NCT00939770 · ADVERSE EVENTS

Adverse events

Crizotinib in Treating Younger Patients With Relapsed or Refractory Solid Tumors or Anaplastic Large Cell Lymphoma · Source last updated 2020-06-09

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: Up to 3 years
Other-event reporting threshold: 0%

Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Phase 1: Part A: PF-02341066 100 mg/m²/Dose BID Part A1: Patients with relapsed/refractory solid tumors or anaplastic large cell lymphoma (ALCL) Part A2: Patients with recurrent/refractory malignancies who have confirmed ALK fusion proteins, ALK mutations, ALK amplification or evidence for MET mutation or amplification. Once Parts B and C are open to accrual, patients who are not eligible for either Part should enroll on Part A2, Part A3: Patients with recurrent/refractory neuroblastoma, who are not eligible for Part A1 or A2 or who cannot enroll on Part A1 because of stratum suspension or lack of available slots.	3 / 6	6 / 6	0 / 6
Phase 1: Part A: PF-02341066 130 mg/m²/Dose BID Part A1: Patients with relapsed/refractory solid tumors or anaplastic large cell lymphoma (ALCL) Part A2: Patients with recurrent/refractory malignancies who have confirmed ALK fusion proteins, ALK mutations, ALK amplification or evidence for MET mutation or amplification. Once Parts B and C are open to accrual, patients who are not eligible for either Part should enroll on Part A2, Part A3: Patients with recurrent/refractory neuroblastoma, who are not eligible for Part A1 or A2 or who cannot enroll on Part A1 because of stratum suspension or lack of available slots.	6 / 8	8 / 8	0 / 8
Phase 1: Part A: PF-02341066 165 mg/m²/Dose BID Part A1: Patients with relapsed/refractory solid tumors or anaplastic large cell lymphoma (ALCL) Part A2: Patients with recurrent/refractory malignancies who have confirmed ALK fusion proteins, ALK mutations, ALK amplification or evidence for MET mutation or amplification. Once Parts B and C are open to accrual, patients who are not eligible for either Part should enroll on Part A2, Part A3: Patients with recurrent/refractory neuroblastoma, who are not eligible for Part A1 or A2 or who cannot enroll on Part A1 because of stratum suspension or lack of available slots.	18 / 23	23 / 23	3 / 23
Phase 1: Part A: PF-02341066 215 mg/m²/Dose BID Part A1: Patients with relapsed/refractory solid tumors or anaplastic large cell lymphoma (ALCL) Part A2: Patients with recurrent/refractory malignancies who have confirmed ALK fusion proteins, ALK mutations, ALK amplification or evidence for MET mutation or amplification. Once Parts B and C are open to accrual, patients who are not eligible for either Part should enroll on Part A2, Part A3: Patients with recurrent/refractory neuroblastoma, who are not eligible for Part A1 or A2 or who cannot enroll on Part A1 because of stratum suspension or lack of available slots.	10 / 12	12 / 12	2 / 12
Phase 1: Part A: PF-02341066 280 mg/m2/Dose BID Part A1: Patients with relapsed/refractory solid tumors or anaplastic large cell lymphoma (ALCL) Part A2: Patients with recurrent/refractory malignancies who have confirmed ALK fusion proteins, ALK mutations, ALK amplification or evidence for MET mutation or amplification. Once Parts B and C are open to accrual, patients who are not eligible for either Part should enroll on Part A2, Part A3: Patients with recurrent/refractory neuroblastoma, who are not eligible for Part A1 or A2 or who cannot enroll on Part A1 because of stratum suspension or lack of available slots.	33 / 38	38 / 38	2 / 38
Phase 1: Part A: PF-02341066 365 mg/m2/Dose BID Part A1: Patients with relapsed/refractory solid tumors or anaplastic large cell lymphoma (ALCL) Part A2: Patients with recurrent/refractory malignancies who have confirmed ALK fusion proteins, ALK mutations, ALK amplification or evidence for MET mutation or amplification. Once Parts B and C are open to accrual, patients who are not eligible for either Part should enroll on Part A2, Part A3: Patients with recurrent/refractory neuroblastoma, who are not eligible for Part A1 or A2 or who cannot enroll on Part A1 because of stratum suspension or lack of available slots.	11 / 11	11 / 11	1 / 11
Phase 2: Part B: PF-02341066 280 mg/m2/Dose BID Part B: Patients with ALK+ relapsed/refractory neuroblastoma	13 / 14	14 / 14	1 / 14
Phase 2: Part C: PF-02341066 280 mg/m2/Dose BID Part C: Patients with ALK+ relapsed/refractory ALCL	10 / 10	10 / 10	0 / 10

