NCT00585195 · ADVERSE EVENTS

Adverse events

A Study Of Oral PF-02341066, A C-Met/Hepatocyte Growth Factor Tyrosine Kinase Inhibitor, In Patients With Advanced Cancer · Source last updated 2023-02-08

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 maximum of 189 months
Other-event reporting threshold: 5%

Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Low Dose Escalation Cohort: Crizotinib 50 mg QD Participants received Crizotinib 50 milligram (mg) capsule or tablet orally once daily (QD) for up to 34 cycles (each cycle 28 days).	0 / 3	3 / 3	0 / 3
Low Dose Escalation Cohort: Crizotinib 100 mg QD Participants received Crizotinib 100 mg capsule or tablet orally QD for up to 34 cycles (each cycle 28 days) and 2 mg oral dose of Midazolam along with Crizotinib 100 mg on Cycle 2 Day 1 only. Participants who did not receive Crizotinib on Day -7, received single 2 mg oral dose of Midazolam on Day -7.	0 / 4	4 / 4	0 / 4
Low Dose Escalation Cohort: Crizotinib 200 mg QD Participants received Crizotinib 200 mg (2 capsules/tablet of 100 mg each) capsule/tablet orally QD for up to 34 cycles (each cycle 28 days).	1 / 8	8 / 8	0 / 8
Low Dose Escalation Cohort: Crizotinib 200 mg BID Participants received Crizotinib 200 mg (2 capsules/tablet of 100 mg each) capsule/tablet orally twice daily (BID) for up to 34 cycles (each cycle 28 days).	2 / 7	7 / 7	0 / 7
Low Dose Escalation Cohort: Crizotinib 250 mg BID Participants received Crizotinib 250 mg (2 capsules/tablet of 100 mg each + 1 capsule/tablet of 50 mg) capsule/tablet BID for up to 34 cycles (each cycle 28 days).	4 / 8	8 / 8	0 / 8
Low Dose Escalation Cohort: Crizotinib 300 mg BID Participants received Crizotinib 300 mg (3 capsules/tablet of 100 mg each) capsule/tablet orally BID for up to 34 cycles (each cycle 28 days) and 2 mg oral dose of Midazolam along with Crizotinib 300 mg on Cycle 2 Day 1 only. Participants who did not receive Crizotinib on Day -7, received single 2 mg oral dose of Midazolam on Day -7.	2 / 6	6 / 6	0 / 6
High Dose Escalation Cohort: Crizotinib 300 mg QD Participants received Crizotinib 300 mg (3 capsules/tablet of 100 mg each) capsule/tablet QD for up to 7 cycles (each cycle 28 days).	2 / 6	6 / 6	1 / 6
High Dose Escalation Cohort: Crizotinib 400 mg QD Participants received Crizotinib 400 mg (4 capsules/tablet of 100 mg each) capsule/tablet QD for up to 7 cycles (each cycle 28 days).	2 / 5	4 / 5	0 / 5
High Dose Escalation Cohort: Crizotinib 500 mg QD Participants received Crizotinib 500 mg (5 capsules/tablet of 100 mg each) capsule/tablet QD for up to 7 cycles (each cycle 28 days).	1 / 3	3 / 3	1 / 3
High Dose Escalation Cohort: Crizotinib 650 mg QD Participants received Crizotinib 650 mg (6 capsules/tablet of 100 mg each + 1 capsule/tablet of 50 mg) capsule/tablet twice daily (BID) for up to 7 cycles (each cycle 28 days).	2 / 6	6 / 6	1 / 6
High Dose Escalation Cohort: Crizotinib 800 mg QD Participants received Crizotinib 800 mg (8 capsules/tablet of 100 mg each) capsule/tablet QD for up to 7 cycles (each cycle 28 days).	4 / 9	9 / 9	1 / 9
