NCT03157128 · ADVERSE EVENTS

Adverse events

A Study of Selpercatinib (LOXO-292) in Participants With Advanced Solid Tumors, RET Fusion-Positive Solid Tumors, and Medullary Thyroid Cancer (LIBRETTO-001) · Source last updated 2026-04-16

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: Phase 1: Up to 28 days; Phase 2: Up to 7 years 8 months
Other-event reporting threshold: 5%

All Participants who received at least 1 or more doses of Selpercatinib.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Phase 1: 20 mg Selpercatinib QD Participants received Selpercatinib 20 milligrams (mg) administered orally once daily (QD), in a 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons.	4 / 6	6 / 6	0 / 6
Phase 1: 20 mg Selpercatinib BID Participants received Selpercatinib 20 milligrams (mg) administered orally twice daily (BID), in a 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons.	8 / 10	10 / 10	0 / 10
Phase 1: 40 mg Selpercatinib BID Participants received Selpercatinib 40 milligrams (mg) administered orally twice daily (BID), in a 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons.	9 / 16	16 / 16	0 / 16
Phase 1: 60 mg Selpercatinib BID Participants received Selpercatinib 60 milligrams (mg) administered orally twice daily (BID), in a 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons.	7 / 12	12 / 12	0 / 12
Phase 1: 160 mg Selpercatinib QD Participants received Selpercatinib 160 milligrams (mg) administered orally once daily (QD), in a 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons.	1 / 1	1 / 1	0 / 1
Phase 1: 80 mg Selpercatinib BID Participants received Selpercatinib 80 milligrams (mg) administered orally twice daily (BID), in a 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons.	13 / 20	20 / 20	0 / 20
Phase 1: 120 mg Selpercatinib BID Participants received Selpercatinib 120 milligrams (mg) administered orally twice daily (BID), in a 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons.	11 / 19	19 / 19	0 / 19
Phase 1: 160 mg Selpercatinib BID Participants received Selpercatinib 160 milligrams (mg) administered orally twice daily (BID), in a 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons.	380 / 764	764 / 764	0 / 764
Phase 1: 200 mg Selpercatinib BID Participants received Selpercatinib 200 milligrams (mg) administered orally twice daily (BID), in a 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons.	3 / 3	3 / 3	0 / 3
Phase 1: 240 mg Selpercatinib BID Participants received Selpercatinib 240 milligrams (mg) administered orally twice daily (BID), in a 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons.	3 / 6	6 / 6	0 / 6
Phase 2, Cohort 1: RET Fusion Solid Tumor Participants with Rearranged during transfection (RET) Fusion solid tumor progressed on/intolerant to standard first line therapy received Selpercatinib 160 milligrams (mg) administered orally twice daily (BID), in a continuous 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons.	187 / 307	307 / 307	147 / 307
Phase 2, Cohort 2: RET Fusion Solid Tumor Without Standard Therapy Participants with RET Fusion solid tumor without standard first line therapy received Selpercatinib 160 milligrams (mg) administered orally twice daily (BID), in a continuous 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons.	39 / 74	74 / 74	27 / 74
Phase 2, Cohort 3: RET Mutant MTC Participants with RET mutant medullary thyroid cancer (MTC) progressed on/intolerant to standard first line therapy received Selpercatinib 160 milligrams (mg) administered orally twice daily (BID), in a continuous 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons.	93 / 143	143 / 143	67 / 143
Phase 2, Cohort 4: RET Mutant MTC Without Standard Therapy Participants with RET mutant MTC without prior standard first line therapy or other kinase inhibitor(s) with anti-RET activity received Selpercatinib 160 milligrams (mg) administered orally twice daily (BID), in a continuous 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons.	65 / 116	116 / 116	18 / 116
Phase 2, Cohort 5: Advanced RET Altered Solid Tumor Participants with RET altered solid tumor (cohorts 1-4, disease not measurable; MTC not eligible for Cohort 3 or 4; MTC syndrome spectrum cancer; circulating free tumor DNA \[cfDNA+\] for RET alteration not known to be present in tumor) received Selpercatinib 160 milligrams (mg) administered orally twice daily (BID), in a continuous 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons.	114 / 201	201 / 201	83 / 201
Phase 2, Cohort 6: RET Inhibitor-Discontinued Participants Participants otherwise eligible for Cohorts 1-5 who discontinued other RET inhibitors received Selpercatinib 160 milligrams (mg) administered orally twice daily (BID), in a continuous 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons.	8 / 16	16 / 16	8 / 16

Group identifiers: EG000: Phase 1: 20 mg Selpercatinib QD · EG001: Phase 1: 20 mg Selpercatinib BID · EG002: Phase 1: 40 mg Selpercatinib BID · EG003: Phase 1: 60 mg Selpercatinib BID · EG004: Phase 1: 160 mg Selpercatinib QD · EG005: Phase 1: 80 mg Selpercatinib BID · EG006: Phase 1: 120 mg Selpercatinib BID · EG007: Phase 1: 160 mg Selpercatinib BID · EG008: Phase 1: 200 mg Selpercatinib BID · EG009: Phase 1: 240 mg Selpercatinib BID · EG010: Phase 2, Cohort 1: RET Fusion Solid Tumor · EG011: Phase 2, Cohort 2: RET Fusion Solid Tumor Without Standard Therapy · EG012: Phase 2, Cohort 3: RET Mutant MTC · EG013: Phase 2, Cohort 4: RET Mutant MTC Without Standard Therapy · EG014: Phase 2, Cohort 5: Advanced RET Altered Solid Tumor · EG015: Phase 2, Cohort 6: RET Inhibitor-Discontinued Participants

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
Blood and lymphatic system disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
10
group Id
EG002
num Affected
0
num At Risk
16
group Id
EG003
num Affected
0
num At Risk
12
group Id
EG004
num Affected
0
num At Risk
1
group Id
EG005
num Affected
0
num At Risk
20
group Id
EG006
num Affected
0
num At Risk
19
group Id
EG007
num Affected
2
num At Risk
764
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
307
group Id
EG011
num Affected
0
num At Risk
74
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
10
group Id
EG002
num Affected
0
num At Risk
16
group Id
EG003
num Affected
0
num At Risk
12
group Id
EG004
num Affected
0
num At Risk
1
group Id
EG005
num Affected
0
num At Risk
20
group Id
EG006
num Affected
0
num At Risk
19
group Id
EG007
num Affected
1
num At Risk
764
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
307
group Id
EG011
num Affected
0
num At Risk
74
term
Disseminated intravascular coagulation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
10
group Id
EG002
num Affected
0
num At Risk
16
group Id
EG003
num Affected
0
num At Risk
12
group Id
EG004
num Affected
0
num At Risk
1
group Id
EG005
num Affected
0
num At Risk
20
group Id
EG006
num Affected
0
num At Risk
19
group Id
EG007
num Affected
3
num At Risk
764
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
2
num At Risk
307
group Id
EG011
num Affected
0
num At Risk
74
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
10
group Id
EG002
num Affected
0
num At Risk
16
group Id
EG003
num Affected
0
num At Risk
12
group Id
EG004
num Affected
0
num At Risk
1
group Id
EG005
num Affected
0
num At Risk
20
group Id
EG006
num Affected
0
num At Risk
19
group Id
EG007
num Affected
1
num At Risk
764
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
307
group Id
EG011
num Affected
0
num At Risk
74
term
Leukocytosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
10
group Id
EG002
num Affected
0
num At Risk
16
group Id
EG003
num Affected
0
num At Risk
12
group Id
EG004
num Affected
0
num At Risk
1
group Id
EG005
num Affected
0
num At Risk
20
group Id
EG006
num Affected
0
num At Risk
19
group Id
EG007
num Affected
1
num At Risk
764
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
307
group Id
EG011
num Affected
0
num At Risk
74
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
10
group Id
EG002
num Affected
0
num At Risk
16
group Id
EG003
num Affected
0
num At Risk
12
group Id
EG004
num Affected
0
num At Risk
1
group Id
EG005
num Affected
0
num At Risk
20
group Id
EG006
num Affected
1
num At Risk
19
group Id
EG007
num Affected
0
num At Risk
764
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
307
group Id
EG011
num Affected
0
num At Risk
74
term
Lymphopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
10
group Id
EG002
num Affected
0
num At Risk
16
group Id
EG003
num Affected
0
num At Risk
12
group Id
EG004
num Affected
0
num At Risk
1
group Id
EG005
num Affected
0
num At Risk
20
group Id
EG006
num Affected
0
num At Risk
19
group Id
EG007
num Affected
2
num At Risk
764
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
307
group Id
EG011
num Affected
0
num At Risk
74
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
10
group Id
EG002
num Affected
0
num At Risk
16
group Id
EG003
num Affected
0
num At Risk
12
group Id
EG004
num Affected
0
num At Risk
1
group Id
EG005
num Affected
0
num At Risk
20
group Id
EG006
num Affected
0
num At Risk
19
group Id
EG007
num Affected
6
num At Risk
764
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
2
num At Risk
307
group Id
EG011
num Affected
0
num At Risk
74
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
10
group Id
EG002
num Affected
0
num At Risk
16
group Id
EG003
num Affected
1
num At Risk
12
group Id
EG004
num Affected
0
num At Risk
1
group Id
EG005
num Affected
0
num At Risk
20
group Id
EG006
num Affected
0
num At Risk
19
group Id
EG007
num Affected
0
num At Risk
764
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
307
group Id
EG011
num Affected
0
num At Risk
74
term
Accelerated idioventricular rhythm
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
10
group Id
EG002
num Affected
0
num At Risk
16
group Id
EG003
num Affected
0
num At Risk
12
group Id
EG004
num Affected
0
num At Risk
1
group Id
EG005
num Affected
0
num At Risk
20
group Id
EG006
num Affected
1
num At Risk
19
group Id
EG007
num Affected
0
num At Risk
764
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
307
group Id
EG011
num Affected
0
num At Risk
74
term
Acute left ventricular failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
10
group Id
EG002
num Affected
0
num At Risk
16
group Id
EG003
num Affected
0
num At Risk
12
group Id
EG004
num Affected
0
num At Risk
1
group Id
EG005
num Affected
0
num At Risk
20
group Id
EG006
num Affected
0
num At Risk
19
group Id
EG007
num Affected
4
num At Risk
764
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
307
group Id
EG011
num Affected
0
num At Risk
74
term
Acute myocardial infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
10
group Id
EG002
num Affected
0
num At Risk
16
group Id
EG003
num Affected
0
num At Risk
12
group Id
EG004
num Affected
0
num At Risk
1
group Id
EG005
num Affected
0
num At Risk
20
group Id
EG006
num Affected
0
num At Risk
19
group Id
EG007
num Affected
2
num At Risk
764
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
307
group Id
EG011
num Affected
1
num At Risk
74
term
Angina pectoris

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
Blood and lymphatic system disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
2
num At Risk
6
group Id
EG001
num Affected
1
num At Risk
10
group Id
EG002
num Affected
1
num At Risk
16
group Id
EG003
num Affected
2
num At Risk
12
group Id
EG004
num Affected
0
num At Risk
1
group Id
EG005
num Affected
5
num At Risk
20
group Id
EG006
num Affected
5
num At Risk
19
group Id
EG007
num Affected
115
num At Risk
764
group Id
EG008
num Affected
0
num At Risk
3
group Id
EG009
num Affected
2
num At Risk
6
group Id
EG010
num Affected
45
num At Risk
307
group Id
EG011
num Affected
12
num At Risk
74
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
1
num At Risk
10
group Id
EG002
num Affected
2
num At Risk
16
group Id
EG003
num Affected
2
num At Risk
12
group Id
EG004
num Affected
0
num At Risk
1
group Id
EG005
num Affected
4
num At Risk
20
group Id
EG006
num Affected
2
num At Risk
19
group Id
EG007
num Affected
121
num At Risk
764
group Id
EG008
num Affected
0
num At Risk
3
group Id
EG009
num Affected
2
num At Risk
6
group Id
EG010
num Affected
58
num At Risk
307
group Id
EG011
num Affected
9
num At Risk
74
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
1
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
10
group Id
EG002
num Affected
4
num At Risk
16
group Id
EG003
num Affected
4
num At Risk
12
group Id
EG004
num Affected
0
num At Risk
1
group Id
EG005
num Affected
7
num At Risk
20
group Id
EG006
num Affected
1
num At Risk
19
group Id
EG007
num Affected
108
num At Risk
764
group Id
EG008
num Affected
1
num At Risk
3
group Id
EG009
num Affected
1
num At Risk
6
group Id
EG010
num Affected
34
num At Risk
307
group Id
EG011
num Affected
11
num At Risk
74
term
Lymphopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
10
group Id
EG002
num Affected
2
num At Risk
16
group Id
EG003
num Affected
1
num At Risk
12
group Id
EG004
num Affected
0
num At Risk
1
group Id
EG005
num Affected
2
num At Risk
20
group Id
EG006
num Affected
3
num At Risk
19
group Id
EG007
num Affected
94
num At Risk
764
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
47
num At Risk
307
group Id
EG011
num Affected
6
num At Risk
74
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
10
group Id
EG002
num Affected
1
num At Risk
16
group Id
EG003
num Affected
1
num At Risk
12
group Id
EG004
num Affected
0
num At Risk
1
group Id
EG005
num Affected
2
num At Risk
20
group Id
EG006
num Affected
3
num At Risk
19
group Id
EG007
num Affected
142
num At Risk
764
group Id
EG008
num Affected
1
num At Risk
3
group Id
EG009
num Affected
2
num At Risk
6
group Id
EG010
num Affected
76
num At Risk
307
group Id
EG011
num Affected
13
num At Risk
74
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
1
num At Risk
10
group Id
EG002
num Affected
1
num At Risk
16
group Id
EG003
num Affected
0
num At Risk
12
group Id
EG004
num Affected
0
num At Risk
1
group Id
EG005
num Affected
3
num At Risk
20
group Id
EG006
num Affected
1
num At Risk
19
group Id
EG007
num Affected
10
num At Risk
764
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
5
num At Risk
307
group Id
EG011
num Affected
0
num At Risk
74
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
10
group Id
EG002
num Affected
2
num At Risk
16
group Id
EG003
num Affected
0
num At Risk
12
group Id
EG004
num Affected
0
num At Risk
1
group Id
EG005
num Affected
0
num At Risk
20
group Id
EG006
num Affected
0
num At Risk
19
group Id
EG007
num Affected
3
num At Risk
764
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
2
num At Risk
307
group Id
EG011
num Affected
0
num At Risk
74
term
Atrial flutter
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
10
group Id
EG002
num Affected
0
num At Risk
16
group Id
EG003
num Affected
1
num At Risk
12
group Id
EG004
num Affected
0
num At Risk
1
group Id
EG005
num Affected
0
num At Risk
20
group Id
EG006
num Affected
0
num At Risk
19
group Id
EG007
num Affected
10
num At Risk
764
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
2
num At Risk
307
group Id
EG011
num Affected
0
num At Risk
74
term
Cardiac failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
1
num At Risk
10
group Id
EG002
num Affected
0
num At Risk
16
group Id
EG003
num Affected
0
num At Risk
12
group Id
EG004
num Affected
0
num At Risk
1
group Id
EG005
num Affected
1
num At Risk
20
group Id
EG006
num Affected
1
num At Risk
19
group Id
EG007
num Affected
6
num At Risk
764
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
3
num At Risk
307
group Id
EG011
num Affected
0
num At Risk
74
term
Myocardial infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
1
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
10
group Id
EG002
num Affected
1
num At Risk
16
group Id
EG003
num Affected
0
num At Risk
12
group Id
EG004
num Affected
0
num At Risk
1
group Id
EG005
num Affected
0
num At Risk
20
group Id
EG006
num Affected
0
num At Risk
19
group Id
EG007
num Affected
26
num At Risk
764
group Id
EG008
num Affected
0
num At Risk
3
group Id
EG009
num Affected
2
num At Risk
6
group Id
EG010
num Affected
7
num At Risk
307
group Id
EG011
num Affected
6
num At Risk
74
term
Palpitations
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
10
group Id
EG002
num Affected
1
num At Risk
16
group Id
EG003
num Affected
1
num At Risk
12
group Id
EG004
num Affected
0
num At Risk
1
group Id
EG005
num Affected
1
num At Risk
20
group Id
EG006
num Affected
0
num At Risk
19
group Id
EG007
num Affected
27
num At Risk
764
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
12
num At Risk
307
group Id
EG011
num Affected
3
num At Risk
74
term
Pericardial effusion
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
10
group Id
EG002
num Affected
0
num At Risk
16
group Id
EG003
num Affected
0
num At Risk
12
group Id
EG004
num Affected
0
num At Risk
1
group Id
EG005
num Affected
0
num At Risk
20
group Id
EG006
num Affected
0
num At Risk
19
group Id
EG007
num Affected
1
num At Risk
764
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
307
group Id
EG011
num Affected
0
num At Risk
74
term
Pulmonary valve incompetence

