NCT01871805 · ADVERSE EVENTS

Adverse events

A Study of Alectinib (CH5424802/RO5424802) in Participants With Anaplastic Lymphoma Kinase (ALK)-Rearranged Non-Small Cell Lung Cancer (NSCLC) · Source last updated 2018-08-21

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: Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks)
Other-event reporting threshold: 5%

Safety population

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Alectinib 300 mg (Fasted): Phase I Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 240 or 300 mg on Cycle 1 Day -3 and then received 300 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	1 / 7	7 / 7	7 / 7
Alectinib 460 mg (Fed): Phase I Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 460 mg on Cycle 1 Day -3 and then received 460 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	2 / 7	7 / 7	4 / 7
Alectinib 600 mg (Fed): Phase I Participants received single dose of 20 or 40 or 150 mg alectinib capsules orally to make a dose of 600 mg on Cycle 1 Day -3 and then received 600 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	6 / 13	12 / 13	6 / 13
Alectinib 760 mg (Fed): Phase I Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 760 mg on Cycle 1 Day -3 and then received 760 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	0 / 7	7 / 7	2 / 7
Alectinib 900 mg (Fed): Phase I Participants received single dose of 20 or 40 or 150 mg alectinib capsules orally to make a dose of 900 mg on Cycle 1 Day -3 and then received 900 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	1 / 13	13 / 13	9 / 13
Alectinib 600 mg (Fed): Phase II Participants received 600 mg alectinib capsules orally BID from Cycle 1 Day 1 for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.	21 / 87	85 / 87	45 / 87

Group identifiers: EG000: Alectinib 300 mg (Fasted): Phase I · EG001: Alectinib 460 mg (Fed): Phase I · EG002: Alectinib 600 mg (Fed): Phase I · EG003: Alectinib 760 mg (Fed): Phase I · EG004: Alectinib 900 mg (Fed): Phase I · EG005: Alectinib 600 mg (Fed): Phase II

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
Infections and infestations
source Vocabulary
MedDRA Version 20.0
stats
group Id
EG000
num Affected
0
num At Risk
7
group Id
EG001
num Affected
0
num At Risk
7
group Id
EG002
num Affected
0
num At Risk
13
group Id
EG003
num Affected
0
num At Risk
7
group Id
EG004
num Affected
1
num At Risk
13
group Id
EG005
num Affected
0
num At Risk
87
term
Bronchitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA Version 20.0
stats
group Id
EG000
num Affected
0
num At Risk
7
group Id
EG001
num Affected
0
num At Risk
7
group Id
EG002
num Affected
1
num At Risk
13
group Id
EG003
num Affected
0
num At Risk
7
group Id
EG004
num Affected
0
num At Risk
13
group Id
EG005
num Affected
1
num At Risk
87
term
Pneumonia bacterial
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA Version 20.0
stats
group Id
EG000
num Affected
0
num At Risk
7
group Id
EG001
num Affected
0
num At Risk
7
group Id
EG002
num Affected
2
num At Risk
13
group Id
EG003
num Affected
0
num At Risk
7
group Id
EG004
num Affected
0
num At Risk
13
group Id
EG005
num Affected
1
num At Risk
87
term
Pericardial effusion
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 20.0
stats
group Id
EG000
num Affected
1
num At Risk
7
group Id
EG001
num Affected
0
num At Risk
7
group Id
EG002
num Affected
0
num At Risk
13
group Id
EG003
num Affected
0
num At Risk
7
group Id
EG004
num Affected
0
num At Risk
13
group Id
EG005
num Affected
0
num At Risk
87
term
Nausea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 20.0
stats
group Id
EG000
num Affected
1
num At Risk
7
group Id
EG001
num Affected
0
num At Risk
7
group Id
EG002
num Affected
0
num At Risk
13
group Id
EG003
num Affected
0
num At Risk
7
group Id
EG004
num Affected
0
num At Risk
13
group Id
EG005
num Affected
0
num At Risk
87
term
Vomiting
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Injury, poisoning and procedural complications
source Vocabulary
MedDRA Version 20.0
stats
group Id
EG000
num Affected
0
num At Risk
7
group Id
EG001
num Affected
0
num At Risk
7
group Id
EG002
num Affected
1
num At Risk
13
group Id
EG003
num Affected
0
num At Risk
7
group Id
EG004
num Affected
0
num At Risk
13
group Id
EG005
num Affected
0
num At Risk
87
term
Procedural pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
source Vocabulary
MedDRA Version 20.0
stats
group Id
EG000
num Affected
0
num At Risk
7
group Id
EG001
num Affected
0
num At Risk
7
group Id
EG002
num Affected
1
num At Risk
13
group Id
EG003
num Affected
0
num At Risk
7
group Id
EG004
num Affected
0
num At Risk
13
group Id
EG005
num Affected
0
num At Risk
87
term
Chronic myeloid leukaemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
source Vocabulary
MedDRA Version 20.0
stats
group Id
EG000
num Affected
0
num At Risk
7
group Id
EG001
num Affected
1
num At Risk
7
group Id
EG002
num Affected
0
num At Risk
13
group Id
EG003
num Affected
0
num At Risk
7
group Id
EG004
num Affected
0
num At Risk
13
group Id
EG005
num Affected
0
num At Risk
87
term
Renal failure
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA Version 20.0
stats
group Id
EG000
num Affected
0
num At Risk
7
group Id
EG001
num Affected
0
num At Risk
7
group Id
EG002
num Affected
0
num At Risk
13
group Id
EG003
num Affected
0
num At Risk
7
group Id
EG004
num Affected
0
num At Risk
13
group Id
EG005
num Affected
1
num At Risk
87
term
Brain oedema
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA Version 20.0
stats
group Id
EG000
num Affected
0
num At Risk
7
group Id
EG001
num Affected
0
num At Risk
7
group Id
EG002
num Affected
0
num At Risk
13
group Id
EG003
num Affected
0
num At Risk
7
group Id
EG004
num Affected
0
num At Risk
13
group Id
EG005
num Affected
1
num At Risk
87
term
Cerebral ventricle dilatation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA Version 20.0
stats
group Id
EG000
num Affected
0
num At Risk
7
group Id
EG001
num Affected
0
num At Risk
7
group Id
EG002
num Affected
0
num At Risk
13
group Id
EG003
num Affected
0
num At Risk
7
group Id
EG004
num Affected
0
num At Risk
13
group Id
EG005
num Affected
1
num At Risk
87
term
Embolic stroke
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA Version 20.0
stats
group Id
EG000
num Affected
0
num At Risk
7
group Id
EG001
num Affected
0
num At Risk
7
group Id
EG002
num Affected
1
num At Risk
13
group Id
EG003
num Affected
0
num At Risk
7
group Id
EG004
num Affected
0
num At Risk
13
group Id
EG005
num Affected
1
num At Risk
87
term
Haemorrhage intracranial

