Trial Outcomes & Findings for TIGER-1: Safety and Efficacy Study of Rociletinib (CO-1686) or Erlotinib in Patients With EGFR-mutant/Metastatic NSCLC Who Have Not Had Any Previous EGFR Directed Therapy (NCT NCT02186301)

NCT ID: NCT02186301

Last Updated: 2019-05-07

Results Overview

To compare the antitumor efficacy of oral single-agent rociletinib with that of erlotinib as measured by progression-free survival (PFS), when administered as a first-line targeted treatment to patients with EGFR-mutated, advanced NSCLC.Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.The appearance of one or more new lesions is also considered progression.

Recruitment status

TERMINATED

Study phase

PHASE2/PHASE3

Target enrollment

100 participants

Primary outcome timeframe

Cycle 1 Day 1 to End of Treatment, up to approximately 35 months

Results posted on

2019-05-07

Participant Flow

100 subjects recruited from 74 sites, in 7 countries and randomized (1:1) to treatment with rociletinib or erlotinib.Original protocol had rociletinib starting dose of 625mg. In global Amendment 2, starting dose reduced to 500mg. Crossover to rociletinib was permitted however, only 2 patients did so. Safety data for these 2 patients are reported.

Participant milestones

Participant milestones
Measure
Rociletinib 500mg Tablets
Starting dose of 500mg. Taken orally twice daily (continuous 28 day treatment cycle). Treatment duration until radiographically confirmed disease progression.
Rociletinib 625mg Tablets
Starting dose of 625mg. Taken orally twice daily (continuous 28 day treatment cycle). Treatment duration until radiographically confirmed disease progression.
Erlotinib 150mg Tablets
Starting dose of 150mg. Taken orally once daily (continuous 28 day treatment cycle). Treatment duration until radiographically confirmed disease progression.
Overall Study
STARTED
20
30
50
Overall Study
COMPLETED
0
0
0
Overall Study
NOT COMPLETED
20
30
50

Reasons for withdrawal

Reasons for withdrawal
Measure
Rociletinib 500mg Tablets
Starting dose of 500mg. Taken orally twice daily (continuous 28 day treatment cycle). Treatment duration until radiographically confirmed disease progression.
Rociletinib 625mg Tablets
Starting dose of 625mg. Taken orally twice daily (continuous 28 day treatment cycle). Treatment duration until radiographically confirmed disease progression.
Erlotinib 150mg Tablets
Starting dose of 150mg. Taken orally once daily (continuous 28 day treatment cycle). Treatment duration until radiographically confirmed disease progression.
Overall Study
Progressive Disease
7
22
27
Overall Study
Adverse Event
5
5
5
Overall Study
Death
1
0
0
Overall Study
Withdrawal by Subject
5
1
3
Overall Study
Physician Decision
1
0
1
Overall Study
Study Terminated by Sponsor
1
0
11
Overall Study
Protocol Deviation
0
2
0
Overall Study
Missing
0
0
2
Overall Study
Other
0
0
1

Baseline Characteristics

TIGER-1: Safety and Efficacy Study of Rociletinib (CO-1686) or Erlotinib in Patients With EGFR-mutant/Metastatic NSCLC Who Have Not Had Any Previous EGFR Directed Therapy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Rociletinib 500mg Tablets
n=20 Participants
Starting dose of 500mg. Taken orally twice daily (continuous 28 day treatment cycle). Treatment duration until radiographically confirmed disease progression.
Rociletinib 625mg Tablets
n=30 Participants
Starting dose of 625mg. Taken orally twice daily (continuous 28 day treatment cycle). Treatment duration until radiographically confirmed disease progression.
Erlotinib 150mg Tablets
n=50 Participants
Starting dose of 150mg. Taken orally once daily (continuous 28 day treatment cycle). Treatment duration until radiographically confirmed disease progression.
Total
n=100 Participants
Total of all reporting groups
Age, Customized
66.0 years
n=99 Participants
67.0 years
n=107 Participants
64 years
n=206 Participants
65 years
n=7 Participants
Sex: Female, Male
Female
17 Participants
n=99 Participants
18 Participants
n=107 Participants
32 Participants
n=206 Participants
67 Participants
n=7 Participants
Sex: Female, Male
Male
3 Participants
n=99 Participants
12 Participants
n=107 Participants
18 Participants
n=206 Participants
33 Participants
n=7 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants
n=99 Participants
3 Participants
n=107 Participants
6 Participants
n=206 Participants
9 Participants
n=7 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
19 Participants
n=99 Participants
27 Participants
n=107 Participants
43 Participants
n=206 Participants
89 Participants
n=7 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
1 Participants
n=99 Participants
0 Participants
n=107 Participants
1 Participants
n=206 Participants
2 Participants
n=7 Participants
Race/Ethnicity, Customized
American Indian or Alaska Native
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
0 Participants
n=7 Participants
Race/Ethnicity, Customized
Asian
9 Participants
n=99 Participants
15 Participants
n=107 Participants
25 Participants
n=206 Participants
49 Participants
n=7 Participants
Race/Ethnicity, Customized
Black or African American
2 Participants
n=99 Participants
2 Participants
n=107 Participants
1 Participants
n=206 Participants
5 Participants
n=7 Participants
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
0 Participants
n=7 Participants
Race/Ethnicity, Customized
White
9 Participants
n=99 Participants
12 Participants
n=107 Participants
21 Participants
n=206 Participants
42 Participants
n=7 Participants
Race/Ethnicity, Customized
Other
0 Participants
n=99 Participants
0 Participants
n=107 Participants
1 Participants
n=206 Participants
1 Participants
n=7 Participants
Race/Ethnicity, Customized
Missing
0 Participants
n=99 Participants
1 Participants
n=107 Participants
2 Participants
n=206 Participants
3 Participants
n=7 Participants
Race/Ethnicity, Customized
Non-White, Non-Asian
2 Participants
n=99 Participants
3 Participants
n=107 Participants
4 Participants
n=206 Participants
9 Participants
n=7 Participants
Number of Previous Therapies
0.0 units on a scale
n=99 Participants
0.0 units on a scale
n=107 Participants
0.0 units on a scale
n=206 Participants
0.0 units on a scale
n=7 Participants
Time Since Diagnosis of NSCLC
7.2 months
STANDARD_DEVIATION 14.12 • n=99 Participants
5.3 months
STANDARD_DEVIATION 10.39 • n=107 Participants
8.2 months
STANDARD_DEVIATION 21.83 • n=206 Participants
7.1 months
STANDARD_DEVIATION 17.57 • n=7 Participants
History of CNS Metastases
1 Participants
n=99 Participants
1 Participants
n=107 Participants
2 Participants
n=206 Participants
4 Participants
n=7 Participants

PRIMARY outcome

Timeframe: Cycle 1 Day 1 to End of Treatment, up to approximately 35 months

Population: Intent-to-treat: All patients randomized. 1 patient was not included in analysis, due to discontinuation of study shortly after randomization and prior to first dose of study drug.

To compare the antitumor efficacy of oral single-agent rociletinib with that of erlotinib as measured by progression-free survival (PFS), when administered as a first-line targeted treatment to patients with EGFR-mutated, advanced NSCLC.Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.The appearance of one or more new lesions is also considered progression.

Outcome measures

Outcome measures
Measure
Rociletinib 500mg Tablets
n=18 Participants
Starting dose of 500mg. Taken orally twice daily (continuous 28 day treatment cycle). Treatment duration until radiographically confirmed disease progression.
Rociletinib 625mg Tablets
n=30 Participants
Starting dose of 625mg. Taken orally twice daily (continuous 28 day treatment cycle). Treatment duration until radiographically confirmed disease progression.
Erlotinib 150mg Tablets
n=50 Participants
Starting dose of 150mg. Taken orally once daily (continuous 28 day treatment cycle). Treatment duration until radiographically confirmed disease progression.
Progression Free Survival (PFS) According to RECIST Version 1.1 as Determined by Investigator Review (invPFS)
274 Days
Interval 109.0 to
Upper Confidence Limit is not available because it cannot be calculated.
207 Days
Interval 112.0 to 260.0
390 Days
Interval 282.0 to 499.0

SECONDARY outcome

Timeframe: Cycle 1 Day 1 to End of Treatment, up to approximately 35 months.

