NCT01583686 · ADVERSE EVENTS

Adverse events

CAR T Cell Receptor Immunotherapy Targeting Mesothelin for Patients With Metastatic Cancer · Source last updated 2019-10-14

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: Date treatment consent signed to date off study, approximately 6 months and 17 days for Group A01, 16 months and 13 days for Group A02, 13 months and 3 days for Group A03, 10 months and 16 days for Group A04, and 11 months and 26 days for Group A05.
Other-event reporting threshold: 0%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Arm A01 Anti-mesothelin CAR PBL 1x10^6 + IL-2 1/Phase I: Drug: Fludarabine Days -5 to Day -1: Fludarabine 25 mg/m\^2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days. Other Names: •Fludara Biological/Vaccine: Anti-mesothelin chimeric T cell receptor (CAR) transduced peripheral blood lymphocytes (PBL) Day 0: Cells will be infused intravenously (IV) on the Patient Care Unit over 20 to 30 minutes. Drug: Cyclophosphamide Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml 5% dextrose in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr. Other Names: •Cytoxan Drug: Aldesleukin Aldesleukin 72,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses). Other Names: •Proleukin	1 / 3	3 / 3	0 / 3
Arm A02 Anti-mesothelin CAR PBL 3x10^6 + IL-2 1/Phase I: Drug: Fludarabine Days -5 to Day -1: Fludarabine 25 mg/m\^2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days. Other Names: •Fludara Biological/Vaccine: Anti-mesothelin chimeric T cell receptor (CAR) transduced peripheral blood lymphocytes (PBL) Day 0: Cells will be infused intravenously (IV) on the Patient Care Unit over 20 to 30 minutes. Drug: Cyclophosphamide Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml 5% dextrose in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr. Other Names: •Cytoxan Drug: Aldesleukin Aldesleukin 72,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses). Other Names: •Proleukin	2 / 3	3 / 3	0 / 3
Arm A03 Anti-mesothelin CAR PBL 1x10^7 + IL-2 1/Phase I: Drug: Fludarabine Days -5 to Day -1: Fludarabine 25 mg/m\^2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days. Other Names: •Fludara Biological/Vaccine: Anti-mesothelin chimeric T cell receptor (CAR) transduced peripheral blood lymphocytes (PBL) Day 0: Cells will be infused intravenously (IV) on the Patient Care Unit over 20 to 30 minutes. Drug: Cyclophosphamide Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml 5% dextrose in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr. Other Names: •Cytoxan Drug: Aldesleukin Aldesleukin 72,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses). Other Names: •Proleukin	0 / 3	3 / 3	0 / 3
Arm A04 Anti-mesothelin CAR PBL 3x10^7 + IL-2 1/Phase I: Drug: Fludarabine Days -5 to Day -1: Fludarabine 25 mg/m\^2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days. Other Names: •Fludara Biological/Vaccine: Anti-mesothelin chimeric T cell receptor (CAR) transduced peripheral blood lymphocytes (PBL) Day 0: Cells will be infused intravenously (IV) on the Patient Care Unit over 20 to 30 minutes. Drug: Cyclophosphamide Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml 5% dextrose in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr. Other Names: •Cytoxan Drug: Aldesleukin Aldesleukin 72,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses). Other Names: •Proleukin	1 / 3	3 / 3	0 / 3
Arm A05 Anti-mesothelin CAR PBL 1x10^8 + IL-2 1/Phase I: Drug: Fludarabine Days -5 to Day -1: Fludarabine 25 mg/m\^2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days. Other Names: •Fludara Biological/Vaccine: Anti-mesothelin chimeric T cell receptor (CAR) transduced peripheral blood lymphocytes (PBL) Day 0: Cells will be infused intravenously (IV) on the Patient Care Unit over 20 to 30 minutes. Drug: Cyclophosphamide Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml 5% dextrose in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr. Other Names: •Cytoxan Drug: Aldesleukin Aldesleukin 72,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses). Other Names: •Proleukin	2 / 3	3 / 3	1 / 3

Group identifiers: EG000: Arm A01 Anti-mesothelin CAR PBL 1x10^6 + IL-2 · EG001: Arm A02 Anti-mesothelin CAR PBL 3x10^6 + IL-2 · EG002: Arm A03 Anti-mesothelin CAR PBL 1x10^7 + IL-2 · EG003: Arm A04 Anti-mesothelin CAR PBL 3x10^7 + IL-2 · EG004: Arm A05 Anti-mesothelin CAR PBL 1x10^8 + IL-2

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
Gastrointestinal disorders
source Vocabulary
CTCAE (4.0)
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
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
3
num Events
0
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE (4.0)
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
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
3
num Events
0
term
Hypoxia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (4.0)
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
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
3
num Events
0
term
Platelet count decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (4.0)
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
3
num Events
0
group Id
EG004
num Affected
1
num At Risk
3
num Events
1
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (4.0)
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
3
num Events
1
group Id
EG004
num Affected
1
num At Risk
3
num Events
1
term
Lymphocyte count decreased

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
Gastrointestinal disorders
source Vocabulary
CTCAE (4.0)
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
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
3
num Events
0
term
Pain: Abdomen NOS
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
2
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
1
num At Risk
3
num Events
1
group Id
EG003
num Affected
3
num At Risk
3
num Events
3
group Id
EG004
num Affected
0
num At Risk
3
num Events
0
term
Fatigue (asthenia, lethargy, malaise)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (4.0)
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
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
3
num Events
0
term
Infection with unknown ANC: Nerve-peripheral
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
3
num At Risk
3
num Events
3
group Id
EG001
num Affected
3
num At Risk
3
num Events
3
group Id
EG002
num Affected
3
num At Risk
3
num Events
3
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
3
num Events
0
term
White blood cell count decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE (4.0)
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
1
num At Risk
3
num Events
1
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
3
num Events
0
term
Albumin (hypoalbuminemia)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
source Vocabulary
CTCAE (4.0)
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
1
group Id
EG002
num Affected
1
num At Risk
3
num Events
1
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
1
num At Risk
3
num Events
1
term
Psychosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE (4.0)
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
3
num Events
0
group Id
EG004
num Affected
2
num At Risk
3
num Events
2
term
Hypoxia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
CTCAE (4.0)
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
3
num Events
2
group Id
EG003
num Affected
1
num At Risk
3
num Events
1
group Id
EG004
num Affected
0
num At Risk
3
num Events
0
term
Hypotension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (4.0)
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
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
3
num Events
0
term
Supraventricular and nodal arrhythmia: Sinus tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
3
num At Risk
3
num Events
3
group Id
EG001
num Affected
3
num At Risk
3
num Events
3
group Id
EG002
num Affected
3
num At Risk
3
num Events
3
group Id
EG003
num Affected
2
num At Risk
3
num Events
2
group Id
EG004
num Affected
3
num At Risk
3
num Events
3
term
Lymphopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
3
num At Risk
3
num Events
3
group Id
EG001
num Affected
3
num At Risk
3
num Events
3
group Id
EG002
num Affected
3
num At Risk
3
num Events
3
group Id
EG003
num Affected
3
num At Risk
3
num Events
3
group Id
EG004
num Affected
3
num At Risk
3
num Events
3
term
Neutrophils/granulocytes (ANC/AGC) count decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
3
num At Risk
3
num Events
3
group Id
EG001
num Affected
2
num At Risk
3
num Events
2
group Id
EG002
num Affected
2
num At Risk
3
num Events
2
group Id
EG003
num Affected
2
num At Risk
3
num Events
2
group Id
EG004
num Affected
3
num At Risk
3
num Events
3
term
Platelets

Complete source fields

event Groups

deaths Num Affected
0
deaths Num At Risk
3
description
1/Phase I: Drug: Fludarabine Days -5 to Day -1: Fludarabine 25 mg/m\^2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days. Other Names: •Fludara Biological/Vaccine: Anti-mesothelin chimeric T cell receptor (CAR) transduced peripheral blood lymphocytes (PBL) Day 0: Cells will be infused intravenously (IV) on the Patient Care Unit over 20 to 30 minutes. Drug: Cyclophosphamide Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml 5% dextrose in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr. Other Names: •Cytoxan Drug: Aldesleukin Aldesleukin 72,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses). Other Names: •Proleukin
id
EG000
other Num Affected
3
other Num At Risk
3
serious Num Affected
1
serious Num At Risk
3
title
Arm A01 Anti-mesothelin CAR PBL 1x10^6 + IL-2
deaths Num Affected
0
deaths Num At Risk
3
description
1/Phase I: Drug: Fludarabine Days -5 to Day -1: Fludarabine 25 mg/m\^2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days. Other Names: •Fludara Biological/Vaccine: Anti-mesothelin chimeric T cell receptor (CAR) transduced peripheral blood lymphocytes (PBL) Day 0: Cells will be infused intravenously (IV) on the Patient Care Unit over 20 to 30 minutes. Drug: Cyclophosphamide Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml 5% dextrose in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr. Other Names: •Cytoxan Drug: Aldesleukin Aldesleukin 72,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses). Other Names: •Proleukin
id
EG001
other Num Affected
3
other Num At Risk
3
serious Num Affected
2
serious Num At Risk
3
title
Arm A02 Anti-mesothelin CAR PBL 3x10^6 + IL-2
deaths Num Affected
0
deaths Num At Risk
3
description
1/Phase I: Drug: Fludarabine Days -5 to Day -1: Fludarabine 25 mg/m\^2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days. Other Names: •Fludara Biological/Vaccine: Anti-mesothelin chimeric T cell receptor (CAR) transduced peripheral blood lymphocytes (PBL) Day 0: Cells will be infused intravenously (IV) on the Patient Care Unit over 20 to 30 minutes. Drug: Cyclophosphamide Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml 5% dextrose in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr. Other Names: •Cytoxan Drug: Aldesleukin Aldesleukin 72,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses). Other Names: •Proleukin
id
EG002
other Num Affected
3
other Num At Risk
3
serious Num Affected
0
serious Num At Risk
3
title
Arm A03 Anti-mesothelin CAR PBL 1x10^7 + IL-2
deaths Num Affected
0
deaths Num At Risk
3
description
1/Phase I: Drug: Fludarabine Days -5 to Day -1: Fludarabine 25 mg/m\^2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days. Other Names: •Fludara Biological/Vaccine: Anti-mesothelin chimeric T cell receptor (CAR) transduced peripheral blood lymphocytes (PBL) Day 0: Cells will be infused intravenously (IV) on the Patient Care Unit over 20 to 30 minutes. Drug: Cyclophosphamide Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml 5% dextrose in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr. Other Names: •Cytoxan Drug: Aldesleukin Aldesleukin 72,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses). Other Names: •Proleukin
id
EG003
other Num Affected
3
other Num At Risk
3
serious Num Affected
1
serious Num At Risk
3
title
Arm A04 Anti-mesothelin CAR PBL 3x10^7 + IL-2
deaths Num Affected
1
deaths Num At Risk
3
description
1/Phase I: Drug: Fludarabine Days -5 to Day -1: Fludarabine 25 mg/m\^2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days. Other Names: •Fludara Biological/Vaccine: Anti-mesothelin chimeric T cell receptor (CAR) transduced peripheral blood lymphocytes (PBL) Day 0: Cells will be infused intravenously (IV) on the Patient Care Unit over 20 to 30 minutes. Drug: Cyclophosphamide Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml 5% dextrose in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr. Other Names: •Cytoxan Drug: Aldesleukin Aldesleukin 72,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses). Other Names: •Proleukin
id
EG004
other Num Affected
3
other Num At Risk
3
serious Num Affected
2
serious Num At Risk
3
title
Arm A05 Anti-mesothelin CAR PBL 1x10^8 + IL-2

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.0)
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
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
3
num Events
0
term
Pain: Abdomen NOS
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
2
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
1
num At Risk
3
num Events
1
group Id
EG003
num Affected
3
num At Risk
3
num Events
3
group Id
EG004
num Affected
0
num At Risk
3
num Events
0
term
Fatigue (asthenia, lethargy, malaise)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (4.0)
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
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
3
num Events
0
term
Infection with unknown ANC: Nerve-peripheral
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
3
num At Risk
3
num Events
3
group Id
EG001
num Affected
3
num At Risk
3
num Events
3
group Id
EG002
num Affected
3
num At Risk
3
num Events
3
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
3
num Events
0
term
White blood cell count decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE (4.0)
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
1
num At Risk
3
num Events
1
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
3
num Events
0
term
Albumin (hypoalbuminemia)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
source Vocabulary
CTCAE (4.0)
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
1
group Id
EG002
num Affected
1
num At Risk
3
num Events
1
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
1
num At Risk
3
num Events
1
term
Psychosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE (4.0)
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
3
num Events
0
group Id
EG004
num Affected
2
num At Risk
3
num Events
2
term
Hypoxia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
CTCAE (4.0)
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
3
num Events
2
group Id
EG003
num Affected
1
num At Risk
3
num Events
1
group Id
EG004
num Affected
0
num At Risk
3
num Events
0
term
Hypotension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (4.0)
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
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
3
num Events
0
term
Supraventricular and nodal arrhythmia: Sinus tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
3
num At Risk
3
num Events
3
group Id
EG001
num Affected
3
num At Risk
3
num Events
3
group Id
EG002
num Affected
3
num At Risk
3
num Events
3
group Id
EG003
num Affected
2
num At Risk
3
num Events
2
group Id
EG004
num Affected
3
num At Risk
3
num Events
3
term
Lymphopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
3
num At Risk
3
num Events
3
group Id
EG001
num Affected
3
num At Risk
3
num Events
3
group Id
EG002
num Affected
3
num At Risk
3
num Events
3
group Id
EG003
num Affected
3
num At Risk
3
num Events
3
group Id
EG004
num Affected
3
num At Risk
3
num Events
3
term
Neutrophils/granulocytes (ANC/AGC) count decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
3
num At Risk
3
num Events
3
group Id
EG001
num Affected
2
num At Risk
3
num Events
2
group Id
EG002
num Affected
2
num At Risk
3
num Events
2
group Id
EG003
num Affected
2
num At Risk
3
num Events
2
group Id
EG004
num Affected
3
num At Risk
3
num Events
3
term
Platelets

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.0)
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
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
3
num Events
0
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE (4.0)
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
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
3
num Events
0
term
Hypoxia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (4.0)
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
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
3
num Events
0
term
Platelet count decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (4.0)
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
3
num Events
0
group Id
EG004
num Affected
1
num At Risk
3
num Events
1
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (4.0)
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
3
num Events
1
group Id
EG004
num Affected
1
num At Risk
3
num Events
1
term
Lymphocyte count decreased

time Frame

Date treatment consent signed to date off study, approximately 6 months and 17 days for Group A01, 16 months and 13 days for Group A02, 13 months and 3 days for Group A03, 10 months and 16 days for Group A04, and 11 months and 26 days for Group A05.

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Preserved source evidence · Not medical advice