NCT03164616 · ADVERSE EVENTS

Adverse events

Study of Durvalumab + Tremelimumab With Chemotherapy or Durvalumab With Chemotherapy or Chemotherapy Alone for Patients With Lung Cancer (POSEIDON). · Source last updated 2026-03-13

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: Adverse events: from first dose of study treatment until the earlier of 90 days after last dose or the date of first subsequent anticancer therapy. All-cause mortality (death due to any cause): from randomization up to global cohort final analysis DCO (12 March 2021). Maximum timeframe of approximately 45 months.
Other-event reporting threshold: 5%

Safety analysis set included all patients who received at least 1 dose of study treatment (analyzed according to actual treatment received). 1 patient randomized to T + D + SoC arm and 1 patient randomized to D + SoC arm only received SoC and were included in SoC alone arm of the safety analysis set. All-cause mortality was determined for patients in the FAS (analyzed according to randomized treatment arm, regardless of the treatment received). Results are reported for the global cohort only.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
T + D + SoC During chemotherapy (combination) stage: Patients received tremelimumab 75 mg + durvalumab 1500 mg combination therapy + SoC chemotherapy via IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). The SoC chemotherapy was the Investigator's choice of one of the following regimens: abraxane + carboplatin (squamous and non-squamous patients), pemetrexed + cisplatin or carboplatin (non-squamous patients only), or gemcitabine + cisplatin or carboplatin (squamous patients only). Post-chemotherapy (maintenance) stage: Patients then continued to receive durvalumab monotherapy 1500 mg IV infusion Q4W from Week 12 until PD, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met. Patients also received an additional dose of tremelimumab 75 mg (in combination with durvalumab) at Week 16 post-chemotherapy. Non-squamous patients who received pemetrexed + carboplatin/cisplatin during chemotherapy stage could receive pemetrexed maintenance therapy, given Q4W from Week 12 until PD, unless contraindicated per the Investigator.	146 / 330	309 / 330	251 / 338
D + SoC During chemotherapy (combination) stage: Patients received durvalumab 1500 mg monotherapy + SoC chemotherapy via IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). The SoC chemotherapy was the Investigator's choice of one of the following regimens: abraxane + carboplatin (squamous and non-squamous patients), pemetrexed + cisplatin or carboplatin (non-squamous patients only), or gemcitabine + cisplatin or carboplatin (squamous patients only). Post-chemotherapy (maintenance) stage: Patients then continued to receive durvalumab monotherapy 1500 mg IV infusion Q4W from Week 12 until PD, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met. Non-squamous patients who received pemetrexed + carboplatin/cisplatin during chemotherapy stage could receive pemetrexed maintenance therapy, given Q4W from Week 12 until PD, unless contraindicated per the Investigator.	134 / 334	302 / 334	265 / 338
SoC Alone During chemotherapy (combination) stage: Patients received SoC chemotherapy alone via IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). Patients could also receive SoC chemotherapy for an additional 2 cycles Q3W on Weeks 12 and 15 if clinically indicated and at the Investigator's discretion before the patient entered follow-up. The SoC chemotherapy was the Investigator's choice of one of the following regimens: abraxane + carboplatin (squamous and non-squamous patients), pemetrexed + cisplatin or carboplatin (non-squamous patients only), or gemcitabine + cisplatin or carboplatin (squamous patients only). Post-chemotherapy (maintenance) stage: Non-squamous patients who received pemetrexed + carboplatin/cisplatin during chemotherapy stage could receive pemetrexed maintenance therapy, given Q3W or Q4W (dependent on Investigator decision and local standards) from Week 12 until PD, unless contraindicated per the Investigator.	117 / 333	301 / 333	285 / 337

Group identifiers: EG000: T + D + SoC · EG001: D + SoC · EG002: SoC Alone

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 23.1
stats
group Id
EG000
num Affected
0
num At Risk
330
num Events
0
group Id
EG001
num Affected
1
num At Risk
334
num Events
1
group Id
EG002
num Affected
0
num At Risk
333
num Events
0
term
Abdominal discomfort
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
0
num At Risk
330
num Events
0
group Id
EG001
num Affected
1
num At Risk
334
num Events
1
group Id
EG002
num Affected
0
num At Risk
333
num Events
0
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
1
num At Risk
330
num Events
1
group Id
EG001
num Affected
0
num At Risk
334
num Events
0
group Id
EG002
num Affected
0
num At Risk
333
num Events
0
term
Autoimmune pancreatitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
5
num At Risk
330
num Events
5
group Id
EG001
num Affected
3
num At Risk
334
num Events
3
group Id
EG002
num Affected
0
num At Risk
333
num Events
0
term
Colitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
8
num At Risk
330
num Events
8
group Id
EG001
num Affected
3
num At Risk
334
num Events
4
group Id
EG002
num Affected
2
num At Risk
333
num Events
2
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
0
num At Risk
330
num Events
0
group Id
EG001
num Affected
1
num At Risk
334
num Events
1
group Id
EG002
num Affected
0
num At Risk
333
num Events
0
term
Diverticular perforation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
1
num At Risk
330
num Events
1
group Id
EG001
num Affected
0
num At Risk
334
num Events
0
group Id
EG002
num Affected
0
num At Risk
333
num Events
0
term
Duodenal ulcer haemorrhage
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
1
num At Risk
330
num Events
1
group Id
EG001
num Affected
0
num At Risk
334
num Events
0
group Id
EG002
num Affected
0
num At Risk
333
num Events
0
term
Dysphagia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
1
num At Risk
330
num Events
1
group Id
EG001
num Affected
0
num At Risk
334
num Events
0
group Id
EG002
num Affected
0
num At Risk
333
num Events
0
term
Enteritis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
2
num At Risk
330
num Events
2
group Id
EG001
num Affected
0
num At Risk
334
num Events
0
group Id
EG002
num Affected
0
num At Risk
333
num Events
0
term
Enterocolitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
1
num At Risk
330
num Events
1
group Id
EG001
num Affected
0
num At Risk
334
num Events
0
group Id
EG002
num Affected
0
num At Risk
333
num Events
0
term
Faecaloma
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
1
num At Risk
330
num Events
1
group Id
EG001
num Affected
0
num At Risk
334
num Events
0
group Id
EG002
num Affected
0
num At Risk
333
num Events
0
term
Gastric ulcer

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 23.1
stats
group Id
EG000
num Affected
19
num At Risk
330
num Events
22
group Id
EG001
num Affected
16
num At Risk
334
num Events
19
group Id
EG002
num Affected
10
num At Risk
333
num Events
10
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
63
num At Risk
330
num Events
85
group Id
EG001
num Affected
72
num At Risk
334
num Events
98
group Id
EG002
num Affected
79
num At Risk
333
num Events
96
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
65
num At Risk
330
num Events
98
group Id
EG001
num Affected
57
num At Risk
334
num Events
72
group Id
EG002
num Affected
49
num At Risk
333
num Events
66
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
41
num At Risk
330
num Events
80
group Id
EG001
num Affected
32
num At Risk
334
num Events
59
group Id
EG002
num Affected
39
num At Risk
333
num Events
80
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
136
num At Risk
330
num Events
281
group Id
EG001
num Affected
120
num At Risk
334
num Events
258
group Id
EG002
num Affected
121
num At Risk
333
num Events
243
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
150
num At Risk
330
num Events
213
group Id
EG001
num Affected
137
num At Risk
334
num Events
188
group Id
EG002
num Affected
146
num At Risk
333
num Events
203
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
98
num At Risk
330
num Events
177
group Id
EG001
num Affected
75
num At Risk
334
num Events
135
group Id
EG002
num Affected
77
num At Risk
333
num Events
161
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
17
num At Risk
330
num Events
18
group Id
EG001
num Affected
20
num At Risk
334
num Events
25
group Id
EG002
num Affected
16
num At Risk
333
num Events
17
term
Stomatitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
59
num At Risk
330
num Events
82
group Id
EG001
num Affected
51
num At Risk
334
num Events
74
group Id
EG002
num Affected
45
num At Risk
333
num Events
80
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
56
num At Risk
330
num Events
67
group Id
EG001
num Affected
31
num At Risk
334
num Events
42
group Id
EG002
num Affected
39
num At Risk
333
num Events
49
term
Asthenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
81
num At Risk
330
num Events
116
group Id
EG001
num Affected
80
num At Risk
334
num Events
119
group Id
EG002
num Affected
74
num At Risk
333
num Events
93
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
17
num At Risk
330
num Events
19
group Id
EG001
num Affected
11
num At Risk
334
num Events
15
group Id
EG002
num Affected
6
num At Risk
333
num Events
6
term
Mucosal inflammation

Complete source fields

description

event Groups

deaths Num Affected
251
deaths Num At Risk
338
description
During chemotherapy (combination) stage: Patients received tremelimumab 75 mg + durvalumab 1500 mg combination therapy + SoC chemotherapy via IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). The SoC chemotherapy was the Investigator's choice of one of the following regimens: abraxane + carboplatin (squamous and non-squamous patients), pemetrexed + cisplatin or carboplatin (non-squamous patients only), or gemcitabine + cisplatin or carboplatin (squamous patients only). Post-chemotherapy (maintenance) stage: Patients then continued to receive durvalumab monotherapy 1500 mg IV infusion Q4W from Week 12 until PD, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met. Patients also received an additional dose of tremelimumab 75 mg (in combination with durvalumab) at Week 16 post-chemotherapy. Non-squamous patients who received pemetrexed + carboplatin/cisplatin during chemotherapy stage could receive pemetrexed maintenance therapy, given Q4W from Week 12 until PD, unless contraindicated per the Investigator.
id
EG000
other Num Affected
309
other Num At Risk
330
serious Num Affected
146
serious Num At Risk
330
title
T + D + SoC
deaths Num Affected
265
deaths Num At Risk
338
description
During chemotherapy (combination) stage: Patients received durvalumab 1500 mg monotherapy + SoC chemotherapy via IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). The SoC chemotherapy was the Investigator's choice of one of the following regimens: abraxane + carboplatin (squamous and non-squamous patients), pemetrexed + cisplatin or carboplatin (non-squamous patients only), or gemcitabine + cisplatin or carboplatin (squamous patients only). Post-chemotherapy (maintenance) stage: Patients then continued to receive durvalumab monotherapy 1500 mg IV infusion Q4W from Week 12 until PD, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met. Non-squamous patients who received pemetrexed + carboplatin/cisplatin during chemotherapy stage could receive pemetrexed maintenance therapy, given Q4W from Week 12 until PD, unless contraindicated per the Investigator.
id
EG001
other Num Affected
302
other Num At Risk
334
serious Num Affected
134
serious Num At Risk
334
title
D + SoC
deaths Num Affected
285
deaths Num At Risk
337
description
During chemotherapy (combination) stage: Patients received SoC chemotherapy alone via IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). Patients could also receive SoC chemotherapy for an additional 2 cycles Q3W on Weeks 12 and 15 if clinically indicated and at the Investigator's discretion before the patient entered follow-up. The SoC chemotherapy was the Investigator's choice of one of the following regimens: abraxane + carboplatin (squamous and non-squamous patients), pemetrexed + cisplatin or carboplatin (non-squamous patients only), or gemcitabine + cisplatin or carboplatin (squamous patients only). Post-chemotherapy (maintenance) stage: Non-squamous patients who received pemetrexed + carboplatin/cisplatin during chemotherapy stage could receive pemetrexed maintenance therapy, given Q3W or Q4W (dependent on Investigator decision and local standards) from Week 12 until PD, unless contraindicated per the Investigator.
id
EG002
other Num Affected
301
other Num At Risk
333
serious Num Affected
117
serious Num At Risk
333
title
SoC Alone

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
19
num At Risk
330
num Events
22
group Id
EG001
num Affected
16
num At Risk
334
num Events
19
group Id
EG002
num Affected
10
num At Risk
333
num Events
10
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
63
num At Risk
330
num Events
85
group Id
EG001
num Affected
72
num At Risk
334
num Events
98
group Id
EG002
num Affected
79
num At Risk
333
num Events
96
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
65
num At Risk
330
num Events
98
group Id
EG001
num Affected
57
num At Risk
334
num Events
72
group Id
EG002
num Affected
49
num At Risk
333
num Events
66
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
41
num At Risk
330
num Events
80
group Id
EG001
num Affected
32
num At Risk
334
num Events
59
group Id
EG002
num Affected
39
num At Risk
333
num Events
80
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
136
num At Risk
330
num Events
281
group Id
EG001
num Affected
120
num At Risk
334
num Events
258
group Id
EG002
num Affected
121
num At Risk
333
num Events
243
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
150
num At Risk
330
num Events
213
group Id
EG001
num Affected
137
num At Risk
334
num Events
188
group Id
EG002
num Affected
146
num At Risk
333
num Events
203
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
98
num At Risk
330
num Events
177
group Id
EG001
num Affected
75
num At Risk
334
num Events
135
group Id
EG002
num Affected
77
num At Risk
333
num Events
161
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
17
num At Risk
330
num Events
18
group Id
EG001
num Affected
20
num At Risk
334
num Events
25
group Id
EG002
num Affected
16
num At Risk
333
num Events
17
term
Stomatitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
59
num At Risk
330
num Events
82
group Id
EG001
num Affected
51
num At Risk
334
num Events
74
group Id
EG002
num Affected
45
num At Risk
333
num Events
80
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
56
num At Risk
330
num Events
67
group Id
EG001
num Affected
31
num At Risk
334
num Events
42
group Id
EG002
num Affected
39
num At Risk
333
num Events
49
term
Asthenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
81
num At Risk
330
num Events
116
group Id
EG001
num Affected
80
num At Risk
334
num Events
119
group Id
EG002
num Affected
74
num At Risk
333
num Events
93
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
17
num At Risk
330
num Events
19
group Id
EG001
num Affected
11
num At Risk
334
num Events
15
group Id
EG002
num Affected
6
num At Risk
333
num Events
6
term
Mucosal inflammation

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
0
num At Risk
330
num Events
0
group Id
EG001
num Affected
1
num At Risk
334
num Events
1
group Id
EG002
num Affected
0
num At Risk
333
num Events
0
term
Abdominal discomfort
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
0
num At Risk
330
num Events
0
group Id
EG001
num Affected
1
num At Risk
334
num Events
1
group Id
EG002
num Affected
0
num At Risk
333
num Events
0
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
1
num At Risk
330
num Events
1
group Id
EG001
num Affected
0
num At Risk
334
num Events
0
group Id
EG002
num Affected
0
num At Risk
333
num Events
0
term
Autoimmune pancreatitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
5
num At Risk
330
num Events
5
group Id
EG001
num Affected
3
num At Risk
334
num Events
3
group Id
EG002
num Affected
0
num At Risk
333
num Events
0
term
Colitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
8
num At Risk
330
num Events
8
group Id
EG001
num Affected
3
num At Risk
334
num Events
4
group Id
EG002
num Affected
2
num At Risk
333
num Events
2
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
0
num At Risk
330
num Events
0
group Id
EG001
num Affected
1
num At Risk
334
num Events
1
group Id
EG002
num Affected
0
num At Risk
333
num Events
0
term
Diverticular perforation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
1
num At Risk
330
num Events
1
group Id
EG001
num Affected
0
num At Risk
334
num Events
0
group Id
EG002
num Affected
0
num At Risk
333
num Events
0
term
Duodenal ulcer haemorrhage
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
1
num At Risk
330
num Events
1
group Id
EG001
num Affected
0
num At Risk
334
num Events
0
group Id
EG002
num Affected
0
num At Risk
333
num Events
0
term
Dysphagia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
1
num At Risk
330
num Events
1
group Id
EG001
num Affected
0
num At Risk
334
num Events
0
group Id
EG002
num Affected
0
num At Risk
333
num Events
0
term
Enteritis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
2
num At Risk
330
num Events
2
group Id
EG001
num Affected
0
num At Risk
334
num Events
0
group Id
EG002
num Affected
0
num At Risk
333
num Events
0
term
Enterocolitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
1
num At Risk
330
num Events
1
group Id
EG001
num Affected
0
num At Risk
334
num Events
0
group Id
EG002
num Affected
0
num At Risk
333
num Events
0
term
Faecaloma
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
1
num At Risk
330
num Events
1
group Id
EG001
num Affected
0
num At Risk
334
num Events
0
group Id
EG002
num Affected
0
num At Risk
333
num Events
0
term
Gastric ulcer

time Frame

Adverse events: from first dose of study treatment until the earlier of 90 days after last dose or the date of first subsequent anticancer therapy. All-cause mortality (death due to any cause): from randomization up to global cohort final analysis DCO (12 March 2021). Maximum timeframe of approximately 45 months.

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

Preserved source evidence · Not medical advice