NCT02451943 · ADVERSE EVENTS

Adverse events

A Study of Doxorubicin Plus Olaratumab (LY3012207) in Participants With Advanced or Metastatic Soft Tissue Sarcoma · Source last updated 2025-07-15

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 41 Months
Other-event reporting threshold: 5%

All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the treatments the participants received.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Doxorubicin + Olaratumab 75 milligrams per meter squared (mg/m\^2) doxorubicin administered intravenously (IV) on day 1 of each 21 day cycle for 8 cycles plus 20 milligrams per kilogram (mg/kg) dose of olaratumab administered IV on day 1 and day 8 of cycle 1 and 15 mg/kg olaratumab administered IV on day 1 and day 8 of cycles 2-8. Beginning with cycle 9, 15 mg/kg olaratumab administered IV on day 1 and day 8 of each subsequent 21 day cycle until documented progressive disease (PD) or discontinuation for any other reason.	105 / 257	248 / 257	170 / 257
Doxorubicin + Placebo 75 mg/m\^2 doxorubicin administered IV on day 1 of each 21 day cycle for 8 cycles plus placebo (equivalent volume) administered IV on day 1 and day 8 for 8 cycles. Beginning with cycle 9, placebo (equivalent volume) administered on days 1 and 8 of each subsequent 21 day cycle until PD or discontinuation for any other reason.	89 / 249	244 / 249	158 / 249

Group identifiers: EG000: Doxorubicin + Olaratumab · EG001: Doxorubicin + Placebo

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 28.0
stats
group Id
EG000
num Affected
4
num At Risk
257
num Events
4
group Id
EG001
num Affected
2
num At Risk
249
num Events
2
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
0
num At Risk
257
num Events
0
group Id
EG001
num Affected
1
num At Risk
249
num Events
1
term
Febrile bone marrow aplasia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
34
num At Risk
257
num Events
37
group Id
EG001
num Affected
33
num At Risk
249
num Events
37
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
1
num At Risk
257
num Events
1
group Id
EG001
num Affected
0
num At Risk
249
num Events
0
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
8
num At Risk
257
num Events
10
group Id
EG001
num Affected
8
num At Risk
249
num Events
8
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
1
num At Risk
257
num Events
1
group Id
EG001
num Affected
1
num At Risk
249
num Events
1
term
Pancytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
1
num At Risk
257
num Events
2
group Id
EG001
num Affected
2
num At Risk
249
num Events
5
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
1
num At Risk
257
num Events
1
group Id
EG001
num Affected
0
num At Risk
249
num Events
0
term
Arrhythmia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
2
num At Risk
257
num Events
2
group Id
EG001
num Affected
0
num At Risk
249
num Events
0
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
0
num At Risk
257
num Events
0
group Id
EG001
num Affected
1
num At Risk
249
num Events
1
term
Cardiac failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
1
num At Risk
257
num Events
1
group Id
EG001
num Affected
0
num At Risk
249
num Events
0
term
Cardiac failure acute
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
0
num At Risk
257
num Events
0
group Id
EG001
num Affected
2
num At Risk
249
num Events
2
term
Cardiac failure congestive

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 28.0
stats
group Id
EG000
num Affected
115
num At Risk
257
num Events
169
group Id
EG001
num Affected
121
num At Risk
249
num Events
230
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
13
num At Risk
257
num Events
13
group Id
EG001
num Affected
9
num At Risk
249
num Events
12
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
14
num At Risk
257
num Events
36
group Id
EG001
num Affected
11
num At Risk
249
num Events
23
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
59
num At Risk
257
num Events
131
group Id
EG001
num Affected
59
num At Risk
249
num Events
121
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
14
num At Risk
257
num Events
29
group Id
EG001
num Affected
19
num At Risk
249
num Events
35
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
31
num At Risk
257
num Events
43
group Id
EG001
num Affected
44
num At Risk
249
num Events
55
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
17
num At Risk
257
num Events
23
group Id
EG001
num Affected
20
num At Risk
249
num Events
23
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
86
num At Risk
257
num Events
122
group Id
EG001
num Affected
94
num At Risk
249
num Events
144
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
79
num At Risk
257
num Events
123
group Id
EG001
num Affected
76
num At Risk
249
num Events
118
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
22
num At Risk
257
num Events
23
group Id
EG001
num Affected
19
num At Risk
249
num Events
21
term
Dry mouth
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
28
num At Risk
257
num Events
33
group Id
EG001
num Affected
29
num At Risk
249
num Events
34
term
Dyspepsia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
16
num At Risk
257
num Events
17
group Id
EG001
num Affected
18
num At Risk
249
num Events
19
term
Gastrooesophageal reflux disease

Complete source fields

description

event Groups

deaths Num Affected
170
deaths Num At Risk
257
description
75 milligrams per meter squared (mg/m\^2) doxorubicin administered intravenously (IV) on day 1 of each 21 day cycle for 8 cycles plus 20 milligrams per kilogram (mg/kg) dose of olaratumab administered IV on day 1 and day 8 of cycle 1 and 15 mg/kg olaratumab administered IV on day 1 and day 8 of cycles 2-8. Beginning with cycle 9, 15 mg/kg olaratumab administered IV on day 1 and day 8 of each subsequent 21 day cycle until documented progressive disease (PD) or discontinuation for any other reason.
id
EG000
other Num Affected
248
other Num At Risk
257
serious Num Affected
105
serious Num At Risk
257
title
Doxorubicin + Olaratumab
deaths Num Affected
158
deaths Num At Risk
249
description
75 mg/m\^2 doxorubicin administered IV on day 1 of each 21 day cycle for 8 cycles plus placebo (equivalent volume) administered IV on day 1 and day 8 for 8 cycles. Beginning with cycle 9, placebo (equivalent volume) administered on days 1 and 8 of each subsequent 21 day cycle until PD or discontinuation for any other reason.
id
EG001
other Num Affected
244
other Num At Risk
249
serious Num Affected
89
serious Num At Risk
249
title
Doxorubicin + Placebo

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
115
num At Risk
257
num Events
169
group Id
EG001
num Affected
121
num At Risk
249
num Events
230
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
13
num At Risk
257
num Events
13
group Id
EG001
num Affected
9
num At Risk
249
num Events
12
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
14
num At Risk
257
num Events
36
group Id
EG001
num Affected
11
num At Risk
249
num Events
23
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
59
num At Risk
257
num Events
131
group Id
EG001
num Affected
59
num At Risk
249
num Events
121
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
14
num At Risk
257
num Events
29
group Id
EG001
num Affected
19
num At Risk
249
num Events
35
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
31
num At Risk
257
num Events
43
group Id
EG001
num Affected
44
num At Risk
249
num Events
55
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
17
num At Risk
257
num Events
23
group Id
EG001
num Affected
20
num At Risk
249
num Events
23
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
86
num At Risk
257
num Events
122
group Id
EG001
num Affected
94
num At Risk
249
num Events
144
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
79
num At Risk
257
num Events
123
group Id
EG001
num Affected
76
num At Risk
249
num Events
118
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
22
num At Risk
257
num Events
23
group Id
EG001
num Affected
19
num At Risk
249
num Events
21
term
Dry mouth
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
28
num At Risk
257
num Events
33
group Id
EG001
num Affected
29
num At Risk
249
num Events
34
term
Dyspepsia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
16
num At Risk
257
num Events
17
group Id
EG001
num Affected
18
num At Risk
249
num Events
19
term
Gastrooesophageal reflux disease

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
4
num At Risk
257
num Events
4
group Id
EG001
num Affected
2
num At Risk
249
num Events
2
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
0
num At Risk
257
num Events
0
group Id
EG001
num Affected
1
num At Risk
249
num Events
1
term
Febrile bone marrow aplasia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
34
num At Risk
257
num Events
37
group Id
EG001
num Affected
33
num At Risk
249
num Events
37
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
1
num At Risk
257
num Events
1
group Id
EG001
num Affected
0
num At Risk
249
num Events
0
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
8
num At Risk
257
num Events
10
group Id
EG001
num Affected
8
num At Risk
249
num Events
8
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
1
num At Risk
257
num Events
1
group Id
EG001
num Affected
1
num At Risk
249
num Events
1
term
Pancytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
1
num At Risk
257
num Events
2
group Id
EG001
num Affected
2
num At Risk
249
num Events
5
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
1
num At Risk
257
num Events
1
group Id
EG001
num Affected
0
num At Risk
249
num Events
0
term
Arrhythmia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
2
num At Risk
257
num Events
2
group Id
EG001
num Affected
0
num At Risk
249
num Events
0
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
0
num At Risk
257
num Events
0
group Id
EG001
num Affected
1
num At Risk
249
num Events
1
term
Cardiac failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
1
num At Risk
257
num Events
1
group Id
EG001
num Affected
0
num At Risk
249
num Events
0
term
Cardiac failure acute
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
0
num At Risk
257
num Events
0
group Id
EG001
num Affected
2
num At Risk
249
num Events
2
term
Cardiac failure congestive

time Frame

Baseline Up To 41 Months

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Preserved source evidence · Not medical advice