NCT00450814 · ADVERSE EVENTS

Adverse events

Vaccine Therapy With or Without Cyclophosphamide in Treating Patients With Recurrent or Refractory Multiple Myeloma · Source last updated 2019-12-16

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: Up to 1 year
Other-event reporting threshold: 0%

Only patients who received at least 1 cycle of treatment and submitted AE data are summarized below. Each CTCAE term is a specific event used for medical documentation \& is a single MedDRA Lowest Level Term (LLT). Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table. Phase II Cohort A and B combined as they received the same treatment.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Phase I: Stage 1 (MV-NIS Alone) Dose Level 1 Patients receive 1x10\^6 MV-NIS (TCID50) IV over 1 hour on day 1.	2 / 3	3 / 3	2 / 3
Phase I: Stage 1 (MV-NIS Alone) Dose Level 2 Patients receive 1x10\^7 MV-NIS (TCID50) IV over 1 hour on day 1.	0 / 3	3 / 3	2 / 3
Phase I: Stage 1 (MV-NIS Alone) Dose Level 3 Patients receive 1x10\^8 MV-NIS (TCID50) IV over 1 hour on day 1.	0 / 3	3 / 3	2 / 3
Phase I: Stage 1 (MV-NIS Alone) Dose Level 4 Patients receive 1x10\^9 MV-NIS (TCID50) IV over 1 hour on day 1.	1 / 4	3 / 4	2 / 4
Phase I: Stage 1 (MV-NIS Alone) Dose Level 5 Patients receive 1x10\^10 MV-NIS (TCID50) IV over 1 hour on day 1.	1 / 4	4 / 4	3 / 4
Phase I: Stage 1 (MV-NIS Alone) Dose Level 6 Patients receive 1x10\^11 MV-NIS (TCID50) IV over 1 hour on day 1.	1 / 7	7 / 7	5 / 7
Phase I: Stage 2 (MV-NIS and Cyclophosphamide) Dose Level 1 Patients receive 10 mg/kg cyclophosphamide IV over 30 minutes and then (Stage 1 MTD/100=10\^7) MV-NIS (TCID50) IV over 1 hour 2 days later. (Temporarily closed to accrual on 10/13/11)	0 / 3	3 / 3	2 / 3
Phase I: Stage 2 (MV-NIS and Cyclophosphamide) Dose Level 2 Patients receive 10 mg/kg cyclophosphamide IV over 30 minutes and then 3 x 10\^7 MV-NIS (TCID50) IV over 1 hour 2 days later. (Temporarily closed to accrual on 10/13/11)	0 / 3	3 / 3	3 / 3
Phase I: Stage 2 (MV-NIS and Cyclophosphamide) Dose Level 3 Patients receive 10 mg/kg cyclophosphamide IV over 30 minutes and then 9 x 10\^7 MV-NIS (TCID50) IV over 1 hour 2 days later. (Temporarily closed to accrual on 10/13/11)	0 / 2	2 / 2	1 / 2
Phase II (Acetaminophen + Benadryl + MV-NIS) Patients receive 650 mg Acetaminophen and 50 mg Benadryl orally 30 minutes prior to MV-NIS then receive MV-NIS IV over 1 hour on day 1.	1 / 15	15 / 15	6 / 15

Group identifiers: EG000: Phase I: Stage 1 (MV-NIS Alone) Dose Level 1 · EG001: Phase I: Stage 1 (MV-NIS Alone) Dose Level 2 · EG002: Phase I: Stage 1 (MV-NIS Alone) Dose Level 3 · EG003: Phase I: Stage 1 (MV-NIS Alone) Dose Level 4 · EG004: Phase I: Stage 1 (MV-NIS Alone) Dose Level 5 · EG005: Phase I: Stage 1 (MV-NIS Alone) Dose Level 6 · EG006: Phase I: Stage 2 (MV-NIS and Cyclophosphamide) Dose Level 1 · EG007: Phase I: Stage 2 (MV-NIS and Cyclophosphamide) Dose Level 2 · EG008: Phase I: Stage 2 (MV-NIS and Cyclophosphamide) Dose Level 3 · EG009: Phase II (Acetaminophen + Benadryl + MV-NIS)