RP2D Cohort: ROS1-Positive NSCLC: Crizotinib 250 mg Participants received Crizotinib 250 mg (2 capsules/tablet of 100 mg each + 1 capsule/tablet of 50 mg) capsule/tablet orally twice daily (BID) with or without food for up to 105 cycles (each cycle 28 days).	24 / 53	53 / 53	10 / 53
RP2D Cohort: MET Exon 14 Alterations NSCLC: Crizotinib 250 mg Participants received Crizotinib 250 mg (2 capsules/tablet of 100 mg each + 1 capsule/tablet of 50 mg) capsule/tablet orally twice daily (BID) with or without food for up to 55 cycles (each cycle 28 days).	54 / 85	85 / 85	15 / 85
RP2D Cohort: MET Amplification NSCLC: Crizotinib 250 mg Participants received Crizotinib 250 mg (2 capsules/tablet of 100 mg each + 1 capsule/tablet of 50 mg) capsule/tablet orally twice daily (BID) with or without food for up to 101 cycles (each cycle 28 days).	25 / 41	41 / 41	8 / 41
RP2D Cohort: ALK-Negative Cohort 1, NSCLC: Crizotinib 250 mg Participants received Crizotinib 250 mg (2 capsules/tablet of 100 mg each + 1 capsule/tablet of 50 mg) capsule/tablet twice daily (BID) with or without food for up to 70 cycles (each cycle 21 days).	22 / 48	46 / 48	13 / 48
RP2D Cohort: ALK-Negative Cohort 2, NSCLC: Crizotinib 250 mg Participants received Crizotinib 250 mg (2 capsules/tablet of 100 mg each + 1 capsule/tablet of 50 mg) capsule/tablet orally BID with or without food for up to 70 cycles (each cycle 21 days).	9 / 18	18 / 18	9 / 18
RP2D Cohort: ALK-Positive Cohort, NSCLC: Crizotinib 250 mg Participants received Crizotinib 250 mg (2 capsules/tablet of 100 mg each + 1 capsule/tablet of 50 mg) capsule/tablet twice daily (BID) with or without food for up to 133 cycles (each cycle 28 days).	75 / 154	154 / 154	25 / 154
RP2D Cohort: Enriched Other: Crizotinib 250 mg Participants received Crizotinib 250 mg (2 capsules/tablet of 100 mg each + 1 capsule/tablet of 50 mg) capsule/tablet orally twice daily (BID) with or without food for up to 54 cycles (each cycle 28 days).	29 / 66	66 / 66	15 / 66
Itraconazole Interaction Sub-study: Crizotinib 250 mg Participants received Crizotinib 250 mg (2 capsules/tablet of 100 mg each + 1 capsule/tablet of 50 mg) capsule/tablet QD from Cycle 1Day1 to Cycle 2 Day1 thereafter 250 mg BID from Cycle 2 Day 2 up to 58 cycles (each cycle 28 days). Participants also received Itraconazole 200 mg QD from Cycle 1 Day 1 to Cycle 1 Day 16.	7 / 18	18 / 18	0 / 18
RP2D Cohort: Rifampin Interaction: Crizotinib 250 mg +Rifampin Participants received Crizotinib 250 mg (2 capsules/tablet of 100 mg each + 1 capsule/tablet of 50 mg) capsule/tablet twice daily (BID) with or without food from Cycle 1 Day 1 up to 13 cycles (each cycle 28 days). Participants also received commercially available Rifampin 650 mg QD from Cycle 1 Day 16 to Cycle 2 Day 1 (14 days) either one hour before or 2 hours after food.	6 / 18	18 / 18	1 / 18
Midazolam Interaction Cohort: Crizotinib 250 Participants received Crizotinib 250 mg tablet/capsule (2 capsules/tablet of 100 mg each + 1 capsule/tablet of 50 mg) orally BID from Day 1Cycle 1 up to p to 133 cycles (each cycle 28 days). Participants also received single 2 mg oral dose of Midazolam on Day -7 and another single 2-mg oral dose of Midazolam concurrently with Crizotinib on Cycle 2 Day 1.	6 / 12	12 / 12	4 / 12