Population: Intent-to-treat: All patients randomized

Proportion of patients with a best overall confirmed response of partial response (PR) or complete response (CR) recorded from the start of the treatment until disease progression or recurrence. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions, defined by and assessed as: Complete Response (CR), is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. Partial Response (PR),at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameter. Overall Response (OR),is the best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the treatment started). The patient's best response assignment was dependent on the achievement of both measurement and confirmation criteria.

Outcome measures

Outcome measures
Measure
Rociletinib 500mg Tablets
n=20 Participants
Starting dose of 500mg. Taken orally twice daily (continuous 28 day treatment cycle). Treatment duration until radiographically confirmed disease progression.
Rociletinib 625mg Tablets
n=30 Participants
Starting dose of 625mg. Taken orally twice daily (continuous 28 day treatment cycle). Treatment duration until radiographically confirmed disease progression.
Erlotinib 150mg Tablets
n=50 Participants
Starting dose of 150mg. Taken orally once daily (continuous 28 day treatment cycle). Treatment duration until radiographically confirmed disease progression.
Confirmed Response Rate
25.0 percentage of participants
Interval 8.7 to 49.1
40.0 percentage of participants
Interval 22.7 to 59.4
78.0 percentage of participants
Interval 64.0 to 88.5

SECONDARY outcome

Timeframe: Cycle 1 Day 1 to End of Treatment, up to approximately 35 months

Duration of Response in Patients with Confirmed Response per Investigator

Outcome measures

Outcome measures
Measure
Rociletinib 500mg Tablets
n=5 Participants
Starting dose of 500mg. Taken orally twice daily (continuous 28 day treatment cycle). Treatment duration until radiographically confirmed disease progression.
Rociletinib 625mg Tablets
n=12 Participants
Starting dose of 625mg. Taken orally twice daily (continuous 28 day treatment cycle). Treatment duration until radiographically confirmed disease progression.
Erlotinib 150mg Tablets
n=39 Participants
Starting dose of 150mg. Taken orally once daily (continuous 28 day treatment cycle). Treatment duration until radiographically confirmed disease progression.
Duration of Response
225 Days
Interval 113.0 to
Upper Confidence Limit is not available because it cannot be calculated.
195.5 Days
Interval 143.0 to 617.0
335.0 Days
Interval 282.0 to 480.0

Adverse Events

Rociletinib 500mg Tablets

Serious events: 10 serious events
Other events: 19 other events
Deaths: 3 deaths

Rociletinib 625mg Tablets

Serious events: 15 serious events
Other events: 30 other events
Deaths: 1 deaths

Erlotinib 150mg Tablets

Serious events: 7 serious events
Other events: 50 other events
Deaths: 2 deaths

Crossover From Erlotinib 150mg to Rociletinib 500mg

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

Crossover From Erlotinib 150mg to Rociletinib 625mg

Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
Rociletinib 500mg Tablets
n=19 participants at risk
Starting dose of 500mg. Taken orally twice daily (continuous 28 day treatment cycle). Treatment duration until radiographically confirmed disease progression.
Rociletinib 625mg Tablets
n=30 participants at risk
Starting dose of 625mg. Taken orally twice daily (continuous 28 day treatment cycle). Treatment duration until radiographically confirmed disease progression.
Erlotinib 150mg Tablets
n=50 participants at risk
Starting dose of 150mg. Taken orally once daily (continuous 28 day treatment cycle). Treatment duration until radiographically confirmed disease progression.
Crossover From Erlotinib 150mg to Rociletinib 500mg
n=1 participants at risk
Patients initially randomized to erlotinib were eligible to participate in an optional crossover phase to receive CO-1686. Starting dose of 500mg CO-1686. Taken orally twice daily (continuous 28 day treatment cycle). Treatment duration until radiographically confirmed disease progression.
Crossover From Erlotinib 150mg to Rociletinib 625mg
n=1 participants at risk
Patients initially randomized to erlotinib were eligible to participate in an optional crossover phase to receive CO-1686. Starting dose of 625mg. Taken orally twice daily (continuous 28 day treatment cycle). Treatment duration until radiographically confirmed disease progression.
Endocrine disorders
Diabetic ketoacidosis
5.3%
1/19 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/30 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/50 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
Endocrine disorders
Hyperglycaemia
5.3%
1/19 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
3.3%
1/30 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/50 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
0.00%
0/19 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
3.3%
1/30 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/50 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
Respiratory, thoracic and mediastinal disorders
Pneumonitis
0.00%
0/19 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
3.3%
1/30 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/50 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
Cardiac disorders
Torsade de pointes
0.00%
0/19 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
3.3%
1/30 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/50 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
Skin and subcutaneous tissue disorders
Dermatitis acneiform
0.00%
0/19 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/30 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
2.0%
1/50 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
Hepatobiliary disorders
Acute cholangtis, Acute cholecystitis and acute
0.00%
0/19 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
3.3%
1/30 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/50 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
Blood and lymphatic system disorders
Anaemia
5.3%
1/19 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/30 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/50 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
Cardiac disorders
Angina pectoris
0.00%
0/19 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
3.3%
1/30 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/50 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
Cardiac disorders
Pericardial effusion
0.00%
0/19 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
3.3%
1/30 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/50 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
Cardiac disorders
Tachycardia
0.00%
0/19 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/30 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
2.0%
1/50 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
Eye disorders
Cataract
5.3%
1/19 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/30 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/50 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
Gastrointestinal disorders
Abdominal pain upper
5.3%
1/19 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/30 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/50 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
Gastrointestinal disorders
Nausea
10.5%
2/19 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/30 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/50 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
Gastrointestinal disorders
Pancreatitis
0.00%
0/19 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
3.3%
1/30 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/50 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
Gastrointestinal disorders
Vomiting
10.5%
2/19 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
3.3%
1/30 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/50 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
General disorders
Catheter site haematoma
5.3%
1/19 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/30 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/50 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
General disorders
Fatigue
0.00%
0/19 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/30 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
2.0%
1/50 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
General disorders
Non-cardiac chest pain
5.3%
1/19 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/30 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/50 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
Hepatobiliary disorders
Cholecystitis
0.00%
0/19 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
3.3%
1/30 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/50 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
Hepatobiliary disorders
Cholecystitis acute
5.3%
1/19 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/30 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/50 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
Infections and infestations
Enterocolitis infectious
0.00%
0/19 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/30 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
2.0%
1/50 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
Infections and infestations
Pneumonia
10.5%
2/19 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
6.7%
2/30 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
4.0%
2/50 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
Infections and infestations
Pneumonia viral
0.00%
0/19 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
3.3%
1/30 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/50 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
Infections and infestations
Urinary tract infection
0.00%
0/19 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/30 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
2.0%
1/50 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
Injury, poisoning and procedural complications
Femur fracture
0.00%
0/19 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
3.3%
1/30 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/50 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
Injury, poisoning and procedural complications
Radius fracture
0.00%
0/19 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
3.3%
1/30 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/50 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
Injury, poisoning and procedural complications
Subdural haematoma
0.00%
0/19 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
3.3%
1/30 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/50 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
Investigations
Cardiac murmur
0.00%
0/19 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/30 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
2.0%
1/50 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
Metabolism and nutrition disorders
Dehydration
0.00%
0/19 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
3.3%
1/30 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
2.0%
1/50 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
Metabolism and nutrition disorders
Diabetic ketoacidosis
5.3%
1/19 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/30 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/50 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
Metabolism and nutrition disorders
Hyperglycaemia
5.3%
1/19 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
3.3%
1/30 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/50 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
Metabolism and nutrition disorders
Polydipsia
0.00%
0/19 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
3.3%
1/30 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/50 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
Musculoskeletal and connective tissue disorders
Muscle spasms
0.00%
0/19 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
3.3%
1/30 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/50 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
0.00%
0/19 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/30 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
2.0%
1/50 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
5.3%
1/19 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/30 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
2.0%
1/50 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
100.0%
1/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to bone
0.00%
0/19 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
3.3%
1/30 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/50 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
Nervous system disorders
Cerebrovascular accident
0.00%
0/19 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/30 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
2.0%
1/50 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
Nervous system disorders
Syncope
0.00%
0/19 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
3.3%
1/30 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/50 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
Renal and urinary disorders
Renal failure acute
5.3%
1/19 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/30 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/50 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
5.3%
1/19 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
3.3%
1/30 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/50 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
Respiratory, thoracic and mediastinal disorders
Dyspnoea
0.00%
0/19 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
3.3%
1/30 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/50 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
Respiratory, thoracic and mediastinal disorders
Paranasal cyst
0.00%
0/19 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/30 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
2.0%
1/50 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
Respiratory, thoracic and mediastinal disorders
Pleural effusion
5.3%
1/19 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
3.3%
1/30 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/50 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
5.3%
1/19 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/30 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/50 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
0.00%
0/19 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/30 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
2.0%
1/50 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
Investigations
Ejection fraction decreased
0.00%
0/19 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/30 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/50 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
100.0%
1/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.

Other adverse events

Other adverse events
Measure
Rociletinib 500mg Tablets
n=19 participants at risk
Starting dose of 500mg. Taken orally twice daily (continuous 28 day treatment cycle). Treatment duration until radiographically confirmed disease progression.
Rociletinib 625mg Tablets
n=30 participants at risk
Starting dose of 625mg. Taken orally twice daily (continuous 28 day treatment cycle). Treatment duration until radiographically confirmed disease progression.
Erlotinib 150mg Tablets
n=50 participants at risk
Starting dose of 150mg. Taken orally once daily (continuous 28 day treatment cycle). Treatment duration until radiographically confirmed disease progression.
Crossover From Erlotinib 150mg to Rociletinib 500mg
n=1 participants at risk
Patients initially randomized to erlotinib were eligible to participate in an optional crossover phase to receive CO-1686. Starting dose of 500mg CO-1686. Taken orally twice daily (continuous 28 day treatment cycle). Treatment duration until radiographically confirmed disease progression.
Crossover From Erlotinib 150mg to Rociletinib 625mg
n=1 participants at risk
Patients initially randomized to erlotinib were eligible to participate in an optional crossover phase to receive CO-1686. Starting dose of 625mg. Taken orally twice daily (continuous 28 day treatment cycle). Treatment duration until radiographically confirmed disease progression.
Infections and infestations
Paronychia
0.00%
0/19 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
3.3%
1/30 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
20.0%
10/50 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
Endocrine disorders
Combined Terms of Hyperglycemia
52.6%
10/19 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
53.3%
16/30 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
6.0%
3/50 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
Cardiac disorders
Combined Terms of QTc Prolongation
10.5%
2/19 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
26.7%
8/30 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
2.0%
1/50 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
Skin and subcutaneous tissue disorders
Combined Terms of Rash
26.3%
5/19 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
13.3%
4/30 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
86.0%
43/50 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
Blood and lymphatic system disorders
Anaemia
31.6%
6/19 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
6.7%
2/30 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
2.0%
1/50 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
100.0%
1/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
Blood and lymphatic system disorders
Leukopenia
0.00%
0/19 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
6.7%
2/30 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/50 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
Blood and lymphatic system disorders
Thrombocytopenia
5.3%
1/19 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
3.3%
1/30 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/50 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
Cardiac disorders
Palpitations
5.3%
1/19 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/30 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
6.0%
3/50 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
Cardiac disorders
Tachycardia
15.8%
3/19 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/30 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
4.0%
2/50 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
Ear and labyrinth disorders
Ear congestion
5.3%
1/19 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/30 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/50 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
Eye disorders
Cataract
5.3%
1/19 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
6.7%
2/30 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
2.0%
1/50 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
Eye disorders
Dry eye
0.00%
0/19 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/30 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
14.0%
7/50 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
Gastrointestinal disorders
Abdominal pain
15.8%
3/19 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
10.0%
3/30 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
8.0%
4/50 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
Gastrointestinal disorders
Abdominal pain upper
15.8%
3/19 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
3.3%
1/30 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
4.0%
2/50 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
Gastrointestinal disorders
Constipation
15.8%
3/19 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
20.0%
6/30 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
4.0%
2/50 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
100.0%
1/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
Gastrointestinal disorders
Diarrhoea
36.8%
7/19 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
50.0%
15/30 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
66.0%
33/50 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
Gastrointestinal disorders
Dry mouth
5.3%
1/19 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
3.3%
1/30 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
6.0%
3/50 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
Gastrointestinal disorders
Dyspepsia
21.1%
4/19 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
3.3%
1/30 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
6.0%
3/50 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
Gastrointestinal disorders
Gastrooesophageal reflux disease
10.5%
2/19 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
10.0%
3/30 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
12.0%
6/50 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
100.0%
1/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
Gastrointestinal disorders
Haemorrhoids
5.3%
1/19 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/30 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/50 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
Gastrointestinal disorders
Nausea
52.6%
10/19 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
26.7%
8/30 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
14.0%
7/50 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
100.0%
1/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
Gastrointestinal disorders
Stomatitis
0.00%
0/19 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
6.7%
2/30 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
18.0%
9/50 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
Gastrointestinal disorders
Vomiting
26.3%
5/19 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
20.0%
6/30 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
8.0%
4/50 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
100.0%
1/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
General disorders
Asthenia
5.3%
1/19 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
6.7%
2/30 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
4.0%
2/50 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
General disorders
Catheter site haematoma
5.3%
1/19 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/30 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/50 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
General disorders
Catheter site inflammation
5.3%
1/19 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/30 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/50 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
General disorders
Catheter site pain
5.3%
1/19 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/30 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/50 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
General disorders
Chest discomfort
5.3%
1/19 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
6.7%
2/30 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
4.0%
2/50 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
General disorders
Chest pain
0.00%
0/19 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
6.7%
2/30 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
8.0%
4/50 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
General disorders
Chills
0.00%
0/19 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
6.7%
2/30 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
4.0%
2/50 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
General disorders
Fatigue
31.6%
6/19 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
30.0%
9/30 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
24.0%
12/50 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
100.0%
1/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
General disorders
Malaise
0.00%
0/19 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
10.0%
3/30 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/50 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
General disorders
Mucosal inflammation
5.3%
1/19 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/30 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/50 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
General disorders
Non-cardiac chest pain
5.3%
1/19 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
3.3%
1/30 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
10.0%
5/50 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
General disorders
Oedema peripheral
10.5%
2/19 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
13.3%
4/30 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
10.0%
5/50 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
100.0%
1/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
General disorders
Pain
0.00%
0/19 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/30 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
6.0%
3/50 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
General disorders
Pyrexia
0.00%
0/19 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
10.0%
3/30 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
4.0%
2/50 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
Hepatobiliary disorders
Cholecystitis acute
5.3%
1/19 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/30 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/50 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
Hepatobiliary disorders
Cholecystitis chronic
5.3%
1/19 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/30 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/50 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
Hepatobiliary disorders
Cholelithiasis
5.3%
1/19 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/30 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/50 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
Hepatobiliary disorders
Hyperbilirubinaemia
5.3%
1/19 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/30 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
2.0%
1/50 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
Infections and infestations
Bronchitis
5.3%
1/19 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/30 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/50 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
Infections and infestations
Candida infection
5.3%
1/19 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
3.3%
1/30 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/50 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
Infections and infestations
Conjunctivitis
0.00%
0/19 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/30 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
6.0%
3/50 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
Infections and infestations
Infection
5.3%
1/19 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/30 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/50 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
Infections and infestations
Nasopharyngitis
10.5%
2/19 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/30 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
6.0%
3/50 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
Infections and infestations
Oral candidiasis
0.00%
0/19 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
10.0%
3/30 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/50 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
Infections and infestations
Oral herpes
5.3%
1/19 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/30 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/50 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
Infections and infestations
Pneumonia
10.5%
2/19 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
10.0%
3/30 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
4.0%
2/50 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
Infections and infestations
Upper respiratory tract infection
0.00%
0/19 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
3.3%
1/30 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
16.0%
8/50 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
Infections and infestations
Urinary tract infection
0.00%
0/19 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
13.3%
4/30 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
12.0%
6/50 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
Infections and infestations
Vaginal infection
5.3%
1/19 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/30 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/50 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
Investigations
Alanine aminotransferase increased
5.3%
1/19 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/30 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
8.0%
4/50 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
Investigations
Aspartate aminotransferase increased
5.3%
1/19 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/30 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
10.0%
5/50 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
Investigations
Blood alkaline phosphatase increased
5.3%
1/19 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
3.3%
1/30 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
2.0%
1/50 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
Investigations
Blood bilirubin increased
5.3%
1/19 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/30 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
10.0%
5/50 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
Investigations
Blood cholesterol increased
5.3%
1/19 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/30 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/50 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
Investigations
Blood creatinine increased
5.3%
1/19 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
6.7%
2/30 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/50 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
Investigations
Blood lactate dehydrogenase increased
5.3%
1/19 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/30 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/50 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
Investigations
Electrocardiogram QT prolonged
10.5%
2/19 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
23.3%
7/30 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
2.0%
1/50 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
Investigations
Neutrophil count decreased
5.3%
1/19 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
3.3%
1/30 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/50 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
100.0%
1/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
Investigations
Platelet count decreased
0.00%
0/19 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
6.7%
2/30 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/50 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
Investigations
Weight decreased
15.8%
3/19 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
16.7%
5/30 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
8.0%
4/50 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
Investigations
White blood cell count decreased
5.3%
1/19 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
6.7%
2/30 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/50 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
Metabolism and nutrition disorders
Decreased appetite
26.3%
5/19 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
16.7%
5/30 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
18.0%
9/50 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
100.0%
1/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
Metabolism and nutrition disorders
Dehydration
15.8%
3/19 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
10.0%
3/30 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
2.0%
1/50 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
Metabolism and nutrition disorders
Diabetic ketoacidosis
5.3%
1/19 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/30 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/50 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
Metabolism and nutrition disorders
Hyperglycaemia
52.6%
10/19 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
50.0%
15/30 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
4.0%
2/50 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
Metabolism and nutrition disorders
Hyperkalaemia
5.3%
1/19 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/30 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
2.0%
1/50 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
Metabolism and nutrition disorders
Hypocalcaemia
5.3%
1/19 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
3.3%
1/30 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/50 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
Metabolism and nutrition disorders
Hypokalaemia
15.8%
3/19 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
6.7%
2/30 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/50 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
Metabolism and nutrition disorders
Hypomagnesaemia
5.3%
1/19 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
3.3%
1/30 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
4.0%
2/50 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
Metabolism and nutrition disorders
Hyponatraemia
10.5%
2/19 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/30 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/50 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
Metabolism and nutrition disorders
Polydipsia
0.00%
0/19 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
6.7%
2/30 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/50 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
Musculoskeletal and connective tissue disorders
Arthralgia
5.3%
1/19 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
6.7%
2/30 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
8.0%
4/50 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
Musculoskeletal and connective tissue disorders
Back pain
0.00%
0/19 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
13.3%
4/30 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
14.0%
7/50 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
Musculoskeletal and connective tissue disorders
Muscle spasms
26.3%
5/19 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
16.7%
5/30 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
6.0%
3/50 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
0.00%
0/19 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
6.7%
2/30 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
6.0%
3/50 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
10.5%
2/19 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
3.3%
1/30 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
10.0%
5/50 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
Musculoskeletal and connective tissue disorders
Myalgia
10.5%
2/19 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
3.3%
1/30 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
2.0%
1/50 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
Musculoskeletal and connective tissue disorders
Pain in extremity
0.00%
0/19 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
3.3%
1/30 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
12.0%
6/50 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
5.3%
1/19 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
3.3%
1/30 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
2.0%
1/50 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
100.0%
1/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
Gastrointestinal disorders
Abdominal discomfort
0.00%
0/19 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
6.7%
2/30 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/50 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
Nervous system disorders
Carpal tunnel syndrome
5.3%
1/19 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/30 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/50 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
Nervous system disorders
Dizziness
15.8%
3/19 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
6.7%
2/30 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
18.0%
9/50 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
Nervous system disorders
Headache
10.5%
2/19 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
16.7%
5/30 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
6.0%
3/50 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
Nervous system disorders
Neuropathy peripheral
5.3%
1/19 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
3.3%
1/30 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/50 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
100.0%
1/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
Nervous system disorders
Syncope
0.00%
0/19 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
10.0%
3/30 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
4.0%
2/50 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
Psychiatric disorders
Anxiety
5.3%
1/19 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
13.3%
4/30 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
14.0%
7/50 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
Psychiatric disorders
Depression
5.3%
1/19 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
20.0%
6/30 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
8.0%
4/50 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
Psychiatric disorders
Insomnia
26.3%
5/19 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
10.0%
3/30 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
14.0%
7/50 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
Renal and urinary disorders
Renal failure acute
5.3%
1/19 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/30 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
2.0%
1/50 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
5.3%
1/19 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
3.3%
1/30 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/50 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
Respiratory, thoracic and mediastinal disorders
Cough
26.3%
5/19 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
20.0%
6/30 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
26.0%
13/50 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
100.0%
1/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
Respiratory, thoracic and mediastinal disorders
Dysphonia
0.00%
0/19 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/30 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
6.0%
3/50 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
Respiratory, thoracic and mediastinal disorders
Dyspnoea
21.1%
4/19 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
23.3%
7/30 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
14.0%
7/50 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
100.0%
1/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
5.3%
1/19 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
6.7%
2/30 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
4.0%
2/50 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
Respiratory, thoracic and mediastinal disorders
Hypoxia
0.00%
0/19 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
6.7%
2/30 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/50 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
0.00%
0/19 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
6.7%
2/30 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
8.0%
4/50 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
Respiratory, thoracic and mediastinal disorders
Pleural effusion
10.5%
2/19 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
3.3%
1/30 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
2.0%
1/50 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
5.3%
1/19 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/30 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/50 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
10.5%
2/19 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
3.3%
1/30 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
12.0%
6/50 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
100.0%
1/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
0.00%
0/19 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/30 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
6.0%
3/50 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
Respiratory, thoracic and mediastinal disorders
Wheezing
5.3%
1/19 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/30 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
2.0%
1/50 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
Skin and subcutaneous tissue disorders
Alopecia
0.00%
0/19 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
3.3%
1/30 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
16.0%
8/50 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
Skin and subcutaneous tissue disorders
Dermatitis acneiform
0.00%
0/19 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
3.3%
1/30 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
36.0%
18/50 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
Skin and subcutaneous tissue disorders
Dry skin
0.00%
0/19 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
3.3%
1/30 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
18.0%
9/50 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
Skin and subcutaneous tissue disorders
Hyperhidrosis
5.3%
1/19 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
3.3%
1/30 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/50 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
Skin and subcutaneous tissue disorders
Pruritus
0.00%
0/19 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
6.7%
2/30 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
12.0%
6/50 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
Skin and subcutaneous tissue disorders
Pruritus generalised
5.3%
1/19 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/30 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/50 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
Skin and subcutaneous tissue disorders
Rash
21.1%
4/19 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
10.0%
3/30 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
52.0%
26/50 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
Skin and subcutaneous tissue disorders
Rash maculo-papular
5.3%
1/19 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/30 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
2.0%
1/50 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
Skin and subcutaneous tissue disorders
Skin fissures
0.00%
0/19 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/30 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
8.0%
4/50 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
Cardiac disorders
Sinus tachycardia
5.3%
1/19 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/30 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/50 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
Eye disorders
Vision blurred
5.3%
1/19 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
3.3%
1/30 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/50 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
Blood and lymphatic system disorders
Lymphopenia
0.00%
0/19 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/30 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/50 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
100.0%
1/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
Nervous system disorders
Dysgeusia
0.00%
0/19 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/30 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/50 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
100.0%
1/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
Investigations
Ejection fraction decreased
0.00%
0/19 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/30 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/50 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
100.0%
1/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
Gastrointestinal disorders
Odynophagia
0.00%
0/19 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/30 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/50 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
0.00%
0/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.
100.0%
1/1 • Adverse events (AEs) were reported from the time the first dose of study drug is administered, and until 28 days after the last dose. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class). Treatment Arm/Groups for subjects (n=2) who crossed over to Rociletinib from Erlotinib are included.

Additional Information

Vi Nguyen

Clovis Oncology

Phone: +1 415 915 9982

Results disclosure agreements

  • Principal investigator is a sponsor employee All parties agree to submit all manuscripts or abstracts to all other parties 30 days prior to submission. This will enable all parties to protect proprietary information and to provide comments based on information that may not yet be available to other parties. The sponsor may request a delay in publication if there are important intellectual property concerns relating to publication, but does not have the right to suppress publication of the study results indefinitely.
  • Publication restrictions are in place

Restriction type: OTHER