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Trial Outcomes & Findings for BELIEF (Bevacizumab and ErLotinib In EGFR Mut+ NSCLC) (NCT NCT01562028)

NCT ID: NCT01562028

Last Updated: 2022-08-24

Results Overview

Time from the date of enrollment until an investigator-documented progression or death, whichever occurs first. Assessment of Progressive Disease (PD) is based on Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1): at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum recorded on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

109 participants

Primary outcome timeframe

From the date of enrollment until documented progression or death, whichever occurs first, assessed up to 48 months.

Results posted on

2022-08-24

Participant Flow

Between June 11, 2012 and Oct 28, 2014, 109 eligible patients were enrolled in 29 centers of eight European countries (Spain, Switzerland, UK, Greece, Italy, Ireland, France and Germany). All patients were included in the efficacy analysis.

Participant milestones

Participant milestones
Measure
T790M Positive
Treatment-naive patients with advanced non-small-cell lung cancer positive for an activating EGFR mutation (exon 19 deletion or L858R mutation), with T790M, treated with erlotinib (150 mg p.o., daily) and bevacizumab (15 mg/kg i.v. on day 1 of each 21 day cycle).
T790M Negative
Treatment-naive patients with advanced non-small-cell lung cancer positive for an activating EGFR mutation (exon 19 deletion or L858R mutation), without T790M, treated with erlotinib (150 mg p.o., daily) and bevacizumab (15 mg/kg i.v. on day 1 of each 21 day cycle).
Overall Study
STARTED
37
72
Overall Study
COMPLETED
34
70
Overall Study
NOT COMPLETED
3
2

Reasons for withdrawal

Reasons for withdrawal
Measure
T790M Positive
Treatment-naive patients with advanced non-small-cell lung cancer positive for an activating EGFR mutation (exon 19 deletion or L858R mutation), with T790M, treated with erlotinib (150 mg p.o., daily) and bevacizumab (15 mg/kg i.v. on day 1 of each 21 day cycle).
T790M Negative
Treatment-naive patients with advanced non-small-cell lung cancer positive for an activating EGFR mutation (exon 19 deletion or L858R mutation), without T790M, treated with erlotinib (150 mg p.o., daily) and bevacizumab (15 mg/kg i.v. on day 1 of each 21 day cycle).
Overall Study
Withdrawal by Subject
1
1
Overall Study
Lost to Follow-up
2
1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
T790M Positive
n=37 Participants
Treatment-naive patients with advanced non-small-cell lung cancer positive for an activating EGFR mutation (exon 19 deletion or L858R mutation), with T790M, treated with erlotinib (150 mg p.o., daily) and bevacizumab (15 mg/kg i.v. on day 1 of each 21 day cycle).
T790M Negative
n=72 Participants
Treatment-naive patients with advanced non-small-cell lung cancer positive for an activating EGFR mutation (exon 19 deletion or L858R mutation), without T790M, treated with erlotinib (150 mg p.o., daily) and bevacizumab (15 mg/kg i.v. on day 1 of each 21 day cycle).
Total
n=109 Participants
Total of all reporting groups
AEG1 mRNA expression
No material or no value
14 Participants
n=37 Participants
34 Participants
n=72 Participants
48 Participants
n=109 Participants
Age, Continuous
69.5 years
n=37 Participants
63 years
n=72 Participants
66.1 years
n=109 Participants
Sex: Female, Male
Female
25 Participants
n=37 Participants
42 Participants
n=72 Participants
67 Participants
n=109 Participants
Sex: Female, Male
Male
12 Participants
n=37 Participants
30 Participants
n=72 Participants
42 Participants
n=109 Participants
Race and Ethnicity Not Collected
—
—
0 Participants
Race and Ethnicity were not collected from any participant.
Smoking status
Current smoker
0 Participants
n=37 Participants
7 Participants
n=72 Participants
7 Participants
n=109 Participants
Smoking status
Former smoker
10 Participants
n=37 Participants
20 Participants
n=72 Participants
30 Participants
n=109 Participants
Smoking status
Never smoked
27 Participants
n=37 Participants
45 Participants
n=72 Participants
72 Participants
n=109 Participants
Histological diagnosis
Adenocarcinoma
34 Participants
n=37 Participants
59 Participants
n=72 Participants
93 Participants
n=109 Participants
Histological diagnosis
Adenosquamous carcinoma
1 Participants
n=37 Participants
1 Participants
n=72 Participants
2 Participants
n=109 Participants
Histological diagnosis
Not otherwise specified
1 Participants
n=37 Participants
2 Participants
n=72 Participants
3 Participants
n=109 Participants
Histological diagnosis
Unknown
1 Participants
n=37 Participants
10 Participants
n=72 Participants
11 Participants
n=109 Participants
ECOG performance status
0
17 Participants
n=37 Participants
36 Participants
n=72 Participants
53 Participants
n=109 Participants
ECOG performance status
1
18 Participants
n=37 Participants
32 Participants
n=72 Participants
50 Participants
n=109 Participants
ECOG performance status
2
2 Participants
n=37 Participants
4 Participants
n=72 Participants
6 Participants
n=109 Participants
Brain metastasis
Yes
7 Participants
n=37 Participants
14 Participants
n=72 Participants
21 Participants
n=109 Participants
Brain metastasis
No
30 Participants
n=37 Participants
58 Participants
n=72 Participants
88 Participants
n=109 Participants
Type of EGFR mutation
Deletion of exon 19
23 Participants
n=37 Participants
47 Participants
n=72 Participants
70 Participants
n=109 Participants
Type of EGFR mutation
L858R mutation in exon 21
14 Participants
n=37 Participants
25 Participants
n=72 Participants
39 Participants
n=109 Participants
BRCA1 mRNA expression
Low (<9.2)
10 Participants
n=37 Participants
13 Participants
n=72 Participants
23 Participants
n=109 Participants
BRCA1 mRNA expression
High (≥9.2)
10 Participants
n=37 Participants
13 Participants
n=72 Participants
23 Participants
n=109 Participants
BRCA1 mRNA expression
No material or no value
17 Participants
n=37 Participants
46 Participants
n=72 Participants
63 Participants
n=109 Participants
AEG1 mRNA expression
Low (<1)
11 Participants
n=37 Participants
20 Participants
n=72 Participants
31 Participants
n=109 Participants
AEG1 mRNA expression
High (≥1)
12 Participants
n=37 Participants
18 Participants
n=72 Participants
30 Participants
n=109 Participants

