NCT01801111 · ADVERSE EVENTS

Adverse events

A Study of Alectinib (RO5424802) in Participants With Non-Small Cell Lung Cancer Who Have Anaplastic Lymphoma Kinase (ALK) Mutation and Failed Crizotinib Treatment · Source last updated 2018-11-02

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 Baseline until 28 days after the last dose of study drug (overall up to approximately 4 years)
Other-event reporting threshold: 5%

Analysis was performed on safety population.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Alectinib Participants received alectinib at a dose of 600 mg via capsule, orally, twice daily, continuously starting on Day 1 Cycle 1 (in 28-day cycles) until PD, death, or withdrawal for any other reasons, whichever occurred first. After PD, participants were allowed to continue treatment with alectinib as per the discretion of the treating physician.	39 / 138	133 / 138	75 / 138

Group identifiers: EG000: Alectinib

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
Cardiac disorders
source Vocabulary
MedDRA v20.0
stats
group Id
EG000
num Affected
1
num At Risk
138
term
Myocardial infarction
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA v20.0
stats
group Id
EG000
num Affected
1
num At Risk
138
term
Retinal detachment
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v20.0
stats
group Id
EG000
num Affected
2
num At Risk
138
term
Constipation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v20.0
stats
group Id
EG000
num Affected
1
num At Risk
138
term
Intestinal perforation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v20.0
stats
group Id
EG000
num Affected
1
num At Risk
138
term
Oesophagitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v20.0
stats
group Id
EG000
num Affected
1
num At Risk
138
term
Vomiting
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA v20.0
stats
group Id
EG000
num Affected
1
num At Risk
138
term
Malaise
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Hepatobiliary disorders
source Vocabulary
MedDRA v20.0
stats
group Id
EG000
num Affected
3
num At Risk
138
term
Hyperbilirubinaemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA v20.0
stats
group Id
EG000
num Affected
1
num At Risk
138
term
Appendicitis perforated
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA v20.0
stats
group Id
EG000
num Affected
1
num At Risk
138
term
Intervertebral discitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA v20.0
stats
group Id
EG000
num Affected
1
num At Risk
138
term
Pleural infection
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA v20.0
stats
group Id
EG000
num Affected
2
num At Risk
138
term
Pneumonia

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 v20.0
stats
group Id
EG000
num Affected
19
num At Risk
138
term
Anaemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v20.0
stats
group Id
EG000
num Affected
11
num At Risk
138
term
Abdominal pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v20.0
stats
group Id
EG000
num Affected
17
num At Risk
138
term
Abdominal pain upper
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v20.0
stats
group Id
EG000
num Affected
53
num At Risk
138
term
Constipation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v20.0
stats
group Id
EG000
num Affected
27
num At Risk
138
term
Diarrhoea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v20.0
stats
group Id
EG000
num Affected
32
num At Risk
138
term
Nausea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v20.0
stats
group Id
EG000
num Affected
22
num At Risk
138
term
Vomiting
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA v20.0
stats
group Id
EG000
num Affected
31
num At Risk
138
term
Asthenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA v20.0
stats
group Id
EG000
num Affected
43
num At Risk
138
term
Fatigue
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA v20.0
stats
group Id
EG000
num Affected
9
num At Risk
138
term
Oedema
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA v20.0
stats
group Id
EG000
num Affected
42
num At Risk
138
term
Oedema peripheral
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA v20.0
stats
group Id
EG000
num Affected
17
num At Risk
138
term
Pyrexia

Complete source fields

description

Analysis was performed on safety population.

event Groups

deaths Num Affected
75
deaths Num At Risk
138
description
Participants received alectinib at a dose of 600 mg via capsule, orally, twice daily, continuously starting on Day 1 Cycle 1 (in 28-day cycles) until PD, death, or withdrawal for any other reasons, whichever occurred first. After PD, participants were allowed to continue treatment with alectinib as per the discretion of the treating physician.
id
EG000
other Num Affected
133
other Num At Risk
138
serious Num Affected
39
serious Num At Risk
138
title
Alectinib

frequency Threshold

other Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v20.0
stats
group Id
EG000
num Affected
19
num At Risk
138
term
Anaemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v20.0
stats
group Id
EG000
num Affected
11
num At Risk
138
term
Abdominal pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v20.0
stats
group Id
EG000
num Affected
17
num At Risk
138
term
Abdominal pain upper
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v20.0
stats
group Id
EG000
num Affected
53
num At Risk
138
term
Constipation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v20.0
stats
group Id
EG000
num Affected
27
num At Risk
138
term
Diarrhoea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v20.0
stats
group Id
EG000
num Affected
32
num At Risk
138
term
Nausea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v20.0
stats
group Id
EG000
num Affected
22
num At Risk
138
term
Vomiting
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA v20.0
stats
group Id
EG000
num Affected
31
num At Risk
138
term
Asthenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA v20.0
stats
group Id
EG000
num Affected
43
num At Risk
138
term
Fatigue
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA v20.0
stats
group Id
EG000
num Affected
9
num At Risk
138
term
Oedema
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA v20.0
stats
group Id
EG000
num Affected
42
num At Risk
138
term
Oedema peripheral
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA v20.0
stats
group Id
EG000
num Affected
17
num At Risk
138
term
Pyrexia

serious Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v20.0
stats
group Id
EG000
num Affected
1
num At Risk
138
term
Myocardial infarction
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA v20.0
stats
group Id
EG000
num Affected
1
num At Risk
138
term
Retinal detachment
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v20.0
stats
group Id
EG000
num Affected
2
num At Risk
138
term
Constipation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v20.0
stats
group Id
EG000
num Affected
1
num At Risk
138
term
Intestinal perforation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v20.0
stats
group Id
EG000
num Affected
1
num At Risk
138
term
Oesophagitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v20.0
stats
group Id
EG000
num Affected
1
num At Risk
138
term
Vomiting
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA v20.0
stats
group Id
EG000
num Affected
1
num At Risk
138
term
Malaise
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Hepatobiliary disorders
source Vocabulary
MedDRA v20.0
stats
group Id
EG000
num Affected
3
num At Risk
138
term
Hyperbilirubinaemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA v20.0
stats
group Id
EG000
num Affected
1
num At Risk
138
term
Appendicitis perforated
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA v20.0
stats
group Id
EG000
num Affected
1
num At Risk
138
term
Intervertebral discitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA v20.0
stats
group Id
EG000
num Affected
1
num At Risk
138
term
Pleural infection
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA v20.0
stats
group Id
EG000
num Affected
2
num At Risk
138
term
Pneumonia

time Frame

From Baseline until 28 days after the last dose of study drug (overall up to approximately 4 years)

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Preserved source evidence · Not medical advice