NCT04211337 · ADVERSE EVENTS

Adverse events

A Study of Selpercatinib (LY3527723) in Participants With RET-Mutant Medullary Thyroid Cancer · Source last updated 2026-03-19

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: Baseline up to 39 months
Other-event reporting threshold: 5%

All randomized participants who received at least 1 dose (including a partial dose) of study treatment. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated"). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Selpercatinib - Treatment A (TRT A) 160 milligrams Selpercatinib administered orally (PO) twice daily (BID). Adolescent Dose: 92 milligrams per square meter (mg/m2) BID (not to exceed 160 mg BID).	43 / 193	184 / 193	8 / 193
Cabozantinib or Vandetanib - Treatment B (TRT B) 140 mg Cabozantinib administered orally daily (QD) or 300 mg Vandetanib administered orally QD per physician choice. Cabozantinib Adolescent Dose: 40 mg/m2. Vandetanib Adolescent Dose: 0.7 - \<0.9 - 100 mg every other day (QOD) 0.9 - \<1.2 - 100 mg QD 1.2 - \<1.6 - 7-day schedule 100 mg - 200 mg - 100 mg - 200 mg - 100 mg - 200 mg - 100 mg ≥1.6 - 200 QD	27 / 97	96 / 97	10 / 97

Group identifiers: EG000: Selpercatinib - Treatment A (TRT A) · EG001: Cabozantinib or Vandetanib - Treatment B (TRT B)

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 26.0
stats
group Id
EG000
num Affected
1
num At Risk
193
num Events
1
group Id
EG001
num Affected
1
num At Risk
97
num Events
1
term
Polycythaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
0
num At Risk
193
num Events
0
group Id
EG001
num Affected
1
num At Risk
97
num Events
1
term
Cardiac failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
0
num At Risk
193
num Events
0
group Id
EG001
num Affected
1
num At Risk
97
num Events
1
term
Myocardial infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
1
num At Risk
193
num Events
1
group Id
EG001
num Affected
0
num At Risk
97
num Events
0
term
Vertigo
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
1
num At Risk
193
num Events
2
group Id
EG001
num Affected
0
num At Risk
97
num Events
0
term
Adrenal insufficiency
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
1
num At Risk
193
num Events
1
group Id
EG001
num Affected
0
num At Risk
97
num Events
0
term
Adrenocortical insufficiency acute
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
1
num At Risk
193
num Events
1
group Id
EG001
num Affected
0
num At Risk
97
num Events
0
term
Hypothyroidism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
1
num At Risk
193
num Events
1
group Id
EG001
num Affected
0
num At Risk
97
num Events
0
term
Retinopathy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
0
num At Risk
193
num Events
0
group Id
EG001
num Affected
1
num At Risk
97
num Events
1
term
Anal cyst
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
1
num At Risk
193
num Events
1
group Id
EG001
num Affected
0
num At Risk
97
num Events
0
term
Colitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
1
num At Risk
193
num Events
1
group Id
EG001
num Affected
0
num At Risk
97
num Events
0
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
1
num At Risk
193
num Events
1
group Id
EG001
num Affected
1
num At Risk
97
num Events
1
term
Enteritis

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 26.0
stats
group Id
EG000
num Affected
11
num At Risk
193
num Events
12
group Id
EG001
num Affected
10
num At Risk
97
num Events
16
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
10
num At Risk
193
num Events
13
group Id
EG001
num Affected
6
num At Risk
97
num Events
7
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
10
num At Risk
193
num Events
16
group Id
EG001
num Affected
4
num At Risk
97
num Events
4
term
Lymphopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
3
num At Risk
193
num Events
6
group Id
EG001
num Affected
8
num At Risk
97
num Events
17
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
4
num At Risk
193
num Events
5
group Id
EG001
num Affected
9
num At Risk
97
num Events
10
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
12
num At Risk
193
num Events
18
group Id
EG001
num Affected
4
num At Risk
97
num Events
4
term
Hypothyroidism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
10
num At Risk
193
num Events
16
group Id
EG001
num Affected
2
num At Risk
97
num Events
2
term
Abdominal distension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
19
num At Risk
193
num Events
28
group Id
EG001
num Affected
14
num At Risk
97
num Events
30
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
16
num At Risk
193
num Events
19
group Id
EG001
num Affected
7
num At Risk
97
num Events
12
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
11
num At Risk
193
num Events
11
group Id
EG001
num Affected
0
num At Risk
97
num Events
0
term
Ascites
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
31
num At Risk
193
num Events
58
group Id
EG001
num Affected
12
num At Risk
97
num Events
14
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
51
num At Risk
193
num Events
116
group Id
EG001
num Affected
59
num At Risk
97
num Events
195
term
Diarrhoea

Complete source fields

description

event Groups

deaths Num Affected
8
deaths Num At Risk
193
description
160 milligrams Selpercatinib administered orally (PO) twice daily (BID). Adolescent Dose: 92 milligrams per square meter (mg/m2) BID (not to exceed 160 mg BID).
id
EG000
other Num Affected
184
other Num At Risk
193
serious Num Affected
43
serious Num At Risk
193
title
Selpercatinib - Treatment A (TRT A)
deaths Num Affected
10
deaths Num At Risk
97
description
140 mg Cabozantinib administered orally daily (QD) or 300 mg Vandetanib administered orally QD per physician choice. Cabozantinib Adolescent Dose: 40 mg/m2. Vandetanib Adolescent Dose: 0.7 - \<0.9 - 100 mg every other day (QOD) 0.9 - \<1.2 - 100 mg QD 1.2 - \<1.6 - 7-day schedule 100 mg - 200 mg - 100 mg - 200 mg - 100 mg - 200 mg - 100 mg ≥1.6 - 200 QD
id
EG001
other Num Affected
96
other Num At Risk
97
serious Num Affected
27
serious Num At Risk
97
title
Cabozantinib or Vandetanib - Treatment B (TRT B)

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
11
num At Risk
193
num Events
12
group Id
EG001
num Affected
10
num At Risk
97
num Events
16
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
10
num At Risk
193
num Events
13
group Id
EG001
num Affected
6
num At Risk
97
num Events
7
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
10
num At Risk
193
num Events
16
group Id
EG001
num Affected
4
num At Risk
97
num Events
4
term
Lymphopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
3
num At Risk
193
num Events
6
group Id
EG001
num Affected
8
num At Risk
97
num Events
17
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
4
num At Risk
193
num Events
5
group Id
EG001
num Affected
9
num At Risk
97
num Events
10
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
12
num At Risk
193
num Events
18
group Id
EG001
num Affected
4
num At Risk
97
num Events
4
term
Hypothyroidism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
10
num At Risk
193
num Events
16
group Id
EG001
num Affected
2
num At Risk
97
num Events
2
term
Abdominal distension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
19
num At Risk
193
num Events
28
group Id
EG001
num Affected
14
num At Risk
97
num Events
30
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
16
num At Risk
193
num Events
19
group Id
EG001
num Affected
7
num At Risk
97
num Events
12
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
11
num At Risk
193
num Events
11
group Id
EG001
num Affected
0
num At Risk
97
num Events
0
term
Ascites
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
31
num At Risk
193
num Events
58
group Id
EG001
num Affected
12
num At Risk
97
num Events
14
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
51
num At Risk
193
num Events
116
group Id
EG001
num Affected
59
num At Risk
97
num Events
195
term
Diarrhoea

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
1
num At Risk
193
num Events
1
group Id
EG001
num Affected
1
num At Risk
97
num Events
1
term
Polycythaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
0
num At Risk
193
num Events
0
group Id
EG001
num Affected
1
num At Risk
97
num Events
1
term
Cardiac failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
0
num At Risk
193
num Events
0
group Id
EG001
num Affected
1
num At Risk
97
num Events
1
term
Myocardial infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
1
num At Risk
193
num Events
1
group Id
EG001
num Affected
0
num At Risk
97
num Events
0
term
Vertigo
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
1
num At Risk
193
num Events
2
group Id
EG001
num Affected
0
num At Risk
97
num Events
0
term
Adrenal insufficiency
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
1
num At Risk
193
num Events
1
group Id
EG001
num Affected
0
num At Risk
97
num Events
0
term
Adrenocortical insufficiency acute
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
1
num At Risk
193
num Events
1
group Id
EG001
num Affected
0
num At Risk
97
num Events
0
term
Hypothyroidism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
1
num At Risk
193
num Events
1
group Id
EG001
num Affected
0
num At Risk
97
num Events
0
term
Retinopathy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
0
num At Risk
193
num Events
0
group Id
EG001
num Affected
1
num At Risk
97
num Events
1
term
Anal cyst
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
1
num At Risk
193
num Events
1
group Id
EG001
num Affected
0
num At Risk
97
num Events
0
term
Colitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
1
num At Risk
193
num Events
1
group Id
EG001
num Affected
0
num At Risk
97
num Events
0
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
1
num At Risk
193
num Events
1
group Id
EG001
num Affected
1
num At Risk
97
num Events
1
term
Enteritis

time Frame

Baseline up to 39 months

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Preserved source evidence · Not medical advice