Trial Outcomes & Findings for An Open-Label, Multi-Centre, Study to Assess the Safety of Fixed-Dose Durvalumab + Tremelimumab Combination Therapy or Durvalumab Monotherapy in Advanced Solid Malignancies. (NCT NCT03084471)
NCT ID: NCT03084471
Last Updated: 2022-12-22
Results Overview
Incidence, severity, nature, seriousness, intervention/treatment, outcome, and causality of AESIs were assessed. AESIs included events with a potential inflammatory or immune-mediated mechanism that required interventions such as steroids, immunosuppressants, and/or hormone replacement therapy.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
867 participants
Primary outcome timeframe
From screening to safety follow up visit (90 days after last dose), up to approximately 3 years.
Results posted on
2022-12-22
Participant Flow
Participants who met all the inclusion and none of the exclusion criteria were randomized at 77 study centers across 8 countries (Canada, France, Germany, Italy, Republic of Korea, Netherlands, United Kingdom and United States of America).
During the screening period (4 weeks), eligible participants signed the informed consent. All the study assessments were performed as per the schedule of assessment.
Participant milestones
| Measure |
Durvalumab
All participants received fixed-dose of durvalumab 1500 mg every 4 weeks until disease progression or unacceptable toxicity.
|
|---|---|
|
Overall Study
STARTED
|
867
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
867
|
Reasons for withdrawal
| Measure |
Durvalumab
All participants received fixed-dose of durvalumab 1500 mg every 4 weeks until disease progression or unacceptable toxicity.
|
|---|---|
|
Overall Study
Development of study specific discontinuation criteria
|
2
|
|
Overall Study
Condition under investigation worsened
|
84
|
|
Overall Study
Lack of therapeutic response
|
2
|
|
Overall Study
Protocol Violation
|
1
|
|
Overall Study
Adverse Event
|
73
|
|
Overall Study
Withdrawal by Subject
|
12
|
|
Overall Study
Disease relapse
|
181
|
|
Overall Study
Subjective disease progression
|
359
|
|
Overall Study
Other (as recorded)
|
33
|
|
Overall Study
Patients who were still on study treatment at Data Cutoff
|
120
|
Baseline Characteristics
Race was not a mandatory variable to be collected in some sites due to data privacy reasons. Hence, the total number of participants analysed for race is lesser than Overall (Safety Analysis Set)
Baseline characteristics by cohort
| Measure |
Durvalumab
n=867 Participants
All participants received fixed-dose of durvalumab 1500 mg every 4 weeks until disease progression or unacceptable toxicity.
|
|---|---|
|
Age, Continuous
|
67.5 years
STANDARD_DEVIATION 9.36 • n=867 Participants
|
|
Sex: Female, Male
Female
|
173 Participants
n=867 Participants
|
|
Sex: Female, Male
Male
|
694 Participants
n=867 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=603 Participants • Race was not a mandatory variable to be collected in some sites due to data privacy reasons. Hence, the total number of participants analysed for race is lesser than Overall (Safety Analysis Set)
|
|
Race (NIH/OMB)
Asian
|
65 Participants
n=603 Participants • Race was not a mandatory variable to be collected in some sites due to data privacy reasons. Hence, the total number of participants analysed for race is lesser than Overall (Safety Analysis Set)
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=603 Participants • Race was not a mandatory variable to be collected in some sites due to data privacy reasons. Hence, the total number of participants analysed for race is lesser than Overall (Safety Analysis Set)
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=603 Participants • Race was not a mandatory variable to be collected in some sites due to data privacy reasons. Hence, the total number of participants analysed for race is lesser than Overall (Safety Analysis Set)
|
|
Race (NIH/OMB)
White
|
508 Participants
n=603 Participants • Race was not a mandatory variable to be collected in some sites due to data privacy reasons. Hence, the total number of participants analysed for race is lesser than Overall (Safety Analysis Set)
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=603 Participants • Race was not a mandatory variable to be collected in some sites due to data privacy reasons. Hence, the total number of participants analysed for race is lesser than Overall (Safety Analysis Set)
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
28 Participants
n=603 Participants • Race was not a mandatory variable to be collected in some sites due to data privacy reasons. Hence, the total number of participants analysed for race is lesser than Overall (Safety Analysis Set)
|
PRIMARY outcome
Timeframe: From screening to safety follow up visit (90 days after last dose), up to approximately 3 years.Population: Safety analysis set: all enrolled participants who received at least one dose of durvalumab.
Incidence, severity, nature, seriousness, intervention/treatment, outcome, and causality of AESIs were assessed. AESIs included events with a potential inflammatory or immune-mediated mechanism that required interventions such as steroids, immunosuppressants, and/or hormone replacement therapy.
Outcome measures
| Measure |
AESI
n=867 Participants
AESIs are defined as AEs with a likely inflammatory or immune-mediated pathophysiological basis, resulting from the mechanism of action of durvalumab and/or tremelimumab and requiring more frequent monitoring and/or interventions, such as corticosteroids, immunosuppressants, and/or endocrine therapy.
|
AEPI
n=867 Participants
AEPIs are defined as AEs that could have a potential inflammatory or immune-mediated pathophysiological basis, resulting from the mechanism of action of durvalumab but are more likely to have occurred due to other pathophysiological mechanisms, thus, the likelihood of the event being inflammatory or immune-mediated in nature is not high and/or is most often or usually explained by the other causes.
|
imAE
n=867 Participants
The imAEs that occurred during this study were determined by a programmatic algorithm that required specific treatment for AESIs to be considered imAEs; the same specific treatment was required for AEPIs as well.
|
|---|---|---|---|
|
Number of Participants With Adverse Events of Special Interest (AESIs)
Any adverse event (AE)
|
265 participants
|
300 participants
|
97 participants
|
|
Number of Participants With Adverse Events of Special Interest (AESIs)
Any AE of common terminology criteria for AEs Grade 3 or 4
|
21 participants
|
49 participants
|
17 participants
|
|
Number of Participants With Adverse Events of Special Interest (AESIs)
Any serious adverse event (SAE) (including events with outcome = death)
|
19 participants
|
13 participants
|
11 participants
|
|
Number of Participants With Adverse Events of Special Interest (AESIs)
Any AE with outcome = death
|
1 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Adverse Events of Special Interest (AESIs)
Any AE, causally related to treatment
|
191 participants
|
145 participants
|
87 participants
|
|
Number of Participants With Adverse Events of Special Interest (AESIs)
Any AE of common terminology criteria Grade 3 or 4, causally related to treatment
|
15 participants
|
20 participants
|
16 participants
|
|
Number of Participants With Adverse Events of Special Interest (AESIs)
Any SAE, causally related to treatment
|
14 participants
|
3 participants
|
10 participants
|
|
Number of Participants With Adverse Events of Special Interest (AESIs)
Any AE with outcome = death, causally related to treatment
|
1 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Adverse Events of Special Interest (AESIs)
Any AE leading to discontinuation of study treatment
|
12 participants
|
7 participants
|
10 participants
|
|
Number of Participants With Adverse Events of Special Interest (AESIs)
Event outcome resolved
|
140 participants
|
119 participants
|
32 participants
|
|
Number of Participants With Adverse Events of Special Interest (AESIs)
Event outcome not resolved
|
124 participants
|
181 participants
|
65 participants
|
SECONDARY outcome
Timeframe: From screening to final data cutoff (maximum up to 4 years) following date of first patient treatment initiation.Population: Safety analysis set: all enrolled participants who received at least 1 dose of durvalumab.
Overall survival was defined as the time from the first date of treatment until death due to any cause.
Outcome measures
| Measure |
AESI
n=867 Participants
AESIs are defined as AEs with a likely inflammatory or immune-mediated pathophysiological basis, resulting from the mechanism of action of durvalumab and/or tremelimumab and requiring more frequent monitoring and/or interventions, such as corticosteroids, immunosuppressants, and/or endocrine therapy.
|
AEPI
AEPIs are defined as AEs that could have a potential inflammatory or immune-mediated pathophysiological basis, resulting from the mechanism of action of durvalumab but are more likely to have occurred due to other pathophysiological mechanisms, thus, the likelihood of the event being inflammatory or immune-mediated in nature is not high and/or is most often or usually explained by the other causes.
|
imAE
The imAEs that occurred during this study were determined by a programmatic algorithm that required specific treatment for AESIs to be considered imAEs; the same specific treatment was required for AEPIs as well.
|
|---|---|---|---|
|
Overall Survival
|
7.0 months
Interval 6.44 to 8.18
|
—
|
—
|
SECONDARY outcome
Timeframe: From screening to safety follow up visit (90 days after last dose), maximum up to 4 years.Population: Safety analysis set: all enrolled participants who received at least one dose of durvalumab.
Incidence, severity, nature, seriousness, intervention/treatment, outcome, and causality of treatment-emergent AEs (including SAEs) will be assessed
Outcome measures
| Measure |
AESI
n=867 Participants
AESIs are defined as AEs with a likely inflammatory or immune-mediated pathophysiological basis, resulting from the mechanism of action of durvalumab and/or tremelimumab and requiring more frequent monitoring and/or interventions, such as corticosteroids, immunosuppressants, and/or endocrine therapy.
|
AEPI
AEPIs are defined as AEs that could have a potential inflammatory or immune-mediated pathophysiological basis, resulting from the mechanism of action of durvalumab but are more likely to have occurred due to other pathophysiological mechanisms, thus, the likelihood of the event being inflammatory or immune-mediated in nature is not high and/or is most often or usually explained by the other causes.
|
imAE
The imAEs that occurred during this study were determined by a programmatic algorithm that required specific treatment for AESIs to be considered imAEs; the same specific treatment was required for AEPIs as well.
|
|---|---|---|---|
|
Number of Participants With Adverse Events
Any AE
|
787 participants
|
—
|
—
|
|
Number of Participants With Adverse Events
Any AE causally related to any study treatment
|
407 participants
|
—
|
—
|
|
Number of Participants With Adverse Events
Any AE of common terminology criteria grade 3 or higher
|
365 participants
|
—
|
—
|
|
Number of Participants With Adverse Events
Any AE of common terminology criteria grade 3 or higher, causally related to study treatment
|
78 participants
|
—
|
—
|
|
Number of Participants With Adverse Events
Any AE with outcome = death
|
42 participants
|
—
|
—
|
|
Number of Participants With Adverse Events
Any AE with outcome = death causally related to study treatment
|
9 participants
|
—
|
—
|
|
Number of Participants With Adverse Events
Any SAE (including events with outcome = death)
|
254 participants
|
—
|
—
|
|
Number of Participants With Adverse Events
Any SAE (including events with outcome = death) causally related to study treatment
|
41 participants
|
—
|
—
|
|
Number of Participants With Adverse Events
Any AE leading to discontinuation of study treatment
|
77 participants
|
—
|
—
|
|
Number of Participants With Adverse Events
Any AE leading to discontinuation of study treatment causally related to study treatment
|
33 participants
|
—
|
—
|
Adverse Events
Durvalumab
Serious events: 254 serious events
Other events: 669 other events
Deaths: 600 deaths
Serious adverse events
| Measure |
Durvalumab
n=867 participants at risk
All participants received fixed-dose of durvalumab 1500 mg every 4 weeks until disease progression or unacceptable toxicity.
|
|---|---|
|
Infections and infestations
Sepsis
|
2.1%
18/867 • From screening to safety follow up visit (90 days after last dose), maximum up to 4 years.
MedDRA version 23.0
|
|
Infections and infestations
Urinary tract infection
|
2.0%
17/867 • From screening to safety follow up visit (90 days after last dose), maximum up to 4 years.
MedDRA version 23.0
|
|
Infections and infestations
Pyelonephritis
|
0.92%
8/867 • From screening to safety follow up visit (90 days after last dose), maximum up to 4 years.
MedDRA version 23.0
|
|
Infections and infestations
Device related infection
|
0.81%
7/867 • From screening to safety follow up visit (90 days after last dose), maximum up to 4 years.
MedDRA version 23.0
|
|
Infections and infestations
Pneumonia
|
0.69%
6/867 • From screening to safety follow up visit (90 days after last dose), maximum up to 4 years.
MedDRA version 23.0
|
|
Infections and infestations
Urosepsis
|
0.58%
5/867 • From screening to safety follow up visit (90 days after last dose), maximum up to 4 years.
MedDRA version 23.0
|
|
Infections and infestations
Pyelonephritis acute
|
0.46%
4/867 • From screening to safety follow up visit (90 days after last dose), maximum up to 4 years.
MedDRA version 23.0
|
|
Infections and infestations
Bacterial infection
|
0.35%
3/867 • From screening to safety follow up visit (90 days after last dose), maximum up to 4 years.
MedDRA version 23.0
|
|
Infections and infestations
Cellulitis
|
0.23%
2/867 • From screening to safety follow up visit (90 days after last dose), maximum up to 4 years.
MedDRA version 23.0
|
|
Infections and infestations
Septic shock
|
0.23%
2/867 • From screening to safety follow up visit (90 days after last dose), maximum up to 4 years.
MedDRA version 23.0
|
|
Infections and infestations
Atypical pneumonia
|
0.12%
1/867 • From screening to safety follow up visit (90 days after last dose), maximum up to 4 years.
MedDRA version 23.0
|
|
Infections and infestations
Bacteraemia
|
0.12%
1/867 • From screening to safety follow up visit (90 days after last dose), maximum up to 4 years.
MedDRA version 23.0
|
|
Infections and infestations
COVID-19
|
0.12%
1/867 • From screening to safety follow up visit (90 days after last dose), maximum up to 4 years.
MedDRA version 23.0
|
|
Infections and infestations
Clostridium colitis
|
0.12%
1/867 • From screening to safety follow up visit (90 days after last dose), maximum up to 4 years.
MedDRA version 23.0
|
|
Infections and infestations
Cystitis
|
0.12%
1/867 • From screening to safety follow up visit (90 days after last dose), maximum up to 4 years.
MedDRA version 23.0
|
|
Infections and infestations
Diverticulitis
|
0.12%
1/867 • From screening to safety follow up visit (90 days after last dose), maximum up to 4 years.
MedDRA version 23.0
|
|
Infections and infestations
Enterobacter infection
|
0.12%
1/867 • From screening to safety follow up visit (90 days after last dose), maximum up to 4 years.
MedDRA version 23.0
|
|
Infections and infestations
Enterobacter sepsis
|
0.12%
1/867 • From screening to safety follow up visit (90 days after last dose), maximum up to 4 years.
MedDRA version 23.0
|
|
Infections and infestations
Escherichia infection
|
0.12%
1/867 • From screening to safety follow up visit (90 days after last dose), maximum up to 4 years.
MedDRA version 23.0
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.12%
1/867 • From screening to safety follow up visit (90 days after last dose), maximum up to 4 years.
MedDRA version 23.0
|
|
Infections and infestations
Fournier's gangrene
|
0.12%
1/867 • From screening to safety follow up visit (90 days after last dose), maximum up to 4 years.
MedDRA version 23.0
|
|
Infections and infestations
Hepatitis E
|
0.12%
1/867 • From screening to safety follow up visit (90 days after last dose), maximum up to 4 years.
MedDRA version 23.0
|
|
Infections and infestations
Infection
|
0.12%
1/867 • From screening to safety follow up visit (90 days after last dose), maximum up to 4 years.
MedDRA version 23.0
|
|
Infections and infestations
Pneumocystis jirovecii infection
|
0.12%
1/867 • From screening to safety follow up visit (90 days after last dose), maximum up to 4 years.
MedDRA version 23.0
|
|
Infections and infestations
Spinal cord infection
|
0.12%
1/867 • From screening to safety follow up visit (90 days after last dose), maximum up to 4 years.
MedDRA version 23.0
|
|
Infections and infestations
Staphylococcal infection
|
0.12%
1/867 • From screening to safety follow up visit (90 days after last dose), maximum up to 4 years.
MedDRA version 23.0
|
|
Infections and infestations
Staphylococcal sepsis
|
0.12%
1/867 • From screening to safety follow up visit (90 days after last dose), maximum up to 4 years.
MedDRA version 23.0
|
|
Infections and infestations
Streptococcal infection
|
0.12%
1/867 • From screening to safety follow up visit (90 days after last dose), maximum up to 4 years.
MedDRA version 23.0
|
|
Infections and infestations
Tracheitis
|
0.12%
1/867 • From screening to safety follow up visit (90 days after last dose), maximum up to 4 years.
MedDRA version 23.0
|
|
Infections and infestations
Upper respiratory tract infection
|
0.12%
1/867 • From screening to safety follow up visit (90 days after last dose), maximum up to 4 years.
MedDRA version 23.0
|
|
Infections and infestations
Urinary tract infection enterococcal
|
0.12%
1/867 • From screening to safety follow up visit (90 days after last dose), maximum up to 4 years.
MedDRA version 23.0
|
|
Gastrointestinal disorders
Diarrhoea
|
0.81%
7/867 • From screening to safety follow up visit (90 days after last dose), maximum up to 4 years.
MedDRA version 23.0
|
|
Gastrointestinal disorders
Abdominal pain
|
0.58%
5/867 • From screening to safety follow up visit (90 days after last dose), maximum up to 4 years.
MedDRA version 23.0
|
|
Gastrointestinal disorders
Constipation
|
0.58%
5/867 • From screening to safety follow up visit (90 days after last dose), maximum up to 4 years.
MedDRA version 23.0
|
|
Gastrointestinal disorders
Colitis
|
0.46%
4/867 • From screening to safety follow up visit (90 days after last dose), maximum up to 4 years.
MedDRA version 23.0
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.23%
2/867 • From screening to safety follow up visit (90 days after last dose), maximum up to 4 years.
MedDRA version 23.0
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.23%
2/867 • From screening to safety follow up visit (90 days after last dose), maximum up to 4 years.
MedDRA version 23.0
|
|
Gastrointestinal disorders
Subileus
|
0.23%
2/867 • From screening to safety follow up visit (90 days after last dose), maximum up to 4 years.
MedDRA version 23.0
|
|
Gastrointestinal disorders
Anal fistula
|
0.12%
1/867 • From screening to safety follow up visit (90 days after last dose), maximum up to 4 years.
MedDRA version 23.0
|
|
Gastrointestinal disorders
Autoimmune colitis
|
0.12%
1/867 • From screening to safety follow up visit (90 days after last dose), maximum up to 4 years.
MedDRA version 23.0
|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.12%
1/867 • From screening to safety follow up visit (90 days after last dose), maximum up to 4 years.
MedDRA version 23.0
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.12%
1/867 • From screening to safety follow up visit (90 days after last dose), maximum up to 4 years.
MedDRA version 23.0
|
|
Gastrointestinal disorders
Duodenitis haemorrhagic
|
0.12%
1/867 • From screening to safety follow up visit (90 days after last dose), maximum up to 4 years.
MedDRA version 23.0
|
|
Gastrointestinal disorders
Enterocolitis
|
0.12%
1/867 • From screening to safety follow up visit (90 days after last dose), maximum up to 4 years.
MedDRA version 23.0
|
|
Gastrointestinal disorders
Enterovesical fistula
|
0.12%
1/867 • From screening to safety follow up visit (90 days after last dose), maximum up to 4 years.
MedDRA version 23.0
|
|
Gastrointestinal disorders
Ileus
|
0.12%
1/867 • From screening to safety follow up visit (90 days after last dose), maximum up to 4 years.
MedDRA version 23.0
|
|
Gastrointestinal disorders
Ileus paralytic
|
0.12%
1/867 • From screening to safety follow up visit (90 days after last dose), maximum up to 4 years.
MedDRA version 23.0
|
|
Gastrointestinal disorders
Intestinal atony
|
0.12%
1/867 • From screening to safety follow up visit (90 days after last dose), maximum up to 4 years.
MedDRA version 23.0
|
|
Gastrointestinal disorders
Intestinal ischaemia
|
0.12%
1/867 • From screening to safety follow up visit (90 days after last dose), maximum up to 4 years.
MedDRA version 23.0
|
|
Gastrointestinal disorders
Intestinal pseudo-obstruction
|
0.12%
1/867 • From screening to safety follow up visit (90 days after last dose), maximum up to 4 years.
MedDRA version 23.0
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.12%
1/867 • From screening to safety follow up visit (90 days after last dose), maximum up to 4 years.
MedDRA version 23.0
|
|
Gastrointestinal disorders
Nausea
|
0.12%
1/867 • From screening to safety follow up visit (90 days after last dose), maximum up to 4 years.
MedDRA version 23.0
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.12%
1/867 • From screening to safety follow up visit (90 days after last dose), maximum up to 4 years.
MedDRA version 23.0
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.12%
1/867 • From screening to safety follow up visit (90 days after last dose), maximum up to 4 years.
MedDRA version 23.0
|
|
Gastrointestinal disorders
Stomatitis
|
0.12%
1/867 • From screening to safety follow up visit (90 days after last dose), maximum up to 4 years.
MedDRA version 23.0
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.12%
1/867 • From screening to safety follow up visit (90 days after last dose), maximum up to 4 years.
MedDRA version 23.0
|
|
Renal and urinary disorders
Acute kidney injury
|
0.92%
8/867 • From screening to safety follow up visit (90 days after last dose), maximum up to 4 years.
MedDRA version 23.0
|
|
Renal and urinary disorders
Haematuria
|
0.81%
7/867 • From screening to safety follow up visit (90 days after last dose), maximum up to 4 years.
MedDRA version 23.0
|
|
Renal and urinary disorders
Renal failure
|
0.46%
4/867 • From screening to safety follow up visit (90 days after last dose), maximum up to 4 years.
MedDRA version 23.0
|
|
Renal and urinary disorders
Hydronephrosis
|
0.35%
3/867 • From screening to safety follow up visit (90 days after last dose), maximum up to 4 years.
MedDRA version 23.0
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.35%
3/867 • From screening to safety follow up visit (90 days after last dose), maximum up to 4 years.
MedDRA version 23.0
|
|
Renal and urinary disorders
Urinary tract inflammation
|
0.23%
2/867 • From screening to safety follow up visit (90 days after last dose), maximum up to 4 years.
MedDRA version 23.0
|
|
Renal and urinary disorders
Renal impairment
|
0.12%
1/867 • From screening to safety follow up visit (90 days after last dose), maximum up to 4 years.
MedDRA version 23.0
|
|
Renal and urinary disorders
Ureteric stenosis
|
0.12%
1/867 • From screening to safety follow up visit (90 days after last dose), maximum up to 4 years.
MedDRA version 23.0
|
|
Renal and urinary disorders
Urinary retention
|
0.12%
1/867 • From screening to safety follow up visit (90 days after last dose), maximum up to 4 years.
MedDRA version 23.0
|
|
Renal and urinary disorders
Urine abnormality
|
0.12%
1/867 • From screening to safety follow up visit (90 days after last dose), maximum up to 4 years.
MedDRA version 23.0
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour hyperprogression
|
1.3%
11/867 • From screening to safety follow up visit (90 days after last dose), maximum up to 4 years.
MedDRA version 23.0
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.23%
2/867 • From screening to safety follow up visit (90 days after last dose), maximum up to 4 years.
MedDRA version 23.0
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour associated fever
|
0.23%
2/867 • From screening to safety follow up visit (90 days after last dose), maximum up to 4 years.
MedDRA version 23.0
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer recurrent
|
0.12%
1/867 • From screening to safety follow up visit (90 days after last dose), maximum up to 4 years.
MedDRA version 23.0
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder neoplasm
|
0.12%
1/867 • From screening to safety follow up visit (90 days after last dose), maximum up to 4 years.
MedDRA version 23.0
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bronchial carcinoma
|
0.12%
1/867 • From screening to safety follow up visit (90 days after last dose), maximum up to 4 years.
MedDRA version 23.0
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.12%
1/867 • From screening to safety follow up visit (90 days after last dose), maximum up to 4 years.
MedDRA version 23.0
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.12%
1/867 • From screening to safety follow up visit (90 days after last dose), maximum up to 4 years.
MedDRA version 23.0
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Infected neoplasm
|
0.12%
1/867 • From screening to safety follow up visit (90 days after last dose), maximum up to 4 years.
MedDRA version 23.0
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphangiosis carcinomatosa
|
0.12%
1/867 • From screening to safety follow up visit (90 days after last dose), maximum up to 4 years.
MedDRA version 23.0
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neuroendocrine tumour
|
0.12%
1/867 • From screening to safety follow up visit (90 days after last dose), maximum up to 4 years.
MedDRA version 23.0
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pelvic neoplasm
|
0.12%
1/867 • From screening to safety follow up visit (90 days after last dose), maximum up to 4 years.
MedDRA version 23.0
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.12%
1/867 • From screening to safety follow up visit (90 days after last dose), maximum up to 4 years.
MedDRA version 23.0
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
|
0.12%
1/867 • From screening to safety follow up visit (90 days after last dose), maximum up to 4 years.
MedDRA version 23.0
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.12%
1/867 • From screening to safety follow up visit (90 days after last dose), maximum up to 4 years.
MedDRA version 23.0
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.81%
7/867 • From screening to safety follow up visit (90 days after last dose), maximum up to 4 years.
MedDRA version 23.0
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.46%
4/867 • From screening to safety follow up visit (90 days after last dose), maximum up to 4 years.
MedDRA version 23.0
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.46%
4/867 • From screening to safety follow up visit (90 days after last dose), maximum up to 4 years.
MedDRA version 23.0
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.35%
3/867 • From screening to safety follow up visit (90 days after last dose), maximum up to 4 years.
MedDRA version 23.0
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.23%
2/867 • From screening to safety follow up visit (90 days after last dose), maximum up to 4 years.
MedDRA version 23.0
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.23%
2/867 • From screening to safety follow up visit (90 days after last dose), maximum up to 4 years.
MedDRA version 23.0
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.12%
1/867 • From screening to safety follow up visit (90 days after last dose), maximum up to 4 years.
MedDRA version 23.0
|
|
Respiratory, thoracic and mediastinal disorders
Bronchiectasis
|
0.12%
1/867 • From screening to safety follow up visit (90 days after last dose), maximum up to 4 years.
MedDRA version 23.0
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.12%
1/867 • From screening to safety follow up visit (90 days after last dose), maximum up to 4 years.
MedDRA version 23.0
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.12%
1/867 • From screening to safety follow up visit (90 days after last dose), maximum up to 4 years.
MedDRA version 23.0
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.12%
1/867 • From screening to safety follow up visit (90 days after last dose), maximum up to 4 years.
MedDRA version 23.0
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.12%
1/867 • From screening to safety follow up visit (90 days after last dose), maximum up to 4 years.
MedDRA version 23.0
|
|
Respiratory, thoracic and mediastinal disorders
Pleural thickening
|
0.12%
1/867 • From screening to safety follow up visit (90 days after last dose), maximum up to 4 years.
MedDRA version 23.0
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.12%
1/867 • From screening to safety follow up visit (90 days after last dose), maximum up to 4 years.
MedDRA version 23.0
|
|
General disorders
General physical health deterioration
|
0.81%
7/867 • From screening to safety follow up visit (90 days after last dose), maximum up to 4 years.
MedDRA version 23.0
|
|
General disorders
Death
|
0.58%
5/867 • From screening to safety follow up visit (90 days after last dose), maximum up to 4 years.
MedDRA version 23.0
|
|
General disorders
Pyrexia
|
0.35%
3/867 • From screening to safety follow up visit (90 days after last dose), maximum up to 4 years.
MedDRA version 23.0
|
|
General disorders
Asthenia
|
0.23%
2/867 • From screening to safety follow up visit (90 days after last dose), maximum up to 4 years.
MedDRA version 23.0
|
|
General disorders
Chest pain
|
0.12%
1/867 • From screening to safety follow up visit (90 days after last dose), maximum up to 4 years.
MedDRA version 23.0
|
|
General disorders
Drug intolerance
|
0.12%
1/867 • From screening to safety follow up visit (90 days after last dose), maximum up to 4 years.
MedDRA version 23.0
|
|
General disorders
Generalised oedema
|
0.12%
1/867 • From screening to safety follow up visit (90 days after last dose), maximum up to 4 years.
MedDRA version 23.0
|
|
General disorders
Hyperthermia
|
0.12%
1/867 • From screening to safety follow up visit (90 days after last dose), maximum up to 4 years.
MedDRA version 23.0
|
|
General disorders
Hyperthermia malignant
|
0.12%
1/867 • From screening to safety follow up visit (90 days after last dose), maximum up to 4 years.
MedDRA version 23.0
|
|
General disorders
Performance status decreased
|
0.12%
1/867 • From screening to safety follow up visit (90 days after last dose), maximum up to 4 years.
MedDRA version 23.0
|
|
General disorders
Vascular stent thrombosis
|
0.12%
1/867 • From screening to safety follow up visit (90 days after last dose), maximum up to 4 years.
MedDRA version 23.0
|
|
Injury, poisoning and procedural complications
Fall
|
0.46%
4/867 • From screening to safety follow up visit (90 days after last dose), maximum up to 4 years.
MedDRA version 23.0
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.23%
2/867 • From screening to safety follow up visit (90 days after last dose), maximum up to 4 years.
MedDRA version 23.0
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.12%
1/867 • From screening to safety follow up visit (90 days after last dose), maximum up to 4 years.
MedDRA version 23.0
|
|
Injury, poisoning and procedural complications
Forearm fracture
|
0.12%
1/867 • From screening to safety follow up visit (90 days after last dose), maximum up to 4 years.
MedDRA version 23.0
|
|
Injury, poisoning and procedural complications
Fracture
|
0.12%
1/867 • From screening to safety follow up visit (90 days after last dose), maximum up to 4 years.
MedDRA version 23.0
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.12%
1/867 • From screening to safety follow up visit (90 days after last dose), maximum up to 4 years.
MedDRA version 23.0
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.12%
1/867 • From screening to safety follow up visit (90 days after last dose), maximum up to 4 years.
MedDRA version 23.0
|
|
Injury, poisoning and procedural complications
Overdose
|
0.12%
1/867 • From screening to safety follow up visit (90 days after last dose), maximum up to 4 years.
MedDRA version 23.0
|
|
Injury, poisoning and procedural complications
Postoperative ileus
|
0.12%
1/867 • From screening to safety follow up visit (90 days after last dose), maximum up to 4 years.
MedDRA version 23.0
|
|
Injury, poisoning and procedural complications
Stomal hernia
|
0.12%
1/867 • From screening to safety follow up visit (90 days after last dose), maximum up to 4 years.
MedDRA version 23.0
|
|
Injury, poisoning and procedural complications
Urinary tract stoma complication
|
0.12%
1/867 • From screening to safety follow up visit (90 days after last dose), maximum up to 4 years.
MedDRA version 23.0
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.35%
3/867 • From screening to safety follow up visit (90 days after last dose), maximum up to 4 years.
MedDRA version 23.0
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.23%
2/867 • From screening to safety follow up visit (90 days after last dose), maximum up to 4 years.
MedDRA version 23.0
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.23%
2/867 • From screening to safety follow up visit (90 days after last dose), maximum up to 4 years.
MedDRA version 23.0
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.12%
1/867 • From screening to safety follow up visit (90 days after last dose), maximum up to 4 years.
MedDRA version 23.0
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.12%
1/867 • From screening to safety follow up visit (90 days after last dose), maximum up to 4 years.
MedDRA version 23.0
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.12%
1/867 • From screening to safety follow up visit (90 days after last dose), maximum up to 4 years.
MedDRA version 23.0
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.12%
1/867 • From screening to safety follow up visit (90 days after last dose), maximum up to 4 years.
MedDRA version 23.0
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.12%
1/867 • From screening to safety follow up visit (90 days after last dose), maximum up to 4 years.
MedDRA version 23.0
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.12%
1/867 • From screening to safety follow up visit (90 days after last dose), maximum up to 4 years.
MedDRA version 23.0
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
0.12%
1/867 • From screening to safety follow up visit (90 days after last dose), maximum up to 4 years.
MedDRA version 23.0
|
|
Cardiac disorders
Cardiac failure
|
0.46%
4/867 • From screening to safety follow up visit (90 days after last dose), maximum up to 4 years.
MedDRA version 23.0
|
|
Cardiac disorders
Pericardial effusion
|
0.23%
2/867 • From screening to safety follow up visit (90 days after last dose), maximum up to 4 years.
MedDRA version 23.0
|
|
Cardiac disorders
Acute myocardial infarction
|
0.12%
1/867 • From screening to safety follow up visit (90 days after last dose), maximum up to 4 years.
MedDRA version 23.0
|
|
Cardiac disorders
Angina pectoris
|
0.12%
1/867 • From screening to safety follow up visit (90 days after last dose), maximum up to 4 years.
MedDRA version 23.0
|
|
Cardiac disorders
Arrhythmia
|
0.12%
1/867 • From screening to safety follow up visit (90 days after last dose), maximum up to 4 years.
MedDRA version 23.0
|
|
Cardiac disorders
Cardiac arrest
|
0.12%
1/867 • From screening to safety follow up visit (90 days after last dose), maximum up to 4 years.
MedDRA version 23.0
|
|
Cardiac disorders
Coronary artery occlusion
|
0.12%
1/867 • From screening to safety follow up visit (90 days after last dose), maximum up to 4 years.
MedDRA version 23.0
|
|
Cardiac disorders
Left ventricular dysfunction
|
0.12%
1/867 • From screening to safety follow up visit (90 days after last dose), maximum up to 4 years.
MedDRA version 23.0
|
|
Blood and lymphatic system disorders
Anaemia
|
0.69%
6/867 • From screening to safety follow up visit (90 days after last dose), maximum up to 4 years.
MedDRA version 23.0
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.46%
4/867 • From screening to safety follow up visit (90 days after last dose), maximum up to 4 years.
MedDRA version 23.0
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.12%
1/867 • From screening to safety follow up visit (90 days after last dose), maximum up to 4 years.
MedDRA version 23.0
|
|
Nervous system disorders
Ischaemic stroke
|
0.23%
2/867 • From screening to safety follow up visit (90 days after last dose), maximum up to 4 years.
MedDRA version 23.0
|
|
Nervous system disorders
Basilar artery occlusion
|
0.12%
1/867 • From screening to safety follow up visit (90 days after last dose), maximum up to 4 years.
MedDRA version 23.0
|
|
Nervous system disorders
Embolic stroke
|
0.12%
1/867 • From screening to safety follow up visit (90 days after last dose), maximum up to 4 years.
MedDRA version 23.0
|
|
Nervous system disorders
Frontal lobe epilepsy
|
0.12%
1/867 • From screening to safety follow up visit (90 days after last dose), maximum up to 4 years.
MedDRA version 23.0
|
|
Nervous system disorders
IIIrd nerve paralysis
|
0.12%
1/867 • From screening to safety follow up visit (90 days after last dose), maximum up to 4 years.
MedDRA version 23.0
|
|
Nervous system disorders
Peroneal nerve palsy
|
0.12%
1/867 • From screening to safety follow up visit (90 days after last dose), maximum up to 4 years.
MedDRA version 23.0
|
|
Nervous system disorders
Somnolence
|
0.12%
1/867 • From screening to safety follow up visit (90 days after last dose), maximum up to 4 years.
MedDRA version 23.0
|
|
Nervous system disorders
Syncope
|
0.12%
1/867 • From screening to safety follow up visit (90 days after last dose), maximum up to 4 years.
MedDRA version 23.0
|
|
Nervous system disorders
VIth nerve disorder
|
0.12%
1/867 • From screening to safety follow up visit (90 days after last dose), maximum up to 4 years.
MedDRA version 23.0
|
|
Investigations
Blood creatinine increased
|
0.58%
5/867 • From screening to safety follow up visit (90 days after last dose), maximum up to 4 years.
MedDRA version 23.0
|
|
Investigations
Aspartate aminotransferase increased
|
0.23%
2/867 • From screening to safety follow up visit (90 days after last dose), maximum up to 4 years.
MedDRA version 23.0
|
|
Investigations
Ejection fraction decreased
|
0.12%
1/867 • From screening to safety follow up visit (90 days after last dose), maximum up to 4 years.
MedDRA version 23.0
|
|
Investigations
Troponin increased
|
0.12%
1/867 • From screening to safety follow up visit (90 days after last dose), maximum up to 4 years.
MedDRA version 23.0
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.12%
1/867 • From screening to safety follow up visit (90 days after last dose), maximum up to 4 years.
MedDRA version 23.0
|
|
Metabolism and nutrition disorders
Dehydration
|
0.12%
1/867 • From screening to safety follow up visit (90 days after last dose), maximum up to 4 years.
MedDRA version 23.0
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.12%
1/867 • From screening to safety follow up visit (90 days after last dose), maximum up to 4 years.
MedDRA version 23.0
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.12%
1/867 • From screening to safety follow up visit (90 days after last dose), maximum up to 4 years.
MedDRA version 23.0
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.12%
1/867 • From screening to safety follow up visit (90 days after last dose), maximum up to 4 years.
MedDRA version 23.0
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.12%
1/867 • From screening to safety follow up visit (90 days after last dose), maximum up to 4 years.
MedDRA version 23.0
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.12%
1/867 • From screening to safety follow up visit (90 days after last dose), maximum up to 4 years.
MedDRA version 23.0
|
|
Metabolism and nutrition disorders
Ketoacidosis
|
0.12%
1/867 • From screening to safety follow up visit (90 days after last dose), maximum up to 4 years.
MedDRA version 23.0
|
|
Vascular disorders
Deep vein thrombosis
|
0.23%
2/867 • From screening to safety follow up visit (90 days after last dose), maximum up to 4 years.
MedDRA version 23.0
|
|
Vascular disorders
Haemorrhage
|
0.12%
1/867 • From screening to safety follow up visit (90 days after last dose), maximum up to 4 years.
MedDRA version 23.0
|
|
Vascular disorders
Lymphoedema
|
0.12%
1/867 • From screening to safety follow up visit (90 days after last dose), maximum up to 4 years.
MedDRA version 23.0
|
|
Vascular disorders
Peripheral ischaemia
|
0.12%
1/867 • From screening to safety follow up visit (90 days after last dose), maximum up to 4 years.
MedDRA version 23.0
|
|
Vascular disorders
Shock haemorrhagic
|
0.12%
1/867 • From screening to safety follow up visit (90 days after last dose), maximum up to 4 years.
MedDRA version 23.0
|
|
Vascular disorders
Thrombosis
|
0.12%
1/867 • From screening to safety follow up visit (90 days after last dose), maximum up to 4 years.
MedDRA version 23.0
|
|
Hepatobiliary disorders
Hepatitis
|
0.23%
2/867 • From screening to safety follow up visit (90 days after last dose), maximum up to 4 years.
MedDRA version 23.0
|
|
Hepatobiliary disorders
Hepatocellular injury
|
0.12%
1/867 • From screening to safety follow up visit (90 days after last dose), maximum up to 4 years.
MedDRA version 23.0
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.12%
1/867 • From screening to safety follow up visit (90 days after last dose), maximum up to 4 years.
MedDRA version 23.0
|
|
Hepatobiliary disorders
Portal vein thrombosis
|
0.12%
1/867 • From screening to safety follow up visit (90 days after last dose), maximum up to 4 years.
MedDRA version 23.0
|
|
Product Issues
Device occlusion
|
0.23%
2/867 • From screening to safety follow up visit (90 days after last dose), maximum up to 4 years.
MedDRA version 23.0
|
|
Product Issues
Device dislocation
|
0.12%
1/867 • From screening to safety follow up visit (90 days after last dose), maximum up to 4 years.
MedDRA version 23.0
|
|
Product Issues
Stent malfunction
|
0.12%
1/867 • From screening to safety follow up visit (90 days after last dose), maximum up to 4 years.
MedDRA version 23.0
|
|
Psychiatric disorders
Confusional state
|
0.12%
1/867 • From screening to safety follow up visit (90 days after last dose), maximum up to 4 years.
MedDRA version 23.0
|
|
Psychiatric disorders
Delirium
|
0.12%
1/867 • From screening to safety follow up visit (90 days after last dose), maximum up to 4 years.
MedDRA version 23.0
|
|
Psychiatric disorders
Mental status changes
|
0.12%
1/867 • From screening to safety follow up visit (90 days after last dose), maximum up to 4 years.
MedDRA version 23.0
|
|
Endocrine disorders
Hyperthyroidism
|
0.12%
1/867 • From screening to safety follow up visit (90 days after last dose), maximum up to 4 years.
MedDRA version 23.0
|
|
Endocrine disorders
Hypophysitis
|
0.12%
1/867 • From screening to safety follow up visit (90 days after last dose), maximum up to 4 years.
MedDRA version 23.0
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.12%
1/867 • From screening to safety follow up visit (90 days after last dose), maximum up to 4 years.
MedDRA version 23.0
|
|
Reproductive system and breast disorders
Scrotal mass
|
0.12%
1/867 • From screening to safety follow up visit (90 days after last dose), maximum up to 4 years.
MedDRA version 23.0
|
|
Immune system disorders
Haemophagocytic lymphohistiocytosis
|
0.12%
1/867 • From screening to safety follow up visit (90 days after last dose), maximum up to 4 years.
MedDRA version 23.0
|
Other adverse events
| Measure |
Durvalumab
n=867 participants at risk
All participants received fixed-dose of durvalumab 1500 mg every 4 weeks until disease progression or unacceptable toxicity.
|
|---|---|
|
General disorders
Asthenia
|
26.3%
228/867 • From screening to safety follow up visit (90 days after last dose), maximum up to 4 years.
MedDRA version 23.0
|
|
General disorders
Fatigue
|
9.6%
83/867 • From screening to safety follow up visit (90 days after last dose), maximum up to 4 years.
MedDRA version 23.0
|
|
General disorders
Pyrexia
|
9.1%
79/867 • From screening to safety follow up visit (90 days after last dose), maximum up to 4 years.
MedDRA version 23.0
|
|
General disorders
Oedema peripheral
|
8.7%
75/867 • From screening to safety follow up visit (90 days after last dose), maximum up to 4 years.
MedDRA version 23.0
|
|
Gastrointestinal disorders
Constipation
|
19.7%
171/867 • From screening to safety follow up visit (90 days after last dose), maximum up to 4 years.
MedDRA version 23.0
|
|
Gastrointestinal disorders
Diarrhoea
|
15.7%
136/867 • From screening to safety follow up visit (90 days after last dose), maximum up to 4 years.
MedDRA version 23.0
|
|
Gastrointestinal disorders
Nausea
|
14.5%
126/867 • From screening to safety follow up visit (90 days after last dose), maximum up to 4 years.
MedDRA version 23.0
|
|
Gastrointestinal disorders
Vomiting
|
8.8%
76/867 • From screening to safety follow up visit (90 days after last dose), maximum up to 4 years.
MedDRA version 23.0
|
|
Gastrointestinal disorders
Abdominal pain
|
7.4%
64/867 • From screening to safety follow up visit (90 days after last dose), maximum up to 4 years.
MedDRA version 23.0
|
|
Blood and lymphatic system disorders
Anaemia
|
19.8%
172/867 • From screening to safety follow up visit (90 days after last dose), maximum up to 4 years.
MedDRA version 23.0
|
|
Metabolism and nutrition disorders
Decreased appetite
|
17.2%
149/867 • From screening to safety follow up visit (90 days after last dose), maximum up to 4 years.
MedDRA version 23.0
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
9.7%
84/867 • From screening to safety follow up visit (90 days after last dose), maximum up to 4 years.
MedDRA version 23.0
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
8.5%
74/867 • From screening to safety follow up visit (90 days after last dose), maximum up to 4 years.
MedDRA version 23.0
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
9.5%
82/867 • From screening to safety follow up visit (90 days after last dose), maximum up to 4 years.
MedDRA version 23.0
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.5%
65/867 • From screening to safety follow up visit (90 days after last dose), maximum up to 4 years.
MedDRA version 23.0
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
12.6%
109/867 • From screening to safety follow up visit (90 days after last dose), maximum up to 4 years.
MedDRA version 23.0
|
|
Investigations
Blood creatinine increased
|
5.5%
48/867 • From screening to safety follow up visit (90 days after last dose), maximum up to 4 years.
MedDRA version 23.0
|
|
Investigations
Weight decreased
|
5.3%
46/867 • From screening to safety follow up visit (90 days after last dose), maximum up to 4 years.
MedDRA version 23.0
|
|
Infections and infestations
Urinary tract infection
|
9.7%
84/867 • From screening to safety follow up visit (90 days after last dose), maximum up to 4 years.
MedDRA version 23.0
|
|
Renal and urinary disorders
Haematuria
|
7.4%
64/867 • From screening to safety follow up visit (90 days after last dose), maximum up to 4 years.
MedDRA version 23.0
|
|
Endocrine disorders
Hypothyroidism
|
6.6%
57/867 • From screening to safety follow up visit (90 days after last dose), maximum up to 4 years.
MedDRA version 23.0
|
Additional Information
Global Clinical Lead
AstraZeneca Clinical study Information Center
Phone: 1-877-240-9479
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Disclosure of study information is prohibited without providing advance notice to AstraZeneca and opportunity to object.
- Publication restrictions are in place
Restriction type: OTHER