Trial Outcomes & Findings for Phase II Concurrent Durvalumab and Radiotherapy for for Stage III Non-Small Cell Lung Cancer (NCT NCT04003246)

Last Updated: 2025-03-21

Results Overview

To determine the 12-month progression-free survival (PFS) for Stage III non-small cell lung cancer patients treated with concurrent durvalumab and radiotherapy followed by consolidative durvalumab. PFS rate is based on an assessment by an investigator according to RECIST 1.1 criteria; PFS is defined as the time from the study enrollment to documented progressive disease or death due to any cause, whichever occurs first.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

10 participants

Primary outcome timeframe

Twelve months from the study enrollment

Results posted on

2025-03-21

Participant Flow

Participant milestones

Participant milestones
Measure	Single Arm: Therapeutic Intervention Thoracic RT and Durvalumab: 1500mg every 4 weeks \[Q4W\] intravenous \[IV\], first dose within 3 days of RT initiation Consolidative Durvalumab: 1500mg every 4 weeks \[Q4W\] intravenous \[IV\] up to one year
Overall Study STARTED	10
Overall Study Thoracic RT and Durvalumab	10
Overall Study Consolidative Durvalumab	9
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	9

Reasons for withdrawal

Reasons for withdrawal
Measure	Single Arm: Therapeutic Intervention Thoracic RT and Durvalumab: 1500mg every 4 weeks \[Q4W\] intravenous \[IV\], first dose within 3 days of RT initiation Consolidative Durvalumab: 1500mg every 4 weeks \[Q4W\] intravenous \[IV\] up to one year
Overall Study Death	9

Baseline Characteristics

Phase II Concurrent Durvalumab and Radiotherapy for for Stage III Non-Small Cell Lung Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Single Arm: Therapeutic Intervention n=10 Participants Thoracic RT and Durvalumab: 1500mg every 4 weeks \[Q4W\] intravenous \[IV\], first dose within 3 days of RT initiation Consolidative Durvalumab: 1500mg every 4 weeks \[Q4W\] intravenous \[IV\] up to one year
Age, Customized Median Age	65.5 years n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants
Race/Ethnicity, Customized White	9 Participants n=5 Participants
Race/Ethnicity, Customized Black/African American	1 Participants n=5 Participants
Race/Ethnicity, Customized Non-Hispanic	7 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic	3 Participants n=5 Participants
Region of Enrollment United States	10 participants n=5 Participants
ECOG Performance Status 0	2 Participants n=5 Participants
ECOG Performance Status 1	8 Participants n=5 Participants
Smoking Status Current	2 Participants n=5 Participants
Smoking Status Former	8 Participants n=5 Participants

PRIMARY outcome

Timeframe: Twelve months from the study enrollment

Outcome measures

Outcome measures
Measure	Single Arm: Therapeutic Intervention n=10 Participants Thoracic RT and Durvalumab: 1500mg every 4 weeks \[Q4W\] intravenous \[IV\], first dose within 3 days of RT initiation Consolidative Durvalumab: 1500mg every 4 weeks \[Q4W\] intravenous \[IV\] up to one year
12-Month Progression-free Survival (PFS) Time	208 days Interval 0.0 to 365.0

SECONDARY outcome

Timeframe: 4 years from study enrollment

To assess the safety and tolerability of concurrent durvalumab and radiotherapy compared to historical data from patients treated with standard of care chemo-radiation using adverse event according to CTCAE V.5

Outcome measures

Outcome measures
Measure	Single Arm: Therapeutic Intervention n=22 Grade 3 or higher adverse events Thoracic RT and Durvalumab: 1500mg every 4 weeks \[Q4W\] intravenous \[IV\], first dose within 3 days of RT initiation Consolidative Durvalumab: 1500mg every 4 weeks \[Q4W\] intravenous \[IV\] up to one year
Safety and Tolerability Not treatment-related	7 Grade 3 or higher adverse events
Safety and Tolerability Treatment-related	15 Grade 3 or higher adverse events

SECONDARY outcome

Timeframe: Up to 4 years (1461 days) from study enrollment

Population: Active, living participants and participants that have experienced death due to any cause.

To determine the overall survival (OS) defined as the time from study enrollment to death due to any cause

Outcome measures

Outcome measures
Measure	Single Arm: Therapeutic Intervention n=10 Participants Thoracic RT and Durvalumab: 1500mg every 4 weeks \[Q4W\] intravenous \[IV\], first dose within 3 days of RT initiation Consolidative Durvalumab: 1500mg every 4 weeks \[Q4W\] intravenous \[IV\] up to one year
Overall Survival	486 days Interval 0.0 to 1460.0

SECONDARY outcome

Timeframe: From date of study enrollment until the date of first documented new distant lesion or date of death from any cause, whichever came first, assessed to the end of the study (approximately 55 months).

Population: Active patients without demonstrated distant metastasis, patients with any distant metastatic new lesion, and deceased patients that were on the study.

Time from study enrollment to any new distant lesion.

Outcome measures

Outcome measures
Measure	Single Arm: Therapeutic Intervention n=10 Participants Thoracic RT and Durvalumab: 1500mg every 4 weeks \[Q4W\] intravenous \[IV\], first dose within 3 days of RT initiation Consolidative Durvalumab: 1500mg every 4 weeks \[Q4W\] intravenous \[IV\] up to one year
Distant Metastases Free Survival Time	501 days Interval 0.0 to 1677.0

SECONDARY outcome

Timeframe: From date of study enrollment until the date of first documented local and regional lesion, assessed to the end of the study (approximately 55 months).

Population: Active participants and all previous patients with demonstrated new local and regional lesions.

The time from the study enrollment to any local and regional lesion.

Outcome measures

Outcome measures
Measure	Single Arm: Therapeutic Intervention n=4 Participants Thoracic RT and Durvalumab: 1500mg every 4 weeks \[Q4W\] intravenous \[IV\], first dose within 3 days of RT initiation Consolidative Durvalumab: 1500mg every 4 weeks \[Q4W\] intravenous \[IV\] up to one year
Local and Regional Control Time	457 days Interval 0.0 to 1677.0

Adverse Events

Single Arm: Therapeutic Intervention

Serious events: 7 serious events

Other events: 10 other events

Deaths: 9 deaths

Serious adverse events

Serious adverse events
Measure	Single Arm: Therapeutic Intervention n=10 participants at risk Thoracic RT and Durvalumab: 1500mg every 4 weeks \[Q4W\] intravenous \[IV\], first dose within 3 days of RT initiation Consolidative Durvalumab: 1500mg every 4 weeks \[Q4W\] intravenous \[IV\] up to one year
Renal and urinary disorders Acute kidney injury	10.0% 1/10 • Number of events 1 • Adverse have been collected from baseline until death of the patient or end of the study (approximately 4 years and 7 months). Adverse events were collected weekly during the concurrent phase (up to 6 weeks after enrollment), then monthly during the consolidative phase (up to 1 year after beginning the consolidative phase). Then, adverse events were collected every 3 months until 2 years post concurrent treatment. After year 3, adverse events were collected every 6 months until end of study. Adverse events are not divided into arms for concurrent vs consolidative durvalumab as all patients were prescribed the same treatment, and the aim of the study was not to separate the two factors.
Respiratory, thoracic and mediastinal disorders Adult respiratory distress syndrome	10.0% 1/10 • Number of events 1 • Adverse have been collected from baseline until death of the patient or end of the study (approximately 4 years and 7 months). Adverse events were collected weekly during the concurrent phase (up to 6 weeks after enrollment), then monthly during the consolidative phase (up to 1 year after beginning the consolidative phase). Then, adverse events were collected every 3 months until 2 years post concurrent treatment. After year 3, adverse events were collected every 6 months until end of study. Adverse events are not divided into arms for concurrent vs consolidative durvalumab as all patients were prescribed the same treatment, and the aim of the study was not to separate the two factors.
Blood and lymphatic system disorders Anemia	20.0% 2/10 • Number of events 2 • Adverse have been collected from baseline until death of the patient or end of the study (approximately 4 years and 7 months). Adverse events were collected weekly during the concurrent phase (up to 6 weeks after enrollment), then monthly during the consolidative phase (up to 1 year after beginning the consolidative phase). Then, adverse events were collected every 3 months until 2 years post concurrent treatment. After year 3, adverse events were collected every 6 months until end of study. Adverse events are not divided into arms for concurrent vs consolidative durvalumab as all patients were prescribed the same treatment, and the aim of the study was not to separate the two factors.
Respiratory, thoracic and mediastinal disorders Aspiration	10.0% 1/10 • Number of events 1 • Adverse have been collected from baseline until death of the patient or end of the study (approximately 4 years and 7 months). Adverse events were collected weekly during the concurrent phase (up to 6 weeks after enrollment), then monthly during the consolidative phase (up to 1 year after beginning the consolidative phase). Then, adverse events were collected every 3 months until 2 years post concurrent treatment. After year 3, adverse events were collected every 6 months until end of study. Adverse events are not divided into arms for concurrent vs consolidative durvalumab as all patients were prescribed the same treatment, and the aim of the study was not to separate the two factors.
Musculoskeletal and connective tissue disorders Bone pain	10.0% 1/10 • Number of events 1 • Adverse have been collected from baseline until death of the patient or end of the study (approximately 4 years and 7 months). Adverse events were collected weekly during the concurrent phase (up to 6 weeks after enrollment), then monthly during the consolidative phase (up to 1 year after beginning the consolidative phase). Then, adverse events were collected every 3 months until 2 years post concurrent treatment. After year 3, adverse events were collected every 6 months until end of study. Adverse events are not divided into arms for concurrent vs consolidative durvalumab as all patients were prescribed the same treatment, and the aim of the study was not to separate the two factors.
Investigations Creatinine increased	10.0% 1/10 • Number of events 1 • Adverse have been collected from baseline until death of the patient or end of the study (approximately 4 years and 7 months). Adverse events were collected weekly during the concurrent phase (up to 6 weeks after enrollment), then monthly during the consolidative phase (up to 1 year after beginning the consolidative phase). Then, adverse events were collected every 3 months until 2 years post concurrent treatment. After year 3, adverse events were collected every 6 months until end of study. Adverse events are not divided into arms for concurrent vs consolidative durvalumab as all patients were prescribed the same treatment, and the aim of the study was not to separate the two factors.
Skin and subcutaneous tissue disorders Dermatitis	10.0% 1/10 • Number of events 1 • Adverse have been collected from baseline until death of the patient or end of the study (approximately 4 years and 7 months). Adverse events were collected weekly during the concurrent phase (up to 6 weeks after enrollment), then monthly during the consolidative phase (up to 1 year after beginning the consolidative phase). Then, adverse events were collected every 3 months until 2 years post concurrent treatment. After year 3, adverse events were collected every 6 months until end of study. Adverse events are not divided into arms for concurrent vs consolidative durvalumab as all patients were prescribed the same treatment, and the aim of the study was not to separate the two factors.
Respiratory, thoracic and mediastinal disorders Dyspnea	10.0% 1/10 • Number of events 1 • Adverse have been collected from baseline until death of the patient or end of the study (approximately 4 years and 7 months). Adverse events were collected weekly during the concurrent phase (up to 6 weeks after enrollment), then monthly during the consolidative phase (up to 1 year after beginning the consolidative phase). Then, adverse events were collected every 3 months until 2 years post concurrent treatment. After year 3, adverse events were collected every 6 months until end of study. Adverse events are not divided into arms for concurrent vs consolidative durvalumab as all patients were prescribed the same treatment, and the aim of the study was not to separate the two factors.
Gastrointestinal disorders Esophageal fistula	10.0% 1/10 • Number of events 2 • Adverse have been collected from baseline until death of the patient or end of the study (approximately 4 years and 7 months). Adverse events were collected weekly during the concurrent phase (up to 6 weeks after enrollment), then monthly during the consolidative phase (up to 1 year after beginning the consolidative phase). Then, adverse events were collected every 3 months until 2 years post concurrent treatment. After year 3, adverse events were collected every 6 months until end of study. Adverse events are not divided into arms for concurrent vs consolidative durvalumab as all patients were prescribed the same treatment, and the aim of the study was not to separate the two factors.
General disorders Fatigue	10.0% 1/10 • Number of events 1 • Adverse have been collected from baseline until death of the patient or end of the study (approximately 4 years and 7 months). Adverse events were collected weekly during the concurrent phase (up to 6 weeks after enrollment), then monthly during the consolidative phase (up to 1 year after beginning the consolidative phase). Then, adverse events were collected every 3 months until 2 years post concurrent treatment. After year 3, adverse events were collected every 6 months until end of study. Adverse events are not divided into arms for concurrent vs consolidative durvalumab as all patients were prescribed the same treatment, and the aim of the study was not to separate the two factors.
Gastrointestinal disorders Hemorrhoids	10.0% 1/10 • Number of events 1 • Adverse have been collected from baseline until death of the patient or end of the study (approximately 4 years and 7 months). Adverse events were collected weekly during the concurrent phase (up to 6 weeks after enrollment), then monthly during the consolidative phase (up to 1 year after beginning the consolidative phase). Then, adverse events were collected every 3 months until 2 years post concurrent treatment. After year 3, adverse events were collected every 6 months until end of study. Adverse events are not divided into arms for concurrent vs consolidative durvalumab as all patients were prescribed the same treatment, and the aim of the study was not to separate the two factors.
Investigations Hypercalcemia	10.0% 1/10 • Number of events 1 • Adverse have been collected from baseline until death of the patient or end of the study (approximately 4 years and 7 months). Adverse events were collected weekly during the concurrent phase (up to 6 weeks after enrollment), then monthly during the consolidative phase (up to 1 year after beginning the consolidative phase). Then, adverse events were collected every 3 months until 2 years post concurrent treatment. After year 3, adverse events were collected every 6 months until end of study. Adverse events are not divided into arms for concurrent vs consolidative durvalumab as all patients were prescribed the same treatment, and the aim of the study was not to separate the two factors.
Investigations Hyperglycemia	10.0% 1/10 • Number of events 1 • Adverse have been collected from baseline until death of the patient or end of the study (approximately 4 years and 7 months). Adverse events were collected weekly during the concurrent phase (up to 6 weeks after enrollment), then monthly during the consolidative phase (up to 1 year after beginning the consolidative phase). Then, adverse events were collected every 3 months until 2 years post concurrent treatment. After year 3, adverse events were collected every 6 months until end of study. Adverse events are not divided into arms for concurrent vs consolidative durvalumab as all patients were prescribed the same treatment, and the aim of the study was not to separate the two factors.
Infections and infestations Lung infection	30.0% 3/10 • Number of events 4 • Adverse have been collected from baseline until death of the patient or end of the study (approximately 4 years and 7 months). Adverse events were collected weekly during the concurrent phase (up to 6 weeks after enrollment), then monthly during the consolidative phase (up to 1 year after beginning the consolidative phase). Then, adverse events were collected every 3 months until 2 years post concurrent treatment. After year 3, adverse events were collected every 6 months until end of study. Adverse events are not divided into arms for concurrent vs consolidative durvalumab as all patients were prescribed the same treatment, and the aim of the study was not to separate the two factors.
General disorders Non-cardiac chest pain	10.0% 1/10 • Number of events 1 • Adverse have been collected from baseline until death of the patient or end of the study (approximately 4 years and 7 months). Adverse events were collected weekly during the concurrent phase (up to 6 weeks after enrollment), then monthly during the consolidative phase (up to 1 year after beginning the consolidative phase). Then, adverse events were collected every 3 months until 2 years post concurrent treatment. After year 3, adverse events were collected every 6 months until end of study. Adverse events are not divided into arms for concurrent vs consolidative durvalumab as all patients were prescribed the same treatment, and the aim of the study was not to separate the two factors.
Respiratory, thoracic and mediastinal disorders Pneumonitis	30.0% 3/10 • Number of events 3 • Adverse have been collected from baseline until death of the patient or end of the study (approximately 4 years and 7 months). Adverse events were collected weekly during the concurrent phase (up to 6 weeks after enrollment), then monthly during the consolidative phase (up to 1 year after beginning the consolidative phase). Then, adverse events were collected every 3 months until 2 years post concurrent treatment. After year 3, adverse events were collected every 6 months until end of study. Adverse events are not divided into arms for concurrent vs consolidative durvalumab as all patients were prescribed the same treatment, and the aim of the study was not to separate the two factors.
Infections and infestations Sepsis	20.0% 2/10 • Number of events 2 • Adverse have been collected from baseline until death of the patient or end of the study (approximately 4 years and 7 months). Adverse events were collected weekly during the concurrent phase (up to 6 weeks after enrollment), then monthly during the consolidative phase (up to 1 year after beginning the consolidative phase). Then, adverse events were collected every 3 months until 2 years post concurrent treatment. After year 3, adverse events were collected every 6 months until end of study. Adverse events are not divided into arms for concurrent vs consolidative durvalumab as all patients were prescribed the same treatment, and the aim of the study was not to separate the two factors.
Nervous system disorders Syncope	10.0% 1/10 • Number of events 1 • Adverse have been collected from baseline until death of the patient or end of the study (approximately 4 years and 7 months). Adverse events were collected weekly during the concurrent phase (up to 6 weeks after enrollment), then monthly during the consolidative phase (up to 1 year after beginning the consolidative phase). Then, adverse events were collected every 3 months until 2 years post concurrent treatment. After year 3, adverse events were collected every 6 months until end of study. Adverse events are not divided into arms for concurrent vs consolidative durvalumab as all patients were prescribed the same treatment, and the aim of the study was not to separate the two factors.

Other adverse events

Other adverse events
Measure	Single Arm: Therapeutic Intervention n=10 participants at risk Thoracic RT and Durvalumab: 1500mg every 4 weeks \[Q4W\] intravenous \[IV\], first dose within 3 days of RT initiation Consolidative Durvalumab: 1500mg every 4 weeks \[Q4W\] intravenous \[IV\] up to one year
General disorders Fever	10.0% 1/10 • Number of events 1 • Adverse have been collected from baseline until death of the patient or end of the study (approximately 4 years and 7 months). Adverse events were collected weekly during the concurrent phase (up to 6 weeks after enrollment), then monthly during the consolidative phase (up to 1 year after beginning the consolidative phase). Then, adverse events were collected every 3 months until 2 years post concurrent treatment. After year 3, adverse events were collected every 6 months until end of study. Adverse events are not divided into arms for concurrent vs consolidative durvalumab as all patients were prescribed the same treatment, and the aim of the study was not to separate the two factors.
Musculoskeletal and connective tissue disorders Flank pain	10.0% 1/10 • Number of events 1 • Adverse have been collected from baseline until death of the patient or end of the study (approximately 4 years and 7 months). Adverse events were collected weekly during the concurrent phase (up to 6 weeks after enrollment), then monthly during the consolidative phase (up to 1 year after beginning the consolidative phase). Then, adverse events were collected every 3 months until 2 years post concurrent treatment. After year 3, adverse events were collected every 6 months until end of study. Adverse events are not divided into arms for concurrent vs consolidative durvalumab as all patients were prescribed the same treatment, and the aim of the study was not to separate the two factors.
Gastrointestinal disorders Abdominal pain	50.0% 5/10 • Number of events 7 • Adverse have been collected from baseline until death of the patient or end of the study (approximately 4 years and 7 months). Adverse events were collected weekly during the concurrent phase (up to 6 weeks after enrollment), then monthly during the consolidative phase (up to 1 year after beginning the consolidative phase). Then, adverse events were collected every 3 months until 2 years post concurrent treatment. After year 3, adverse events were collected every 6 months until end of study. Adverse events are not divided into arms for concurrent vs consolidative durvalumab as all patients were prescribed the same treatment, and the aim of the study was not to separate the two factors.
Investigations Alanine aminotransferase increased	40.0% 4/10 • Number of events 4 • Adverse have been collected from baseline until death of the patient or end of the study (approximately 4 years and 7 months). Adverse events were collected weekly during the concurrent phase (up to 6 weeks after enrollment), then monthly during the consolidative phase (up to 1 year after beginning the consolidative phase). Then, adverse events were collected every 3 months until 2 years post concurrent treatment. After year 3, adverse events were collected every 6 months until end of study. Adverse events are not divided into arms for concurrent vs consolidative durvalumab as all patients were prescribed the same treatment, and the aim of the study was not to separate the two factors.
Investigations Alkaline phosphatase increased	40.0% 4/10 • Number of events 4 • Adverse have been collected from baseline until death of the patient or end of the study (approximately 4 years and 7 months). Adverse events were collected weekly during the concurrent phase (up to 6 weeks after enrollment), then monthly during the consolidative phase (up to 1 year after beginning the consolidative phase). Then, adverse events were collected every 3 months until 2 years post concurrent treatment. After year 3, adverse events were collected every 6 months until end of study. Adverse events are not divided into arms for concurrent vs consolidative durvalumab as all patients were prescribed the same treatment, and the aim of the study was not to separate the two factors.
Respiratory, thoracic and mediastinal disorders Allergic rhinitis	10.0% 1/10 • Number of events 1 • Adverse have been collected from baseline until death of the patient or end of the study (approximately 4 years and 7 months). Adverse events were collected weekly during the concurrent phase (up to 6 weeks after enrollment), then monthly during the consolidative phase (up to 1 year after beginning the consolidative phase). Then, adverse events were collected every 3 months until 2 years post concurrent treatment. After year 3, adverse events were collected every 6 months until end of study. Adverse events are not divided into arms for concurrent vs consolidative durvalumab as all patients were prescribed the same treatment, and the aim of the study was not to separate the two factors.
Blood and lymphatic system disorders Anemia	50.0% 5/10 • Number of events 10 • Adverse have been collected from baseline until death of the patient or end of the study (approximately 4 years and 7 months). Adverse events were collected weekly during the concurrent phase (up to 6 weeks after enrollment), then monthly during the consolidative phase (up to 1 year after beginning the consolidative phase). Then, adverse events were collected every 3 months until 2 years post concurrent treatment. After year 3, adverse events were collected every 6 months until end of study. Adverse events are not divided into arms for concurrent vs consolidative durvalumab as all patients were prescribed the same treatment, and the aim of the study was not to separate the two factors.
Metabolism and nutrition disorders Anorexia	70.0% 7/10 • Number of events 9 • Adverse have been collected from baseline until death of the patient or end of the study (approximately 4 years and 7 months). Adverse events were collected weekly during the concurrent phase (up to 6 weeks after enrollment), then monthly during the consolidative phase (up to 1 year after beginning the consolidative phase). Then, adverse events were collected every 3 months until 2 years post concurrent treatment. After year 3, adverse events were collected every 6 months until end of study. Adverse events are not divided into arms for concurrent vs consolidative durvalumab as all patients were prescribed the same treatment, and the aim of the study was not to separate the two factors.
Psychiatric disorders Anxiety	10.0% 1/10 • Number of events 1 • Adverse have been collected from baseline until death of the patient or end of the study (approximately 4 years and 7 months). Adverse events were collected weekly during the concurrent phase (up to 6 weeks after enrollment), then monthly during the consolidative phase (up to 1 year after beginning the consolidative phase). Then, adverse events were collected every 3 months until 2 years post concurrent treatment. After year 3, adverse events were collected every 6 months until end of study. Adverse events are not divided into arms for concurrent vs consolidative durvalumab as all patients were prescribed the same treatment, and the aim of the study was not to separate the two factors.
Musculoskeletal and connective tissue disorders Arthralgia	10.0% 1/10 • Number of events 1 • Adverse have been collected from baseline until death of the patient or end of the study (approximately 4 years and 7 months). Adverse events were collected weekly during the concurrent phase (up to 6 weeks after enrollment), then monthly during the consolidative phase (up to 1 year after beginning the consolidative phase). Then, adverse events were collected every 3 months until 2 years post concurrent treatment. After year 3, adverse events were collected every 6 months until end of study. Adverse events are not divided into arms for concurrent vs consolidative durvalumab as all patients were prescribed the same treatment, and the aim of the study was not to separate the two factors.
Musculoskeletal and connective tissue disorders Arthritis	10.0% 1/10 • Number of events 1 • Adverse have been collected from baseline until death of the patient or end of the study (approximately 4 years and 7 months). Adverse events were collected weekly during the concurrent phase (up to 6 weeks after enrollment), then monthly during the consolidative phase (up to 1 year after beginning the consolidative phase). Then, adverse events were collected every 3 months until 2 years post concurrent treatment. After year 3, adverse events were collected every 6 months until end of study. Adverse events are not divided into arms for concurrent vs consolidative durvalumab as all patients were prescribed the same treatment, and the aim of the study was not to separate the two factors.
Investigations Aspartate aminotransferase increased	30.0% 3/10 • Number of events 4 • Adverse have been collected from baseline until death of the patient or end of the study (approximately 4 years and 7 months). Adverse events were collected weekly during the concurrent phase (up to 6 weeks after enrollment), then monthly during the consolidative phase (up to 1 year after beginning the consolidative phase). Then, adverse events were collected every 3 months until 2 years post concurrent treatment. After year 3, adverse events were collected every 6 months until end of study. Adverse events are not divided into arms for concurrent vs consolidative durvalumab as all patients were prescribed the same treatment, and the aim of the study was not to separate the two factors.
Respiratory, thoracic and mediastinal disorders Atelectasis	10.0% 1/10 • Number of events 1 • Adverse have been collected from baseline until death of the patient or end of the study (approximately 4 years and 7 months). Adverse events were collected weekly during the concurrent phase (up to 6 weeks after enrollment), then monthly during the consolidative phase (up to 1 year after beginning the consolidative phase). Then, adverse events were collected every 3 months until 2 years post concurrent treatment. After year 3, adverse events were collected every 6 months until end of study. Adverse events are not divided into arms for concurrent vs consolidative durvalumab as all patients were prescribed the same treatment, and the aim of the study was not to separate the two factors.
Musculoskeletal and connective tissue disorders Back pain	10.0% 1/10 • Number of events 1 • Adverse have been collected from baseline until death of the patient or end of the study (approximately 4 years and 7 months). Adverse events were collected weekly during the concurrent phase (up to 6 weeks after enrollment), then monthly during the consolidative phase (up to 1 year after beginning the consolidative phase). Then, adverse events were collected every 3 months until 2 years post concurrent treatment. After year 3, adverse events were collected every 6 months until end of study. Adverse events are not divided into arms for concurrent vs consolidative durvalumab as all patients were prescribed the same treatment, and the aim of the study was not to separate the two factors.
Gastrointestinal disorders Bloating	20.0% 2/10 • Number of events 2 • Adverse have been collected from baseline until death of the patient or end of the study (approximately 4 years and 7 months). Adverse events were collected weekly during the concurrent phase (up to 6 weeks after enrollment), then monthly during the consolidative phase (up to 1 year after beginning the consolidative phase). Then, adverse events were collected every 3 months until 2 years post concurrent treatment. After year 3, adverse events were collected every 6 months until end of study. Adverse events are not divided into arms for concurrent vs consolidative durvalumab as all patients were prescribed the same treatment, and the aim of the study was not to separate the two factors.
Investigations Blood bilirubin increased	10.0% 1/10 • Number of events 2 • Adverse have been collected from baseline until death of the patient or end of the study (approximately 4 years and 7 months). Adverse events were collected weekly during the concurrent phase (up to 6 weeks after enrollment), then monthly during the consolidative phase (up to 1 year after beginning the consolidative phase). Then, adverse events were collected every 3 months until 2 years post concurrent treatment. After year 3, adverse events were collected every 6 months until end of study. Adverse events are not divided into arms for concurrent vs consolidative durvalumab as all patients were prescribed the same treatment, and the aim of the study was not to separate the two factors.
Musculoskeletal and connective tissue disorders Chest wall pain	20.0% 2/10 • Number of events 2 • Adverse have been collected from baseline until death of the patient or end of the study (approximately 4 years and 7 months). Adverse events were collected weekly during the concurrent phase (up to 6 weeks after enrollment), then monthly during the consolidative phase (up to 1 year after beginning the consolidative phase). Then, adverse events were collected every 3 months until 2 years post concurrent treatment. After year 3, adverse events were collected every 6 months until end of study. Adverse events are not divided into arms for concurrent vs consolidative durvalumab as all patients were prescribed the same treatment, and the aim of the study was not to separate the two factors.
Investigations Cholesterol high	10.0% 1/10 • Number of events 1 • Adverse have been collected from baseline until death of the patient or end of the study (approximately 4 years and 7 months). Adverse events were collected weekly during the concurrent phase (up to 6 weeks after enrollment), then monthly during the consolidative phase (up to 1 year after beginning the consolidative phase). Then, adverse events were collected every 3 months until 2 years post concurrent treatment. After year 3, adverse events were collected every 6 months until end of study. Adverse events are not divided into arms for concurrent vs consolidative durvalumab as all patients were prescribed the same treatment, and the aim of the study was not to separate the two factors.
Psychiatric disorders Confusion	10.0% 1/10 • Number of events 1 • Adverse have been collected from baseline until death of the patient or end of the study (approximately 4 years and 7 months). Adverse events were collected weekly during the concurrent phase (up to 6 weeks after enrollment), then monthly during the consolidative phase (up to 1 year after beginning the consolidative phase). Then, adverse events were collected every 3 months until 2 years post concurrent treatment. After year 3, adverse events were collected every 6 months until end of study. Adverse events are not divided into arms for concurrent vs consolidative durvalumab as all patients were prescribed the same treatment, and the aim of the study was not to separate the two factors.
Gastrointestinal disorders Constipation	40.0% 4/10 • Number of events 5 • Adverse have been collected from baseline until death of the patient or end of the study (approximately 4 years and 7 months). Adverse events were collected weekly during the concurrent phase (up to 6 weeks after enrollment), then monthly during the consolidative phase (up to 1 year after beginning the consolidative phase). Then, adverse events were collected every 3 months until 2 years post concurrent treatment. After year 3, adverse events were collected every 6 months until end of study. Adverse events are not divided into arms for concurrent vs consolidative durvalumab as all patients were prescribed the same treatment, and the aim of the study was not to separate the two factors.
Respiratory, thoracic and mediastinal disorders Cough	10.0% 1/10 • Number of events 1 • Adverse have been collected from baseline until death of the patient or end of the study (approximately 4 years and 7 months). Adverse events were collected weekly during the concurrent phase (up to 6 weeks after enrollment), then monthly during the consolidative phase (up to 1 year after beginning the consolidative phase). Then, adverse events were collected every 3 months until 2 years post concurrent treatment. After year 3, adverse events were collected every 6 months until end of study. Adverse events are not divided into arms for concurrent vs consolidative durvalumab as all patients were prescribed the same treatment, and the aim of the study was not to separate the two factors.
Investigations Creatinine increased	10.0% 1/10 • Number of events 1 • Adverse have been collected from baseline until death of the patient or end of the study (approximately 4 years and 7 months). Adverse events were collected weekly during the concurrent phase (up to 6 weeks after enrollment), then monthly during the consolidative phase (up to 1 year after beginning the consolidative phase). Then, adverse events were collected every 3 months until 2 years post concurrent treatment. After year 3, adverse events were collected every 6 months until end of study. Adverse events are not divided into arms for concurrent vs consolidative durvalumab as all patients were prescribed the same treatment, and the aim of the study was not to separate the two factors.
Metabolism and nutrition disorders Dehydration	10.0% 1/10 • Number of events 1 • Adverse have been collected from baseline until death of the patient or end of the study (approximately 4 years and 7 months). Adverse events were collected weekly during the concurrent phase (up to 6 weeks after enrollment), then monthly during the consolidative phase (up to 1 year after beginning the consolidative phase). Then, adverse events were collected every 3 months until 2 years post concurrent treatment. After year 3, adverse events were collected every 6 months until end of study. Adverse events are not divided into arms for concurrent vs consolidative durvalumab as all patients were prescribed the same treatment, and the aim of the study was not to separate the two factors.
Psychiatric disorders Delirium	10.0% 1/10 • Number of events 1 • Adverse have been collected from baseline until death of the patient or end of the study (approximately 4 years and 7 months). Adverse events were collected weekly during the concurrent phase (up to 6 weeks after enrollment), then monthly during the consolidative phase (up to 1 year after beginning the consolidative phase). Then, adverse events were collected every 3 months until 2 years post concurrent treatment. After year 3, adverse events were collected every 6 months until end of study. Adverse events are not divided into arms for concurrent vs consolidative durvalumab as all patients were prescribed the same treatment, and the aim of the study was not to separate the two factors.
Gastrointestinal disorders Diarrhea	50.0% 5/10 • Number of events 7 • Adverse have been collected from baseline until death of the patient or end of the study (approximately 4 years and 7 months). Adverse events were collected weekly during the concurrent phase (up to 6 weeks after enrollment), then monthly during the consolidative phase (up to 1 year after beginning the consolidative phase). Then, adverse events were collected every 3 months until 2 years post concurrent treatment. After year 3, adverse events were collected every 6 months until end of study. Adverse events are not divided into arms for concurrent vs consolidative durvalumab as all patients were prescribed the same treatment, and the aim of the study was not to separate the two factors.
Nervous system disorders Dizziness	40.0% 4/10 • Number of events 4 • Adverse have been collected from baseline until death of the patient or end of the study (approximately 4 years and 7 months). Adverse events were collected weekly during the concurrent phase (up to 6 weeks after enrollment), then monthly during the consolidative phase (up to 1 year after beginning the consolidative phase). Then, adverse events were collected every 3 months until 2 years post concurrent treatment. After year 3, adverse events were collected every 6 months until end of study. Adverse events are not divided into arms for concurrent vs consolidative durvalumab as all patients were prescribed the same treatment, and the aim of the study was not to separate the two factors.
Eye disorders Dry eye	20.0% 2/10 • Number of events 2 • Adverse have been collected from baseline until death of the patient or end of the study (approximately 4 years and 7 months). Adverse events were collected weekly during the concurrent phase (up to 6 weeks after enrollment), then monthly during the consolidative phase (up to 1 year after beginning the consolidative phase). Then, adverse events were collected every 3 months until 2 years post concurrent treatment. After year 3, adverse events were collected every 6 months until end of study. Adverse events are not divided into arms for concurrent vs consolidative durvalumab as all patients were prescribed the same treatment, and the aim of the study was not to separate the two factors.
Gastrointestinal disorders Dry mouth	30.0% 3/10 • Number of events 5 • Adverse have been collected from baseline until death of the patient or end of the study (approximately 4 years and 7 months). Adverse events were collected weekly during the concurrent phase (up to 6 weeks after enrollment), then monthly during the consolidative phase (up to 1 year after beginning the consolidative phase). Then, adverse events were collected every 3 months until 2 years post concurrent treatment. After year 3, adverse events were collected every 6 months until end of study. Adverse events are not divided into arms for concurrent vs consolidative durvalumab as all patients were prescribed the same treatment, and the aim of the study was not to separate the two factors.
Skin and subcutaneous tissue disorders Dry skin	10.0% 1/10 • Number of events 1 • Adverse have been collected from baseline until death of the patient or end of the study (approximately 4 years and 7 months). Adverse events were collected weekly during the concurrent phase (up to 6 weeks after enrollment), then monthly during the consolidative phase (up to 1 year after beginning the consolidative phase). Then, adverse events were collected every 3 months until 2 years post concurrent treatment. After year 3, adverse events were collected every 6 months until end of study. Adverse events are not divided into arms for concurrent vs consolidative durvalumab as all patients were prescribed the same treatment, and the aim of the study was not to separate the two factors.
Nervous system disorders Dysgeusia	20.0% 2/10 • Number of events 3 • Adverse have been collected from baseline until death of the patient or end of the study (approximately 4 years and 7 months). Adverse events were collected weekly during the concurrent phase (up to 6 weeks after enrollment), then monthly during the consolidative phase (up to 1 year after beginning the consolidative phase). Then, adverse events were collected every 3 months until 2 years post concurrent treatment. After year 3, adverse events were collected every 6 months until end of study. Adverse events are not divided into arms for concurrent vs consolidative durvalumab as all patients were prescribed the same treatment, and the aim of the study was not to separate the two factors.
Gastrointestinal disorders Dyspepsia	10.0% 1/10 • Number of events 1 • Adverse have been collected from baseline until death of the patient or end of the study (approximately 4 years and 7 months). Adverse events were collected weekly during the concurrent phase (up to 6 weeks after enrollment), then monthly during the consolidative phase (up to 1 year after beginning the consolidative phase). Then, adverse events were collected every 3 months until 2 years post concurrent treatment. After year 3, adverse events were collected every 6 months until end of study. Adverse events are not divided into arms for concurrent vs consolidative durvalumab as all patients were prescribed the same treatment, and the aim of the study was not to separate the two factors.
Gastrointestinal disorders Dysphagia	10.0% 1/10 • Number of events 1 • Adverse have been collected from baseline until death of the patient or end of the study (approximately 4 years and 7 months). Adverse events were collected weekly during the concurrent phase (up to 6 weeks after enrollment), then monthly during the consolidative phase (up to 1 year after beginning the consolidative phase). Then, adverse events were collected every 3 months until 2 years post concurrent treatment. After year 3, adverse events were collected every 6 months until end of study. Adverse events are not divided into arms for concurrent vs consolidative durvalumab as all patients were prescribed the same treatment, and the aim of the study was not to separate the two factors.
Respiratory, thoracic and mediastinal disorders Dyspnea	50.0% 5/10 • Number of events 6 • Adverse have been collected from baseline until death of the patient or end of the study (approximately 4 years and 7 months). Adverse events were collected weekly during the concurrent phase (up to 6 weeks after enrollment), then monthly during the consolidative phase (up to 1 year after beginning the consolidative phase). Then, adverse events were collected every 3 months until 2 years post concurrent treatment. After year 3, adverse events were collected every 6 months until end of study. Adverse events are not divided into arms for concurrent vs consolidative durvalumab as all patients were prescribed the same treatment, and the aim of the study was not to separate the two factors.
Ear and labyrinth disorders Ear and labyrinth disorders - Other, ear discharge	10.0% 1/10 • Number of events 1 • Adverse have been collected from baseline until death of the patient or end of the study (approximately 4 years and 7 months). Adverse events were collected weekly during the concurrent phase (up to 6 weeks after enrollment), then monthly during the consolidative phase (up to 1 year after beginning the consolidative phase). Then, adverse events were collected every 3 months until 2 years post concurrent treatment. After year 3, adverse events were collected every 6 months until end of study. Adverse events are not divided into arms for concurrent vs consolidative durvalumab as all patients were prescribed the same treatment, and the aim of the study was not to separate the two factors.
Ear and labyrinth disorders Ear pain	10.0% 1/10 • Number of events 1 • Adverse have been collected from baseline until death of the patient or end of the study (approximately 4 years and 7 months). Adverse events were collected weekly during the concurrent phase (up to 6 weeks after enrollment), then monthly during the consolidative phase (up to 1 year after beginning the consolidative phase). Then, adverse events were collected every 3 months until 2 years post concurrent treatment. After year 3, adverse events were collected every 6 months until end of study. Adverse events are not divided into arms for concurrent vs consolidative durvalumab as all patients were prescribed the same treatment, and the aim of the study was not to separate the two factors.
General disorders Edema Limbs	20.0% 2/10 • Number of events 2 • Adverse have been collected from baseline until death of the patient or end of the study (approximately 4 years and 7 months). Adverse events were collected weekly during the concurrent phase (up to 6 weeks after enrollment), then monthly during the consolidative phase (up to 1 year after beginning the consolidative phase). Then, adverse events were collected every 3 months until 2 years post concurrent treatment. After year 3, adverse events were collected every 6 months until end of study. Adverse events are not divided into arms for concurrent vs consolidative durvalumab as all patients were prescribed the same treatment, and the aim of the study was not to separate the two factors.
Skin and subcutaneous tissue disorders Erythema	10.0% 1/10 • Number of events 1 • Adverse have been collected from baseline until death of the patient or end of the study (approximately 4 years and 7 months). Adverse events were collected weekly during the concurrent phase (up to 6 weeks after enrollment), then monthly during the consolidative phase (up to 1 year after beginning the consolidative phase). Then, adverse events were collected every 3 months until 2 years post concurrent treatment. After year 3, adverse events were collected every 6 months until end of study. Adverse events are not divided into arms for concurrent vs consolidative durvalumab as all patients were prescribed the same treatment, and the aim of the study was not to separate the two factors.
Gastrointestinal disorders Esophagitis	20.0% 2/10 • Number of events 2 • Adverse have been collected from baseline until death of the patient or end of the study (approximately 4 years and 7 months). Adverse events were collected weekly during the concurrent phase (up to 6 weeks after enrollment), then monthly during the consolidative phase (up to 1 year after beginning the consolidative phase). Then, adverse events were collected every 3 months until 2 years post concurrent treatment. After year 3, adverse events were collected every 6 months until end of study. Adverse events are not divided into arms for concurrent vs consolidative durvalumab as all patients were prescribed the same treatment, and the aim of the study was not to separate the two factors.
General disorders Facial pain	10.0% 1/10 • Number of events 1 • Adverse have been collected from baseline until death of the patient or end of the study (approximately 4 years and 7 months). Adverse events were collected weekly during the concurrent phase (up to 6 weeks after enrollment), then monthly during the consolidative phase (up to 1 year after beginning the consolidative phase). Then, adverse events were collected every 3 months until 2 years post concurrent treatment. After year 3, adverse events were collected every 6 months until end of study. Adverse events are not divided into arms for concurrent vs consolidative durvalumab as all patients were prescribed the same treatment, and the aim of the study was not to separate the two factors.
General disorders Fatigue	70.0% 7/10 • Number of events 11 • Adverse have been collected from baseline until death of the patient or end of the study (approximately 4 years and 7 months). Adverse events were collected weekly during the concurrent phase (up to 6 weeks after enrollment), then monthly during the consolidative phase (up to 1 year after beginning the consolidative phase). Then, adverse events were collected every 3 months until 2 years post concurrent treatment. After year 3, adverse events were collected every 6 months until end of study. Adverse events are not divided into arms for concurrent vs consolidative durvalumab as all patients were prescribed the same treatment, and the aim of the study was not to separate the two factors.
Gastrointestinal disorders Flatulence	10.0% 1/10 • Number of events 1 • Adverse have been collected from baseline until death of the patient or end of the study (approximately 4 years and 7 months). Adverse events were collected weekly during the concurrent phase (up to 6 weeks after enrollment), then monthly during the consolidative phase (up to 1 year after beginning the consolidative phase). Then, adverse events were collected every 3 months until 2 years post concurrent treatment. After year 3, adverse events were collected every 6 months until end of study. Adverse events are not divided into arms for concurrent vs consolidative durvalumab as all patients were prescribed the same treatment, and the aim of the study was not to separate the two factors.
General disorders Flu like symptoms	10.0% 1/10 • Number of events 1 • Adverse have been collected from baseline until death of the patient or end of the study (approximately 4 years and 7 months). Adverse events were collected weekly during the concurrent phase (up to 6 weeks after enrollment), then monthly during the consolidative phase (up to 1 year after beginning the consolidative phase). Then, adverse events were collected every 3 months until 2 years post concurrent treatment. After year 3, adverse events were collected every 6 months until end of study. Adverse events are not divided into arms for concurrent vs consolidative durvalumab as all patients were prescribed the same treatment, and the aim of the study was not to separate the two factors.
Injury, poisoning and procedural complications Fracture	10.0% 1/10 • Number of events 1 • Adverse have been collected from baseline until death of the patient or end of the study (approximately 4 years and 7 months). Adverse events were collected weekly during the concurrent phase (up to 6 weeks after enrollment), then monthly during the consolidative phase (up to 1 year after beginning the consolidative phase). Then, adverse events were collected every 3 months until 2 years post concurrent treatment. After year 3, adverse events were collected every 6 months until end of study. Adverse events are not divided into arms for concurrent vs consolidative durvalumab as all patients were prescribed the same treatment, and the aim of the study was not to separate the two factors.
General disorders Gait disturbance	10.0% 1/10 • Number of events 1 • Adverse have been collected from baseline until death of the patient or end of the study (approximately 4 years and 7 months). Adverse events were collected weekly during the concurrent phase (up to 6 weeks after enrollment), then monthly during the consolidative phase (up to 1 year after beginning the consolidative phase). Then, adverse events were collected every 3 months until 2 years post concurrent treatment. After year 3, adverse events were collected every 6 months until end of study. Adverse events are not divided into arms for concurrent vs consolidative durvalumab as all patients were prescribed the same treatment, and the aim of the study was not to separate the two factors.
Gastrointestinal disorders Gastroesophageal reflux disease	40.0% 4/10 • Number of events 4 • Adverse have been collected from baseline until death of the patient or end of the study (approximately 4 years and 7 months). Adverse events were collected weekly during the concurrent phase (up to 6 weeks after enrollment), then monthly during the consolidative phase (up to 1 year after beginning the consolidative phase). Then, adverse events were collected every 3 months until 2 years post concurrent treatment. After year 3, adverse events were collected every 6 months until end of study. Adverse events are not divided into arms for concurrent vs consolidative durvalumab as all patients were prescribed the same treatment, and the aim of the study was not to separate the two factors.
Gastrointestinal disorders Gastrointestinal disorders - Other, dark stools, blood in stools	10.0% 1/10 • Number of events 1 • Adverse have been collected from baseline until death of the patient or end of the study (approximately 4 years and 7 months). Adverse events were collected weekly during the concurrent phase (up to 6 weeks after enrollment), then monthly during the consolidative phase (up to 1 year after beginning the consolidative phase). Then, adverse events were collected every 3 months until 2 years post concurrent treatment. After year 3, adverse events were collected every 6 months until end of study. Adverse events are not divided into arms for concurrent vs consolidative durvalumab as all patients were prescribed the same treatment, and the aim of the study was not to separate the two factors.
General disorders General disorders and administration site conditions - Other, heat intolerance	10.0% 1/10 • Number of events 1 • Adverse have been collected from baseline until death of the patient or end of the study (approximately 4 years and 7 months). Adverse events were collected weekly during the concurrent phase (up to 6 weeks after enrollment), then monthly during the consolidative phase (up to 1 year after beginning the consolidative phase). Then, adverse events were collected every 3 months until 2 years post concurrent treatment. After year 3, adverse events were collected every 6 months until end of study. Adverse events are not divided into arms for concurrent vs consolidative durvalumab as all patients were prescribed the same treatment, and the aim of the study was not to separate the two factors.
General disorders General disorders and administration site conditions - Other, cold intolerance	10.0% 1/10 • Number of events 1 • Adverse have been collected from baseline until death of the patient or end of the study (approximately 4 years and 7 months). Adverse events were collected weekly during the concurrent phase (up to 6 weeks after enrollment), then monthly during the consolidative phase (up to 1 year after beginning the consolidative phase). Then, adverse events were collected every 3 months until 2 years post concurrent treatment. After year 3, adverse events were collected every 6 months until end of study. Adverse events are not divided into arms for concurrent vs consolidative durvalumab as all patients were prescribed the same treatment, and the aim of the study was not to separate the two factors.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	10.0% 1/10 • Number of events 1 • Adverse have been collected from baseline until death of the patient or end of the study (approximately 4 years and 7 months). Adverse events were collected weekly during the concurrent phase (up to 6 weeks after enrollment), then monthly during the consolidative phase (up to 1 year after beginning the consolidative phase). Then, adverse events were collected every 3 months until 2 years post concurrent treatment. After year 3, adverse events were collected every 6 months until end of study. Adverse events are not divided into arms for concurrent vs consolidative durvalumab as all patients were prescribed the same treatment, and the aim of the study was not to separate the two factors.
Psychiatric disorders Hallucinations	10.0% 1/10 • Number of events 1 • Adverse have been collected from baseline until death of the patient or end of the study (approximately 4 years and 7 months). Adverse events were collected weekly during the concurrent phase (up to 6 weeks after enrollment), then monthly during the consolidative phase (up to 1 year after beginning the consolidative phase). Then, adverse events were collected every 3 months until 2 years post concurrent treatment. After year 3, adverse events were collected every 6 months until end of study. Adverse events are not divided into arms for concurrent vs consolidative durvalumab as all patients were prescribed the same treatment, and the aim of the study was not to separate the two factors.
Nervous system disorders Headache	10.0% 1/10 • Number of events 1 • Adverse have been collected from baseline until death of the patient or end of the study (approximately 4 years and 7 months). Adverse events were collected weekly during the concurrent phase (up to 6 weeks after enrollment), then monthly during the consolidative phase (up to 1 year after beginning the consolidative phase). Then, adverse events were collected every 3 months until 2 years post concurrent treatment. After year 3, adverse events were collected every 6 months until end of study. Adverse events are not divided into arms for concurrent vs consolidative durvalumab as all patients were prescribed the same treatment, and the aim of the study was not to separate the two factors.
Ear and labyrinth disorders Hearing impaired	10.0% 1/10 • Number of events 1 • Adverse have been collected from baseline until death of the patient or end of the study (approximately 4 years and 7 months). Adverse events were collected weekly during the concurrent phase (up to 6 weeks after enrollment), then monthly during the consolidative phase (up to 1 year after beginning the consolidative phase). Then, adverse events were collected every 3 months until 2 years post concurrent treatment. After year 3, adverse events were collected every 6 months until end of study. Adverse events are not divided into arms for concurrent vs consolidative durvalumab as all patients were prescribed the same treatment, and the aim of the study was not to separate the two factors.
Renal and urinary disorders Hematuria	10.0% 1/10 • Number of events 1 • Adverse have been collected from baseline until death of the patient or end of the study (approximately 4 years and 7 months). Adverse events were collected weekly during the concurrent phase (up to 6 weeks after enrollment), then monthly during the consolidative phase (up to 1 year after beginning the consolidative phase). Then, adverse events were collected every 3 months until 2 years post concurrent treatment. After year 3, adverse events were collected every 6 months until end of study. Adverse events are not divided into arms for concurrent vs consolidative durvalumab as all patients were prescribed the same treatment, and the aim of the study was not to separate the two factors.
Vascular disorders Hot flashes	10.0% 1/10 • Number of events 1 • Adverse have been collected from baseline until death of the patient or end of the study (approximately 4 years and 7 months). Adverse events were collected weekly during the concurrent phase (up to 6 weeks after enrollment), then monthly during the consolidative phase (up to 1 year after beginning the consolidative phase). Then, adverse events were collected every 3 months until 2 years post concurrent treatment. After year 3, adverse events were collected every 6 months until end of study. Adverse events are not divided into arms for concurrent vs consolidative durvalumab as all patients were prescribed the same treatment, and the aim of the study was not to separate the two factors.
Metabolism and nutrition disorders Hypercalcemia	20.0% 2/10 • Number of events 2 • Adverse have been collected from baseline until death of the patient or end of the study (approximately 4 years and 7 months). Adverse events were collected weekly during the concurrent phase (up to 6 weeks after enrollment), then monthly during the consolidative phase (up to 1 year after beginning the consolidative phase). Then, adverse events were collected every 3 months until 2 years post concurrent treatment. After year 3, adverse events were collected every 6 months until end of study. Adverse events are not divided into arms for concurrent vs consolidative durvalumab as all patients were prescribed the same treatment, and the aim of the study was not to separate the two factors.
Metabolism and nutrition disorders Hyperglycemia	10.0% 1/10 • Number of events 1 • Adverse have been collected from baseline until death of the patient or end of the study (approximately 4 years and 7 months). Adverse events were collected weekly during the concurrent phase (up to 6 weeks after enrollment), then monthly during the consolidative phase (up to 1 year after beginning the consolidative phase). Then, adverse events were collected every 3 months until 2 years post concurrent treatment. After year 3, adverse events were collected every 6 months until end of study. Adverse events are not divided into arms for concurrent vs consolidative durvalumab as all patients were prescribed the same treatment, and the aim of the study was not to separate the two factors.
Metabolism and nutrition disorders Hyperlipidemia	10.0% 1/10 • Number of events 1 • Adverse have been collected from baseline until death of the patient or end of the study (approximately 4 years and 7 months). Adverse events were collected weekly during the concurrent phase (up to 6 weeks after enrollment), then monthly during the consolidative phase (up to 1 year after beginning the consolidative phase). Then, adverse events were collected every 3 months until 2 years post concurrent treatment. After year 3, adverse events were collected every 6 months until end of study. Adverse events are not divided into arms for concurrent vs consolidative durvalumab as all patients were prescribed the same treatment, and the aim of the study was not to separate the two factors.
Vascular disorders Hypertension	10.0% 1/10 • Number of events 1 • Adverse have been collected from baseline until death of the patient or end of the study (approximately 4 years and 7 months). Adverse events were collected weekly during the concurrent phase (up to 6 weeks after enrollment), then monthly during the consolidative phase (up to 1 year after beginning the consolidative phase). Then, adverse events were collected every 3 months until 2 years post concurrent treatment. After year 3, adverse events were collected every 6 months until end of study. Adverse events are not divided into arms for concurrent vs consolidative durvalumab as all patients were prescribed the same treatment, and the aim of the study was not to separate the two factors.
Metabolism and nutrition disorders Hypoalbuminemia	10.0% 1/10 • Number of events 1 • Adverse have been collected from baseline until death of the patient or end of the study (approximately 4 years and 7 months). Adverse events were collected weekly during the concurrent phase (up to 6 weeks after enrollment), then monthly during the consolidative phase (up to 1 year after beginning the consolidative phase). Then, adverse events were collected every 3 months until 2 years post concurrent treatment. After year 3, adverse events were collected every 6 months until end of study. Adverse events are not divided into arms for concurrent vs consolidative durvalumab as all patients were prescribed the same treatment, and the aim of the study was not to separate the two factors.
Metabolism and nutrition disorders Hypocalcemia	10.0% 1/10 • Number of events 1 • Adverse have been collected from baseline until death of the patient or end of the study (approximately 4 years and 7 months). Adverse events were collected weekly during the concurrent phase (up to 6 weeks after enrollment), then monthly during the consolidative phase (up to 1 year after beginning the consolidative phase). Then, adverse events were collected every 3 months until 2 years post concurrent treatment. After year 3, adverse events were collected every 6 months until end of study. Adverse events are not divided into arms for concurrent vs consolidative durvalumab as all patients were prescribed the same treatment, and the aim of the study was not to separate the two factors.
Metabolism and nutrition disorders Hypokalemia	30.0% 3/10 • Number of events 4 • Adverse have been collected from baseline until death of the patient or end of the study (approximately 4 years and 7 months). Adverse events were collected weekly during the concurrent phase (up to 6 weeks after enrollment), then monthly during the consolidative phase (up to 1 year after beginning the consolidative phase). Then, adverse events were collected every 3 months until 2 years post concurrent treatment. After year 3, adverse events were collected every 6 months until end of study. Adverse events are not divided into arms for concurrent vs consolidative durvalumab as all patients were prescribed the same treatment, and the aim of the study was not to separate the two factors.
Metabolism and nutrition disorders Hyponatremia	40.0% 4/10 • Number of events 6 • Adverse have been collected from baseline until death of the patient or end of the study (approximately 4 years and 7 months). Adverse events were collected weekly during the concurrent phase (up to 6 weeks after enrollment), then monthly during the consolidative phase (up to 1 year after beginning the consolidative phase). Then, adverse events were collected every 3 months until 2 years post concurrent treatment. After year 3, adverse events were collected every 6 months until end of study. Adverse events are not divided into arms for concurrent vs consolidative durvalumab as all patients were prescribed the same treatment, and the aim of the study was not to separate the two factors.
Respiratory, thoracic and mediastinal disorders Hypoxia	20.0% 2/10 • Number of events 2 • Adverse have been collected from baseline until death of the patient or end of the study (approximately 4 years and 7 months). Adverse events were collected weekly during the concurrent phase (up to 6 weeks after enrollment), then monthly during the consolidative phase (up to 1 year after beginning the consolidative phase). Then, adverse events were collected every 3 months until 2 years post concurrent treatment. After year 3, adverse events were collected every 6 months until end of study. Adverse events are not divided into arms for concurrent vs consolidative durvalumab as all patients were prescribed the same treatment, and the aim of the study was not to separate the two factors.
Infections and infestations Infections and infestations - Other, COVID-19	20.0% 2/10 • Number of events 2 • Adverse have been collected from baseline until death of the patient or end of the study (approximately 4 years and 7 months). Adverse events were collected weekly during the concurrent phase (up to 6 weeks after enrollment), then monthly during the consolidative phase (up to 1 year after beginning the consolidative phase). Then, adverse events were collected every 3 months until 2 years post concurrent treatment. After year 3, adverse events were collected every 6 months until end of study. Adverse events are not divided into arms for concurrent vs consolidative durvalumab as all patients were prescribed the same treatment, and the aim of the study was not to separate the two factors.
Psychiatric disorders Insomnia	40.0% 4/10 • Number of events 5 • Adverse have been collected from baseline until death of the patient or end of the study (approximately 4 years and 7 months). Adverse events were collected weekly during the concurrent phase (up to 6 weeks after enrollment), then monthly during the consolidative phase (up to 1 year after beginning the consolidative phase). Then, adverse events were collected every 3 months until 2 years post concurrent treatment. After year 3, adverse events were collected every 6 months until end of study. Adverse events are not divided into arms for concurrent vs consolidative durvalumab as all patients were prescribed the same treatment, and the aim of the study was not to separate the two factors.
Investigations Investigations - Other, Iron decreased	10.0% 1/10 • Number of events 1 • Adverse have been collected from baseline until death of the patient or end of the study (approximately 4 years and 7 months). Adverse events were collected weekly during the concurrent phase (up to 6 weeks after enrollment), then monthly during the consolidative phase (up to 1 year after beginning the consolidative phase). Then, adverse events were collected every 3 months until 2 years post concurrent treatment. After year 3, adverse events were collected every 6 months until end of study. Adverse events are not divided into arms for concurrent vs consolidative durvalumab as all patients were prescribed the same treatment, and the aim of the study was not to separate the two factors.
Investigations Investigations - Other, Neutrophil increased	20.0% 2/10 • Number of events 2 • Adverse have been collected from baseline until death of the patient or end of the study (approximately 4 years and 7 months). Adverse events were collected weekly during the concurrent phase (up to 6 weeks after enrollment), then monthly during the consolidative phase (up to 1 year after beginning the consolidative phase). Then, adverse events were collected every 3 months until 2 years post concurrent treatment. After year 3, adverse events were collected every 6 months until end of study. Adverse events are not divided into arms for concurrent vs consolidative durvalumab as all patients were prescribed the same treatment, and the aim of the study was not to separate the two factors.
Investigations Investigations - Other, creatinine decreased	40.0% 4/10 • Number of events 4 • Adverse have been collected from baseline until death of the patient or end of the study (approximately 4 years and 7 months). Adverse events were collected weekly during the concurrent phase (up to 6 weeks after enrollment), then monthly during the consolidative phase (up to 1 year after beginning the consolidative phase). Then, adverse events were collected every 3 months until 2 years post concurrent treatment. After year 3, adverse events were collected every 6 months until end of study. Adverse events are not divided into arms for concurrent vs consolidative durvalumab as all patients were prescribed the same treatment, and the aim of the study was not to separate the two factors.
Investigations Investigations - Other, T3 total decreased	10.0% 1/10 • Number of events 2 • Adverse have been collected from baseline until death of the patient or end of the study (approximately 4 years and 7 months). Adverse events were collected weekly during the concurrent phase (up to 6 weeks after enrollment), then monthly during the consolidative phase (up to 1 year after beginning the consolidative phase). Then, adverse events were collected every 3 months until 2 years post concurrent treatment. After year 3, adverse events were collected every 6 months until end of study. Adverse events are not divided into arms for concurrent vs consolidative durvalumab as all patients were prescribed the same treatment, and the aim of the study was not to separate the two factors.
Investigations Investigations - Other, cortisol decreased	10.0% 1/10 • Number of events 1 • Adverse have been collected from baseline until death of the patient or end of the study (approximately 4 years and 7 months). Adverse events were collected weekly during the concurrent phase (up to 6 weeks after enrollment), then monthly during the consolidative phase (up to 1 year after beginning the consolidative phase). Then, adverse events were collected every 3 months until 2 years post concurrent treatment. After year 3, adverse events were collected every 6 months until end of study. Adverse events are not divided into arms for concurrent vs consolidative durvalumab as all patients were prescribed the same treatment, and the aim of the study was not to separate the two factors.
Investigations Investigations - Other, ferritin increased	10.0% 1/10 • Number of events 1 • Adverse have been collected from baseline until death of the patient or end of the study (approximately 4 years and 7 months). Adverse events were collected weekly during the concurrent phase (up to 6 weeks after enrollment), then monthly during the consolidative phase (up to 1 year after beginning the consolidative phase). Then, adverse events were collected every 3 months until 2 years post concurrent treatment. After year 3, adverse events were collected every 6 months until end of study. Adverse events are not divided into arms for concurrent vs consolidative durvalumab as all patients were prescribed the same treatment, and the aim of the study was not to separate the two factors.
Investigations Investigations - Other, free T4 increased	10.0% 1/10 • Number of events 1 • Adverse have been collected from baseline until death of the patient or end of the study (approximately 4 years and 7 months). Adverse events were collected weekly during the concurrent phase (up to 6 weeks after enrollment), then monthly during the consolidative phase (up to 1 year after beginning the consolidative phase). Then, adverse events were collected every 3 months until 2 years post concurrent treatment. After year 3, adverse events were collected every 6 months until end of study. Adverse events are not divided into arms for concurrent vs consolidative durvalumab as all patients were prescribed the same treatment, and the aim of the study was not to separate the two factors.
Investigations Investigations - Other, TSH decreased	10.0% 1/10 • Number of events 1 • Adverse have been collected from baseline until death of the patient or end of the study (approximately 4 years and 7 months). Adverse events were collected weekly during the concurrent phase (up to 6 weeks after enrollment), then monthly during the consolidative phase (up to 1 year after beginning the consolidative phase). Then, adverse events were collected every 3 months until 2 years post concurrent treatment. After year 3, adverse events were collected every 6 months until end of study. Adverse events are not divided into arms for concurrent vs consolidative durvalumab as all patients were prescribed the same treatment, and the aim of the study was not to separate the two factors.
Investigations Investigations - Other, phosphorus decreased	10.0% 1/10 • Number of events 1 • Adverse have been collected from baseline until death of the patient or end of the study (approximately 4 years and 7 months). Adverse events were collected weekly during the concurrent phase (up to 6 weeks after enrollment), then monthly during the consolidative phase (up to 1 year after beginning the consolidative phase). Then, adverse events were collected every 3 months until 2 years post concurrent treatment. After year 3, adverse events were collected every 6 months until end of study. Adverse events are not divided into arms for concurrent vs consolidative durvalumab as all patients were prescribed the same treatment, and the aim of the study was not to separate the two factors.
Investigations Investigations - Other, ACTH decreased	20.0% 2/10 • Number of events 2 • Adverse have been collected from baseline until death of the patient or end of the study (approximately 4 years and 7 months). Adverse events were collected weekly during the concurrent phase (up to 6 weeks after enrollment), then monthly during the consolidative phase (up to 1 year after beginning the consolidative phase). Then, adverse events were collected every 3 months until 2 years post concurrent treatment. After year 3, adverse events were collected every 6 months until end of study. Adverse events are not divided into arms for concurrent vs consolidative durvalumab as all patients were prescribed the same treatment, and the aim of the study was not to separate the two factors.
Investigations Investigations - Other, ALT decreased	10.0% 1/10 • Number of events 1 • Adverse have been collected from baseline until death of the patient or end of the study (approximately 4 years and 7 months). Adverse events were collected weekly during the concurrent phase (up to 6 weeks after enrollment), then monthly during the consolidative phase (up to 1 year after beginning the consolidative phase). Then, adverse events were collected every 3 months until 2 years post concurrent treatment. After year 3, adverse events were collected every 6 months until end of study. Adverse events are not divided into arms for concurrent vs consolidative durvalumab as all patients were prescribed the same treatment, and the aim of the study was not to separate the two factors.
Investigations Investigations - Other, AST decreased	10.0% 1/10 • Number of events 1 • Adverse have been collected from baseline until death of the patient or end of the study (approximately 4 years and 7 months). Adverse events were collected weekly during the concurrent phase (up to 6 weeks after enrollment), then monthly during the consolidative phase (up to 1 year after beginning the consolidative phase). Then, adverse events were collected every 3 months until 2 years post concurrent treatment. After year 3, adverse events were collected every 6 months until end of study. Adverse events are not divided into arms for concurrent vs consolidative durvalumab as all patients were prescribed the same treatment, and the aim of the study was not to separate the two factors.
Investigations Investigations - Other, BUN increased	10.0% 1/10 • Number of events 1 • Adverse have been collected from baseline until death of the patient or end of the study (approximately 4 years and 7 months). Adverse events were collected weekly during the concurrent phase (up to 6 weeks after enrollment), then monthly during the consolidative phase (up to 1 year after beginning the consolidative phase). Then, adverse events were collected every 3 months until 2 years post concurrent treatment. After year 3, adverse events were collected every 6 months until end of study. Adverse events are not divided into arms for concurrent vs consolidative durvalumab as all patients were prescribed the same treatment, and the aim of the study was not to separate the two factors.
Investigations Investigations - Other, chloride decreased	20.0% 2/10 • Number of events 4 • Adverse have been collected from baseline until death of the patient or end of the study (approximately 4 years and 7 months). Adverse events were collected weekly during the concurrent phase (up to 6 weeks after enrollment), then monthly during the consolidative phase (up to 1 year after beginning the consolidative phase). Then, adverse events were collected every 3 months until 2 years post concurrent treatment. After year 3, adverse events were collected every 6 months until end of study. Adverse events are not divided into arms for concurrent vs consolidative durvalumab as all patients were prescribed the same treatment, and the aim of the study was not to separate the two factors.
Investigations Investigations - Other, Eosinophils decreased	10.0% 1/10 • Number of events 1 • Adverse have been collected from baseline until death of the patient or end of the study (approximately 4 years and 7 months). Adverse events were collected weekly during the concurrent phase (up to 6 weeks after enrollment), then monthly during the consolidative phase (up to 1 year after beginning the consolidative phase). Then, adverse events were collected every 3 months until 2 years post concurrent treatment. After year 3, adverse events were collected every 6 months until end of study. Adverse events are not divided into arms for concurrent vs consolidative durvalumab as all patients were prescribed the same treatment, and the aim of the study was not to separate the two factors.
Investigations Investigations - Other, free T3 decreased	10.0% 1/10 • Number of events 2 • Adverse have been collected from baseline until death of the patient or end of the study (approximately 4 years and 7 months). Adverse events were collected weekly during the concurrent phase (up to 6 weeks after enrollment), then monthly during the consolidative phase (up to 1 year after beginning the consolidative phase). Then, adverse events were collected every 3 months until 2 years post concurrent treatment. After year 3, adverse events were collected every 6 months until end of study. Adverse events are not divided into arms for concurrent vs consolidative durvalumab as all patients were prescribed the same treatment, and the aim of the study was not to separate the two factors.
Investigations Investigations - Other, MCHC decreased	10.0% 1/10 • Number of events 1 • Adverse have been collected from baseline until death of the patient or end of the study (approximately 4 years and 7 months). Adverse events were collected weekly during the concurrent phase (up to 6 weeks after enrollment), then monthly during the consolidative phase (up to 1 year after beginning the consolidative phase). Then, adverse events were collected every 3 months until 2 years post concurrent treatment. After year 3, adverse events were collected every 6 months until end of study. Adverse events are not divided into arms for concurrent vs consolidative durvalumab as all patients were prescribed the same treatment, and the aim of the study was not to separate the two factors.
Investigations Investigations - Other, Monocytes absolute increased	10.0% 1/10 • Number of events 1 • Adverse have been collected from baseline until death of the patient or end of the study (approximately 4 years and 7 months). Adverse events were collected weekly during the concurrent phase (up to 6 weeks after enrollment), then monthly during the consolidative phase (up to 1 year after beginning the consolidative phase). Then, adverse events were collected every 3 months until 2 years post concurrent treatment. After year 3, adverse events were collected every 6 months until end of study. Adverse events are not divided into arms for concurrent vs consolidative durvalumab as all patients were prescribed the same treatment, and the aim of the study was not to separate the two factors.
Investigations Investigations - Other, MPV decreased	10.0% 1/10 • Number of events 1 • Adverse have been collected from baseline until death of the patient or end of the study (approximately 4 years and 7 months). Adverse events were collected weekly during the concurrent phase (up to 6 weeks after enrollment), then monthly during the consolidative phase (up to 1 year after beginning the consolidative phase). Then, adverse events were collected every 3 months until 2 years post concurrent treatment. After year 3, adverse events were collected every 6 months until end of study. Adverse events are not divided into arms for concurrent vs consolidative durvalumab as all patients were prescribed the same treatment, and the aim of the study was not to separate the two factors.
Investigations Investigations - Other, platelet count increased	20.0% 2/10 • Number of events 2 • Adverse have been collected from baseline until death of the patient or end of the study (approximately 4 years and 7 months). Adverse events were collected weekly during the concurrent phase (up to 6 weeks after enrollment), then monthly during the consolidative phase (up to 1 year after beginning the consolidative phase). Then, adverse events were collected every 3 months until 2 years post concurrent treatment. After year 3, adverse events were collected every 6 months until end of study. Adverse events are not divided into arms for concurrent vs consolidative durvalumab as all patients were prescribed the same treatment, and the aim of the study was not to separate the two factors.
Investigations Investigations - Other, RDW-CV increased	10.0% 1/10 • Number of events 1 • Adverse have been collected from baseline until death of the patient or end of the study (approximately 4 years and 7 months). Adverse events were collected weekly during the concurrent phase (up to 6 weeks after enrollment), then monthly during the consolidative phase (up to 1 year after beginning the consolidative phase). Then, adverse events were collected every 3 months until 2 years post concurrent treatment. After year 3, adverse events were collected every 6 months until end of study. Adverse events are not divided into arms for concurrent vs consolidative durvalumab as all patients were prescribed the same treatment, and the aim of the study was not to separate the two factors.
Investigations Investigations - Other, Leukocyte count decreased	10.0% 1/10 • Number of events 1 • Adverse have been collected from baseline until death of the patient or end of the study (approximately 4 years and 7 months). Adverse events were collected weekly during the concurrent phase (up to 6 weeks after enrollment), then monthly during the consolidative phase (up to 1 year after beginning the consolidative phase). Then, adverse events were collected every 3 months until 2 years post concurrent treatment. After year 3, adverse events were collected every 6 months until end of study. Adverse events are not divided into arms for concurrent vs consolidative durvalumab as all patients were prescribed the same treatment, and the aim of the study was not to separate the two factors.
Investigations Lipase increased	30.0% 3/10 • Number of events 7 • Adverse have been collected from baseline until death of the patient or end of the study (approximately 4 years and 7 months). Adverse events were collected weekly during the concurrent phase (up to 6 weeks after enrollment), then monthly during the consolidative phase (up to 1 year after beginning the consolidative phase). Then, adverse events were collected every 3 months until 2 years post concurrent treatment. After year 3, adverse events were collected every 6 months until end of study. Adverse events are not divided into arms for concurrent vs consolidative durvalumab as all patients were prescribed the same treatment, and the aim of the study was not to separate the two factors.
Infections and infestations Lung infection	20.0% 2/10 • Number of events 2 • Adverse have been collected from baseline until death of the patient or end of the study (approximately 4 years and 7 months). Adverse events were collected weekly during the concurrent phase (up to 6 weeks after enrollment), then monthly during the consolidative phase (up to 1 year after beginning the consolidative phase). Then, adverse events were collected every 3 months until 2 years post concurrent treatment. After year 3, adverse events were collected every 6 months until end of study. Adverse events are not divided into arms for concurrent vs consolidative durvalumab as all patients were prescribed the same treatment, and the aim of the study was not to separate the two factors.
Investigations Lymphocyte count decreased	60.0% 6/10 • Number of events 17 • Adverse have been collected from baseline until death of the patient or end of the study (approximately 4 years and 7 months). Adverse events were collected weekly during the concurrent phase (up to 6 weeks after enrollment), then monthly during the consolidative phase (up to 1 year after beginning the consolidative phase). Then, adverse events were collected every 3 months until 2 years post concurrent treatment. After year 3, adverse events were collected every 6 months until end of study. Adverse events are not divided into arms for concurrent vs consolidative durvalumab as all patients were prescribed the same treatment, and the aim of the study was not to separate the two factors.
Metabolism and nutrition disorders Metabolism and nutrition disorders - Other, polydipsia	10.0% 1/10 • Number of events 1 • Adverse have been collected from baseline until death of the patient or end of the study (approximately 4 years and 7 months). Adverse events were collected weekly during the concurrent phase (up to 6 weeks after enrollment), then monthly during the consolidative phase (up to 1 year after beginning the consolidative phase). Then, adverse events were collected every 3 months until 2 years post concurrent treatment. After year 3, adverse events were collected every 6 months until end of study. Adverse events are not divided into arms for concurrent vs consolidative durvalumab as all patients were prescribed the same treatment, and the aim of the study was not to separate the two factors.
Gastrointestinal disorders Mouth sores	10.0% 1/10 • Number of events 1 • Adverse have been collected from baseline until death of the patient or end of the study (approximately 4 years and 7 months). Adverse events were collected weekly during the concurrent phase (up to 6 weeks after enrollment), then monthly during the consolidative phase (up to 1 year after beginning the consolidative phase). Then, adverse events were collected every 3 months until 2 years post concurrent treatment. After year 3, adverse events were collected every 6 months until end of study. Adverse events are not divided into arms for concurrent vs consolidative durvalumab as all patients were prescribed the same treatment, and the aim of the study was not to separate the two factors.
Gastrointestinal disorders Mucositis oral	10.0% 1/10 • Number of events 1 • Adverse have been collected from baseline until death of the patient or end of the study (approximately 4 years and 7 months). Adverse events were collected weekly during the concurrent phase (up to 6 weeks after enrollment), then monthly during the consolidative phase (up to 1 year after beginning the consolidative phase). Then, adverse events were collected every 3 months until 2 years post concurrent treatment. After year 3, adverse events were collected every 6 months until end of study. Adverse events are not divided into arms for concurrent vs consolidative durvalumab as all patients were prescribed the same treatment, and the aim of the study was not to separate the two factors.
Musculoskeletal and connective tissue disorders Muscle cramp	10.0% 1/10 • Number of events 1 • Adverse have been collected from baseline until death of the patient or end of the study (approximately 4 years and 7 months). Adverse events were collected weekly during the concurrent phase (up to 6 weeks after enrollment), then monthly during the consolidative phase (up to 1 year after beginning the consolidative phase). Then, adverse events were collected every 3 months until 2 years post concurrent treatment. After year 3, adverse events were collected every 6 months until end of study. Adverse events are not divided into arms for concurrent vs consolidative durvalumab as all patients were prescribed the same treatment, and the aim of the study was not to separate the two factors.
Musculoskeletal and connective tissue disorders Muscle weakness lower limb	10.0% 1/10 • Number of events 1 • Adverse have been collected from baseline until death of the patient or end of the study (approximately 4 years and 7 months). Adverse events were collected weekly during the concurrent phase (up to 6 weeks after enrollment), then monthly during the consolidative phase (up to 1 year after beginning the consolidative phase). Then, adverse events were collected every 3 months until 2 years post concurrent treatment. After year 3, adverse events were collected every 6 months until end of study. Adverse events are not divided into arms for concurrent vs consolidative durvalumab as all patients were prescribed the same treatment, and the aim of the study was not to separate the two factors.
Musculoskeletal and connective tissue disorders Myalgia	30.0% 3/10 • Number of events 3 • Adverse have been collected from baseline until death of the patient or end of the study (approximately 4 years and 7 months). Adverse events were collected weekly during the concurrent phase (up to 6 weeks after enrollment), then monthly during the consolidative phase (up to 1 year after beginning the consolidative phase). Then, adverse events were collected every 3 months until 2 years post concurrent treatment. After year 3, adverse events were collected every 6 months until end of study. Adverse events are not divided into arms for concurrent vs consolidative durvalumab as all patients were prescribed the same treatment, and the aim of the study was not to separate the two factors.
Respiratory, thoracic and mediastinal disorders Nasal congestion	20.0% 2/10 • Number of events 2 • Adverse have been collected from baseline until death of the patient or end of the study (approximately 4 years and 7 months). Adverse events were collected weekly during the concurrent phase (up to 6 weeks after enrollment), then monthly during the consolidative phase (up to 1 year after beginning the consolidative phase). Then, adverse events were collected every 3 months until 2 years post concurrent treatment. After year 3, adverse events were collected every 6 months until end of study. Adverse events are not divided into arms for concurrent vs consolidative durvalumab as all patients were prescribed the same treatment, and the aim of the study was not to separate the two factors.
Gastrointestinal disorders Nausea	40.0% 4/10 • Number of events 6 • Adverse have been collected from baseline until death of the patient or end of the study (approximately 4 years and 7 months). Adverse events were collected weekly during the concurrent phase (up to 6 weeks after enrollment), then monthly during the consolidative phase (up to 1 year after beginning the consolidative phase). Then, adverse events were collected every 3 months until 2 years post concurrent treatment. After year 3, adverse events were collected every 6 months until end of study. Adverse events are not divided into arms for concurrent vs consolidative durvalumab as all patients were prescribed the same treatment, and the aim of the study was not to separate the two factors.
Musculoskeletal and connective tissue disorders Neck pain	10.0% 1/10 • Number of events 1 • Adverse have been collected from baseline until death of the patient or end of the study (approximately 4 years and 7 months). Adverse events were collected weekly during the concurrent phase (up to 6 weeks after enrollment), then monthly during the consolidative phase (up to 1 year after beginning the consolidative phase). Then, adverse events were collected every 3 months until 2 years post concurrent treatment. After year 3, adverse events were collected every 6 months until end of study. Adverse events are not divided into arms for concurrent vs consolidative durvalumab as all patients were prescribed the same treatment, and the aim of the study was not to separate the two factors.
Investigations Neutrophil count decreased	20.0% 2/10 • Number of events 6 • Adverse have been collected from baseline until death of the patient or end of the study (approximately 4 years and 7 months). Adverse events were collected weekly during the concurrent phase (up to 6 weeks after enrollment), then monthly during the consolidative phase (up to 1 year after beginning the consolidative phase). Then, adverse events were collected every 3 months until 2 years post concurrent treatment. After year 3, adverse events were collected every 6 months until end of study. Adverse events are not divided into arms for concurrent vs consolidative durvalumab as all patients were prescribed the same treatment, and the aim of the study was not to separate the two factors.
General disorders Non-cardiac chest pain	50.0% 5/10 • Number of events 6 • Adverse have been collected from baseline until death of the patient or end of the study (approximately 4 years and 7 months). Adverse events were collected weekly during the concurrent phase (up to 6 weeks after enrollment), then monthly during the consolidative phase (up to 1 year after beginning the consolidative phase). Then, adverse events were collected every 3 months until 2 years post concurrent treatment. After year 3, adverse events were collected every 6 months until end of study. Adverse events are not divided into arms for concurrent vs consolidative durvalumab as all patients were prescribed the same treatment, and the aim of the study was not to separate the two factors.
Gastrointestinal disorders Oral gingivitis	10.0% 1/10 • Number of events 1 • Adverse have been collected from baseline until death of the patient or end of the study (approximately 4 years and 7 months). Adverse events were collected weekly during the concurrent phase (up to 6 weeks after enrollment), then monthly during the consolidative phase (up to 1 year after beginning the consolidative phase). Then, adverse events were collected every 3 months until 2 years post concurrent treatment. After year 3, adverse events were collected every 6 months until end of study. Adverse events are not divided into arms for concurrent vs consolidative durvalumab as all patients were prescribed the same treatment, and the aim of the study was not to separate the two factors.
General disorders Pain	30.0% 3/10 • Number of events 3 • Adverse have been collected from baseline until death of the patient or end of the study (approximately 4 years and 7 months). Adverse events were collected weekly during the concurrent phase (up to 6 weeks after enrollment), then monthly during the consolidative phase (up to 1 year after beginning the consolidative phase). Then, adverse events were collected every 3 months until 2 years post concurrent treatment. After year 3, adverse events were collected every 6 months until end of study. Adverse events are not divided into arms for concurrent vs consolidative durvalumab as all patients were prescribed the same treatment, and the aim of the study was not to separate the two factors.
Musculoskeletal and connective tissue disorders Pain in extremity	10.0% 1/10 • Number of events 1 • Adverse have been collected from baseline until death of the patient or end of the study (approximately 4 years and 7 months). Adverse events were collected weekly during the concurrent phase (up to 6 weeks after enrollment), then monthly during the consolidative phase (up to 1 year after beginning the consolidative phase). Then, adverse events were collected every 3 months until 2 years post concurrent treatment. After year 3, adverse events were collected every 6 months until end of study. Adverse events are not divided into arms for concurrent vs consolidative durvalumab as all patients were prescribed the same treatment, and the aim of the study was not to separate the two factors.
Nervous system disorders Paresthesia	20.0% 2/10 • Number of events 2 • Adverse have been collected from baseline until death of the patient or end of the study (approximately 4 years and 7 months). Adverse events were collected weekly during the concurrent phase (up to 6 weeks after enrollment), then monthly during the consolidative phase (up to 1 year after beginning the consolidative phase). Then, adverse events were collected every 3 months until 2 years post concurrent treatment. After year 3, adverse events were collected every 6 months until end of study. Adverse events are not divided into arms for concurrent vs consolidative durvalumab as all patients were prescribed the same treatment, and the aim of the study was not to separate the two factors.
Cardiac disorders Pericardial effusion	10.0% 1/10 • Number of events 1 • Adverse have been collected from baseline until death of the patient or end of the study (approximately 4 years and 7 months). Adverse events were collected weekly during the concurrent phase (up to 6 weeks after enrollment), then monthly during the consolidative phase (up to 1 year after beginning the consolidative phase). Then, adverse events were collected every 3 months until 2 years post concurrent treatment. After year 3, adverse events were collected every 6 months until end of study. Adverse events are not divided into arms for concurrent vs consolidative durvalumab as all patients were prescribed the same treatment, and the aim of the study was not to separate the two factors.
Investigations Platelet count decreased	10.0% 1/10 • Number of events 3 • Adverse have been collected from baseline until death of the patient or end of the study (approximately 4 years and 7 months). Adverse events were collected weekly during the concurrent phase (up to 6 weeks after enrollment), then monthly during the consolidative phase (up to 1 year after beginning the consolidative phase). Then, adverse events were collected every 3 months until 2 years post concurrent treatment. After year 3, adverse events were collected every 6 months until end of study. Adverse events are not divided into arms for concurrent vs consolidative durvalumab as all patients were prescribed the same treatment, and the aim of the study was not to separate the two factors.
Respiratory, thoracic and mediastinal disorders Pleural effusion	40.0% 4/10 • Number of events 4 • Adverse have been collected from baseline until death of the patient or end of the study (approximately 4 years and 7 months). Adverse events were collected weekly during the concurrent phase (up to 6 weeks after enrollment), then monthly during the consolidative phase (up to 1 year after beginning the consolidative phase). Then, adverse events were collected every 3 months until 2 years post concurrent treatment. After year 3, adverse events were collected every 6 months until end of study. Adverse events are not divided into arms for concurrent vs consolidative durvalumab as all patients were prescribed the same treatment, and the aim of the study was not to separate the two factors.
Respiratory, thoracic and mediastinal disorders Pneumonitis	20.0% 2/10 • Number of events 2 • Adverse have been collected from baseline until death of the patient or end of the study (approximately 4 years and 7 months). Adverse events were collected weekly during the concurrent phase (up to 6 weeks after enrollment), then monthly during the consolidative phase (up to 1 year after beginning the consolidative phase). Then, adverse events were collected every 3 months until 2 years post concurrent treatment. After year 3, adverse events were collected every 6 months until end of study. Adverse events are not divided into arms for concurrent vs consolidative durvalumab as all patients were prescribed the same treatment, and the aim of the study was not to separate the two factors.
Respiratory, thoracic and mediastinal disorders Postnasal drip	20.0% 2/10 • Number of events 2 • Adverse have been collected from baseline until death of the patient or end of the study (approximately 4 years and 7 months). Adverse events were collected weekly during the concurrent phase (up to 6 weeks after enrollment), then monthly during the consolidative phase (up to 1 year after beginning the consolidative phase). Then, adverse events were collected every 3 months until 2 years post concurrent treatment. After year 3, adverse events were collected every 6 months until end of study. Adverse events are not divided into arms for concurrent vs consolidative durvalumab as all patients were prescribed the same treatment, and the aim of the study was not to separate the two factors.
Nervous system disorders Presyncope	10.0% 1/10 • Number of events 1 • Adverse have been collected from baseline until death of the patient or end of the study (approximately 4 years and 7 months). Adverse events were collected weekly during the concurrent phase (up to 6 weeks after enrollment), then monthly during the consolidative phase (up to 1 year after beginning the consolidative phase). Then, adverse events were collected every 3 months until 2 years post concurrent treatment. After year 3, adverse events were collected every 6 months until end of study. Adverse events are not divided into arms for concurrent vs consolidative durvalumab as all patients were prescribed the same treatment, and the aim of the study was not to separate the two factors.
Respiratory, thoracic and mediastinal disorders Productive cough	50.0% 5/10 • Number of events 7 • Adverse have been collected from baseline until death of the patient or end of the study (approximately 4 years and 7 months). Adverse events were collected weekly during the concurrent phase (up to 6 weeks after enrollment), then monthly during the consolidative phase (up to 1 year after beginning the consolidative phase). Then, adverse events were collected every 3 months until 2 years post concurrent treatment. After year 3, adverse events were collected every 6 months until end of study. Adverse events are not divided into arms for concurrent vs consolidative durvalumab as all patients were prescribed the same treatment, and the aim of the study was not to separate the two factors.
Skin and subcutaneous tissue disorders Pruritus	20.0% 2/10 • Number of events 2 • Adverse have been collected from baseline until death of the patient or end of the study (approximately 4 years and 7 months). Adverse events were collected weekly during the concurrent phase (up to 6 weeks after enrollment), then monthly during the consolidative phase (up to 1 year after beginning the consolidative phase). Then, adverse events were collected every 3 months until 2 years post concurrent treatment. After year 3, adverse events were collected every 6 months until end of study. Adverse events are not divided into arms for concurrent vs consolidative durvalumab as all patients were prescribed the same treatment, and the aim of the study was not to separate the two factors.
Respiratory, thoracic and mediastinal disorders Pulmonary fibrosis	20.0% 2/10 • Number of events 2 • Adverse have been collected from baseline until death of the patient or end of the study (approximately 4 years and 7 months). Adverse events were collected weekly during the concurrent phase (up to 6 weeks after enrollment), then monthly during the consolidative phase (up to 1 year after beginning the consolidative phase). Then, adverse events were collected every 3 months until 2 years post concurrent treatment. After year 3, adverse events were collected every 6 months until end of study. Adverse events are not divided into arms for concurrent vs consolidative durvalumab as all patients were prescribed the same treatment, and the aim of the study was not to separate the two factors.
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders - Other, Emphysema	20.0% 2/10 • Number of events 2 • Adverse have been collected from baseline until death of the patient or end of the study (approximately 4 years and 7 months). Adverse events were collected weekly during the concurrent phase (up to 6 weeks after enrollment), then monthly during the consolidative phase (up to 1 year after beginning the consolidative phase). Then, adverse events were collected every 3 months until 2 years post concurrent treatment. After year 3, adverse events were collected every 6 months until end of study. Adverse events are not divided into arms for concurrent vs consolidative durvalumab as all patients were prescribed the same treatment, and the aim of the study was not to separate the two factors.
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders - Other, development of new lung nodules	10.0% 1/10 • Number of events 1 • Adverse have been collected from baseline until death of the patient or end of the study (approximately 4 years and 7 months). Adverse events were collected weekly during the concurrent phase (up to 6 weeks after enrollment), then monthly during the consolidative phase (up to 1 year after beginning the consolidative phase). Then, adverse events were collected every 3 months until 2 years post concurrent treatment. After year 3, adverse events were collected every 6 months until end of study. Adverse events are not divided into arms for concurrent vs consolidative durvalumab as all patients were prescribed the same treatment, and the aim of the study was not to separate the two factors.
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders - Other, seasonal allergies	10.0% 1/10 • Number of events 1 • Adverse have been collected from baseline until death of the patient or end of the study (approximately 4 years and 7 months). Adverse events were collected weekly during the concurrent phase (up to 6 weeks after enrollment), then monthly during the consolidative phase (up to 1 year after beginning the consolidative phase). Then, adverse events were collected every 3 months until 2 years post concurrent treatment. After year 3, adverse events were collected every 6 months until end of study. Adverse events are not divided into arms for concurrent vs consolidative durvalumab as all patients were prescribed the same treatment, and the aim of the study was not to separate the two factors.
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders - Other, hemoptysis	10.0% 1/10 • Number of events 1 • Adverse have been collected from baseline until death of the patient or end of the study (approximately 4 years and 7 months). Adverse events were collected weekly during the concurrent phase (up to 6 weeks after enrollment), then monthly during the consolidative phase (up to 1 year after beginning the consolidative phase). Then, adverse events were collected every 3 months until 2 years post concurrent treatment. After year 3, adverse events were collected every 6 months until end of study. Adverse events are not divided into arms for concurrent vs consolidative durvalumab as all patients were prescribed the same treatment, and the aim of the study was not to separate the two factors.
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders - Other, right upper lobe consolidation and traction	10.0% 1/10 • Number of events 1 • Adverse have been collected from baseline until death of the patient or end of the study (approximately 4 years and 7 months). Adverse events were collected weekly during the concurrent phase (up to 6 weeks after enrollment), then monthly during the consolidative phase (up to 1 year after beginning the consolidative phase). Then, adverse events were collected every 3 months until 2 years post concurrent treatment. After year 3, adverse events were collected every 6 months until end of study. Adverse events are not divided into arms for concurrent vs consolidative durvalumab as all patients were prescribed the same treatment, and the aim of the study was not to separate the two factors.
Infections and infestations Sepsis	10.0% 1/10 • Number of events 1 • Adverse have been collected from baseline until death of the patient or end of the study (approximately 4 years and 7 months). Adverse events were collected weekly during the concurrent phase (up to 6 weeks after enrollment), then monthly during the consolidative phase (up to 1 year after beginning the consolidative phase). Then, adverse events were collected every 3 months until 2 years post concurrent treatment. After year 3, adverse events were collected every 6 months until end of study. Adverse events are not divided into arms for concurrent vs consolidative durvalumab as all patients were prescribed the same treatment, and the aim of the study was not to separate the two factors.
Investigations Serum amylase increased	30.0% 3/10 • Number of events 5 • Adverse have been collected from baseline until death of the patient or end of the study (approximately 4 years and 7 months). Adverse events were collected weekly during the concurrent phase (up to 6 weeks after enrollment), then monthly during the consolidative phase (up to 1 year after beginning the consolidative phase). Then, adverse events were collected every 3 months until 2 years post concurrent treatment. After year 3, adverse events were collected every 6 months until end of study. Adverse events are not divided into arms for concurrent vs consolidative durvalumab as all patients were prescribed the same treatment, and the aim of the study was not to separate the two factors.
Infections and infestations Shingles	10.0% 1/10 • Number of events 1 • Adverse have been collected from baseline until death of the patient or end of the study (approximately 4 years and 7 months). Adverse events were collected weekly during the concurrent phase (up to 6 weeks after enrollment), then monthly during the consolidative phase (up to 1 year after beginning the consolidative phase). Then, adverse events were collected every 3 months until 2 years post concurrent treatment. After year 3, adverse events were collected every 6 months until end of study. Adverse events are not divided into arms for concurrent vs consolidative durvalumab as all patients were prescribed the same treatment, and the aim of the study was not to separate the two factors.
Cardiac disorders Sinus tachycardia	20.0% 2/10 • Number of events 2 • Adverse have been collected from baseline until death of the patient or end of the study (approximately 4 years and 7 months). Adverse events were collected weekly during the concurrent phase (up to 6 weeks after enrollment), then monthly during the consolidative phase (up to 1 year after beginning the consolidative phase). Then, adverse events were collected every 3 months until 2 years post concurrent treatment. After year 3, adverse events were collected every 6 months until end of study. Adverse events are not divided into arms for concurrent vs consolidative durvalumab as all patients were prescribed the same treatment, and the aim of the study was not to separate the two factors.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, change in mole	10.0% 1/10 • Number of events 1 • Adverse have been collected from baseline until death of the patient or end of the study (approximately 4 years and 7 months). Adverse events were collected weekly during the concurrent phase (up to 6 weeks after enrollment), then monthly during the consolidative phase (up to 1 year after beginning the consolidative phase). Then, adverse events were collected every 3 months until 2 years post concurrent treatment. After year 3, adverse events were collected every 6 months until end of study. Adverse events are not divided into arms for concurrent vs consolidative durvalumab as all patients were prescribed the same treatment, and the aim of the study was not to separate the two factors.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, oily and clammy skin	10.0% 1/10 • Number of events 1 • Adverse have been collected from baseline until death of the patient or end of the study (approximately 4 years and 7 months). Adverse events were collected weekly during the concurrent phase (up to 6 weeks after enrollment), then monthly during the consolidative phase (up to 1 year after beginning the consolidative phase). Then, adverse events were collected every 3 months until 2 years post concurrent treatment. After year 3, adverse events were collected every 6 months until end of study. Adverse events are not divided into arms for concurrent vs consolidative durvalumab as all patients were prescribed the same treatment, and the aim of the study was not to separate the two factors.
Social circumstances Social circumstances - Other, food insecurity	10.0% 1/10 • Number of events 1 • Adverse have been collected from baseline until death of the patient or end of the study (approximately 4 years and 7 months). Adverse events were collected weekly during the concurrent phase (up to 6 weeks after enrollment), then monthly during the consolidative phase (up to 1 year after beginning the consolidative phase). Then, adverse events were collected every 3 months until 2 years post concurrent treatment. After year 3, adverse events were collected every 6 months until end of study. Adverse events are not divided into arms for concurrent vs consolidative durvalumab as all patients were prescribed the same treatment, and the aim of the study was not to separate the two factors.
Nervous system disorders Somnolence	10.0% 1/10 • Number of events 1 • Adverse have been collected from baseline until death of the patient or end of the study (approximately 4 years and 7 months). Adverse events were collected weekly during the concurrent phase (up to 6 weeks after enrollment), then monthly during the consolidative phase (up to 1 year after beginning the consolidative phase). Then, adverse events were collected every 3 months until 2 years post concurrent treatment. After year 3, adverse events were collected every 6 months until end of study. Adverse events are not divided into arms for concurrent vs consolidative durvalumab as all patients were prescribed the same treatment, and the aim of the study was not to separate the two factors.
Respiratory, thoracic and mediastinal disorders Sore throat	30.0% 3/10 • Number of events 3 • Adverse have been collected from baseline until death of the patient or end of the study (approximately 4 years and 7 months). Adverse events were collected weekly during the concurrent phase (up to 6 weeks after enrollment), then monthly during the consolidative phase (up to 1 year after beginning the consolidative phase). Then, adverse events were collected every 3 months until 2 years post concurrent treatment. After year 3, adverse events were collected every 6 months until end of study. Adverse events are not divided into arms for concurrent vs consolidative durvalumab as all patients were prescribed the same treatment, and the aim of the study was not to separate the two factors.
Surgical and medical procedures Surgical and medical procedures - Other, chronic draining scrotal abscess	10.0% 1/10 • Number of events 1 • Adverse have been collected from baseline until death of the patient or end of the study (approximately 4 years and 7 months). Adverse events were collected weekly during the concurrent phase (up to 6 weeks after enrollment), then monthly during the consolidative phase (up to 1 year after beginning the consolidative phase). Then, adverse events were collected every 3 months until 2 years post concurrent treatment. After year 3, adverse events were collected every 6 months until end of study. Adverse events are not divided into arms for concurrent vs consolidative durvalumab as all patients were prescribed the same treatment, and the aim of the study was not to separate the two factors.
Vascular disorders Thromboembolic event	10.0% 1/10 • Number of events 1 • Adverse have been collected from baseline until death of the patient or end of the study (approximately 4 years and 7 months). Adverse events were collected weekly during the concurrent phase (up to 6 weeks after enrollment), then monthly during the consolidative phase (up to 1 year after beginning the consolidative phase). Then, adverse events were collected every 3 months until 2 years post concurrent treatment. After year 3, adverse events were collected every 6 months until end of study. Adverse events are not divided into arms for concurrent vs consolidative durvalumab as all patients were prescribed the same treatment, and the aim of the study was not to separate the two factors.
Investigations Thyroid stimulating hormone increased	20.0% 2/10 • Number of events 2 • Adverse have been collected from baseline until death of the patient or end of the study (approximately 4 years and 7 months). Adverse events were collected weekly during the concurrent phase (up to 6 weeks after enrollment), then monthly during the consolidative phase (up to 1 year after beginning the consolidative phase). Then, adverse events were collected every 3 months until 2 years post concurrent treatment. After year 3, adverse events were collected every 6 months until end of study. Adverse events are not divided into arms for concurrent vs consolidative durvalumab as all patients were prescribed the same treatment, and the aim of the study was not to separate the two factors.
Ear and labyrinth disorders Tinnitus	10.0% 1/10 • Number of events 1 • Adverse have been collected from baseline until death of the patient or end of the study (approximately 4 years and 7 months). Adverse events were collected weekly during the concurrent phase (up to 6 weeks after enrollment), then monthly during the consolidative phase (up to 1 year after beginning the consolidative phase). Then, adverse events were collected every 3 months until 2 years post concurrent treatment. After year 3, adverse events were collected every 6 months until end of study. Adverse events are not divided into arms for concurrent vs consolidative durvalumab as all patients were prescribed the same treatment, and the aim of the study was not to separate the two factors.
Surgical and medical procedures Tooth extraction	10.0% 1/10 • Number of events 1 • Adverse have been collected from baseline until death of the patient or end of the study (approximately 4 years and 7 months). Adverse events were collected weekly during the concurrent phase (up to 6 weeks after enrollment), then monthly during the consolidative phase (up to 1 year after beginning the consolidative phase). Then, adverse events were collected every 3 months until 2 years post concurrent treatment. After year 3, adverse events were collected every 6 months until end of study. Adverse events are not divided into arms for concurrent vs consolidative durvalumab as all patients were prescribed the same treatment, and the aim of the study was not to separate the two factors.
Renal and urinary disorders Urinary frequency	10.0% 1/10 • Number of events 1 • Adverse have been collected from baseline until death of the patient or end of the study (approximately 4 years and 7 months). Adverse events were collected weekly during the concurrent phase (up to 6 weeks after enrollment), then monthly during the consolidative phase (up to 1 year after beginning the consolidative phase). Then, adverse events were collected every 3 months until 2 years post concurrent treatment. After year 3, adverse events were collected every 6 months until end of study. Adverse events are not divided into arms for concurrent vs consolidative durvalumab as all patients were prescribed the same treatment, and the aim of the study was not to separate the two factors.
Infections and infestations Urinary tract infection	10.0% 1/10 • Number of events 1 • Adverse have been collected from baseline until death of the patient or end of the study (approximately 4 years and 7 months). Adverse events were collected weekly during the concurrent phase (up to 6 weeks after enrollment), then monthly during the consolidative phase (up to 1 year after beginning the consolidative phase). Then, adverse events were collected every 3 months until 2 years post concurrent treatment. After year 3, adverse events were collected every 6 months until end of study. Adverse events are not divided into arms for concurrent vs consolidative durvalumab as all patients were prescribed the same treatment, and the aim of the study was not to separate the two factors.
Renal and urinary disorders Urinary urgency	10.0% 1/10 • Number of events 1 • Adverse have been collected from baseline until death of the patient or end of the study (approximately 4 years and 7 months). Adverse events were collected weekly during the concurrent phase (up to 6 weeks after enrollment), then monthly during the consolidative phase (up to 1 year after beginning the consolidative phase). Then, adverse events were collected every 3 months until 2 years post concurrent treatment. After year 3, adverse events were collected every 6 months until end of study. Adverse events are not divided into arms for concurrent vs consolidative durvalumab as all patients were prescribed the same treatment, and the aim of the study was not to separate the two factors.
Ear and labyrinth disorders Vestibular disorder	10.0% 1/10 • Number of events 1 • Adverse have been collected from baseline until death of the patient or end of the study (approximately 4 years and 7 months). Adverse events were collected weekly during the concurrent phase (up to 6 weeks after enrollment), then monthly during the consolidative phase (up to 1 year after beginning the consolidative phase). Then, adverse events were collected every 3 months until 2 years post concurrent treatment. After year 3, adverse events were collected every 6 months until end of study. Adverse events are not divided into arms for concurrent vs consolidative durvalumab as all patients were prescribed the same treatment, and the aim of the study was not to separate the two factors.
Gastrointestinal disorders Vomiting	20.0% 2/10 • Number of events 2 • Adverse have been collected from baseline until death of the patient or end of the study (approximately 4 years and 7 months). Adverse events were collected weekly during the concurrent phase (up to 6 weeks after enrollment), then monthly during the consolidative phase (up to 1 year after beginning the consolidative phase). Then, adverse events were collected every 3 months until 2 years post concurrent treatment. After year 3, adverse events were collected every 6 months until end of study. Adverse events are not divided into arms for concurrent vs consolidative durvalumab as all patients were prescribed the same treatment, and the aim of the study was not to separate the two factors.
Investigations Weight gain	10.0% 1/10 • Number of events 1 • Adverse have been collected from baseline until death of the patient or end of the study (approximately 4 years and 7 months). Adverse events were collected weekly during the concurrent phase (up to 6 weeks after enrollment), then monthly during the consolidative phase (up to 1 year after beginning the consolidative phase). Then, adverse events were collected every 3 months until 2 years post concurrent treatment. After year 3, adverse events were collected every 6 months until end of study. Adverse events are not divided into arms for concurrent vs consolidative durvalumab as all patients were prescribed the same treatment, and the aim of the study was not to separate the two factors.
Investigations Weight loss	80.0% 8/10 • Number of events 15 • Adverse have been collected from baseline until death of the patient or end of the study (approximately 4 years and 7 months). Adverse events were collected weekly during the concurrent phase (up to 6 weeks after enrollment), then monthly during the consolidative phase (up to 1 year after beginning the consolidative phase). Then, adverse events were collected every 3 months until 2 years post concurrent treatment. After year 3, adverse events were collected every 6 months until end of study. Adverse events are not divided into arms for concurrent vs consolidative durvalumab as all patients were prescribed the same treatment, and the aim of the study was not to separate the two factors.
Respiratory, thoracic and mediastinal disorders Wheezing	50.0% 5/10 • Number of events 5 • Adverse have been collected from baseline until death of the patient or end of the study (approximately 4 years and 7 months). Adverse events were collected weekly during the concurrent phase (up to 6 weeks after enrollment), then monthly during the consolidative phase (up to 1 year after beginning the consolidative phase). Then, adverse events were collected every 3 months until 2 years post concurrent treatment. After year 3, adverse events were collected every 6 months until end of study. Adverse events are not divided into arms for concurrent vs consolidative durvalumab as all patients were prescribed the same treatment, and the aim of the study was not to separate the two factors.
Investigations White blood cell decreased	30.0% 3/10 • Number of events 5 • Adverse have been collected from baseline until death of the patient or end of the study (approximately 4 years and 7 months). Adverse events were collected weekly during the concurrent phase (up to 6 weeks after enrollment), then monthly during the consolidative phase (up to 1 year after beginning the consolidative phase). Then, adverse events were collected every 3 months until 2 years post concurrent treatment. After year 3, adverse events were collected every 6 months until end of study. Adverse events are not divided into arms for concurrent vs consolidative durvalumab as all patients were prescribed the same treatment, and the aim of the study was not to separate the two factors.

Additional Information

Dr. Yuanyuan Zhang

University of Texas Southwestern Medical Center

Phone: 2146458525

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place