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
General disorders
source Vocabulary
MedDRA Version 20.0
stats
group Id
EG000
num Affected
4
num At Risk
7
group Id
EG001
num Affected
3
num At Risk
7
group Id
EG002
num Affected
3
num At Risk
13
group Id
EG003
num Affected
5
num At Risk
7
group Id
EG004
num Affected
7
num At Risk
13
group Id
EG005
num Affected
36
num At Risk
87
term
Fatigue
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA Version 20.0
stats
group Id
EG000
num Affected
1
num At Risk
7
group Id
EG001
num Affected
1
num At Risk
7
group Id
EG002
num Affected
2
num At Risk
13
group Id
EG003
num Affected
2
num At Risk
7
group Id
EG004
num Affected
3
num At Risk
13
group Id
EG005
num Affected
22
num At Risk
87
term
Oedema peripheral
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA Version 20.0
stats
group Id
EG000
num Affected
0
num At Risk
7
group Id
EG001
num Affected
0
num At Risk
7
group Id
EG002
num Affected
3
num At Risk
13
group Id
EG003
num Affected
0
num At Risk
7
group Id
EG004
num Affected
1
num At Risk
13
group Id
EG005
num Affected
9
num At Risk
87
term
Pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA Version 20.0
stats
group Id
EG000
num Affected
0
num At Risk
7
group Id
EG001
num Affected
1
num At Risk
7
group Id
EG002
num Affected
2
num At Risk
13
group Id
EG003
num Affected
0
num At Risk
7
group Id
EG004
num Affected
0
num At Risk
13
group Id
EG005
num Affected
5
num At Risk
87
term
Pyrexia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA Version 20.0
stats
group Id
EG000
num Affected
0
num At Risk
7
group Id
EG001
num Affected
1
num At Risk
7
group Id
EG002
num Affected
0
num At Risk
13
group Id
EG003
num Affected
0
num At Risk
7
group Id
EG004
num Affected
1
num At Risk
13
group Id
EG005
num Affected
0
num At Risk
87
term
Asthenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA Version 20.0
stats
group Id
EG000
num Affected
0
num At Risk
7
group Id
EG001
num Affected
0
num At Risk
7
group Id
EG002
num Affected
1
num At Risk
13
group Id
EG003
num Affected
0
num At Risk
7
group Id
EG004
num Affected
0
num At Risk
13
group Id
EG005
num Affected
0
num At Risk
87
term
Chest discomfort
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA Version 20.0
stats
group Id
EG000
num Affected
0
num At Risk
7
group Id
EG001
num Affected
0
num At Risk
7
group Id
EG002
num Affected
0
num At Risk
13
group Id
EG003
num Affected
1
num At Risk
7
group Id
EG004
num Affected
1
num At Risk
13
group Id
EG005
num Affected
5
num At Risk
87
term
Chest pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA Version 20.0
stats
group Id
EG000
num Affected
1
num At Risk
7
group Id
EG001
num Affected
0
num At Risk
7
group Id
EG002
num Affected
0
num At Risk
13
group Id
EG003
num Affected
0
num At Risk
7
group Id
EG004
num Affected
0
num At Risk
13
group Id
EG005
num Affected
0
num At Risk
87
term
Face oedema
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA Version 20.0
stats
group Id
EG000
num Affected
0
num At Risk
7
group Id
EG001
num Affected
1
num At Risk
7
group Id
EG002
num Affected
1
num At Risk
13
group Id
EG003
num Affected
0
num At Risk
7
group Id
EG004
num Affected
0
num At Risk
13
group Id
EG005
num Affected
0
num At Risk
87
term
Gait disturbance
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA Version 20.0
stats
group Id
EG000
num Affected
0
num At Risk
7
group Id
EG001
num Affected
0
num At Risk
7
group Id
EG002
num Affected
1
num At Risk
13
group Id
EG003
num Affected
0
num At Risk
7
group Id
EG004
num Affected
0
num At Risk
13
group Id
EG005
num Affected
0
num At Risk
87
term
Injection site haemorrhage
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA Version 20.0
stats
group Id
EG000
num Affected
0
num At Risk
7
group Id
EG001
num Affected
0
num At Risk
7
group Id
EG002
num Affected
1
num At Risk
13
group Id
EG003
num Affected
0
num At Risk
7
group Id
EG004
num Affected
0
num At Risk
13
group Id
EG005
num Affected
0
num At Risk
87
term
Injection site reaction
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA Version 20.0
stats
group Id
EG000
num Affected
1
num At Risk
7
group Id
EG001
num Affected
0
num At Risk
7
group Id
EG002
num Affected
0
num At Risk
13
group Id
EG003
num Affected
0
num At Risk
7
group Id
EG004
num Affected
0
num At Risk
13
group Id
EG005
num Affected
0
num At Risk
87
term
Mucosal inflammation

Complete source fields

description

Safety population

event Groups

deaths Num Affected
7
deaths Num At Risk
7
description
Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 240 or 300 mg on Cycle 1 Day -3 and then received 300 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
id
EG000
other Num Affected
7
other Num At Risk
7
serious Num Affected
1
serious Num At Risk
7
title
Alectinib 300 mg (Fasted): Phase I
deaths Num Affected
4
deaths Num At Risk
7
description
Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 460 mg on Cycle 1 Day -3 and then received 460 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
id
EG001
other Num Affected
7
other Num At Risk
7
serious Num Affected
2
serious Num At Risk
7
title
Alectinib 460 mg (Fed): Phase I
deaths Num Affected
6
deaths Num At Risk
13
description
Participants received single dose of 20 or 40 or 150 mg alectinib capsules orally to make a dose of 600 mg on Cycle 1 Day -3 and then received 600 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
id
EG002
other Num Affected
12
other Num At Risk
13
serious Num Affected
6
serious Num At Risk
13
title
Alectinib 600 mg (Fed): Phase I
deaths Num Affected
2
deaths Num At Risk
7
description
Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 760 mg on Cycle 1 Day -3 and then received 760 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
id
EG003
other Num Affected
7
other Num At Risk
7
serious Num Affected
0
serious Num At Risk
7
title
Alectinib 760 mg (Fed): Phase I
deaths Num Affected
9
deaths Num At Risk
13
description
Participants received single dose of 20 or 40 or 150 mg alectinib capsules orally to make a dose of 900 mg on Cycle 1 Day -3 and then received 900 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
id
EG004
other Num Affected
13
other Num At Risk
13
serious Num Affected
1
serious Num At Risk
13
title
Alectinib 900 mg (Fed): Phase I
deaths Num Affected
45
deaths Num At Risk
87
description
Participants received 600 mg alectinib capsules orally BID from Cycle 1 Day 1 for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
id
EG005
other Num Affected
85
other Num At Risk
87
serious Num Affected
21
serious Num At Risk
87
title
Alectinib 600 mg (Fed): Phase II

