NCT01121588 · ADVERSE EVENTS

Adverse events

Studying An Investigational Drug Crizotinib (PF-02341066) In Non Non-Small Cell Lung Cancer Tumors That Are Positive For Anaplastic Lymphoma Kinase (ALK) · Source last updated 2025-01-23

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 the first dose of study treatment up to 28 days after the last dose of study treatment (maximum duration between first and last dose: 444 weeks)
Other-event reporting threshold: 5%

The same event may appear as both an AE and an SAE. 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. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
ALCL Arm In ALK genetic event positive participants with ALCL, crizotinib 250 mg twice daily (BID) was administered orally at approximately the same time each day on a continuous daily dosing schedule. Crizotinib was allowed to be taken without regard to meals. Cycles were defined in 21 day periods. Participants could have continued treatment with crizotinib on this study as long as there was evidence of clinical benefit in the judgment of the Investigator.	8 / 17	16 / 17	5 / 17
IMT Arm In ALK genetic event positive participants with IMT, crizotinib 250 mg twice daily (BID) was administered orally at approximately the same time each day on a continuous daily dosing schedule. Crizotinib was allowed to be taken without regard to meals. Cycles were defined in 21 day periods. Participants could have continued treatment with crizotinib on this study as long as there was evidence of clinical benefit in the judgment of the Investigator.	4 / 9	9 / 9	3 / 9
Other Tumors In ALK genetic event positive participants with other tumors (excluding non-small cell lung cancer), crizotinib 250 mg twice daily (BID) was administered orally at approximately the same time each day on a continuous daily dosing schedule. Crizotinib was allowed to be taken without regard to meals. Cycles were defined in 21 day periods. Participants could have continued treatment with crizotinib on this study as long as there was evidence of clinical benefit in the judgment of the Investigator.	7 / 18	17 / 18	13 / 18

Group identifiers: EG000: ALCL Arm · EG001: IMT Arm · EG002: Other 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
Cardiac disorders
source Vocabulary
MedDRA v26.0
stats
group Id
EG000
num Affected
0
num At Risk
17
group Id
EG001
num Affected
1
num At Risk
9
group Id
EG002
num Affected
0
num At Risk
18
term
Cardiac failure congestive
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v26.0
stats
group Id
EG000
num Affected
0
num At Risk
17
group Id
EG001
num Affected
1
num At Risk
9
group Id
EG002
num Affected
0
num At Risk
18
term
Myocardial ischaemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA v26.0
stats
group Id
EG000
num Affected
0
num At Risk
17
group Id
EG001
num Affected
1
num At Risk
9
group Id
EG002
num Affected
0
num At Risk
18
term
Eyelid ptosis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA v26.0
stats
group Id
EG000
num Affected
0
num At Risk
17
group Id
EG001
num Affected
1
num At Risk
9
group Id
EG002
num Affected
0
num At Risk
18
term
Visual acuity reduced
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v26.0
stats
group Id
EG000
num Affected
1
num At Risk
17
group Id
EG001
num Affected
0
num At Risk
9
group Id
EG002
num Affected
0
num At Risk
18
term
Abdominal pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v26.0
stats
group Id
EG000
num Affected
0
num At Risk
17
group Id
EG001
num Affected
1
num At Risk
9
group Id
EG002
num Affected
0
num At Risk
18
term
Diarrhoea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v26.0
stats
group Id
EG000
num Affected
0
num At Risk
17
group Id
EG001
num Affected
0
num At Risk
9
group Id
EG002
num Affected
1
num At Risk
18
term
Faecaloma
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v26.0
stats
group Id
EG000
num Affected
0
num At Risk
17
group Id
EG001
num Affected
0
num At Risk
9
group Id
EG002
num Affected
1
num At Risk
18
term
Intestinal obstruction
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v26.0
stats
group Id
EG000
num Affected
1
num At Risk
17
group Id
EG001
num Affected
0
num At Risk
9
group Id
EG002
num Affected
0
num At Risk
18
term
Nausea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v26.0
stats
group Id
EG000
num Affected
0
num At Risk
17
group Id
EG001
num Affected
1
num At Risk
9
group Id
EG002
num Affected
0
num At Risk
18
term
Small intestinal obstruction
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v26.0
stats
group Id
EG000
num Affected
0
num At Risk
17
group Id
EG001
num Affected
1
num At Risk
9
group Id
EG002
num Affected
0
num At Risk
18
term
Vomiting
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA v26.0
stats
group Id
EG000
num Affected
0
num At Risk
17
group Id
EG001
num Affected
0
num At Risk
9
group Id
EG002
num Affected
1
num At Risk
18
term
Asthenia

