NCT00697346 · ADVERSE EVENTS

Adverse events

Study of MLN8237 in Participants With Advanced Hematological Malignancies · Source last updated 2019-05-31

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: From first dose of study drug to 30 days after the last dose (up to 422 days)
Other-event reporting threshold: 5%

At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Part 1 PIC Dose Escalation Alisertib 25 or 35 mg, Powder-in-Capsule (PIC) formulation, orally, once daily (QD) for 21 days followed by a 7-day recovery period in 28-day cycles or alisertib 35, 45, 65 or 90 mg PIC, orally, QD for 14 days followed by a 14-day recovery period in 28-day cycles, until disease progression or unacceptable alisertib-related toxicity (up to 14 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose), followed by their respective dosage assignment.	12 / 28	28 / 28	Not reported / Not reported
Part 1 ECT Dose Escalation Alisertib 40 mg, Enteric-coated Tablet (ECT) formulation, orally, QD for 14 days followed by a 14-day recovery period in 28-day cycles, or alisertib 30, 40 or 50 mg ECT, orally BID for 7 days followed by a 14-day recovery period in 21-day cycles, until disease progression or unacceptable alisertib-related toxicity (up to 15 cycles).	15 / 28	28 / 28	Not reported / Not reported
Part 2 PTCL Participants with peripheral T-cell lymphoma (PTCL) received alisertib 50 mg ECT, orally, BID for 7 days followed by a 14-day recovery period in 21-day cycles, until disease progression or unacceptable alisertib-related toxicity (up to 2 cycles).	2 / 2	2 / 2	Not reported / Not reported

Group identifiers: EG000: Part 1 PIC Dose Escalation · EG001: Part 1 ECT Dose Escalation · EG002: Part 2 PTCL

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
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA version 14.0
stats
group Id
EG000
num Affected
2
num At Risk
28
num Events
2
group Id
EG001
num Affected
0
num At Risk
28
num Events
0
group Id
EG002
num Affected
0
num At Risk
2
num Events
0
term
Musculoskeletal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA version 14.0
stats
group Id
EG000
num Affected
1
num At Risk
28
num Events
1
group Id
EG001
num Affected
1
num At Risk
28
num Events
2
group Id
EG002
num Affected
0
num At Risk
2
num Events
0
term
Back pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA version 14.0
stats
group Id
EG000
num Affected
1
num At Risk
28
num Events
1
group Id
EG001
num Affected
0
num At Risk
28
num Events
0
group Id
EG002
num Affected
0
num At Risk
2
num Events
0
term
Flank pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA version 14.0
stats
group Id
EG000
num Affected
1
num At Risk
28
num Events
1
group Id
EG001
num Affected
0
num At Risk
28
num Events
0
group Id
EG002
num Affected
0
num At Risk
2
num Events
0
term
Pathological fracture
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 14.0
stats
group Id
EG000
num Affected
1
num At Risk
28
num Events
1
group Id
EG001
num Affected
4
num At Risk
28
num Events
5
group Id
EG002
num Affected
0
num At Risk
2
num Events
0
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 14.0
stats
group Id
EG000
num Affected
1
num At Risk
28
num Events
1
group Id
EG001
num Affected
1
num At Risk
28
num Events
1
group Id
EG002
num Affected
0
num At Risk
2
num Events
0
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA version 14.0
stats
group Id
EG000
num Affected
1
num At Risk
28
num Events
1
group Id
EG001
num Affected
1
num At Risk
28
num Events
1
group Id
EG002
num Affected
0
num At Risk
2
num Events
0
term
Septic shock
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA version 14.0
stats
group Id
EG000
num Affected
1
num At Risk
28
num Events
1
group Id
EG001
num Affected
0
num At Risk
28
num Events
0
group Id
EG002
num Affected
0
num At Risk
2
num Events
0
term
Staphylococcal infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA version 14.0
stats
group Id
EG000
num Affected
1
num At Risk
28
num Events
1
group Id
EG001
num Affected
0
num At Risk
28
num Events
0
group Id
EG002
num Affected
0
num At Risk
2
num Events
0
term
Urinary tract infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA version 14.0
stats
group Id
EG000
num Affected
1
num At Risk
28
num Events
1
group Id
EG001
num Affected
0
num At Risk
28
num Events
0
group Id
EG002
num Affected
0
num At Risk
2
num Events
0
term
Dyspnoea
assessment Type
SYSTEMATIC_ASSESSMENT
notes
One treatment-emergent death occurred during treatment with alisertib 65 mg and was not related.
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA version 14.0
stats
group Id
EG000
num Affected
1
num At Risk
28
num Events
1
group Id
EG001
num Affected
0
num At Risk
28
num Events
0
group Id
EG002
num Affected
0
num At Risk
2
num Events
0
term
Obstructive airways disorder
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 14.0
stats
group Id
EG000
num Affected
1
num At Risk
28
num Events
1
group Id
EG001
num Affected
0
num At Risk
28
num Events
0
group Id
EG002
num Affected
0
num At Risk
2
num Events
0
term
Constipation