Group identifiers: EG000: Phase 1: Part A: PF-02341066 100 mg/m²/Dose BID · EG001: Phase 1: Part A: PF-02341066 130 mg/m²/Dose BID · EG002: Phase 1: Part A: PF-02341066 165 mg/m²/Dose BID · EG003: Phase 1: Part A: PF-02341066 215 mg/m²/Dose BID · EG004: Phase 1: Part A: PF-02341066 280 mg/m2/Dose BID · EG005: Phase 1: Part A: PF-02341066 365 mg/m2/Dose BID · EG006: Phase 2: Part B: PF-02341066 280 mg/m2/Dose BID · EG007: Phase 2: Part C: PF-02341066 280 mg/m2/Dose BID

Serious adverse events

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

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
8
group Id
EG002
num Affected
1
num At Risk
23
group Id
EG003
num Affected
0
num At Risk
12
group Id
EG004
num Affected
0
num At Risk
38
group Id
EG005
num Affected
1
num At Risk
11
group Id
EG006
num Affected
0
num At Risk
14
group Id
EG007
num Affected
0
num At Risk
10
term
Abdominal distension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
8
group Id
EG002
num Affected
1
num At Risk
23
group Id
EG003
num Affected
0
num At Risk
12
group Id
EG004
num Affected
0
num At Risk
38
group Id
EG005
num Affected
0
num At Risk
11
group Id
EG006
num Affected
1
num At Risk
14
group Id
EG007
num Affected
0
num At Risk
10
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
8
group Id
EG002
num Affected
1
num At Risk
23
group Id
EG003
num Affected
0
num At Risk
12
group Id
EG004
num Affected
0
num At Risk
38
group Id
EG005
num Affected
0
num At Risk
11
group Id
EG006
num Affected
0
num At Risk
14
group Id
EG007
num Affected
0
num At Risk
10
term
Abducens nerve disorder
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
8
group Id
EG002
num Affected
0
num At Risk
23
group Id
EG003
num Affected
1
num At Risk
12
group Id
EG004
num Affected
0
num At Risk
38
group Id
EG005
num Affected
0
num At Risk
11
group Id
EG006
num Affected
0
num At Risk
14
group Id
EG007
num Affected
0
num At Risk
10
term
Activated partial thromboplastin time prolonged
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
8
group Id
EG002
num Affected
0
num At Risk
23
group Id
EG003
num Affected
0
num At Risk
12
group Id
EG004
num Affected
0
num At Risk
38
group Id
EG005
num Affected
0
num At Risk
11
group Id
EG006
num Affected
1
num At Risk
14
group Id
EG007
num Affected
0
num At Risk
10
term
Acute kidney injury
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
8
group Id
EG002
num Affected
1
num At Risk
23
group Id
EG003
num Affected
0
num At Risk
12
group Id
EG004