PRIMARY outcome

Timeframe: From the date of enrollment until documented progression or death, whichever occurs first, assessed up to 48 months.

Time from the date of enrollment until an investigator-documented progression or death, whichever occurs first. Assessment of Progressive Disease (PD) is based on Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1): at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum recorded on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.

Outcome measures

Outcome measures
Measure
T790M Positive
n=37 Participants
Treatment-naive patients with advanced non-small-cell lung cancer positive for an activating EGFR mutation (exon 19 deletion or L858R mutation), with T790M, treated with erlotinib (150 mg p.o., daily) and bevacizumab (15 mg/kg i.v. on day 1 of each 21 day cycle).
T790M Negative
n=72 Participants
Treatment-naive patients with advanced non-small-cell lung cancer positive for an activating EGFR mutation (exon 19 deletion or L858R mutation), without T790M, treated with erlotinib (150 mg p.o., daily) and bevacizumab (15 mg/kg i.v. on day 1 of each 21 day cycle).
Progression Free Survival
16 months
Interval 12.7 to
The upper 95% confidence limit is not estimable, since the number of patients with events is not sufficient.
10.5 months
Interval 9.4 to 14.2

SECONDARY outcome

Timeframe: From the date of enrollment until death, assessed up to 48 months.

Time from the date of enrollment until death from any cause.

Outcome measures

Outcome measures
Measure
T790M Positive
n=37 Participants
Treatment-naive patients with advanced non-small-cell lung cancer positive for an activating EGFR mutation (exon 19 deletion or L858R mutation), with T790M, treated with erlotinib (150 mg p.o., daily) and bevacizumab (15 mg/kg i.v. on day 1 of each 21 day cycle).
T790M Negative
n=72 Participants
Treatment-naive patients with advanced non-small-cell lung cancer positive for an activating EGFR mutation (exon 19 deletion or L858R mutation), without T790M, treated with erlotinib (150 mg p.o., daily) and bevacizumab (15 mg/kg i.v. on day 1 of each 21 day cycle).
Overall Survival
NA months
Interval 18.6 to
The median is not reached and the upper 95% confidence limit is not estimable, since the number of patients with events is not sufficient.
28.2 months
Interval 21.4 to 41.8

SECONDARY outcome

Timeframe: From the date of enrollment until discontinuation of treatment, assessed up to 48 months.

Time from the date of enrollment to discontinuation of treatment for any reason including progression of disease (based on RECIST v1.1), treatment toxicity (adverse events classified according to NCI CTCAE version 4.), refusal and death.

Outcome measures

Outcome measures
Measure
T790M Positive
n=37 Participants
Treatment-naive patients with advanced non-small-cell lung cancer positive for an activating EGFR mutation (exon 19 deletion or L858R mutation), with T790M, treated with erlotinib (150 mg p.o., daily) and bevacizumab (15 mg/kg i.v. on day 1 of each 21 day cycle).
T790M Negative
n=72 Participants
Treatment-naive patients with advanced non-small-cell lung cancer positive for an activating EGFR mutation (exon 19 deletion or L858R mutation), without T790M, treated with erlotinib (150 mg p.o., daily) and bevacizumab (15 mg/kg i.v. on day 1 of each 21 day cycle).
Time to Treatment Failure
13.4 months
Interval 5.6 to 19.6
8.3 months
Interval 6.3 to 9.8

SECONDARY outcome

Timeframe: Assessed across all time-points from enrollment to termination of trial treatment (max 48 months).

Population: Patients with only 1 tumor assessment are classified as "Non-Evaluable", because they cannot be accounted for the Objective Response rate.

Objective response is defined as best overall response (CR or PR) across all assessment time-points during the period from enrollment to termination of trial treatment. Objective response, along with progressive and stable disease, will be determined using RECIST 1.1 criteria: Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum of diameters. Progression (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum recorded on the trial. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as reference the smallest sum of diameters recorded on the trial.

Outcome measures

Outcome measures
Measure
T790M Positive
n=37 Participants
Treatment-naive patients with advanced non-small-cell lung cancer positive for an activating EGFR mutation (exon 19 deletion or L858R mutation), with T790M, treated with erlotinib (150 mg p.o., daily) and bevacizumab (15 mg/kg i.v. on day 1 of each 21 day cycle).
T790M Negative
n=72 Participants
Treatment-naive patients with advanced non-small-cell lung cancer positive for an activating EGFR mutation (exon 19 deletion or L858R mutation), without T790M, treated with erlotinib (150 mg p.o., daily) and bevacizumab (15 mg/kg i.v. on day 1 of each 21 day cycle).
Objective Response
Stable Disease
8 Participants
9 Participants
Objective Response
Progressive Disease
1 Participants
3 Participants
Objective Response
Non-Evaluable
1 Participants
3 Participants
Objective Response
Complete Response
3 Participants
3 Participants
Objective Response
Partial Response
24 Participants
54 Participants

SECONDARY outcome

Timeframe: Assessed across all time-points from enrollment to termination of trial treatment (max 48 months).

Disease control is defined as achieving objective response (CR or PR, across all time-points from enrollment to termination of trial treatment) or stable disease for at least 6 weeks. Objective response, along with SD (disease control) and PD (no disease control), will be determined using RECIST 1.1 criteria: Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum of diameters.Progression (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum recorded on the trial. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as reference the smallest sum of diameters recorded on the trial.

Outcome measures

Outcome measures
Measure
T790M Positive
n=37 Participants
Treatment-naive patients with advanced non-small-cell lung cancer positive for an activating EGFR mutation (exon 19 deletion or L858R mutation), with T790M, treated with erlotinib (150 mg p.o., daily) and bevacizumab (15 mg/kg i.v. on day 1 of each 21 day cycle).
T790M Negative
n=72 Participants
Treatment-naive patients with advanced non-small-cell lung cancer positive for an activating EGFR mutation (exon 19 deletion or L858R mutation), without T790M, treated with erlotinib (150 mg p.o., daily) and bevacizumab (15 mg/kg i.v. on day 1 of each 21 day cycle).
Disease Control
Disease Control
35 Participants
66 Participants
Disease Control
No Disease Control
2 Participants
6 Participants

SECONDARY outcome

Timeframe: Assessed across all time-points from enrollment to to the date of first documented progression or relapse (max 48 months).

Interval from the date of first documentation of objective response (CR or PR) to the date of first documented progression or relapse. Assessment of Objective response and Progressive Disease (PD) is based on the RECIST 1.1 criteria: Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum of diameters. Progression (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum recorded on the trial. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as reference the smallest sum of diameters recorded on the trial.

Outcome measures

Outcome measures
Measure
T790M Positive
n=37 Participants
Treatment-naive patients with advanced non-small-cell lung cancer positive for an activating EGFR mutation (exon 19 deletion or L858R mutation), with T790M, treated with erlotinib (150 mg p.o., daily) and bevacizumab (15 mg/kg i.v. on day 1 of each 21 day cycle).
T790M Negative
n=72 Participants
Treatment-naive patients with advanced non-small-cell lung cancer positive for an activating EGFR mutation (exon 19 deletion or L858R mutation), without T790M, treated with erlotinib (150 mg p.o., daily) and bevacizumab (15 mg/kg i.v. on day 1 of each 21 day cycle).
Duration of Response
NA months
Interval 14.7 to
The median is not reached and the upper 95% confidence limit is not estimable, since the number of patients with events is not sufficient.
12 months
Interval 8.2 to 20.2

SECONDARY outcome

Timeframe: Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).

Population: Three patients never started treatment (2 lost to follow-up, one from each arm and 1 withdrawal from T790M negative arm).

Adverse events graded according to NCI CTCAE V4.

Outcome measures

Outcome measures
Measure
T790M Positive
n=36 Participants
Treatment-naive patients with advanced non-small-cell lung cancer positive for an activating EGFR mutation (exon 19 deletion or L858R mutation), with T790M, treated with erlotinib (150 mg p.o., daily) and bevacizumab (15 mg/kg i.v. on day 1 of each 21 day cycle).
T790M Negative
n=70 Participants
Treatment-naive patients with advanced non-small-cell lung cancer positive for an activating EGFR mutation (exon 19 deletion or L858R mutation), without T790M, treated with erlotinib (150 mg p.o., daily) and bevacizumab (15 mg/kg i.v. on day 1 of each 21 day cycle).
Adverse Events
Experienced AE/SAE
36 Participants
69 Participants
Adverse Events
No AE/SAE
0 Participants
1 Participants
Adverse Events
Experienced SAE
12 Participants
19 Participants

