Trial Outcomes & Findings for Study of AZD9291 Plus MEDI4736 Versus AZD9291 Monotherapy in NSCLC After Previous EGFR TKI Therapy in T790M Mutation Positive Tumours (NCT NCT02454933)
NCT ID: NCT02454933
Last Updated: 2024-09-19
Results Overview
As a measure of the safety and tolerability of osimertinib in combination with durvalumab the number of subjects who experienced any treatment emergent AE (TEAE), any causally related AE, any serious AE (SAE), and any causally related SAE are presented.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
29 participants
Primary outcome timeframe
From Baseline up to primary analysis data cut-off (up to 24 months).
Results posted on
2024-09-19
Participant Flow
Subjects were recruited to this study in 9 centres in South Korea, Canada and Taiwan. First subject first visit: 26 August 2015.
60 subjects with a confirmed diagnosis of Epidermal Growth Factor Receptor (EGFR) T790M mutation postive non-small cell lung cancer (Stage IIIB-IV) with progression following prior therapy with an approved EGFR tyrosine kinase inhibitor agent were screened, and 29 were assigned to treatment.
Participant milestones
| Measure |
Osimertinib 80 mg
Subjects were randomised to receive osimertinib (AZD9291) monotherapy (80 milligrams \[mg\], orally, once daily).
|
Osimertinib 80 mg + Durvalumab 10 mg/kg
Subjects were randomised to receive osimertinib 80 mg, orally, once daily in combination with durvalumab (MEDI4736) 10 mg/kilogram (mg/kg) intravenous (IV) infusion every 2 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
17
|
12
|
|
Overall Study
Treatment Group Randomised to
|
15
|
14
|
|
Overall Study
Ongoing at Primary Analysis Data Cut-off
|
9
|
4
|
|
Overall Study
COMPLETED
|
5
|
1
|
|
Overall Study
NOT COMPLETED
|
12
|
11
|
Reasons for withdrawal
| Measure |
Osimertinib 80 mg
Subjects were randomised to receive osimertinib (AZD9291) monotherapy (80 milligrams \[mg\], orally, once daily).
|
Osimertinib 80 mg + Durvalumab 10 mg/kg
Subjects were randomised to receive osimertinib 80 mg, orally, once daily in combination with durvalumab (MEDI4736) 10 mg/kilogram (mg/kg) intravenous (IV) infusion every 2 weeks.
|
|---|---|---|
|
Overall Study
Progressive disease
|
10
|
7
|
|
Overall Study
Adverse Event
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
3
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
Baseline Characteristics
Study of AZD9291 Plus MEDI4736 Versus AZD9291 Monotherapy in NSCLC After Previous EGFR TKI Therapy in T790M Mutation Positive Tumours
Baseline characteristics by cohort
| Measure |
Osimertinib 80 mg
n=17 Participants
Subjects were randomised to receive osimertinib (AZD9291) monotherapy (80 mg, orally, once daily).
|
Osimertinib 80 mg + Durvalumab 10mg/kg
n=12 Participants
Subjects were randomised to receive osimertinib 80 mg, orally, once daily in combination with durvalumab (MEDI4736) 10 mg/kg IV infusion every 2 weeks.
|
Total
n=29 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.3 years
STANDARD_DEVIATION 10.6 • n=99 Participants
|
57.6 years
STANDARD_DEVIATION 11.2 • n=107 Participants
|
60.3 years
STANDARD_DEVIATION 10.9 • n=206 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
16 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
28 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
15 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
26 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: From Baseline up to primary analysis data cut-off (up to 24 months).Population: The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
As a measure of the safety and tolerability of osimertinib in combination with durvalumab the number of subjects who experienced any treatment emergent AE (TEAE), any causally related AE, any serious AE (SAE), and any causally related SAE are presented.
Outcome measures
| Measure |
Osimertinib 80 mg + Durvalumab 10mg/kg
n=12 Participants
Subjects were randomised to receive osimertinib 80 mg, orally, once daily in combination with durvalumab (MEDI4736) 10 mg/kg IV infusion every 2 weeks.
|
|---|---|
|
Number of Subjects With Adverse Events (AEs) as a Measure of the Safety and Tolerability of Osimertinib in Combination With Durvalumab
Any AE
|
12 Participants
|
|
Number of Subjects With Adverse Events (AEs) as a Measure of the Safety and Tolerability of Osimertinib in Combination With Durvalumab
Any AE causally related to treatment
|
8 Participants
|
|
Number of Subjects With Adverse Events (AEs) as a Measure of the Safety and Tolerability of Osimertinib in Combination With Durvalumab
Any AE causally related to osimertinib only
|
8 Participants
|
|
Number of Subjects With Adverse Events (AEs) as a Measure of the Safety and Tolerability of Osimertinib in Combination With Durvalumab
Any AE causally related to durvalumab only
|
4 Participants
|
|
Number of Subjects With Adverse Events (AEs) as a Measure of the Safety and Tolerability of Osimertinib in Combination With Durvalumab
Any AE causally related to osimertinib+durvalumab
|
3 Participants
|
|
Number of Subjects With Adverse Events (AEs) as a Measure of the Safety and Tolerability of Osimertinib in Combination With Durvalumab
Any SAE
|
3 Participants
|
|
Number of Subjects With Adverse Events (AEs) as a Measure of the Safety and Tolerability of Osimertinib in Combination With Durvalumab
Any SAE causally related to treatment
|
1 Participants
|
Adverse Events
Osimertinib 80 mg
Serious events: 6 serious events
Other events: 17 other events
Deaths: 4 deaths
Osimertinib 80 mg + Durvalumab 10 mg/kg
Serious events: 3 serious events
Other events: 12 other events
Deaths: 8 deaths
Serious adverse events
| Measure |
Osimertinib 80 mg
n=17 participants at risk
Subjects were randomised to receive osimertinib (AZD9291) monotherapy (80 mg, orally, once daily).
|
Osimertinib 80 mg + Durvalumab 10 mg/kg
n=12 participants at risk
Subjects were randomised to receive osimertinib 80 mg, orally, once daily in combination with durvalumab (MEDI4736) 10 mg/kg IV infusion every 2 weeks.
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
5.9%
1/17 • Number of events 1 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
0.00%
0/12 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
|
Gastrointestinal disorders
Vomiting
|
5.9%
1/17 • Number of events 1 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
0.00%
0/12 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
|
General disorders
Oedema peripheral
|
0.00%
0/17 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
8.3%
1/12 • Number of events 1 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
|
General disorders
Pyrexia
|
5.9%
1/17 • Number of events 2 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
0.00%
0/12 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
|
Infections and infestations
Pneumonia
|
17.6%
3/17 • Number of events 3 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
0.00%
0/12 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
|
Infections and infestations
Urinary tract infection
|
5.9%
1/17 • Number of events 1 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
0.00%
0/12 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
|
Musculoskeletal and connective tissue disorders
Myopathy
|
0.00%
0/17 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
8.3%
1/12 • Number of events 1 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal cancer
|
5.9%
1/17 • Number of events 1 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
0.00%
0/12 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
|
Nervous system disorders
Headache
|
0.00%
0/17 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
8.3%
1/12 • Number of events 1 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.00%
0/17 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
8.3%
1/12 • Number of events 1 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
Other adverse events
| Measure |
Osimertinib 80 mg
n=17 participants at risk
Subjects were randomised to receive osimertinib (AZD9291) monotherapy (80 mg, orally, once daily).
|
Osimertinib 80 mg + Durvalumab 10 mg/kg
n=12 participants at risk
Subjects were randomised to receive osimertinib 80 mg, orally, once daily in combination with durvalumab (MEDI4736) 10 mg/kg IV infusion every 2 weeks.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
5.9%
1/17 • Number of events 1 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
8.3%
1/12 • Number of events 3 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/17 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
8.3%
1/12 • Number of events 3 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/17 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
8.3%
1/12 • Number of events 1 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
|
Blood and lymphatic system disorders
Neutropenia
|
23.5%
4/17 • Number of events 35 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
0.00%
0/12 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
|
Blood and lymphatic system disorders
Neutrophilia
|
0.00%
0/17 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
8.3%
1/12 • Number of events 1 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/17 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
8.3%
1/12 • Number of events 3 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
|
Blood and lymphatic system disorders
Spontaneous haemorrhage
|
5.9%
1/17 • Number of events 1 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
0.00%
0/12 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/17 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
8.3%
1/12 • Number of events 3 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
|
Ear and labyrinth disorders
Ear discomfort
|
5.9%
1/17 • Number of events 1 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
0.00%
0/12 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/17 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
8.3%
1/12 • Number of events 1 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
|
Ear and labyrinth disorders
Hypoacusis
|
5.9%
1/17 • Number of events 1 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
8.3%
1/12 • Number of events 1 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
|
Ear and labyrinth disorders
Tinnitus
|
5.9%
1/17 • Number of events 1 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
0.00%
0/12 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/17 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
8.3%
1/12 • Number of events 1 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
|
Eye disorders
Blepharitis
|
5.9%
1/17 • Number of events 1 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
0.00%
0/12 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
|
Eye disorders
Blepharospasm
|
5.9%
1/17 • Number of events 1 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
0.00%
0/12 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
|
Eye disorders
Dry eye
|
5.9%
1/17 • Number of events 1 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
16.7%
2/12 • Number of events 2 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
|
Eye disorders
Eyelid pain
|
5.9%
1/17 • Number of events 1 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
0.00%
0/12 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
|
Eye disorders
Ocular hyperaemia
|
5.9%
1/17 • Number of events 1 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
0.00%
0/12 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
|
Eye disorders
Periorbital oedema
|
0.00%
0/17 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
8.3%
1/12 • Number of events 1 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
|
Eye disorders
Retinal drusen
|
5.9%
1/17 • Number of events 1 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
0.00%
0/12 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
|
Eye disorders
Vision blurred
|
0.00%
0/17 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
8.3%
1/12 • Number of events 1 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/17 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
8.3%
1/12 • Number of events 1 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
5.9%
1/17 • Number of events 1 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
8.3%
1/12 • Number of events 1 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/17 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
16.7%
2/12 • Number of events 2 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
|
Gastrointestinal disorders
Constipation
|
17.6%
3/17 • Number of events 3 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
33.3%
4/12 • Number of events 4 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
47.1%
8/17 • Number of events 12 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
50.0%
6/12 • Number of events 7 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/17 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
8.3%
1/12 • Number of events 1 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/17 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
8.3%
1/12 • Number of events 1 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
|
Gastrointestinal disorders
Epigastric discomfort
|
5.9%
1/17 • Number of events 1 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
0.00%
0/12 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
|
Gastrointestinal disorders
Flatulence
|
5.9%
1/17 • Number of events 1 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
0.00%
0/12 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
|
Gastrointestinal disorders
Gastritis
|
5.9%
1/17 • Number of events 1 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
8.3%
1/12 • Number of events 1 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
|
Gastrointestinal disorders
Hypoaesthesia oral
|
0.00%
0/17 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
8.3%
1/12 • Number of events 1 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
|
Gastrointestinal disorders
Mouth ulceration
|
5.9%
1/17 • Number of events 1 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
16.7%
2/12 • Number of events 4 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
|
Gastrointestinal disorders
Nausea
|
17.6%
3/17 • Number of events 4 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
8.3%
1/12 • Number of events 1 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
|
Gastrointestinal disorders
Oesophageal pain
|
5.9%
1/17 • Number of events 1 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
0.00%
0/12 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
|
Gastrointestinal disorders
Stomatitis
|
29.4%
5/17 • Number of events 6 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
0.00%
0/12 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
|
Gastrointestinal disorders
Toothache
|
5.9%
1/17 • Number of events 1 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
0.00%
0/12 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
|
Gastrointestinal disorders
Vomiting
|
11.8%
2/17 • Number of events 3 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
8.3%
1/12 • Number of events 1 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
|
General disorders
Asthenia
|
5.9%
1/17 • Number of events 1 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
0.00%
0/12 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
|
General disorders
Catheter site injury
|
5.9%
1/17 • Number of events 1 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
8.3%
1/12 • Number of events 1 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
|
General disorders
Chest pain
|
0.00%
0/17 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
8.3%
1/12 • Number of events 1 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
|
General disorders
Chills
|
0.00%
0/17 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
16.7%
2/12 • Number of events 2 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
|
General disorders
Complication associated with device
|
5.9%
1/17 • Number of events 1 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
8.3%
1/12 • Number of events 1 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
|
General disorders
Fatigue
|
5.9%
1/17 • Number of events 3 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
8.3%
1/12 • Number of events 1 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/17 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
8.3%
1/12 • Number of events 1 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
|
General disorders
Oedema peripheral
|
0.00%
0/17 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
8.3%
1/12 • Number of events 1 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
|
General disorders
Pain
|
5.9%
1/17 • Number of events 1 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
0.00%
0/12 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
|
General disorders
Pyrexia
|
0.00%
0/17 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
16.7%
2/12 • Number of events 2 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
|
General disorders
Vessel puncture site bruise
|
0.00%
0/17 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
8.3%
1/12 • Number of events 2 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.00%
0/17 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
8.3%
1/12 • Number of events 1 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
|
Immune system disorders
Seasonal allergy
|
5.9%
1/17 • Number of events 1 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
0.00%
0/12 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
|
Infections and infestations
Atypical pneumonia
|
5.9%
1/17 • Number of events 1 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
0.00%
0/12 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
|
Infections and infestations
Cystitis
|
5.9%
1/17 • Number of events 1 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
0.00%
0/12 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
|
Infections and infestations
Gastroenteritis
|
5.9%
1/17 • Number of events 1 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
0.00%
0/12 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
|
Infections and infestations
Herpes simplex
|
0.00%
0/17 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
8.3%
1/12 • Number of events 1 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/17 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
8.3%
1/12 • Number of events 1 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
|
Infections and infestations
Influenza
|
5.9%
1/17 • Number of events 1 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
8.3%
1/12 • Number of events 1 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
|
Infections and infestations
Localised infection
|
0.00%
0/17 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
8.3%
1/12 • Number of events 1 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
|
Infections and infestations
Lower respiratory tract infection
|
5.9%
1/17 • Number of events 2 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
0.00%
0/12 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
|
Infections and infestations
Lung infection
|
11.8%
2/17 • Number of events 2 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
0.00%
0/12 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
|
Infections and infestations
Mucosal infection
|
0.00%
0/17 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
8.3%
1/12 • Number of events 1 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
|
Infections and infestations
Onychomycosis
|
0.00%
0/17 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
8.3%
1/12 • Number of events 2 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
|
Infections and infestations
Oral candidiasis
|
5.9%
1/17 • Number of events 1 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
0.00%
0/12 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
|
Infections and infestations
Paronychia
|
41.2%
7/17 • Number of events 10 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
16.7%
2/12 • Number of events 2 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/17 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
16.7%
2/12 • Number of events 2 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
|
Infections and infestations
Salmonellosis
|
0.00%
0/17 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
8.3%
1/12 • Number of events 1 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
|
Infections and infestations
Sinusitis
|
5.9%
1/17 • Number of events 1 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
8.3%
1/12 • Number of events 1 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
|
Infections and infestations
Upper respiratory tract infection
|
17.6%
3/17 • Number of events 3 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
8.3%
1/12 • Number of events 4 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
|
Infections and infestations
Urinary tract infection
|
5.9%
1/17 • Number of events 2 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
8.3%
1/12 • Number of events 1 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
|
Infections and infestations
Vestibulitis
|
0.00%
0/17 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
8.3%
1/12 • Number of events 1 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
23.5%
4/17 • Number of events 6 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
8.3%
1/12 • Number of events 2 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
|
Injury, poisoning and procedural complications
Avulsion fracture
|
5.9%
1/17 • Number of events 1 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
0.00%
0/12 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/17 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
8.3%
1/12 • Number of events 1 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
|
Injury, poisoning and procedural complications
Fall
|
5.9%
1/17 • Number of events 1 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
8.3%
1/12 • Number of events 2 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/17 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
8.3%
1/12 • Number of events 1 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
5.9%
1/17 • Number of events 1 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
8.3%
1/12 • Number of events 1 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
|
Injury, poisoning and procedural complications
Procedural dizziness
|
0.00%
0/17 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
8.3%
1/12 • Number of events 1 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
|
Injury, poisoning and procedural complications
Radiation skin injury
|
0.00%
0/17 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
8.3%
1/12 • Number of events 1 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
|
Investigations
Alanine aminotransferase increased
|
11.8%
2/17 • Number of events 5 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
16.7%
2/12 • Number of events 2 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
|
Investigations
Aspartate aminotransferase increased
|
11.8%
2/17 • Number of events 4 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
25.0%
3/12 • Number of events 3 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
|
Investigations
Electrocardiogram QT prolonged
|
11.8%
2/17 • Number of events 5 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
0.00%
0/12 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
|
Investigations
Neutrophil count decreased
|
17.6%
3/17 • Number of events 6 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
0.00%
0/12 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
|
Investigations
Platelet count decreased
|
0.00%
0/17 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
8.3%
1/12 • Number of events 1 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
|
Investigations
Urine analysis abnormal
|
5.9%
1/17 • Number of events 1 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
0.00%
0/12 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
|
Investigations
Weight decreased
|
0.00%
0/17 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
8.3%
1/12 • Number of events 1 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
11.8%
2/17 • Number of events 3 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
50.0%
6/12 • Number of events 6 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/17 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
8.3%
1/12 • Number of events 1 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/17 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
8.3%
1/12 • Number of events 1 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/17 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
8.3%
1/12 • Number of events 1 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
29.4%
5/17 • Number of events 7 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
16.7%
2/12 • Number of events 3 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/17 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
8.3%
1/12 • Number of events 1 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
17.6%
3/17 • Number of events 3 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
25.0%
3/12 • Number of events 3 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
5.9%
1/17 • Number of events 1 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
8.3%
1/12 • Number of events 1 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
|
Musculoskeletal and connective tissue disorders
Chest wall mass
|
0.00%
0/17 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
8.3%
1/12 • Number of events 1 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
5.9%
1/17 • Number of events 1 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
0.00%
0/12 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
5.9%
1/17 • Number of events 1 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
8.3%
1/12 • Number of events 2 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
11.8%
2/17 • Number of events 3 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
0.00%
0/12 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
5.9%
1/17 • Number of events 1 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
16.7%
2/12 • Number of events 3 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/17 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
8.3%
1/12 • Number of events 1 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
|
Musculoskeletal and connective tissue disorders
Neck mass
|
0.00%
0/17 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
8.3%
1/12 • Number of events 1 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
5.9%
1/17 • Number of events 2 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
0.00%
0/12 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
5.9%
1/17 • Number of events 1 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
0.00%
0/12 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.9%
1/17 • Number of events 1 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
16.7%
2/12 • Number of events 3 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
|
Nervous system disorders
Amnesia
|
5.9%
1/17 • Number of events 1 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
0.00%
0/12 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
|
Nervous system disorders
Balance disorder
|
0.00%
0/17 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
8.3%
1/12 • Number of events 1 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
|
Nervous system disorders
Disturbance in attention
|
0.00%
0/17 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
8.3%
1/12 • Number of events 1 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
|
Nervous system disorders
Dizziness
|
11.8%
2/17 • Number of events 2 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
0.00%
0/12 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
|
Nervous system disorders
Headache
|
5.9%
1/17 • Number of events 1 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
8.3%
1/12 • Number of events 1 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
|
Nervous system disorders
Hypoaesthesia
|
5.9%
1/17 • Number of events 1 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
25.0%
3/12 • Number of events 3 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/17 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
8.3%
1/12 • Number of events 1 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
|
Nervous system disorders
Paraesthesia
|
5.9%
1/17 • Number of events 1 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
8.3%
1/12 • Number of events 1 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
|
Psychiatric disorders
Anxiety
|
5.9%
1/17 • Number of events 1 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
0.00%
0/12 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
|
Psychiatric disorders
Insomnia
|
5.9%
1/17 • Number of events 1 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
8.3%
1/12 • Number of events 1 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/17 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
8.3%
1/12 • Number of events 1 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/17 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
8.3%
1/12 • Number of events 2 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
|
Renal and urinary disorders
Renal vein embolism
|
5.9%
1/17 • Number of events 1 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
0.00%
0/12 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
|
Renal and urinary disorders
Urinary incontinence
|
5.9%
1/17 • Number of events 1 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
8.3%
1/12 • Number of events 1 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
|
Reproductive system and breast disorders
Uterine mass
|
5.9%
1/17 • Number of events 1 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
0.00%
0/12 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
5.9%
1/17 • Number of events 2 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
0.00%
0/12 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
23.5%
4/17 • Number of events 5 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
33.3%
4/12 • Number of events 4 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
11.8%
2/17 • Number of events 2 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
8.3%
1/12 • Number of events 1 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
23.5%
4/17 • Number of events 6 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
0.00%
0/12 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
11.8%
2/17 • Number of events 2 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
8.3%
1/12 • Number of events 1 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/17 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
8.3%
1/12 • Number of events 1 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/17 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
8.3%
1/12 • Number of events 1 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal haemorrhage
|
5.9%
1/17 • Number of events 1 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
0.00%
0/12 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
5.9%
1/17 • Number of events 1 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
8.3%
1/12 • Number of events 1 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal polyps
|
0.00%
0/17 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
8.3%
1/12 • Number of events 1 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Organising pneumonia
|
5.9%
1/17 • Number of events 1 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
0.00%
0/12 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
5.9%
1/17 • Number of events 1 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
0.00%
0/12 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
17.6%
3/17 • Number of events 5 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
8.3%
1/12 • Number of events 1 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary pain
|
0.00%
0/17 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
8.3%
1/12 • Number of events 1 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
17.6%
3/17 • Number of events 4 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
25.0%
3/12 • Number of events 4 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
5.9%
1/17 • Number of events 1 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
0.00%
0/12 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
5.9%
1/17 • Number of events 1 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
0.00%
0/12 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/17 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
8.3%
1/12 • Number of events 1 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
41.2%
7/17 • Number of events 8 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
16.7%
2/12 • Number of events 2 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
17.6%
3/17 • Number of events 3 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
33.3%
4/12 • Number of events 4 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
|
Skin and subcutaneous tissue disorders
Eczema asteatotic
|
5.9%
1/17 • Number of events 1 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
0.00%
0/12 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
|
Skin and subcutaneous tissue disorders
Intertrigo
|
5.9%
1/17 • Number of events 1 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
0.00%
0/12 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
|
Skin and subcutaneous tissue disorders
Milia
|
5.9%
1/17 • Number of events 1 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
0.00%
0/12 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
|
Skin and subcutaneous tissue disorders
Onychoclasis
|
5.9%
1/17 • Number of events 1 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
0.00%
0/12 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
5.9%
1/17 • Number of events 1 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
0.00%
0/12 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
5.9%
1/17 • Number of events 1 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
0.00%
0/12 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
23.5%
4/17 • Number of events 4 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
41.7%
5/12 • Number of events 5 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
5.9%
1/17 • Number of events 2 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
0.00%
0/12 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.9%
1/17 • Number of events 1 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
8.3%
1/12 • Number of events 1 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
5.9%
1/17 • Number of events 1 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
8.3%
1/12 • Number of events 1 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
11.8%
2/17 • Number of events 2 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
16.7%
2/12 • Number of events 2 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.00%
0/17 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
8.3%
1/12 • Number of events 1 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
|
Skin and subcutaneous tissue disorders
Skin fissures
|
5.9%
1/17 • Number of events 1 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
8.3%
1/12 • Number of events 1 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
5.9%
1/17 • Number of events 1 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
8.3%
1/12 • Number of events 1 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
|
Skin and subcutaneous tissue disorders
Xanthelasma
|
5.9%
1/17 • Number of events 1 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
0.00%
0/12 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
|
Vascular disorders
Haematoma
|
0.00%
0/17 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
8.3%
1/12 • Number of events 1 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
|
Vascular disorders
Hot flush
|
5.9%
1/17 • Number of events 1 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
0.00%
0/12 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
|
Vascular disorders
Hypertension
|
5.9%
1/17 • Number of events 1 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
0.00%
0/12 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
|
Vascular disorders
Orthostatic hypotension
|
5.9%
1/17 • Number of events 1 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
0.00%
0/12 • TEAEs are presented from the date of first dose and up to and including 30 days following the date of the last dose of osimertinib or 90 days following the date of last dose of durvalumab (up to approximately 31 months).
The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The PI shall provide AstraZeneca with an opportunity to review/comment on drafts of any publication, review article or presentation (Publication) and shall afford AstraZeneca the opportunity to review the final draft of the Publication before its submission. The PI shall give AstraZeneca up to 45 days to respond with any proposed corrections and shall delete any confidential information before submission. If requested the PI shall delay submission for an additional period, not more than 60 days.
- Publication restrictions are in place
Restriction type: OTHER