NCT01774721 · ADVERSE EVENTS

Adverse events

ARCHER1050: A Study of Dacomitinib vs. Gefitinib in 1st-Line Treatment Of Advanced NSCLC. · Source last updated 2023-11-14

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 randomization until death or last date known as alive, up to 91 months
Other-event reporting threshold: 5%

The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants who received at least 1 dose of study medication, with treatment assignments designated according to actual study treatment received.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Dacomitinib Participants received 45 mg of dacomitinib tablets orally once daily in each treatment cycle of 28 days, up to a maximum of 48 months until disease progression, intolerable toxicities, withdrawal, death, or investigator decision dictated by protocol compliance, whichever occurred first.	69 / 227	224 / 227	133 / 227
Gefitinib Participants received 250 mg of gefitinib tablets orally once daily in each treatment cycle of 28 days, for maximum of 48 months until disease progression, intolerable toxicities, withdrawal, death, or investigator decision dictated by protocol compliance, whichever occurred first.	53 / 224	217 / 224	152 / 224
Dacomitinib (Ongoing at DCO) DCO was the protocol-defined cutoff at 48 months from first dosing of the last enrolled participant (13 May 2019). At the DCO, 11 participants were ongoing in the dacomitinib arm and continued study treatment until disease progression, intolerable toxicities, withdrawal, death, or study terminated by sponsor, whichever occurred first. The 11 participants were analyzed for adverse events after LPLV on 27 Jan 2022.	4 / 11	11 / 11	1 / 11

Group identifiers: EG000: Dacomitinib · EG001: Gefitinib · EG002: Dacomitinib (Ongoing at DCO)

Serious adverse events

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

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 24.1
stats
group Id
EG000
num Affected
1
num At Risk
227
group Id
EG001
num Affected
0
num At Risk
224
group Id
EG002
num Affected
0
num At Risk
11
term
Leukocytosis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 24.1
stats
group Id
EG000
num Affected
1
num At Risk
227
group Id
EG001
num Affected
0
num At Risk
224
group Id
EG002
num Affected
0
num At Risk
11
term
Cardiac tamponade
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 24.1
stats
group Id
EG000
num Affected
0
num At Risk
227
group Id
EG001
num Affected
1
num At Risk
224
group Id
EG002
num Affected
0
num At Risk
11
term
Arteriosclerosis coronary artery
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 24.1
stats
group Id
EG000
num Affected
1
num At Risk
227
group Id
EG001
num Affected
0
num At Risk
224
group Id
EG002
num Affected
0
num At Risk
11
term
Keratitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 24.1
stats
group Id
EG000
num Affected
5
num At Risk
227
group Id
EG001
num Affected
0
num At Risk
224
group Id
EG002
num Affected
1
num At Risk
11
term
Diarrhoea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 24.1
stats
group Id
EG000
num Affected
2
num At Risk
227
group Id
EG001
num Affected
0
num At Risk
224
group Id
EG002
num Affected
0
num At Risk
11
term
Abdominal pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 24.1
stats
group Id
EG000
num Affected
1
num At Risk
227
group Id
EG001
num Affected
0
num At Risk
224
group Id
EG002
num Affected
0
num At Risk
11
term
Abdominal distension
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 24.1
stats
group Id
EG000
num Affected
1
num At Risk
227
group Id
EG001
num Affected
0
num At Risk
224
group Id
EG002
num Affected
0
num At Risk
11
term
Gastric ulcer haemorrhage
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 24.1
stats
group Id
EG000
num Affected
2
num At Risk
227
group Id
EG001
num Affected
0
num At Risk
224
group Id
EG002
num Affected
0
num At Risk
11
term
Ileus
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 24.1
stats
group Id
EG000
num Affected
1
num At Risk
227
group Id
EG001
num Affected
0
num At Risk
224
group Id
EG002
num Affected
0
num At Risk
11
term
Mouth haemorrhage
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 24.1
stats
group Id
EG000
num Affected
1
num At Risk
227
group Id
EG001
num Affected
0
num At Risk
224
group Id
EG002
num Affected
0
num At Risk
11
term
Rectal haemorrhage
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 24.1
stats
group Id
EG000
num Affected
1
num At Risk
227
group Id
EG001
num Affected
0
num At Risk
224
group Id
EG002
num Affected
0
num At Risk
11
term
Stomatitis

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
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 24.1
stats
group Id
EG000
num Affected
27
num At Risk
227
group Id
EG001
num Affected
18
num At Risk
224
group Id
EG002
num Affected
5
num At Risk
11
term
Anaemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 24.1
stats
group Id
EG000
num Affected
199
num At Risk
227
group Id
EG001
num Affected
125
num At Risk
224
group Id
EG002
num Affected
10
num At Risk
11
term
Diarrhoea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 24.1
stats
group Id
EG000
num Affected
99
num At Risk
227
group Id
EG001
num Affected
41
num At Risk
224
group Id
EG002
num Affected
6
num At Risk
11
term
Stomatitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 24.1
stats
group Id
EG000
num Affected
45
num At Risk
227
group Id
EG001
num Affected
50
num At Risk
224
group Id
EG002
num Affected
3
num At Risk
11
term
Nausea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 24.1
stats
group Id
EG000
num Affected
32
num At Risk
227
group Id
EG001
num Affected
29
num At Risk
224
group Id
EG002
num Affected
2
num At Risk
11
term
Constipation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 24.1
stats
group Id
EG000
num Affected
32
num At Risk
227
group Id
EG001
num Affected
14
num At Risk
224
group Id
EG002
num Affected
3
num At Risk
11
term
Mouth ulceration
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 24.1
stats
group Id
EG000
num Affected
22
num At Risk
227
group Id
EG001
num Affected
29
num At Risk
224
group Id
EG002
num Affected
0
num At Risk
11
term
Vomiting
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 24.1
stats
group Id
EG000
num Affected
13
num At Risk
227
group Id
EG001
num Affected
6
num At Risk
224
group Id
EG002
num Affected
0
num At Risk
11
term
Aphthous ulcer
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 24.1
stats
group Id
EG000
num Affected
13
num At Risk
227
group Id
EG001
num Affected
1
num At Risk
224
group Id
EG002
num Affected
4
num At Risk
11
term
Oral pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 24.1
stats
group Id
EG000
num Affected
14
num At Risk
227
group Id
EG001
num Affected
13
num At Risk
224
group Id
EG002
num Affected
0
num At Risk
11
term
Abdominal pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 24.1
stats
group Id
EG000
num Affected
10
num At Risk
227
group Id
EG001
num Affected
12
num At Risk
224
group Id
EG002
num Affected
1
num At Risk
11
term
Dysphagia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 24.1
stats
group Id
EG000
num Affected
10
num At Risk
227
group Id
EG001
num Affected
14
num At Risk
224
group Id
EG002
num Affected
0
num At Risk
11
term
Abdominal pain upper

Complete source fields

description

event Groups

deaths Num Affected
133
deaths Num At Risk
227
description
Participants received 45 mg of dacomitinib tablets orally once daily in each treatment cycle of 28 days, up to a maximum of 48 months until disease progression, intolerable toxicities, withdrawal, death, or investigator decision dictated by protocol compliance, whichever occurred first.
id
EG000
other Num Affected
224
other Num At Risk
227
serious Num Affected
69
serious Num At Risk
227
title
Dacomitinib
deaths Num Affected
152
deaths Num At Risk
224
description
Participants received 250 mg of gefitinib tablets orally once daily in each treatment cycle of 28 days, for maximum of 48 months until disease progression, intolerable toxicities, withdrawal, death, or investigator decision dictated by protocol compliance, whichever occurred first.
id
EG001
other Num Affected
217
other Num At Risk
224
serious Num Affected
53
serious Num At Risk
224
title
Gefitinib
deaths Num Affected
1
deaths Num At Risk
11
description
DCO was the protocol-defined cutoff at 48 months from first dosing of the last enrolled participant (13 May 2019). At the DCO, 11 participants were ongoing in the dacomitinib arm and continued study treatment until disease progression, intolerable toxicities, withdrawal, death, or study terminated by sponsor, whichever occurred first. The 11 participants were analyzed for adverse events after LPLV on 27 Jan 2022.
id
EG002
other Num Affected
11
other Num At Risk
11
serious Num Affected
4
serious Num At Risk
11
title
Dacomitinib (Ongoing at DCO)

frequency Threshold

other Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 24.1
stats
group Id
EG000
num Affected
27
num At Risk
227
group Id
EG001
num Affected
18
num At Risk
224
group Id
EG002
num Affected
5
num At Risk
11
term
Anaemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 24.1
stats
group Id
EG000
num Affected
199
num At Risk
227
group Id
EG001
num Affected
125
num At Risk
224
group Id
EG002
num Affected
10
num At Risk
11
term
Diarrhoea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 24.1
stats
group Id
EG000
num Affected
99
num At Risk
227
group Id
EG001
num Affected
41
num At Risk
224
group Id
EG002
num Affected
6
num At Risk
11
term
Stomatitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 24.1
stats
group Id
EG000
num Affected
45
num At Risk
227
group Id
EG001
num Affected
50
num At Risk
224
group Id
EG002
num Affected
3
num At Risk
11
term
Nausea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 24.1
stats
group Id
EG000
num Affected
32
num At Risk
227
group Id
EG001
num Affected
29
num At Risk
224
group Id
EG002
num Affected
2
num At Risk
11
term
Constipation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 24.1
stats
group Id
EG000
num Affected
32
num At Risk
227
group Id
EG001
num Affected
14
num At Risk
224
group Id
EG002
num Affected
3
num At Risk
11
term
Mouth ulceration
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 24.1
stats
group Id
EG000
num Affected
22
num At Risk
227
group Id
EG001
num Affected
29
num At Risk
224
group Id
EG002
num Affected
0
num At Risk
11
term
Vomiting
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 24.1
stats
group Id
EG000
num Affected
13
num At Risk
227
group Id
EG001
num Affected
6
num At Risk
224
group Id
EG002
num Affected
0
num At Risk
11
term
Aphthous ulcer
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 24.1
stats
group Id
EG000
num Affected
13
num At Risk
227
group Id
EG001
num Affected
1
num At Risk
224
group Id
EG002
num Affected
4
num At Risk
11
term
Oral pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 24.1
stats
group Id
EG000
num Affected
14
num At Risk
227
group Id
EG001
num Affected
13
num At Risk
224
group Id
EG002
num Affected
0
num At Risk
11
term
Abdominal pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 24.1
stats
group Id
EG000
num Affected
10
num At Risk
227
group Id
EG001
num Affected
12
num At Risk
224
group Id
EG002
num Affected
1
num At Risk
11
term
Dysphagia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 24.1
stats
group Id
EG000
num Affected
10
num At Risk
227
group Id
EG001
num Affected
14
num At Risk
224
group Id
EG002
num Affected
0
num At Risk
11
term
Abdominal pain upper

serious Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 24.1
stats
group Id
EG000
num Affected
1
num At Risk
227
group Id
EG001
num Affected
0
num At Risk
224
group Id
EG002
num Affected
0
num At Risk
11
term
Leukocytosis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 24.1
stats
group Id
EG000
num Affected
1
num At Risk
227
group Id
EG001
num Affected
0
num At Risk
224
group Id
EG002
num Affected
0
num At Risk
11
term
Cardiac tamponade
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 24.1
stats
group Id
EG000
num Affected
0
num At Risk
227
group Id
EG001
num Affected
1
num At Risk
224
group Id
EG002
num Affected
0
num At Risk
11
term
Arteriosclerosis coronary artery
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 24.1
stats
group Id
EG000
num Affected
1
num At Risk
227
group Id
EG001
num Affected
0
num At Risk
224
group Id
EG002
num Affected
0
num At Risk
11
term
Keratitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 24.1
stats
group Id
EG000
num Affected
5
num At Risk
227
group Id
EG001
num Affected
0
num At Risk
224
group Id
EG002
num Affected
1
num At Risk
11
term
Diarrhoea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 24.1
stats
group Id
EG000
num Affected
2
num At Risk
227
group Id
EG001
num Affected
0
num At Risk
224
group Id
EG002
num Affected
0
num At Risk
11
term
Abdominal pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 24.1
stats
group Id
EG000
num Affected
1
num At Risk
227
group Id
EG001
num Affected
0
num At Risk
224
group Id
EG002
num Affected
0
num At Risk
11
term
Abdominal distension
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 24.1
stats
group Id
EG000
num Affected
1
num At Risk
227
group Id
EG001
num Affected
0
num At Risk
224
group Id
EG002
num Affected
0
num At Risk
11
term
Gastric ulcer haemorrhage
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 24.1
stats
group Id
EG000
num Affected
2
num At Risk
227
group Id
EG001
num Affected
0
num At Risk
224
group Id
EG002
num Affected
0
num At Risk
11
term
Ileus
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 24.1
stats
group Id
EG000
num Affected
1
num At Risk
227
group Id
EG001
num Affected
0
num At Risk
224
group Id
EG002
num Affected
0
num At Risk
11
term
Mouth haemorrhage
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 24.1
stats
group Id
EG000
num Affected
1
num At Risk
227
group Id
EG001
num Affected
0
num At Risk
224
group Id
EG002
num Affected
0
num At Risk
11
term
Rectal haemorrhage
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 24.1
stats
group Id
EG000
num Affected
1
num At Risk
227
group Id
EG001
num Affected
0
num At Risk
224
group Id
EG002
num Affected
0
num At Risk
11
term
Stomatitis

time Frame

From randomization until death or last date known as alive, up to 91 months

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