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 9
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
4
num Events
0
group Id
EG004
num Affected
0
num At Risk
4
num Events
0
group Id
EG005
num Affected
0
num At Risk
7
num Events
0
group Id
EG006
num Affected
0
num At Risk
3
num Events
0
group Id
EG007
num Affected
0
num At Risk
3
num Events
0
group Id
EG008
num Affected
0
num At Risk
2
num Events
0
group Id
EG009
num Affected
1
num At Risk
15
num Events
1
term
Hemoglobin decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
4
num Events
0
group Id
EG004
num Affected
1
num At Risk
4
num Events
1
group Id
EG005
num Affected
0
num At Risk
7
num Events
0
group Id
EG006
num Affected
0
num At Risk
3
num Events
0
group Id
EG007
num Affected
0
num At Risk
3
num Events
0
group Id
EG008
num Affected
0
num At Risk
2
num Events
0
group Id
EG009
num Affected
0
num At Risk
15
num Events
0
term
Restrictive cardiomyopathy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
4
num Events
0
group Id
EG004
num Affected
0
num At Risk
4
num Events
0
group Id
EG005
num Affected
0
num At Risk
7
num Events
0
group Id
EG006
num Affected
0
num At Risk
3
num Events
0
group Id
EG007
num Affected
0
num At Risk
3
num Events
0
group Id
EG008
num Affected
0
num At Risk
2
num Events
0
group Id
EG009
num Affected
0
num At Risk
15
num Events
0
term
Duodenal hemorrhage
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
4
num Events
0
group Id
EG004
num Affected
0
num At Risk
4
num Events
0
group Id
EG005
num Affected
0
num At Risk
7
num Events
0
group Id
EG006
num Affected
0
num At Risk
3
num Events
0
group Id
EG007
num Affected
0
num At Risk
3
num Events
0
group Id
EG008
num Affected
0
num At Risk
2
num Events
0
group Id
EG009
num Affected
0
num At Risk
15
num Events
0
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
4
num Events
0
group Id
EG004
num Affected
0
num At Risk
4
num Events
0
group Id
EG005
num Affected
0
num At Risk
7
num Events
0
group Id
EG006
num Affected
0
num At Risk
3
num Events
0
group Id
EG007
num Affected
0
num At Risk
3
num Events
0
group Id
EG008
num Affected
0
num At Risk
2
num Events
0
group Id
EG009
num Affected
0
num At Risk
15
num Events
0
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
4
num Events
0
group Id
EG004
num Affected
0
num At Risk
4
num Events
0
group Id
EG005
num Affected
0
num At Risk
7
num Events
0
group Id
EG006
num Affected
0
num At Risk
3
num Events
0
group Id
EG007
num Affected
0
num At Risk
3
num Events
0
group Id
EG008
num Affected
0
num At Risk
2
num Events
0
group Id
EG009
num Affected
0
num At Risk
15
num Events
0
term
Fever
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
4
num Events
0
group Id
EG004
num Affected
0
num At Risk
4
num Events
0
group Id
EG005
num Affected
1
num At Risk
7
num Events
1
group Id
EG006
num Affected
0
num At Risk
3
num Events
0
group Id
EG007
num Affected
0
num At Risk
3
num Events
0
group Id
EG008
num Affected
0
num At Risk
2
num Events
0
group Id
EG009
num Affected
0
num At Risk
15
num Events
0
term
Neutrophil count decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
4
num Events
0
group Id
EG004
num Affected
1
num At Risk
4
num Events
1
group Id
EG005
num Affected
0
num At Risk
7
num Events
0
group Id
EG006
num Affected
0
num At Risk
3
num Events
0
group Id
EG007
num Affected
0
num At Risk
3
num Events
0
group Id
EG008
num Affected
0
num At Risk
2
num Events
0
group Id
EG009
num Affected
0
num At Risk
15
num Events
0
term
Platelet count decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
4
num Events
0
group Id
EG004
num Affected
0
num At Risk
4
num Events
0
group Id
EG005
num Affected
0
num At Risk
7
num Events
0
group Id
EG006
num Affected
0
num At Risk
3
num Events
0
group Id
EG007
num Affected
0
num At Risk
3
num Events
0
group Id
EG008
num Affected
0
num At Risk
2
num Events
0
group Id
EG009
num Affected
0
num At Risk
15
num Events
0
term
Dehydration
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
1
num At Risk
4
num Events
1
group Id
EG004
num Affected
0
num At Risk
4
num Events
0
group Id
EG005
num Affected
0
num At Risk
7
num Events
0
group Id
EG006
num Affected
0
num At Risk
3
num Events
0
group Id
EG007
num Affected
0
num At Risk
3
num Events
0
group Id
EG008
num Affected
0
num At Risk
2
num Events
0
group Id
EG009
num Affected
0
num At Risk
15
num Events
0
term
Pneumonitis

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 9
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
4
num Events
0
group Id
EG004
num Affected
0
num At Risk
4
num Events
0
group Id
EG005
num Affected
0
num At Risk
7
num Events
0
group Id
EG006
num Affected
0
num At Risk
3
num Events
0
group Id
EG007
num Affected
0
num At Risk
3
num Events
0
group Id
EG008
num Affected
0
num At Risk
2
num Events
0
group Id
EG009
num Affected
2
num At Risk
15
num Events
2
term
Disseminated intravascular coagulation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
4
num Events
0
group Id
EG004
num Affected
1
num At Risk
4
num Events
1
group Id
EG005
num Affected
1
num At Risk
7
num Events
1
group Id
EG006
num Affected
0
num At Risk
3
num Events
0
group Id
EG007
num Affected
0
num At Risk
3
num Events
0
group Id
EG008
num Affected
0
num At Risk
2
num Events
0
group Id
EG009
num Affected
1
num At Risk
15
num Events
2
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
3
num At Risk
3
num Events
8
group Id
EG001
num Affected
3
num At Risk
3
num Events
10
group Id
EG002
num Affected
3
num At Risk
3
num Events
7
group Id
EG003
num Affected
3
num At Risk
4
num Events
4
group Id
EG004
num Affected
4
num At Risk
4
num Events
7
group Id
EG005
num Affected
7
num At Risk
7
num Events
13
group Id
EG006
num Affected
3
num At Risk
3
num Events
12
group Id
EG007
num Affected
3
num At Risk
3
num Events
10
group Id
EG008
num Affected
2
num At Risk
2
num Events
8
group Id
EG009
num Affected
15
num At Risk
15
num Events
23
term
Hemoglobin decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
4
num Events
0
group Id
EG004
num Affected
0
num At Risk
4
num Events
0
group Id
EG005
num Affected
0
num At Risk
7
num Events
0
group Id
EG006
num Affected
0
num At Risk
3
num Events
0
group Id
EG007
num Affected
0
num At Risk
3
num Events
0
group Id
EG008
num Affected
1
num At Risk
2
num Events
1
group Id
EG009
num Affected
0
num At Risk
15
num Events
0
term
Left ventricular failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
4
num Events
0
group Id
EG004
num Affected
0
num At Risk
4
num Events
0
group Id
EG005
num Affected
0
num At Risk
7
num Events
0
group Id
EG006
num Affected
0
num At Risk
3
num Events
0
group Id
EG007
num Affected
0
num At Risk
3
num Events
0
group Id
EG008
num Affected
0
num At Risk
2
num Events
0
group Id
EG009
num Affected
1
num At Risk
15
num Events
1
term
Sinus bradycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
4
num Events
0
group Id
EG004
num Affected
1
num At Risk
4
num Events
1
group Id
EG005
num Affected
1
num At Risk
7
num Events
1
group Id
EG006
num Affected
0
num At Risk
3
num Events
0
group Id
EG007
num Affected
0
num At Risk
3
num Events
0
group Id
EG008
num Affected
0
num At Risk
2
num Events
0
group Id
EG009
num Affected
1
num At Risk
15
num Events
1
term
Hypothyroidism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
4
num Events
0
group Id
EG004
num Affected
0
num At Risk
4
num Events
0
group Id
EG005
num Affected
1
num At Risk
7
num Events
1
group Id
EG006
num Affected
0
num At Risk
3
num Events
0
group Id
EG007
num Affected
0
num At Risk
3
num Events
0
group Id
EG008
num Affected
0
num At Risk
2
num Events
0
group Id
EG009
num Affected
0
num At Risk
15
num Events
0
term
Photophobia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
1
num At Risk
3
num Events
1
group Id
EG003
num Affected
1
num At Risk
4
num Events
1
group Id
EG004
num Affected
3
num At Risk
4
num Events
4
group Id
EG005
num Affected
3
num At Risk
7
num Events
4
group Id
EG006
num Affected
1
num At Risk
3
num Events
1
group Id
EG007
num Affected
2
num At Risk
3
num Events
2
group Id
EG008
num Affected
1
num At Risk
2
num Events
1
group Id
EG009
num Affected
10
num At Risk
15
num Events
11
term
Diarrhea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
4
num Events
0
group Id
EG004
num Affected
0
num At Risk
4
num Events
0
group Id
EG005
num Affected
0
num At Risk
7
num Events
0
group Id
EG006
num Affected
0
num At Risk
3
num Events
0
group Id
EG007
num Affected
0
num At Risk
3
num Events
0
group Id
EG008
num Affected
0
num At Risk
2
num Events
0
group Id
EG009
num Affected
1
num At Risk
15
num Events
1
term
Ear, nose and throat examination abnormal
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
group Id
EG001
num Affected
2
num At Risk
3
num Events
4
group Id
EG002
num Affected
2
num At Risk
3
num Events
2
group Id
EG003
num Affected
1
num At Risk
4
num Events
1
group Id
EG004
num Affected
3
num At Risk
4
num Events
5
group Id
EG005
num Affected
5
num At Risk
7
num Events
5
group Id
EG006
num Affected
2
num At Risk
3
num Events
2
group Id
EG007
num Affected
3
num At Risk
3
num Events
4
group Id
EG008
num Affected
2
num At Risk
2
num Events
4
group Id
EG009
num Affected
12
num At Risk
15
num Events
14
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
3
num At Risk
3
num Events
4
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
4
num Events
0
group Id
EG004
num Affected
3
num At Risk
4
num Events
3
group Id
EG005
num Affected
2
num At Risk
7
num Events
2
group Id
EG006
num Affected
0
num At Risk
3
num Events
0
group Id
EG007
num Affected
1
num At Risk
3
num Events
1
group Id
EG008
num Affected
0
num At Risk
2
num Events
0
group Id
EG009
num Affected
8
num At Risk
15
num Events
9
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
group Id
EG001
num Affected
2
num At Risk
3
num Events
3
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
1
num At Risk
4
num Events
1
group Id
EG004
num Affected
3
num At Risk
4
num Events
3
group Id
EG005
num Affected
5
num At Risk
7
num Events
5
group Id
EG006
num Affected
1
num At Risk
3
num Events
1
group Id
EG007
num Affected
0
num At Risk
3
num Events
0
group Id
EG008
num Affected
0
num At Risk
2
num Events
0
group Id
EG009
num Affected
11
num At Risk
15
num Events
12
term
Chills

Complete source fields

description

event Groups

deaths Num Affected
2
deaths Num At Risk
3
description
Patients receive 1x10\^6 MV-NIS (TCID50) IV over 1 hour on day 1.
id
EG000
other Num Affected
3
other Num At Risk
3
serious Num Affected
2
serious Num At Risk
3
title
Phase I: Stage 1 (MV-NIS Alone) Dose Level 1
deaths Num Affected
2
deaths Num At Risk
3
description
Patients receive 1x10\^7 MV-NIS (TCID50) IV over 1 hour on day 1.
id
EG001
other Num Affected
3
other Num At Risk
3
serious Num Affected
0
serious Num At Risk
3
title
Phase I: Stage 1 (MV-NIS Alone) Dose Level 2
deaths Num Affected
2
deaths Num At Risk
3
description
Patients receive 1x10\^8 MV-NIS (TCID50) IV over 1 hour on day 1.
id
EG002
other Num Affected
3
other Num At Risk
3
serious Num Affected
0
serious Num At Risk
3
title
Phase I: Stage 1 (MV-NIS Alone) Dose Level 3
deaths Num Affected
2
deaths Num At Risk
4
description
Patients receive 1x10\^9 MV-NIS (TCID50) IV over 1 hour on day 1.
id
EG003
other Num Affected
3
other Num At Risk
4
serious Num Affected
1
serious Num At Risk
4
title
Phase I: Stage 1 (MV-NIS Alone) Dose Level 4
deaths Num Affected
3
deaths Num At Risk
4
description
Patients receive 1x10\^10 MV-NIS (TCID50) IV over 1 hour on day 1.
id
EG004
other Num Affected
4
other Num At Risk
4
serious Num Affected
1
serious Num At Risk
4
title
Phase I: Stage 1 (MV-NIS Alone) Dose Level 5
deaths Num Affected
5
deaths Num At Risk
7
description
Patients receive 1x10\^11 MV-NIS (TCID50) IV over 1 hour on day 1.
id
EG005
other Num Affected
7
other Num At Risk
7
serious Num Affected
1
serious Num At Risk
7
title
Phase I: Stage 1 (MV-NIS Alone) Dose Level 6
deaths Num Affected
2
deaths Num At Risk
3
description
Patients receive 10 mg/kg cyclophosphamide IV over 30 minutes and then (Stage 1 MTD/100=10\^7) MV-NIS (TCID50) IV over 1 hour 2 days later. (Temporarily closed to accrual on 10/13/11)
id
EG006
other Num Affected
3
other Num At Risk
3
serious Num Affected
0
serious Num At Risk
3
title
Phase I: Stage 2 (MV-NIS and Cyclophosphamide) Dose Level 1
deaths Num Affected
3
deaths Num At Risk
3
description
Patients receive 10 mg/kg cyclophosphamide IV over 30 minutes and then 3 x 10\^7 MV-NIS (TCID50) IV over 1 hour 2 days later. (Temporarily closed to accrual on 10/13/11)
id
EG007
other Num Affected
3
other Num At Risk
3
serious Num Affected
0
serious Num At Risk
3
title
Phase I: Stage 2 (MV-NIS and Cyclophosphamide) Dose Level 2
deaths Num Affected
1
deaths Num At Risk
2
description
Patients receive 10 mg/kg cyclophosphamide IV over 30 minutes and then 9 x 10\^7 MV-NIS (TCID50) IV over 1 hour 2 days later. (Temporarily closed to accrual on 10/13/11)
id
EG008
other Num Affected
2
other Num At Risk
2
serious Num Affected
0
serious Num At Risk
2
title
Phase I: Stage 2 (MV-NIS and Cyclophosphamide) Dose Level 3
deaths Num Affected
6
deaths Num At Risk
15
description
Patients receive 650 mg Acetaminophen and 50 mg Benadryl orally 30 minutes prior to MV-NIS then receive MV-NIS IV over 1 hour on day 1.
id
EG009
other Num Affected
15
other Num At Risk
15
serious Num Affected
1
serious Num At Risk
15
title
Phase II (Acetaminophen + Benadryl + MV-NIS)

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
4
num Events
0
group Id
EG004
num Affected
0
num At Risk
4
num Events
0
group Id
EG005
num Affected
0
num At Risk
7
num Events
0
group Id
EG006
num Affected
0
num At Risk
3
num Events
0
group Id
EG007
num Affected
0
num At Risk
3
num Events
0
group Id
EG008
num Affected
0
num At Risk
2
num Events
0
group Id
EG009
num Affected
2
num At Risk
15
num Events
2
term
Disseminated intravascular coagulation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
4
num Events
0
group Id
EG004
num Affected
1
num At Risk
4
num Events
1
group Id
EG005
num Affected
1
num At Risk
7
num Events
1
group Id
EG006
num Affected
0
num At Risk
3
num Events
0
group Id
EG007
num Affected
0
num At Risk
3
num Events
0
group Id
EG008
num Affected
0
num At Risk
2
num Events
0
group Id
EG009
num Affected
1
num At Risk
15
num Events
2
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
3
num At Risk
3
num Events
8
group Id
EG001
num Affected
3
num At Risk
3
num Events
10
group Id
EG002
num Affected
3
num At Risk
3
num Events
7
group Id
EG003
num Affected
3
num At Risk
4
num Events
4
group Id
EG004
num Affected
4
num At Risk
4
num Events
7
group Id
EG005
num Affected
7
num At Risk
7
num Events
13
group Id
EG006
num Affected
3
num At Risk
3
num Events
12
group Id
EG007
num Affected
3
num At Risk
3
num Events
10
group Id
EG008
num Affected
2
num At Risk
2
num Events
8
group Id
EG009
num Affected
15
num At Risk
15
num Events
23
term
Hemoglobin decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
4
num Events
0
group Id
EG004
num Affected
0
num At Risk
4
num Events
0
group Id
EG005
num Affected
0
num At Risk
7
num Events
0
group Id
EG006
num Affected
0
num At Risk
3
num Events
0
group Id
EG007
num Affected
0
num At Risk
3
num Events
0
group Id
EG008
num Affected
1
num At Risk
2
num Events
1
group Id
EG009
num Affected
0
num At Risk
15
num Events
0
term
Left ventricular failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
4
num Events
0
group Id
EG004
num Affected
0
num At Risk
4
num Events
0
group Id
EG005
num Affected
0
num At Risk
7
num Events
0
group Id
EG006
num Affected
0
num At Risk
3
num Events
0
group Id
EG007
num Affected
0
num At Risk
3
num Events
0
group Id
EG008
num Affected
0
num At Risk
2
num Events
0
group Id
EG009
num Affected
1
num At Risk
15
num Events
1
term
Sinus bradycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
4
num Events
0
group Id
EG004
num Affected
1
num At Risk
4
num Events
1
group Id
EG005
num Affected
1
num At Risk
7
num Events
1
group Id
EG006
num Affected
0
num At Risk
3
num Events
0
group Id
EG007
num Affected
0
num At Risk
3
num Events
0
group Id
EG008
num Affected
0
num At Risk
2
num Events
0
group Id
EG009
num Affected
1
num At Risk
15
num Events
1
term
Hypothyroidism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
4
num Events
0
group Id
EG004
num Affected
0
num At Risk
4
num Events
0
group Id
EG005
num Affected
1
num At Risk
7
num Events
1
group Id
EG006
num Affected
0
num At Risk
3
num Events
0
group Id
EG007
num Affected
0
num At Risk
3
num Events
0
group Id
EG008
num Affected
0
num At Risk
2
num Events
0
group Id
EG009
num Affected
0
num At Risk
15
num Events
0
term
Photophobia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
1
num At Risk
3
num Events
1
group Id
EG003
num Affected
1
num At Risk
4
num Events
1
group Id
EG004
num Affected
3
num At Risk
4
num Events
4
group Id
EG005
num Affected
3
num At Risk
7
num Events
4
group Id
EG006
num Affected
1
num At Risk
3
num Events
1
group Id
EG007
num Affected
2
num At Risk
3
num Events
2
group Id
EG008
num Affected
1
num At Risk
2
num Events
1
group Id
EG009
num Affected
10
num At Risk
15
num Events
11
term
Diarrhea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
4
num Events
0
group Id
EG004
num Affected
0
num At Risk
4
num Events
0
group Id
EG005
num Affected
0
num At Risk
7
num Events
0
group Id
EG006
num Affected
0
num At Risk
3
num Events
0
group Id
EG007
num Affected
0
num At Risk
3
num Events
0
group Id
EG008
num Affected
0
num At Risk
2
num Events
0
group Id
EG009
num Affected
1
num At Risk
15
num Events
1
term
Ear, nose and throat examination abnormal
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
group Id
EG001
num Affected
2
num At Risk
3
num Events
4
group Id
EG002
num Affected
2
num At Risk
3
num Events
2
group Id
EG003
num Affected
1
num At Risk
4
num Events
1
group Id
EG004
num Affected
3
num At Risk
4
num Events
5
group Id
EG005
num Affected
5
num At Risk
7
num Events
5
group Id
EG006
num Affected
2
num At Risk
3
num Events
2
group Id
EG007
num Affected
3
num At Risk
3
num Events
4
group Id
EG008
num Affected
2
num At Risk
2
num Events
4
group Id
EG009
num Affected
12
num At Risk
15
num Events
14
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
3
num At Risk
3
num Events
4
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
4
num Events
0
group Id
EG004
num Affected
3
num At Risk
4
num Events
3
group Id
EG005
num Affected
2
num At Risk
7
num Events
2
group Id
EG006
num Affected
0
num At Risk
3
num Events
0
group Id
EG007
num Affected
1
num At Risk
3
num Events
1
group Id
EG008
num Affected
0
num At Risk
2
num Events
0
group Id
EG009
num Affected
8
num At Risk
15
num Events
9
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
group Id
EG001
num Affected
2
num At Risk
3
num Events
3
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
1
num At Risk
4
num Events
1
group Id
EG004
num Affected
3
num At Risk
4
num Events
3
group Id
EG005
num Affected
5
num At Risk
7
num Events
5
group Id
EG006
num Affected
1
num At Risk
3
num Events
1
group Id
EG007
num Affected
0
num At Risk
3
num Events
0
group Id
EG008
num Affected
0
num At Risk
2
num Events
0
group Id
EG009
num Affected
11
num At Risk
15
num Events
12
term
Chills

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
4
num Events
0
group Id
EG004
num Affected
0
num At Risk
4
num Events
0
group Id
EG005
num Affected
0
num At Risk
7
num Events
0
group Id
EG006
num Affected
0
num At Risk
3
num Events
0
group Id
EG007
num Affected
0
num At Risk
3
num Events
0
group Id
EG008
num Affected
0
num At Risk
2
num Events
0
group Id
EG009
num Affected
1
num At Risk
15
num Events
1
term
Hemoglobin decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
4
num Events
0
group Id
EG004
num Affected
1
num At Risk
4
num Events
1
group Id
EG005
num Affected
0
num At Risk
7
num Events
0
group Id
EG006
num Affected
0
num At Risk
3
num Events
0
group Id
EG007
num Affected
0
num At Risk
3
num Events
0
group Id
EG008
num Affected
0
num At Risk
2
num Events
0
group Id
EG009
num Affected
0
num At Risk
15
num Events
0
term
Restrictive cardiomyopathy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
4
num Events
0
group Id
EG004
num Affected
0
num At Risk
4
num Events
0
group Id
EG005
num Affected
0
num At Risk
7
num Events
0
group Id
EG006
num Affected
0
num At Risk
3
num Events
0
group Id
EG007
num Affected
0
num At Risk
3
num Events
0
group Id
EG008
num Affected
0
num At Risk
2
num Events
0
group Id
EG009
num Affected
0
num At Risk
15
num Events
0
term
Duodenal hemorrhage
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
4
num Events
0
group Id
EG004
num Affected
0
num At Risk
4
num Events
0
group Id
EG005
num Affected
0
num At Risk
7
num Events
0
group Id
EG006
num Affected
0
num At Risk
3
num Events
0
group Id
EG007
num Affected
0
num At Risk
3
num Events
0
group Id
EG008
num Affected
0
num At Risk
2
num Events
0
group Id
EG009
num Affected
0
num At Risk
15
num Events
0
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
4
num Events
0
group Id
EG004
num Affected
0
num At Risk
4
num Events
0
group Id
EG005
num Affected
0
num At Risk
7
num Events
0
group Id
EG006
num Affected
0
num At Risk
3
num Events
0
group Id
EG007
num Affected
0
num At Risk
3
num Events
0
group Id
EG008
num Affected
0
num At Risk
2
num Events
0
group Id
EG009
num Affected
0
num At Risk
15
num Events
0
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
4
num Events
0
group Id
EG004
num Affected
0
num At Risk
4
num Events
0
group Id
EG005
num Affected
0
num At Risk
7
num Events
0
group Id
EG006
num Affected
0
num At Risk
3
num Events
0
group Id
EG007
num Affected
0
num At Risk
3
num Events
0
group Id
EG008
num Affected
0
num At Risk
2
num Events
0
group Id
EG009
num Affected
0
num At Risk
15
num Events
0
term
Fever
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
4
num Events
0
group Id
EG004
num Affected
0
num At Risk
4
num Events
0
group Id
EG005
num Affected
1
num At Risk
7
num Events
1
group Id
EG006
num Affected
0
num At Risk
3
num Events
0
group Id
EG007
num Affected
0
num At Risk
3
num Events
0
group Id
EG008
num Affected
0
num At Risk
2
num Events
0
group Id
EG009
num Affected
0
num At Risk
15
num Events
0
term
Neutrophil count decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
4
num Events
0
group Id
EG004
num Affected
1
num At Risk
4
num Events
1
group Id
EG005
num Affected
0
num At Risk
7
num Events
0
group Id
EG006
num Affected
0
num At Risk
3
num Events
0
group Id
EG007
num Affected
0
num At Risk
3
num Events
0
group Id
EG008
num Affected
0
num At Risk
2
num Events
0
group Id
EG009
num Affected
0
num At Risk
15
num Events
0
term
Platelet count decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
4
num Events
0
group Id
EG004
num Affected
0
num At Risk
4
num Events
0
group Id
EG005
num Affected
0
num At Risk
7
num Events
0
group Id
EG006
num Affected
0
num At Risk
3
num Events
0
group Id
EG007
num Affected
0
num At Risk
3
num Events
0
group Id
EG008
num Affected
0
num At Risk
2
num Events
0
group Id
EG009
num Affected
0
num At Risk
15
num Events
0
term
Dehydration
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA 9
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
1
num At Risk
4
num Events
1
group Id
EG004
num Affected
0
num At Risk
4
num Events
0
group Id
EG005
num Affected
0
num At Risk
7
num Events
0
group Id
EG006
num Affected
0
num At Risk
3
num Events
0
group Id
EG007
num Affected
0
num At Risk
3
num Events
0
group Id
EG008
num Affected
0
num At Risk
2
num Events
0
group Id
EG009
num Affected
0
num At Risk
15
num Events
0
term
Pneumonitis

time Frame

Up to 1 year

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Preserved source evidence · Not medical advice