Trial Outcomes & Findings for A Study to Determine Safety of Durvalumab After Sequential Chemo Radiation in Patients With Unresectable Stage III Non-Small Cell Lung Cancer (NCT NCT03693300)
NCT ID: NCT03693300
Last Updated: 2024-06-18
Results Overview
Safety and tolerability of Durvalumab as defined by Grade 3 and Grade 4 TRAEs following IV infusion administration was assessed.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
117 participants
Primary outcome timeframe
Up to 6 months
Results posted on
2024-06-18
Participant Flow
The study was conducted from 16 April 2019 to 21 April 2023 at 25 sites in the United States of America (USA), France, Germany, Italy, Spain, and the United Kingdom.
Patients who met all the inclusion and none of the exclusion criteria were included in the study. The screening period was from Day -28 to Day -1. The Study was scheduled from initiation of durvalumab up to a maximum of 24 months of treatment, 3 months of safety follow up and subsequent survival follow up as per CSP. Informed consent form was signed prior to screening procedures.
Participant milestones
| Measure |
Durvalumab Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1
Patients received 1500 mg Durvalumab monotherapy via Intravenous (IV) infusion every 4 weeks (q4w).
|
Durvalumab ECOG PS 2
Patients received 1500 mg Durvalumab monotherapy via IV infusion q4w.
|
|---|---|---|
|
Overall Study
STARTED
|
114
|
3
|
|
Overall Study
COMPLETED
|
56
|
1
|
|
Overall Study
NOT COMPLETED
|
58
|
2
|
Reasons for withdrawal
| Measure |
Durvalumab Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1
Patients received 1500 mg Durvalumab monotherapy via Intravenous (IV) infusion every 4 weeks (q4w).
|
Durvalumab ECOG PS 2
Patients received 1500 mg Durvalumab monotherapy via IV infusion q4w.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
6
|
0
|
|
Overall Study
Death
|
50
|
2
|
|
Overall Study
Lost to Follow-up
|
2
|
0
|
Baseline Characteristics
A Study to Determine Safety of Durvalumab After Sequential Chemo Radiation in Patients With Unresectable Stage III Non-Small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
Durvalumab ECOG PS 0 or 1
n=114 Participants
Patients received 1500 mg Durvalumab monotherapy via IV infusion q4w.
|
Durvalumab ECOG PS 2
n=3 Participants
Patients received 1500 mg Durvalumab monotherapy via IV infusion q4w.
|
Total
n=117 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
67.0 years
STANDARD_DEVIATION 8.46 • n=5 Participants
|
65.0 years
STANDARD_DEVIATION 12.00 • n=7 Participants
|
66.9 years
STANDARD_DEVIATION 8.50 • n=5 Participants
|
|
Sex: Female, Male
Female
|
43 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
71 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
73 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
103 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
106 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
10 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
101 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
104 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
13 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 6 monthsPopulation: The safety analysis set consisted of all patients who received at least one dose of IP (partial or in full).
Safety and tolerability of Durvalumab as defined by Grade 3 and Grade 4 TRAEs following IV infusion administration was assessed.
Outcome measures
| Measure |
Durvalumab ECOG PS 0 or 1
n=114 Participants
Patients received 1500 mg Durvalumab monotherapy via IV infusion q4w.
|
Durvalumab ECOG PS 2
n=3 Participants
Patients received 1500 mg Durvalumab monotherapy via IV infusion q4w.
|
Durvalumab Total
n=117 Participants
Patients received 1500 mg Durvalumab monotherapy via IV infusion q4w.
|
|---|---|---|---|
|
Number of Patients With Grade 3 and Grade 4 Treatment-related Adverse Events (TRAEs)
Any possibly related AEs of CTCAE Grade 3 or Grade 4
|
7 Participants
|
0 Participants
|
7 Participants
|
|
Number of Patients With Grade 3 and Grade 4 Treatment-related Adverse Events (TRAEs)
Any possibly related AEs of Grade 3 or Grade 4 with onset date within 6 months of the first dose
|
5 Participants
|
0 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: From the first date of treatment until the date of objective disease progression or death (approximately upto 48 months)Population: The safety analysis set consisted of all patients who received at least one dose of IP (partial or in full).
The efficacy of Durvalumab (MEDI4736) treatment in terms of PFS. PFS was defined as the time from the first date of treatment until the date of objective disease progression based on Investigator's assessment according to RECIST 1.1 or death (by any cause in the absence of progression) regardless of whether the patient withdraws from IP or receives another anticancer therapy prior to progression.
Outcome measures
| Measure |
Durvalumab ECOG PS 0 or 1
n=114 Participants
Patients received 1500 mg Durvalumab monotherapy via IV infusion q4w.
|
Durvalumab ECOG PS 2
n=3 Participants
Patients received 1500 mg Durvalumab monotherapy via IV infusion q4w.
|
Durvalumab Total
n=117 Participants
Patients received 1500 mg Durvalumab monotherapy via IV infusion q4w.
|
|---|---|---|---|
|
Progression-free Survival (PFS)
|
13.1 Months
Interval 7.36 to 19.91
|
3.7 Months
Interval 1.81 to
Not calculated due to low number of events as well as low sample size.
|
13.1 Months
Interval 7.36 to 19.91
|
SECONDARY outcome
Timeframe: From the first date of treatment until the date of objective disease progression or death (upto 12 months)Population: The safety analysis set consisted of all patients who received at least one dose of IP (partial or in full).
The percentage of patients treated with Durvalumab who are progression-free was estimated. PFS12 according to RECIST 1.1 as assessed by the Investigator.