frequency Threshold

other Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA Version 20.0
stats
group Id
EG000
num Affected
4
num At Risk
7
group Id
EG001
num Affected
3
num At Risk
7
group Id
EG002
num Affected
3
num At Risk
13
group Id
EG003
num Affected
5
num At Risk
7
group Id
EG004
num Affected
7
num At Risk
13
group Id
EG005
num Affected
36
num At Risk
87
term
Fatigue
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA Version 20.0
stats
group Id
EG000
num Affected
1
num At Risk
7
group Id
EG001
num Affected
1
num At Risk
7
group Id
EG002
num Affected
2
num At Risk
13
group Id
EG003
num Affected
2
num At Risk
7
group Id
EG004
num Affected
3
num At Risk
13
group Id
EG005
num Affected
22
num At Risk
87
term
Oedema peripheral
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA Version 20.0
stats
group Id
EG000
num Affected
0
num At Risk
7
group Id
EG001
num Affected
0
num At Risk
7
group Id
EG002
num Affected
3
num At Risk
13
group Id
EG003
num Affected
0
num At Risk
7
group Id
EG004
num Affected
1
num At Risk
13
group Id
EG005
num Affected
9
num At Risk
87
term
Pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA Version 20.0
stats
group Id
EG000
num Affected
0
num At Risk
7
group Id
EG001
num Affected
1
num At Risk
7
group Id
EG002
num Affected
2
num At Risk
13
group Id
EG003
num Affected
0
num At Risk
7
group Id
EG004
num Affected
0
num At Risk
13
group Id
EG005
num Affected
5
num At Risk
87
term
Pyrexia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA Version 20.0
stats
group Id
EG000
num Affected
0
num At Risk
7
group Id
EG001
num Affected
1
num At Risk
7
group Id
EG002
num Affected
0
num At Risk
13
group Id
EG003
num Affected
0
num At Risk
7
group Id
EG004
num Affected
1
num At Risk
13
group Id
EG005
num Affected
0
num At Risk
87
term
Asthenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA Version 20.0
stats
group Id
EG000
num Affected
0
num At Risk
7
group Id
EG001
num Affected
0
num At Risk
7
group Id
EG002
num Affected
1
num At Risk
13
group Id
EG003
num Affected
0
num At Risk
7
group Id
EG004
num Affected
0
num At Risk
13
group Id
EG005
num Affected
0
num At Risk
87
term
Chest discomfort
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA Version 20.0
stats
group Id
EG000
num Affected
0
num At Risk
7
group Id
EG001
num Affected
0
num At Risk
7
group Id
EG002
num Affected
0
num At Risk
13
group Id
EG003
num Affected
1
num At Risk
7
group Id
EG004
num Affected
1
num At Risk
13
group Id
EG005
num Affected
5
num At Risk
87
term
Chest pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA Version 20.0
stats
group Id
EG000
num Affected
1
num At Risk
7
group Id
EG001
num Affected
0
num At Risk
7
group Id
EG002
num Affected
0
num At Risk
13
group Id
EG003
num Affected
0
num At Risk
7
group Id
EG004
num Affected
0
num At Risk
13
group Id
EG005
num Affected
0
num At Risk
87
term
Face oedema
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA Version 20.0
stats
group Id
EG000
num Affected
0
num At Risk
7
group Id
EG001
num Affected
1
num At Risk
7
group Id
EG002
num Affected
1
num At Risk
13
group Id
EG003
num Affected
0
num At Risk
7
group Id
EG004
num Affected
0
num At Risk
13
group Id
EG005
num Affected
0
num At Risk
87
term
Gait disturbance
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA Version 20.0
stats
group Id
EG000
num Affected
0
num At Risk
7
group Id
EG001
num Affected
0
num At Risk
7
group Id
EG002
num Affected
1
num At Risk
13
group Id
EG003
num Affected
0
num At Risk
7
group Id
EG004
num Affected
0
num At Risk
13
group Id
EG005
num Affected
0
num At Risk
87
term
Injection site haemorrhage
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA Version 20.0
stats
group Id
EG000
num Affected
0
num At Risk
7
group Id
EG001
num Affected
0
num At Risk
7
group Id
EG002
num Affected
1
num At Risk
13
group Id
EG003
num Affected
0
num At Risk
7
group Id
EG004
num Affected
0
num At Risk
13
group Id
EG005
num Affected
0
num At Risk
87
term
Injection site reaction
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA Version 20.0
stats
group Id
EG000
num Affected
1
num At Risk
7
group Id
EG001
num Affected
0
num At Risk
7
group Id
EG002
num Affected
0
num At Risk
13
group Id
EG003
num Affected
0
num At Risk
7
group Id
EG004
num Affected
0
num At Risk
13
group Id
EG005
num Affected
0
num At Risk
87
term
Mucosal inflammation

serious Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA Version 20.0
stats
group Id
EG000
num Affected
0
num At Risk
7
group Id
EG001
num Affected
0
num At Risk
7
group Id
EG002
num Affected
0
num At Risk
13
group Id
EG003
num Affected
0
num At Risk
7
group Id
EG004
num Affected
1
num At Risk
13
group Id
EG005
num Affected
0
num At Risk
87
term
Bronchitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA Version 20.0
stats
group Id
EG000
num Affected
0
num At Risk
7
group Id
EG001
num Affected
0
num At Risk
7
group Id
EG002
num Affected
1
num At Risk
13
group Id
EG003
num Affected
0
num At Risk
7
group Id
EG004
num Affected
0
num At Risk
13
group Id
EG005
num Affected
1
num At Risk
87
term
Pneumonia bacterial
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA Version 20.0
stats
group Id
EG000
num Affected
0
num At Risk
7
group Id
EG001
num Affected
0
num At Risk
7
group Id
EG002
num Affected
2
num At Risk
13
group Id
EG003
num Affected
0
num At Risk
7
group Id
EG004
num Affected
0
num At Risk
13
group Id
EG005
num Affected
1
num At Risk
87
term
Pericardial effusion
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 20.0
stats
group Id
EG000
num Affected
1
num At Risk
7
group Id
EG001
num Affected
0
num At Risk
7
group Id
EG002
num Affected
0
num At Risk
13
group Id
EG003
num Affected
0
num At Risk
7
group Id
EG004
num Affected
0
num At Risk
13
group Id
EG005
num Affected
0
num At Risk
87
term
Nausea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 20.0
stats
group Id
EG000
num Affected
1
num At Risk
7
group Id
EG001
num Affected
0
num At Risk
7
group Id
EG002
num Affected
0
num At Risk
13
group Id
EG003
num Affected
0
num At Risk
7
group Id
EG004
num Affected
0
num At Risk
13
group Id
EG005
num Affected
0
num At Risk
87
term
Vomiting
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Injury, poisoning and procedural complications
source Vocabulary
MedDRA Version 20.0
stats
group Id
EG000
num Affected
0
num At Risk
7
group Id
EG001
num Affected
0
num At Risk
7
group Id
EG002
num Affected
1
num At Risk
13
group Id
EG003
num Affected
0
num At Risk
7
group Id
EG004
num Affected
0
num At Risk
13
group Id
EG005
num Affected
0
num At Risk
87
term
Procedural pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
source Vocabulary
MedDRA Version 20.0
stats
group Id
EG000
num Affected
0
num At Risk
7
group Id
EG001
num Affected
0
num At Risk
7
group Id
EG002
num Affected
1
num At Risk
13
group Id
EG003
num Affected
0
num At Risk
7
group Id
EG004
num Affected
0
num At Risk
13
group Id
EG005
num Affected
0
num At Risk
87
term
Chronic myeloid leukaemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
source Vocabulary
MedDRA Version 20.0
stats
group Id
EG000
num Affected
0
num At Risk
7
group Id
EG001
num Affected
1
num At Risk
7
group Id
EG002
num Affected
0
num At Risk
13
group Id
EG003
num Affected
0
num At Risk
7
group Id
EG004
num Affected
0
num At Risk
13
group Id
EG005
num Affected
0
num At Risk
87
term
Renal failure
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA Version 20.0
stats
group Id
EG000
num Affected
0
num At Risk
7
group Id
EG001
num Affected
0
num At Risk
7
group Id
EG002
num Affected
0
num At Risk
13
group Id
EG003
num Affected
0
num At Risk
7
group Id
EG004
num Affected
0
num At Risk
13
group Id
EG005
num Affected
1
num At Risk
87
term
Brain oedema
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA Version 20.0
stats
group Id
EG000
num Affected
0
num At Risk
7
group Id
EG001
num Affected
0
num At Risk
7
group Id
EG002
num Affected
0
num At Risk
13
group Id
EG003
num Affected
0
num At Risk
7
group Id
EG004
num Affected
0
num At Risk
13
group Id
EG005
num Affected
1
num At Risk
87
term
Cerebral ventricle dilatation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA Version 20.0
stats
group Id
EG000
num Affected
0
num At Risk
7
group Id
EG001
num Affected
0
num At Risk
7
group Id
EG002
num Affected
0
num At Risk
13
group Id
EG003
num Affected
0
num At Risk
7
group Id
EG004
num Affected
0
num At Risk
13
group Id
EG005
num Affected
1
num At Risk
87
term
Embolic stroke
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA Version 20.0
stats
group Id
EG000
num Affected
0
num At Risk
7
group Id
EG001
num Affected
0
num At Risk
7
group Id
EG002
num Affected
1
num At Risk
13
group Id
EG003
num Affected
0
num At Risk
7
group Id
EG004
num Affected
0
num At Risk
13
group Id
EG005
num Affected
1
num At Risk
87
term
Haemorrhage intracranial

time Frame

Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks)

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

Preserved source evidence · Not medical advice