Group identifiers: EG000: Low Dose Escalation Cohort: Crizotinib 50 mg QD · EG001: Low Dose Escalation Cohort: Crizotinib 100 mg QD · EG002: Low Dose Escalation Cohort: Crizotinib 200 mg QD · EG003: Low Dose Escalation Cohort: Crizotinib 200 mg BID · EG004: Low Dose Escalation Cohort: Crizotinib 250 mg BID · EG005: Low Dose Escalation Cohort: Crizotinib 300 mg BID · EG006: High Dose Escalation Cohort: Crizotinib 300 mg QD · EG007: High Dose Escalation Cohort: Crizotinib 400 mg QD · EG008: High Dose Escalation Cohort: Crizotinib 500 mg QD · EG009: High Dose Escalation Cohort: Crizotinib 650 mg QD · EG010: High Dose Escalation Cohort: Crizotinib 800 mg QD · EG011: RP2D Cohort: ROS1-Positive NSCLC: Crizotinib 250 mg · EG012: RP2D Cohort: MET Exon 14 Alterations NSCLC: Crizotinib 250 mg · EG013: RP2D Cohort: MET Amplification NSCLC: Crizotinib 250 mg · EG014: RP2D Cohort: ALK-Negative Cohort 1, NSCLC: Crizotinib 250 mg · EG015: RP2D Cohort: ALK-Negative Cohort 2, NSCLC: Crizotinib 250 mg · EG016: RP2D Cohort: ALK-Positive Cohort, NSCLC: Crizotinib 250 mg · EG017: RP2D Cohort: Enriched Other: Crizotinib 250 mg · EG018: Itraconazole Interaction Sub-study: Crizotinib 250 mg · EG019: RP2D Cohort: Rifampin Interaction: Crizotinib 250 mg +Rifampin · EG020: Midazolam Interaction Cohort: Crizotinib 250