Outcome measures
| Measure |
Durvalumab ECOG PS 0 or 1
n=114 Participants
Patients received 1500 mg Durvalumab monotherapy via IV infusion q4w.
|
Durvalumab ECOG PS 2
n=3 Participants
Patients received 1500 mg Durvalumab monotherapy via IV infusion q4w.
|
Durvalumab Total
n=117 Participants
Patients received 1500 mg Durvalumab monotherapy via IV infusion q4w.
|
|---|---|---|---|
|
Percentage of Patients Progression-free at 12 Months
|
51.1 Percentage of patient
Interval 41.29 to 60.02
|
33.3 Percentage of patient
Interval 0.9 to 77.41
|
50.6 Percentage of patient
Interval 40.97 to 59.45
|
SECONDARY outcome
Timeframe: From the first date of treatment until death due to any cause (approximately upto 48 months)Population: The safety analysis set consisted of all patients who received at least one dose of IP (partial or in full).
The efficacy of Durvalumab (MEDI4736) treatment in terms of OS were assessed. OS was defined as the time from the first date of treatment until death due to any cause. Any patient not known to have died at the time of analysis will be censored based on the last recorded date on which the patient was known to be alive.
Outcome measures
| Measure |
Durvalumab ECOG PS 0 or 1
n=114 Participants
Patients received 1500 mg Durvalumab monotherapy via IV infusion q4w.
|
Durvalumab ECOG PS 2
n=3 Participants
Patients received 1500 mg Durvalumab monotherapy via IV infusion q4w.
|
Durvalumab Total
n=117 Participants
Patients received 1500 mg Durvalumab monotherapy via IV infusion q4w.
|
|---|---|---|---|
|
Overall Survival (OS)
|
39.0 Months
Interval 30.59 to
Not calculated due to insufficient number of events.
|
12.3 Months
Interval 4.96 to
Not calculated due to insufficient number of events.
|
39.0 Months
Interval 30.59 to
Not calculated due to insufficient number of events.
|
SECONDARY outcome
Timeframe: From the first date of treatment until the date of objective disease progression or death (12 months, 24 months, and 36 months)Population: The safety analysis set consisted of all patients who received at least one dose of IP (partial or in full).
Percentage of patients alive at 12 months, 24 months, and 36 months were estimated.
Outcome measures
| Measure |
Durvalumab ECOG PS 0 or 1
n=114 Participants
Patients received 1500 mg Durvalumab monotherapy via IV infusion q4w.
|
Durvalumab ECOG PS 2
n=3 Participants
Patients received 1500 mg Durvalumab monotherapy via IV infusion q4w.
|
Durvalumab Total
n=117 Participants
Patients received 1500 mg Durvalumab monotherapy via IV infusion q4w.
|
|---|---|---|---|
|
Percentage of Patients Alive
Survival at 12 months
|
83.9 Percentage of patient
Interval 75.73 to 89.57
|
66.7 Percentage of patient
Interval 5.41 to 94.52
|
83.5 Percentage of patient
Interval 75.36 to 89.15
|
|
Percentage of Patients Alive
Survival at 24 months
|
68.2 Percentage of patient
Interval 58.54 to 76.0
|
33.3 Percentage of patient
Interval 0.9 to 77.41
|
67.2 Percentage of patient
Interval 57.73 to 75.08
|
|
Percentage of Patients Alive
Survival at 36 months
|
57.2 Percentage of patient
Interval 46.94 to 66.2
|
NA Percentage of patient
Not calculated due to insufficient number of events.
|
56.5 Percentage of patient
Interval 46.41 to 65.46
|
SECONDARY outcome
Timeframe: From 8 weeks ±1 week after investigational product (IP) treatment initiation and continue every 8 weeks (q8w) ±1 week through 52 weeks and every 12 weeks (q12w) ±1 week until disease progression (approximately upto 48 months)Population: The safety analysis set consisted of all patients who received at least one dose of IP (partial or in full). Patients without a post-baseline assessment were not included.
The efficacy of Durvalumab (MEDI4736) treatment in terms of ORR were assessed. ORR (based on Investigator assessed response to treatment of complete response (CR) and partial response (PR) as per RECIST 1.1 criteria), together with the corresponding 95% CI, was reported for patients. Objective response is complete response (CR), or partial response (PR) confirmed by a follow-up visit at least 4 weeks after. Both visits contributing to response should have occurred before any further anti-cancer therapy, in order for the patient to be considered a responder. Responses that occurred after the start of subsequent anti-cancer therapy were not included in the numerator. Response excluded unconfirmed response. Participants with unconfirmed responses include those whose CR, or PR don't have a confirmed response. These responses occur at any time during the study, recur after anti-cancer therapy, and these participants were missing for a follow-up visit 4 weeks after.
Outcome measures
| Measure |
Durvalumab ECOG PS 0 or 1
n=114 Participants
Patients received 1500 mg Durvalumab monotherapy via IV infusion q4w.
|
Durvalumab ECOG PS 2
n=3 Participants
Patients received 1500 mg Durvalumab monotherapy via IV infusion q4w.
|
Durvalumab Total
n=117 Participants
Patients received 1500 mg Durvalumab monotherapy via IV infusion q4w.
|
|---|---|---|---|
|
Objective Response Rate (ORR)
Number of patients with response
|
24 Participants
|
0 Participants
|
24 Participants
|
|
Objective Response Rate (ORR)
Number of patients with unconfirmed response
|
5 Participants
|
0 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: From 8 weeks ±1 week after IP treatment initiation and continue q8w ±1 week through 52 weeks and q12w ±1 week until disease progression (approximately upto 48 months)Population: The safety analysis set consisted of all patients who received at least one dose of IP (partial or in full). The patients with objective response were evaluated.
The efficacy of Durvalumab (MEDI4736) treatment in terms of DoR were assessed. DoR was defined as the time from the date of first documented response per RECIST1.1 until the first date of documented progression per RECIST1.1 or death in the absence of disease progression. If a patient did not progress following a response, then the patients' DoR was censored at the PFS censoring time.
Outcome measures
| Measure |
Durvalumab ECOG PS 0 or 1
n=24 Participants
Patients received 1500 mg Durvalumab monotherapy via IV infusion q4w.
|
Durvalumab ECOG PS 2
Patients received 1500 mg Durvalumab monotherapy via IV infusion q4w.
|
Durvalumab Total
n=24 Participants
Patients received 1500 mg Durvalumab monotherapy via IV infusion q4w.
|
|---|---|---|---|
|
Duration of Response (DOR) From Onset of Response
|
NA Weeks
Not calculated due to insufficient number of events.
|
—
|
NA Weeks
Not calculated due to insufficient number of events.
|
SECONDARY outcome
Timeframe: From date of treatment start until death due to lung cancer (approximately upto 48 months)Population: The safety analysis set consisted of all patients who received at least one dose of IP (partial or in full). Patients who had died due to causes related to non-small cell lung cancer were evaluated.
The efficacy of durvalumab (MEDI4736) treatment in terms of lung cancer mortality was assessed. Lung Cancer Mortality was defined as the time from the date of treatment start until death due to lung cancer. Any patient not known to have died due to lung cancer will be censored based on the last recorded date on which the patient was known to be alive or died due to reason other than lung cancer.
Outcome measures
| Measure |
Durvalumab ECOG PS 0 or 1
n=40 Participants
Patients received 1500 mg Durvalumab monotherapy via IV infusion q4w.
|
Durvalumab ECOG PS 2
n=1 Participants
Patients received 1500 mg Durvalumab monotherapy via IV infusion q4w.
|
Durvalumab Total
n=41 Participants
Patients received 1500 mg Durvalumab monotherapy via IV infusion q4w.
|
|---|---|---|---|
|
Lung Cancer Mortality
|
41.8 Months
Interval 36.5 to
Not calculated due to insufficient number of events.
|
NA Months
Interval 4.96 to
Not calculated due to insufficient number of events.
|
41.8 Months
Interval 36.5 to
Not calculated due to insufficient number of events.
|
SECONDARY outcome
Timeframe: Until the final visit (upto 48 months)Population: The safety analysis set consisted of all patients who received at least one dose of IP (partial or in full). This include treatment emergent AEs only, ie. AEs occurred during screening period are NOT included.
The safety and tolerability profile of Durvalumab(MEDI4736) treatment, including all AEs were assessed.
Outcome measures
| Measure |
Durvalumab ECOG PS 0 or 1
n=114 Participants
Patients received 1500 mg Durvalumab monotherapy via IV infusion q4w.
|
Durvalumab ECOG PS 2
n=3 Participants
Patients received 1500 mg Durvalumab monotherapy via IV infusion q4w.
|
Durvalumab Total
n=117 Participants
Patients received 1500 mg Durvalumab monotherapy via IV infusion q4w.
|
|---|---|---|---|
|
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Adverse Event of Special Interests (AESIs), and Immune-mediated Adverse Event (imAEs)
Any AE
|
108 Participants
|
3 Participants
|
111 Participants
|
|
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Adverse Event of Special Interests (AESIs), and Immune-mediated Adverse Event (imAEs)
Any AE possibly related to treatment
|
87 Participants
|
3 Participants
|
90 Participants
|
|
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Adverse Event of Special Interests (AESIs), and Immune-mediated Adverse Event (imAEs)
Any AE of CTCAE Grade 3 or Grade 4
|
32 Participants
|
0 Participants
|
32 Participants
|
|
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Adverse Event of Special Interests (AESIs), and Immune-mediated Adverse Event (imAEs)
Any AE of CTCAE Grade 3 or Grade 4, possibly related to treatment
|
7 Participants
|
0 Participants
|
7 Participants
|
|
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Adverse Event of Special Interests (AESIs), and Immune-mediated Adverse Event (imAEs)
Any AE with outcome of death
|
3 Participants
|
0 Participants
|
3 Participants
|
|
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Adverse Event of Special Interests (AESIs), and Immune-mediated Adverse Event (imAEs)
Any AE with outcome of death, possibly related to treatment
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Adverse Event of Special Interests (AESIs), and Immune-mediated Adverse Event (imAEs)
Any SAE (including events with outcome of death)
|
32 Participants
|
0 Participants
|
32 Participants
|
|
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Adverse Event of Special Interests (AESIs), and Immune-mediated Adverse Event (imAEs)
Any SAE (including events with outcome of death), possibly related to treatment
|
7 Participants
|
0 Participants
|
7 Participants
|
|
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Adverse Event of Special Interests (AESIs), and Immune-mediated Adverse Event (imAEs)
Any AE leading to discontinuation of treatment
|
32 Participants
|
0 Participants
|
32 Participants
|
|
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Adverse Event of Special Interests (AESIs), and Immune-mediated Adverse Event (imAEs)
Any AE leading to discontinuation of treatment, possibly related to treatment
|
19 Participants
|
0 Participants
|
19 Participants
|
|
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Adverse Event of Special Interests (AESIs), and Immune-mediated Adverse Event (imAEs)
Any AE leading to treatment interruption
|
52 Participants
|
1 Participants
|
53 Participants
|
|
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Adverse Event of Special Interests (AESIs), and Immune-mediated Adverse Event (imAEs)
Any AE leading to treatment interruption, possibly related to treatment
|
24 Participants
|
1 Participants
|
25 Participants
|
|
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Adverse Event of Special Interests (AESIs), and Immune-mediated Adverse Event (imAEs)
Any AESI or AEPI (including events with outcome of death)
|
86 Participants
|
3 Participants
|
89 Participants
|
|
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Adverse Event of Special Interests (AESIs), and Immune-mediated Adverse Event (imAEs)
Any AESI or AEPI (including events with outcome of death), possibly related to treatment
|
73 Participants
|
2 Participants
|
75 Participants
|
|
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Adverse Event of Special Interests (AESIs), and Immune-mediated Adverse Event (imAEs)
Any imAE
|
48 Participants
|
2 Participants
|
50 Participants
|
|
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Adverse Event of Special Interests (AESIs), and Immune-mediated Adverse Event (imAEs)
Any imAE, possibly related to treatment
|
43 Participants
|
2 Participants
|
45 Participants
|
|
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Adverse Event of Special Interests (AESIs), and Immune-mediated Adverse Event (imAEs)
Any imAE as assessed by Investigator
|
64 Participants
|
1 Participants
|
65 Participants
|
|
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Adverse Event of Special Interests (AESIs), and Immune-mediated Adverse Event (imAEs)
Any imAE as assessed by Investigator, possibly related to treatment
|
64 Participants
|
1 Participants
|
65 Participants
|
Adverse Events
Durvalumab ECOG PS 0 or 1
Serious events: 32 serious events
Other events: 106 other events
Deaths: 50 deaths
Durvalumab ECOG PS 2
Serious events: 0 serious events
Other events: 3 other events
Deaths: 2 deaths
Durvalumab Total
Serious events: 32 serious events
Other events: 109 other events
Deaths: 52 deaths
Serious adverse events
| Measure |
Durvalumab ECOG PS 0 or 1
n=114 participants at risk
Patients received 1500 mg Durvalumab monotherapy via IV infusion q4w.
|
Durvalumab ECOG PS 2
n=3 participants at risk
Patients received 1500 mg Durvalumab monotherapy via IV infusion q4w.
|
Durvalumab Total
n=117 participants at risk
Patients received 1500 mg Durvalumab monotherapy via IV infusion q4w.
|
|---|---|---|---|
|
Infections and infestations
Pneumonia
|
4.4%
5/114 • Number of events 7 • Upto 48 months
|
0.00%
0/3 • Upto 48 months
|
4.3%
5/117 • Number of events 7 • Upto 48 months
|
|
Infections and infestations
Covid-19
|
0.88%
1/114 • Number of events 1 • Upto 48 months
|
0.00%
0/3 • Upto 48 months
|
0.85%
1/117 • Number of events 1 • Upto 48 months
|
|
Infections and infestations
Covid-19 pneumonia
|
0.88%
1/114 • Number of events 1 • Upto 48 months
|
0.00%
0/3 • Upto 48 months
|
0.85%
1/117 • Number of events 1 • Upto 48 months
|
|
Infections and infestations
Influenza
|
0.88%
1/114 • Number of events 1 • Upto 48 months
|
0.00%
0/3 • Upto 48 months
|
0.85%
1/117 • Number of events 1 • Upto 48 months
|
|
Infections and infestations
Osteomyelitis
|
0.88%
1/114 • Number of events 2 • Upto 48 months
|
0.00%
0/3 • Upto 48 months
|
0.85%
1/117 • Number of events 2 • Upto 48 months
|
|
Infections and infestations
Pneumocystis jirovecii pneumonia
|
0.88%
1/114 • Number of events 1 • Upto 48 months
|
0.00%
0/3 • Upto 48 months
|
0.85%
1/117 • Number of events 1 • Upto 48 months
|
|
Infections and infestations
Pneumonia legionella
|
0.88%
1/114 • Number of events 1 • Upto 48 months
|
0.00%
0/3 • Upto 48 months
|
0.85%
1/117 • Number of events 1 • Upto 48 months
|
|
Infections and infestations
Pulmonary sepsis
|
0.88%
1/114 • Number of events 1 • Upto 48 months
|
0.00%
0/3 • Upto 48 months
|
0.85%
1/117 • Number of events 1 • Upto 48 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.88%
1/114 • Number of events 1 • Upto 48 months
|
0.00%
0/3 • Upto 48 months
|
0.85%
1/117 • Number of events 1 • Upto 48 months
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.88%
1/114 • Number of events 1 • Upto 48 months
|
0.00%
0/3 • Upto 48 months
|
0.85%
1/117 • Number of events 1 • Upto 48 months
|
|
Psychiatric disorders
Confusional state
|
0.88%
1/114 • Number of events 1 • Upto 48 months
|
0.00%
0/3 • Upto 48 months
|
0.85%
1/117 • Number of events 1 • Upto 48 months
|
|
Nervous system disorders
Partial seizures
|
0.88%
1/114 • Number of events 1 • Upto 48 months
|
0.00%
0/3 • Upto 48 months
|
0.85%
1/117 • Number of events 1 • Upto 48 months
|
|
Nervous system disorders
Presyncope
|
0.88%
1/114 • Number of events 1 • Upto 48 months
|
0.00%
0/3 • Upto 48 months
|
0.85%
1/117 • Number of events 1 • Upto 48 months
|
|
Cardiac disorders
Atrial fibrillation
|
1.8%
2/114 • Number of events 2 • Upto 48 months
|
0.00%
0/3 • Upto 48 months
|
1.7%
2/117 • Number of events 2 • Upto 48 months
|
|
Vascular disorders
Superior vena cava syndrome
|
0.88%
1/114 • Number of events 1 • Upto 48 months
|
0.00%
0/3 • Upto 48 months
|
0.85%
1/117 • Number of events 1 • Upto 48 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
4.4%
5/114 • Number of events 5 • Upto 48 months
|
0.00%
0/3 • Upto 48 months
|
4.3%
5/117 • Number of events 5 • Upto 48 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.8%
2/114 • Number of events 2 • Upto 48 months
|
0.00%
0/3 • Upto 48 months
|
1.7%
2/117 • Number of events 2 • Upto 48 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.88%
1/114 • Number of events 3 • Upto 48 months
|
0.00%
0/3 • Upto 48 months
|
0.85%
1/117 • Number of events 3 • Upto 48 months
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.88%
1/114 • Number of events 1 • Upto 48 months
|
0.00%
0/3 • Upto 48 months
|
0.85%
1/117 • Number of events 1 • Upto 48 months
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.88%
1/114 • Number of events 1 • Upto 48 months
|
0.00%
0/3 • Upto 48 months
|
0.85%
1/117 • Number of events 1 • Upto 48 months
|
|
Respiratory, thoracic and mediastinal disorders
Tracheal stenosis
|
0.88%
1/114 • Number of events 1 • Upto 48 months
|
0.00%
0/3 • Upto 48 months
|
0.85%
1/117 • Number of events 1 • Upto 48 months
|
|
Hepatobiliary disorders
Cholecystitis
|
0.88%
1/114 • Number of events 1 • Upto 48 months
|
0.00%
0/3 • Upto 48 months
|
0.85%
1/117 • Number of events 1 • Upto 48 months
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.88%
1/114 • Number of events 1 • Upto 48 months
|
0.00%
0/3 • Upto 48 months
|
0.85%
1/117 • Number of events 1 • Upto 48 months
|
|
Injury, poisoning and procedural complications
Radiation pneumonitis
|
1.8%
2/114 • Number of events 2 • Upto 48 months
|
0.00%
0/3 • Upto 48 months
|
1.7%
2/117 • Number of events 2 • Upto 48 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.88%
1/114 • Number of events 1 • Upto 48 months
|
0.00%
0/3 • Upto 48 months
|
0.85%
1/117 • Number of events 1 • Upto 48 months
|
|
Nervous system disorders
Encephalopathy
|
0.88%
1/114 • Number of events 1 • Upto 48 months
|
0.00%
0/3 • Upto 48 months
|
0.85%
1/117 • Number of events 1 • Upto 48 months
|
|
Nervous system disorders
Spinal cord compression
|
0.88%
1/114 • Number of events 1 • Upto 48 months
|
0.00%
0/3 • Upto 48 months
|
0.85%
1/117 • Number of events 1 • Upto 48 months
|
|
Nervous system disorders
Transient ischaemic attack
|
0.88%
1/114 • Number of events 1 • Upto 48 months
|
0.00%
0/3 • Upto 48 months
|
0.85%
1/117 • Number of events 1 • Upto 48 months
|
|
Cardiac disorders
Cardiac arrest
|
0.88%
1/114 • Number of events 2 • Upto 48 months
|
0.00%
0/3 • Upto 48 months
|
0.85%
1/117 • Number of events 2 • Upto 48 months
|
|
Cardiac disorders
Cardiac failure
|
0.88%
1/114 • Number of events 2 • Upto 48 months
|
0.00%
0/3 • Upto 48 months
|
0.85%
1/117 • Number of events 2 • Upto 48 months
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.88%
1/114 • Number of events 1 • Upto 48 months
|
0.00%
0/3 • Upto 48 months
|
0.85%
1/117 • Number of events 1 • Upto 48 months
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.88%
1/114 • Number of events 1 • Upto 48 months
|
0.00%
0/3 • Upto 48 months
|
0.85%
1/117 • Number of events 1 • Upto 48 months
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.88%
1/114 • Number of events 1 • Upto 48 months
|
0.00%
0/3 • Upto 48 months
|
0.85%
1/117 • Number of events 1 • Upto 48 months
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.88%
1/114 • Number of events 1 • Upto 48 months
|
0.00%
0/3 • Upto 48 months
|
0.85%
1/117 • Number of events 1 • Upto 48 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.88%
1/114 • Number of events 1 • Upto 48 months
|
0.00%
0/3 • Upto 48 months
|
0.85%
1/117 • Number of events 1 • Upto 48 months
|
|
Renal and urinary disorders
Acute kidney injury
|
0.88%
1/114 • Number of events 1 • Upto 48 months
|
0.00%
0/3 • Upto 48 months
|
0.85%
1/117 • Number of events 1 • Upto 48 months
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.88%
1/114 • Number of events 1 • Upto 48 months
|
0.00%
0/3 • Upto 48 months
|
0.85%
1/117 • Number of events 1 • Upto 48 months
|
Other adverse events
| Measure |
Durvalumab ECOG PS 0 or 1
n=114 participants at risk
Patients received 1500 mg Durvalumab monotherapy via IV infusion q4w.
|
Durvalumab ECOG PS 2
n=3 participants at risk
Patients received 1500 mg Durvalumab monotherapy via IV infusion q4w.
|
Durvalumab Total
n=117 participants at risk
Patients received 1500 mg Durvalumab monotherapy via IV infusion q4w.
|
|---|---|---|---|
|
Infections and infestations
Pneumonia
|
7.0%
8/114 • Number of events 8 • Upto 48 months
|
0.00%
0/3 • Upto 48 months
|
6.8%
8/117 • Number of events 8 • Upto 48 months
|
|
Infections and infestations
Nasopharyngitis
|
8.8%
10/114 • Number of events 12 • Upto 48 months
|
0.00%
0/3 • Upto 48 months
|
8.5%
10/117 • Number of events 12 • Upto 48 months
|
|
Endocrine disorders
Hypothyroidism
|
13.2%
15/114 • Number of events 15 • Upto 48 months
|
33.3%
1/3 • Number of events 1 • Upto 48 months
|
13.7%
16/117 • Number of events 16 • Upto 48 months
|
|
Endocrine disorders
Hyperthyroidism
|
10.5%
12/114 • Number of events 12 • Upto 48 months
|
0.00%
0/3 • Upto 48 months
|
10.3%
12/117 • Number of events 12 • Upto 48 months
|
|
Metabolism and nutrition disorders
Decreased appetite
|
12.3%
14/114 • Number of events 14 • Upto 48 months
|
33.3%
1/3 • Number of events 2 • Upto 48 months
|
12.8%
15/117 • Number of events 16 • Upto 48 months
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
6.1%
7/114 • Number of events 8 • Upto 48 months
|
33.3%
1/3 • Number of events 1 • Upto 48 months
|
6.8%
8/117 • Number of events 9 • Upto 48 months
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
5.3%
6/114 • Number of events 6 • Upto 48 months
|
0.00%
0/3 • Upto 48 months
|
5.1%
6/117 • Number of events 6 • Upto 48 months
|
|
Psychiatric disorders
Insomnia
|
6.1%
7/114 • Number of events 7 • Upto 48 months
|
0.00%
0/3 • Upto 48 months
|
6.0%
7/117 • Number of events 7 • Upto 48 months
|
|
Nervous system disorders
Headache
|
14.9%
17/114 • Number of events 18 • Upto 48 months
|
33.3%
1/3 • Number of events 1 • Upto 48 months
|
15.4%
18/117 • Number of events 19 • Upto 48 months
|
|
Nervous system disorders
Paraesthesia
|
7.9%
9/114 • Number of events 9 • Upto 48 months
|
0.00%
0/3 • Upto 48 months
|
7.7%
9/117 • Number of events 9 • Upto 48 months
|
|
Vascular disorders
Hypertension
|
6.1%
7/114 • Number of events 8 • Upto 48 months
|
33.3%
1/3 • Number of events 2 • Upto 48 months
|
6.8%
8/117 • Number of events 10 • Upto 48 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
37.7%