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 v26.0
stats
group Id
EG000
num Affected
2
num At Risk
17
group Id
EG001
num Affected
2
num At Risk
9
group Id
EG002
num Affected
6
num At Risk
18
term
Anaemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v26.0
stats
group Id
EG000
num Affected
1
num At Risk
17
group Id
EG001
num Affected
2
num At Risk
9
group Id
EG002
num Affected
2
num At Risk
18
term
Leukopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v26.0
stats
group Id
EG000
num Affected
2
num At Risk
17
group Id
EG001
num Affected
0
num At Risk
9
group Id
EG002
num Affected
0
num At Risk
18
term
Lymph node pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v26.0
stats
group Id
EG000
num Affected
1
num At Risk
17
group Id
EG001
num Affected
0
num At Risk
9
group Id
EG002
num Affected
0
num At Risk
18
term
Lymphoid tissue hyperplasia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v26.0
stats
group Id
EG000
num Affected
3
num At Risk
17
group Id
EG001
num Affected
1
num At Risk
9
group Id
EG002
num Affected
1
num At Risk
18
term
Lymphopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v26.0
stats
group Id
EG000
num Affected
0
num At Risk
17
group Id
EG001
num Affected
1
num At Risk
9
group Id
EG002
num Affected
0
num At Risk
18
term
Myelosuppression
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v26.0
stats
group Id
EG000
num Affected
7
num At Risk
17
group Id
EG001
num Affected
4
num At Risk
9
group Id
EG002
num Affected
3
num At Risk
18
term
Neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v26.0
stats
group Id
EG000
num Affected
2
num At Risk
17
group Id
EG001
num Affected
0
num At Risk
9
group Id
EG002
num Affected
1
num At Risk
18
term
Thrombocytopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v26.0
stats
group Id
EG000
num Affected
1
num At Risk
17
group Id
EG001
num Affected
0
num At Risk
9
group Id
EG002
num Affected
0
num At Risk
18
term
Palpitations
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v26.0
stats
group Id
EG000
num Affected
1
num At Risk
17
group Id
EG001
num Affected
0
num At Risk
9
group Id
EG002
num Affected
0
num At Risk
18
term
Sinus bradycardia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v26.0
stats
group Id
EG000
num Affected
1
num At Risk
17
group Id
EG001
num Affected
0
num At Risk
9
group Id
EG002
num Affected
0
num At Risk
18
term
Tachycardia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Congenital, familial and genetic disorders
source Vocabulary
MedDRA v26.0
stats
group Id
EG000
num Affected
1
num At Risk
17
group Id
EG001
num Affected
0
num At Risk
9
group Id
EG002
num Affected
0
num At Risk
18
term
Gilbert's syndrome

Complete source fields

description

event Groups

deaths Num Affected
5
deaths Num At Risk
17
description
In ALK genetic event positive participants with ALCL, crizotinib 250 mg twice daily (BID) was administered orally at approximately the same time each day on a continuous daily dosing schedule. Crizotinib was allowed to be taken without regard to meals. Cycles were defined in 21 day periods. Participants could have continued treatment with crizotinib on this study as long as there was evidence of clinical benefit in the judgment of the Investigator.
id
EG000
other Num Affected
16
other Num At Risk
17
serious Num Affected
8
serious Num At Risk
17
title
ALCL Arm
deaths Num Affected
3
deaths Num At Risk
9
description
In ALK genetic event positive participants with IMT, crizotinib 250 mg twice daily (BID) was administered orally at approximately the same time each day on a continuous daily dosing schedule. Crizotinib was allowed to be taken without regard to meals. Cycles were defined in 21 day periods. Participants could have continued treatment with crizotinib on this study as long as there was evidence of clinical benefit in the judgment of the Investigator.
id
EG001
other Num Affected
9
other Num At Risk
9
serious Num Affected
4
serious Num At Risk
9
title
IMT Arm
deaths Num Affected
13
deaths Num At Risk
18
description
In ALK genetic event positive participants with other tumors (excluding non-small cell lung cancer), crizotinib 250 mg twice daily (BID) was administered orally at approximately the same time each day on a continuous daily dosing schedule. Crizotinib was allowed to be taken without regard to meals. Cycles were defined in 21 day periods. Participants could have continued treatment with crizotinib on this study as long as there was evidence of clinical benefit in the judgment of the Investigator.
id
EG002
other Num Affected
17
other Num At Risk
18
serious Num Affected
7
serious Num At Risk
18
title
Other Tumors

frequency Threshold

other Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v26.0
stats
group Id
EG000
num Affected
2
num At Risk
17
group Id
EG001
num Affected
2
num At Risk
9
group Id
EG002
num Affected
6
num At Risk
18
term
Anaemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v26.0
stats
group Id
EG000
num Affected
1
num At Risk
17
group Id
EG001
num Affected
2
num At Risk
9
group Id
EG002
num Affected
2
num At Risk
18
term
Leukopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v26.0
stats
group Id
EG000
num Affected
2
num At Risk
17
group Id
EG001
num Affected
0
num At Risk
9
group Id
EG002
num Affected
0
num At Risk
18
term
Lymph node pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v26.0
stats
group Id
EG000
num Affected
1
num At Risk
17
group Id
EG001
num Affected
0
num At Risk
9
group Id
EG002
num Affected
0
num At Risk
18
term
Lymphoid tissue hyperplasia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v26.0
stats
group Id
EG000
num Affected
3
num At Risk
17
group Id
EG001
num Affected
1
num At Risk
9
group Id
EG002
num Affected
1
num At Risk
18
term
Lymphopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v26.0
stats
group Id
EG000
num Affected
0
num At Risk
17
group Id
EG001
num Affected
1
num At Risk
9
group Id
EG002
num Affected
0
num At Risk
18
term
Myelosuppression
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v26.0
stats
group Id
EG000
num Affected
7
num At Risk
17
group Id
EG001
num Affected
4
num At Risk
9
group Id
EG002
num Affected
3
num At Risk
18
term
Neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v26.0
stats
group Id
EG000
num Affected
2
num At Risk
17
group Id
EG001
num Affected
0
num At Risk
9
group Id
EG002
num Affected
1
num At Risk
18
term
Thrombocytopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v26.0
stats
group Id
EG000
num Affected
1
num At Risk
17
group Id
EG001
num Affected
0
num At Risk
9
group Id
EG002
num Affected
0
num At Risk
18
term
Palpitations
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v26.0
stats
group Id
EG000
num Affected
1
num At Risk
17
group Id
EG001
num Affected
0
num At Risk
9
group Id
EG002
num Affected
0
num At Risk
18
term
Sinus bradycardia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v26.0
stats
group Id
EG000
num Affected
1
num At Risk
17
group Id
EG001
num Affected
0
num At Risk
9
group Id
EG002
num Affected
0
num At Risk
18
term
Tachycardia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Congenital, familial and genetic disorders
source Vocabulary
MedDRA v26.0
stats
group Id
EG000
num Affected
1
num At Risk
17
group Id
EG001
num Affected
0
num At Risk
9
group Id
EG002
num Affected
0
num At Risk
18
term
Gilbert's syndrome

serious Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v26.0
stats
group Id
EG000
num Affected
0
num At Risk
17
group Id
EG001
num Affected
1
num At Risk
9
group Id
EG002
num Affected
0
num At Risk
18
term
Cardiac failure congestive
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v26.0
stats
group Id
EG000
num Affected
0
num At Risk
17
group Id
EG001
num Affected
1
num At Risk
9
group Id
EG002
num Affected
0
num At Risk
18
term
Myocardial ischaemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA v26.0
stats
group Id
EG000
num Affected
0
num At Risk
17
group Id
EG001
num Affected
1
num At Risk
9
group Id
EG002
num Affected
0
num At Risk
18
term
Eyelid ptosis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA v26.0
stats
group Id
EG000
num Affected
0
num At Risk
17
group Id
EG001
num Affected
1
num At Risk
9
group Id
EG002
num Affected
0
num At Risk
18
term
Visual acuity reduced
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v26.0
stats
group Id
EG000
num Affected
1
num At Risk
17
group Id
EG001
num Affected
0
num At Risk
9
group Id
EG002
num Affected
0
num At Risk
18
term
Abdominal pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v26.0
stats
group Id
EG000
num Affected
0
num At Risk
17
group Id
EG001
num Affected
1
num At Risk
9
group Id
EG002
num Affected
0
num At Risk
18
term
Diarrhoea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v26.0
stats
group Id
EG000
num Affected
0
num At Risk
17
group Id
EG001
num Affected
0
num At Risk
9
group Id
EG002
num Affected
1
num At Risk
18
term
Faecaloma
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v26.0
stats
group Id
EG000
num Affected
0
num At Risk
17
group Id
EG001
num Affected
0
num At Risk
9
group Id
EG002
num Affected
1
num At Risk
18
term
Intestinal obstruction
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v26.0
stats
group Id
EG000
num Affected
1
num At Risk
17
group Id
EG001
num Affected
0
num At Risk
9
group Id
EG002
num Affected
0
num At Risk
18
term
Nausea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v26.0
stats
group Id
EG000
num Affected
0
num At Risk
17
group Id
EG001
num Affected
1
num At Risk
9
group Id
EG002
num Affected
0
num At Risk
18
term
Small intestinal obstruction
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v26.0
stats
group Id
EG000
num Affected
0
num At Risk
17
group Id
EG001
num Affected
1
num At Risk
9
group Id
EG002
num Affected
0
num At Risk
18
term
Vomiting
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA v26.0
stats
group Id
EG000
num Affected
0
num At Risk
17
group Id
EG001
num Affected
0
num At Risk
9
group Id
EG002
num Affected
1
num At Risk
18
term
Asthenia

time Frame

From the first dose of study treatment up to 28 days after the last dose of study treatment (maximum duration between first and last dose: 444 weeks)

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