Complete source fields

description

All Participants who received at least 1 or more doses of Selpercatinib.

event Groups

deaths Num Affected
0
deaths Num At Risk
6
description
Participants received Selpercatinib 20 milligrams (mg) administered orally once daily (QD), in a 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons.
id
EG000
other Num Affected
6
other Num At Risk
6
serious Num Affected
4
serious Num At Risk
6
title
Phase 1: 20 mg Selpercatinib QD
deaths Num Affected
0
deaths Num At Risk
10
description
Participants received Selpercatinib 20 milligrams (mg) administered orally twice daily (BID), in a 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons.
id
EG001
other Num Affected
10
other Num At Risk
10
serious Num Affected
8
serious Num At Risk
10
title
Phase 1: 20 mg Selpercatinib BID
deaths Num Affected
0
deaths Num At Risk
16
description
Participants received Selpercatinib 40 milligrams (mg) administered orally twice daily (BID), in a 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons.
id
EG002
other Num Affected
16
other Num At Risk
16
serious Num Affected
9
serious Num At Risk
16
title
Phase 1: 40 mg Selpercatinib BID
deaths Num Affected
0
deaths Num At Risk
12
description
Participants received Selpercatinib 60 milligrams (mg) administered orally twice daily (BID), in a 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons.
id
EG003
other Num Affected
12
other Num At Risk
12
serious Num Affected
7
serious Num At Risk
12
title
Phase 1: 60 mg Selpercatinib BID
deaths Num Affected
0
deaths Num At Risk
1
description
Participants received Selpercatinib 160 milligrams (mg) administered orally once daily (QD), in a 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons.
id
EG004
other Num Affected
1
other Num At Risk
1
serious Num Affected
1
serious Num At Risk
1
title
Phase 1: 160 mg Selpercatinib QD
deaths Num Affected
0
deaths Num At Risk
20
description
Participants received Selpercatinib 80 milligrams (mg) administered orally twice daily (BID), in a 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons.
id
EG005
other Num Affected
20
other Num At Risk
20
serious Num Affected
13
serious Num At Risk
20
title
Phase 1: 80 mg Selpercatinib BID
deaths Num Affected
0
deaths Num At Risk
19
description
Participants received Selpercatinib 120 milligrams (mg) administered orally twice daily (BID), in a 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons.
id
EG006
other Num Affected
19
other Num At Risk
19
serious Num Affected
11
serious Num At Risk
19
title
Phase 1: 120 mg Selpercatinib BID
deaths Num Affected
0
deaths Num At Risk
764
description
Participants received Selpercatinib 160 milligrams (mg) administered orally twice daily (BID), in a 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons.
id
EG007
other Num Affected
764
other Num At Risk
764
serious Num Affected
380
serious Num At Risk
764
title
Phase 1: 160 mg Selpercatinib BID
deaths Num Affected
0
deaths Num At Risk
3
description
Participants received Selpercatinib 200 milligrams (mg) administered orally twice daily (BID), in a 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons.
id
EG008
other Num Affected
3
other Num At Risk
3
serious Num Affected
3
serious Num At Risk
3
title
Phase 1: 200 mg Selpercatinib BID
deaths Num Affected
0
deaths Num At Risk
6
description
Participants received Selpercatinib 240 milligrams (mg) administered orally twice daily (BID), in a 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons.
id
EG009
other Num Affected
6
other Num At Risk
6
serious Num Affected
3
serious Num At Risk
6
title
Phase 1: 240 mg Selpercatinib BID
deaths Num Affected
147
deaths Num At Risk
307
description
Participants with Rearranged during transfection (RET) Fusion solid tumor progressed on/intolerant to standard first line therapy received Selpercatinib 160 milligrams (mg) administered orally twice daily (BID), in a continuous 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons.
id
EG010
other Num Affected
307
other Num At Risk
307
serious Num Affected
187
serious Num At Risk
307
title
Phase 2, Cohort 1: RET Fusion Solid Tumor
deaths Num Affected
27
deaths Num At Risk
74
description
Participants with RET Fusion solid tumor without standard first line therapy received Selpercatinib 160 milligrams (mg) administered orally twice daily (BID), in a continuous 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons.
id
EG011
other Num Affected
74
other Num At Risk
74
serious Num Affected
39
serious Num At Risk
74
title
Phase 2, Cohort 2: RET Fusion Solid Tumor Without Standard Therapy

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
2
num At Risk
6
group Id
EG001
num Affected
1
num At Risk
10
group Id
EG002
num Affected
1
num At Risk
16
group Id
EG003
num Affected
2
num At Risk
12
group Id
EG004
num Affected
0
num At Risk
1
group Id
EG005
num Affected
5
num At Risk
20
group Id
EG006
num Affected
5
num At Risk
19
group Id
EG007
num Affected
115
num At Risk
764
group Id
EG008
num Affected
0
num At Risk
3
group Id
EG009
num Affected
2
num At Risk
6
group Id
EG010
num Affected
45
num At Risk
307
group Id
EG011
num Affected
12
num At Risk
74
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
1
num At Risk
10
group Id
EG002
num Affected
2
num At Risk
16
group Id
EG003
num Affected
2
num At Risk
12
group Id
EG004
num Affected
0
num At Risk
1
group Id
EG005
num Affected
4
num At Risk
20
group Id
EG006
num Affected
2
num At Risk
19
group Id
EG007
num Affected
121
num At Risk
764
group Id
EG008
num Affected
0
num At Risk
3
group Id
EG009
num Affected
2
num At Risk
6
group Id
EG010
num Affected
58
num At Risk
307
group Id
EG011
num Affected
9
num At Risk
74
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
1
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
10
group Id
EG002
num Affected
4
num At Risk
16
group Id
EG003
num Affected
4
num At Risk
12
group Id
EG004
num Affected
0
num At Risk
1
group Id
EG005
num Affected
7
num At Risk
20
group Id
EG006
num Affected
1
num At Risk
19
group Id
EG007
num Affected
108
num At Risk
764
group Id
EG008
num Affected
1
num At Risk
3
group Id
EG009
num Affected
1
num At Risk
6
group Id
EG010
num Affected
34
num At Risk
307
group Id
EG011
num Affected
11
num At Risk
74
term
Lymphopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
10
group Id
EG002
num Affected
2
num At Risk
16
group Id
EG003
num Affected
1
num At Risk
12
group Id
EG004
num Affected
0
num At Risk
1
group Id
EG005
num Affected
2
num At Risk
20
group Id
EG006
num Affected
3
num At Risk
19
group Id
EG007
num Affected
94
num At Risk
764
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
47
num At Risk
307
group Id
EG011
num Affected
6
num At Risk
74
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
10
group Id
EG002
num Affected
1
num At Risk
16
group Id
EG003
num Affected
1
num At Risk
12
group Id
EG004
num Affected
0
num At Risk
1
group Id
EG005
num Affected
2
num At Risk
20
group Id
EG006
num Affected
3
num At Risk
19
group Id
EG007
num Affected
142
num At Risk
764
group Id
EG008
num Affected
1
num At Risk
3
group Id
EG009
num Affected
2
num At Risk
6
group Id
EG010
num Affected
76
num At Risk
307
group Id
EG011
num Affected
13
num At Risk
74
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
1
num At Risk
10
group Id
EG002
num Affected
1
num At Risk
16
group Id
EG003
num Affected
0
num At Risk
12
group Id
EG004
num Affected
0
num At Risk
1
group Id
EG005
num Affected
3
num At Risk
20
group Id
EG006
num Affected
1
num At Risk
19
group Id
EG007
num Affected
10
num At Risk
764
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
5
num At Risk
307
group Id
EG011
num Affected
0
num At Risk
74
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
10
group Id
EG002
num Affected
2
num At Risk
16
group Id
EG003
num Affected
0
num At Risk
12
group Id
EG004
num Affected
0
num At Risk
1
group Id
EG005
num Affected
0
num At Risk
20
group Id
EG006
num Affected
0
num At Risk
19
group Id
EG007
num Affected
3
num At Risk
764
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
2
num At Risk
307
group Id
EG011
num Affected
0
num At Risk
74
term
Atrial flutter
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
10
group Id
EG002
num Affected
0
num At Risk
16
group Id
EG003
num Affected
1
num At Risk
12
group Id
EG004
num Affected
0
num At Risk
1
group Id
EG005
num Affected
0
num At Risk
20
group Id
EG006
num Affected
0
num At Risk
19
group Id
EG007
num Affected
10
num At Risk
764
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
2
num At Risk
307
group Id
EG011
num Affected
0
num At Risk
74
term
Cardiac failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
1
num At Risk
10
group Id
EG002
num Affected
0
num At Risk
16
group Id
EG003
num Affected
0
num At Risk
12
group Id
EG004
num Affected
0
num At Risk
1
group Id
EG005
num Affected
1
num At Risk
20
group Id
EG006
num Affected
1
num At Risk
19
group Id
EG007
num Affected
6
num At Risk
764
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
3
num At Risk
307
group Id
EG011
num Affected
0
num At Risk
74
term
Myocardial infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
1
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
10
group Id
EG002
num Affected
1
num At Risk
16
group Id
EG003
num Affected
0
num At Risk
12
group Id
EG004
num Affected
0
num At Risk
1
group Id
EG005
num Affected
0
num At Risk
20
group Id
EG006
num Affected
0
num At Risk
19
group Id
EG007
num Affected
26
num At Risk
764
group Id
EG008
num Affected
0
num At Risk
3
group Id
EG009
num Affected
2
num At Risk
6
group Id
EG010
num Affected
7
num At Risk
307
group Id
EG011
num Affected
6
num At Risk
74
term
Palpitations
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
10
group Id
EG002
num Affected
1
num At Risk
16
group Id
EG003
num Affected
1
num At Risk
12
group Id
EG004
num Affected
0
num At Risk
1
group Id
EG005
num Affected
1
num At Risk
20
group Id
EG006
num Affected
0
num At Risk
19
group Id
EG007
num Affected
27
num At Risk
764
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
12
num At Risk
307
group Id
EG011
num Affected
3
num At Risk
74
term
Pericardial effusion
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
10
group Id
EG002
num Affected
0
num At Risk
16
group Id
EG003
num Affected
0
num At Risk
12
group Id
EG004
num Affected
0
num At Risk
1
group Id
EG005
num Affected
0
num At Risk
20
group Id
EG006
num Affected
0
num At Risk
19
group Id
EG007
num Affected
1
num At Risk
764
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
307
group Id
EG011
num Affected
0
num At Risk
74
term
Pulmonary valve incompetence

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
10
group Id
EG002
num Affected
0
num At Risk
16
group Id
EG003
num Affected
0
num At Risk
12
group Id
EG004
num Affected
0
num At Risk
1
group Id
EG005
num Affected
0
num At Risk
20
group Id
EG006
num Affected
0
num At Risk
19
group Id
EG007
num Affected
2
num At Risk
764
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
307
group Id
EG011
num Affected
0
num At Risk
74
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
10
group Id
EG002
num Affected
0
num At Risk
16
group Id
EG003
num Affected
0
num At Risk
12
group Id
EG004
num Affected
0
num At Risk
1
group Id
EG005
num Affected
0
num At Risk
20
group Id
EG006
num Affected
0
num At Risk
19
group Id
EG007
num Affected
1
num At Risk
764
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
307
group Id
EG011
num Affected
0
num At Risk
74
term
Disseminated intravascular coagulation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
10
group Id
EG002
num Affected
0
num At Risk
16
group Id
EG003
num Affected
0
num At Risk
12
group Id
EG004
num Affected
0
num At Risk
1
group Id
EG005
num Affected
0
num At Risk
20
group Id
EG006
num Affected
0
num At Risk
19
group Id
EG007
num Affected
3
num At Risk
764
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
2
num At Risk
307
group Id
EG011
num Affected
0
num At Risk
74
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
10
group Id
EG002
num Affected
0
num At Risk
16
group Id
EG003
num Affected
0
num At Risk
12
group Id
EG004
num Affected
0
num At Risk
1
group Id
EG005
num Affected
0
num At Risk
20
group Id
EG006
num Affected
0
num At Risk
19
group Id
EG007
num Affected
1
num At Risk
764
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
307
group Id
EG011
num Affected
0
num At Risk
74
term
Leukocytosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
10
group Id
EG002
num Affected
0
num At Risk
16
group Id
EG003
num Affected
0
num At Risk
12
group Id
EG004
num Affected
0
num At Risk
1
group Id
EG005
num Affected
0
num At Risk
20
group Id
EG006
num Affected
0
num At Risk
19
group Id
EG007
num Affected
1
num At Risk
764
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
307
group Id
EG011
num Affected
0
num At Risk
74
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
10
group Id
EG002
num Affected
0
num At Risk
16
group Id
EG003
num Affected
0
num At Risk
12
group Id
EG004
num Affected
0
num At Risk
1
group Id
EG005
num Affected
0
num At Risk
20
group Id
EG006
num Affected
1
num At Risk
19
group Id
EG007
num Affected
0
num At Risk
764
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
307
group Id
EG011
num Affected
0
num At Risk
74
term
Lymphopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
10
group Id
EG002
num Affected
0
num At Risk
16
group Id
EG003
num Affected
0
num At Risk
12
group Id
EG004
num Affected
0
num At Risk
1
group Id
EG005
num Affected
0
num At Risk
20
group Id
EG006
num Affected
0
num At Risk
19
group Id
EG007
num Affected
2
num At Risk
764
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
307
group Id
EG011
num Affected
0
num At Risk
74
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
10
group Id
EG002
num Affected
0
num At Risk
16
group Id
EG003
num Affected
0
num At Risk
12
group Id
EG004
num Affected
0
num At Risk
1
group Id
EG005
num Affected
0
num At Risk
20
group Id
EG006
num Affected
0
num At Risk
19
group Id
EG007
num Affected
6
num At Risk
764
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
2
num At Risk
307
group Id
EG011
num Affected
0
num At Risk
74
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
10
group Id
EG002
num Affected
0
num At Risk
16
group Id
EG003
num Affected
1
num At Risk
12
group Id
EG004
num Affected
0
num At Risk
1
group Id
EG005
num Affected
0
num At Risk
20
group Id
EG006
num Affected
0
num At Risk
19
group Id
EG007
num Affected
0
num At Risk
764
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
307
group Id
EG011
num Affected
0
num At Risk
74
term
Accelerated idioventricular rhythm
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
10
group Id
EG002
num Affected
0
num At Risk
16
group Id
EG003
num Affected
0
num At Risk
12
group Id
EG004
num Affected
0
num At Risk
1
group Id
EG005
num Affected
0
num At Risk
20
group Id
EG006
num Affected
1
num At Risk
19
group Id
EG007
num Affected
0
num At Risk
764
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
307
group Id
EG011
num Affected
0
num At Risk
74
term
Acute left ventricular failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
10
group Id
EG002
num Affected
0
num At Risk
16
group Id
EG003
num Affected
0
num At Risk
12
group Id
EG004
num Affected
0
num At Risk
1
group Id
EG005
num Affected
0
num At Risk
20
group Id
EG006
num Affected
0
num At Risk
19
group Id
EG007
num Affected
4
num At Risk
764
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
307
group Id
EG011
num Affected
0
num At Risk
74
term
Acute myocardial infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
10
group Id
EG002
num Affected
0
num At Risk
16
group Id
EG003
num Affected
0
num At Risk
12
group Id
EG004
num Affected
0
num At Risk
1
group Id
EG005
num Affected
0
num At Risk
20
group Id
EG006
num Affected
0
num At Risk
19
group Id
EG007
num Affected
2
num At Risk
764
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
307
group Id
EG011
num Affected
1
num At Risk
74
term
Angina pectoris

time Frame

Phase 1: Up to 28 days; Phase 2: Up to 7 years 8 months

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

Preserved source evidence · Independent clinical review pending · Not medical advice