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 23.0
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
4
group Id
EG002
num Affected
0
num At Risk
8
group Id
EG003
num Affected
0
num At Risk
7
group Id
EG004
num Affected
0
num At Risk
8
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
6
group Id
EG007
num Affected
0
num At Risk
5
group Id
EG008
num Affected
0
num At Risk
3
group Id
EG009
num Affected
0
num At Risk
6
group Id
EG010
num Affected
0
num At Risk
9
group Id
EG011
num Affected
1
num At Risk
53
term
Bradycardia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
4
group Id
EG002
num Affected
0
num At Risk
8
group Id
EG003
num Affected
0
num At Risk
7
group Id
EG004
num Affected
0
num At Risk
8
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
6
group Id
EG007
num Affected
0
num At Risk
5
group Id
EG008
num Affected
0
num At Risk
3
group Id
EG009
num Affected
0
num At Risk
6
group Id
EG010
num Affected
0
num At Risk
9
group Id
EG011
num Affected
1
num At Risk
53
term
Pericardial effusion
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
4
group Id
EG002
num Affected
0
num At Risk
8
group Id
EG003
num Affected
0
num At Risk
7
group Id
EG004
num Affected
0
num At Risk
8
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
6
group Id
EG007
num Affected
0
num At Risk
5
group Id
EG008
num Affected
0
num At Risk
3
group Id
EG009
num Affected
0
num At Risk
6
group Id
EG010
num Affected
0
num At Risk
9
group Id
EG011
num Affected
1
num At Risk
53
term
Adrenal insufficiency
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
4
group Id
EG002
num Affected
0
num At Risk
8
group Id
EG003
num Affected
0
num At Risk
7
group Id
EG004
num Affected
0
num At Risk
8
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
6
group Id
EG007
num Affected
0
num At Risk
5
group Id
EG008
num Affected
0
num At Risk
3
group Id
EG009
num Affected
0
num At Risk
6
group Id
EG010
num Affected
0
num At Risk
9
group Id
EG011
num Affected
1
num At Risk
53
term
Abdominal pain upper
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
4
group Id
EG002
num Affected
0
num At Risk
8
group Id
EG003
num Affected
0
num At Risk
7
group Id
EG004
num Affected
0
num At Risk
8
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
6
group Id
EG007
num Affected
0
num At Risk
5
group Id
EG008
num Affected
0
num At Risk
3
group Id
EG009
num Affected
0
num At Risk
6
group Id
EG010
num Affected
0
num At Risk
9
group Id
EG011
num Affected
1
num At Risk
53
term
Gastrointestinal amyloidosis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
4
group Id
EG002
num Affected
0
num At Risk
8
group Id
EG003
num Affected
0
num At Risk
7
group Id
EG004
num Affected
0
num At Risk
8
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
6
group Id
EG007
num Affected
0
num At Risk
5
group Id
EG008
num Affected
0
num At Risk
3
group Id
EG009
num Affected
0
num At Risk
6
group Id
EG010
num Affected
0
num At Risk
9
group Id
EG011
num Affected
1
num At Risk
53
term
Large intestine perforation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
4
group Id
EG002
num Affected
0
num At Risk
8
group Id
EG003
num Affected
0
num At Risk
7
group Id
EG004
num Affected
0
num At Risk
8
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
6
group Id
EG007
num Affected
0
num At Risk
5
group Id
EG008
num Affected
0
num At Risk
3
group Id
EG009
num Affected
0
num At Risk
6
group Id
EG010
num Affected
0
num At Risk
9
group Id
EG011
num Affected
2
num At Risk
53
term
Nausea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
4
group Id
EG002
num Affected
0
num At Risk
8
group Id
EG003
num Affected
1
num At Risk
7
group Id
EG004
num Affected
1
num At Risk
8
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
6
group Id
EG007
num Affected
0
num At Risk
5
group Id
EG008
num Affected
0
num At Risk
3
group Id
EG009
num Affected
0
num At Risk
6
group Id
EG010
num Affected
0
num At Risk
9
group Id
EG011
num Affected
1
num At Risk
53
term
Vomiting
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
4
group Id
EG002
num Affected
0
num At Risk
8
group Id
EG003
num Affected
0
num At Risk
7
group Id
EG004
num Affected
0
num At Risk
8
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
6
group Id
EG007
num Affected
0
num At Risk
5
group Id
EG008
num Affected
0
num At Risk
3
group Id
EG009
num Affected
0
num At Risk
6
group Id
EG010
num Affected
0
num At Risk
9
group Id
EG011
num Affected
1
num At Risk
53
term
Chest discomfort
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
4
group Id
EG002
num Affected
0
num At Risk
8
group Id
EG003
num Affected
0
num At Risk
7
group Id
EG004
num Affected
2
num At Risk
8
group Id
EG005
num Affected
1
num At Risk
6
group Id
EG006
num Affected
1
num At Risk
6
group Id
EG007
num Affected
0
num At Risk
5
group Id
EG008
num Affected
0
num At Risk
3
group Id
EG009
num Affected
1
num At Risk
6
group Id
EG010
num Affected
1
num At Risk
9
group Id
EG011
num Affected
10
num At Risk
53
term
Disease progression
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Hepatobiliary disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
4
group Id
EG002
num Affected
0
num At Risk
8
group Id
EG003
num Affected
0
num At Risk
7
group Id
EG004
num Affected
0
num At Risk
8
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
6
group Id
EG007
num Affected
0
num At Risk
5
group Id
EG008
num Affected
0
num At Risk
3
group Id
EG009
num Affected
0
num At Risk
6
group Id
EG010
num Affected
0
num At Risk
9
group Id
EG011
num Affected
1
num At Risk
53
term
Cholangitis acute
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Hepatobiliary disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
4
group Id
EG002
num Affected
0
num At Risk
8
group Id
EG003
num Affected
0
num At Risk
7
group Id
EG004
num Affected
0
num At Risk
8
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
6
group Id
EG007
num Affected
0
num At Risk
5
group Id
EG008
num Affected
0
num At Risk
3
group Id
EG009
num Affected
0
num At Risk
6
group Id
EG010
num Affected
0
num At Risk
9
group Id
EG011
num Affected
1
num At Risk
53
term
Drug-induced liver injury

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 23.0
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
4
group Id
EG002
num Affected
2
num At Risk
8
group Id
EG003
num Affected
1
num At Risk
7
group Id
EG004
num Affected
0
num At Risk
8
group Id
EG005
num Affected
1
num At Risk
6
group Id
EG006
num Affected
2
num At Risk
6
group Id
EG007
num Affected
1
num At Risk
5
group Id
EG008
num Affected
0
num At Risk
3
group Id
EG009
num Affected
1
num At Risk
6
group Id
EG010
num Affected
3
num At Risk
9
group Id
EG011
num Affected
8
num At Risk
53
term
Anaemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
4
group Id
EG002
num Affected
0
num At Risk
8
group Id
EG003
num Affected
1
num At Risk
7
group Id
EG004
num Affected
0
num At Risk
8
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
6
group Id
EG007
num Affected
0
num At Risk
5
group Id
EG008
num Affected
0
num At Risk
3
group Id
EG009
num Affected
0
num At Risk
6
group Id
EG010
num Affected
0
num At Risk
9
group Id
EG011
num Affected
3
num At Risk
53
term
Leukopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
4
group Id
EG002
num Affected
1
num At Risk
8
group Id
EG003
num Affected
0
num At Risk
7
group Id
EG004
num Affected
0
num At Risk
8
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
6
group Id
EG007
num Affected
0
num At Risk
5
group Id
EG008
num Affected
0
num At Risk
3
group Id
EG009
num Affected
1
num At Risk
6
group Id
EG010
num Affected
1
num At Risk
9
group Id
EG011
num Affected
9
num At Risk
53
term
Neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
4
group Id
EG002
num Affected
1
num At Risk
8
group Id
EG003
num Affected
0
num At Risk
7
group Id
EG004
num Affected
0
num At Risk
8
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
6
group Id
EG007
num Affected
0
num At Risk
5
group Id
EG008
num Affected
0
num At Risk
3
group Id
EG009
num Affected
0
num At Risk
6
group Id
EG010
num Affected
0
num At Risk
9
group Id
EG011
num Affected
4
num At Risk
53
term
Thrombocytopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
4
group Id
EG002
num Affected
0
num At Risk
8
group Id
EG003
num Affected
0
num At Risk
7
group Id
EG004
num Affected
0
num At Risk
8
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
6
group Id
EG007
num Affected
0
num At Risk
5
group Id
EG008
num Affected
0
num At Risk
3
group Id
EG009
num Affected
1
num At Risk
6
group Id
EG010
num Affected
0
num At Risk
9
group Id
EG011
num Affected
7
num At Risk
53
term
Bradycardia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
4
group Id
EG002
num Affected
0
num At Risk
8
group Id
EG003
num Affected
0
num At Risk
7
group Id
EG004
num Affected
0
num At Risk
8
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
6
group Id
EG007
num Affected
0
num At Risk
5
group Id
EG008
num Affected
0
num At Risk
3
group Id
EG009
num Affected
1
num At Risk
6
group Id
EG010
num Affected
1
num At Risk
9
group Id
EG011
num Affected
5
num At Risk
53
term
Sinus bradycardia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
4
group Id
EG002
num Affected
0
num At Risk
8
group Id
EG003
num Affected
0
num At Risk
7
group Id
EG004
num Affected
0
num At Risk
8
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
6
group Id
EG007
num Affected
0
num At Risk
5
group Id
EG008
num Affected
0
num At Risk
3
group Id
EG009
num Affected
0
num At Risk
6
group Id
EG010
num Affected
1
num At Risk
9
group Id
EG011
num Affected
3
num At Risk
53
term
Syncope
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
4
group Id
EG002
num Affected
0
num At Risk
8
group Id
EG003
num Affected
0
num At Risk
7
group Id
EG004
num Affected
0
num At Risk
8
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
6
group Id
EG007
num Affected
0
num At Risk
5
group Id
EG008
num Affected
0
num At Risk
3
group Id
EG009
num Affected
0
num At Risk
6
group Id
EG010
num Affected
0
num At Risk
9
group Id
EG011
num Affected
5
num At Risk
53
term
Tinnitus
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
4
group Id
EG002
num Affected
0
num At Risk
8
group Id
EG003
num Affected
0
num At Risk
7
group Id
EG004
num Affected
0
num At Risk
8
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
6
group Id
EG007
num Affected
0
num At Risk
5
group Id
EG008
num Affected
0
num At Risk
3
group Id
EG009
num Affected
0
num At Risk
6
group Id
EG010
num Affected
0
num At Risk
9
group Id
EG011
num Affected
5
num At Risk
53
term
Cataract
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
4
group Id
EG002
num Affected
0
num At Risk
8
group Id
EG003
num Affected
0
num At Risk
7
group Id
EG004
num Affected
0
num At Risk
8
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
6
group Id
EG007
num Affected
1
num At Risk
5
group Id
EG008
num Affected
0
num At Risk
3
group Id
EG009
num Affected
0
num At Risk
6
group Id
EG010
num Affected
0
num At Risk
9
group Id
EG011
num Affected
7
num At Risk
53
term
Vision blurred
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
4
group Id
EG002
num Affected
0
num At Risk
8
group Id
EG003
num Affected
1
num At Risk
7
group Id
EG004
num Affected
0
num At Risk
8
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
1
num At Risk
6
group Id
EG007
num Affected
2
num At Risk
5
group Id
EG008
num Affected
0
num At Risk
3
group Id
EG009
num Affected
4
num At Risk
6
group Id
EG010
num Affected
3
num At Risk
9
group Id
EG011
num Affected
43
num At Risk
53
term
Visual impairment
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
4
group Id
EG002
num Affected
0
num At Risk
8
group Id
EG003
num Affected
0
num At Risk
7
group Id
EG004
num Affected
0
num At Risk
8
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
6
group Id
EG007
num Affected
0
num At Risk
5
group Id
EG008
num Affected
0
num At Risk
3
group Id
EG009
num Affected
0
num At Risk
6
group Id
EG010
num Affected
0
num At Risk
9
group Id
EG011
num Affected
3
num At Risk
53
term
Vitreous detachment

