed by gefitinib 500 mg as maintenance therapy
|
|---|---|---|---|---|---|---|---|
|
Complete Response
|
28 Participants
|
7 Participants
|
11 Participants
|
13 Participants
|
6 Participants
|
14 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: 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 progressionA 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.
Outcome measures
| Measure |
Placebo/Placebo
n=60 Participants
Concomitant placebo (plus cisplatin and radiotherapy) followed by placebo as maintenance therapy
|
250mg/Placebo
n=24 Participants
Concomitant gefitinib 250 mg (plus cisplatin and radiotherapy) followed by placebo as maintenance therapy
|
500mg/Placebo
n=31 Participants
Concomitant gefitinib 500 mg (plus cisplatin and radiotherapy) followed by placebo as maintenance therapy
|
250mg/250mg
n=31 Participants
Concomitant gefitinib 250 mg (plus cisplatin and radiotherapy) followed by gefitinib 250 mg as maintenance therapy
|
500mg/500mg
n=24 Participants
Concomitant gefitinib 500 mg (plus cisplatin and radiotherapy) followed by gefitinib 500 mg as maintenance therapy
|
Placebo/250mg
n=34 Participants
Concomitant placebo (plus cisplatin and radiotherapy) followed by gefitinib 250 mg as maintenance therapy
|
Placebo/500mg
n=22 Participants
Concomitant placebo (plus cisplatin and radiotherapy) followed by gefitinib 500 mg as maintenance therapy
|
|---|---|---|---|---|---|---|---|
|
Tumour Response (Complete Response + Partial Response)
|
34 Participants
|
11 Participants
|
17 Participants
|
18 Participants
|
11 Participants
|
22 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: 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)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).
Outcome measures
| Measure |
Placebo/Placebo
n=60 Participants
Concomitant placebo (plus cisplatin and radiotherapy) followed by placebo as maintenance therapy
|
250mg/Placebo
n=24 Participants
Concomitant gefitinib 250 mg (plus cisplatin and radiotherapy) followed by placebo as maintenance therapy
|
500mg/Placebo
n=31 Participants
Concomitant gefitinib 500 mg (plus cisplatin and radiotherapy) followed by placebo as maintenance therapy
|
250mg/250mg
n=31 Participants
Concomitant gefitinib 250 mg (plus cisplatin and radiotherapy) followed by gefitinib 250 mg as maintenance therapy
|
500mg/500mg
n=24 Participants
Concomitant gefitinib 500 mg (plus cisplatin and radiotherapy) followed by gefitinib 500 mg as maintenance therapy
|
Placebo/250mg
n=34 Participants
Concomitant placebo (plus cisplatin and radiotherapy) followed by gefitinib 250 mg as maintenance therapy
|
Placebo/500mg
n=22 Participants
Concomitant placebo (plus cisplatin and radiotherapy) followed by gefitinib 500 mg as maintenance therapy
|
|---|---|---|---|---|---|---|---|
|
Progression Free Survival
|
41.9 Percentage of participants
|
43.1 Percentage of participants
|
58.1 Percentage of participants
|
31.2 Percentage of participants
|
43.1 Percentage of participants
|
30.0 Percentage of participants
|
42.9 Percentage of participants
|
SECONDARY outcome
Timeframe: Overall survival assessed at 2 yearsPercentage 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)).
Outcome measures
| Measure |
Placebo/Placebo
n=60 Participants
Concomitant placebo (plus cisplatin and radiotherapy) followed by placebo as maintenance therapy
|
250mg/Placebo
n=24 Participants
Concomitant gefitinib 250 mg (plus cisplatin and radiotherapy) followed by placebo as maintenance therapy
|
500mg/Placebo
n=31 Participants
Concomitant gefitinib 500 mg (plus cisplatin and radiotherapy) followed by placebo as maintenance therapy
|
250mg/250mg
n=31 Participants
Concomitant gefitinib 250 mg (plus cisplatin and radiotherapy) followed by gefitinib 250 mg as maintenance therapy
|
500mg/500mg
n=24 Participants
Concomitant gefitinib 500 mg (plus cisplatin and radiotherapy) followed by gefitinib 500 mg as maintenance therapy
|
Placebo/250mg
n=34 Participants
Concomitant placebo (plus cisplatin and radiotherapy) followed by gefitinib 250 mg as maintenance therapy
|
Placebo/500mg
n=22 Participants
Concomitant placebo (plus cisplatin and radiotherapy) followed by gefitinib 500 mg as maintenance therapy
|
|---|---|---|---|---|---|---|---|
|
Overall Survival
|
64.6 Percentage of participants
|
60.0 Percentage of participants
|
74.8 Percentage of participants
|
43.2 Percentage of participants
|
49.4 Percentage of participants
|
48.2 Percentage of participants
|
61.1 Percentage of participants
|
SECONDARY outcome
Timeframe: Assessed over two yearsOutcome measures
Outcome data not reported
Adverse Events
Placebo/Placebo
Serious events: 23 serious events
Other events: 58 other events
Deaths: 0 deaths
250mg/Placebo
Serious events: 9 serious events
Other events: 23 other events
Deaths: 0 deaths
500mg/Placebo
Serious events: 21 serious events
Other events: 30 other events
Deaths: 0 deaths
250mg/250mg
Serious events: 15 serious events
Other events: 30 other events
Deaths: 0 deaths
500mg/500mg
Serious events: 14 serious events
Other events: 23 other events
Deaths: 0 deaths
Placebo/250mg
Serious events: 16 serious events
Other events: 32 other events
Deaths: 0 deaths
Placebo/500mg
Serious events: 11 serious events
Other events: 21 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo/Placebo
Concomitant placebo (plus cisplatin and radiotherapy) followed by placebo as maintenance therapy
|
250mg/Placebo
Concomitant gefitinib 250 mg (plus cisplatin and radiotherapy) followed by placebo as maintenance therapy
|
500mg/Placebo
Concomitant gefitinib 500 mg (plus cisplatin and radiotherapy) followed by placebo as maintenance therapy
|
250mg/250mg
Concomitant gefitinib 250 mg (plus cisplatin and radiotherapy) followed by gefitinib 250 mg as maintenance therapy
|
500mg/500mg
Concomitant gefitinib 500 mg (plus cisplatin and radiotherapy) followed by gefitinib 500 mg as maintenance therapy
|
Placebo/250mg
Concomitant placebo (plus cisplatin and radiotherapy) followed by gefitinib 250 mg as maintenance therapy
|
Placebo/500mg
Concomitant placebo (plus cisplatin and radiotherapy) followed by gefitinib 500 mg as maintenance therapy
|
|---|---|---|---|---|---|---|---|
|
Ear and labyrinth disorders
Hypoacusis
|
0.00%
0/60
|
0.00%
0/24
|
3.2%
1/31
|
0.00%
0/31
|
0.00%
0/24
|
0.00%
0/34
|
0.00%
0/22
|
|
Eye disorders
Visual Disturbance
|
0.00%
0/60
|
0.00%
0/24
|
0.00%
0/31
|
3.2%
1/31
|
0.00%
0/24
|
0.00%
0/34
|
0.00%
0/22
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
0.00%
0/60
|
0.00%
0/24
|
0.00%
0/31
|
0.00%
0/31
|
4.2%
1/24
|
0.00%
0/34
|
0.00%
0/22
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/60
|
0.00%
0/24
|
9.7%
3/31
|
3.2%
1/31
|
0.00%
0/24
|
0.00%
0/34
|
0.00%
0/22
|
|
Gastrointestinal disorders
Dysphagia
|
3.3%
2/60
|
0.00%
0/24
|
0.00%
0/31
|
0.00%
0/31
|
0.00%
0/24
|
2.9%
1/34
|
0.00%
0/22
|
|
Gastrointestinal disorders
Gastric Ulcer
|
0.00%
0/60
|
0.00%
0/24
|
0.00%
0/31
|
0.00%
0/31
|
0.00%
0/24
|
2.9%
1/34
|
0.00%
0/22
|
|
Gastrointestinal disorders
Gastric Ulcer Perforation
|
1.7%
1/60
|
0.00%
0/24
|
3.2%
1/31
|
0.00%
0/31
|
0.00%
0/24
|
0.00%
0/34
|
0.00%
0/22
|
|
Gastrointestinal disorders
Gastrointestinal Disorder
|
1.7%
1/60
|
0.00%
0/24
|
0.00%
0/31
|
0.00%
0/31
|
4.2%
1/24
|
0.00%
0/34
|
0.00%
0/22
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/60
|
0.00%
0/24
|
0.00%
0/31
|
0.00%
0/31
|
4.2%
1/24
|
0.00%
0/34
|
0.00%
0/22
|
|
Gastrointestinal disorders
Intestinal Ischaemia
|
0.00%
0/60
|
0.00%
0/24
|
0.00%
0/31
|
0.00%
0/31
|
4.2%
1/24
|
0.00%
0/34
|
0.00%
0/22
|
|
Gastrointestinal disorders
Mouth Haemorrhage
|
1.7%
1/60
|
0.00%
0/24
|
0.00%
0/31
|
0.00%
0/31
|
0.00%
0/24
|
0.00%
0/34
|
0.00%
0/22
|
|
Gastrointestinal disorders
Nausea
|
1.7%
1/60
|
0.00%
0/24
|
0.00%
0/31
|
0.00%
0/31
|
0.00%
0/24
|
0.00%
0/34
|
0.00%
0/22
|
|
Gastrointestinal disorders
Oesophagitis
|
1.7%
1/60
|
0.00%
0/24
|
0.00%
0/31
|
0.00%
0/31
|
0.00%
0/24
|
0.00%
0/34
|
0.00%
0/22
|
|
Gastrointestinal disorders
Peptic Ulcer
|
0.00%
0/60
|
0.00%
0/24
|
0.00%
0/31
|
0.00%
0/31
|
0.00%
0/24
|
2.9%
1/34
|
0.00%
0/22
|
|
Gastrointestinal disorders
Pneumoperitoneum
|
0.00%
0/60
|
0.00%
0/24
|
0.00%
0/31
|
3.2%
1/31
|
0.00%
0/24
|
0.00%
0/34
|
0.00%
0/22
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/60
|
0.00%
0/24
|
0.00%
0/31
|
3.2%
1/31
|
0.00%
0/24
|
0.00%
0/34
|
4.5%
1/22
|
|
Gastrointestinal disorders
Upper Gastrointestinal Haemorrhage
|
1.7%
1/60
|
4.2%
1/24
|
0.00%
0/31
|
0.00%
0/31
|
0.00%
0/24
|
2.9%
1/34
|
0.00%
0/22
|
|
Gastrointestinal disorders
Vomiting
|
1.7%
1/60
|
4.2%
1/24
|
0.00%
0/31
|
3.2%
1/31
|
0.00%
0/24
|
0.00%
0/34
|
4.5%
1/22
|
|
General disorders
Death
|
3.3%
2/60
|
4.2%
1/24
|
0.00%
0/31
|
3.2%
1/31
|
8.3%
2/24
|
0.00%
0/34
|
0.00%
0/22
|
|
General disorders
Facial Pain
|
0.00%
0/60
|
0.00%
0/24
|
0.00%
0/31
|
0.00%
0/31
|
0.00%
0/24
|
2.9%
1/34
|
0.00%
0/22
|
|
General disorders
Fatigue
|
1.7%
1/60
|
4.2%
1/24
|
3.2%
1/31
|
3.2%
1/31
|
0.00%
0/24
|
2.9%
1/34
|
0.00%
0/22
|
|
General disorders
General Physical Health Deterioration
|
1.7%
1/60
|
0.00%
0/24
|
0.00%
0/31
|
0.00%
0/31
|
4.2%
1/24
|
0.00%
0/34
|
0.00%
0/22
|
|
General disorders
Localised Oedema
|
0.00%
0/60
|
0.00%
0/24
|
0.00%
0/31
|
0.00%
0/31
|
0.00%
0/24
|
2.9%
1/34
|
0.00%
0/22
|
|
General disorders
Pyrexia
|
1.7%
1/60
|
0.00%
0/24
|
12.9%
4/31
|
0.00%
0/31
|
0.00%
0/24
|
0.00%
0/34
|
0.00%
0/22
|
|
General disorders
Sudden Death
|
0.00%
0/60
|
4.2%
1/24
|
0.00%
0/31
|
3.2%
1/31
|
0.00%
0/24
|
0.00%
0/34
|
0.00%
0/22
|
|
Hepatobiliary disorders
Hepatic Failure
|
0.00%
0/60
|
0.00%
0/24
|
0.00%
0/31
|
3.2%
1/31
|
0.00%
0/24
|
0.00%
0/34
|
0.00%
0/22
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/60
|
0.00%
0/24
|
0.00%
0/31
|
0.00%
0/31
|
0.00%
0/24
|
2.9%
1/34
|
0.00%
0/22
|
|
Infections and infestations
Bronchitis
|
0.00%
0/60
|
4.2%
1/24
|
0.00%
0/31
|
0.00%
0/31
|
0.00%
0/24
|
0.00%
0/34
|
0.00%
0/22
|
|
Infections and infestations
Bronchopneumonia
|
0.00%
0/60
|
0.00%
0/24
|
0.00%
0/31
|
3.2%
1/31
|
0.00%
0/24
|
0.00%
0/34
|
0.00%
0/22
|
|
Infections and infestations
Implant Site Infection
|
0.00%
0/60
|
0.00%
0/24
|
0.00%
0/31
|
0.00%
0/31
|
0.00%
0/24
|
0.00%
0/34
|
4.5%
1/22
|
|
Infections and infestations
Laryngitis
|
0.00%
0/60
|
0.00%
0/24
|
0.00%
0/31
|
0.00%
0/31
|
0.00%
0/24
|
0.00%
0/34
|
4.5%
1/22
|
|
Blood and lymphatic system disorders
Anaemia
|
1.7%
1/60
|
0.00%
0/24
|
0.00%
0/31
|
0.00%
0/31
|
0.00%
0/24
|
2.9%
1/34
|
0.00%
0/22
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
0.00%
0/60
|
0.00%
0/24
|
0.00%
0/31
|
3.2%
1/31
|
0.00%
0/24
|
0.00%
0/34
|
0.00%
0/22
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/60
|
0.00%
0/24
|
0.00%
0/31
|
3.2%
1/31
|
4.2%
1/24
|
2.9%
1/34
|
4.5%
1/22
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/60
|
0.00%
0/24
|
0.00%
0/31
|
3.2%
1/31
|
0.00%
0/24
|
0.00%
0/34
|
0.00%
0/22
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/60
|
0.00%
0/24
|
0.00%
0/31
|
3.2%
1/31
|
0.00%
0/24
|
0.00%
0/34
|
0.00%
0/22
|
|
Cardiac disorders
Cardiac Arrest
|
5.0%
3/60
|
0.00%
0/24
|
0.00%
0/31
|
3.2%
1/31
|
0.00%
0/24
|
0.00%
0/34
|
0.00%
0/22
|
|
Cardiac disorders
Cardiac Failure
|
0.00%
0/60
|
0.00%
0/24
|
3.2%
1/31
|
0.00%
0/31
|
0.00%
0/24
|
2.9%
1/34
|
0.00%
0/22
|
|
Cardiac disorders
Cardiopulmonary Failure
|
1.7%
1/60
|
0.00%
0/24
|
0.00%
0/31
|
0.00%
0/31
|
4.2%
1/24
|
0.00%
0/34
|
0.00%
0/22
|
|
Cardiac disorders
Cardio-Respiratory Arrest
|
0.00%
0/60
|
0.00%
0/24
|
6.5%
2/31
|
0.00%
0/31
|
0.00%
0/24
|
0.00%
0/34
|
0.00%
0/22
|
|
Cardiac disorders
Myocardial Infarction
|
1.7%
1/60
|
0.00%
0/24
|
3.2%
1/31
|
0.00%
0/31
|
4.2%
1/24
|
0.00%
0/34
|
4.5%
1/22
|
|
Ear and labyrinth disorders
Deafness Bilateral
|
0.00%
0/60
|
0.00%
0/24
|
3.2%
1/31
|
0.00%
0/31
|
0.00%
0/24
|
0.00%
0/34
|
0.00%
0/22
|
|
Infections and infestations
Lobar Pneumonia
|
0.00%
0/60
|
0.00%
0/24
|
3.2%
1/31
|
0.00%
0/31
|
0.00%
0/24
|
0.00%
0/34
|
0.00%
0/22
|
|
Infections and infestations
Lower Respiratory Tract Infection
|
0.00%
0/60
|
0.00%
0/24
|
3.2%
1/31
|
0.00%
0/31
|
0.00%
0/24
|
0.00%
0/34
|
0.00%
0/22
|
|
Infections and infestations
Lymph Gland Infection
|
0.00%
0/60
|
0.00%
0/24
|
3.2%
1/31
|
0.00%
0/31
|
0.00%
0/24
|
0.00%
0/34
|
0.00%
0/22
|
|
Infections and infestations
Pharyngitis
|
1.7%
1/60
|
4.2%
1/24
|
0.00%
0/31
|
3.2%
1/31
|
4.2%
1/24
|
0.00%
0/34
|
0.00%
0/22
|
|
Infections and infestations
Pneumonia
|
6.7%
4/60
|
4.2%
1/24
|
3.2%
1/31
|
0.00%
0/31
|
4.2%
1/24
|
2.9%
1/34
|
4.5%
1/22
|
|
Infections and infestations
Pneumonia Fungal
|
0.00%
0/60
|
0.00%
0/24
|
0.00%
0/31
|
3.2%
1/31
|
0.00%
0/24
|
0.00%
0/34
|
0.00%
0/22
|
|
Infections and infestations
Sepsis
|
0.00%
0/60
|
4.2%
1/24
|
0.00%
0/31
|
0.00%
0/31
|
0.00%
0/24
|
2.9%
1/34
|
0.00%
0/22
|
|
Infections and infestations
Septic Shock
|
0.00%
0/60
|
4.2%
1/24
|
0.00%
0/31
|
0.00%
0/31
|
0.00%
0/24
|
0.00%
0/34
|
4.5%
1/22
|
|
Infections and infestations
Soft Tissue Infection
|
0.00%
0/60
|
0.00%
0/24
|
3.2%
1/31
|
0.00%
0/31
|
0.00%
0/24
|
0.00%
0/34
|
0.00%
0/22
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/60
|
0.00%
0/24
|
0.00%
0/31
|
0.00%
0/31
|
0.00%
0/24
|
0.00%
0/34
|
4.5%
1/22
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/60
|
0.00%
0/24
|
3.2%
1/31
|
0.00%
0/31
|
0.00%
0/24
|
0.00%
0/34
|
0.00%
0/22
|
|
Injury, poisoning and procedural complications
Femur Fracture
|
0.00%
0/60
|
0.00%
0/24
|
0.00%
0/31
|
0.00%
0/31
|
0.00%
0/24
|
2.9%
1/34
|
0.00%
0/22
|
|
Injury, poisoning and procedural complications
Post Procedural Haemorrhage
|
1.7%
1/60
|
0.00%
0/24
|
0.00%
0/31
|
0.00%
0/31
|
0.00%
0/24
|
0.00%
0/34
|
0.00%
0/22
|
|
Injury, poisoning and procedural complications
Radiation Mucositis
|
0.00%
0/60
|
0.00%
0/24
|
0.00%
0/31
|
0.00%
0/31
|
4.2%
1/24
|
0.00%
0/34
|
0.00%
0/22
|
|
Injury, poisoning and procedural complications
Tibia Fracture
|
0.00%
0/60
|
0.00%
0/24
|
0.00%
0/31
|
0.00%
0/31
|
4.2%
1/24
|
0.00%
0/34
|
0.00%
0/22
|
|
Injury, poisoning and procedural complications
Tracheal Obstruction
|
1.7%
1/60
|
0.00%
0/24
|
0.00%
0/31
|
0.00%
0/31
|
0.00%
0/24
|
0.00%
0/34
|
0.00%
0/22
|
|
Injury, poisoning and procedural complications
Traumatic Brain Injury
|
0.00%
0/60
|
0.00%
0/24
|
0.00%
0/31
|
0.00%
0/31
|
0.00%
0/24
|
2.9%
1/34
|
0.00%
0/22
|
|
Injury, poisoning and procedural complications
Blood Creatinine Increased
|
0.00%
0/60
|
0.00%
0/24
|
0.00%
0/31
|
3.2%
1/31
|
0.00%
0/24
|
0.00%
0/34
|
4.5%
1/22
|
|
Injury, poisoning and procedural complications
Blood Potassium Increased
|
0.00%
0/60
|
0.00%
0/24
|
0.00%
0/31
|
0.00%
0/31
|
0.00%
0/24
|
0.00%
0/34
|
4.5%
1/22
|
|
Injury, poisoning and procedural complications
Fibrin D Dimer Increased
|
1.7%
1/60
|
0.00%
0/24
|
0.00%
0/31
|
0.00%
0/31
|
0.00%
0/24
|
0.00%
0/34
|
0.00%
0/22
|
|
Injury, poisoning and procedural complications
Renal Function Test Abnormal
|
0.00%
0/60
|
0.00%
0/24
|
3.2%
1/31
|
0.00%
0/31
|
0.00%
0/24
|
0.00%
0/34
|
0.00%
0/22
|
|
Metabolism and nutrition disorders
Anorexia
|
1.7%
1/60
|
0.00%
0/24
|
0.00%
0/31
|
0.00%
0/31
|
4.2%
1/24
|
0.00%
0/34
|
0.00%
0/22
|
|
Metabolism and nutrition disorders
Cachexia
|
0.00%
0/60
|
4.2%
1/24
|
0.00%
0/31
|
0.00%
0/31
|
0.00%
0/24
|
2.9%
1/34
|
4.5%
1/22
|
|
Metabolism and nutrition disorders
Dehydration
|
3.3%
2/60
|
4.2%
1/24
|
6.5%
2/31
|
0.00%
0/31
|
4.2%
1/24
|
2.9%
1/34
|
9.1%
2/22
|
|
Metabolism and nutrition disorders
Electrolyte Imbalance
|
0.00%
0/60
|
0.00%
0/24
|
3.2%
1/31
|
3.2%
1/31
|
4.2%
1/24
|
0.00%
0/34
|
0.00%
0/22
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/60
|
0.00%
0/24
|
0.00%
0/31
|
0.00%
0/31
|
0.00%
0/24
|
2.9%
1/34
|
0.00%
0/22
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/60
|
0.00%
0/24
|
3.2%
1/31
|
0.00%
0/31
|
0.00%
0/24
|
0.00%
0/34
|
0.00%
0/22
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/60
|
0.00%
0/24
|
0.00%
0/31
|
3.2%
1/31
|
0.00%
0/24
|
0.00%
0/34
|
0.00%
0/22
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
3.3%
2/60
|
0.00%
0/24
|
3.2%
1/31
|
0.00%
0/31
|
0.00%
0/24
|
0.00%
0/34
|
0.00%
0/22
|
|
Musculoskeletal and connective tissue disorders
Neck Mass
|
0.00%
0/60
|
0.00%
0/24
|
0.00%
0/31
|
0.00%
0/31
|
4.2%
1/24
|
0.00%
0/34
|
0.00%
0/22
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
0.00%
0/60
|
0.00%
0/24
|
3.2%
1/31
|
0.00%
0/31
|
0.00%
0/24
|
0.00%
0/34
|
0.00%
0/22
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
1.7%
1/60
|
0.00%
0/24
|
0.00%
0/31
|
0.00%
0/31
|
0.00%
0/24
|
2.9%
1/34
|
0.00%
0/22
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Degeneration Of Uterine Fibroid
|
0.00%
0/60
|
0.00%
0/24
|
0.00%
0/31
|
0.00%
0/31
|
4.2%
1/24
|
0.00%
0/34
|
0.00%
0/22
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oropharyngeal Neoplasm
|
0.00%
0/60
|
0.00%
0/24
|
0.00%
0/31
|
0.00%
0/31
|
0.00%
0/24
|
0.00%
0/34
|
4.5%
1/22
|
|
Nervous system disorders
Cerebral Artery Embolism
|
0.00%
0/60
|
0.00%
0/24
|
0.00%
0/31
|
3.2%
1/31
|
0.00%
0/24
|
0.00%
0/34
|
0.00%
0/22
|
|
Nervous system disorders
Cerebral Haematoma
|
0.00%
0/60
|
0.00%
0/24
|
0.00%
0/31
|
0.00%
0/31
|
0.00%
0/24
|
2.9%
1/34
|
0.00%
0/22
|
|
Nervous system disorders
Convulsion
|
0.00%
0/60
|
0.00%
0/24
|
3.2%
1/31
|
0.00%
0/31
|
0.00%
0/24
|
0.00%
0/34
|
0.00%
0/22
|
|
Nervous system disorders
Dizziness
|
0.00%
0/60
|
0.00%
0/24
|
0.00%
0/31
|
0.00%
0/31
|
4.2%
1/24
|
0.00%
0/34
|
0.00%
0/22
|
|
Nervous system disorders
Epilepsy
|
0.00%
0/60
|
0.00%
0/24
|
0.00%
0/31
|
0.00%
0/31
|
4.2%
1/24
|
0.00%
0/34
|
4.5%
1/22
|
|
Nervous system disorders
Hypoxic Encephalopathy
|
1.7%
1/60
|
0.00%
0/24
|
0.00%
0/31
|
0.00%
0/31
|
0.00%
0/24
|
0.00%
0/34
|
0.00%
0/22
|
|
Psychiatric disorders
Depression
|
0.00%
0/60
|
4.2%
1/24
|
0.00%
0/31
|
0.00%
0/31
|
0.00%
0/24
|
0.00%
0/34
|
0.00%
0/22
|
|
Renal and urinary disorders
Acute Prerenal Failure
|
0.00%
0/60
|
0.00%
0/24
|
3.2%
1/31
|
0.00%
0/31
|
0.00%
0/24
|
0.00%
0/34
|
0.00%
0/22
|
|
Renal and urinary disorders
Azotaemia
|
0.00%
0/60
|
0.00%
0/24
|
0.00%
0/31
|
3.2%
1/31
|
0.00%
0/24
|
0.00%
0/34
|
0.00%
0/22
|
|
Renal and urinary disorders
Renal Failure
|
1.7%
1/60
|
0.00%
0/24
|
3.2%
1/31
|
3.2%
1/31
|
0.00%
0/24
|
0.00%
0/34
|
0.00%
0/22
|
|
Renal and urinary disorders
Renal Failure Acute
|
5.0%
3/60
|
0.00%
0/24
|
0.00%
0/31
|
6.5%
2/31
|
0.00%
0/24
|
0.00%
0/34
|
4.5%
1/22
|
|
Renal and urinary disorders
Renal Impairment
|
0.00%
0/60
|
0.00%
0/24
|
0.00%
0/31
|
0.00%
0/31
|
4.2%
1/24
|
0.00%
0/34
|
0.00%
0/22
|
|
Respiratory, thoracic and mediastinal disorders
Choking
|
0.00%
0/60
|
0.00%
0/24
|
0.00%
0/31
|
0.00%
0/31
|
4.2%
1/24
|
0.00%
0/34
|
0.00%
0/22
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
3.3%
2/60
|
4.2%
1/24
|
3.2%
1/31
|
3.2%
1/31
|
4.2%
1/24
|
2.9%
1/34
|
0.00%
0/22
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal Oedema
|
1.7%
1/60
|
4.2%
1/24
|
3.2%
1/31
|
0.00%
0/31
|
0.00%
0/24
|
0.00%
0/34
|
0.00%
0/22
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal Haemorrhage
|
0.00%
0/60
|
0.00%
0/24
|
0.00%
0/31
|
0.00%
0/31
|
0.00%
0/24
|
2.9%
1/34
|
0.00%
0/22
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal Inflammation
|
0.00%
0/60
|
0.00%
0/24
|
0.00%
0/31
|
3.2%
1/31
|
0.00%
0/24
|
0.00%
0/34
|
0.00%
0/22
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.00%
0/60
|
0.00%
0/24
|
0.00%
0/31
|
0.00%
0/31
|
0.00%
0/24
|
2.9%
1/34
|
0.00%
0/22
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
1.7%
1/60
|
0.00%
0/24
|
0.00%
0/31
|
3.2%
1/31
|
0.00%
0/24
|
0.00%
0/34
|
0.00%
0/22
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Distress
|
1.7%
1/60
|
0.00%
0/24
|
0.00%
0/31
|
0.00%
0/31
|
0.00%
0/24
|
0.00%
0/34
|
0.00%
0/22
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
0.00%
0/60
|
0.00%
0/24
|
0.00%
0/31
|
3.2%
1/31
|
0.00%
0/24
|
5.9%
2/34
|
0.00%
0/22
|
|
Respiratory, thoracic and mediastinal disorders
Stridor
|
0.00%
0/60
|
0.00%
0/24
|
0.00%
0/31
|
3.2%
1/31
|
0.00%
0/24
|
2.9%
1/34
|
0.00%
0/22
|
|
Skin and subcutaneous tissue disorders
Livedo Reticularis
|
0.00%
0/60
|
4.2%
1/24
|
0.00%
0/31
|
0.00%
0/31
|
0.00%
0/24
|
0.00%
0/34
|
0.00%
0/22
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/60
|
0.00%
0/24
|
0.00%
0/31
|
0.00%
0/31
|
0.00%
0/24
|
0.00%
0/34
|
4.5%
1/22
|
|
Vascular disorders
Aortic Thrombosis
|
1.7%
1/60
|
0.00%
0/24
|
0.00%
0/31
|
0.00%
0/31
|
0.00%
0/24
|
0.00%
0/34
|
0.00%
0/22
|
|
Vascular disorders
Arterial Thrombosis Limb
|
0.00%
0/60
|
4.2%
1/24
|
0.00%
0/31
|
0.00%
0/31
|
0.00%
0/24
|
0.00%
0/34
|
0.00%
0/22
|
|
Vascular disorders
Arteriosclerosis Obliterans
|
0.00%
0/60
|
0.00%
0/24
|
0.00%
0/31
|
3.2%
1/31
|
0.00%
0/24
|
0.00%
0/34
|
0.00%
0/22
|
|
Vascular disorders
Circulatory Collapse
|
0.00%
0/60
|
0.00%
0/24
|
0.00%
0/31
|
3.2%
1/31
|
0.00%
0/24
|
0.00%
0/34
|
0.00%
0/22
|
|
Vascular disorders
Hypertension
|
1.7%
1/60
|
0.00%
0/24
|
0.00%
0/31
|
0.00%
0/31
|
0.00%
0/24
|
0.00%
0/34
|
4.5%
1/22
|
|
Vascular disorders
Hypotension
|
0.00%
0/60
|
0.00%
0/24
|
0.00%
0/31
|
0.00%
0/31
|
4.2%
1/24
|
0.00%
0/34
|
0.00%
0/22
|
|
Vascular disorders
Subclavian Artery Stenosis
|
0.00%
0/60
|
0.00%
0/24
|
0.00%
0/31
|
0.00%
0/31
|
0.00%
0/24
|
2.9%
1/34
|
0.00%
0/22
|
Other adverse events
| Measure |
Placebo/Placebo
Concomitant placebo (plus cisplatin and radiotherapy) followed by placebo as maintenance therapy
|
250mg/Placebo
Concomitant gefitinib 250 mg (plus cisplatin and radiotherapy) followed by placebo as maintenance therapy
|
500mg/Placebo
Concomitant gefitinib 500 mg (plus cisplatin and radiotherapy) followed by placebo as maintenance therapy
|
250mg/250mg
Concomitant gefitinib 250 mg (plus cisplatin and radiotherapy) followed by gefitinib 250 mg as maintenance therapy
|
500mg/500mg
Concomitant gefitinib 500 mg (plus cisplatin and radiotherapy) followed by gefitinib 500 mg as maintenance therapy
|
Placebo/250mg
Concomitant placebo (plus cisplatin and radiotherapy) followed by gefitinib 250 mg as maintenance therapy
|
Placebo/500mg
Concomitant placebo (plus cisplatin and radiotherapy) followed by gefitinib 500 mg as maintenance therapy
|
|---|---|---|---|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Acne
|
1.7%
1/60
|
0.00%
0/24
|
6.5%
2/31
|
3.2%
1/31
|
8.3%
2/24
|
0.00%
0/34
|
0.00%
0/22
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
10.0%
6/60
|
12.5%
3/24
|
9.7%
3/31
|
12.9%
4/31
|
12.5%
3/24
|
5.9%
2/34
|
18.2%
4/22
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
13.3%
8/60
|
16.7%
4/24
|
22.6%
7/31
|
12.9%
4/31
|
25.0%
6/24
|
17.6%
6/34
|
18.2%
4/22
|
|
Skin and subcutaneous tissue disorders
Dermatitis Acneiform
|
1.7%
1/60
|
0.00%
0/24
|
6.5%
2/31
|
0.00%
0/31
|
4.2%
1/24
|
2.9%
1/34
|
4.5%
1/22
|
|
Skin and subcutaneous tissue disorders
Dermatitis Allergic
|
0.00%
0/60
|
0.00%
0/24
|
0.00%
0/31
|
6.5%
2/31
|
0.00%
0/24
|
0.00%
0/34
|
0.00%
0/22
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
1.7%
1/60
|
0.00%
0/24
|
0.00%
0/31
|
0.00%
0/31
|
8.3%
2/24
|
2.9%
1/34
|
4.5%
1/22
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/60
|
0.00%
0/24
|
0.00%
0/31
|
6.5%
2/31
|
0.00%
0/24
|
0.00%
0/34
|
0.00%
0/22
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
1.7%
1/60
|
0.00%
0/24
|
12.9%
4/31
|
0.00%
0/31
|
8.3%
2/24
|
0.00%
0/34
|
0.00%
0/22
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.0%
3/60
|
8.3%
2/24
|
35.5%
11/31
|
29.0%
9/31
|
8.3%
2/24
|
14.7%
5/34
|
22.7%
5/22
|
|
Skin and subcutaneous tissue disorders
Rash Pruritic
|
0.00%
0/60
|
0.00%
0/24
|
6.5%
2/31
|
3.2%
1/31
|
4.2%
1/24
|
2.9%
1/34
|
4.5%
1/22
|
|
Skin and subcutaneous tissue disorders
Skin Exfoliation
|
1.7%
1/60
|
8.3%
2/24
|
0.00%
0/31
|
0.00%
0/31
|
0.00%
0/24
|
2.9%
1/34
|
0.00%
0/22
|
|
Skin and subcutaneous tissue disorders
Skin Fibrosis
|
5.0%
3/60
|
4.2%
1/24
|
9.7%
3/31
|
3.2%
1/31
|
12.5%
3/24
|
8.8%
3/34
|
4.5%
1/22
|
|
Skin and subcutaneous tissue disorders
Skin Hyperpigmentation
|
5.0%
3/60
|
4.2%
1/24
|
6.5%
2/31
|
6.5%
2/31
|
8.3%
2/24
|
8.8%
3/34
|
4.5%
1/22
|
|
Skin and subcutaneous tissue disorders
Skin Reaction
|
10.0%
6/60
|
4.2%
1/24
|
6.5%
2/31
|
12.9%
4/31
|
8.3%
2/24
|
0.00%
0/34
|
13.6%
3/22
|
|
Skin and subcutaneous tissue disorders
Skin Ulcer
|
0.00%
0/60
|
0.00%
0/24
|
0.00%
0/31
|
0.00%
0/31
|
0.00%
0/24
|
5.9%
2/34
|
0.00%
0/22
|
|
Vascular disorders
Hypertension
|
8.3%
5/60
|
12.5%
3/24
|
3.2%
1/31
|
3.2%
1/31
|
4.2%
1/24
|
0.00%
0/34
|
9.1%
2/22
|
|
Vascular disorders
Hypotension
|
3.3%
2/60
|
0.00%
0/24
|
6.5%
2/31
|
0.00%
0/31
|
0.00%
0/24
|
5.9%
2/34
|
0.00%
0/22
|
|
Vascular disorders
Lymphoedema
|
1.7%
1/60
|
0.00%
0/24
|
0.00%
0/31
|
0.00%
0/31
|
4.2%
1/24
|
5.9%
2/34
|
9.1%
2/22
|
|
Blood and lymphatic system disorders
Anaemia
|
15.0%
9/60
|
25.0%
6/24
|
22.6%
7/31
|
32.3%
10/31
|
25.0%
6/24
|
23.5%
8/34
|
9.1%
2/22
|
|
Blood and lymphatic system disorders
Leukopenia
|
13.3%
8/60
|
20.8%
5/24
|
16.1%
5/31
|
19.4%
6/31
|
20.8%
5/24
|
20.6%
7/34
|
18.2%
4/22
|
|
Blood and lymphatic system disorders
Neutropenia
|
13.3%
8/60
|
16.7%
4/24
|
19.4%
6/31
|
19.4%
6/31
|
16.7%
4/24
|
20.6%
7/34
|
22.7%
5/22
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
3.3%
2/60
|
0.00%
0/24
|
9.7%
3/31
|
3.2%
1/31
|
0.00%
0/24
|
0.00%
0/34
|
0.00%
0/22
|
|
Cardiac disorders
Atrial Fibrillation
|
5.0%
3/60
|
0.00%
0/24
|
0.00%
0/31
|
0.00%
0/31
|
0.00%
0/24
|
0.00%
0/34
|
0.00%
0/22
|
|
Ear and labyrinth disorders
Deafness
|
3.3%
2/60
|
0.00%
0/24
|
0.00%
0/31
|
3.2%
1/31
|
8.3%
2/24
|
0.00%
0/34
|
0.00%
0/22
|
|
Ear and labyrinth disorders
Ear Pain
|
10.0%
6/60
|
8.3%
2/24
|
0.00%
0/31
|
6.5%
2/31
|
0.00%
0/24
|
8.8%
3/34
|
0.00%
0/22
|
|
Ear and labyrinth disorders
Hypoacusis
|
0.00%
0/60
|
0.00%
0/24
|
0.00%
0/31
|
0.00%
0/31
|
4.2%
1/24
|
5.9%
2/34
|
0.00%
0/22
|
|
Ear and labyrinth disorders
Tinnitus
|
1.7%
1/60
|
0.00%
0/24
|
6.5%
2/31
|
3.2%
1/31
|
4.2%
1/24
|
2.9%
1/34
|
4.5%
1/22
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/60
|
0.00%
0/24
|
6.5%
2/31
|
0.00%
0/31
|
4.2%
1/24
|
0.00%
0/34
|
4.5%
1/22
|
|
Gastrointestinal disorders
Abdominal Pain
|
1.7%
1/60
|
0.00%
0/24
|
6.5%
2/31
|
3.2%
1/31
|
4.2%
1/24
|
8.8%
3/34
|
13.6%
3/22
|
|
Gastrointestinal disorders
Constipation
|
26.7%
16/60
|
16.7%
4/24
|
25.8%
8/31
|
12.9%
4/31
|
16.7%
4/24
|
38.2%
13/34
|
40.9%
9/22
|
|
Gastrointestinal disorders
Diarrhoea
|
15.0%
9/60
|
16.7%
4/24
|
58.1%
18/31
|
32.3%
10/31
|
45.8%
11/24
|
11.8%
4/34
|
36.4%
8/22
|
|
Gastrointestinal disorders
Dry Mouth
|
41.7%
25/60
|
50.0%
12/24
|
45.2%
14/31
|
41.9%
13/31
|
50.0%
12/24
|
50.0%
17/34
|
72.7%
16/22
|
|
Gastrointestinal disorders
Dyspepsia
|
1.7%
1/60
|
0.00%
0/24
|
3.2%
1/31
|
3.2%
1/31
|
8.3%
2/24
|
0.00%
0/34
|
0.00%
0/22
|
|
Gastrointestinal disorders
Dysphagia
|
35.0%
21/60
|
16.7%
4/24
|
41.9%
13/31
|
29.0%
9/31
|
29.2%
7/24
|
47.1%
16/34
|
36.4%
8/22
|
|
Gastrointestinal disorders
Gastritis
|
1.7%
1/60
|
0.00%
0/24
|
16.1%
5/31
|
6.5%
2/31
|
0.00%
0/24
|
8.8%
3/34
|
0.00%
0/22
|
|
Gastrointestinal disorders
Glossodynia
|
0.00%
0/60
|
0.00%
0/24
|
0.00%
0/31
|
6.5%
2/31
|
0.00%
0/24
|
2.9%
1/34
|
4.5%
1/22
|
|
Gastrointestinal disorders
Nausea
|
46.7%
28/60
|
50.0%
12/24
|
48.4%
15/31
|
51.6%
16/31
|
41.7%
10/24
|
47.1%
16/34
|
59.1%
13/22
|
|
Gastrointestinal disorders
Odynophagia
|
5.0%
3/60
|
0.00%
0/24
|
12.9%
4/31
|
3.2%
1/31
|
12.5%
3/24
|
11.8%
4/34
|
9.1%
2/22
|
|
Gastrointestinal disorders
Oral Discomfort
|
1.7%
1/60
|
4.2%
1/24
|
0.00%
0/31
|
0.00%
0/31
|
0.00%
0/24
|
5.9%
2/34
|
9.1%
2/22
|
|
Gastrointestinal disorders
Oral Pain
|
10.0%
6/60
|
12.5%
3/24
|
12.9%
4/31
|
9.7%
3/31
|
4.2%
1/24
|
11.8%
4/34
|
0.00%
0/22
|
|
Gastrointestinal disorders
Saliva Altered
|
5.0%
3/60
|
0.00%
0/24
|
3.2%
1/31
|
0.00%
0/31
|
8.3%
2/24
|
0.00%
0/34
|
0.00%
0/22
|
|
Gastrointestinal disorders
Stomatitis
|
35.0%
21/60
|
33.3%
8/24
|
38.7%
12/31
|
41.9%
13/31
|
41.7%
10/24
|
29.4%
10/34
|
31.8%
7/22
|
|
Gastrointestinal disorders
Vomiting
|
50.0%
30/60
|
37.5%
9/24
|
58.1%
18/31
|
51.6%
16/31
|
58.3%
14/24
|
41.2%
14/34
|
54.5%
12/22
|
|
General disorders
Asthenia
|
6.7%
4/60
|
8.3%
2/24
|
3.2%
1/31
|
3.2%
1/31
|
8.3%
2/24
|
5.9%
2/34
|
4.5%
1/22
|
|
General disorders
Chest Pain
|
1.7%
1/60
|
4.2%
1/24
|
6.5%
2/31
|
6.5%
2/31
|
0.00%
0/24
|
2.9%
1/34
|
4.5%
1/22
|
|
General disorders
Chills
|
0.00%
0/60
|
0.00%
0/24
|
3.2%
1/31
|
6.5%
2/31
|
0.00%
0/24
|
2.9%
1/34
|
4.5%
1/22
|
|
General disorders
Face Oedema
|
0.00%
0/60
|
8.3%
2/24
|
0.00%
0/31
|
0.00%
0/31
|
0.00%
0/24
|
0.00%
0/34
|
0.00%
0/22
|
|
General disorders
Fatigue
|
11.7%
7/60
|
12.5%
3/24
|
25.8%
8/31
|
16.1%
5/31
|
8.3%
2/24
|
11.8%
4/34
|
13.6%
3/22
|
|
General disorders
Localised Oedema
|
1.7%
1/60
|
0.00%
0/24
|
0.00%
0/31
|
9.7%
3/31
|
0.00%
0/24
|
5.9%
2/34
|
0.00%
0/22
|
|
General disorders
Oedema Peripheral
|
3.3%
2/60
|
8.3%
2/24
|
6.5%
2/31
|
3.2%
1/31
|
4.2%
1/24
|
2.9%
1/34
|
0.00%
0/22
|
|
General disorders
Pain
|
0.00%
0/60
|
8.3%
2/24
|
3.2%
1/31
|
3.2%
1/31
|
0.00%
0/24
|
5.9%
2/34
|
13.6%
3/22
|
|
General disorders
Pyrexia
|
20.0%
12/60
|
20.8%
5/24
|
25.8%
8/31
|
22.6%
7/31
|
25.0%
6/24
|
32.4%
11/34
|
27.3%
6/22
|
|
Infections and infestations
Bronchitis
|
0.00%
0/60
|
8.3%
2/24
|
—
0/0
|
0.00%
0/31
|
0.00%
0/24
|
0.00%
0/34
|
4.5%
1/22
|
|
Infections and infestations
Candidiasis
|
0.00%
0/60
|
0.00%
0/24
|
6.5%
2/31
|
3.2%
1/31
|
0.00%
0/24
|
2.9%
1/34
|
4.5%
1/22
|
|
Infections and infestations
Cellulitis
|
0.00%
0/60
|
0.00%
0/24
|
0.00%
0/31
|
0.00%
0/31
|
8.3%
2/24
|
0.00%
0/34
|
0.00%
0/22
|
|
Infections and infestations
Folliculitis
|
0.00%
0/60
|
0.00%
0/24
|
3.2%
1/31
|
0.00%
0/31
|
8.3%
2/24
|
2.9%
1/34
|
0.00%
0/22
|
|
Infections and infestations
Furuncle
|
0.00%
0/60
|
0.00%
0/24
|
0.00%
0/31
|
0.00%
0/31
|
0.00%
0/24
|
5.9%
2/34
|
0.00%
0/22
|
|
Infections and infestations
Implant Site Infection
|
0.00%
0/60
|
0.00%
0/24
|
6.5%
2/31
|
3.2%
1/31
|
4.2%
1/24
|
2.9%
1/34
|
0.00%
0/22
|
|
Infections and infestations
Laryngitis
|
1.7%
1/60
|
0.00%
0/24
|
3.2%
1/31
|
3.2%
1/31
|
0.00%
0/24
|
5.9%
2/34
|
0.00%
0/22
|
|
Infections and infestations
Lung Infection
|
0.00%
0/60
|
4.2%
1/24
|
0.00%
0/31
|
9.7%
3/31
|
4.2%
1/24
|
0.00%
0/34
|
0.00%
0/22
|
|
Infections and infestations
Oral Candidiasis
|
3.3%
2/60
|
4.2%
1/24
|
3.2%
1/31
|
0.00%
0/31
|
8.3%
2/24
|
8.8%
3/34
|
0.00%
0/22
|
|
Infections and infestations
Oral Fungal Infection
|
0.00%
0/60
|
0.00%
0/24
|
6.5%
2/31
|
3.2%
1/31
|
4.2%
1/24
|
5.9%
2/34
|
4.5%
1/22
|
|
Infections and infestations
Oral Infection
|
0.00%
0/60
|
0.00%
0/24
|
3.2%
1/31
|
0.00%
0/31
|
0.00%
0/24
|
5.9%
2/34
|
0.00%
0/22
|
|
Infections and infestations
Oropharyngitis Fungal
|
1.7%
1/60
|
4.2%
1/24
|
0.00%
0/31
|
6.5%
2/31
|
4.2%
1/24
|
0.00%
0/34
|
0.00%
0/22
|
|
Infections and infestations
Pharyngitis
|
11.7%
7/60
|
4.2%
1/24
|
19.4%
6/31
|
19.4%
6/31
|
8.3%
2/24
|
14.7%
5/34
|
13.6%
3/22
|
|
Infections and infestations
Rash Pustular
|
0.00%
0/60
|
4.2%
1/24
|
3.2%
1/31
|
6.5%
2/31
|
0.00%
0/24
|
2.9%
1/34
|
4.5%
1/22
|
|
Infections and infestations
Respiratory Tract Infection
|
3.3%
2/60
|
4.2%
1/24
|
6.5%
2/31
|
0.00%
0/31
|
0.00%
0/24
|
0.00%
0/34
|
0.00%
0/22
|
|
Infections and infestations
Rhinitis
|
1.7%
1/60
|
8.3%
2/24
|
6.5%
2/31
|
3.2%
1/31
|
4.2%
1/24
|
2.9%
1/34
|
4.5%
1/22
|
|
Infections and infestations
Tracheostomy Infection
|
1.7%
1/60
|
4.2%
1/24
|
0.00%
0/31
|
0.00%
0/31
|
0.00%
0/24
|
5.9%
2/34
|
0.00%
0/22
|
|
Injury, poisoning and procedural complications
Procedural Pain
|
1.7%
1/60
|
8.3%
2/24
|
0.00%
0/31
|
9.7%
3/31
|
0.00%
0/24
|
5.9%
2/34
|
0.00%
0/22
|
|
Injury, poisoning and procedural complications
Radiation Associated Pain
|
5.0%
3/60
|
4.2%
1/24
|
0.00%
0/31
|
12.9%
4/31
|
12.5%
3/24
|
5.9%
2/34
|
0.00%
0/22
|
|
Injury, poisoning and procedural complications
Radiation Dysphagia
|
5.0%
3/60
|
16.7%
4/24
|
0.00%
0/31
|
9.7%
3/31
|
0.00%
0/24
|
8.8%
3/34
|
9.1%
2/22
|
|
Injury, poisoning and procedural complications
Radiation Mucositis
|
35.0%
21/60
|
50.0%
12/24
|
38.7%
12/31
|
29.0%
9/31
|
33.3%
8/24
|
35.3%
12/34
|
36.4%
8/22
|
|
Injury, poisoning and procedural complications
Radiation Skin Injury
|
21.7%
13/60
|
33.3%
8/24
|
25.8%
8/31
|
22.6%
7/31
|
29.2%
7/24
|
29.4%
10/34
|
27.3%
6/22
|
|
Injury, poisoning and procedural complications
Aspartate Aminotransferase Increased
|
3.3%
2/60
|
0.00%
0/24
|
0.00%
0/31
|
6.5%
2/31
|
0.00%
0/24
|
0.00%
0/34
|
0.00%
0/22
|
|
Injury, poisoning and procedural complications
Blood Creatinine Increased
|
1.7%
1/60
|
4.2%
1/24
|
6.5%
2/31
|
12.9%
4/31
|
4.2%
1/24
|
5.9%
2/34
|
4.5%
1/22
|
|
Injury, poisoning and procedural complications
Creatinine Renal Clearance Decreased
|
5.0%
3/60
|
0.00%
0/24
|
3.2%
1/31
|
6.5%
2/31
|
4.2%
1/24
|
0.00%
0/34
|
0.00%
0/22
|
|
Injury, poisoning and procedural complications
Hepatic Enzyme Increased
|
0.00%
0/60
|
0.00%
0/24
|
0.00%
0/31
|
0.00%
0/31
|
0.00%
0/24
|
2.9%
1/34
|
9.1%
2/22
|
|
Injury, poisoning and procedural complications
Weight Decreased
|
21.7%
13/60
|
33.3%
8/24
|
29.0%
9/31
|
32.3%
10/31
|
37.5%
9/24
|
35.3%
12/34
|
31.8%
7/22
|
|
Metabolism and nutrition disorders
Anorexia
|
15.0%
9/60
|
8.3%
2/24
|
6.5%
2/31
|
22.6%
7/31
|
20.8%
5/24
|
11.8%
4/34
|
18.2%
4/22
|
|
Metabolism and nutrition disorders
Dehydration
|
6.7%
4/60
|
4.2%
1/24
|
12.9%
4/31
|
16.1%
5/31
|
4.2%
1/24
|
11.8%
4/34
|
9.1%
2/22
|
|
Metabolism and nutrition disorders
Electrolyte Imbalance
|
1.7%
1/60
|
8.3%
2/24
|
0.00%
0/31
|
0.00%
0/31
|
0.00%
0/24
|
2.9%
1/34
|
4.5%
1/22
|
|
Metabolism and nutrition disorders
Hypercreatininaemia
|
0.00%
0/60
|
0.00%
0/24
|
6.5%
2/31
|
3.2%
1/31
|
4.2%
1/24
|
0.00%
0/34
|
0.00%
0/22
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/60
|
0.00%
0/24
|
9.7%
3/31
|
0.00%
0/31
|
4.2%
1/24
|
0.00%
0/34
|
0.00%
0/22
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
6.7%
4/60
|
4.2%
1/24
|
9.7%
3/31
|
6.5%
2/31
|
4.2%
1/24
|
2.9%
1/34
|
0.00%
0/22
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/60
|
0.00%
0/24
|
6.5%
2/31
|
3.2%
1/31
|
4.2%
1/24
|
2.9%
1/34
|
0.00%
0/22
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
8.3%
5/60
|
16.7%
4/24
|
16.1%
5/31
|
6.5%
2/31
|
8.3%
2/24
|
5.9%
2/34
|
13.6%
3/22
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
5.0%
3/60
|
8.3%
2/24
|
12.9%
4/31
|
9.7%
3/31
|
8.3%
2/24
|
2.9%
1/34
|
4.5%
1/22
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
5.0%
3/60
|
0.00%
0/24
|
6.5%
2/31
|
9.7%
3/31
|
0.00%
0/24
|
5.9%
2/34
|
0.00%
0/22
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/60
|
8.3%
2/24
|
6.5%
2/31
|
0.00%
0/31
|
0.00%
0/24
|
0.00%
0/34
|
9.1%
2/22
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
3.3%
2/60
|
0.00%
0/24
|
3.2%
1/31
|
0.00%
0/31
|
0.00%
0/24
|
0.00%
0/34
|
9.1%
2/22
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
1.7%
1/60
|
12.5%
3/24
|
3.2%
1/31
|
0.00%
0/31
|
0.00%
0/24
|
2.9%
1/34
|
9.1%
2/22
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour Pain
|
1.7%
1/60
|
4.2%
1/24
|
0.00%
0/31
|
0.00%
0/31
|
12.5%
3/24
|
5.9%
2/34
|
9.1%
2/22
|
|
Nervous system disorders
Ageusia
|
3.3%
2/60
|
4.2%
1/24
|
6.5%
2/31
|
0.00%
0/31
|
4.2%
1/24
|
2.9%
1/34
|
4.5%
1/22
|
|
Nervous system disorders
Dizziness
|
1.7%
1/60
|
8.3%
2/24
|
9.7%
3/31
|
6.5%
2/31
|
8.3%
2/24
|
8.8%
3/34
|
4.5%
1/22
|
|
Nervous system disorders
Dysgeusia
|
8.3%
5/60
|
4.2%
1/24
|
12.9%
4/31
|
12.9%
4/31
|
12.5%
3/24
|
5.9%
2/34
|
13.6%
3/22
|
|
Nervous system disorders
Headache
|
6.7%
4/60
|
12.5%
3/24
|
6.5%
2/31
|
9.7%
3/31
|
8.3%
2/24
|
5.9%
2/34
|
4.5%
1/22
|
|
Psychiatric disorders
Anxiety
|
8.3%
5/60
|
12.5%
3/24
|
0.00%
0/31
|
6.5%
2/31
|
8.3%
2/24
|
5.9%
2/34
|
4.5%
1/22
|
|
Psychiatric disorders
Confusional State
|
0.00%
0/60
|
0.00%
0/24
|
6.5%
2/31
|
0.00%
0/31
|
4.2%
1/24
|
0.00%
0/34
|
0.00%
0/22
|
|
Psychiatric disorders
Insomnia
|
16.7%
10/60
|
16.7%
4/24
|
9.7%
3/31
|
12.9%
4/31
|
12.5%
3/24
|
5.9%
2/34
|
18.2%
4/22
|
|
Renal and urinary disorders
Oliguria
|
0.00%
0/60
|
0.00%
0/24
|
3.2%
1/31
|
3.2%
1/31
|
0.00%
0/24
|
5.9%
2/34
|
0.00%
0/22
|
|
Renal and urinary disorders
Renal Failure
|
6.7%
4/60
|
12.5%
3/24
|
3.2%
1/31
|
6.5%
2/31
|
8.3%
2/24
|
2.9%
1/34
|
0.00%
0/22
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
16.7%
10/60
|
12.5%
3/24
|
22.6%
7/31
|
3.2%
1/31
|
8.3%
2/24
|
17.6%
6/34
|
9.1%
2/22
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
8.3%
5/60
|
4.2%
1/24
|
9.7%
3/31
|
9.7%
3/31
|
16.7%
4/24
|
14.7%
5/34
|
13.6%
3/22
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
10.0%
6/60
|
4.2%
1/24
|
6.5%
2/31
|
0.00%
0/31
|
4.2%
1/24
|
2.9%
1/34
|
4.5%
1/22
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/60
|
4.2%
1/24
|
3.2%
1/31
|
0.00%
0/31
|
4.2%
1/24
|
5.9%
2/34
|
0.00%
0/22
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal Oedema
|
8.3%
5/60
|
4.2%
1/24
|
9.7%
3/31
|
3.2%
1/31
|
4.2%
1/24
|
11.8%
4/34
|
4.5%
1/22
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal Inflammation
|
16.7%
10/60
|
4.2%
1/24
|
19.4%
6/31
|
16.1%
5/31
|
4.2%
1/24
|
14.7%
5/34
|
22.7%
5/22
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal Pain
|
30.0%
18/60
|
12.5%
3/24
|
29.0%
9/31
|
22.6%
7/31
|
29.2%
7/24
|
20.6%
7/34
|
13.6%
3/22
|
|
Respiratory, thoracic and mediastinal disorders
Productive Cough
|
10.0%
6/60
|
8.3%
2/24
|
9.7%
3/31
|
9.7%
3/31
|
12.5%
3/24
|
5.9%
2/34
|
4.5%
1/22
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER