Trial Outcomes & Findings for Phase II Single Arm Study of AZD9291 to Treat NSCLC Patients in Asia Pacific (NCT NCT02442349)

NCT ID: NCT02442349

Last Updated: 2026-01-09

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

171 participants

Primary outcome timeframe

At baseline and every 6 weeks from time of first dose until objective disease progression,up to 24 months after Last Patient First Dose(LPFD)

Results posted on

2026-01-09

Participant Flow

First patient enrolled: 22 June 2015, The study was open for enrollment at 31 study centres in China (24 sites), South Korea (4 sites), and Australia (3 sites)

319 signed informed consent from 306 patients (13 patients were re-screened). Patients were assigned to treatment if they met all the inclusion and none of the exclusion criteria. 130 patients failed inclusion/exclusion criteria and 5 patients withdrew consent so were not eligible to be assigned treatment. Thus, 171 patients received treatment.

Participant milestones

Participant milestones
Measure	AZD9291 Once daily tablet 80 mg
Overall Study STARTED	171
Overall Study COMPLETED	46
Overall Study NOT COMPLETED	125

Reasons for withdrawal

Reasons for withdrawal
Measure	AZD9291 Once daily tablet 80 mg
Overall Study Death	95
Overall Study Withdrawal by Subject	27
Overall Study poor compliance after treatment discontinuation	2
Overall Study Lost to Follow-up	1

Baseline Characteristics

Phase II Single Arm Study of AZD9291 to Treat NSCLC Patients in Asia Pacific

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	AZD9291 n=171 Participants Once daily tablet 80 mg
Age, Continuous	58.3 Years STANDARD_DEVIATION 10.81 • n=8 Participants
Age, Customized <50 Years	38 Participants n=8 Participants
Age, Customized >=50-<65 Years	79 Participants n=8 Participants
Age, Customized >=65-<75 Years	45 Participants n=8 Participants
Age, Customized >=75 Years	9 Participants n=8 Participants
Sex: Female, Male Female	117 Participants n=8 Participants
Sex: Female, Male Male	54 Participants n=8 Participants
Race/Ethnicity, Customized Asian	168 Participants n=8 Participants
Race/Ethnicity, Customized White	2 Participants n=8 Participants
Race/Ethnicity, Customized Other	1 Participants n=8 Participants

PRIMARY outcome

Timeframe: At baseline and every 6 weeks from time of first dose until objective disease progression,up to 24 months after Last Patient First Dose(LPFD)

Population: All patients who received at least 1 dose of study treatment and had measurable disease at baseline according to the independent review of baseline imaging data.

Outcome measures

Outcome measures
Measure	AZD9291 n=166 Participants Once daily tablet 80 mg
ORR According to RECIST 1.1 by Independent Review	62.0 % of participants Interval 54.2 to 69.5

SECONDARY outcome

Timeframe: At baseline and every 6 weeks from time first dose until date of progression, up to 24 months after LPFD.

Population: All patients who received at least 1 dose of study treatment, had measurable disease at baseline according to the independent review of baseline imaging data and had confirmed response.

Outcome measures

Outcome measures
Measure	AZD9291 n=103 Participants Once daily tablet 80 mg
DoR According to RECIST 1.1 by Independent Review	9.9 Months Interval 8.3 to 12.9

SECONDARY outcome

Timeframe: At baseline and every 6 weeks from time first dose until date of progression, up to 24 months after Last Patient First Dose(LPFD)

Population: All patients who received at least 1 dose of study treatment and had measurable disease at baseline according to the independent review of baseline imaging data.

Per Response Evaluation Criteria in Solid Tumours (RECIST v1.1) assessed by MRI or CT: Complete Response (CR): Disappearance of all target and non-target lesions and no new lesions; Partial Response (PR): \>= 30% decrease in the sum of diameters of Target Lesions (compared to baseline) and no new lesions; Stable disease (SD): Neither sufficient shrinkage to qualify as a response nor sufficient growth to qualify as progression; Progressive Disease (PD): \>= 20% increase in the sum of diameters of TLs and an absolute increase in sum of diameters of \>=5mm (compared to the previous minimum sum) or progression of NTLs or a new lesion. DCR is the percentage of patients with best response of CR, PR or SD (according to independent review), prior to progression (PD) or further anti-cancer therapy.

Outcome measures

Outcome measures
Measure	AZD9291 n=166 Participants Once daily tablet 80 mg
DCR According to RECIST 1.1 by Independent Review	88.0 % of participants Interval 82.0 to 92.5

SECONDARY outcome

Timeframe: At baseline and every 6 weeks from time of first dose until date of progression, up to 24 months after LPFD.

Population: All patients who received at least 1 dose of study treatment and had measurable disease at baseline according to the independent review of baseline imaging data.

Per Response Evaluation Criteria in Solid Tumours (RECIST v1.1) assessed by MRI or CT: Tumour size was calculated as the sum of the longest diameters (SLD) of the Target Lesions. Tumour shrinkage is the best percentage change in tumour size from baseline using RECIST v1.1 tumour response.

Outcome measures

Outcome measures
Measure	AZD9291 n=166 Participants Once daily tablet 80 mg
Tumour Shrinkage According to RECIST 1.1 by Independent Review	-46.1 % change from baseline in target lesion Standard Deviation 28.40

SECONDARY outcome

Timeframe: At baseline and every 6 weeks from time of first dose until objective disease progression, up to 24 months after LPFD.

Population: All patients who received at least 1 dose of study treatment.

Per Response Evaluation Criteria in Solid Tumours (RECIST v1.1) assessed by MRI or CT: Progressive Disease (PD): \>= 20% increase in the sum of diameters of TLs and an absolute increase in sum of diameters of \>=5mm (compared to the previous minimum sum) or progression of NTLs or a new lesion. PFS is the time from date of first dose until the date of PD (by independent review) or death (by any cause in the absence of progression) regardless of whether the patient withdrew from AZD9291 therapy or received another anti-cancer therapy prior to progression. Patients who had not progressed or died at the time of analysis were censored at the time of the latest date of assessment from their last evaluable RECIST 1.1 assessment.

Outcome measures

Outcome measures
Measure	AZD9291 n=171 Participants Once daily tablet 80 mg
PFS According to RECIST 1.1 by Independent Review	9.7 Months Interval 7.0 to 11.1

SECONDARY outcome

Timeframe: From first dose to end of study or date of death from any cause, whichever comes first, assessed every 6 weeks up to approximately 95 OS events (about 55% maturity) have been observed out of all enrolled patients.

Population: All patients who received at least 1 dose of study treatment.

Defined as the time from first dose until death from any cause. Any patient not known to have died at the time of analysis will be censored based on the last recorded date on which the patient was known to be alive.

Outcome measures

Outcome measures
Measure	AZD9291 n=171 Participants Once daily tablet 80 mg
Overall Survival (OS)	23.2 Months Interval 20.0 to 26.7

Adverse Events

AZD9291 80mg

Serious events: 42 serious events

Other events: 163 other events

Deaths: 11 deaths

Serious adverse events

Serious adverse events
Measure	AZD9291 80mg n=171 participants at risk Once daily tablet 80 mg
General disorders Sudden death	0.58% 1/171 • Number of events 1 • AEs were collected from time of signature of informed consent throughout the treatment period and including the 28-day safety follow-up after the last dose of the study treatment, approximately 33 months
Infections and infestations Bronchitis	0.58% 1/171 • Number of events 1 • AEs were collected from time of signature of informed consent throughout the treatment period and including the 28-day safety follow-up after the last dose of the study treatment, approximately 33 months
Infections and infestations Tuberculosis	0.58% 1/171 • Number of events 1 • AEs were collected from time of signature of informed consent throughout the treatment period and including the 28-day safety follow-up after the last dose of the study treatment, approximately 33 months
Blood and lymphatic system disorders Bone marrow failure	0.58% 1/171 • Number of events 1 • AEs were collected from time of signature of informed consent throughout the treatment period and including the 28-day safety follow-up after the last dose of the study treatment, approximately 33 months
Cardiac disorders Cardiac failure	0.58% 1/171 • Number of events 1 • AEs were collected from time of signature of informed consent throughout the treatment period and including the 28-day safety follow-up after the last dose of the study treatment, approximately 33 months
Cardiac disorders Coronary artery disease	0.58% 1/171 • Number of events 1 • AEs were collected from time of signature of informed consent throughout the treatment period and including the 28-day safety follow-up after the last dose of the study treatment, approximately 33 months
Cardiac disorders Pericardial effusion	1.2% 2/171 • Number of events 2 • AEs were collected from time of signature of informed consent throughout the treatment period and including the 28-day safety follow-up after the last dose of the study treatment, approximately 33 months
Eye disorders Cataract	0.58% 1/171 • Number of events 1 • AEs were collected from time of signature of informed consent throughout the treatment period and including the 28-day safety follow-up after the last dose of the study treatment, approximately 33 months
General disorders Chest discomfort	0.58% 1/171 • Number of events 1 • AEs were collected from time of signature of informed consent throughout the treatment period and including the 28-day safety follow-up after the last dose of the study treatment, approximately 33 months
General disorders Death	0.58% 1/171 • Number of events 1 • AEs were collected from time of signature of informed consent throughout the treatment period and including the 28-day safety follow-up after the last dose of the study treatment, approximately 33 months
Infections and infestations Gastroenteritis	0.58% 1/171 • Number of events 1 • AEs were collected from time of signature of informed consent throughout the treatment period and including the 28-day safety follow-up after the last dose of the study treatment, approximately 33 months
Infections and infestations Infectious pleural effusion	0.58% 1/171 • Number of events 2 • AEs were collected from time of signature of informed consent throughout the treatment period and including the 28-day safety follow-up after the last dose of the study treatment, approximately 33 months
Infections and infestations Lung infection	1.8% 3/171 • Number of events 3 • AEs were collected from time of signature of informed consent throughout the treatment period and including the 28-day safety follow-up after the last dose of the study treatment, approximately 33 months
Infections and infestations Paronychia	0.58% 1/171 • Number of events 1 • AEs were collected from time of signature of informed consent throughout the treatment period and including the 28-day safety follow-up after the last dose of the study treatment, approximately 33 months
Infections and infestations Pneumonia	2.3% 4/171 • Number of events 5 • AEs were collected from time of signature of informed consent throughout the treatment period and including the 28-day safety follow-up after the last dose of the study treatment, approximately 33 months
Infections and infestations Upper respiratory tract infection	1.2% 2/171 • Number of events 2 • AEs were collected from time of signature of informed consent throughout the treatment period and including the 28-day safety follow-up after the last dose of the study treatment, approximately 33 months
Injury, poisoning and procedural complications Compression fracture	0.58% 1/171 • Number of events 1 • AEs were collected from time of signature of informed consent throughout the treatment period and including the 28-day safety follow-up after the last dose of the study treatment, approximately 33 months
Injury, poisoning and procedural complications Femoral neck fracture	0.58% 1/171 • Number of events 1 • AEs were collected from time of signature of informed consent throughout the treatment period and including the 28-day safety follow-up after the last dose of the study treatment, approximately 33 months
Injury, poisoning and procedural complications Thoracic vertebral fracture	0.58% 1/171 • Number of events 1 • AEs were collected from time of signature of informed consent throughout the treatment period and including the 28-day safety follow-up after the last dose of the study treatment, approximately 33 months
Investigations Liver function test abnormal	0.58% 1/171 • Number of events 1 • AEs were collected from time of signature of informed consent throughout the treatment period and including the 28-day safety follow-up after the last dose of the study treatment, approximately 33 months
Investigations Platelet count decreased	0.58% 1/171 • Number of events 1 • AEs were collected from time of signature of informed consent throughout the treatment period and including the 28-day safety follow-up after the last dose of the study treatment, approximately 33 months
Metabolism and nutrition disorders Decreased appetite	0.58% 1/171 • Number of events 1 • AEs were collected from time of signature of informed consent throughout the treatment period and including the 28-day safety follow-up after the last dose of the study treatment, approximately 33 months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm	0.58% 1/171 • Number of events 1 • AEs were collected from time of signature of informed consent throughout the treatment period and including the 28-day safety follow-up after the last dose of the study treatment, approximately 33 months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.58% 1/171 • Number of events 1 • AEs were collected from time of signature of informed consent throughout the treatment period and including the 28-day safety follow-up after the last dose of the study treatment, approximately 33 months
Nervous system disorders Cerebral haemorrhage	0.58% 1/171 • Number of events 1 • AEs were collected from time of signature of informed consent throughout the treatment period and including the 28-day safety follow-up after the last dose of the study treatment, approximately 33 months
Nervous system disorders Cerebral infarction	0.58% 1/171 • Number of events 1 • AEs were collected from time of signature of informed consent throughout the treatment period and including the 28-day safety follow-up after the last dose of the study treatment, approximately 33 months
Nervous system disorders Embolic stroke	0.58% 1/171 • Number of events 1 • AEs were collected from time of signature of informed consent throughout the treatment period and including the 28-day safety follow-up after the last dose of the study treatment, approximately 33 months
Nervous system disorders Hydrocephalus	0.58% 1/171 • Number of events 1 • AEs were collected from time of signature of informed consent throughout the treatment period and including the 28-day safety follow-up after the last dose of the study treatment, approximately 33 months
Nervous system disorders Neuralgia	0.58% 1/171 • Number of events 1 • AEs were collected from time of signature of informed consent throughout the treatment period and including the 28-day safety follow-up after the last dose of the study treatment, approximately 33 months
Nervous system disorders Spinal cord compression	0.58% 1/171 • Number of events 1 • AEs were collected from time of signature of informed consent throughout the treatment period and including the 28-day safety follow-up after the last dose of the study treatment, approximately 33 months
Psychiatric disorders Major depression	0.58% 1/171 • Number of events 1 • AEs were collected from time of signature of informed consent throughout the treatment period and including the 28-day safety follow-up after the last dose of the study treatment, approximately 33 months
Respiratory, thoracic and mediastinal disorders Bronchiectasis	0.58% 1/171 • Number of events 2 • AEs were collected from time of signature of informed consent throughout the treatment period and including the 28-day safety follow-up after the last dose of the study treatment, approximately 33 months
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.58% 1/171 • Number of events 1 • AEs were collected from time of signature of informed consent throughout the treatment period and including the 28-day safety follow-up after the last dose of the study treatment, approximately 33 months
Respiratory, thoracic and mediastinal disorders Dyspnoea	1.8% 3/171 • Number of events 3 • AEs were collected from time of signature of informed consent throughout the treatment period and including the 28-day safety follow-up after the last dose of the study treatment, approximately 33 months
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.58% 1/171 • Number of events 1 • AEs were collected from time of signature of informed consent throughout the treatment period and including the 28-day safety follow-up after the last dose of the study treatment, approximately 33 months
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	0.58% 1/171 • Number of events 1 • AEs were collected from time of signature of informed consent throughout the treatment period and including the 28-day safety follow-up after the last dose of the study treatment, approximately 33 months
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.58% 1/171 • Number of events 1 • AEs were collected from time of signature of informed consent throughout the treatment period and including the 28-day safety follow-up after the last dose of the study treatment, approximately 33 months
Respiratory, thoracic and mediastinal disorders Respiratory failure	1.2% 2/171 • Number of events 2 • AEs were collected from time of signature of informed consent throughout the treatment period and including the 28-day safety follow-up after the last dose of the study treatment, approximately 33 months
Vascular disorders Deep vein thrombosis	1.2% 2/171 • Number of events 2 • AEs were collected from time of signature of informed consent throughout the treatment period and including the 28-day safety follow-up after the last dose of the study treatment, approximately 33 months

Other adverse events

Other adverse events
Measure	AZD9291 80mg n=171 participants at risk Once daily tablet 80 mg
Musculoskeletal and connective tissue disorders Back pain	11.1% 19/171 • Number of events 33 • AEs were collected from time of signature of informed consent throughout the treatment period and including the 28-day safety follow-up after the last dose of the study treatment, approximately 33 months
Musculoskeletal and connective tissue disorders Pain in extremity	8.8% 15/171 • Number of events 18 • AEs were collected from time of signature of informed consent throughout the treatment period and including the 28-day safety follow-up after the last dose of the study treatment, approximately 33 months
Nervous system disorders Dizziness	8.2% 14/171 • Number of events 19 • AEs were collected from time of signature of informed consent throughout the treatment period and including the 28-day safety follow-up after the last dose of the study treatment, approximately 33 months
Nervous system disorders Headache	8.8% 15/171 • Number of events 17 • AEs were collected from time of signature of informed consent throughout the treatment period and including the 28-day safety follow-up after the last dose of the study treatment, approximately 33 months
Renal and urinary disorders Proteinuria	5.3% 9/171 • Number of events 13 • AEs were collected from time of signature of informed consent throughout the treatment period and including the 28-day safety follow-up after the last dose of the study treatment, approximately 33 months
Respiratory, thoracic and mediastinal disorders Cough	24.6% 42/171 • Number of events 58 • AEs were collected from time of signature of informed consent throughout the treatment period and including the 28-day safety follow-up after the last dose of the study treatment, approximately 33 months
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	5.3% 9/171 • Number of events 11 • AEs were collected from time of signature of informed consent throughout the treatment period and including the 28-day safety follow-up after the last dose of the study treatment, approximately 33 months
Skin and subcutaneous tissue disorders Dry skin	15.2% 26/171 • Number of events 39 • AEs were collected from time of signature of informed consent throughout the treatment period and including the 28-day safety follow-up after the last dose of the study treatment, approximately 33 months
Skin and subcutaneous tissue disorders Pruritus	15.2% 26/171 • Number of events 51 • AEs were collected from time of signature of informed consent throughout the treatment period and including the 28-day safety follow-up after the last dose of the study treatment, approximately 33 months
Skin and subcutaneous tissue disorders Rash	10.5% 18/171 • Number of events 26 • AEs were collected from time of signature of informed consent throughout the treatment period and including the 28-day safety follow-up after the last dose of the study treatment, approximately 33 months
Skin and subcutaneous tissue disorders Rash papular	5.3% 9/171 • Number of events 10 • AEs were collected from time of signature of informed consent throughout the treatment period and including the 28-day safety follow-up after the last dose of the study treatment, approximately 33 months
General disorders Pyrexia	7.6% 13/171 • Number of events 26 • AEs were collected from time of signature of informed consent throughout the treatment period and including the 28-day safety follow-up after the last dose of the study treatment, approximately 33 months
Hepatobiliary disorders Hepatic function abnormal	5.3% 9/171 • Number of events 10 • AEs were collected from time of signature of informed consent throughout the treatment period and including the 28-day safety follow-up after the last dose of the study treatment, approximately 33 months
Infections and infestations Influenza	9.9% 17/171 • Number of events 28 • AEs were collected from time of signature of informed consent throughout the treatment period and including the 28-day safety follow-up after the last dose of the study treatment, approximately 33 months
Infections and infestations Paronychia	11.1% 19/171 • Number of events 26 • AEs were collected from time of signature of informed consent throughout the treatment period and including the 28-day safety follow-up after the last dose of the study treatment, approximately 33 months
Infections and infestations Upper respiratory tract infection	16.4% 28/171 • Number of events 53 • AEs were collected from time of signature of informed consent throughout the treatment period and including the 28-day safety follow-up after the last dose of the study treatment, approximately 33 months
Infections and infestations Urinary tract infection	9.9% 17/171 • Number of events 23 • AEs were collected from time of signature of informed consent throughout the treatment period and including the 28-day safety follow-up after the last dose of the study treatment, approximately 33 months
Infections and infestations Viral upper respiratory tract infection	14.0% 24/171 • Number of events 31 • AEs were collected from time of signature of informed consent throughout the treatment period and including the 28-day safety follow-up after the last dose of the study treatment, approximately 33 months
Investigations Alanine aminotransferase increased	7.6% 13/171 • Number of events 16 • AEs were collected from time of signature of informed consent throughout the treatment period and including the 28-day safety follow-up after the last dose of the study treatment, approximately 33 months
Investigations Aspartate aminotransferase increased	8.8% 15/171 • Number of events 23 • AEs were collected from time of signature of informed consent throughout the treatment period and including the 28-day safety follow-up after the last dose of the study treatment, approximately 33 months
Investigations Blood creatinine increased	8.2% 14/171 • Number of events 18 • AEs were collected from time of signature of informed consent throughout the treatment period and including the 28-day safety follow-up after the last dose of the study treatment, approximately 33 months
Investigations Haemoglobin decreased	7.0% 12/171 • Number of events 13 • AEs were collected from time of signature of informed consent throughout the treatment period and including the 28-day safety follow-up after the last dose of the study treatment, approximately 33 months
Investigations Neutrophil count decreased	11.1% 19/171 • Number of events 47 • AEs were collected from time of signature of informed consent throughout the treatment period and including the 28-day safety follow-up after the last dose of the study treatment, approximately 33 months
Investigations Platelet count decreased	18.1% 31/171 • Number of events 54 • AEs were collected from time of signature of informed consent throughout the treatment period and including the 28-day safety follow-up after the last dose of the study treatment, approximately 33 months
Investigations Weight decreased	5.3% 9/171 • Number of events 9 • AEs were collected from time of signature of informed consent throughout the treatment period and including the 28-day safety follow-up after the last dose of the study treatment, approximately 33 months
Investigations White blood cell count decreased	17.5% 30/171 • Number of events 68 • AEs were collected from time of signature of informed consent throughout the treatment period and including the 28-day safety follow-up after the last dose of the study treatment, approximately 33 months
Metabolism and nutrition disorders Decreased appetite	9.9% 17/171 • Number of events 22 • AEs were collected from time of signature of informed consent throughout the treatment period and including the 28-day safety follow-up after the last dose of the study treatment, approximately 33 months
Blood and lymphatic system disorders Anaemia	14.6% 25/171 • Number of events 32 • AEs were collected from time of signature of informed consent throughout the treatment period and including the 28-day safety follow-up after the last dose of the study treatment, approximately 33 months
Blood and lymphatic system disorders Leukopenia	21.1% 36/171 • Number of events 90 • AEs were collected from time of signature of informed consent throughout the treatment period and including the 28-day safety follow-up after the last dose of the study treatment, approximately 33 months
Blood and lymphatic system disorders Neutropenia	11.7% 20/171 • Number of events 45 • AEs were collected from time of signature of informed consent throughout the treatment period and including the 28-day safety follow-up after the last dose of the study treatment, approximately 33 months
Blood and lymphatic system disorders Thrombocytopenia	14.6% 25/171 • Number of events 43 • AEs were collected from time of signature of informed consent throughout the treatment period and including the 28-day safety follow-up after the last dose of the study treatment, approximately 33 months
Gastrointestinal disorders Abdominal discomfort	7.0% 12/171 • Number of events 12 • AEs were collected from time of signature of informed consent throughout the treatment period and including the 28-day safety follow-up after the last dose of the study treatment, approximately 33 months
Gastrointestinal disorders Constipation	7.6% 13/171 • Number of events 18 • AEs were collected from time of signature of informed consent throughout the treatment period and including the 28-day safety follow-up after the last dose of the study treatment, approximately 33 months
Gastrointestinal disorders Diarrhoea	35.1% 60/171 • Number of events 186 • AEs were collected from time of signature of informed consent throughout the treatment period and including the 28-day safety follow-up after the last dose of the study treatment, approximately 33 months
Gastrointestinal disorders Mouth ulceration	6.4% 11/171 • Number of events 14 • AEs were collected from time of signature of informed consent throughout the treatment period and including the 28-day safety follow-up after the last dose of the study treatment, approximately 33 months
Gastrointestinal disorders Nausea	14.0% 24/171 • Number of events 32 • AEs were collected from time of signature of informed consent throughout the treatment period and including the 28-day safety follow-up after the last dose of the study treatment, approximately 33 months
Gastrointestinal disorders Vomiting	11.7% 20/171 • Number of events 23 • AEs were collected from time of signature of informed consent throughout the treatment period and including the 28-day safety follow-up after the last dose of the study treatment, approximately 33 months
General disorders Asthenia	5.8% 10/171 • Number of events 11 • AEs were collected from time of signature of informed consent throughout the treatment period and including the 28-day safety follow-up after the last dose of the study treatment, approximately 33 months
General disorders Non-cardiac chest pain	5.8% 10/171 • Number of events 13 • AEs were collected from time of signature of informed consent throughout the treatment period and including the 28-day safety follow-up after the last dose of the study treatment, approximately 33 months

Additional Information

Global Clinical Lead, Yuri Rukazenkov

AstraZeneca

Phone: +441625231825

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60