NCT00903968 · ADVERSE EVENTS

Adverse events

Combination Plerixafor (AMD3100)and Bortezomib in Relapsed or Relapsed/Refractory Multiple Myeloma · Source last updated 2020-06-02

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: Assessed each treatment cycle from time of first dose and up to day 30 post treatment.
Other-event reporting threshold: 0%

Maximum grade toxicity by type was first calculated. Serius AEs were defined as events with plerixafor, bortezomib and/or dexamethasone (phase II only) treatment-attribution of at least possibly and grade 3 or higher per CTCAE v. 3.0. Other AEs were defined as events with plerixafor, bortezomib and/or dexamethasone (phase II only) treatment-attribution of at least possibly and grades 1 or 2 per CTCAE v. 3.0.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Phase I Dose Level 1 Phase I Dose Level 1 patients received plerixafor 160ug/kg by injection on days 1-6 and bortezomib 1.0 mg/m2 intravenously days 3, 6, 10, and 13 of each 21 day cycle until disease progression or unacceptable toxicity.	1 / 3	3 / 3	Not reported / Not reported
Phase I Dose Level 2 Phase I Dose Level 2 patients received plerixafor 160ug/kg by injection on days 1-6 and bortezomib 1.3 mg/m2 intravenously days 3, 6, 10, and 13 of each 21 day cycle until disease progression or unacceptable toxicity.	1 / 3	3 / 3	Not reported / Not reported
Phase I Dose Level 3 Phase I Dose Level 3 patients received plerixafor 240ug/kg by injection on days 1-6 and bortezomib 1.0 mg/m2 intravenously days 3, 6, 10, and 13 of each 21 day cycle until disease progression or unacceptable toxicity.	0 / 3	3 / 3	Not reported / Not reported
Phase I Dose Level 4 Phase I Dose Level 4 patients received plerixafor 240ug/kg by injection on days 1-6 and bortezomib 1.3 mg/m2 intravenously days 3, 6, 10, and 13 of each 21 day cycle until disease progression or unacceptable toxicity.	2 / 3	3 / 3	Not reported / Not reported
Phase I Dose Level 5 Phase I Dose Level 5 patients received plerixafor 320ug/kg by injection on days 1-6 and bortezomib 1.3 mg/m2 intravenously days 3, 6, 10, and 13 of each 21 day cycle until disease progression or unacceptable toxicity.	2 / 4	4 / 4	Not reported / Not reported
Phase I Dose Level 5B Phase I Dose Level 5B patients received plerixafor 320ug/kg by injection on days 1, 2, 3, 6, 10, and 13 and bortezomib 1.3 mg/m2 intravenously days 3, 6, 10, and 13 of each 21 day cycle until disease progression or unacceptable toxicity.	2 / 6	6 / 6	Not reported / Not reported
Phase I Dose Level 6 Phase I Dose Level 6 patients received plerixafor 400ug/kg by injection on days 1, 2, 3, 6, 10, and 13 and bortezomib 1.3 mg/m2 intravenously days 3, 6, 10, and 13 of each 21 day cycle until disease progression or unacceptable toxicity.	0 / 3	3 / 3	Not reported / Not reported
All Phase I Participants All Phase I participants received plerixafor by injection and bortezomib intravenously according to the established dose escalation schedule. Participants were treated until disease progression or unacceptable toxicity.	8 / 25	25 / 25	Not reported / Not reported
All Phase II Participants All Phase II participants received plerixafor 320ug/kg by injection on days 1, 2, 3, 6, 10, and 13, bortezomib 1.3 mg/m2 intravenously or subcutaneously days 3, 6, 10, and 13, and dexamethasone 40mg orally days 3, 6, 10, and 13 of each 21 day cycle during induction. In maintenance, participants received plerixafor, bortezomib, and dexamethasone days 1, 8, 15, and 22 of each 35 day cycle. Participants were treated until disease progression or unacceptable toxicity.	14 / 33	33 / 33	Not reported / Not reported

Group identifiers: EG000: Phase I Dose Level 1 · EG001: Phase I Dose Level 2 · EG002: Phase I Dose Level 3 · EG003: Phase I Dose Level 4 · EG004: Phase I Dose Level 5 · EG005: Phase I Dose Level 5B · EG006: Phase I Dose Level 6 · EG007: All Phase I Participants · EG008: All Phase II 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
General disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
4
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
3
group Id
EG007
num Affected
0
num At Risk
25
group Id
EG008
num Affected
1
num At Risk
33
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
4
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
3
group Id
EG007
num Affected
0
num At Risk
25
group Id
EG008
num Affected
2
num At Risk
33
term
Insomnia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
1
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
1
num At Risk
4
group Id
EG005
num Affected
1
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
3
group Id
EG007
num Affected
3
num At Risk
25
group Id
EG008
num Affected
3
num At Risk
33
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
3
group Id
EG001
num Affected
1
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
1
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
4
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
3
group Id
EG007
num Affected
3
num At Risk
25
group Id
EG008
num Affected
3
num At Risk
33
term
Lymphocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
4
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
3
group Id
EG007
num Affected
0
num At Risk
25
group Id
EG008
num Affected
1
num At Risk
33
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
1
num At Risk
4
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
3
group Id
EG007
num Affected
1
num At Risk
25
group Id
EG008
num Affected
8
num At Risk
33
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
4
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
3
group Id
EG007
num Affected
0
num At Risk
25
group Id
EG008
num Affected
3
num At Risk
33
term
Upper airway infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
4
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
3
group Id
EG007
num Affected
0
num At Risk
25
group Id
EG008
num Affected
1
num At Risk
33
term
Elevated liver function tests
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
4
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
3
group Id
EG007
num Affected
0
num At Risk
25
group Id
EG008
num Affected
1
num At Risk
33
term
Hyperglycemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
4
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
3
group Id
EG007
num Affected
0
num At Risk
25
group Id
EG008
num Affected
1
num At Risk
33
term
Hyperlipasemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
4
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
3
group Id
EG007
num Affected
0
num At Risk
25
group Id
EG008
num Affected
1
num At Risk
33
term
Hyponatremia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
1
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
4
group Id
EG005
num Affected
1
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
3
group Id
EG007
num Affected
2
num At Risk
25
group Id
EG008
num Affected
0
num At Risk
33
term
Hypophosphatemia

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
Immune system disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
2
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
4
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
3
group Id
EG007
num Affected
3
num At Risk
25
group Id
EG008
num Affected
1
num At Risk
33
term
Allergic reaction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Immune system disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
1
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
4
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
3
group Id
EG007
num Affected
1
num At Risk
25
group Id
EG008
num Affected
0
num At Risk
33
term
Allergic rhinitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Immune system disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
1
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
4
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
3
group Id
EG007
num Affected
1
num At Risk
25
group Id
EG008
num Affected
0
num At Risk
33
term
Allergy-other
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
4
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
3
group Id
EG007
num Affected
0
num At Risk
25
group Id
EG008
num Affected
1
num At Risk
33
term
Hearing w/o audiogr not in monitor prg
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
4
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
3
group Id
EG007
num Affected
0
num At Risk
25
group Id
EG008
num Affected
1
num At Risk
33
term
Hematologic-other
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
4
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
3
group Id
EG007
num Affected
0
num At Risk
25
group Id
EG008
num Affected
3
num At Risk
33
term
Cardiac-other
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
4
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
3
group Id
EG007
num Affected
0
num At Risk
25
group Id
EG008
num Affected
3
num At Risk
33
term
Hypertension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
4
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
3
group Id
EG007
num Affected
0
num At Risk
25
group Id
EG008
num Affected
2
num At Risk
33
term
Hypotension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
4
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
3
group Id
EG007
num Affected
0
num At Risk
25
group Id
EG008
num Affected
3
num At Risk
33
term
Constitutional- other
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
3
num At Risk
3
group Id
EG001
num Affected
3
num At Risk
3
group Id
EG002
num Affected
1
num At Risk
3
group Id
EG003
num Affected
2
num At Risk
3
group Id
EG004
num Affected
4
num At Risk
4
group Id
EG005
num Affected
5
num At Risk
6
group Id
EG006
num Affected
3
num At Risk
3
group Id
EG007
num Affected
21
num At Risk
25
group Id
EG008
num Affected
18
num At Risk
33
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
1
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
4
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
3
group Id
EG007
num Affected
1
num At Risk
25
group Id
EG008
num Affected
3
num At Risk
33
term
Fever w/o neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
2
num At Risk
3
group Id
EG001
num Affected
1
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
1
num At Risk
4
group Id
EG005
num Affected
1
num At Risk
6
group Id
EG006
num Affected
2
num At Risk
3
group Id
EG007
num Affected
7
num At Risk
25
group Id
EG008
num Affected
13
num At Risk
33
term
Insomnia

Complete source fields

description

event Groups

description
Phase I Dose Level 1 patients received plerixafor 160ug/kg by injection on days 1-6 and bortezomib 1.0 mg/m2 intravenously days 3, 6, 10, and 13 of each 21 day cycle until disease progression or unacceptable toxicity.
id
EG000
other Num Affected
3
other Num At Risk
3
serious Num Affected
1
serious Num At Risk
3
title
Phase I Dose Level 1
description
Phase I Dose Level 2 patients received plerixafor 160ug/kg by injection on days 1-6 and bortezomib 1.3 mg/m2 intravenously days 3, 6, 10, and 13 of each 21 day cycle until disease progression or unacceptable toxicity.
id
EG001
other Num Affected
3
other Num At Risk
3
serious Num Affected
1
serious Num At Risk
3
title
Phase I Dose Level 2
description
Phase I Dose Level 3 patients received plerixafor 240ug/kg by injection on days 1-6 and bortezomib 1.0 mg/m2 intravenously days 3, 6, 10, and 13 of each 21 day cycle until disease progression or unacceptable toxicity.
id
EG002
other Num Affected
3
other Num At Risk
3
serious Num Affected
0
serious Num At Risk
3
title
Phase I Dose Level 3
description
Phase I Dose Level 4 patients received plerixafor 240ug/kg by injection on days 1-6 and bortezomib 1.3 mg/m2 intravenously days 3, 6, 10, and 13 of each 21 day cycle until disease progression or unacceptable toxicity.
id
EG003
other Num Affected
3
other Num At Risk
3
serious Num Affected
2
serious Num At Risk
3
title
Phase I Dose Level 4
description
Phase I Dose Level 5 patients received plerixafor 320ug/kg by injection on days 1-6 and bortezomib 1.3 mg/m2 intravenously days 3, 6, 10, and 13 of each 21 day cycle until disease progression or unacceptable toxicity.
id
EG004
other Num Affected
4
other Num At Risk
4
serious Num Affected
2
serious Num At Risk
4
title
Phase I Dose Level 5
description
Phase I Dose Level 5B patients received plerixafor 320ug/kg by injection on days 1, 2, 3, 6, 10, and 13 and bortezomib 1.3 mg/m2 intravenously days 3, 6, 10, and 13 of each 21 day cycle until disease progression or unacceptable toxicity.
id
EG005
other Num Affected
6
other Num At Risk
6
serious Num Affected
2
serious Num At Risk
6
title
Phase I Dose Level 5B
description
Phase I Dose Level 6 patients received plerixafor 400ug/kg by injection on days 1, 2, 3, 6, 10, and 13 and bortezomib 1.3 mg/m2 intravenously days 3, 6, 10, and 13 of each 21 day cycle until disease progression or unacceptable toxicity.
id
EG006
other Num Affected
3
other Num At Risk
3
serious Num Affected
0
serious Num At Risk
3
title
Phase I Dose Level 6
description
All Phase I participants received plerixafor by injection and bortezomib intravenously according to the established dose escalation schedule. Participants were treated until disease progression or unacceptable toxicity.
id
EG007
other Num Affected
25
other Num At Risk
25
serious Num Affected
8
serious Num At Risk
25
title
All Phase I Participants
description
All Phase II participants received plerixafor 320ug/kg by injection on days 1, 2, 3, 6, 10, and 13, bortezomib 1.3 mg/m2 intravenously or subcutaneously days 3, 6, 10, and 13, and dexamethasone 40mg orally days 3, 6, 10, and 13 of each 21 day cycle during induction. In maintenance, participants received plerixafor, bortezomib, and dexamethasone days 1, 8, 15, and 22 of each 35 day cycle. Participants were treated until disease progression or unacceptable toxicity.
id
EG008
other Num Affected
33
other Num At Risk
33
serious Num Affected
14
serious Num At Risk
33
title
All Phase II Participants

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Immune system disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
2
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
4
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
3
group Id
EG007
num Affected
3
num At Risk
25
group Id
EG008
num Affected
1
num At Risk
33
term
Allergic reaction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Immune system disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
1
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
4
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
3
group Id
EG007
num Affected
1
num At Risk
25
group Id
EG008
num Affected
0
num At Risk
33
term
Allergic rhinitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Immune system disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
1
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
4
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
3
group Id
EG007
num Affected
1
num At Risk
25
group Id
EG008
num Affected
0
num At Risk
33
term
Allergy-other
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
4
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
3
group Id
EG007
num Affected
0
num At Risk
25
group Id
EG008
num Affected
1
num At Risk
33
term
Hearing w/o audiogr not in monitor prg
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
4
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
3
group Id
EG007
num Affected
0
num At Risk
25
group Id
EG008
num Affected
1
num At Risk
33
term
Hematologic-other
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
4
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
3
group Id
EG007
num Affected
0
num At Risk
25
group Id
EG008
num Affected
3
num At Risk
33
term
Cardiac-other
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
4
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
3
group Id
EG007
num Affected
0
num At Risk
25
group Id
EG008
num Affected
3
num At Risk
33
term
Hypertension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
4
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
3
group Id
EG007
num Affected
0
num At Risk
25
group Id
EG008
num Affected
2
num At Risk
33
term
Hypotension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
4
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
3
group Id
EG007
num Affected
0
num At Risk
25
group Id
EG008
num Affected
3
num At Risk
33
term
Constitutional- other
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
3
num At Risk
3
group Id
EG001
num Affected
3
num At Risk
3
group Id
EG002
num Affected
1
num At Risk
3
group Id
EG003
num Affected
2
num At Risk
3
group Id
EG004
num Affected
4
num At Risk
4
group Id
EG005
num Affected
5
num At Risk
6
group Id
EG006
num Affected
3
num At Risk
3
group Id
EG007
num Affected
21
num At Risk
25
group Id
EG008
num Affected
18
num At Risk
33
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
1
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
4
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
3
group Id
EG007
num Affected
1
num At Risk
25
group Id
EG008
num Affected
3
num At Risk
33
term
Fever w/o neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
2
num At Risk
3
group Id
EG001
num Affected
1
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
1
num At Risk
4
group Id
EG005
num Affected
1
num At Risk
6
group Id
EG006
num Affected
2
num At Risk
3
group Id
EG007
num Affected
7
num At Risk
25
group Id
EG008
num Affected
13
num At Risk
33
term
Insomnia

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
4
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
3
group Id
EG007
num Affected
0
num At Risk
25
group Id
EG008
num Affected
1
num At Risk
33
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
4
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
3
group Id
EG007
num Affected
0
num At Risk
25
group Id
EG008
num Affected
2
num At Risk
33
term
Insomnia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
1
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
1
num At Risk
4
group Id
EG005
num Affected
1
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
3
group Id
EG007
num Affected
3
num At Risk
25
group Id
EG008
num Affected
3
num At Risk
33
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
3
group Id
EG001
num Affected
1
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
1
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
4
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
3
group Id
EG007
num Affected
3
num At Risk
25
group Id
EG008
num Affected
3
num At Risk
33
term
Lymphocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
4
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
3
group Id
EG007
num Affected
0
num At Risk
25
group Id
EG008
num Affected
1
num At Risk
33
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
1
num At Risk
4
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
3
group Id
EG007
num Affected
1
num At Risk
25
group Id
EG008
num Affected
8
num At Risk
33
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
4
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
3
group Id
EG007
num Affected
0
num At Risk
25
group Id
EG008
num Affected
3
num At Risk
33
term
Upper airway infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
4
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
3
group Id
EG007
num Affected
0
num At Risk
25
group Id
EG008
num Affected
1
num At Risk
33
term
Elevated liver function tests
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
4
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
3
group Id
EG007
num Affected
0
num At Risk
25
group Id
EG008
num Affected
1
num At Risk
33
term
Hyperglycemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
4
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
3
group Id
EG007
num Affected
0
num At Risk
25
group Id
EG008
num Affected
1
num At Risk
33
term
Hyperlipasemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
0
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
4
group Id
EG005
num Affected
0
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
3
group Id
EG007
num Affected
0
num At Risk
25
group Id
EG008
num Affected
1
num At Risk
33
term
Hyponatremia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
3
group Id
EG002
num Affected
0
num At Risk
3
group Id
EG003
num Affected
1
num At Risk
3
group Id
EG004
num Affected
0
num At Risk
4
group Id
EG005
num Affected
1
num At Risk
6
group Id
EG006
num Affected
0
num At Risk
3
group Id
EG007
num Affected
2
num At Risk
25
group Id
EG008
num Affected
0
num At Risk
33
term
Hypophosphatemia

time Frame

Assessed each treatment cycle from time of first dose and up to day 30 post treatment.

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Preserved source evidence · Not medical advice