43/114 • Number of events 49 • Upto 48 months
|
66.7%
2/3 • Number of events 3 • Upto 48 months
|
38.5%
45/117 • Number of events 52 • Upto 48 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
23.7%
27/114 • Number of events 39 • Upto 48 months
|
66.7%
2/3 • Number of events 3 • Upto 48 months
|
24.8%
29/117 • Number of events 42 • Upto 48 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
14.0%
16/114 • Number of events 20 • Upto 48 months
|
33.3%
1/3 • Number of events 1 • Upto 48 months
|
14.5%
17/117 • Number of events 21 • Upto 48 months
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
8.8%
10/114 • Number of events 11 • Upto 48 months
|
0.00%
0/3 • Upto 48 months
|
8.5%
10/117 • Number of events 11 • Upto 48 months
|
|
Gastrointestinal disorders
Constipation
|
20.2%
23/114 • Number of events 24 • Upto 48 months
|
0.00%
0/3 • Upto 48 months
|
19.7%
23/117 • Number of events 24 • Upto 48 months
|
|
Gastrointestinal disorders
Diarrhoea
|
21.1%
24/114 • Number of events 33 • Upto 48 months
|
0.00%
0/3 • Upto 48 months
|
20.5%
24/117 • Number of events 33 • Upto 48 months
|
|
Gastrointestinal disorders
Nausea
|
14.9%
17/114 • Number of events 21 • Upto 48 months
|
0.00%
0/3 • Upto 48 months
|
14.5%
17/117 • Number of events 21 • Upto 48 months
|
|
Gastrointestinal disorders
Vomiting
|
7.9%
9/114 • Number of events 9 • Upto 48 months
|
0.00%
0/3 • Upto 48 months
|
7.7%
9/117 • Number of events 9 • Upto 48 months
|
|
Gastrointestinal disorders
Dry mouth
|
6.1%
7/114 • Number of events 7 • Upto 48 months
|
0.00%
0/3 • Upto 48 months
|
6.0%
7/117 • Number of events 7 • Upto 48 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
16.7%
19/114 • Number of events 21 • Upto 48 months
|
66.7%
2/3 • Number of events 3 • Upto 48 months
|
17.9%
21/117 • Number of events 24 • Upto 48 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
11.4%
13/114 • Number of events 17 • Upto 48 months
|
33.3%
1/3 • Number of events 1 • Upto 48 months
|
12.0%
14/117 • Number of events 18 • Upto 48 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
19.3%
22/114 • Number of events 28 • Upto 48 months
|
33.3%
1/3 • Number of events 2 • Upto 48 months
|
19.7%
23/117 • Number of events 30 • Upto 48 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
14.9%
17/114 • Number of events 17 • Upto 48 months
|
0.00%
0/3 • Upto 48 months
|
14.5%
17/117 • Number of events 17 • Upto 48 months
|
|
General disorders
Asthenia
|
25.4%
29/114 • Number of events 40 • Upto 48 months
|
66.7%
2/3 • Number of events 2 • Upto 48 months
|
26.5%
31/117 • Number of events 42 • Upto 48 months
|
|
General disorders
Fatigue
|
21.1%
24/114 • Number of events 35 • Upto 48 months
|
0.00%
0/3 • Upto 48 months
|
20.5%
24/117 • Number of events 35 • Upto 48 months
|
|
General disorders
Pyrexia
|
19.3%
22/114 • Number of events 25 • Upto 48 months
|
0.00%
0/3 • Upto 48 months
|
18.8%
22/117 • Number of events 25 • Upto 48 months
|
|
General disorders
Non-cardiac chest pain
|
13.2%
15/114 • Number of events 18 • Upto 48 months
|
33.3%
1/3 • Number of events 1 • Upto 48 months
|
13.7%
16/117 • Number of events 19 • Upto 48 months
|
|
General disorders
Oedema peripheral
|
8.8%
10/114 • Number of events 10 • Upto 48 months
|
0.00%
0/3 • Upto 48 months
|
8.5%
10/117 • Number of events 10 • Upto 48 months
|
|
Investigations
Blood creatinine increased
|
7.0%
8/114 • Number of events 13 • Upto 48 months
|
0.00%
0/3 • Upto 48 months
|
6.8%
8/117 • Number of events 13 • Upto 48 months
|
|
Investigations
Gamma-glutamyltransferase increased
|
6.1%
7/114 • Number of events 9 • Upto 48 months
|
0.00%
0/3 • Upto 48 months
|
6.0%
7/117 • Number of events 9 • Upto 48 months
|
|
Investigations
Alanine aminotransferase increased
|
5.3%
6/114 • Number of events 7 • Upto 48 months
|
0.00%
0/3 • Upto 48 months
|
5.1%
6/117 • Number of events 7 • Upto 48 months
|
|
Investigations
Weight decreased
|
7.0%
8/114 • Number of events 8 • Upto 48 months
|
0.00%
0/3 • Upto 48 months
|
6.8%
8/117 • Number of events 8 • Upto 48 months
|
|
Infections and infestations
Conjunctivitis
|
3.5%
4/114 • Number of events 4 • Upto 48 months
|
0.00%
0/3 • Upto 48 months
|
3.4%
4/117 • Number of events 4 • Upto 48 months
|
|
Infections and infestations
Lower respiratory tract infection
|
3.5%
4/114 • Number of events 6 • Upto 48 months
|
0.00%
0/3 • Upto 48 months
|
3.4%
4/117 • Number of events 6 • Upto 48 months
|
|
Infections and infestations
Oral candidiasis
|
3.5%
4/114 • Number of events 4 • Upto 48 months
|
0.00%
0/3 • Upto 48 months
|
3.4%
4/117 • Number of events 4 • Upto 48 months
|
|
Infections and infestations
Urinary tract infection
|
4.4%
5/114 • Number of events 5 • Upto 48 months
|
0.00%
0/3 • Upto 48 months
|
4.3%
5/117 • Number of events 5 • Upto 48 months
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
2.6%
3/114 • Number of events 3 • Upto 48 months
|
0.00%
0/3 • Upto 48 months
|
2.6%
3/117 • Number of events 3 • Upto 48 months
|
|
Psychiatric disorders
Anxiety
|
5.3%
6/114 • Number of events 6 • Upto 48 months
|
0.00%
0/3 • Upto 48 months
|
5.1%
6/117 • Number of events 6 • Upto 48 months
|
|
Psychiatric disorders
Depressed mood
|
3.5%
4/114 • Number of events 4 • Upto 48 months
|
0.00%
0/3 • Upto 48 months
|
3.4%
4/117 • Number of events 4 • Upto 48 months
|
|
Blood and lymphatic system disorders
Anaemia
|
5.3%
6/114 • Number of events 8 • Upto 48 months
|
0.00%
0/3 • Upto 48 months
|
5.1%
6/117 • Number of events 8 • Upto 48 months
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/114 • Upto 48 months
|
33.3%
1/3 • Number of events 1 • Upto 48 months
|
0.85%
1/117 • Number of events 1 • Upto 48 months
|
|
Blood and lymphatic system disorders
Lymphopenia
|
5.3%
6/114 • Number of events 8 • Upto 48 months
|
0.00%
0/3 • Upto 48 months
|
5.1%
6/117 • Number of events 8 • Upto 48 months
|
|
Ear and labyrinth disorders
Vertigo
|
3.5%
4/114 • Number of events 5 • Upto 48 months
|
0.00%
0/3 • Upto 48 months
|
3.4%
4/117 • Number of events 5 • Upto 48 months
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
5.3%
6/114 • Number of events 8 • Upto 48 months
|
0.00%
0/3 • Upto 48 months
|
5.1%
6/117 • Number of events 8 • Upto 48 months
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal discomfort
|
0.00%
0/114 • Upto 48 months
|
33.3%
1/3 • Number of events 1 • Upto 48 months
|
0.85%
1/117 • Number of events 1 • Upto 48 months
|
|
Gastrointestinal disorders
Abdominal pain
|
4.4%
5/114 • Number of events 5 • Upto 48 months
|
0.00%
0/3 • Upto 48 months
|
4.3%
5/117 • Number of events 5 • Upto 48 months
|
|
Gastrointestinal disorders
Abdominal pain upper
|
5.3%
6/114 • Number of events 6 • Upto 48 months
|
0.00%
0/3 • Upto 48 months
|
5.1%
6/117 • Number of events 6 • Upto 48 months
|
|
Gastrointestinal disorders
Dyspepsia
|
3.5%
4/114 • Number of events 4 • Upto 48 months
|
0.00%
0/3 • Upto 48 months
|
3.4%
4/117 • Number of events 4 • Upto 48 months
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
4.4%
5/114 • Number of events 5 • Upto 48 months
|
0.00%
0/3 • Upto 48 months
|
4.3%
5/117 • Number of events 5 • Upto 48 months
|
|
Gastrointestinal disorders
Noninfective gingivitis
|
0.00%
0/114 • Upto 48 months
|
33.3%
1/3 • Number of events 1 • Upto 48 months
|
0.85%
1/117 • Number of events 1 • Upto 48 months
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
3.5%
4/114 • Number of events 4 • Upto 48 months
|
0.00%
0/3 • Upto 48 months
|
3.4%
4/117 • Number of events 4 • Upto 48 months
|
|
Skin and subcutaneous tissue disorders
Erythema
|
3.5%
4/114 • Number of events 4 • Upto 48 months
|
0.00%
0/3 • Upto 48 months
|
3.4%
4/117 • Number of events 4 • Upto 48 months
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
3.5%
4/114 • Number of events 4 • Upto 48 months
|
0.00%
0/3 • Upto 48 months
|
3.4%
4/117 • Number of events 4 • Upto 48 months
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
3.5%
4/114 • Number of events 5 • Upto 48 months
|
0.00%
0/3 • Upto 48 months
|
3.4%
4/117 • Number of events 5 • Upto 48 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
3.5%
4/114 • Number of events 5 • Upto 48 months
|
0.00%
0/3 • Upto 48 months
|
3.4%
4/117 • Number of events 5 • Upto 48 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
4.4%
5/114 • Number of events 5 • Upto 48 months
|
0.00%
0/3 • Upto 48 months
|
4.3%
5/117 • Number of events 5 • Upto 48 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
4.4%
5/114 • Number of events 5 • Upto 48 months
|
0.00%
0/3 • Upto 48 months
|
4.3%
5/117 • Number of events 5 • Upto 48 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.6%
3/114 • Number of events 4 • Upto 48 months
|
0.00%
0/3 • Upto 48 months
|
2.6%
3/117 • Number of events 4 • Upto 48 months
|
|
Renal and urinary disorders
Renal impairment
|
0.88%
1/114 • Number of events 1 • Upto 48 months
|
33.3%
1/3 • Number of events 1 • Upto 48 months
|
1.7%
2/117 • Number of events 2 • Upto 48 months
|
|
Reproductive system and breast disorders
Breast pain
|
0.00%
0/114 • Upto 48 months
|
33.3%
1/3 • Number of events 1 • Upto 48 months
|
0.85%
1/117 • Number of events 1 • Upto 48 months
|
|
General disorders
Chest discomfort
|
2.6%
3/114 • Number of events 3 • Upto 48 months
|
0.00%
0/3 • Upto 48 months
|
2.6%
3/117 • Number of events 3 • Upto 48 months
|
|
General disorders
Chills
|
2.6%
3/114 • Number of events 3 • Upto 48 months
|
0.00%
0/3 • Upto 48 months
|
2.6%
3/117 • Number of events 3 • Upto 48 months
|
|
Investigations
Aspartate aminotransferase increased
|
2.6%
3/114 • Number of events 3 • Upto 48 months
|
0.00%
0/3 • Upto 48 months
|
2.6%
3/117 • Number of events 3 • Upto 48 months
|
|
Investigations
Blood alkaline phosphatase increased
|
2.6%
3/114 • Number of events 3 • Upto 48 months
|
0.00%
0/3 • Upto 48 months
|
2.6%
3/117 • Number of events 3 • Upto 48 months
|
|
Investigations
Blood thyroid stimulating hormone increased
|
3.5%
4/114 • Number of events 4 • Upto 48 months
|
0.00%
0/3 • Upto 48 months
|
3.4%
4/117 • Number of events 4 • Upto 48 months
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
2.6%
3/114 • Number of events 4 • Upto 48 months
|
0.00%
0/3 • Upto 48 months
|
2.6%
3/117 • Number of events 4 • Upto 48 months
|
|
Infections and infestations
COVID-19
|
6.1%
7/114 • Number of events 7 • Upto 48 months
|
0.00%
0/3 • Upto 48 months
|
6.0%
7/117 • Number of events 7 • Upto 48 months
|
|
Infections and infestations
Rhinitis
|
2.6%
3/114 • Number of events 3 • Upto 48 months
|
0.00%
0/3 • Upto 48 months
|
2.6%
3/117 • Number of events 3 • Upto 48 months
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
2.6%
3/114 • Number of events 4 • Upto 48 months
|
0.00%
0/3 • Upto 48 months
|
2.6%
3/117 • Number of events 4 • Upto 48 months
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
2.6%
3/114 • Number of events 6 • Upto 48 months
|
0.00%
0/3 • Upto 48 months
|
2.6%
3/117 • Number of events 6 • Upto 48 months
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
3.5%
4/114 • Number of events 4 • Upto 48 months
|
0.00%
0/3 • Upto 48 months
|
3.4%
4/117 • Number of events 4 • Upto 48 months
|
|
Psychiatric disorders
Depression
|
2.6%
3/114 • Number of events 3 • Upto 48 months
|
0.00%
0/3 • Upto 48 months
|
2.6%
3/117 • Number of events 3 • Upto 48 months
|
|
Nervous system disorders
Dizziness
|
6.1%
7/114 • Number of events 13 • Upto 48 months
|
0.00%
0/3 • Upto 48 months
|
6.0%
7/117 • Number of events 13 • Upto 48 months
|
|
Vascular disorders
Deep vein thrombosis
|
2.6%
3/114 • Number of events 3 • Upto 48 months
|
0.00%
0/3 • Upto 48 months
|
2.6%
3/117 • Number of events 3 • Upto 48 months
|
|
Vascular disorders
Hypotension
|
2.6%
3/114 • Number of events 3 • Upto 48 months
|
0.00%
0/3 • Upto 48 months
|
2.6%
3/117 • Number of events 3 • Upto 48 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
2.6%
3/114 • Number of events 3 • Upto 48 months
|
0.00%
0/3 • Upto 48 months
|
2.6%
3/117 • Number of events 3 • Upto 48 months
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
2.6%
3/114 • Number of events 3 • Upto 48 months
|
0.00%
0/3 • Upto 48 months
|
2.6%
3/117 • Number of events 3 • Upto 48 months
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
3.5%
4/114 • Number of events 4 • Upto 48 months
|
0.00%
0/3 • Upto 48 months
|
3.4%
4/117 • Number of events 4 • Upto 48 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
2.6%
3/114 • Number of events 3 • Upto 48 months
|
0.00%
0/3 • Upto 48 months
|
2.6%
3/117 • Number of events 3 • Upto 48 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
2.6%
3/114 • Number of events 3 • Upto 48 months
|
0.00%
0/3 • Upto 48 months
|
2.6%
3/117 • Number of events 3 • Upto 48 months
|
|
Gastrointestinal disorders
Dysphagia
|
2.6%
3/114 • Number of events 4 • Upto 48 months
|
0.00%
0/3 • Upto 48 months
|
2.6%
3/117 • Number of events 4 • Upto 48 months
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
2.6%
3/114 • Number of events 3 • Upto 48 months
|
0.00%
0/3 • Upto 48 months
|
2.6%
3/117 • Number of events 3 • Upto 48 months
|
|
General disorders
Chest pain
|
2.6%
3/114 • Number of events 3 • Upto 48 months
|
0.00%
0/3 • Upto 48 months
|
2.6%
3/117 • Number of events 3 • Upto 48 months
|
|
Investigations
Blood glucose increased
|
2.6%
3/114 • Number of events 3 • Upto 48 months
|
0.00%
0/3 • Upto 48 months
|
2.6%
3/117 • Number of events 3 • Upto 48 months
|
|
Investigations
Lipase increased
|
2.6%
3/114 • Number of events 4 • Upto 48 months
|
0.00%
0/3 • Upto 48 months
|
2.6%
3/117 • Number of events 4 • Upto 48 months
|
|
Investigations
Platelet count decreased
|
2.6%
3/114 • Number of events 4 • Upto 48 months
|
0.00%
0/3 • Upto 48 months
|
2.6%
3/117 • Number of events 4 • Upto 48 months
|
|
Injury, poisoning and procedural complications
Radiation pneumonitis
|
3.5%
4/114 • Number of events 4 • Upto 48 months
|
0.00%
0/3 • Upto 48 months
|
3.4%
4/117 • Number of events 4 • Upto 48 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee This document contains trade secrets and confidential commercial information, disclosure of which is prohibited without providing advance notice to AstraZeneca and opportunity to object.
- Publication restrictions are in place
Restriction type: OTHER