Adverse Events

T790M Positive

Serious events: 12 serious events
Other events: 36 other events
Deaths: 1 deaths

T790M Negative

Serious events: 19 serious events
Other events: 69 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
T790M Positive
n=36 participants at risk
Treatment-naive patients with advanced non-small-cell lung cancer positive for an activating EGFR mutation (exon 19 deletion or L858R mutation), with T790M, treated with erlotinib (150 mg p.o., daily) and bevacizumab (15 mg/kg i.v. on day 1 of each 21 day cycle).
T790M Negative
n=70 participants at risk
Treatment-naive patients with advanced non-small-cell lung cancer positive for an activating EGFR mutation (exon 19 deletion or L858R mutation), without T790M, treated with erlotinib (150 mg p.o., daily) and bevacizumab (15 mg/kg i.v. on day 1 of each 21 day cycle).
Vascular disorders
Thromboembolic event
2.8%
1/36 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
4.3%
3/70 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
Gastrointestinal disorders
Abdominal pain
2.8%
1/36 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
1.4%
1/70 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
Infections and infestations
Appendicitis
0.00%
0/36 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
2.9%
2/70 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
Gastrointestinal disorders
Colonic perforation
2.8%
1/36 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
1.4%
1/70 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
Psychiatric disorders
Confusion
5.6%
2/36 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
0.00%
0/70 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
Metabolism and nutrition disorders
Dehydration
5.6%
2/36 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
0.00%
0/70 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
Gastrointestinal disorders
Diarrhea
0.00%
0/36 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
2.9%
2/70 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
Infections and infestations
Lung infection
0.00%
0/36 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
2.9%
2/70 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
Nervous system disorders
Other
0.00%
0/36 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
2.9%
2/70 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
Gastrointestinal disorders
Pancreatitis
0.00%
0/36 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
2.9%
2/70 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
Infections and infestations
Urinary tract infection
5.6%
2/36 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
0.00%
0/70 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
Infections and infestations
Abdominal infection
2.8%
1/36 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
0.00%
0/70 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
Cardiac disorders
Acute coronary syndrome
0.00%
0/36 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
1.4%
1/70 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
Gastrointestinal disorders
Anal hemorrhage
2.8%
1/36 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
0.00%
0/70 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
Musculoskeletal and connective tissue disorders
Back pain
0.00%
0/36 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
1.4%
1/70 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
Infections and infestations
Biliary tract infection
0.00%
0/36 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
1.4%
1/70 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
Infections and infestations
Bone infection
0.00%
0/36 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
1.4%
1/70 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
Infections and infestations
Bronchial infection
2.8%
1/36 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
0.00%
0/70 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
Nervous system disorders
Cognitive disturbance
2.8%
1/36 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
0.00%
0/70 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
Gastrointestinal disorders
Colitis
2.8%
1/36 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
0.00%
0/70 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
Blood and lymphatic system disorders
Disseminated intravascular coagulation
0.00%
0/36 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
1.4%
1/70 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
Nervous system disorders
Dizziness
0.00%
0/36 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
1.4%
1/70 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
Gastrointestinal disorders
Dysphagia
2.8%
1/36 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
0.00%
0/70 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
General disorders
Fever
0.00%
0/36 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
1.4%
1/70 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
Gastrointestinal disorders
Other
0.00%
0/36 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
1.4%
1/70 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
Hepatobiliary disorders
Other
0.00%
0/36 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
1.4%
1/70 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
Injury, poisoning and procedural complications
Hip fracture
2.8%
1/36 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
0.00%
0/70 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
Vascular disorders
Hypotension
2.8%
1/36 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
0.00%
0/70 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
Musculoskeletal and connective tissue disorders
Other
0.00%
0/36 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
1.4%
1/70 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Other
0.00%
0/36 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
1.4%
1/70 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
Respiratory, thoracic and mediastinal disorders
Pneumothorax
0.00%
0/36 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
1.4%
1/70 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
Skin and subcutaneous tissue disorders
Rash maculo-papular
2.8%
1/36 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
0.00%
0/70 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
Respiratory, thoracic and mediastinal disorders
Other
0.00%
0/36 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
1.4%
1/70 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
Nervous system disorders
Seizure
0.00%
0/36 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
1.4%
1/70 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
Infections and infestations
Sepsis
2.8%
1/36 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
1.4%
1/70 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
Investigations
Serum amylase increased
2.8%
1/36 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
0.00%
0/70 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
Gastrointestinal disorders
Vomiting
2.8%
1/36 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
0.00%
0/70 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).

Other adverse events

Other adverse events
Measure
T790M Positive
n=36 participants at risk
Treatment-naive patients with advanced non-small-cell lung cancer positive for an activating EGFR mutation (exon 19 deletion or L858R mutation), with T790M, treated with erlotinib (150 mg p.o., daily) and bevacizumab (15 mg/kg i.v. on day 1 of each 21 day cycle).
T790M Negative
n=70 participants at risk
Treatment-naive patients with advanced non-small-cell lung cancer positive for an activating EGFR mutation (exon 19 deletion or L858R mutation), without T790M, treated with erlotinib (150 mg p.o., daily) and bevacizumab (15 mg/kg i.v. on day 1 of each 21 day cycle).
Vascular disorders
Hypertension
91.7%
33/36 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
88.6%
62/70 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
Gastrointestinal disorders
Diarrhea
83.3%
30/36 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
78.6%
55/70 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
Skin and subcutaneous tissue disorders
Rash maculo-papular
77.8%
28/36 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
78.6%
55/70 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
Renal and urinary disorders
Proteinuria
75.0%
27/36 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
48.6%
34/70 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
General disorders
Fatigue
63.9%
23/36 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
48.6%
34/70 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
Respiratory, thoracic and mediastinal disorders
Cough
66.7%
24/36 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
42.9%
30/70 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
Respiratory, thoracic and mediastinal disorders
Epistaxis
50.0%
18/36 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
28.6%
20/70 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
Skin and subcutaneous tissue disorders
Dry skin
47.2%
17/36 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
28.6%
20/70 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
Gastrointestinal disorders
Nausea
36.1%
13/36 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
28.6%
20/70 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
Respiratory, thoracic and mediastinal disorders
Dyspnea
33.3%
12/36 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
25.7%
18/70 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
Gastrointestinal disorders
Mucositis oral
41.7%
15/36 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
21.4%
15/70 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
Investigations
Alanine aminotransferase increase
22.2%
8/36 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
30.0%
21/70 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
Metabolism and nutrition disorders
Anorexia
27.8%
10/36 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
25.7%
18/70 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
Investigations
Aspartate aminotransferase increase
19.4%
7/36 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
30.0%
21/70 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
Skin and subcutaneous tissue disorders
Rash acneiform
27.8%
10/36 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
18.6%
13/70 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
General disorders
Pain
27.8%
10/36 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
17.1%
12/70 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
Skin and subcutaneous tissue disorders
Other
25.0%
9/36 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
18.6%
13/70 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
Gastrointestinal disorders
Abdominal pain
11.1%
4/36 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
21.4%
15/70 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
Musculoskeletal and connective tissue disorders
Bone pain
22.2%
8/36 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
18.6%
13/70 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
Nervous system disorders
Headache
22.2%
8/36 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
18.6%
13/70 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
Musculoskeletal and connective tissue disorders
Back pain
11.1%
4/36 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
21.4%
15/70 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
Gastrointestinal disorders
Constipation
22.2%
8/36 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
17.1%
12/70 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
Skin and subcutaneous tissue disorders
Alopecia
22.2%
8/36 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
15.7%
11/70 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
Eye disorders
Conjunctivitis
25.0%
9/36 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
12.9%
9/70 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
Nervous system disorders
Dysgeusia
16.7%
6/36 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
17.1%
12/70 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
Gastrointestinal disorders
Vomiting
19.4%
7/36 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
1.4%
1/70 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
Nervous system disorders
Dizziness
16.7%
6/36 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
14.3%
10/70 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
Infections and infestations
Paronychia
22.2%
8/36 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
11.4%
8/70 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
Skin and subcutaneous tissue disorders
Pruritus
27.8%
10/36 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
8.6%
6/70 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
Infections and infestations
Urinary tract infection
16.7%
6/36 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
10.0%
7/70 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
Musculoskeletal and connective tissue disorders
Arthralgia
19.4%
7/36 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
10.0%
7/70 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
Musculoskeletal and connective tissue disorders
Pain in extremity
16.7%
6/36 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
11.4%
8/70 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
Skin and subcutaneous tissue disorders
Erythema multiforme
16.7%
6/36 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
8.6%
6/70 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
Eye disorders
Other
13.9%
5/36 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
10.0%
7/70 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
Infections and infestations
Upper respiratory infection
16.7%
6/36 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
8.6%
6/70 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
Metabolism and nutrition disorders
Other
11.1%
4/36 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
10.0%
7/70 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
Gastrointestinal disorders
Other
16.7%
6/36 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
4.3%
3/70 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
Infections and infestations
Other
13.9%
5/36 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
7.1%
5/70 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
Psychiatric disorders
Depression
5.6%
2/36 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
10.0%
7/70 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
General disorders
Edema limbs
13.9%
5/36 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
5.7%
4/70 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
General disorders
Fever
8.3%
3/36 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
7.1%
5/70 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
Gastrointestinal disorders
Hemorrhoids
11.1%
4/36 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
7.1%
5/70 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
Infections and infestations
Nail infection
8.3%
3/36 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
8.6%
6/70 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
Nervous system disorders
Paresthesia
8.3%
3/36 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
8.6%
6/70 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
Respiratory, thoracic and mediastinal disorders
Other
11.1%
4/36 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
5.7%
4/70 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
Respiratory, thoracic and mediastinal disorders
Voice alteration
13.9%
5/36 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
5.7%
4/70 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
Gastrointestinal disorders
Anal hemorrhage
11.1%
4/36 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
4.3%
3/70 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
Eye disorders
Dry eye
8.3%
3/36 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
7.1%
5/70 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
Gastrointestinal disorders
Dry mouth
13.9%
5/36 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
4.3%
3/70 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
Respiratory, thoracic and mediastinal disorders
Hoarseness
8.3%
3/36 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
7.1%
5/70 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
Musculoskeletal and connective tissue disorders
Myalgia
5.6%
2/36 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
8.6%
6/70 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
Gastrointestinal disorders
Oral hemorrhage
8.3%
3/36 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
7.1%
5/70 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
Vascular disorders
Thromboembolic event
5.6%
2/36 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
2.9%
2/70 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
Gastrointestinal disorders
Dysphagia
11.1%
4/36 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
2.9%
2/70 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
General disorders
Flu like symptoms
8.3%
3/36 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
5.7%
4/70 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
Gastrointestinal disorders
Gastroesophageal reflux disease
5.6%
2/36 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
7.1%
5/70 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
General disorders
Other
8.3%
3/36 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
4.3%
3/70 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
Infections and infestations
Lung infection
5.6%
2/36 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
2.9%
2/70 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
Infections and infestations
Mucosal infection
8.3%
3/36 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
4.3%
3/70 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
Musculoskeletal and connective tissue disorders
Other
2.8%
1/36 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
5.7%
4/70 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
Nervous system disorders
Other
5.6%
2/36 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
2.9%
2/70 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
Blood and lymphatic system disorders
Anemia
2.8%
1/36 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
5.7%
4/70 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
Psychiatric disorders
Anxiety
5.6%
2/36 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
4.3%
3/70 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
Infections and infestations
Bronchial infection
5.6%
2/36 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
2.9%
2/70 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
Musculoskeletal and connective tissue disorders
Chest wall pain
2.8%
1/36 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
5.7%
4/70 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
Investigations
Creatinine increased
8.3%
3/36 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
2.9%
2/70 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
Vascular disorders
Hematoma
5.6%
2/36 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
4.3%
3/70 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
Renal and urinary disorders
Hematuria
2.8%
1/36 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
5.7%
4/70 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
Skin and subcutaneous tissue disorders
Nail ridging
5.6%
2/36 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
4.3%
3/70 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
Renal and urinary disorders
Other
0.00%
0/36 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
7.1%
5/70 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
Nervous system disorders
Aphonia
11.1%
4/36 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
0.00%
0/70 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
Musculoskeletal and connective tissue disorders
Arthritis
5.6%
2/36 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
2.9%
2/70 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
Blood and lymphatic system disorders
Other
5.6%
2/36 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
2.9%
2/70 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
Investigations
Blood bilirubin increased
2.8%
1/36 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
4.3%
3/70 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
Gastrointestinal disorders
Dyspepsia
2.8%
1/36 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
4.3%
3/70 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
Gastrointestinal disorders
Gastritis
5.6%
2/36 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
2.9%
2/70 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
Gastrointestinal disorders
Hemorrhoidal hemorrhage
5.6%
2/36 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
2.9%
2/70 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
Psychiatric disorders
Insomnia
5.6%
2/36 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
2.9%
2/70 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
General disorders
Non-cardiac chest pain
5.6%
2/36 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
2.9%
2/70 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
Nervous system disorders
Peripheral sensory neuropathy
2.8%
1/36 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
4.3%
3/70 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
Infections and infestations
Rhinitis infective
2.8%
1/36 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
4.3%
3/70 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
Ear and labyrinth disorders
Vertigo
0.00%
0/36 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
5.7%
4/70 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
Cardiac disorders
Chest pain - cardiac
0.00%
0/36 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
4.3%
3/70 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
Infections and infestations
Lip infection
0.00%
0/36 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
4.3%
3/70 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
Skin and subcutaneous tissue disorders
Nail discoloration
5.6%
2/36 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
1.4%
1/70 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
Gastrointestinal disorders
Oral pain
5.6%
2/36 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
1.4%
1/70 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrome
0.00%
0/36 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
4.3%
3/70 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
Skin and subcutaneous tissue disorders
Skin ulceration
0.00%
0/36 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
4.3%
3/70 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
Eye disorders
Watering eyes
5.6%
2/36 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).
1.4%
1/70 • Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).
One patient from the T790 positive arm never started treatment (lost to follow-up). Two patients from the T790 negative arm never started treatment (one lost to follow-up and one withdrawal).

Additional Information

Heidi Roschitzki-Voser

European Thoracic Oncology Platform (ETOP)

Phone: +41 31 511 94 18

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place