num Affected
0
num At Risk
38
group Id
EG005
num Affected
0
num At Risk
11
group Id
EG006
num Affected
0
num At Risk
14
group Id
EG007
num Affected
0
num At Risk
10
term
Agitation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
stats
group Id
EG000
num Affected
1
num At Risk
6
group Id
EG001
num Affected
1
num At Risk
8
group Id
EG002
num Affected
0
num At Risk
23
group Id
EG003
num Affected
0
num At Risk
12
group Id
EG004
num Affected
4
num At Risk
38
group Id
EG005
num Affected
1
num At Risk
11
group Id
EG006
num Affected
1
num At Risk
14
group Id
EG007
num Affected
1
num At Risk
10
term
Alanine aminotransferase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
8
group Id
EG002
num Affected
1
num At Risk
23
group Id
EG003
num Affected
0
num At Risk
12
group Id
EG004
num Affected
0
num At Risk
38
group Id
EG005
num Affected
2
num At Risk
11
group Id
EG006
num Affected
0
num At Risk
14
group Id
EG007
num Affected
0
num At Risk
10
term
Alkaline phosphatase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Immune system disorders
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
8
group Id
EG002
num Affected
0
num At Risk
23
group Id
EG003
num Affected
1
num At Risk
12
group Id
EG004
num Affected
0
num At Risk
38
group Id
EG005
num Affected
0
num At Risk
11
group Id
EG006
num Affected
0
num At Risk
14
group Id
EG007
num Affected
0
num At Risk
10
term
Anaphylaxis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
1
num At Risk
6
group Id
EG001
num Affected
2
num At Risk
8
group Id
EG002
num Affected
5
num At Risk
23
group Id
EG003
num Affected
1
num At Risk
12
group Id
EG004
num Affected
5
num At Risk
38
group Id
EG005
num Affected
0
num At Risk
11
group Id
EG006
num Affected
4
num At Risk
14
group Id
EG007
num Affected
5
num At Risk
10
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
2
num At Risk
8
group Id
EG002
num Affected
4
num At Risk
23
group Id
EG003
num Affected
0
num At Risk
12
group Id
EG004
num Affected
1
num At Risk
38
group Id
EG005
num Affected
0
num At Risk
11
group Id
EG006
num Affected
2
num At Risk
14
group Id
EG007
num Affected
0
num At Risk
10
term
Anorexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
8
group Id
EG002
num Affected
1
num At Risk
23
group Id
EG003
num Affected
0
num At Risk
12
group Id
EG004
num Affected
1
num At Risk
38
group Id
EG005
num Affected
0
num At Risk
11
group Id
EG006
num Affected
0
num At Risk
14
group Id
EG007
num Affected
0
num At Risk
10
term
Anxiety

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
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
1
num At Risk
8
group Id
EG002
num Affected
3
num At Risk
23
group Id
EG003
num Affected
0
num At Risk
12
group Id
EG004
num Affected
5
num At Risk
38
group Id
EG005
num Affected
1
num At Risk
11
group Id
EG006
num Affected
3
num At Risk
14
group Id
EG007
num Affected
0
num At Risk
10
term
Abdominal distension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
2
num At Risk
6
group Id
EG001
num Affected
1
num At Risk
8
group Id
EG002
num Affected
13
num At Risk
23
group Id
EG003
num Affected
2
num At Risk
12
group Id
EG004
num Affected
18
num At Risk
38
group Id
EG005
num Affected
3
num At Risk
11
group Id
EG006
num Affected
7
num At Risk
14
group Id
EG007
num Affected
2
num At Risk
10
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
8
group Id
EG002
num Affected
2
num At Risk
23
group Id
EG003
num Affected
0
num At Risk
12
group Id
EG004
num Affected
0
num At Risk
38
group Id
EG005
num Affected
0
num At Risk
11
group Id
EG006
num Affected
0
num At Risk
14
group Id
EG007
num Affected
0
num At Risk
10
term
Abducens nerve disorder
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
1
num At Risk
8
group Id
EG002
num Affected
0
num At Risk
23
group Id
EG003
num Affected
0
num At Risk
12
group Id
EG004
num Affected
0
num At Risk
38
group Id
EG005
num Affected
0
num At Risk
11
group Id
EG006
num Affected
0
num At Risk
14
group Id
EG007
num Affected
0
num At Risk
10
term
Accessory nerve disorder
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
1
num At Risk
8
group Id
EG002
num Affected
4
num At Risk
23
group Id
EG003
num Affected
1
num At Risk
12
group Id
EG004
num Affected
0
num At Risk
38
group Id
EG005
num Affected
0
num At Risk
11
group Id
EG006
num Affected
0
num At Risk
14
group Id
EG007
num Affected
0
num At Risk
10
term
Acidosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
8
group Id
EG002
num Affected
3
num At Risk
23
group Id
EG003
num Affected
0
num At Risk
12
group Id
EG004
num Affected
2
num At Risk
38
group Id
EG005
num Affected
2
num At Risk
11
group Id
EG006
num Affected
2
num At Risk
14
group Id
EG007
num Affected
0
num At Risk
10
term
Activated partial thromboplastin time prolonged
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
8
group Id
EG002
num Affected
0
num At Risk
23
group Id
EG003
num Affected
0
num At Risk
12
group Id
EG004
num Affected
0
num At Risk
38
group Id
EG005
num Affected
0
num At Risk
11
group Id
EG006
num Affected
0
num At Risk
14
group Id
EG007
num Affected
1
num At Risk
10
term
Acute kidney injury
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
1
num At Risk
8
group Id
EG002
num Affected
8
num At Risk
23
group Id
EG003
num Affected
0
num At Risk
12
group Id
EG004
num Affected
4
num At Risk
38
group Id
EG005
num Affected
1
num At Risk
11
group Id
EG006
num Affected
1
num At Risk
14
group Id
EG007
num Affected
1
num At Risk
10
term
Agitation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
stats
group Id
EG000
num Affected
6
num At Risk
6
group Id
EG001
num Affected
3
num At Risk
8
group Id
EG002
num Affected
20
num At Risk
23
group Id
EG003
num Affected
11
num At Risk
12
group Id
EG004
num Affected
33
num At Risk
38
group Id
EG005
num Affected
8
num At Risk
11
group Id
EG006
num Affected
12
num At Risk
14
group Id
EG007
num Affected
9
num At Risk
10
term
Alanine aminotransferase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
2
num At Risk
8
group Id
EG002
num Affected
9
num At Risk
23
group Id
EG003
num Affected
5
num At Risk
12
group Id
EG004
num Affected
12
num At Risk
38
group Id
EG005
num Affected
2
num At Risk
11
group Id
EG006
num Affected
2
num At Risk
14
group Id
EG007
num Affected
0
num At Risk
10
term
Alkaline phosphatase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
8
group Id
EG002
num Affected
0
num At Risk
23
group Id
EG003
num Affected
1
num At Risk
12
group Id
EG004
num Affected
0
num At Risk
38
group Id
EG005
num Affected
0
num At Risk
11
group Id
EG006
num Affected
0
num At Risk
14
group Id
EG007
num Affected
0
num At Risk
10
term
Alkalosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Immune system disorders
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
8
group Id
EG002
num Affected
1
num At Risk
23
group Id
EG003
num Affected
0
num At Risk
12
group Id
EG004
num Affected
1
num At Risk
38
group Id
EG005
num Affected
0
num At Risk
11
group Id
EG006
num Affected
0
num At Risk
14
group Id
EG007
num Affected
0
num At Risk
10
term
Allergic reaction

Complete source fields

description

event Groups

deaths Num Affected
0
deaths Num At Risk
6
description
Part A1: Patients with relapsed/refractory solid tumors or anaplastic large cell lymphoma (ALCL) Part A2: Patients with recurrent/refractory malignancies who have confirmed ALK fusion proteins, ALK mutations, ALK amplification or evidence for MET mutation or amplification. Once Parts B and C are open to accrual, patients who are not eligible for either Part should enroll on Part A2, Part A3: Patients with recurrent/refractory neuroblastoma, who are not eligible for Part A1 or A2 or who cannot enroll on Part A1 because of stratum suspension or lack of available slots.
id
EG000
other Num Affected
6
other Num At Risk
6
serious Num Affected
3
serious Num At Risk
6
title
Phase 1: Part A: PF-02341066 100 mg/m²/Dose BID
deaths Num Affected
0
deaths Num At Risk
8
description
Part A1: Patients with relapsed/refractory solid tumors or anaplastic large cell lymphoma (ALCL) Part A2: Patients with recurrent/refractory malignancies who have confirmed ALK fusion proteins, ALK mutations, ALK amplification or evidence for MET mutation or amplification. Once Parts B and C are open to accrual, patients who are not eligible for either Part should enroll on Part A2, Part A3: Patients with recurrent/refractory neuroblastoma, who are not eligible for Part A1 or A2 or who cannot enroll on Part A1 because of stratum suspension or lack of available slots.
id
EG001
other Num Affected
8
other Num At Risk
8
serious Num Affected
6
serious Num At Risk
8
title
Phase 1: Part A: PF-02341066 130 mg/m²/Dose BID
deaths Num Affected
3
deaths Num At Risk
23
description
Part A1: Patients with relapsed/refractory solid tumors or anaplastic large cell lymphoma (ALCL) Part A2: Patients with recurrent/refractory malignancies who have confirmed ALK fusion proteins, ALK mutations, ALK amplification or evidence for MET mutation or amplification. Once Parts B and C are open to accrual, patients who are not eligible for either Part should enroll on Part A2, Part A3: Patients with recurrent/refractory neuroblastoma, who are not eligible for Part A1 or A2 or who cannot enroll on Part A1 because of stratum suspension or lack of available slots.
id
EG002
other Num Affected
23
other Num At Risk
23
serious Num Affected
18
serious Num At Risk
23
title
Phase 1: Part A: PF-02341066 165 mg/m²/Dose BID
deaths Num Affected
2
deaths Num At Risk
12
description
Part A1: Patients with relapsed/refractory solid tumors or anaplastic large cell lymphoma (ALCL) Part A2: Patients with recurrent/refractory malignancies who have confirmed ALK fusion proteins, ALK mutations, ALK amplification or evidence for MET mutation or amplification. Once Parts B and C are open to accrual, patients who are not eligible for either Part should enroll on Part A2, Part A3: Patients with recurrent/refractory neuroblastoma, who are not eligible for Part A1 or A2 or who cannot enroll on Part A1 because of stratum suspension or lack of available slots.
id
EG003
other Num Affected
12
other Num At Risk
12
serious Num Affected
10
serious Num At Risk
12
title
Phase 1: Part A: PF-02341066 215 mg/m²/Dose BID
deaths Num Affected
2
deaths Num At Risk
38
description
Part A1: Patients with relapsed/refractory solid tumors or anaplastic large cell lymphoma (ALCL) Part A2: Patients with recurrent/refractory malignancies who have confirmed ALK fusion proteins, ALK mutations, ALK amplification or evidence for MET mutation or amplification. Once Parts B and C are open to accrual, patients who are not eligible for either Part should enroll on Part A2, Part A3: Patients with recurrent/refractory neuroblastoma, who are not eligible for Part A1 or A2 or who cannot enroll on Part A1 because of stratum suspension or lack of available slots.
id
EG004
other Num Affected
38
other Num At Risk
38
serious Num Affected
33
serious Num At Risk
38
title
Phase 1: Part A: PF-02341066 280 mg/m2/Dose BID
deaths Num Affected
1
deaths Num At Risk
11
description
Part A1: Patients with relapsed/refractory solid tumors or anaplastic large cell lymphoma (ALCL) Part A2: Patients with recurrent/refractory malignancies who have confirmed ALK fusion proteins, ALK mutations, ALK amplification or evidence for MET mutation or amplification. Once Parts B and C are open to accrual, patients who are not eligible for either Part should enroll on Part A2, Part A3: Patients with recurrent/refractory neuroblastoma, who are not eligible for Part A1 or A2 or who cannot enroll on Part A1 because of stratum suspension or lack of available slots.
id
EG005
other Num Affected
11
other Num At Risk
11
serious Num Affected
11
serious Num At Risk
11
title
Phase 1: Part A: PF-02341066 365 mg/m2/Dose BID
deaths Num Affected
1
deaths Num At Risk
14
description
Part B: Patients with ALK+ relapsed/refractory neuroblastoma
id
EG006
other Num Affected
14
other Num At Risk
14
serious Num Affected
13
serious Num At Risk
14
title
Phase 2: Part B: PF-02341066 280 mg/m2/Dose BID
deaths Num Affected
0
deaths Num At Risk
10
description
Part C: Patients with ALK+ relapsed/refractory ALCL
id
EG007
other Num Affected
10
other Num At Risk
10
serious Num Affected
10
serious Num At Risk
10
title
Phase 2: Part C: PF-02341066 280 mg/m2/Dose BID

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
1
num At Risk
8
group Id
EG002
num Affected
3
num At Risk
23
group Id
EG003
num Affected
0
num At Risk
12
group Id
EG004
num Affected
5
num At Risk
38
group Id
EG005
num Affected
1
num At Risk
11
group Id
EG006
num Affected
3
num At Risk
14
group Id
EG007
num Affected
0
num At Risk
10
term
Abdominal distension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
2
num At Risk
6
group Id
EG001
num Affected
1
num At Risk
8
group Id
EG002
num Affected
13
num At Risk
23
group Id
EG003
num Affected
2
num At Risk
12
group Id
EG004
num Affected
18
num At Risk
38
group Id
EG005
num Affected
3
num At Risk
11
group Id
EG006
num Affected
7
num At Risk
14
group Id
EG007
num Affected
2
num At Risk
10
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
8
group Id
EG002
num Affected
2
num At Risk
23
group Id
EG003
num Affected
0
num At Risk
12
group Id
EG004
num Affected
0
num At Risk
38
group Id
EG005
num Affected
0
num At Risk
11
group Id
EG006
num Affected
0
num At Risk
14
group Id
EG007
num Affected
0
num At Risk
10
term
Abducens nerve disorder
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
1
num At Risk
8
group Id
EG002
num Affected
0
num At Risk
23
group Id
EG003
num Affected
0
num At Risk
12
group Id
EG004
num Affected
0
num At Risk
38
group Id
EG005
num Affected
0
num At Risk
11
group Id
EG006
num Affected
0
num At Risk
14
group Id
EG007
num Affected
0
num At Risk
10
term
Accessory nerve disorder
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
1
num At Risk
8
group Id
EG002
num Affected
4
num At Risk
23
group Id
EG003
num Affected
1
num At Risk
12
group Id
EG004
num Affected
0
num At Risk
38
group Id
EG005
num Affected
0
num At Risk
11
group Id
EG006
num Affected
0
num At Risk
14
group Id
EG007
num Affected
0
num At Risk
10
term
Acidosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
8
group Id
EG002
num Affected
3
num At Risk
23
group Id
EG003
num Affected
0
num At Risk
12
group Id
EG004
num Affected
2
num At Risk
38
group Id
EG005
num Affected
2
num At Risk
11
group Id
EG006
num Affected
2
num At Risk
14
group Id
EG007
num Affected
0
num At Risk
10
term
Activated partial thromboplastin time prolonged
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
8
group Id
EG002
num Affected
0
num At Risk
23
group Id
EG003
num Affected
0
num At Risk
12
group Id
EG004
num Affected
0
num At Risk
38
group Id
EG005
num Affected
0
num At Risk
11
group Id
EG006
num Affected
0
num At Risk
14
group Id
EG007
num Affected
1
num At Risk
10
term
Acute kidney injury
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
1
num At Risk
8
group Id
EG002
num Affected
8
num At Risk
23
group Id
EG003
num Affected
0
num At Risk
12
group Id
EG004
num Affected
4
num At Risk
38
group Id
EG005
num Affected
1
num At Risk
11
group Id
EG006
num Affected
1
num At Risk
14
group Id
EG007
num Affected
1
num At Risk
10
term
Agitation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
stats
group Id
EG000
num Affected
6
num At Risk
6
group Id
EG001
num Affected
3
num At Risk
8
group Id
EG002
num Affected
20
num At Risk
23
group Id
EG003
num Affected
11
num At Risk
12
group Id
EG004
num Affected
33
num At Risk
38
group Id
EG005
num Affected
8
num At Risk
11
group Id
EG006
num Affected
12
num At Risk
14
group Id
EG007
num Affected
9
num At Risk
10
term
Alanine aminotransferase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
2
num At Risk
8
group Id
EG002
num Affected
9
num At Risk
23
group Id
EG003
num Affected
5
num At Risk
12
group Id
EG004
num Affected
12
num At Risk
38
group Id
EG005
num Affected
2
num At Risk
11
group Id
EG006
num Affected
2
num At Risk
14
group Id
EG007
num Affected
0
num At Risk
10
term
Alkaline phosphatase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
8
group Id
EG002
num Affected
0
num At Risk
23
group Id
EG003
num Affected
1
num At Risk
12
group Id
EG004
num Affected
0
num At Risk
38
group Id
EG005
num Affected
0
num At Risk
11
group Id
EG006
num Affected
0
num At Risk
14
group Id
EG007
num Affected
0
num At Risk
10
term
Alkalosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Immune system disorders
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
8
group Id
EG002
num Affected
1
num At Risk
23
group Id
EG003
num Affected
0
num At Risk
12
group Id
EG004
num Affected
1
num At Risk
38
group Id
EG005
num Affected
0
num At Risk
11
group Id
EG006
num Affected
0
num At Risk
14
group Id
EG007
num Affected
0
num At Risk
10
term
Allergic reaction

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
8
group Id
EG002
num Affected
1
num At Risk
23
group Id
EG003
num Affected
0
num At Risk
12
group Id
EG004
num Affected
0
num At Risk
38
group Id
EG005
num Affected
1
num At Risk
11
group Id
EG006
num Affected
0
num At Risk
14
group Id
EG007
num Affected
0
num At Risk
10
term
Abdominal distension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
8
group Id
EG002
num Affected
1
num At Risk
23
group Id
EG003
num Affected
0
num At Risk
12
group Id
EG004
num Affected
0
num At Risk
38
group Id
EG005
num Affected
0
num At Risk
11
group Id
EG006
num Affected
1
num At Risk
14
group Id
EG007
num Affected
0
num At Risk
10
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
8
group Id
EG002
num Affected
1
num At Risk
23
group Id
EG003
num Affected
0
num At Risk
12
group Id
EG004
num Affected
0
num At Risk
38
group Id
EG005
num Affected
0
num At Risk
11
group Id
EG006
num Affected
0
num At Risk
14
group Id
EG007
num Affected
0
num At Risk
10
term
Abducens nerve disorder
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
8
group Id
EG002
num Affected
0
num At Risk
23
group Id
EG003
num Affected
1
num At Risk
12
group Id
EG004
num Affected
0
num At Risk
38
group Id
EG005
num Affected
0
num At Risk
11
group Id
EG006
num Affected
0
num At Risk
14
group Id
EG007
num Affected
0
num At Risk
10
term
Activated partial thromboplastin time prolonged
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
8
group Id
EG002
num Affected
0
num At Risk
23
group Id
EG003
num Affected
0
num At Risk
12
group Id
EG004
num Affected
0
num At Risk
38
group Id
EG005
num Affected
0
num At Risk
11
group Id
EG006
num Affected
1
num At Risk
14
group Id
EG007
num Affected
0
num At Risk
10
term
Acute kidney injury
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
8
group Id
EG002
num Affected
1
num At Risk
23
group Id
EG003
num Affected
0
num At Risk
12
group Id
EG004
num Affected
0
num At Risk
38
group Id
EG005
num Affected
0
num At Risk
11
group Id
EG006
num Affected
0
num At Risk
14
group Id
EG007
num Affected
0
num At Risk
10
term
Agitation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
stats
group Id
EG000
num Affected
1
num At Risk
6
group Id
EG001
num Affected
1
num At Risk
8
group Id
EG002
num Affected
0
num At Risk
23
group Id
EG003
num Affected
0
num At Risk
12
group Id
EG004
num Affected
4
num At Risk
38
group Id
EG005
num Affected
1
num At Risk
11
group Id
EG006
num Affected
1
num At Risk
14
group Id
EG007
num Affected
1
num At Risk
10
term
Alanine aminotransferase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
8
group Id
EG002
num Affected
1
num At Risk
23
group Id
EG003
num Affected
0
num At Risk
12
group Id
EG004
num Affected
0
num At Risk
38
group Id
EG005
num Affected
2
num At Risk
11
group Id
EG006
num Affected
0
num At Risk
14
group Id
EG007
num Affected
0
num At Risk
10
term
Alkaline phosphatase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Immune system disorders
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
8
group Id
EG002
num Affected
0
num At Risk
23
group Id
EG003
num Affected
1
num At Risk
12
group Id
EG004
num Affected
0
num At Risk
38
group Id
EG005
num Affected
0
num At Risk
11
group Id
EG006
num Affected
0
num At Risk
14
group Id
EG007
num Affected
0
num At Risk
10
term
Anaphylaxis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
1
num At Risk
6
group Id
EG001
num Affected
2
num At Risk
8
group Id
EG002
num Affected
5
num At Risk
23
group Id
EG003
num Affected
1
num At Risk
12
group Id
EG004
num Affected
5
num At Risk
38
group Id
EG005
num Affected
0
num At Risk
11
group Id
EG006
num Affected
4
num At Risk
14
group Id
EG007
num Affected
5
num At Risk
10
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
2
num At Risk
8
group Id
EG002
num Affected
4
num At Risk
23
group Id
EG003
num Affected
0
num At Risk
12
group Id
EG004
num Affected
1
num At Risk
38
group Id
EG005
num Affected
0
num At Risk
11
group Id
EG006
num Affected
2
num At Risk
14
group Id
EG007
num Affected
0
num At Risk
10
term
Anorexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
8
group Id
EG002
num Affected
1
num At Risk
23
group Id
EG003
num Affected
0
num At Risk
12
group Id
EG004
num Affected
1
num At Risk
38
group Id
EG005
num Affected
0
num At Risk
11
group Id
EG006
num Affected
0
num At Risk
14
group Id
EG007
num Affected
0
num At Risk
10
term
Anxiety

time Frame

Up to 3 years

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

Preserved source evidence · Not medical advice