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 version 14.0
stats
group Id
EG000
num Affected
13
num At Risk
28
num Events
21
group Id
EG001
num Affected
18
num At Risk
28
num Events
35
group Id
EG002
num Affected
2
num At Risk
2
num Events
4
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 14.0
stats
group Id
EG000
num Affected
11
num At Risk
28
num Events
14
group Id
EG001
num Affected
13
num At Risk
28
num Events
16
group Id
EG002
num Affected
2
num At Risk
2
num Events
3
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 14.0
stats
group Id
EG000
num Affected
11
num At Risk
28
num Events
15
group Id
EG001
num Affected
12
num At Risk
28
num Events
18
group Id
EG002
num Affected
2
num At Risk
2
num Events
5
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 14.0
stats
group Id
EG000
num Affected
4
num At Risk
28
num Events
7
group Id
EG001
num Affected
11
num At Risk
28
num Events
22
group Id
EG002
num Affected
0
num At Risk
2
num Events
0
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 14.0
stats
group Id
EG000
num Affected
2
num At Risk
28
num Events
3
group Id
EG001
num Affected
6
num At Risk
28
num Events
9
group Id
EG002
num Affected
0
num At Risk
2
num Events
0
term
Lymphopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 14.0
stats
group Id
EG000
num Affected
0
num At Risk
28
num Events
0
group Id
EG001
num Affected
0
num At Risk
28
num Events
0
group Id
EG002
num Affected
1
num At Risk
2
num Events
1
term
Leukocytosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 14.0
stats
group Id
EG000
num Affected
0
num At Risk
28
num Events
0
group Id
EG001
num Affected
0
num At Risk
28
num Events
0
group Id
EG002
num Affected
1
num At Risk
2
num Events
1
term
Splenomegaly
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 14.0
stats
group Id
EG000
num Affected
9
num At Risk
28
num Events
12
group Id
EG001
num Affected
14
num At Risk
28
num Events
20
group Id
EG002
num Affected
1
num At Risk
2
num Events
1
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 14.0
stats
group Id
EG000
num Affected
11
num At Risk
28
num Events
13
group Id
EG001
num Affected
9
num At Risk
28
num Events
10
group Id
EG002
num Affected
0
num At Risk
2
num Events
0
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 14.0
stats
group Id
EG000
num Affected
6
num At Risk
28
num Events
7
group Id
EG001
num Affected
6
num At Risk
28
num Events
8
group Id
EG002
num Affected
0
num At Risk
2
num Events
0
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 14.0
stats
group Id
EG000
num Affected
2
num At Risk
28
num Events
2
group Id
EG001
num Affected
5
num At Risk
28
num Events
5
group Id
EG002
num Affected
2
num At Risk
2
num Events
2
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 14.0
stats
group Id
EG000
num Affected
3
num At Risk
28
num Events
3
group Id
EG001
num Affected
2
num At Risk
28
num Events
2
group Id
EG002
num Affected
2
num At Risk
2
num Events
2
term
Stomatitis

Complete source fields

description

event Groups

description
Alisertib 25 or 35 mg, Powder-in-Capsule (PIC) formulation, orally, once daily (QD) for 21 days followed by a 7-day recovery period in 28-day cycles or alisertib 35, 45, 65 or 90 mg PIC, orally, QD for 14 days followed by a 14-day recovery period in 28-day cycles, until disease progression or unacceptable alisertib-related toxicity (up to 14 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose), followed by their respective dosage assignment.
id
EG000
other Num Affected
28
other Num At Risk
28
serious Num Affected
12
serious Num At Risk
28
title
Part 1 PIC Dose Escalation
description
Alisertib 40 mg, Enteric-coated Tablet (ECT) formulation, orally, QD for 14 days followed by a 14-day recovery period in 28-day cycles, or alisertib 30, 40 or 50 mg ECT, orally BID for 7 days followed by a 14-day recovery period in 21-day cycles, until disease progression or unacceptable alisertib-related toxicity (up to 15 cycles).
id
EG001
other Num Affected
28
other Num At Risk
28
serious Num Affected
15
serious Num At Risk
28
title
Part 1 ECT Dose Escalation
description
Participants with peripheral T-cell lymphoma (PTCL) received alisertib 50 mg ECT, orally, BID for 7 days followed by a 14-day recovery period in 21-day cycles, until disease progression or unacceptable alisertib-related toxicity (up to 2 cycles).
id
EG002
other Num Affected
2
other Num At Risk
2
serious Num Affected
2
serious Num At Risk
2
title
Part 2 PTCL

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 14.0
stats
group Id
EG000
num Affected
13
num At Risk
28
num Events
21
group Id
EG001
num Affected
18
num At Risk
28
num Events
35
group Id
EG002
num Affected
2
num At Risk
2
num Events
4
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 14.0
stats
group Id
EG000
num Affected
11
num At Risk
28
num Events
14
group Id
EG001
num Affected
13
num At Risk
28
num Events
16
group Id
EG002
num Affected
2
num At Risk
2
num Events
3
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 14.0
stats
group Id
EG000
num Affected
11
num At Risk
28
num Events
15
group Id
EG001
num Affected
12
num At Risk
28
num Events
18
group Id
EG002
num Affected
2
num At Risk
2
num Events
5
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 14.0
stats
group Id
EG000
num Affected
4
num At Risk
28
num Events
7
group Id
EG001
num Affected
11
num At Risk
28
num Events
22
group Id
EG002
num Affected
0
num At Risk
2
num Events
0
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 14.0
stats
group Id
EG000
num Affected
2
num At Risk
28
num Events
3
group Id
EG001
num Affected
6
num At Risk
28
num Events
9
group Id
EG002
num Affected
0
num At Risk
2
num Events
0
term
Lymphopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 14.0
stats
group Id
EG000
num Affected
0
num At Risk
28
num Events
0
group Id
EG001
num Affected
0
num At Risk
28
num Events
0
group Id
EG002
num Affected
1
num At Risk
2
num Events
1
term
Leukocytosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 14.0
stats
group Id
EG000
num Affected
0
num At Risk
28
num Events
0
group Id
EG001
num Affected
0
num At Risk
28
num Events
0
group Id
EG002
num Affected
1
num At Risk
2
num Events
1
term
Splenomegaly
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 14.0
stats
group Id
EG000
num Affected
9
num At Risk
28
num Events
12
group Id
EG001
num Affected
14
num At Risk
28
num Events
20
group Id
EG002
num Affected
1
num At Risk
2
num Events
1
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 14.0
stats
group Id
EG000
num Affected
11
num At Risk
28
num Events
13
group Id
EG001
num Affected
9
num At Risk
28
num Events
10
group Id
EG002
num Affected
0
num At Risk
2
num Events
0
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 14.0
stats
group Id
EG000
num Affected
6
num At Risk
28
num Events
7
group Id
EG001
num Affected
6
num At Risk
28
num Events
8
group Id
EG002
num Affected
0
num At Risk
2
num Events
0
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 14.0
stats
group Id
EG000
num Affected
2
num At Risk
28
num Events
2
group Id
EG001
num Affected
5
num At Risk
28
num Events
5
group Id
EG002
num Affected
2
num At Risk
2
num Events
2
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 14.0
stats
group Id
EG000
num Affected
3
num At Risk
28
num Events
3
group Id
EG001
num Affected
2
num At Risk
28
num Events
2
group Id
EG002
num Affected
2
num At Risk
2
num Events
2
term
Stomatitis

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA version 14.0
stats
group Id
EG000
num Affected
2
num At Risk
28
num Events
2
group Id
EG001
num Affected
0
num At Risk
28
num Events
0
group Id
EG002
num Affected
0
num At Risk
2
num Events
0
term
Musculoskeletal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA version 14.0
stats
group Id
EG000
num Affected
1
num At Risk
28
num Events
1
group Id
EG001
num Affected
1
num At Risk
28
num Events
2
group Id
EG002
num Affected
0
num At Risk
2
num Events
0
term
Back pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA version 14.0
stats
group Id
EG000
num Affected
1
num At Risk
28
num Events
1
group Id
EG001
num Affected
0
num At Risk
28
num Events
0
group Id
EG002
num Affected
0
num At Risk
2
num Events
0
term
Flank pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA version 14.0
stats
group Id
EG000
num Affected
1
num At Risk
28
num Events
1
group Id
EG001
num Affected
0
num At Risk
28
num Events
0
group Id
EG002
num Affected
0
num At Risk
2
num Events
0
term
Pathological fracture
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 14.0
stats
group Id
EG000
num Affected
1
num At Risk
28
num Events
1
group Id
EG001
num Affected
4
num At Risk
28
num Events
5
group Id
EG002
num Affected
0
num At Risk
2
num Events
0
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 14.0
stats
group Id
EG000
num Affected
1
num At Risk
28
num Events
1
group Id
EG001
num Affected
1
num At Risk
28
num Events
1
group Id
EG002
num Affected
0
num At Risk
2
num Events
0
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA version 14.0
stats
group Id
EG000
num Affected
1
num At Risk
28
num Events
1
group Id
EG001
num Affected
1
num At Risk
28
num Events
1
group Id
EG002
num Affected
0
num At Risk
2
num Events
0
term
Septic shock
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA version 14.0
stats
group Id
EG000
num Affected
1
num At Risk
28
num Events
1
group Id
EG001
num Affected
0
num At Risk
28
num Events
0
group Id
EG002
num Affected
0
num At Risk
2
num Events
0
term
Staphylococcal infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA version 14.0
stats
group Id
EG000
num Affected
1
num At Risk
28
num Events
1
group Id
EG001
num Affected
0
num At Risk
28
num Events
0
group Id
EG002
num Affected
0
num At Risk
2
num Events
0
term
Urinary tract infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA version 14.0
stats
group Id
EG000
num Affected
1
num At Risk
28
num Events
1
group Id
EG001
num Affected
0
num At Risk
28
num Events
0
group Id
EG002
num Affected
0
num At Risk
2
num Events
0
term
Dyspnoea
assessment Type
SYSTEMATIC_ASSESSMENT
notes
One treatment-emergent death occurred during treatment with alisertib 65 mg and was not related.
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA version 14.0
stats
group Id
EG000
num Affected
1
num At Risk
28
num Events
1
group Id
EG001
num Affected
0
num At Risk
28
num Events
0
group Id
EG002
num Affected
0
num At Risk
2
num Events
0
term
Obstructive airways disorder
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 14.0
stats
group Id
EG000
num Affected
1
num At Risk
28
num Events
1
group Id
EG001
num Affected
0
num At Risk
28
num Events
0
group Id
EG002
num Affected
0
num At Risk
2
num Events
0
term
Constipation

time Frame

From first dose of study drug to 30 days after the last dose (up to 422 days)

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice