NCT03732677 · ADVERSE EVENTS

Adverse events

Durvalumab+ Gemcitabine/Cisplatin (Neoadjuvant Treatment) and Durvalumab (Adjuvant Treatment) in Patients With MIBC · Source last updated 2026-07-17

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.

Collection time frame: Includes AEs between date of first dose and the earliest of: maximum date of (last dose or surgery) + 90days, date of first dose of subsequent anti-cancer therapy. Total follow up about 2 years. The frequency assessment was: Neoadjuvant, every 3 weeks, Post Surgery, every week, Adjuvant and Follow Up: every 4 weeks. All-cause mortality (death due to any cause): from randomization up to EFS IA2 DCO (April 29, 2024). Maximum timeframe of approximately 5.4 years.
Other-event reporting threshold: 5%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Durvalumab + Gemcitabine + Cisplatin Treatments and dosing regimens: Durvalumab 1500 mg IV q3w (neoadjuvant) 1500 mg IV q4w (adjuvant post-radical cystectomy) Day 1 and Day 8 (gemcitabine 1000 mg/m2 IV) of each 21-day cycle (neoadjuvant) Day 1 and Day 8 (cisplatin 35mg/m2 IV) or Day 1 (cisplatin 70 mg/m2 IV) each 21-day cycle (neoadjuvant) Dosing will be adjusted based on renal function	326 / 530	522 / 530	27 / 533
Gemcitabine + Cisplatin Treatments and dosing regimens: Day 1 and Day 8 (gemcitabine1000 mg/m2 IV) of each 21-day cycle (neoadjuvant) Day 1 and Day 8 (cisplatin 35mg/m2 IV) or Day 1 (cisplatin 70 mg/m2 IV) each 21-day cycle (neoadjuvant) Dosing will be adjusted based on renal function	287 / 526	511 / 526	29 / 526

Group identifiers: EG000: Durvalumab + Gemcitabine + Cisplatin · EG001: Gemcitabine + Cisplatin

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
0
num At Risk
530
num Events
0
group Id
EG001
num Affected
2
num At Risk
526
num Events
2
term
Angina pectoris
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
0
num At Risk
530
num Events
0
group Id
EG001
num Affected
1
num At Risk
526
num Events
1
term
Catheter site infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
1
num At Risk
530
num Events
1
group Id
EG001
num Affected
1
num At Risk
526
num Events
1
term
Cellulitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
2
num At Risk
530
num Events
3
group Id
EG001
num Affected
0
num At Risk
526
num Events
0
term
Clostridium difficile colitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
1
num At Risk
530
num Events
1
group Id
EG001
num Affected
1
num At Risk
526
num Events
1
term
Clostridium difficile infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
0
num At Risk
530
num Events
0
group Id
EG001
num Affected
1
num At Risk
526
num Events
2
term
Cystitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
1
num At Risk
530
num Events
1
group Id
EG001
num Affected
0
num At Risk
526
num Events
0
term
Dengue fever
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
1
num At Risk
530
num Events
1
group Id
EG001
num Affected
0
num At Risk
526
num Events
0
term
Device related infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
2
num At Risk
530
num Events
2
group Id
EG001
num Affected
0
num At Risk
526
num Events
0
term
Diarrhoea infectious
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
1
num At Risk
530
num Events
1
group Id
EG001
num Affected
0
num At Risk
526
num Events
0
term
Diverticulitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
0
num At Risk
530
num Events
0
group Id
EG001
num Affected
2
num At Risk
526
num Events
2
term
Endocarditis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
2
num At Risk
530
num Events
2
group Id
EG001
num Affected
0
num At Risk
526
num Events
0
term
Atrial fibrillation

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
124
num At Risk
530
num Events
181
group Id
EG001
num Affected
108
num At Risk
526
num Events
158
term
Urinary tract infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Injury, poisoning and procedural complications
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
46
num At Risk
530
num Events
49
group Id
EG001
num Affected
38
num At Risk
526
num Events
43
term
Procedural pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
46
num At Risk
530
num Events
65
group Id
EG001
num Affected
38
num At Risk
526
num Events
48
term
Alanine aminotransferase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
34
num At Risk
530
num Events
43
group Id
EG001
num Affected
19
num At Risk
526
num Events
26
term
Amylase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
94
num At Risk
530
num Events
131
group Id
EG001
num Affected
76
num At Risk
526
num Events
97
term
Blood creatinine increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
39
num At Risk
530
num Events
49
group Id
EG001
num Affected
27
num At Risk
526
num Events
32
term
Lipase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
80
num At Risk
530
num Events
121
group Id
EG001
num Affected
72
num At Risk
526
num Events
102
term
Neutrophil count decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
35
num At Risk
530
num Events
48
group Id
EG001
num Affected
32
num At Risk
526
num Events
43
term
Platelet count decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
41
num At Risk
530
num Events
41
group Id
EG001
num Affected
27
num At Risk
526
num Events
28
term
Weight decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
28
num At Risk
530
num Events
47
group Id
EG001
num Affected
35
num At Risk
526
num Events
58
term
White blood cell count decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
140
num At Risk
530
num Events
196
group Id
EG001
num Affected
131
num At Risk
526
num Events
175
term
Decreased appetite
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
200
num At Risk
530
num Events
257
group Id
EG001
num Affected
200
num At Risk
526
num Events
239
term
Anaemia

Complete source fields

event Groups

deaths Num Affected
27
deaths Num At Risk
533
description
Treatments and dosing regimens: Durvalumab 1500 mg IV q3w (neoadjuvant) 1500 mg IV q4w (adjuvant post-radical cystectomy) Day 1 and Day 8 (gemcitabine 1000 mg/m2 IV) of each 21-day cycle (neoadjuvant) Day 1 and Day 8 (cisplatin 35mg/m2 IV) or Day 1 (cisplatin 70 mg/m2 IV) each 21-day cycle (neoadjuvant) Dosing will be adjusted based on renal function
id
EG000
other Num Affected
522
other Num At Risk
530
serious Num Affected
326
serious Num At Risk
530
title
Durvalumab + Gemcitabine + Cisplatin
deaths Num Affected
29
deaths Num At Risk
526
description
Treatments and dosing regimens: Day 1 and Day 8 (gemcitabine1000 mg/m2 IV) of each 21-day cycle (neoadjuvant) Day 1 and Day 8 (cisplatin 35mg/m2 IV) or Day 1 (cisplatin 70 mg/m2 IV) each 21-day cycle (neoadjuvant) Dosing will be adjusted based on renal function
id
EG001
other Num Affected
511
other Num At Risk
526
serious Num Affected
287
serious Num At Risk
526
title
Gemcitabine + Cisplatin

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
124
num At Risk
530
num Events
181
group Id
EG001
num Affected
108
num At Risk
526
num Events
158
term
Urinary tract infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Injury, poisoning and procedural complications
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
46
num At Risk
530
num Events
49
group Id
EG001
num Affected
38
num At Risk
526
num Events
43
term
Procedural pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
46
num At Risk
530
num Events
65
group Id
EG001
num Affected
38
num At Risk
526
num Events
48
term
Alanine aminotransferase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
34
num At Risk
530
num Events
43
group Id
EG001
num Affected
19
num At Risk
526
num Events
26
term
Amylase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
94
num At Risk
530
num Events
131
group Id
EG001
num Affected
76
num At Risk
526
num Events
97
term
Blood creatinine increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
39
num At Risk
530
num Events
49
group Id
EG001
num Affected
27
num At Risk
526
num Events
32
term
Lipase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
80
num At Risk
530
num Events
121
group Id
EG001
num Affected
72
num At Risk
526
num Events
102
term
Neutrophil count decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
35
num At Risk
530
num Events
48
group Id
EG001
num Affected
32
num At Risk
526
num Events
43
term
Platelet count decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
41
num At Risk
530
num Events
41
group Id
EG001
num Affected
27
num At Risk
526
num Events
28
term
Weight decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
28
num At Risk
530
num Events
47
group Id
EG001
num Affected
35
num At Risk
526
num Events
58
term
White blood cell count decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
140
num At Risk
530
num Events
196
group Id
EG001
num Affected
131
num At Risk
526
num Events
175
term
Decreased appetite
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
200
num At Risk
530
num Events
257
group Id
EG001
num Affected
200
num At Risk
526
num Events
239
term
Anaemia

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
0
num At Risk
530
num Events
0
group Id
EG001
num Affected
2
num At Risk
526
num Events
2
term
Angina pectoris
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
0
num At Risk
530
num Events
0
group Id
EG001
num Affected
1
num At Risk
526
num Events
1
term
Catheter site infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
1
num At Risk
530
num Events
1
group Id
EG001
num Affected
1
num At Risk
526
num Events
1
term
Cellulitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
2
num At Risk
530
num Events
3
group Id
EG001
num Affected
0
num At Risk
526
num Events
0
term
Clostridium difficile colitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
1
num At Risk
530
num Events
1
group Id
EG001
num Affected
1
num At Risk
526
num Events
1
term
Clostridium difficile infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
0
num At Risk
530
num Events
0
group Id
EG001
num Affected
1
num At Risk
526
num Events
2
term
Cystitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
1
num At Risk
530
num Events
1
group Id
EG001
num Affected
0
num At Risk
526
num Events
0
term
Dengue fever
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
1
num At Risk
530
num Events
1
group Id
EG001
num Affected
0
num At Risk
526
num Events
0
term
Device related infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
2
num At Risk
530
num Events
2
group Id
EG001
num Affected
0
num At Risk
526
num Events
0
term
Diarrhoea infectious
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
1
num At Risk
530
num Events
1
group Id
EG001
num Affected
0
num At Risk
526
num Events
0
term
Diverticulitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
0
num At Risk
530
num Events
0
group Id
EG001
num Affected
2
num At Risk
526
num Events
2
term
Endocarditis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
2
num At Risk
530
num Events
2
group Id
EG001
num Affected
0
num At Risk
526
num Events
0
term
Atrial fibrillation

time Frame

Includes AEs between date of first dose and the earliest of: maximum date of (last dose or surgery) + 90days, date of first dose of subsequent anti-cancer therapy. Total follow up about 2 years. The frequency assessment was: Neoadjuvant, every 3 weeks, Post Surgery, every week, Adjuvant and Follow Up: every 4 weeks. All-cause mortality (death due to any cause): from randomization up to EFS IA2 DCO (April 29, 2024). Maximum timeframe of approximately 5.4 years.

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