NCT03703297 · ADVERSE EVENTS

Adverse events

Study of Durvalumab + Tremelimumab, Durvalumab, and Placebo in Limited Stage Small-Cell Lung Cancer in Patients Who Have Not Progressed Following Concurrent Chemoradiation Therapy · Source last updated 2025-11-21

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: From first dose of study drug(Day 1)upto DCO date 15 January 2024(maximum of approximately 1936 days).Safety population:all participants who received at least 1 dose of study drug.Based on results of secondary objectives at interim analysis(reviewed by unblinded IDMC),data for D+T arm were to remain blinded to Sponsor as pre-specified in study's unblinding plan.Since D+T arm was blinded at time of posting results from this interim analysis,results for that arm will be posted at final analysis.
Other-event reporting threshold: 5%

All-cause mortality was assessed for FAS. 1 participant randomized to Durvalumab arm received 2 cycles of tremelimumab and in accordance with SAP was therefore not included in Durva or placebo safety population; will be included in D+T safety population when D+T arm is unblinded.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Durvalumab Participants received durvalumab monotherapy (1500 mg for participants \>30 kg in weight and a weight-based dosing equivalent to 20 mg/kg for participants \<=30 kg in weight) via IV infusion once q4w, until clinical/RECIST 1.1-defined radiological progression, intolerable toxicity, or for a maximum of 24 months, whichever occurred first.	78 / 262	209 / 262	115 / 264
Durvalumab Plus Tremelimumab Participants received durvalumab in combination with tremelimumab (1500 mg durvalumab in combination with 75 mg tremelimumab for participants \>30 kg in weight and a weight-based dosing equivalent to 20 mg/kg durvalumab in combination with 1 mg/kg tremelimumab for participants \<=30 kg in weight) via IV infusion once q4w, until clinical/RECIST 1.1-defined radiological progression, intolerable toxicity, or for a maximum of 24 months, whichever occurred first.	0 / 0	0 / 0	0 / 0
Placebo Participants received matching placebo via IV infusion once q4w for 4 doses/cycles each, until clinical/RECIST 1.1-defined radiological progression, intolerable toxicity, or for a maximum of 24 months, whichever occurred first.	64 / 265	196 / 265	146 / 266

Group identifiers: EG000: Durvalumab · EG001: Durvalumab Plus Tremelimumab · EG002: Placebo

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
Gastrointestinal disorders
source Vocabulary
MedDRA version 26.1
stats
group Id
EG000
num Affected
1
num At Risk
262
num Events
1
group Id
EG001
num At Risk
0
group Id
EG002
num Affected
0
num At Risk
265
num Events
0
term
Gastritis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 26.1
stats
group Id
EG000
num Affected
1
num At Risk
262
num Events
1
group Id
EG001
num At Risk
0
group Id
EG002
num Affected
1
num At Risk
265
num Events
1
term
Ileus
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 26.1
stats
group Id
EG000
num Affected
0
num At Risk
262
num Events
0
group Id
EG001
num At Risk
0
group Id
EG002
num Affected
1
num At Risk
265
num Events
1
term
Inguinal hernia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 26.1
stats
group Id
EG000
num Affected
1
num At Risk
262
num Events
1
group Id
EG001
num At Risk
0
group Id
EG002
num Affected
0
num At Risk
265
num Events
0
term
Oesophageal achalasia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 26.1
stats
group Id
EG000
num Affected
1
num At Risk
262
num Events
1
group Id
EG001
num At Risk
0
group Id
EG002
num Affected
0
num At Risk
265
num Events
0
term
Oesophagitis ulcerative
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 26.1
stats
group Id
EG000
num Affected
1
num At Risk
262
num Events
1
group Id
EG001
num At Risk
0
group Id
EG002
num Affected
0
num At Risk
265
num Events
0
term
Peptic ulcer
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 26.1
stats
group Id
EG000
num Affected
0
num At Risk
262
num Events
0
group Id
EG001
num At Risk
0
group Id
EG002
num Affected
1
num At Risk
265
num Events
1
term
Rectal haemorrhage
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 26.1
stats
group Id
EG000
num Affected
0
num At Risk
262
num Events
0
group Id
EG001
num At Risk
0
group Id
EG002
num Affected
1
num At Risk
265
num Events
1
term
Small intestinal obstruction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA version 26.1
stats
group Id
EG000
num Affected
1
num At Risk
262
num Events
1
group Id
EG001
num At Risk
0
group Id
EG002
num Affected
0
num At Risk
265
num Events
0
term
Acute left ventricular failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 26.1
stats
group Id
EG000
num Affected
0
num At Risk
262
num Events
0
group Id
EG001
num At Risk
0
group Id
EG002
num Affected
1
num At Risk
265
num Events
1
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA version 26.1
stats
group Id
EG000
num Affected
0
num At Risk
262
num Events
0
group Id
EG001
num At Risk
0
group Id
EG002
num Affected
3
num At Risk
265
num Events
3
term
Asthenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA version 26.1
stats
group Id
EG000
num Affected
1
num At Risk
262
num Events
1
group Id
EG001
num At Risk
0
group Id
EG002
num Affected
0
num At Risk
265
num Events
0
term
Acute myocardial infarction

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
Gastrointestinal disorders
source Vocabulary
MedDRA version 26.1
stats
group Id
EG000
num Affected
33
num At Risk
262
num Events
39
group Id
EG001
num At Risk
0
group Id
EG002
num Affected
29
num At Risk
265
num Events
35
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 26.1
stats
group Id
EG000
num Affected
12
num At Risk
262
num Events
14
group Id
EG001
num At Risk
0
group Id
EG002
num Affected
17
num At Risk
265
num Events
18
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA version 26.1
stats
group Id
EG000
num Affected
26
num At Risk
262
num Events
32
group Id
EG001
num At Risk
0
group Id
EG002
num Affected
17
num At Risk
265
num Events
18
term
Asthenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA version 26.1
stats
group Id
EG000
num Affected
31
num At Risk
262
num Events
37
group Id
EG001
num At Risk
0
group Id
EG002
num Affected
33
num At Risk
265
num Events
35
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA version 26.1
stats
group Id
EG000
num Affected
18
num At Risk
262
num Events
18
group Id
EG001
num At Risk
0
group Id
EG002
num Affected
16
num At Risk
265
num Events
16
term
COVID-19
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 26.1
stats
group Id
EG000
num Affected
21
num At Risk
262
num Events
28
group Id
EG001
num At Risk
0
group Id
EG002
num Affected
16
num At Risk
265
num Events
19
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA version 26.1
stats
group Id
EG000
num Affected
19
num At Risk
262
num Events
23
group Id
EG001
num At Risk
0
group Id
EG002
num Affected
11
num At Risk
265
num Events
11
term
Pneumonia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Injury, poisoning and procedural complications
source Vocabulary
MedDRA version 26.1
stats
group Id
EG000
num Affected
49
num At Risk
262
num Events
51
group Id
EG001
num At Risk
0
group Id
EG002
num Affected
55
num At Risk
265
num Events
57
term
Radiation pneumonitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA version 26.1
stats
group Id
EG000
num Affected
15
num At Risk
262
num Events
22
group Id
EG001
num At Risk
0
group Id
EG002
num Affected
13
num At Risk
265
num Events
19
term
Alanine aminotransferase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA version 26.1
stats
group Id
EG000
num Affected
18
num At Risk
262
num Events
20
group Id
EG001
num At Risk
0
group Id
EG002
num Affected
11
num At Risk
265
num Events
17
term
Weight decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA version 26.1
stats
group Id
EG000
num Affected
18
num At Risk
262
num Events
36
group Id
EG001
num At Risk
0
group Id
EG002
num Affected
11
num At Risk
265
num Events
27
term
White blood cell count decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
MedDRA version 26.1
stats
group Id
EG000
num Affected
44
num At Risk
262
num Events
56
group Id
EG001
num At Risk
0
group Id
EG002
num Affected
34
num At Risk
265
num Events
34
term
Decreased appetite

Complete source fields

description

event Groups

deaths Num Affected
115
deaths Num At Risk
264
description
Participants received durvalumab monotherapy (1500 mg for participants \>30 kg in weight and a weight-based dosing equivalent to 20 mg/kg for participants \<=30 kg in weight) via IV infusion once q4w, until clinical/RECIST 1.1-defined radiological progression, intolerable toxicity, or for a maximum of 24 months, whichever occurred first.
id
EG000
other Num Affected
209
other Num At Risk
262
serious Num Affected
78
serious Num At Risk
262
title
Durvalumab
deaths Num Affected
0
deaths Num At Risk
0
description
Participants received durvalumab in combination with tremelimumab (1500 mg durvalumab in combination with 75 mg tremelimumab for participants \>30 kg in weight and a weight-based dosing equivalent to 20 mg/kg durvalumab in combination with 1 mg/kg tremelimumab for participants \<=30 kg in weight) via IV infusion once q4w, until clinical/RECIST 1.1-defined radiological progression, intolerable toxicity, or for a maximum of 24 months, whichever occurred first.
id
EG001
other Num Affected
0
other Num At Risk
0
serious Num Affected
0
serious Num At Risk
0
title
Durvalumab Plus Tremelimumab
deaths Num Affected
146
deaths Num At Risk
266
description
Participants received matching placebo via IV infusion once q4w for 4 doses/cycles each, until clinical/RECIST 1.1-defined radiological progression, intolerable toxicity, or for a maximum of 24 months, whichever occurred first.
id
EG002
other Num Affected
196
other Num At Risk
265
serious Num Affected
64
serious Num At Risk
265
title
Placebo

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 26.1
stats
group Id
EG000
num Affected
33
num At Risk
262
num Events
39
group Id
EG001
num At Risk
0
group Id
EG002
num Affected
29
num At Risk
265
num Events
35
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 26.1
stats
group Id
EG000
num Affected
12
num At Risk
262
num Events
14
group Id
EG001
num At Risk
0
group Id
EG002
num Affected
17
num At Risk
265
num Events
18
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA version 26.1
stats
group Id
EG000
num Affected
26
num At Risk
262
num Events
32
group Id
EG001
num At Risk
0
group Id
EG002
num Affected
17
num At Risk
265
num Events
18
term
Asthenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA version 26.1
stats
group Id
EG000
num Affected
31
num At Risk
262
num Events
37
group Id
EG001
num At Risk
0
group Id
EG002
num Affected
33
num At Risk
265
num Events
35
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA version 26.1
stats
group Id
EG000
num Affected
18
num At Risk
262
num Events
18
group Id
EG001
num At Risk
0
group Id
EG002
num Affected
16
num At Risk
265
num Events
16
term
COVID-19
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 26.1
stats
group Id
EG000
num Affected
21
num At Risk
262
num Events
28
group Id
EG001
num At Risk
0
group Id
EG002
num Affected
16
num At Risk
265
num Events
19
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA version 26.1
stats
group Id
EG000
num Affected
19
num At Risk
262
num Events
23
group Id
EG001
num At Risk
0
group Id
EG002
num Affected
11
num At Risk
265
num Events
11
term
Pneumonia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Injury, poisoning and procedural complications
source Vocabulary
MedDRA version 26.1
stats
group Id
EG000
num Affected
49
num At Risk
262
num Events
51
group Id
EG001
num At Risk
0
group Id
EG002
num Affected
55
num At Risk
265
num Events
57
term
Radiation pneumonitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA version 26.1
stats
group Id
EG000
num Affected
15
num At Risk
262
num Events
22
group Id
EG001
num At Risk
0
group Id
EG002
num Affected
13
num At Risk
265
num Events
19
term
Alanine aminotransferase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA version 26.1
stats
group Id
EG000
num Affected
18
num At Risk
262
num Events
20
group Id
EG001
num At Risk
0
group Id
EG002
num Affected
11
num At Risk
265
num Events
17
term
Weight decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA version 26.1
stats
group Id
EG000
num Affected
18
num At Risk
262
num Events
36
group Id
EG001
num At Risk
0
group Id
EG002
num Affected
11
num At Risk
265
num Events
27
term
White blood cell count decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
MedDRA version 26.1
stats
group Id
EG000
num Affected
44
num At Risk
262
num Events
56
group Id
EG001
num At Risk
0
group Id
EG002
num Affected
34
num At Risk
265
num Events
34
term
Decreased appetite

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 26.1
stats
group Id
EG000
num Affected
1
num At Risk
262
num Events
1
group Id
EG001
num At Risk
0
group Id
EG002
num Affected
0
num At Risk
265
num Events
0
term
Gastritis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 26.1
stats
group Id
EG000
num Affected
1
num At Risk
262
num Events
1
group Id
EG001
num At Risk
0
group Id
EG002
num Affected
1
num At Risk
265
num Events
1
term
Ileus
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 26.1
stats
group Id
EG000
num Affected
0
num At Risk
262
num Events
0
group Id
EG001
num At Risk
0
group Id
EG002
num Affected
1
num At Risk
265
num Events
1
term
Inguinal hernia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 26.1
stats
group Id
EG000
num Affected
1
num At Risk
262
num Events
1
group Id
EG001
num At Risk
0
group Id
EG002
num Affected
0
num At Risk
265
num Events
0
term
Oesophageal achalasia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 26.1
stats
group Id
EG000
num Affected
1
num At Risk
262
num Events
1
group Id
EG001
num At Risk
0
group Id
EG002
num Affected
0
num At Risk
265
num Events
0
term
Oesophagitis ulcerative
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 26.1
stats
group Id
EG000
num Affected
1
num At Risk
262
num Events
1
group Id
EG001
num At Risk
0
group Id
EG002
num Affected
0
num At Risk
265
num Events
0
term
Peptic ulcer
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 26.1
stats
group Id
EG000
num Affected
0
num At Risk
262
num Events
0
group Id
EG001
num At Risk
0
group Id
EG002
num Affected
1
num At Risk
265
num Events
1
term
Rectal haemorrhage
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 26.1
stats
group Id
EG000
num Affected
0
num At Risk
262
num Events
0
group Id
EG001
num At Risk
0
group Id
EG002
num Affected
1
num At Risk
265
num Events
1
term
Small intestinal obstruction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA version 26.1
stats
group Id
EG000
num Affected
1
num At Risk
262
num Events
1
group Id
EG001
num At Risk
0
group Id
EG002
num Affected
0
num At Risk
265
num Events
0
term
Acute left ventricular failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 26.1
stats
group Id
EG000
num Affected
0
num At Risk
262
num Events
0
group Id
EG001
num At Risk
0
group Id
EG002
num Affected
1
num At Risk
265
num Events
1
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA version 26.1
stats
group Id
EG000
num Affected
0
num At Risk
262
num Events
0
group Id
EG001
num At Risk
0
group Id
EG002
num Affected
3
num At Risk
265
num Events
3
term
Asthenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA version 26.1
stats
group Id
EG000
num Affected
1
num At Risk
262
num Events
1
group Id
EG001
num At Risk
0
group Id
EG002
num Affected
0
num At Risk
265
num Events
0
term
Acute myocardial infarction

time Frame

From first dose of study drug(Day 1)upto DCO date 15 January 2024(maximum of approximately 1936 days).Safety population:all participants who received at least 1 dose of study drug.Based on results of secondary objectives at interim analysis(reviewed by unblinded IDMC),data for D+T arm were to remain blinded to Sponsor as pre-specified in study's unblinding plan.Since D+T arm was blinded at time of posting results from this interim analysis,results for that arm will be posted at final analysis.

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice