NCT01177683 · ADVERSE EVENTS

Adverse events

Bendamustine in Combination With Bortezomib and Pegylated Liposomal Doxorubicin for Multiple Myeloma · Source last updated 2023-10-06

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 C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 54 months.
Other-event reporting threshold: 0%

Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Phase I Level 1 : Bendamustine at 90mg/m^2 With Bortezomib and Pegylated Liposomal Doxorubicin. Bendamustine: At Phase I level I, Bendamustine will be administered at 90 mg/m\^2 by IV over 1 hour at days 1 and 4 of the 28 day treatment cycle. Filgrastim (if defined in MTD) will be administered at 5 µg/kg/day SC, starting day 6 until neutrophil recovery to ANC \>1000. Doxorubicin: Pegylated liposomal doxorubicin at phase I will be administered at 30 mg/m2 by IV over 1 hour, at day 4 of the 28 day treatment cycle. Bortezomib: Bortezomib at Phase I will be administered at 1.3 mg/m2 by IV bolus on days 1, 4, 8, and 11 of the 28 day cycle.	1 / 3	3 / 3	2 / 3
Phase I Level 2 : Bendamustine at 120mg/m^2 With Bortezomib and Pegylated Liposomal Doxorubicin. Bendamustine: At Phase I level 2, Bendamustine will be administered at 120 mg/m\^2 by IV over 1 hour at days 1 and 4 of the 28 day treatment cycle. Filgrastim (if defined in MTD) will be administered at 5 µg/kg/day SC, starting day 6 until neutrophil recovery to ANC \>1000. Doxorubicin: Pegylated liposomal doxorubicin at phase I will be administered at 30 mg/m2 by IV over 1 hour, at day 4 of the 28 day treatment cycle. Bortezomib: Bortezomib at Phase I will be administered at 1.3 mg/m2 by IV bolus on days 1, 4, 8, and 11 of the 28 day cycle.	1 / 3	3 / 3	1 / 3
Phase II : Bendamustine in Combination With Bortezomib and Pegylated Liposomal Doxorubicin. Bendamustine: At phase II, Bendamustine will be administered at 90mg/m\^2 by IV over 1 hour at days 1 and 4 of the 28 day treatment cycle. Doxorubicin: Pegylated liposomal doxorubicin at phase II will be administered at 30 mg/m2 by IV over 1 hour,at day 4 of the 28 day treatment cycle. Bortezomib: Bortezomib at Phase II will be administered at 1.3 mg/m2 by IV bolus or SQ injection on days 1, 4, 8, and 11 of the 28 day cycle.	8 / 26	24 / 26	7 / 26

Group identifiers: EG000: Phase I Level 1 : Bendamustine at 90mg/m^2 With Bortezomib and Pegylated Liposomal Doxorubicin. · EG001: Phase I Level 2 : Bendamustine at 120mg/m^2 With Bortezomib and Pegylated Liposomal Doxorubicin. · EG002: Phase II : Bendamustine in Combination With Bortezomib and Pegylated Liposomal Doxorubicin.

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAEv3
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
26
num Events
0
term
Dehydration
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAEv3
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
1
num At Risk
3
num Events
1
group Id
EG002
num Affected
0
num At Risk
26
num Events
0
term
Infection with normal ANC or Grade 1 or 2 neutrophils - Colon
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAEv3
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
26
num Events
1
term
CALCIUM, SERUM-HIGH (HYPERCALCEMIA)
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAEv3
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
26
num Events
2
term
DEHYDRATION
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAEv3
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
26
num Events
1
term
ENTERITIS (INFLAMMATION OF THE SMALL BOWEL)
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAEv3
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
26
num Events
1
term
FEBRILE NEUTROPENIA
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAEv3
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
26
num Events
2
term
GASTROINTESTINAL - OTHER (SPECIFY, __)
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAEv3
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
26
num Events
1
term
HYPOTENSION
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAEv3
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
26
num Events
1
term
INFECTION (MENINGITIS)
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAEv3
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
26
num Events
1
term
INFECTION - OTHER (SPECIFY, __)
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAEv3
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
2
num At Risk
26
num Events
4
term
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS - LUNG (PNEUMONIA)
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAEv3
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
26
num Events
1
term
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS - UPPER AIRWAY NOS

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
NON_SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAEv3
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
2
group Id
EG002
num Affected
0
num At Risk
26
num Events
0
term
Albumin, serum-low (hypoalbuminemia)
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAEv3
stats
group Id
EG000
num Affected
2
num At Risk
3
num Events
3
group Id
EG001
num Affected
3
num At Risk
3
num Events
4
group Id
EG002
num Affected
0
num At Risk
26
num Events
0
term
Anorexia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAEv3
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
3
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
26
num Events
0
term
Calcium, serum-high (hypercalcemia)
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAEv3
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
2
group Id
EG001
num Affected
3
num At Risk
3
num Events
3
group Id
EG002
num Affected
0
num At Risk
26
num Events
0
term
Constipation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAEv3
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
3
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
26
num Events
0
term
Creatinine
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
CTCAEv3
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
2
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
26
num Events
0
term
Dermatology/Skin - Other (Specify, __)
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAEv3
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
4
group Id
EG001
num Affected
1
num At Risk
3
num Events
1
group Id
EG002
num Affected
0
num At Risk
26
num Events
0
term
Diarrhea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAEv3
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
2
group Id
EG001
num Affected
1
num At Risk
3
num Events
1
group Id
EG002
num Affected
0
num At Risk
26
num Events
0
term
Dyspnea (shortness of breath)
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAEv3
stats
group Id
EG000
num Affected
2
num At Risk
3
num Events
5
group Id
EG001
num Affected
3
num At Risk
3
num Events
6
group Id
EG002
num Affected
0
num At Risk
26
num Events
0
term
Fatigue (asthenia, lethargy, malaise)
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAEv3
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
group Id
EG001
num Affected
1
num At Risk
3
num Events
4
group Id
EG002
num Affected
0
num At Risk
26
num Events
0
term
Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
CTCAEv3
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
26
num Events
0
term
Flushing
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
CTCAEv3
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
2
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
26
num Events
0
term
Hearing: patients without baseline audiogram and not enrolled in a monitoring program

Complete source fields

description

event Groups

deaths Num Affected
2
deaths Num At Risk
3
description
Bendamustine: At Phase I level I, Bendamustine will be administered at 90 mg/m\^2 by IV over 1 hour at days 1 and 4 of the 28 day treatment cycle. Filgrastim (if defined in MTD) will be administered at 5 µg/kg/day SC, starting day 6 until neutrophil recovery to ANC \>1000. Doxorubicin: Pegylated liposomal doxorubicin at phase I will be administered at 30 mg/m2 by IV over 1 hour, at day 4 of the 28 day treatment cycle. Bortezomib: Bortezomib at Phase I will be administered at 1.3 mg/m2 by IV bolus on days 1, 4, 8, and 11 of the 28 day cycle.
id
EG000
other Num Affected
3
other Num At Risk
3
serious Num Affected
1
serious Num At Risk
3
title
Phase I Level 1 : Bendamustine at 90mg/m^2 With Bortezomib and Pegylated Liposomal Doxorubicin.
deaths Num Affected
1
deaths Num At Risk
3
description
Bendamustine: At Phase I level 2, Bendamustine will be administered at 120 mg/m\^2 by IV over 1 hour at days 1 and 4 of the 28 day treatment cycle. Filgrastim (if defined in MTD) will be administered at 5 µg/kg/day SC, starting day 6 until neutrophil recovery to ANC \>1000. Doxorubicin: Pegylated liposomal doxorubicin at phase I will be administered at 30 mg/m2 by IV over 1 hour, at day 4 of the 28 day treatment cycle. Bortezomib: Bortezomib at Phase I will be administered at 1.3 mg/m2 by IV bolus on days 1, 4, 8, and 11 of the 28 day cycle.
id
EG001
other Num Affected
3
other Num At Risk
3
serious Num Affected
1
serious Num At Risk
3
title
Phase I Level 2 : Bendamustine at 120mg/m^2 With Bortezomib and Pegylated Liposomal Doxorubicin.
deaths Num Affected
7
deaths Num At Risk
26
description
Bendamustine: At phase II, Bendamustine will be administered at 90mg/m\^2 by IV over 1 hour at days 1 and 4 of the 28 day treatment cycle. Doxorubicin: Pegylated liposomal doxorubicin at phase II will be administered at 30 mg/m2 by IV over 1 hour,at day 4 of the 28 day treatment cycle. Bortezomib: Bortezomib at Phase II will be administered at 1.3 mg/m2 by IV bolus or SQ injection on days 1, 4, 8, and 11 of the 28 day cycle.
id
EG002
other Num Affected
24
other Num At Risk
26
serious Num Affected
8
serious Num At Risk
26
title
Phase II : Bendamustine in Combination With Bortezomib and Pegylated Liposomal Doxorubicin.

frequency Threshold

other Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAEv3
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
2
group Id
EG002
num Affected
0
num At Risk
26
num Events
0
term
Albumin, serum-low (hypoalbuminemia)
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAEv3
stats
group Id
EG000
num Affected
2
num At Risk
3
num Events
3
group Id
EG001
num Affected
3
num At Risk
3
num Events
4
group Id
EG002
num Affected
0
num At Risk
26
num Events
0
term
Anorexia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAEv3
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
3
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
26
num Events
0
term
Calcium, serum-high (hypercalcemia)
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAEv3
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
2
group Id
EG001
num Affected
3
num At Risk
3
num Events
3
group Id
EG002
num Affected
0
num At Risk
26
num Events
0
term
Constipation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAEv3
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
3
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
26
num Events
0
term
Creatinine
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
CTCAEv3
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
2
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
26
num Events
0
term
Dermatology/Skin - Other (Specify, __)
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAEv3
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
4
group Id
EG001
num Affected
1
num At Risk
3
num Events
1
group Id
EG002
num Affected
0
num At Risk
26
num Events
0
term
Diarrhea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAEv3
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
2
group Id
EG001
num Affected
1
num At Risk
3
num Events
1
group Id
EG002
num Affected
0
num At Risk
26
num Events
0
term
Dyspnea (shortness of breath)
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAEv3
stats
group Id
EG000
num Affected
2
num At Risk
3
num Events
5
group Id
EG001
num Affected
3
num At Risk
3
num Events
6
group Id
EG002
num Affected
0
num At Risk
26
num Events
0
term
Fatigue (asthenia, lethargy, malaise)
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAEv3
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
group Id
EG001
num Affected
1
num At Risk
3
num Events
4
group Id
EG002
num Affected
0
num At Risk
26
num Events
0
term
Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
CTCAEv3
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
26
num Events
0
term
Flushing
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
CTCAEv3
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
2
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
26
num Events
0
term
Hearing: patients without baseline audiogram and not enrolled in a monitoring program

serious Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAEv3
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
26
num Events
0
term
Dehydration
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAEv3
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
1
num At Risk
3
num Events
1
group Id
EG002
num Affected
0
num At Risk
26
num Events
0
term
Infection with normal ANC or Grade 1 or 2 neutrophils - Colon
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAEv3
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
26
num Events
1
term
CALCIUM, SERUM-HIGH (HYPERCALCEMIA)
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAEv3
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
26
num Events
2
term
DEHYDRATION
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAEv3
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
26
num Events
1
term
ENTERITIS (INFLAMMATION OF THE SMALL BOWEL)
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAEv3
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
26
num Events
1
term
FEBRILE NEUTROPENIA
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAEv3
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
26
num Events
2
term
GASTROINTESTINAL - OTHER (SPECIFY, __)
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAEv3
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
26
num Events
1
term
HYPOTENSION
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAEv3
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
26
num Events
1
term
INFECTION (MENINGITIS)
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAEv3
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
26
num Events
1
term
INFECTION - OTHER (SPECIFY, __)
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAEv3
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
2
num At Risk
26
num Events
4
term
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS - LUNG (PNEUMONIA)
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAEv3
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
26
num Events
1
term
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS - UPPER AIRWAY NOS

time Frame

From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 54 months.

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

Preserved source evidence · Not medical advice