NCT04194944 · ADVERSE EVENTS

Adverse events

A Study of Selpercatinib (LY3527723) in Participants With Advanced or Metastatic RET Fusion-Positive Non-Small Cell Lung Cancer · Source last updated 2025-10-21

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 38 Months
Other-event reporting threshold: 5%

Safety population is defined as all participants who received study drug regardless of strata and as pre-specified, adverse events were collected for the TRT B treatment arm as a whole. 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").

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Selpercatinib (TRT A) 160 milligram (mg) Selpercatinib administered orally, twice daily (BID continuously in 21-day cycles.	55 / 158	156 / 158	32 / 158
Carboplatin or Cisplatin+Pemetrexed+/-Pembrolizumab (TRT B) Pemetrexed 500 milligrams per meter squared (mg/m2) administered intravenously (IV) on Day 1, every 3 weeks (Q3W), plus at the investigator's choice of carboplatin area under the concentration versus time curve 5 (AUC 5 \[maximum dose 750 mg\]) IV, or cisplatin 75mg/m2 IV on Day 1 Q3W for 4 cycles, plus investigator's choice with or without 200 mg pembrolizumab IV on Day 1 Q3W up to 35 cycles.	23 / 98	97 / 98	17 / 98

Group identifiers: EG000: Selpercatinib (TRT A) · EG001: Carboplatin or Cisplatin+Pemetrexed+/-Pembrolizumab (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
0
num At Risk
158
num Events
0
group Id
EG001
num Affected
2
num At Risk
98
num Events
2
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
0
num At Risk
158
num Events
0
group Id
EG001
num Affected
1
num At Risk
98
num Events
1
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
0
num At Risk
158
num Events
0
group Id
EG001
num Affected
2
num At Risk
98
num Events
2
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
1
num At Risk
158
num Events
1
group Id
EG001
num Affected
0
num At Risk
98
num Events
0
term
Angina pectoris
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
0
num At Risk
158
num Events
0
group Id
EG001
num Affected
1
num At Risk
98
num Events
1
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
1
num At Risk
158
num Events
1
group Id
EG001
num Affected
0
num At Risk
98
num Events
0
term
Cardiac arrest
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
0
num At Risk
158
num Events
0
group Id
EG001
num Affected
1
num At Risk
98
num Events
3
term
Cardiac failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
2
num At Risk
158
num Events
2
group Id
EG001
num Affected
1
num At Risk
98
num Events
1
term
Myocardial infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
1
num At Risk
158
num Events
1
group Id
EG001
num Affected
0
num At Risk
98
num Events
0
term
Myocardial ischaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
2
num At Risk
158
num Events
2
group Id
EG001
num Affected
0
num At Risk
98
num Events
0
term
Pericardial effusion
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
1
num At Risk
158
num Events
2
group Id
EG001
num Affected
0
num At Risk
98
num Events
0
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
3
num At Risk
158
num Events
7
group Id
EG001
num Affected
0
num At Risk
98
num Events
0
term
Ascites

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
18
num At Risk
158
num Events
35
group Id
EG001
num Affected
57
num At Risk
98
num Events
209
term
Anaemia
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
158
num Events
22
group Id
EG001
num Affected
8
num At Risk
98
num Events
37
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
6
num At Risk
158
num Events
13
group Id
EG001
num Affected
18
num At Risk
98
num Events
61
term
Neutropenia
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
158
num Events
17
group Id
EG001
num Affected
10
num At Risk
98
num Events
20
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
4
num At Risk
158
num Events
8
group Id
EG001
num Affected
7
num At Risk
98
num Events
7
term
Hyperthyroidism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
5
num At Risk
158
num Events
7
group Id
EG001
num Affected
6
num At Risk
98
num Events
10
term
Hypothyroidism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
3
num At Risk
158
num Events
5
group Id
EG001
num Affected
13
num At Risk
98
num Events
16
term
Lacrimation increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
9
num At Risk
158
num Events
9
group Id
EG001
num Affected
3
num At Risk
98
num Events
3
term
Abdominal discomfort
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
8
num At Risk
158
num Events
11
group Id
EG001
num Affected
3
num At Risk
98
num Events
3
term
Abdominal distension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
18
num At Risk
158
num Events
34
group Id
EG001
num Affected
7
num At Risk
98
num Events
11
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
20
num At Risk
158
num Events
31
group Id
EG001
num Affected
13
num At Risk
98
num Events
30
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
9
num At Risk
158
num Events
10
group Id
EG001
num Affected
0
num At Risk
98
num Events
0
term
Ascites

Complete source fields

description

event Groups

deaths Num Affected
32
deaths Num At Risk
158
description
160 milligram (mg) Selpercatinib administered orally, twice daily (BID continuously in 21-day cycles.
id
EG000
other Num Affected
156
other Num At Risk
158
serious Num Affected
55
serious Num At Risk
158
title
Selpercatinib (TRT A)
deaths Num Affected
17
deaths Num At Risk
98
description
Pemetrexed 500 milligrams per meter squared (mg/m2) administered intravenously (IV) on Day 1, every 3 weeks (Q3W), plus at the investigator's choice of carboplatin area under the concentration versus time curve 5 (AUC 5 \[maximum dose 750 mg\]) IV, or cisplatin 75mg/m2 IV on Day 1 Q3W for 4 cycles, plus investigator's choice with or without 200 mg pembrolizumab IV on Day 1 Q3W up to 35 cycles.
id
EG001
other Num Affected
97
other Num At Risk
98
serious Num Affected
23
serious Num At Risk
98
title
Carboplatin or Cisplatin+Pemetrexed+/-Pembrolizumab (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
18
num At Risk
158
num Events
35
group Id
EG001
num Affected
57
num At Risk
98
num Events
209
term
Anaemia
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
158
num Events
22
group Id
EG001
num Affected
8
num At Risk
98
num Events
37
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
6
num At Risk
158
num Events
13
group Id
EG001
num Affected
18
num At Risk
98
num Events
61
term
Neutropenia
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
158
num Events
17
group Id
EG001
num Affected
10
num At Risk
98
num Events
20
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
4
num At Risk
158
num Events
8
group Id
EG001
num Affected
7
num At Risk
98
num Events
7
term
Hyperthyroidism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
5
num At Risk
158
num Events
7
group Id
EG001
num Affected
6
num At Risk
98
num Events
10
term
Hypothyroidism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
3
num At Risk
158
num Events
5
group Id
EG001
num Affected
13
num At Risk
98
num Events
16
term
Lacrimation increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
9
num At Risk
158
num Events
9
group Id
EG001
num Affected
3
num At Risk
98
num Events
3
term
Abdominal discomfort
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
8
num At Risk
158
num Events
11
group Id
EG001
num Affected
3
num At Risk
98
num Events
3
term
Abdominal distension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
18
num At Risk
158
num Events
34
group Id
EG001
num Affected
7
num At Risk
98
num Events
11
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
20
num At Risk
158
num Events
31
group Id
EG001
num Affected
13
num At Risk
98
num Events
30
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
9
num At Risk
158
num Events
10
group Id
EG001
num Affected
0
num At Risk
98
num Events
0
term
Ascites

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
0
num At Risk
158
num Events
0
group Id
EG001
num Affected
2
num At Risk
98
num Events
2
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
0
num At Risk
158
num Events
0
group Id
EG001
num Affected
1
num At Risk
98
num Events
1
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
0
num At Risk
158
num Events
0
group Id
EG001
num Affected
2
num At Risk
98
num Events
2
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
1
num At Risk
158
num Events
1
group Id
EG001
num Affected
0
num At Risk
98
num Events
0
term
Angina pectoris
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
0
num At Risk
158
num Events
0
group Id
EG001
num Affected
1
num At Risk
98
num Events
1
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
1
num At Risk
158
num Events
1
group Id
EG001
num Affected
0
num At Risk
98
num Events
0
term
Cardiac arrest
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
0
num At Risk
158
num Events
0
group Id
EG001
num Affected
1
num At Risk
98
num Events
3
term
Cardiac failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
2
num At Risk
158
num Events
2
group Id
EG001
num Affected
1
num At Risk
98
num Events
1
term
Myocardial infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
1
num At Risk
158
num Events
1
group Id
EG001
num Affected
0
num At Risk
98
num Events
0
term
Myocardial ischaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
2
num At Risk
158
num Events
2
group Id
EG001
num Affected
0
num At Risk
98
num Events
0
term
Pericardial effusion
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
1
num At Risk
158
num Events
2
group Id
EG001
num Affected
0
num At Risk
98
num Events
0
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 26.0
stats
group Id
EG000
num Affected
3
num At Risk
158
num Events
7
group Id
EG001
num Affected
0
num At Risk
98
num Events
0
term
Ascites

time Frame

Baseline Up to 38 Months

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Preserved source evidence · Not medical advice