NCT04644315 · ADVERSE EVENTS

Adverse events

A Home-Based Approach Study to Evaluate the Efficacy and Safety of Alectinib in Locally-Advanced or Metastatic ALK-Positive Solid Tumors · Source last updated 2023-08-07

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: Approximately 1 year
Other-event reporting threshold: 0%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
ALK-positive Solid Tumors Participants with locally advanced or metastatic ALK-positive tumors were to receive alectinib twice daily (BID) until disease progression, unacceptable toxicity, death, or withdrawal from the study for any reason.	1 / 1	1 / 1	0 / 1

Group identifiers: EG000: ALK-positive Solid Tumors

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 25.0
stats
group Id
EG000
num Affected
1
num At Risk
1
num Events
1
term
Anaemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
medDRA 25.0
stats
group Id
EG000
num Affected
1
num At Risk
1
num Events
1
term
Myalgia

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
Nervous system disorders
source Vocabulary
medDRA 25.0
stats
group Id
EG000
num Affected
1
num At Risk
1
num Events
1
term
Hypoaesthesia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
medDRA 25.0
stats
group Id
EG000
num Affected
1
num At Risk
1
num Events
1
term
Aspartate aminotransferase increased
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
medDRA 25.0
stats
group Id
EG000
num Affected
1
num At Risk
1
num Events
1
term
Headache
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
medDRA 25.0
stats
group Id
EG000
num Affected
1
num At Risk
1
num Events
1
term
Irritability
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
medDRA 25.0
stats
group Id
EG000
num Affected
1
num At Risk
1
num Events
1
term
Blood alkaline phosphatase increased
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
medDRA 25.0
stats
group Id
EG000
num Affected
1
num At Risk
1
num Events
1
term
Muscular weakness
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
medDRA 25.0
stats
group Id
EG000
num Affected
1
num At Risk
1
num Events
1
term
Weight decreased
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
medDRA 25.0
stats
group Id
EG000
num Affected
1
num At Risk
1
num Events
1
term
Dizziness

Complete source fields

event Groups

deaths Num Affected
0
deaths Num At Risk
1
description
Participants with locally advanced or metastatic ALK-positive tumors were to receive alectinib twice daily (BID) until disease progression, unacceptable toxicity, death, or withdrawal from the study for any reason.
id
EG000
other Num Affected
1
other Num At Risk
1
serious Num Affected
1
serious Num At Risk
1
title
ALK-positive Solid Tumors

frequency Threshold

other Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
medDRA 25.0
stats
group Id
EG000
num Affected
1
num At Risk
1
num Events
1
term
Hypoaesthesia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
medDRA 25.0
stats
group Id
EG000
num Affected
1
num At Risk
1
num Events
1
term
Aspartate aminotransferase increased
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
medDRA 25.0
stats
group Id
EG000
num Affected
1
num At Risk
1
num Events
1
term
Headache
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
medDRA 25.0
stats
group Id
EG000
num Affected
1
num At Risk
1
num Events
1
term
Irritability
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
medDRA 25.0
stats
group Id
EG000
num Affected
1
num At Risk
1
num Events
1
term
Blood alkaline phosphatase increased
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
medDRA 25.0
stats
group Id
EG000
num Affected
1
num At Risk
1
num Events
1
term
Muscular weakness
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
medDRA 25.0
stats
group Id
EG000
num Affected
1
num At Risk
1
num Events
1
term
Weight decreased
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
medDRA 25.0
stats
group Id
EG000
num Affected
1
num At Risk
1
num Events
1
term
Dizziness

serious Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
medDRA 25.0
stats
group Id
EG000
num Affected
1
num At Risk
1
num Events
1
term
Anaemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
medDRA 25.0
stats
group Id
EG000
num Affected
1
num At Risk
1
num Events
1
term
Myalgia

time Frame

Approximately 1 year

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Preserved source evidence · Not medical advice