Trial Outcomes & Findings for Real World Treatment Study of AZD9291 for Advanced/Metastatic EGFR T790M Mutation NSCLC (NCT NCT02474355)
NCT ID: NCT02474355
Last Updated: 2021-11-11
Results Overview
OS was defined as the time, in months from the date of first dose of Osimertinib until death due to any cause, or at last documented contact with participant status "alive" (in this study any participants alive at study discontinuation, or lost to follow-up was considered being censored at study discontinuation date or at the last known date participant was alive). OS was summarized using a Kaplan-Meier (KM) estimate of the median time to death or censoring together with their 95% confidence intervals.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
3017 participants
Primary outcome timeframe
From the date of first dose of Osimertinib until the date of death (due to any cause) or last participant contact [up to 43 months]
Results posted on
2021-11-11
Participant Flow
Participants who met all the inclusion and none of the exclusion criteria received treatment in a total of 209 centres in 16 countries. The study started on 18 September 2015 and primary completion date was 18 April 2019.
During the screening period (28 days), eligible participants signed the informed consent. All the study assessments were performed as per the schedule of assessment. Out of 3017 patients enrolled with treatment dose assigned, 3 died (due to disease progression) prior to starting treatment.
Participant milestones
| Measure |
Osimertinib
All participants received oral 80 mg tablet once a day (the dose could be reduced to 40 mg for management of osimertinib-related toxicities)
|
|---|---|
|
Overall Study
STARTED
|
3014
|
|
Overall Study
COMPLETED
|
1386
|
|
Overall Study
NOT COMPLETED
|
1628
|
Reasons for withdrawal
| Measure |
Osimertinib
All participants received oral 80 mg tablet once a day (the dose could be reduced to 40 mg for management of osimertinib-related toxicities)
|
|---|---|
|
Overall Study
Other
|
43
|
|
Overall Study
Eligibility Criteria not Fulfilled
|
2
|
|
Overall Study
Lost to Follow-up
|
98
|
|
Overall Study
Withdrawal by Subject
|
124
|
|
Overall Study
Death
|
1361
|
Baseline Characteristics
Real World Treatment Study of AZD9291 for Advanced/Metastatic EGFR T790M Mutation NSCLC
Baseline characteristics by cohort
| Measure |
Osimertinib
n=3014 Participants
All participants received oral 80 mg tablet once a day (the dose could be reduced to 40 mg for management of osimertinib-related toxicities)
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1798 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1216 Participants
n=5 Participants
|
|
Age, Continuous
|
61.7 Years
STANDARD_DEVIATION 10.91 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1927 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1087 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2085 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
21 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
897 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
11 Participants
n=5 Participants
|
|
Country
Argentina
|
30 Participants
n=5 Participants
|
|
Country
Australia
|
31 Participants
n=5 Participants
|
|
Country
Austria
|
46 Participants
n=5 Participants
|
|
Country
Belgium
|
31 Participants
n=5 Participants
|
|
Country
Brazil
|
88 Participants
n=5 Participants
|
|
Country
Canada
|
99 Participants
n=5 Participants
|
|
Country
China
|
1350 Participants
n=5 Participants
|
|
Country
Denmark
|
6 Participants
n=5 Participants
|
|
Country
Ireland
|
10 Participants
n=5 Participants
|
|
Country
Italy
|
510 Participants
n=5 Participants
|
|
Country
Saudi Arabia
|
3 Participants
n=5 Participants
|
|
Country
South Korea
|
466 Participants
n=5 Participants
|
|
Country
Spain
|
131 Participants
n=5 Participants
|
|
Country
Sweden
|
7 Participants
n=5 Participants
|
|
Country
Taiwan
|
188 Participants
n=5 Participants
|
|
Country
United Kingdom
|
18 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From the date of first dose of Osimertinib until the date of death (due to any cause) or last participant contact [up to 43 months]Population: The full analysis set included all participants who received at least one dose of study treatment. No statistical tests were performed, the statistical analyses were descriptive.
OS was defined as the time, in months from the date of first dose of Osimertinib until death due to any cause, or at last documented contact with participant status "alive" (in this study any participants alive at study discontinuation, or lost to follow-up was considered being censored at study discontinuation date or at the last known date participant was alive). OS was summarized using a Kaplan-Meier (KM) estimate of the median time to death or censoring together with their 95% confidence intervals.
Outcome measures
| Measure |
Osimertinib
n=3014 Participants
All participants received oral 80 mg tablet once a day (the dose could be reduced to 40 mg for management of osimertinib-related toxicities)
|
|---|---|
|
Overall Survival (OS)
|
22.8 Months
Interval 21.6 to 23.8
|
PRIMARY outcome
Timeframe: From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]Population: The full analysis set included all participants who received at least one dose of study treatment.
Safety assessment of Osimertinib was analyzed by evaluating AEs and SAEs.
Outcome measures
| Measure |
Osimertinib
n=3014 Participants
All participants received oral 80 mg tablet once a day (the dose could be reduced to 40 mg for management of osimertinib-related toxicities)
|
|---|---|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
AESI
|
113 Participants
|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
AE of special interest (AESI) or SAE
|
923 Participants
|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
AESI or SAE a causally related to Osimertinib
|
338 Participants
|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
AE leading to dose modification
|
414 Participants
|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
AE leading to discontinuation
|
191 Participants
|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
AESI causally related to Osimertinib
|
89 Participants
|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
SAE
|
657 Participants
|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
SAE causally related to Osimertinib
|
95 Participants
|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
AE leading to death
|
152 Participants
|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
AE leading to death causally related to Osimertinib
|
19 Participants
|
SECONDARY outcome
Timeframe: From the date of first dose of Osimertinib until disease progression or death in the absence of progression [up to 43 months]Population: The full analysis set included all participants who received at least one dose of study treatment. No statistical tests were performed, the statistical analyses were descriptive.
PFS was defined as the time, in months from first dose of AZD9291/ost/study drug/ study treatment until the date of disease progression or death in the absence of progression. Participants who had not progressed or died at study discontinuation were censored at the time of the latest date of disease assessment. PFS was summarized using KM estimates of the median time to progression or death with their 95% confidence intervals.
Outcome measures
| Measure |
Osimertinib
n=3014 Participants
All participants received oral 80 mg tablet once a day (the dose could be reduced to 40 mg for management of osimertinib-related toxicities)
|
|---|---|
|
Progression Free Survival
|
11.1 Months
Interval 11.0 to 12.0
|
SECONDARY outcome
Timeframe: From the date of first dose of Osimertinib until disease progression or death in the absence of progression [up to 43 months]Population: The full analysis set included all participants who received at least one dose of study treatment. No statistical tests were performed, the statistical analyses were descriptive.
TTD or death was assessed as a supportive summary to PFS and defined as the time from the date of the first dose of osimertinib in the study until the date of osimertinib discontinuation or death, regardless of the reason for discontinuation. TTD was summarized using KM estimates of the median times to progression or death or treatment discontinuation.
Outcome measures
| Measure |
Osimertinib
n=3014 Participants
All participants received oral 80 mg tablet once a day (the dose could be reduced to 40 mg for management of osimertinib-related toxicities)
|
|---|---|
|
Time to Treatment Discontinuation (TTD)
|
13.5 Months
Interval 12.6 to 13.9
|
SECONDARY outcome
Timeframe: From the date of first dose of Osimertinib until disease progression or death in the absence of progression [up to 43 months]Population: The full analysis set included all participants who received at least one dose of study treatment. No statistical tests were performed, the statistical analyses were descriptive.
RR was defined as the number (%) of participants with a best response (by Investigator assessment) of 'responding', regardless of the method of evaluation, and was based on a subset of the full analysis set consisting of subjects with at least one documented response assessment. RR was summarised together with the 95% CI.
Outcome measures
| Measure |
Osimertinib
n=2900 Participants
All participants received oral 80 mg tablet once a day (the dose could be reduced to 40 mg for management of osimertinib-related toxicities)
|
|---|---|
|
Response Rate (RR)
|
57.3 Percentage of participants
Interval 55.5 to 59.2
|
Adverse Events
Osimertinib
Serious events: 657 serious events
Other events: 380 other events
Deaths: 1361 deaths
Serious adverse events
| Measure |
Osimertinib
n=3014 participants at risk
All participants received oral 80 mg tablet once a day (the dose could be reduced to 40 mg for management of osimertinib-related toxicities)
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.13%
4/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Blood and lymphatic system disorders
Myelosuppression
|
0.13%
4/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.13%
4/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Blood and lymphatic system disorders
Anaemia of chronic disease
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Blood and lymphatic system disorders
Blood disorder
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Blood and lymphatic system disorders
Bone marrow disorder
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Cardiac disorders
Cardiac failure
|
0.30%
9/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Cardiac disorders
Cardiac arrest
|
0.20%
6/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Cardiac disorders
Myocardial infarction
|
0.13%
4/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.10%
3/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Cardiac disorders
Angina pectoris
|
0.07%
2/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Cardiac disorders
Atrial fibrillation
|
0.07%
2/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Cardiac disorders
Cardiac failure acute
|
0.07%
2/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Cardiac disorders
Cardiomyopathy
|
0.07%
2/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Cardiac disorders
Palpitations
|
0.07%
2/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Cardiac disorders
Pericardial effusion
|
0.07%
2/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.07%
2/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Cardiac disorders
Arrhythmia
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Cardiac disorders
Cardiac disorder
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Cardiac disorders
Cardiac dysfunction
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Cardiac disorders
Cardiopulmonary failure
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Cardiac disorders
Cardiotoxicity
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Cardiac disorders
Congestive cardiomyopathy
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Cardiac disorders
Coronary artery disease
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Cardiac disorders
Hypertensive heart disease
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Cardiac disorders
Sinus tachycardia
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Cardiac disorders
Ventricular fibrillation
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Ear and labyrinth disorders
Vertigo
|
0.13%
4/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Ear and labyrinth disorders
Middle ear inflammation
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Endocrine disorders
Inappropriate antidiuretic hormone secretion
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Eye disorders
Cataract
|
0.10%
3/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Eye disorders
Dacryostenosis acquired
|
0.07%
2/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Eye disorders
Glaucoma
|
0.07%
2/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Gastrointestinal disorders
Vomiting
|
0.43%
13/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.40%
12/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.23%
7/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Gastrointestinal disorders
Nausea
|
0.20%
6/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Gastrointestinal disorders
Constipation
|
0.13%
4/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Gastrointestinal disorders
Enteritis
|
0.13%
4/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Gastrointestinal disorders
Ascites
|
0.10%
3/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Gastrointestinal disorders
Chronic gastritis
|
0.10%
3/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Gastrointestinal disorders
Dysphagia
|
0.10%
3/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Gastrointestinal disorders
Gastritis
|
0.10%
3/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.10%
3/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.10%
3/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.10%
3/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Gastrointestinal disorders
Colitis
|
0.07%
2/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.07%
2/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Gastrointestinal disorders
Diverticulum intestinal haemorrhagic
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Gastrointestinal disorders
Duodenal ulcer haemorrhage
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Gastrointestinal disorders
Enterocolitis
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Gastrointestinal disorders
Gastric perforation
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Gastrointestinal disorders
Gastrointestinal perforation
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Gastrointestinal disorders
Gingival ulceration
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Gastrointestinal disorders
Haematemesis
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Gastrointestinal disorders
Haematochezia
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Gastrointestinal disorders
Ileus
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Gastrointestinal disorders
Ischaemic enteritis
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Gastrointestinal disorders
Large intestinal obstruction
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Gastrointestinal disorders
Obstructive pancreatitis
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Gastrointestinal disorders
Peptic ulcer
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Gastrointestinal disorders
Peptic ulcer haemorrhage
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Gastrointestinal disorders
Stomatitis
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
General disorders
Death
|
1.1%
34/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
General disorders
Pyrexia
|
0.40%
12/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
General disorders
Asthenia
|
0.13%
4/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
General disorders
Sudden death
|
0.13%
4/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
General disorders
Malaise
|
0.10%
3/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
General disorders
Gait disturbance
|
0.07%
2/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.07%
2/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
General disorders
Chest discomfort
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
General disorders
Condition aggravated
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
General disorders
Cyst
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
General disorders
Fatigue
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
General disorders
Granuloma
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
General disorders
Sudden cardiac death
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.17%
5/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Hepatobiliary disorders
Drug-induced liver injury
|
0.10%
3/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.10%
3/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Hepatobiliary disorders
Biliary colic
|
0.07%
2/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Hepatobiliary disorders
Jaundice cholestatic
|
0.07%
2/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Hepatobiliary disorders
Hepatotoxicity
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Hepatobiliary disorders
Liver injury
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Infections and infestations
Pneumonia
|
2.5%
74/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.33%
10/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Infections and infestations
Urinary tract infection
|
0.33%
10/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Infections and infestations
Respiratory tract infection
|
0.23%
7/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Infections and infestations
Bronchitis
|
0.20%
6/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Infections and infestations
Gastroenteritis
|
0.20%
6/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Infections and infestations
Herpes zoster
|
0.17%
5/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Infections and infestations
Cellulitis
|
0.10%
3/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Infections and infestations
Osteomyelitis
|
0.10%
3/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Infections and infestations
Urosepsis
|
0.10%
3/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Infections and infestations
Device related infection
|
0.07%
2/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Infections and infestations
Empyema
|
0.07%
2/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Infections and infestations
Pulmonary sepsis
|
0.07%
2/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Infections and infestations
Abdominal abscess
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Infections and infestations
Appendicitis
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Infections and infestations
Bacteraemia
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Infections and infestations
Complicated appendicitis
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Infections and infestations
Diarrhoea infectious
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Infections and infestations
Diverticulitis
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Infections and infestations
Enterobacter pneumonia
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Infections and infestations
Enterocolitis infectious
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Infections and infestations
Haemorrhagic fever
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Infections and infestations
Infection
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Infections and infestations
Infectious pleural effusion
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Infections and infestations
Infective spondylitis
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Infections and infestations
Influenza
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Infections and infestations
Labyrinthitis
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Infections and infestations
Laryngitis
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Infections and infestations
Localised infection
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Infections and infestations
Lower respiratory tract infection bacterial
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Infections and infestations
Lymphangitis
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Infections and infestations
Meningitis aseptic
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Infections and infestations
Mucosal infection
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Infections and infestations
Nasal abscess
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Infections and infestations
Otitis media acute
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Infections and infestations
Peripheral nerve infection
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Infections and infestations
Pneumocystis jirovecii pneumonia
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Infections and infestations
Pneumonia fungal
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Infections and infestations
Postoperative wound infection
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Infections and infestations
Respiratory tract infection bacterial
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Infections and infestations
Scrub typhus
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Infections and infestations
Septic shock
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Infections and infestations
Sinusitis
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Infections and infestations
Soft tissue infection
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Infections and infestations
Upper respiratory tract infection bacterial
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Infections and infestations
Urinary tract infection bacterial
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Infections and infestations
Wound infection
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Infections and infestations
Sepsis
|
0.17%
5/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.27%
8/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.10%
3/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.10%
3/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.10%
3/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Injury, poisoning and procedural complications
Traumatic fracture
|
0.10%
3/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.07%
2/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.07%
2/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.07%
2/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Injury, poisoning and procedural complications
Multiple injuries
|
0.07%
2/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.07%
2/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
0.07%
2/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Injury, poisoning and procedural complications
Brain herniation
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Injury, poisoning and procedural complications
Compression fracture
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Injury, poisoning and procedural complications
Fall
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Injury, poisoning and procedural complications
Foreign body in respiratory tract
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Injury, poisoning and procedural complications
Radiation pneumonitis
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Injury, poisoning and procedural complications
Subdural haemorrhage
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Injury, poisoning and procedural complications
Traumatic intracranial haemorrhage
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Injury, poisoning and procedural complications
Ulna fracture
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Injury, poisoning and procedural complications
Ulnar nerve injury
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Investigations
Electrocardiogram QT prolonged
|
0.17%
5/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Investigations
Alanine aminotransferase increased
|
0.10%
3/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Investigations
Neutrophil count decreased
|
0.10%
3/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Investigations
Amylase increased
|
0.07%
2/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Investigations
Aspartate aminotransferase increased
|
0.07%
2/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Investigations
Blood creatinine increased
|
0.07%
2/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Investigations
Platelet count decreased
|
0.07%
2/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Investigations
Eastern Cooperative Oncology Group performance status worsened
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Investigations
Influenza A virus test
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Investigations
Lipase increased
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Investigations
Troponin increased
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.27%
8/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.17%
5/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.13%
4/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.10%
3/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.10%
3/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Metabolism and nutrition disorders
Cachexia
|
0.07%
2/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.07%
2/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.07%
2/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.23%
7/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.20%
6/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.07%
2/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.07%
2/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Musculoskeletal and connective tissue disorders
Osteoporotic fracture
|
0.07%
2/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Musculoskeletal and connective tissue disorders
Fracture pain
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Musculoskeletal and connective tissue disorders
Malignant psoas syndrome
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Musculoskeletal and connective tissue disorders
Myopathy
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Musculoskeletal and connective tissue disorders
Spondylolisthesis
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Musculoskeletal and connective tissue disorders
Synovitis
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Musculoskeletal and connective tissue disorders
Vertebral lesion
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.07%
2/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant pleural effusion
|
0.07%
2/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute promyelocytic leukaemia
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign breast neoplasm
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer recurrent
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder neoplasm
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder transitional cell carcinoma
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer female
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Glioblastoma
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Laryngeal cancer
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to bone
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to meninges
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal carcinoma
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cancer metastatic
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell carcinoma
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Nervous system disorders
Cerebral infarction
|
0.73%
22/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Nervous system disorders
Headache
|
0.20%
6/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.17%
5/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.17%
5/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.13%
4/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Nervous system disorders
Epilepsy
|
0.13%
4/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Nervous system disorders
Cognitive disorder
|
0.10%
3/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Nervous system disorders
Lacunar infarction
|
0.10%
3/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Nervous system disorders
Dizziness
|
0.07%
2/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Nervous system disorders
Generalised tonic-clonic seizure
|
0.07%
2/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.07%
2/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Nervous system disorders
Haemorrhagic stroke
|
0.07%
2/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Nervous system disorders
Apraxia
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Nervous system disorders
Basal ganglia infarction
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Nervous system disorders
Brain oedema
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Nervous system disorders
Cerebellar infarction
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Nervous system disorders
Cerebellar ischaemia
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Nervous system disorders
Cerebral ischaemia
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Nervous system disorders
Coma
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Nervous system disorders
Dysarthria
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Nervous system disorders
Facial paralysis
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Nervous system disorders
Hemiparesis
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Nervous system disorders
Nervous system disorder
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Nervous system disorders
Polyneuropathy
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Nervous system disorders
Presyncope
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Nervous system disorders
Psychomotor hyperactivity
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Nervous system disorders
Psychomotor skills impaired
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Nervous system disorders
Seizure
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Nervous system disorders
Somnolence
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Nervous system disorders
Spinal cord compression
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Nervous system disorders
Syncope
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Nervous system disorders
Thrombotic stroke
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Nervous system disorders
Tremor
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Nervous system disorders
Vascular headache
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Pregnancy, puerperium and perinatal conditions
Unintended pregnancy
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Product Issues
Device dislocation
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Psychiatric disorders
Completed suicide
|
0.07%
2/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Psychiatric disorders
Delirium
|
0.07%
2/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Psychiatric disorders
Depression
|
0.07%
2/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Psychiatric disorders
Breath holding
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.17%
5/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Renal and urinary disorders
Renal failure
|
0.13%
4/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Renal and urinary disorders
Haematuria
|
0.10%
3/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.07%
2/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Renal and urinary disorders
Calculus urinary
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Renal and urinary disorders
Nephrotic syndrome
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Renal and urinary disorders
Renal impairment
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Renal and urinary disorders
Renal injury
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Reproductive system and breast disorders
Endometrial hyperplasia
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Reproductive system and breast disorders
Prostatic obstruction
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.6%
49/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.66%
20/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.50%
15/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.36%
11/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.30%
9/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.30%
9/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.17%
5/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Respiratory, thoracic and mediastinal disorders
Asphyxia
|
0.13%
4/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.13%
4/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.13%
4/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis chronic
|
0.10%
3/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.10%
3/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.07%
2/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial haemorrhage
|
0.07%
2/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Respiratory, thoracic and mediastinal disorders
Acute interstitial pneumonitis
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchiectasis
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Respiratory, thoracic and mediastinal disorders
Emphysema
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal oedema
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary artery thrombosis
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary toxicity
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory arrest
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Skin and subcutaneous tissue disorders
Cutaneous lupus erythematosus
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Skin and subcutaneous tissue disorders
Diabetic foot
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Vascular disorders
Deep vein thrombosis
|
0.56%
17/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Vascular disorders
Embolism
|
0.07%
2/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Vascular disorders
Hypotension
|
0.07%
2/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Vascular disorders
Thrombosis
|
0.07%
2/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Vascular disorders
Venous thrombosis limb
|
0.07%
2/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Vascular disorders
Hypertension
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Vascular disorders
Superior vena cava occlusion
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Vascular disorders
Superior vena cava syndrome
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Vascular disorders
Vena cava thrombosis
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Vascular disorders
Venous thrombosis
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
Other adverse events
| Measure |
Osimertinib
n=3014 participants at risk
All participants received oral 80 mg tablet once a day (the dose could be reduced to 40 mg for management of osimertinib-related toxicities)
|
|---|---|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.66%
20/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.53%
16/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Blood and lymphatic system disorders
Myelosuppression
|
0.20%
6/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.17%
5/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.10%
3/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Cardiac disorders
Sinus bradycardia
|
0.07%
2/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.07%
2/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Cardiac disorders
Atrial fibrillation
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Cardiac disorders
Atrioventricular block first degree
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Cardiac disorders
Bundle branch block left
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Cardiac disorders
Cardiac failure
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Cardiac disorders
Extrasystoles
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Cardiac disorders
Nodal rhythm
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Cardiac disorders
Supraventricular extrasystoles
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Cardiac disorders
Ventricular arrhythmia
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Ear and labyrinth disorders
Vertigo
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Eye disorders
Blepharitis
|
0.07%
2/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Eye disorders
Cataract
|
0.07%
2/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Eye disorders
Ulcerative keratitis
|
0.07%
2/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Eye disorders
Conjunctival haemorrhage
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Eye disorders
Dry eye
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Eye disorders
Swelling of eyelid
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Eye disorders
Visual acuity reduced
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Eye disorders
Vitreoretinal traction syndrome
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Gastrointestinal disorders
Diarrhoea
|
1.00%
30/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Gastrointestinal disorders
Nausea
|
0.36%
11/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Gastrointestinal disorders
Vomiting
|
0.33%
10/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Gastrointestinal disorders
Stomatitis
|
0.30%
9/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.07%
2/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Gastrointestinal disorders
Dysphagia
|
0.07%
2/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Gastrointestinal disorders
Anal inflammation
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Gastrointestinal disorders
Gastritis
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Gastrointestinal disorders
Lip swelling
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
General disorders
Asthenia
|
0.27%
8/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
General disorders
Pyrexia
|
0.23%
7/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
General disorders
Fatigue
|
0.13%
4/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
General disorders
General physical health deterioration
|
0.13%
4/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
General disorders
Inflammation
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
General disorders
Influenza like illness
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
General disorders
Malaise
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
General disorders
Mucosal inflammation
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
General disorders
Non-cardiac chest pain
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
General disorders
Peripheral swelling
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.10%
3/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Hepatobiliary disorders
Drug-induced liver injury
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Hepatobiliary disorders
Hepatotoxicity
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Hepatobiliary disorders
Liver injury
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Infections and infestations
Paronychia
|
0.36%
11/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Infections and infestations
Influenza
|
0.23%
7/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Infections and infestations
Herpes zoster
|
0.20%
6/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Infections and infestations
Pneumonia
|
0.17%
5/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Infections and infestations
Atypical pneumonia
|
0.07%
2/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Infections and infestations
Cystitis
|
0.07%
2/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Infections and infestations
Gastroenteritis viral
|
0.07%
2/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Infections and infestations
Herpes ophthalmic
|
0.07%
2/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Infections and infestations
Pneumonia viral
|
0.07%
2/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Infections and infestations
Bronchitis
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Infections and infestations
Cellulitis
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Infections and infestations
Conjunctivitis
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Infections and infestations
Gingivitis
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Infections and infestations
Nasopharyngitis
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Infections and infestations
Oral herpes
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Infections and infestations
Respiratory tract infection
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Injury, poisoning and procedural complications
Radiation pneumonitis
|
0.07%
2/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Injury, poisoning and procedural complications
Chemical burns of eye
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Injury, poisoning and procedural complications
Corneal abrasion
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Investigations
Electrocardiogram QT prolonged
|
2.9%
88/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Investigations
Platelet count decreased
|
0.56%
17/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Investigations
Aspartate aminotransferase increased
|
0.33%
10/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Investigations
Blood creatinine increased
|
0.33%
10/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Investigations
Alanine aminotransferase increased
|
0.30%
9/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Investigations
Neutrophil count decreased
|
0.30%
9/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Investigations
White blood cell count decreased
|
0.27%
8/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Investigations
Amylase increased
|
0.07%
2/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.07%
2/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.07%
2/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.07%
2/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Investigations
Weight decreased
|
0.07%
2/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Investigations
Blood bilirubin increased
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Investigations
Blood pressure systolic increased
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Investigations
Blood uric acid increased
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Investigations
Hepatic enzyme increased
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Investigations
Lipase increased
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Investigations
Transaminases increased
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.17%
5/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.10%
3/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Metabolism and nutrition disorders
Abnormal loss of weight
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Musculoskeletal and connective tissue disorders
Hypercreatinaemia
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
B-cell lymphoma
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphangiosis carcinomatosa
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Nervous system disorders
Headache
|
0.10%
3/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Nervous system disorders
Presyncope
|
0.07%
2/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Nervous system disorders
Balance disorder
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Nervous system disorders
Brain oedema
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Nervous system disorders
Cognitive disorder
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Nervous system disorders
Demyelination
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Nervous system disorders
Dizziness
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Nervous system disorders
Facial nerve disorder
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Nervous system disorders
Nervous system disorder
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Nervous system disorders
Psychomotor skills impaired
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Nervous system disorders
Sciatica
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Nervous system disorders
Seizure
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Nervous system disorders
Tremor
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Renal and urinary disorders
Azotaemia
|
0.07%
2/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Renal and urinary disorders
Renal impairment
|
0.07%
2/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Renal and urinary disorders
Nephropathy toxic
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Renal and urinary disorders
Proteinuria
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Renal and urinary disorders
Renal disorder
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Reproductive system and breast disorders
Testicular cyst
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.43%
13/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.13%
4/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.07%
2/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.07%
2/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.07%
2/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Respiratory, thoracic and mediastinal disorders
Organising pneumonia
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary toxicity
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.33%
10/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
0.20%
6/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Skin and subcutaneous tissue disorders
Skin toxicity
|
0.20%
6/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.17%
5/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.10%
3/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
0.07%
2/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Skin and subcutaneous tissue disorders
Eczema asteatotic
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Skin and subcutaneous tissue disorders
Onycholysis
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Skin and subcutaneous tissue disorders
Skin fissures
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Skin and subcutaneous tissue disorders
Skin reaction
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Vascular disorders
Deep vein thrombosis
|
0.07%
2/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Vascular disorders
Haematoma
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
|
Vascular disorders
Hypotension
|
0.03%
1/3014 • From screening to progression follow-up [every 6 weeks +/- 1 week] relative to the date of enrolment until the end of study [up to 43 months]
Safety of AZD9291 by assessment of SAEs, AEs of special interest (AESI) \[Interstitial Lung Disease/pneumonitis-like events, and QTc prolongation events\]. This study did not collect all AEs; only SAEs, adverse events leading to dose modification, adverse events leading to treatment discontinuation and AESI were collected. Therefore non-serious AEs which did not lead to dose modification/discontinuation and were not AESIs are excluded from this table.
|
Additional Information
Global Clinical Lead
AstraZeneca Clinical study Information Center
Phone: 1-877-240-9479
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER