Trial Outcomes & Findings for A Study of Durvalumab (MEDI4736) in Esophageal Cancer (NCT NCT02639065)

Last Updated: 2023-09-25

Results Overview

Relapse free survival is defined as time from the date of surgery until the criteria for disease relapse is met, per Response Evaluation Criteria In Solid Tumors (RECIST 1.1), or death occurs. Complete Response (CR): Disappearance of all target lesions Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started The percentage of subjects who attained relapse free survival for 1 year and 95 % confidence interval has been reported here.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

39 participants

Primary outcome timeframe

From the date of surgery until disease relapse or death up to a maximum of 40 months.

Results posted on

2023-09-25

Participant Flow

Participant milestones

Participant milestones
Measure	Investigational Treatment Durvalumab 1500 mg IV every 4 weeks (1 cycle) for a maximum 13 doses (12 months), or until unacceptable toxicities or disease recurrence.
Study Treatment STARTED	39
Study Treatment COMPLETED	16
Study Treatment NOT COMPLETED	23
Follow up STARTED	39
Follow up COMPLETED	30
Follow up NOT COMPLETED	9

Reasons for withdrawal

Reasons for withdrawal
Measure	Investigational Treatment Durvalumab 1500 mg IV every 4 weeks (1 cycle) for a maximum 13 doses (12 months), or until unacceptable toxicities or disease recurrence.
Study Treatment Disease Progression	13
Study Treatment Adverse Event	9
Study Treatment Withdrawal by Subject	1
Follow up Subject refused to follow up	1
Follow up Symptomatic Deterioration	2
Follow up Death	2
Follow up Study Terminated	1
Follow up Disease Progression	3

Baseline Characteristics

A Study of Durvalumab (MEDI4736) in Esophageal Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Investigational Treatment n=37 Participants Durvalumab 1500 mg IV every 4 weeks (1 cycle) for a maximum 13 doses (12 months), or until unacceptable toxicities or disease recurrence.
Age, Customized	61 years n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	36 Participants n=5 Participants
Race/Ethnicity, Customized Race · White	37 Participants n=5 Participants
Race/Ethnicity, Customized Race · Unknown	0 Participants n=5 Participants
Race/Ethnicity, Customized Ethnicity · Hispanic or Latino	1 Participants n=5 Participants
Race/Ethnicity, Customized Ethnicity · Non-Hispanic	35 Participants n=5 Participants
Race/Ethnicity, Customized Ethnicity · Unknown	1 Participants n=5 Participants
Site Indiana University	25 Participants n=5 Participants
Site University of Iowa	5 Participants n=5 Participants
Site University of Michigan	7 Participants n=5 Participants
Site of Disease Gastroesophageal Junction	18 Participants n=5 Participants
Site of Disease Distal Esophagus	19 Participants n=5 Participants
Chemotherapy Regimen Cisplatin + 5FU	6 Participants n=5 Participants
Chemotherapy Regimen Carboplatin + paclitaxel	31 Participants n=5 Participants

PRIMARY outcome

Timeframe: From the date of surgery until disease relapse or death up to a maximum of 40 months.

Outcome measures

Outcome measures
Measure	Investigational Treatment n=37 Participants Durvalumab 1500 mg IV every 4 weeks (1 cycle) for a maximum 13 doses (12 months), or until unacceptable toxicities or disease recurrence.
Percentage of Participants With One-Year Relapse Free Survival (RFS) With Post-Operative Durvalumab	73 percentage of subjects Interval 56.0 to 84.0

SECONDARY outcome

Timeframe: From the time of consent until 90 days after last dose of durvalumab up to a maximum of 15 months.

One of the secondary objective in this study is to assess toxicity and tolerability of durvalumab following trimodality therapy in patients with esophageal cancer. Adverse events were recorded from the time of consent for at least 90 days after treatment discontinuation, per Common Terminology Criteria for Adverse Events (CTCAE) v4. Events were assessed at every visit at an interval of 4 weeks. Adverse Event severity grades can be described as follows : * Grade 1 indicates a mild event * Grade 2 indicates a moderate event * Grade 3 indicates a severe event * Grade 4 indicates a potentially life-threatening event * Grade 5 indicates death

Outcome measures

Outcome measures
Measure	Investigational Treatment n=37 Participants Durvalumab 1500 mg IV every 4 weeks (1 cycle) for a maximum 13 doses (12 months), or until unacceptable toxicities or disease recurrence.
Number of Patients With Adverse Events as a Measure of Safety and Tolerability Patient had at least one grade 3 or greater treatment related adverse event	10 Participants
Number of Patients With Adverse Events as a Measure of Safety and Tolerability Patient had at least one adverse event of any grade	37 Participants
Number of Patients With Adverse Events as a Measure of Safety and Tolerability Patient had at least one grade 3 or greater adverse event	22 Participants
Number of Patients With Adverse Events as a Measure of Safety and Tolerability Patient having serious adverse event	9 Participants

POST_HOC outcome

Timeframe: From the date of surgery until disease relapse or death up to a maximum of 40 months.

Relapse free survival is defined as time from the date of surgery until the criteria for disease relapse is met, per Response Evaluation Criteria In Solid Tumors (RECIST 1.1), or death occurs. Complete Response (CR): Disappearance of all target lesions Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started Here Median Relapse Free Survival time in months has been reported.

Outcome measures

Outcome measures
Measure	Investigational Treatment n=37 Participants Durvalumab 1500 mg IV every 4 weeks (1 cycle) for a maximum 13 doses (12 months), or until unacceptable toxicities or disease recurrence.
Median Relapse Free Survival.	21.0 months Interval 14.0 to 40.4

Adverse Events

Investigational Treatment

Serious events: 9 serious events

Other events: 37 other events

Deaths: 2 deaths

Serious adverse events

Serious adverse events
Measure	Investigational Treatment n=37 participants at risk Durvalumab 1500 mg IV every 4 weeks (1 cycle) for a maximum 13 doses (12 months), or until unacceptable toxicities or disease recurrence.
Gastrointestinal disorders ABDOMINAL PAIN	2.7% 1/37 • Number of events 1 • Adverse events were recorded from the time of consent until 90 days after last dose of durvalumab up to a maximum of 15 months. Adverse events were recorded from the time of consent for at least 90 days after treatment discontinuation, per Common Terminology Criteria for Adverse Events (CTCAE) v4. Events were assessed at every visit at an interval of 4 weeks.
Investigations ASPARTATE AMINOTRANSFERASE INCREASED	5.4% 2/37 • Number of events 2 • Adverse events were recorded from the time of consent until 90 days after last dose of durvalumab up to a maximum of 15 months. Adverse events were recorded from the time of consent for at least 90 days after treatment discontinuation, per Common Terminology Criteria for Adverse Events (CTCAE) v4. Events were assessed at every visit at an interval of 4 weeks.
Nervous system disorders ENCEPHALOPATHY	2.7% 1/37 • Number of events 2 • Adverse events were recorded from the time of consent until 90 days after last dose of durvalumab up to a maximum of 15 months. Adverse events were recorded from the time of consent for at least 90 days after treatment discontinuation, per Common Terminology Criteria for Adverse Events (CTCAE) v4. Events were assessed at every visit at an interval of 4 weeks.
Renal and urinary disorders HEMATURIA	2.7% 1/37 • Number of events 1 • Adverse events were recorded from the time of consent until 90 days after last dose of durvalumab up to a maximum of 15 months. Adverse events were recorded from the time of consent for at least 90 days after treatment discontinuation, per Common Terminology Criteria for Adverse Events (CTCAE) v4. Events were assessed at every visit at an interval of 4 weeks.
Respiratory, thoracic and mediastinal disorders HYPOXIA	2.7% 1/37 • Number of events 1 • Adverse events were recorded from the time of consent until 90 days after last dose of durvalumab up to a maximum of 15 months. Adverse events were recorded from the time of consent for at least 90 days after treatment discontinuation, per Common Terminology Criteria for Adverse Events (CTCAE) v4. Events were assessed at every visit at an interval of 4 weeks.
Infections and infestations LUNG INFECTION	5.4% 2/37 • Number of events 3 • Adverse events were recorded from the time of consent until 90 days after last dose of durvalumab up to a maximum of 15 months. Adverse events were recorded from the time of consent for at least 90 days after treatment discontinuation, per Common Terminology Criteria for Adverse Events (CTCAE) v4. Events were assessed at every visit at an interval of 4 weeks.
Respiratory, thoracic and mediastinal disorders PNEUMONITIS	5.4% 2/37 • Number of events 2 • Adverse events were recorded from the time of consent until 90 days after last dose of durvalumab up to a maximum of 15 months. Adverse events were recorded from the time of consent for at least 90 days after treatment discontinuation, per Common Terminology Criteria for Adverse Events (CTCAE) v4. Events were assessed at every visit at an interval of 4 weeks.
Psychiatric disorders PSYCHIATRIC DISORDERS - OTHER, SPECIFY	2.7% 1/37 • Number of events 1 • Adverse events were recorded from the time of consent until 90 days after last dose of durvalumab up to a maximum of 15 months. Adverse events were recorded from the time of consent for at least 90 days after treatment discontinuation, per Common Terminology Criteria for Adverse Events (CTCAE) v4. Events were assessed at every visit at an interval of 4 weeks.
Nervous system disorders SYNCOPE	2.7% 1/37 • Number of events 1 • Adverse events were recorded from the time of consent until 90 days after last dose of durvalumab up to a maximum of 15 months. Adverse events were recorded from the time of consent for at least 90 days after treatment discontinuation, per Common Terminology Criteria for Adverse Events (CTCAE) v4. Events were assessed at every visit at an interval of 4 weeks.

Other adverse events

Other adverse events
Measure	Investigational Treatment n=37 participants at risk Durvalumab 1500 mg IV every 4 weeks (1 cycle) for a maximum 13 doses (12 months), or until unacceptable toxicities or disease recurrence.
Infections and infestations ABDOMINAL INFECTION	2.7% 1/37 • Number of events 2 • Adverse events were recorded from the time of consent until 90 days after last dose of durvalumab up to a maximum of 15 months. Adverse events were recorded from the time of consent for at least 90 days after treatment discontinuation, per Common Terminology Criteria for Adverse Events (CTCAE) v4. Events were assessed at every visit at an interval of 4 weeks.
Gastrointestinal disorders ABDOMINAL PAIN	16.2% 6/37 • Number of events 7 • Adverse events were recorded from the time of consent until 90 days after last dose of durvalumab up to a maximum of 15 months. Adverse events were recorded from the time of consent for at least 90 days after treatment discontinuation, per Common Terminology Criteria for Adverse Events (CTCAE) v4. Events were assessed at every visit at an interval of 4 weeks.
Cardiac disorders ACUTE CORONARY SYNDROME	2.7% 1/37 • Number of events 1 • Adverse events were recorded from the time of consent until 90 days after last dose of durvalumab up to a maximum of 15 months. Adverse events were recorded from the time of consent for at least 90 days after treatment discontinuation, per Common Terminology Criteria for Adverse Events (CTCAE) v4. Events were assessed at every visit at an interval of 4 weeks.
Renal and urinary disorders ACUTE KIDNEY INJURY	5.4% 2/37 • Number of events 2 • Adverse events were recorded from the time of consent until 90 days after last dose of durvalumab up to a maximum of 15 months. Adverse events were recorded from the time of consent for at least 90 days after treatment discontinuation, per Common Terminology Criteria for Adverse Events (CTCAE) v4. Events were assessed at every visit at an interval of 4 weeks.
Investigations ALANINE AMINOTRANSFERASE INCREASED	13.5% 5/37 • Number of events 10 • Adverse events were recorded from the time of consent until 90 days after last dose of durvalumab up to a maximum of 15 months. Adverse events were recorded from the time of consent for at least 90 days after treatment discontinuation, per Common Terminology Criteria for Adverse Events (CTCAE) v4. Events were assessed at every visit at an interval of 4 weeks.
Investigations ALKALINE PHOSPHATASE INCREASED	8.1% 3/37 • Number of events 4 • Adverse events were recorded from the time of consent until 90 days after last dose of durvalumab up to a maximum of 15 months. Adverse events were recorded from the time of consent for at least 90 days after treatment discontinuation, per Common Terminology Criteria for Adverse Events (CTCAE) v4. Events were assessed at every visit at an interval of 4 weeks.
Respiratory, thoracic and mediastinal disorders ALLERGIC RHINITIS	5.4% 2/37 • Number of events 2 • Adverse events were recorded from the time of consent until 90 days after last dose of durvalumab up to a maximum of 15 months. Adverse events were recorded from the time of consent for at least 90 days after treatment discontinuation, per Common Terminology Criteria for Adverse Events (CTCAE) v4. Events were assessed at every visit at an interval of 4 weeks.
Blood and lymphatic system disorders ANEMIA	18.9% 7/37 • Number of events 11 • Adverse events were recorded from the time of consent until 90 days after last dose of durvalumab up to a maximum of 15 months. Adverse events were recorded from the time of consent for at least 90 days after treatment discontinuation, per Common Terminology Criteria for Adverse Events (CTCAE) v4. Events were assessed at every visit at an interval of 4 weeks.
Metabolism and nutrition disorders ANOREXIA	21.6% 8/37 • Number of events 9 • Adverse events were recorded from the time of consent until 90 days after last dose of durvalumab up to a maximum of 15 months. Adverse events were recorded from the time of consent for at least 90 days after treatment discontinuation, per Common Terminology Criteria for Adverse Events (CTCAE) v4. Events were assessed at every visit at an interval of 4 weeks.
Psychiatric disorders ANXIETY	10.8% 4/37 • Number of events 4 • Adverse events were recorded from the time of consent until 90 days after last dose of durvalumab up to a maximum of 15 months. Adverse events were recorded from the time of consent for at least 90 days after treatment discontinuation, per Common Terminology Criteria for Adverse Events (CTCAE) v4. Events were assessed at every visit at an interval of 4 weeks.
Musculoskeletal and connective tissue disorders ARTHRALGIA	24.3% 9/37 • Number of events 16 • Adverse events were recorded from the time of consent until 90 days after last dose of durvalumab up to a maximum of 15 months. Adverse events were recorded from the time of consent for at least 90 days after treatment discontinuation, per Common Terminology Criteria for Adverse Events (CTCAE) v4. Events were assessed at every visit at an interval of 4 weeks.
Musculoskeletal and connective tissue disorders ARTHRITIS	2.7% 1/37 • Number of events 1 • Adverse events were recorded from the time of consent until 90 days after last dose of durvalumab up to a maximum of 15 months. Adverse events were recorded from the time of consent for at least 90 days after treatment discontinuation, per Common Terminology Criteria for Adverse Events (CTCAE) v4. Events were assessed at every visit at an interval of 4 weeks.
Investigations ASPARTATE AMINOTRANSFERASE INCREASED	16.2% 6/37 • Number of events 16 • Adverse events were recorded from the time of consent until 90 days after last dose of durvalumab up to a maximum of 15 months. Adverse events were recorded from the time of consent for at least 90 days after treatment discontinuation, per Common Terminology Criteria for Adverse Events (CTCAE) v4. Events were assessed at every visit at an interval of 4 weeks.
Cardiac disorders ATRIAL FIBRILLATION	2.7% 1/37 • Number of events 1 • Adverse events were recorded from the time of consent until 90 days after last dose of durvalumab up to a maximum of 15 months. Adverse events were recorded from the time of consent for at least 90 days after treatment discontinuation, per Common Terminology Criteria for Adverse Events (CTCAE) v4. Events were assessed at every visit at an interval of 4 weeks.
Musculoskeletal and connective tissue disorders BACK PAIN	10.8% 4/37 • Number of events 8 • Adverse events were recorded from the time of consent until 90 days after last dose of durvalumab up to a maximum of 15 months. Adverse events were recorded from the time of consent for at least 90 days after treatment discontinuation, per Common Terminology Criteria for Adverse Events (CTCAE) v4. Events were assessed at every visit at an interval of 4 weeks.
Blood and lymphatic system disorders BLOOD AND LYMPHATIC SYSTEM DISORDERS	2.7% 1/37 • Number of events 1 • Adverse events were recorded from the time of consent until 90 days after last dose of durvalumab up to a maximum of 15 months. Adverse events were recorded from the time of consent for at least 90 days after treatment discontinuation, per Common Terminology Criteria for Adverse Events (CTCAE) v4. Events were assessed at every visit at an interval of 4 weeks.
Investigations BLOOD BILIRUBIN INCREASED	8.1% 3/37 • Number of events 8 • Adverse events were recorded from the time of consent until 90 days after last dose of durvalumab up to a maximum of 15 months. Adverse events were recorded from the time of consent for at least 90 days after treatment discontinuation, per Common Terminology Criteria for Adverse Events (CTCAE) v4. Events were assessed at every visit at an interval of 4 weeks.
Injury, poisoning and procedural complications BURN	2.7% 1/37 • Number of events 1 • Adverse events were recorded from the time of consent until 90 days after last dose of durvalumab up to a maximum of 15 months. Adverse events were recorded from the time of consent for at least 90 days after treatment discontinuation, per Common Terminology Criteria for Adverse Events (CTCAE) v4. Events were assessed at every visit at an interval of 4 weeks.
Cardiac disorders CARDIAC DISORDERS	2.7% 1/37 • Number of events 1 • Adverse events were recorded from the time of consent until 90 days after last dose of durvalumab up to a maximum of 15 months. Adverse events were recorded from the time of consent for at least 90 days after treatment discontinuation, per Common Terminology Criteria for Adverse Events (CTCAE) v4. Events were assessed at every visit at an interval of 4 weeks.
Cardiac disorders CHEST PAIN - CARDIAC	2.7% 1/37 • Number of events 1 • Adverse events were recorded from the time of consent until 90 days after last dose of durvalumab up to a maximum of 15 months. Adverse events were recorded from the time of consent for at least 90 days after treatment discontinuation, per Common Terminology Criteria for Adverse Events (CTCAE) v4. Events were assessed at every visit at an interval of 4 weeks.
Musculoskeletal and connective tissue disorders CHEST WALL PAIN	2.7% 1/37 • Number of events 1 • Adverse events were recorded from the time of consent until 90 days after last dose of durvalumab up to a maximum of 15 months. Adverse events were recorded from the time of consent for at least 90 days after treatment discontinuation, per Common Terminology Criteria for Adverse Events (CTCAE) v4. Events were assessed at every visit at an interval of 4 weeks.
General disorders CHILLS	5.4% 2/37 • Number of events 5 • Adverse events were recorded from the time of consent until 90 days after last dose of durvalumab up to a maximum of 15 months. Adverse events were recorded from the time of consent for at least 90 days after treatment discontinuation, per Common Terminology Criteria for Adverse Events (CTCAE) v4. Events were assessed at every visit at an interval of 4 weeks.
Investigations CHOLESTEROL HIGH	2.7% 1/37 • Number of events 1 • Adverse events were recorded from the time of consent until 90 days after last dose of durvalumab up to a maximum of 15 months. Adverse events were recorded from the time of consent for at least 90 days after treatment discontinuation, per Common Terminology Criteria for Adverse Events (CTCAE) v4. Events were assessed at every visit at an interval of 4 weeks.
Gastrointestinal disorders COLITIS	5.4% 2/37 • Number of events 2 • Adverse events were recorded from the time of consent until 90 days after last dose of durvalumab up to a maximum of 15 months. Adverse events were recorded from the time of consent for at least 90 days after treatment discontinuation, per Common Terminology Criteria for Adverse Events (CTCAE) v4. Events were assessed at every visit at an interval of 4 weeks.
Gastrointestinal disorders CONSTIPATION	13.5% 5/37 • Number of events 5 • Adverse events were recorded from the time of consent until 90 days after last dose of durvalumab up to a maximum of 15 months. Adverse events were recorded from the time of consent for at least 90 days after treatment discontinuation, per Common Terminology Criteria for Adverse Events (CTCAE) v4. Events were assessed at every visit at an interval of 4 weeks.
Respiratory, thoracic and mediastinal disorders COUGH	16.2% 6/37 • Number of events 7 • Adverse events were recorded from the time of consent until 90 days after last dose of durvalumab up to a maximum of 15 months. Adverse events were recorded from the time of consent for at least 90 days after treatment discontinuation, per Common Terminology Criteria for Adverse Events (CTCAE) v4. Events were assessed at every visit at an interval of 4 weeks.
Investigations CREATININE INCREASED	8.1% 3/37 • Number of events 6 • Adverse events were recorded from the time of consent until 90 days after last dose of durvalumab up to a maximum of 15 months. Adverse events were recorded from the time of consent for at least 90 days after treatment discontinuation, per Common Terminology Criteria for Adverse Events (CTCAE) v4. Events were assessed at every visit at an interval of 4 weeks.
Gastrointestinal disorders DENTAL CARIES	2.7% 1/37 • Number of events 1 • Adverse events were recorded from the time of consent until 90 days after last dose of durvalumab up to a maximum of 15 months. Adverse events were recorded from the time of consent for at least 90 days after treatment discontinuation, per Common Terminology Criteria for Adverse Events (CTCAE) v4. Events were assessed at every visit at an interval of 4 weeks.
Psychiatric disorders DEPRESSION	2.7% 1/37 • Number of events 1 • Adverse events were recorded from the time of consent until 90 days after last dose of durvalumab up to a maximum of 15 months. Adverse events were recorded from the time of consent for at least 90 days after treatment discontinuation, per Common Terminology Criteria for Adverse Events (CTCAE) v4. Events were assessed at every visit at an interval of 4 weeks.
Gastrointestinal disorders DIARRHEA	43.2% 16/37 • Number of events 34 • Adverse events were recorded from the time of consent until 90 days after last dose of durvalumab up to a maximum of 15 months. Adverse events were recorded from the time of consent for at least 90 days after treatment discontinuation, per Common Terminology Criteria for Adverse Events (CTCAE) v4. Events were assessed at every visit at an interval of 4 weeks.
Nervous system disorders DIZZINESS	5.4% 2/37 • Number of events 2 • Adverse events were recorded from the time of consent until 90 days after last dose of durvalumab up to a maximum of 15 months. Adverse events were recorded from the time of consent for at least 90 days after treatment discontinuation, per Common Terminology Criteria for Adverse Events (CTCAE) v4. Events were assessed at every visit at an interval of 4 weeks.
Gastrointestinal disorders DRY MOUTH	2.7% 1/37 • Number of events 1 • Adverse events were recorded from the time of consent until 90 days after last dose of durvalumab up to a maximum of 15 months. Adverse events were recorded from the time of consent for at least 90 days after treatment discontinuation, per Common Terminology Criteria for Adverse Events (CTCAE) v4. Events were assessed at every visit at an interval of 4 weeks.
Nervous system disorders DYSGEUSIA	8.1% 3/37 • Number of events 3 • Adverse events were recorded from the time of consent until 90 days after last dose of durvalumab up to a maximum of 15 months. Adverse events were recorded from the time of consent for at least 90 days after treatment discontinuation, per Common Terminology Criteria for Adverse Events (CTCAE) v4. Events were assessed at every visit at an interval of 4 weeks.
Gastrointestinal disorders DYSPEPSIA	2.7% 1/37 • Number of events 2 • Adverse events were recorded from the time of consent until 90 days after last dose of durvalumab up to a maximum of 15 months. Adverse events were recorded from the time of consent for at least 90 days after treatment discontinuation, per Common Terminology Criteria for Adverse Events (CTCAE) v4. Events were assessed at every visit at an interval of 4 weeks.
Gastrointestinal disorders DYSPHAGIA	24.3% 9/37 • Number of events 10 • Adverse events were recorded from the time of consent until 90 days after last dose of durvalumab up to a maximum of 15 months. Adverse events were recorded from the time of consent for at least 90 days after treatment discontinuation, per Common Terminology Criteria for Adverse Events (CTCAE) v4. Events were assessed at every visit at an interval of 4 weeks.
Respiratory, thoracic and mediastinal disorders DYSPNEA	10.8% 4/37 • Number of events 4 • Adverse events were recorded from the time of consent until 90 days after last dose of durvalumab up to a maximum of 15 months. Adverse events were recorded from the time of consent for at least 90 days after treatment discontinuation, per Common Terminology Criteria for Adverse Events (CTCAE) v4. Events were assessed at every visit at an interval of 4 weeks.
Ear and labyrinth disorders EAR PAIN	2.7% 1/37 • Number of events 1 • Adverse events were recorded from the time of consent until 90 days after last dose of durvalumab up to a maximum of 15 months. Adverse events were recorded from the time of consent for at least 90 days after treatment discontinuation, per Common Terminology Criteria for Adverse Events (CTCAE) v4. Events were assessed at every visit at an interval of 4 weeks.
Investigations ELECTROCARDIOGRAM QT CORRECTED INTERVAL PROLONGED	2.7% 1/37 • Number of events 1 • Adverse events were recorded from the time of consent until 90 days after last dose of durvalumab up to a maximum of 15 months. Adverse events were recorded from the time of consent for at least 90 days after treatment discontinuation, per Common Terminology Criteria for Adverse Events (CTCAE) v4. Events were assessed at every visit at an interval of 4 weeks.
Injury, poisoning and procedural complications FALL	5.4% 2/37 • Number of events 4 • Adverse events were recorded from the time of consent until 90 days after last dose of durvalumab up to a maximum of 15 months. Adverse events were recorded from the time of consent for at least 90 days after treatment discontinuation, per Common Terminology Criteria for Adverse Events (CTCAE) v4. Events were assessed at every visit at an interval of 4 weeks.
General disorders FATIGUE	35.1% 13/37 • Number of events 21 • Adverse events were recorded from the time of consent until 90 days after last dose of durvalumab up to a maximum of 15 months. Adverse events were recorded from the time of consent for at least 90 days after treatment discontinuation, per Common Terminology Criteria for Adverse Events (CTCAE) v4. Events were assessed at every visit at an interval of 4 weeks.
Gastrointestinal disorders FECAL INCONTINENCE	2.7% 1/37 • Number of events 1 • Adverse events were recorded from the time of consent until 90 days after last dose of durvalumab up to a maximum of 15 months. Adverse events were recorded from the time of consent for at least 90 days after treatment discontinuation, per Common Terminology Criteria for Adverse Events (CTCAE) v4. Events were assessed at every visit at an interval of 4 weeks.
General disorders FEVER	5.4% 2/37 • Number of events 2 • Adverse events were recorded from the time of consent until 90 days after last dose of durvalumab up to a maximum of 15 months. Adverse events were recorded from the time of consent for at least 90 days after treatment discontinuation, per Common Terminology Criteria for Adverse Events (CTCAE) v4. Events were assessed at every visit at an interval of 4 weeks.
Gastrointestinal disorders FLATULENCE	2.7% 1/37 • Number of events 1 • Adverse events were recorded from the time of consent until 90 days after last dose of durvalumab up to a maximum of 15 months. Adverse events were recorded from the time of consent for at least 90 days after treatment discontinuation, per Common Terminology Criteria for Adverse Events (CTCAE) v4. Events were assessed at every visit at an interval of 4 weeks.
General disorders FLU LIKE SYMPTOMS	2.7% 1/37 • Number of events 1 • Adverse events were recorded from the time of consent until 90 days after last dose of durvalumab up to a maximum of 15 months. Adverse events were recorded from the time of consent for at least 90 days after treatment discontinuation, per Common Terminology Criteria for Adverse Events (CTCAE) v4. Events were assessed at every visit at an interval of 4 weeks.
Gastrointestinal disorders GASTROESOPHAGEAL REFLUX DISEASE	8.1% 3/37 • Number of events 3 • Adverse events were recorded from the time of consent until 90 days after last dose of durvalumab up to a maximum of 15 months. Adverse events were recorded from the time of consent for at least 90 days after treatment discontinuation, per Common Terminology Criteria for Adverse Events (CTCAE) v4. Events were assessed at every visit at an interval of 4 weeks.
Gastrointestinal disorders GASTROINTESTINAL DISORDERS	2.7% 1/37 • Number of events 2 • Adverse events were recorded from the time of consent until 90 days after last dose of durvalumab up to a maximum of 15 months. Adverse events were recorded from the time of consent for at least 90 days after treatment discontinuation, per Common Terminology Criteria for Adverse Events (CTCAE) v4. Events were assessed at every visit at an interval of 4 weeks.
Musculoskeletal and connective tissue disorders GENERALIZED MUSCLE WEAKNESS	5.4% 2/37 • Number of events 4 • Adverse events were recorded from the time of consent until 90 days after last dose of durvalumab up to a maximum of 15 months. Adverse events were recorded from the time of consent for at least 90 days after treatment discontinuation, per Common Terminology Criteria for Adverse Events (CTCAE) v4. Events were assessed at every visit at an interval of 4 weeks.
Nervous system disorders HEADACHE	10.8% 4/37 • Number of events 4 • Adverse events were recorded from the time of consent until 90 days after last dose of durvalumab up to a maximum of 15 months. Adverse events were recorded from the time of consent for at least 90 days after treatment discontinuation, per Common Terminology Criteria for Adverse Events (CTCAE) v4. Events were assessed at every visit at an interval of 4 weeks.
Renal and urinary disorders HEMATURIA	8.1% 3/37 • Number of events 5 • Adverse events were recorded from the time of consent until 90 days after last dose of durvalumab up to a maximum of 15 months. Adverse events were recorded from the time of consent for at least 90 days after treatment discontinuation, per Common Terminology Criteria for Adverse Events (CTCAE) v4. Events were assessed at every visit at an interval of 4 weeks.
Gastrointestinal disorders HEMORRHOIDS	5.4% 2/37 • Number of events 2 • Adverse events were recorded from the time of consent until 90 days after last dose of durvalumab up to a maximum of 15 months. Adverse events were recorded from the time of consent for at least 90 days after treatment discontinuation, per Common Terminology Criteria for Adverse Events (CTCAE) v4. Events were assessed at every visit at an interval of 4 weeks.
Hepatobiliary disorders HEPATOBILIARY DISORDERS	2.7% 1/37 • Number of events 1 • Adverse events were recorded from the time of consent until 90 days after last dose of durvalumab up to a maximum of 15 months. Adverse events were recorded from the time of consent for at least 90 days after treatment discontinuation, per Common Terminology Criteria for Adverse Events (CTCAE) v4. Events were assessed at every visit at an interval of 4 weeks.
Respiratory, thoracic and mediastinal disorders HOARSENESS	2.7% 1/37 • Number of events 1 • Adverse events were recorded from the time of consent until 90 days after last dose of durvalumab up to a maximum of 15 months. Adverse events were recorded from the time of consent for at least 90 days after treatment discontinuation, per Common Terminology Criteria for Adverse Events (CTCAE) v4. Events were assessed at every visit at an interval of 4 weeks.
Vascular disorders HOT FLASHES	2.7% 1/37 • Number of events 2 • Adverse events were recorded from the time of consent until 90 days after last dose of durvalumab up to a maximum of 15 months. Adverse events were recorded from the time of consent for at least 90 days after treatment discontinuation, per Common Terminology Criteria for Adverse Events (CTCAE) v4. Events were assessed at every visit at an interval of 4 weeks.
Metabolism and nutrition disorders HYPERGLYCEMIA	5.4% 2/37 • Number of events 6 • Adverse events were recorded from the time of consent until 90 days after last dose of durvalumab up to a maximum of 15 months. Adverse events were recorded from the time of consent for at least 90 days after treatment discontinuation, per Common Terminology Criteria for Adverse Events (CTCAE) v4. Events were assessed at every visit at an interval of 4 weeks.
Endocrine disorders HYPERPARATHYROIDISM	2.7% 1/37 • Number of events 1 • Adverse events were recorded from the time of consent until 90 days after last dose of durvalumab up to a maximum of 15 months. Adverse events were recorded from the time of consent for at least 90 days after treatment discontinuation, per Common Terminology Criteria for Adverse Events (CTCAE) v4. Events were assessed at every visit at an interval of 4 weeks.
Vascular disorders HYPERTENSION	16.2% 6/37 • Number of events 6 • Adverse events were recorded from the time of consent until 90 days after last dose of durvalumab up to a maximum of 15 months. Adverse events were recorded from the time of consent for at least 90 days after treatment discontinuation, per Common Terminology Criteria for Adverse Events (CTCAE) v4. Events were assessed at every visit at an interval of 4 weeks.
Endocrine disorders HYPERTHYROIDISM	8.1% 3/37 • Number of events 3 • Adverse events were recorded from the time of consent until 90 days after last dose of durvalumab up to a maximum of 15 months. Adverse events were recorded from the time of consent for at least 90 days after treatment discontinuation, per Common Terminology Criteria for Adverse Events (CTCAE) v4. Events were assessed at every visit at an interval of 4 weeks.
Metabolism and nutrition disorders HYPOALBUMINEMIA	2.7% 1/37 • Number of events 2 • Adverse events were recorded from the time of consent until 90 days after last dose of durvalumab up to a maximum of 15 months. Adverse events were recorded from the time of consent for at least 90 days after treatment discontinuation, per Common Terminology Criteria for Adverse Events (CTCAE) v4. Events were assessed at every visit at an interval of 4 weeks.
Metabolism and nutrition disorders HYPOCALCEMIA	2.7% 1/37 • Number of events 1 • Adverse events were recorded from the time of consent until 90 days after last dose of durvalumab up to a maximum of 15 months. Adverse events were recorded from the time of consent for at least 90 days after treatment discontinuation, per Common Terminology Criteria for Adverse Events (CTCAE) v4. Events were assessed at every visit at an interval of 4 weeks.
Metabolism and nutrition disorders HYPOGLYCEMIA	5.4% 2/37 • Number of events 3 • Adverse events were recorded from the time of consent until 90 days after last dose of durvalumab up to a maximum of 15 months. Adverse events were recorded from the time of consent for at least 90 days after treatment discontinuation, per Common Terminology Criteria for Adverse Events (CTCAE) v4. Events were assessed at every visit at an interval of 4 weeks.
Metabolism and nutrition disorders HYPOKALEMIA	10.8% 4/37 • Number of events 7 • Adverse events were recorded from the time of consent until 90 days after last dose of durvalumab up to a maximum of 15 months. Adverse events were recorded from the time of consent for at least 90 days after treatment discontinuation, per Common Terminology Criteria for Adverse Events (CTCAE) v4. Events were assessed at every visit at an interval of 4 weeks.
Metabolism and nutrition disorders HYPOMAGNESEMIA	2.7% 1/37 • Number of events 1 • Adverse events were recorded from the time of consent until 90 days after last dose of durvalumab up to a maximum of 15 months. Adverse events were recorded from the time of consent for at least 90 days after treatment discontinuation, per Common Terminology Criteria for Adverse Events (CTCAE) v4. Events were assessed at every visit at an interval of 4 weeks.
Metabolism and nutrition disorders HYPOPHOSPHATEMIA	2.7% 1/37 • Number of events 1 • Adverse events were recorded from the time of consent until 90 days after last dose of durvalumab up to a maximum of 15 months. Adverse events were recorded from the time of consent for at least 90 days after treatment discontinuation, per Common Terminology Criteria for Adverse Events (CTCAE) v4. Events were assessed at every visit at an interval of 4 weeks.
Vascular disorders HYPOTENSION	2.7% 1/37 • Number of events 1 • Adverse events were recorded from the time of consent until 90 days after last dose of durvalumab up to a maximum of 15 months. Adverse events were recorded from the time of consent for at least 90 days after treatment discontinuation, per Common Terminology Criteria for Adverse Events (CTCAE) v4. Events were assessed at every visit at an interval of 4 weeks.
Endocrine disorders HYPOTHYROIDISM	2.7% 1/37 • Number of events 1 • Adverse events were recorded from the time of consent until 90 days after last dose of durvalumab up to a maximum of 15 months. Adverse events were recorded from the time of consent for at least 90 days after treatment discontinuation, per Common Terminology Criteria for Adverse Events (CTCAE) v4. Events were assessed at every visit at an interval of 4 weeks.
General disorders INFUSION SITE EXTRAVASATION	2.7% 1/37 • Number of events 1 • Adverse events were recorded from the time of consent until 90 days after last dose of durvalumab up to a maximum of 15 months. Adverse events were recorded from the time of consent for at least 90 days after treatment discontinuation, per Common Terminology Criteria for Adverse Events (CTCAE) v4. Events were assessed at every visit at an interval of 4 weeks.
Psychiatric disorders INSOMNIA	10.8% 4/37 • Number of events 4 • Adverse events were recorded from the time of consent until 90 days after last dose of durvalumab up to a maximum of 15 months. Adverse events were recorded from the time of consent for at least 90 days after treatment discontinuation, per Common Terminology Criteria for Adverse Events (CTCAE) v4. Events were assessed at every visit at an interval of 4 weeks.
Investigations INVESTIGATIONS	8.1% 3/37 • Number of events 4 • Adverse events were recorded from the time of consent until 90 days after last dose of durvalumab up to a maximum of 15 months. Adverse events were recorded from the time of consent for at least 90 days after treatment discontinuation, per Common Terminology Criteria for Adverse Events (CTCAE) v4. Events were assessed at every visit at an interval of 4 weeks.
General disorders LOCALIZED EDEMA	2.7% 1/37 • Number of events 1 • Adverse events were recorded from the time of consent until 90 days after last dose of durvalumab up to a maximum of 15 months. Adverse events were recorded from the time of consent for at least 90 days after treatment discontinuation, per Common Terminology Criteria for Adverse Events (CTCAE) v4. Events were assessed at every visit at an interval of 4 weeks.
Infections and infestations LUNG INFECTION	13.5% 5/37 • Number of events 6 • Adverse events were recorded from the time of consent until 90 days after last dose of durvalumab up to a maximum of 15 months. Adverse events were recorded from the time of consent for at least 90 days after treatment discontinuation, per Common Terminology Criteria for Adverse Events (CTCAE) v4. Events were assessed at every visit at an interval of 4 weeks.
Nervous system disorders MEMORY IMPAIRMENT	2.7% 1/37 • Number of events 1 • Adverse events were recorded from the time of consent until 90 days after last dose of durvalumab up to a maximum of 15 months. Adverse events were recorded from the time of consent for at least 90 days after treatment discontinuation, per Common Terminology Criteria for Adverse Events (CTCAE) v4. Events were assessed at every visit at an interval of 4 weeks.
Metabolism and nutrition disorders METABOLISM AND NUTRITION DISORDERS	2.7% 1/37 • Number of events 1 • Adverse events were recorded from the time of consent until 90 days after last dose of durvalumab up to a maximum of 15 months. Adverse events were recorded from the time of consent for at least 90 days after treatment discontinuation, per Common Terminology Criteria for Adverse Events (CTCAE) v4. Events were assessed at every visit at an interval of 4 weeks.
Musculoskeletal and connective tissue disorders MUSCLE WEAKNESS TRUNK	2.7% 1/37 • Number of events 1 • Adverse events were recorded from the time of consent until 90 days after last dose of durvalumab up to a maximum of 15 months. Adverse events were recorded from the time of consent for at least 90 days after treatment discontinuation, per Common Terminology Criteria for Adverse Events (CTCAE) v4. Events were assessed at every visit at an interval of 4 weeks.
Musculoskeletal and connective tissue disorders MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDER	21.6% 8/37 • Number of events 12 • Adverse events were recorded from the time of consent until 90 days after last dose of durvalumab up to a maximum of 15 months. Adverse events were recorded from the time of consent for at least 90 days after treatment discontinuation, per Common Terminology Criteria for Adverse Events (CTCAE) v4. Events were assessed at every visit at an interval of 4 weeks.
Respiratory, thoracic and mediastinal disorders NASAL CONGESTION	8.1% 3/37 • Number of events 3 • Adverse events were recorded from the time of consent until 90 days after last dose of durvalumab up to a maximum of 15 months. Adverse events were recorded from the time of consent for at least 90 days after treatment discontinuation, per Common Terminology Criteria for Adverse Events (CTCAE) v4. Events were assessed at every visit at an interval of 4 weeks.
Gastrointestinal disorders NAUSEA	32.4% 12/37 • Number of events 22 • Adverse events were recorded from the time of consent until 90 days after last dose of durvalumab up to a maximum of 15 months. Adverse events were recorded from the time of consent for at least 90 days after treatment discontinuation, per Common Terminology Criteria for Adverse Events (CTCAE) v4. Events were assessed at every visit at an interval of 4 weeks.
Musculoskeletal and connective tissue disorders NECK PAIN	2.7% 1/37 • Number of events 2 • Adverse events were recorded from the time of consent until 90 days after last dose of durvalumab up to a maximum of 15 months. Adverse events were recorded from the time of consent for at least 90 days after treatment discontinuation, per Common Terminology Criteria for Adverse Events (CTCAE) v4. Events were assessed at every visit at an interval of 4 weeks.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED (INCL CYSTS AND POLYPS)	2.7% 1/37 • Number of events 1 • Adverse events were recorded from the time of consent until 90 days after last dose of durvalumab up to a maximum of 15 months. Adverse events were recorded from the time of consent for at least 90 days after treatment discontinuation, per Common Terminology Criteria for Adverse Events (CTCAE) v4. Events were assessed at every visit at an interval of 4 weeks.
Nervous system disorders NERVOUS SYSTEM DISORDERS	5.4% 2/37 • Number of events 3 • Adverse events were recorded from the time of consent until 90 days after last dose of durvalumab up to a maximum of 15 months. Adverse events were recorded from the time of consent for at least 90 days after treatment discontinuation, per Common Terminology Criteria for Adverse Events (CTCAE) v4. Events were assessed at every visit at an interval of 4 weeks.
Nervous system disorders NEURALGIA	2.7% 1/37 • Number of events 1 • Adverse events were recorded from the time of consent until 90 days after last dose of durvalumab up to a maximum of 15 months. Adverse events were recorded from the time of consent for at least 90 days after treatment discontinuation, per Common Terminology Criteria for Adverse Events (CTCAE) v4. Events were assessed at every visit at an interval of 4 weeks.
Investigations NEUTROPHIL COUNT DECREASED	2.7% 1/37 • Number of events 1 • Adverse events were recorded from the time of consent until 90 days after last dose of durvalumab up to a maximum of 15 months. Adverse events were recorded from the time of consent for at least 90 days after treatment discontinuation, per Common Terminology Criteria for Adverse Events (CTCAE) v4. Events were assessed at every visit at an interval of 4 weeks.
General disorders NON-CARDIAC CHEST PAIN	5.4% 2/37 • Number of events 2 • Adverse events were recorded from the time of consent until 90 days after last dose of durvalumab up to a maximum of 15 months. Adverse events were recorded from the time of consent for at least 90 days after treatment discontinuation, per Common Terminology Criteria for Adverse Events (CTCAE) v4. Events were assessed at every visit at an interval of 4 weeks.
General disorders PAIN	8.1% 3/37 • Number of events 5 • Adverse events were recorded from the time of consent until 90 days after last dose of durvalumab up to a maximum of 15 months. Adverse events were recorded from the time of consent for at least 90 days after treatment discontinuation, per Common Terminology Criteria for Adverse Events (CTCAE) v4. Events were assessed at every visit at an interval of 4 weeks.
Musculoskeletal and connective tissue disorders PAIN IN EXTREMITY	2.7% 1/37 • Number of events 2 • Adverse events were recorded from the time of consent until 90 days after last dose of durvalumab up to a maximum of 15 months. Adverse events were recorded from the time of consent for at least 90 days after treatment discontinuation, per Common Terminology Criteria for Adverse Events (CTCAE) v4. Events were assessed at every visit at an interval of 4 weeks.
Nervous system disorders PARESTHESIA	2.7% 1/37 • Number of events 1 • Adverse events were recorded from the time of consent until 90 days after last dose of durvalumab up to a maximum of 15 months. Adverse events were recorded from the time of consent for at least 90 days after treatment discontinuation, per Common Terminology Criteria for Adverse Events (CTCAE) v4. Events were assessed at every visit at an interval of 4 weeks.
Cardiac disorders PERICARDIAL EFFUSION	2.7% 1/37 • Number of events 1 • Adverse events were recorded from the time of consent until 90 days after last dose of durvalumab up to a maximum of 15 months. Adverse events were recorded from the time of consent for at least 90 days after treatment discontinuation, per Common Terminology Criteria for Adverse Events (CTCAE) v4. Events were assessed at every visit at an interval of 4 weeks.
Nervous system disorders PERIPHERAL SENSORY NEUROPATHY	5.4% 2/37 • Number of events 3 • Adverse events were recorded from the time of consent until 90 days after last dose of durvalumab up to a maximum of 15 months. Adverse events were recorded from the time of consent for at least 90 days after treatment discontinuation, per Common Terminology Criteria for Adverse Events (CTCAE) v4. Events were assessed at every visit at an interval of 4 weeks.
Investigations PLATELET COUNT DECREASED	5.4% 2/37 • Number of events 2 • Adverse events were recorded from the time of consent until 90 days after last dose of durvalumab up to a maximum of 15 months. Adverse events were recorded from the time of consent for at least 90 days after treatment discontinuation, per Common Terminology Criteria for Adverse Events (CTCAE) v4. Events were assessed at every visit at an interval of 4 weeks.
Respiratory, thoracic and mediastinal disorders PRODUCTIVE COUGH	5.4% 2/37 • Number of events 2 • Adverse events were recorded from the time of consent until 90 days after last dose of durvalumab up to a maximum of 15 months. Adverse events were recorded from the time of consent for at least 90 days after treatment discontinuation, per Common Terminology Criteria for Adverse Events (CTCAE) v4. Events were assessed at every visit at an interval of 4 weeks.
Renal and urinary disorders PROTEINURIA	2.7% 1/37 • Number of events 1 • Adverse events were recorded from the time of consent until 90 days after last dose of durvalumab up to a maximum of 15 months. Adverse events were recorded from the time of consent for at least 90 days after treatment discontinuation, per Common Terminology Criteria for Adverse Events (CTCAE) v4. Events were assessed at every visit at an interval of 4 weeks.
Skin and subcutaneous tissue disorders PRURITUS	16.2% 6/37 • Number of events 7 • Adverse events were recorded from the time of consent until 90 days after last dose of durvalumab up to a maximum of 15 months. Adverse events were recorded from the time of consent for at least 90 days after treatment discontinuation, per Common Terminology Criteria for Adverse Events (CTCAE) v4. Events were assessed at every visit at an interval of 4 weeks.
Skin and subcutaneous tissue disorders RASH MACULO-PAPULAR	5.4% 2/37 • Number of events 2 • Adverse events were recorded from the time of consent until 90 days after last dose of durvalumab up to a maximum of 15 months. Adverse events were recorded from the time of consent for at least 90 days after treatment discontinuation, per Common Terminology Criteria for Adverse Events (CTCAE) v4. Events were assessed at every visit at an interval of 4 weeks.
Infections and infestations RASH PUSTULAR	2.7% 1/37 • Number of events 1 • Adverse events were recorded from the time of consent until 90 days after last dose of durvalumab up to a maximum of 15 months. Adverse events were recorded from the time of consent for at least 90 days after treatment discontinuation, per Common Terminology Criteria for Adverse Events (CTCAE) v4. Events were assessed at every visit at an interval of 4 weeks.
Renal and urinary disorders RENAL CALCULI	2.7% 1/37 • Number of events 3 • Adverse events were recorded from the time of consent until 90 days after last dose of durvalumab up to a maximum of 15 months. Adverse events were recorded from the time of consent for at least 90 days after treatment discontinuation, per Common Terminology Criteria for Adverse Events (CTCAE) v4. Events were assessed at every visit at an interval of 4 weeks.
Respiratory, thoracic and mediastinal disorders RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS	2.7% 1/37 • Number of events 1 • Adverse events were recorded from the time of consent until 90 days after last dose of durvalumab up to a maximum of 15 months. Adverse events were recorded from the time of consent for at least 90 days after treatment discontinuation, per Common Terminology Criteria for Adverse Events (CTCAE) v4. Events were assessed at every visit at an interval of 4 weeks.
Nervous system disorders SEIZURE	2.7% 1/37 • Number of events 1 • Adverse events were recorded from the time of consent until 90 days after last dose of durvalumab up to a maximum of 15 months. Adverse events were recorded from the time of consent for at least 90 days after treatment discontinuation, per Common Terminology Criteria for Adverse Events (CTCAE) v4. Events were assessed at every visit at an interval of 4 weeks.
Investigations SERUM AMYLASE INCREASED	5.4% 2/37 • Number of events 7 • Adverse events were recorded from the time of consent until 90 days after last dose of durvalumab up to a maximum of 15 months. Adverse events were recorded from the time of consent for at least 90 days after treatment discontinuation, per Common Terminology Criteria for Adverse Events (CTCAE) v4. Events were assessed at every visit at an interval of 4 weeks.
Cardiac disorders SICK SINUS SYNDROME	2.7% 1/37 • Number of events 1 • Adverse events were recorded from the time of consent until 90 days after last dose of durvalumab up to a maximum of 15 months. Adverse events were recorded from the time of consent for at least 90 days after treatment discontinuation, per Common Terminology Criteria for Adverse Events (CTCAE) v4. Events were assessed at every visit at an interval of 4 weeks.
Infections and infestations SINUSITIS	5.4% 2/37 • Number of events 3 • Adverse events were recorded from the time of consent until 90 days after last dose of durvalumab up to a maximum of 15 months. Adverse events were recorded from the time of consent for at least 90 days after treatment discontinuation, per Common Terminology Criteria for Adverse Events (CTCAE) v4. Events were assessed at every visit at an interval of 4 weeks.
Skin and subcutaneous tissue disorders SKIN AND SUBCUTANEOUS TISSUE DISORDERS	2.7% 1/37 • Number of events 1 • Adverse events were recorded from the time of consent until 90 days after last dose of durvalumab up to a maximum of 15 months. Adverse events were recorded from the time of consent for at least 90 days after treatment discontinuation, per Common Terminology Criteria for Adverse Events (CTCAE) v4. Events were assessed at every visit at an interval of 4 weeks.
Infections and infestations SKIN INFECTION	2.7% 1/37 • Number of events 1 • Adverse events were recorded from the time of consent until 90 days after last dose of durvalumab up to a maximum of 15 months. Adverse events were recorded from the time of consent for at least 90 days after treatment discontinuation, per Common Terminology Criteria for Adverse Events (CTCAE) v4. Events were assessed at every visit at an interval of 4 weeks.
Gastrointestinal disorders STOMACH PAIN	5.4% 2/37 • Number of events 3 • Adverse events were recorded from the time of consent until 90 days after last dose of durvalumab up to a maximum of 15 months. Adverse events were recorded from the time of consent for at least 90 days after treatment discontinuation, per Common Terminology Criteria for Adverse Events (CTCAE) v4. Events were assessed at every visit at an interval of 4 weeks.
Surgical and medical procedures SURGICAL AND MEDICAL PROCEDURES	8.1% 3/37 • Number of events 3 • Adverse events were recorded from the time of consent until 90 days after last dose of durvalumab up to a maximum of 15 months. Adverse events were recorded from the time of consent for at least 90 days after treatment discontinuation, per Common Terminology Criteria for Adverse Events (CTCAE) v4. Events were assessed at every visit at an interval of 4 weeks.
Vascular disorders THROMBOEMBOLIC EVENT	2.7% 1/37 • Number of events 1 • Adverse events were recorded from the time of consent until 90 days after last dose of durvalumab up to a maximum of 15 months. Adverse events were recorded from the time of consent for at least 90 days after treatment discontinuation, per Common Terminology Criteria for Adverse Events (CTCAE) v4. Events were assessed at every visit at an interval of 4 weeks.
Renal and urinary disorders URINARY RETENTION	2.7% 1/37 • Number of events 1 • Adverse events were recorded from the time of consent until 90 days after last dose of durvalumab up to a maximum of 15 months. Adverse events were recorded from the time of consent for at least 90 days after treatment discontinuation, per Common Terminology Criteria for Adverse Events (CTCAE) v4. Events were assessed at every visit at an interval of 4 weeks.
Infections and infestations URINARY TRACT INFECTION	8.1% 3/37 • Number of events 3 • Adverse events were recorded from the time of consent until 90 days after last dose of durvalumab up to a maximum of 15 months. Adverse events were recorded from the time of consent for at least 90 days after treatment discontinuation, per Common Terminology Criteria for Adverse Events (CTCAE) v4. Events were assessed at every visit at an interval of 4 weeks.
Renal and urinary disorders URINE DISCOLORATION	2.7% 1/37 • Number of events 1 • Adverse events were recorded from the time of consent until 90 days after last dose of durvalumab up to a maximum of 15 months. Adverse events were recorded from the time of consent for at least 90 days after treatment discontinuation, per Common Terminology Criteria for Adverse Events (CTCAE) v4. Events were assessed at every visit at an interval of 4 weeks.
Ear and labyrinth disorders VERTIGO	2.7% 1/37 • Number of events 1 • Adverse events were recorded from the time of consent until 90 days after last dose of durvalumab up to a maximum of 15 months. Adverse events were recorded from the time of consent for at least 90 days after treatment discontinuation, per Common Terminology Criteria for Adverse Events (CTCAE) v4. Events were assessed at every visit at an interval of 4 weeks.
Gastrointestinal disorders VOMITING	18.9% 7/37 • Number of events 11 • Adverse events were recorded from the time of consent until 90 days after last dose of durvalumab up to a maximum of 15 months. Adverse events were recorded from the time of consent for at least 90 days after treatment discontinuation, per Common Terminology Criteria for Adverse Events (CTCAE) v4. Events were assessed at every visit at an interval of 4 weeks.
Investigations WEIGHT GAIN	8.1% 3/37 • Number of events 4 • Adverse events were recorded from the time of consent until 90 days after last dose of durvalumab up to a maximum of 15 months. Adverse events were recorded from the time of consent for at least 90 days after treatment discontinuation, per Common Terminology Criteria for Adverse Events (CTCAE) v4. Events were assessed at every visit at an interval of 4 weeks.
Investigations WEIGHT LOSS	21.6% 8/37 • Number of events 12 • Adverse events were recorded from the time of consent until 90 days after last dose of durvalumab up to a maximum of 15 months. Adverse events were recorded from the time of consent for at least 90 days after treatment discontinuation, per Common Terminology Criteria for Adverse Events (CTCAE) v4. Events were assessed at every visit at an interval of 4 weeks.

Additional Information

Annesha Majumdar

Hoosier Cancer Research Network

Phone: 3179212050

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place