Complete source fields

description

event Groups

deaths Num Affected
0
deaths Num At Risk
3
description
Participants received Crizotinib 50 milligram (mg) capsule or tablet orally once daily (QD) for up to 34 cycles (each cycle 28 days).
id
EG000
other Num Affected
3
other Num At Risk
3
serious Num Affected
0
serious Num At Risk
3
title
Low Dose Escalation Cohort: Crizotinib 50 mg QD
deaths Num Affected
0
deaths Num At Risk
4
description
Participants received Crizotinib 100 mg capsule or tablet orally QD for up to 34 cycles (each cycle 28 days) and 2 mg oral dose of Midazolam along with Crizotinib 100 mg on Cycle 2 Day 1 only. Participants who did not receive Crizotinib on Day -7, received single 2 mg oral dose of Midazolam on Day -7.
id
EG001
other Num Affected
4
other Num At Risk
4
serious Num Affected
0
serious Num At Risk
4
title
Low Dose Escalation Cohort: Crizotinib 100 mg QD
deaths Num Affected
0
deaths Num At Risk
8
description
Participants received Crizotinib 200 mg (2 capsules/tablet of 100 mg each) capsule/tablet orally QD for up to 34 cycles (each cycle 28 days).
id
EG002
other Num Affected
8
other Num At Risk
8
serious Num Affected
1
serious Num At Risk
8
title
Low Dose Escalation Cohort: Crizotinib 200 mg QD
deaths Num Affected
0
deaths Num At Risk
7
description
Participants received Crizotinib 200 mg (2 capsules/tablet of 100 mg each) capsule/tablet orally twice daily (BID) for up to 34 cycles (each cycle 28 days).
id
EG003
other Num Affected
7
other Num At Risk
7
serious Num Affected
2
serious Num At Risk
7
title
Low Dose Escalation Cohort: Crizotinib 200 mg BID
deaths Num Affected
0
deaths Num At Risk
8
description
Participants received Crizotinib 250 mg (2 capsules/tablet of 100 mg each + 1 capsule/tablet of 50 mg) capsule/tablet BID for up to 34 cycles (each cycle 28 days).
id
EG004
other Num Affected
8
other Num At Risk
8
serious Num Affected
4
serious Num At Risk
8
title
Low Dose Escalation Cohort: Crizotinib 250 mg BID
deaths Num Affected
0
deaths Num At Risk
6
description
Participants received Crizotinib 300 mg (3 capsules/tablet of 100 mg each) capsule/tablet orally BID for up to 34 cycles (each cycle 28 days) and 2 mg oral dose of Midazolam along with Crizotinib 300 mg on Cycle 2 Day 1 only. Participants who did not receive Crizotinib on Day -7, received single 2 mg oral dose of Midazolam on Day -7.
id
EG005
other Num Affected
6
other Num At Risk
6
serious Num Affected
2
serious Num At Risk
6
title
Low Dose Escalation Cohort: Crizotinib 300 mg BID
deaths Num Affected
1
deaths Num At Risk
6
description
Participants received Crizotinib 300 mg (3 capsules/tablet of 100 mg each) capsule/tablet QD for up to 7 cycles (each cycle 28 days).
id
EG006
other Num Affected
6
other Num At Risk
6
serious Num Affected
2
serious Num At Risk
6
title
High Dose Escalation Cohort: Crizotinib 300 mg QD
deaths Num Affected
0
deaths Num At Risk
5
description
Participants received Crizotinib 400 mg (4 capsules/tablet of 100 mg each) capsule/tablet QD for up to 7 cycles (each cycle 28 days).
id
EG007
other Num Affected
4
other Num At Risk
5
serious Num Affected
2
serious Num At Risk
5
title
High Dose Escalation Cohort: Crizotinib 400 mg QD
deaths Num Affected
1
deaths Num At Risk
3
description
Participants received Crizotinib 500 mg (5 capsules/tablet of 100 mg each) capsule/tablet QD for up to 7 cycles (each cycle 28 days).
id
EG008
other Num Affected
3
other Num At Risk
3
serious Num Affected
1
serious Num At Risk
3
title
High Dose Escalation Cohort: Crizotinib 500 mg QD
deaths Num Affected
1
deaths Num At Risk
6
description
Participants received Crizotinib 650 mg (6 capsules/tablet of 100 mg each + 1 capsule/tablet of 50 mg) capsule/tablet twice daily (BID) for up to 7 cycles (each cycle 28 days).
id
EG009
other Num Affected
6
other Num At Risk
6
serious Num Affected
2
serious Num At Risk
6
title
High Dose Escalation Cohort: Crizotinib 650 mg QD
deaths Num Affected
1
deaths Num At Risk
9
description
Participants received Crizotinib 800 mg (8 capsules/tablet of 100 mg each) capsule/tablet QD for up to 7 cycles (each cycle 28 days).
id
EG010
other Num Affected
9
other Num At Risk
9
serious Num Affected
4
serious Num At Risk
9
title
High Dose Escalation Cohort: Crizotinib 800 mg QD
deaths Num Affected
10
deaths Num At Risk
53
description
Participants received Crizotinib 250 mg (2 capsules/tablet of 100 mg each + 1 capsule/tablet of 50 mg) capsule/tablet orally twice daily (BID) with or without food for up to 105 cycles (each cycle 28 days).
id
EG011
other Num Affected
53
other Num At Risk
53
serious Num Affected
24
serious Num At Risk
53
title
RP2D Cohort: ROS1-Positive NSCLC: Crizotinib 250 mg

frequency Threshold

other Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
4
group Id
EG002
num Affected
2
num At Risk
8
group Id
EG003
num Affected
1
num At Risk
7
group Id
EG004
num Affected
0
num At Risk
8
group Id
EG005
num Affected
1
num At Risk
6
group Id
EG006
num Affected
2
num At Risk
6
group Id
EG007
num Affected
1
num At Risk
5
group Id
EG008
num Affected
0
num At Risk
3
group Id
EG009
num Affected
1
num At Risk
6
group Id
EG010
num Affected
3
num At Risk
9
group Id
EG011
num Affected
8
num At Risk
53
term
Anaemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
4
group Id
EG002
num Affected
0
num At Risk
8
group Id
EG003
num Affected
1
num At Risk
7
group Id
EG004
num Affected
0
num At Risk
8
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
6
group Id
EG007
num Affected
0
num At Risk
5
group Id
EG008
num Affected
0
num At Risk
3
group Id
EG009
num Affected
0
num At Risk
6
group Id
EG010
num Affected
0
num At Risk
9
group Id
EG011
num Affected
3
num At Risk
53
term
Leukopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
4
group Id
EG002
num Affected
1
num At Risk
8
group Id
EG003
num Affected
0
num At Risk
7
group Id
EG004
num Affected
0
num At Risk
8
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
6
group Id
EG007
num Affected
0
num At Risk
5
group Id
EG008
num Affected
0
num At Risk
3
group Id
EG009
num Affected
1
num At Risk
6
group Id
EG010
num Affected
1
num At Risk
9
group Id
EG011
num Affected
9
num At Risk
53
term
Neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
4
group Id
EG002
num Affected
1
num At Risk
8
group Id
EG003
num Affected
0
num At Risk
7
group Id
EG004
num Affected
0
num At Risk
8
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
6
group Id
EG007
num Affected
0
num At Risk
5
group Id
EG008
num Affected
0
num At Risk
3
group Id
EG009
num Affected
0
num At Risk
6
group Id
EG010
num Affected
0
num At Risk
9
group Id
EG011
num Affected
4
num At Risk
53
term
Thrombocytopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
4
group Id
EG002
num Affected
0
num At Risk
8
group Id
EG003
num Affected
0
num At Risk
7
group Id
EG004
num Affected
0
num At Risk
8
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
6
group Id
EG007
num Affected
0
num At Risk
5
group Id
EG008
num Affected
0
num At Risk
3
group Id
EG009
num Affected
1
num At Risk
6
group Id
EG010
num Affected
0
num At Risk
9
group Id
EG011
num Affected
7
num At Risk
53
term
Bradycardia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
4
group Id
EG002
num Affected
0
num At Risk
8
group Id
EG003
num Affected
0
num At Risk
7
group Id
EG004
num Affected
0
num At Risk
8
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
6
group Id
EG007
num Affected
0
num At Risk
5
group Id
EG008
num Affected
0
num At Risk
3
group Id
EG009
num Affected
1
num At Risk
6
group Id
EG010
num Affected
1
num At Risk
9
group Id
EG011
num Affected
5
num At Risk
53
term
Sinus bradycardia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
4
group Id
EG002
num Affected
0
num At Risk
8
group Id
EG003
num Affected
0
num At Risk
7
group Id
EG004
num Affected
0
num At Risk
8
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
6
group Id
EG007
num Affected
0
num At Risk
5
group Id
EG008
num Affected
0
num At Risk
3
group Id
EG009
num Affected
0
num At Risk
6
group Id
EG010
num Affected
1
num At Risk
9
group Id
EG011
num Affected
3
num At Risk
53
term
Syncope
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
4
group Id
EG002
num Affected
0
num At Risk
8
group Id
EG003
num Affected
0
num At Risk
7
group Id
EG004
num Affected
0
num At Risk
8
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
6
group Id
EG007
num Affected
0
num At Risk
5
group Id
EG008
num Affected
0
num At Risk
3
group Id
EG009
num Affected
0
num At Risk
6
group Id
EG010
num Affected
0
num At Risk
9
group Id
EG011
num Affected
5
num At Risk
53
term
Tinnitus
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
4
group Id
EG002
num Affected
0
num At Risk
8
group Id
EG003
num Affected
0
num At Risk
7
group Id
EG004
num Affected
0
num At Risk
8
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
6
group Id
EG007
num Affected
0
num At Risk
5
group Id
EG008
num Affected
0
num At Risk
3
group Id
EG009
num Affected
0
num At Risk
6
group Id
EG010
num Affected
0
num At Risk
9
group Id
EG011
num Affected
5
num At Risk
53
term
Cataract
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
4
group Id
EG002
num Affected
0
num At Risk
8
group Id
EG003
num Affected
0
num At Risk
7
group Id
EG004
num Affected
0
num At Risk
8
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
6
group Id
EG007
num Affected
1
num At Risk
5
group Id
EG008
num Affected
0
num At Risk
3
group Id
EG009
num Affected
0
num At Risk
6
group Id
EG010
num Affected
0
num At Risk
9
group Id
EG011
num Affected
7
num At Risk
53
term
Vision blurred
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
4
group Id
EG002
num Affected
0
num At Risk
8
group Id
EG003
num Affected
1
num At Risk
7
group Id
EG004
num Affected
0
num At Risk
8
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
1
num At Risk
6
group Id
EG007
num Affected
2
num At Risk
5
group Id
EG008
num Affected
0
num At Risk
3
group Id
EG009
num Affected
4
num At Risk
6
group Id
EG010
num Affected
3
num At Risk
9
group Id
EG011
num Affected
43
num At Risk
53
term
Visual impairment
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
4
group Id
EG002
num Affected
0
num At Risk
8
group Id
EG003
num Affected
0
num At Risk
7
group Id
EG004
num Affected
0
num At Risk
8
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
6
group Id
EG007
num Affected
0
num At Risk
5
group Id
EG008
num Affected
0
num At Risk
3
group Id
EG009
num Affected
0
num At Risk
6
group Id
EG010
num Affected
0
num At Risk
9
group Id
EG011
num Affected
3
num At Risk
53
term
Vitreous detachment

serious Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
4
group Id
EG002
num Affected
0
num At Risk
8
group Id
EG003
num Affected
0
num At Risk
7
group Id
EG004
num Affected
0
num At Risk
8
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
6
group Id
EG007
num Affected
0
num At Risk
5
group Id
EG008
num Affected
0
num At Risk
3
group Id
EG009
num Affected
0
num At Risk
6
group Id
EG010
num Affected
0
num At Risk
9
group Id
EG011
num Affected
1
num At Risk
53
term
Bradycardia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
4
group Id
EG002
num Affected
0
num At Risk
8
group Id
EG003
num Affected
0
num At Risk
7
group Id
EG004
num Affected
0
num At Risk
8
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
6
group Id
EG007
num Affected
0
num At Risk
5
group Id
EG008
num Affected
0
num At Risk
3
group Id
EG009
num Affected
0
num At Risk
6
group Id
EG010
num Affected
0
num At Risk
9
group Id
EG011
num Affected
1
num At Risk
53
term
Pericardial effusion
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
4
group Id
EG002
num Affected
0
num At Risk
8
group Id
EG003
num Affected
0
num At Risk
7
group Id
EG004
num Affected
0
num At Risk
8
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
6
group Id
EG007
num Affected
0
num At Risk
5
group Id
EG008
num Affected
0
num At Risk
3
group Id
EG009
num Affected
0
num At Risk
6
group Id
EG010
num Affected
0
num At Risk
9
group Id
EG011
num Affected
1
num At Risk
53
term
Adrenal insufficiency
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
4
group Id
EG002
num Affected
0
num At Risk
8
group Id
EG003
num Affected
0
num At Risk
7
group Id
EG004
num Affected
0
num At Risk
8
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
6
group Id
EG007
num Affected
0
num At Risk
5
group Id
EG008
num Affected
0
num At Risk
3
group Id
EG009
num Affected
0
num At Risk
6
group Id
EG010
num Affected
0
num At Risk
9
group Id
EG011
num Affected
1
num At Risk
53
term
Abdominal pain upper
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
4
group Id
EG002
num Affected
0
num At Risk
8
group Id
EG003
num Affected
0
num At Risk
7
group Id
EG004
num Affected
0
num At Risk
8
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
6
group Id
EG007
num Affected
0
num At Risk
5
group Id
EG008
num Affected
0
num At Risk
3
group Id
EG009
num Affected
0
num At Risk
6
group Id
EG010
num Affected
0
num At Risk
9
group Id
EG011
num Affected
1
num At Risk
53
term
Gastrointestinal amyloidosis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
4
group Id
EG002
num Affected
0
num At Risk
8
group Id
EG003
num Affected
0
num At Risk
7
group Id
EG004
num Affected
0
num At Risk
8
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
6
group Id
EG007
num Affected
0
num At Risk
5
group Id
EG008
num Affected
0
num At Risk
3
group Id
EG009
num Affected
0
num At Risk
6
group Id
EG010
num Affected
0
num At Risk
9
group Id
EG011
num Affected
1
num At Risk
53
term
Large intestine perforation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
4
group Id
EG002
num Affected
0
num At Risk
8
group Id
EG003
num Affected
0
num At Risk
7
group Id
EG004
num Affected
0
num At Risk
8
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
6
group Id
EG007
num Affected
0
num At Risk
5
group Id
EG008
num Affected
0
num At Risk
3
group Id
EG009
num Affected
0
num At Risk
6
group Id
EG010
num Affected
0
num At Risk
9
group Id
EG011
num Affected
2
num At Risk
53
term
Nausea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
4
group Id
EG002
num Affected
0
num At Risk
8
group Id
EG003
num Affected
1
num At Risk
7
group Id
EG004
num Affected
1
num At Risk
8
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
6
group Id
EG007
num Affected
0
num At Risk
5
group Id
EG008
num Affected
0
num At Risk
3
group Id
EG009
num Affected
0
num At Risk
6
group Id
EG010
num Affected
0
num At Risk
9
group Id
EG011
num Affected
1
num At Risk
53
term
Vomiting
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
4
group Id
EG002
num Affected
0
num At Risk
8
group Id
EG003
num Affected
0
num At Risk
7
group Id
EG004
num Affected
0
num At Risk
8
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
6
group Id
EG007
num Affected
0
num At Risk
5
group Id
EG008
num Affected
0
num At Risk
3
group Id
EG009
num Affected
0
num At Risk
6
group Id
EG010
num Affected
0
num At Risk
9
group Id
EG011
num Affected
1
num At Risk
53
term
Chest discomfort
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
4
group Id
EG002
num Affected
0
num At Risk
8
group Id
EG003
num Affected
0
num At Risk
7
group Id
EG004
num Affected
2
num At Risk
8
group Id
EG005
num Affected
1
num At Risk
6
group Id
EG006
num Affected
1
num At Risk
6
group Id
EG007
num Affected
0
num At Risk
5
group Id
EG008
num Affected
0
num At Risk
3
group Id
EG009
num Affected
1
num At Risk
6
group Id
EG010
num Affected
1
num At Risk
9
group Id
EG011
num Affected
10
num At Risk
53
term
Disease progression
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Hepatobiliary disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
4
group Id
EG002
num Affected
0
num At Risk
8
group Id
EG003
num Affected
0
num At Risk
7
group Id
EG004
num Affected
0
num At Risk
8
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
6
group Id
EG007
num Affected
0
num At Risk
5
group Id
EG008
num Affected
0
num At Risk
3
group Id
EG009
num Affected
0
num At Risk
6
group Id
EG010
num Affected
0
num At Risk
9
group Id
EG011
num Affected
1
num At Risk
53
term
Cholangitis acute
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Hepatobiliary disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
4
group Id
EG002
num Affected
0
num At Risk
8
group Id
EG003
num Affected
0
num At Risk
7
group Id
EG004
num Affected
0
num At Risk
8
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
6
group Id
EG007
num Affected
0
num At Risk
5
group Id
EG008
num Affected
0
num At Risk
3
group Id
EG009
num Affected
0
num At Risk
6
group Id
EG010
num Affected
0
num At Risk
9
group Id
EG011
num Affected
1
num At Risk
53
term
Drug-induced liver injury

time Frame

Up to maximum of 189 months

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

Preserved source evidence · Not medical advice