NCT02280811 · ADVERSE EVENTS

Adverse events

T Cell Receptor Immunotherapy Targeting HPV-16 E6 for HPV-Associated Cancers · Source last updated 2017-09-06

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: 19 months and 7 days
Other-event reporting threshold: 0%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
HPV-16 E6 mTCR PBL 1x10^9 + HD IL-2 patients will receive cyclophosphamide and fludarabine followed by infusion of the human papilloma virus (HPV) E6 T cell receptor (TCR), followed by high dose aldesleukin Fludarabine: Patients will receive Fludarabine 25 mg/m\^2/day for 5 days. Cyclophosphamide: Patients will receive Cyclophosphamide 60 mg/kg/day x 2 days E6 TCR: On day 0, cells will be infused intravenously (IV) over 20-30 minute (between 1 and 4 days after the last dose of fludarabine) Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).	0 / 1	1 / 1	0 / 1
HPV-16 E6 mTCR PBL 1x10^10 + HD IL-2 patients will receive cyclophosphamide and fludarabine followed by infusion of the human papilloma virus (HPV) E6 T cell receptor (TCR), followed by high dose aldesleukin Fludarabine: Patients will receive Fludarabine 25 mg/m\^2/day for 5 days. Cyclophosphamide: Patients will receive Cyclophosphamide 60 mg/kg/day x 2 days E6 TCR: On day 0, cells will be infused intravenously (IV) over 20-30 minute (between 1 and 4 days after the last dose of fludarabine) Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).	1 / 2	2 / 2	0 / 2
HPV-16 E6 mTCR PBL 1x10^11 + HD IL-2 patients will receive cyclophosphamide and fludarabine followed by infusion of the human papilloma virus (HPV) E6 T cell receptor (TCR), followed by high dose aldesleukin Fludarabine: Patients will receive Fludarabine 25 mg/m\^2/day for 5 days. Cyclophosphamide: Patients will receive Cyclophosphamide 60 mg/kg/day x 2 days E6 TCR: On day 0, cells will be infused intravenously (IV) over 20-30 minute (between 1 and 4 days after the last dose of fludarabine) Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).	0 / 1	1 / 1	0 / 1
HPV-16 E6 mTCR PBL >1x10^11 up to 2x10^11 + HD IL-2 patients will receive cyclophosphamide and fludarabine followed by infusion of the human papilloma virus (HPV) E6 T cell receptor (TCR), followed by high dose aldesleukin Fludarabine: Patients will receive Fludarabine 25 mg/m\^2/day for 5 days. Cyclophosphamide: Patients will receive Cyclophosphamide 60 mg/kg/day x 2 days E6 TCR: On day 0, cells will be infused intravenously (IV) over 20-30 minute (between 1 and 4 days after the last dose of fludarabine) Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).	2 / 6	6 / 6	0 / 6
HPV-16 E6 mTCR PBL MTD + HD IL-2 patients will receive cyclophosphamide and fludarabine followed by infusion of the human papilloma virus (HPV) E6 T cell receptor (TCR), followed by high dose aldesleukin Fludarabine: Patients will receive Fludarabine 25 mg/m\^2/day for 5 days. Cyclophosphamide: Patients will receive Cyclophosphamide 60 mg/kg/day x 2 days E6 TCR: On day 0, cells will be infused intravenously (IV) over 20-30 minute (between 1 and 4 days after the last dose of fludarabine) Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).	2 / 2	2 / 2	0 / 2
HPV-16 E6 mTCR PBL MTD + HD IL-2-Retreatment patients will receive cyclophosphamide and fludarabine followed by infusion of the human papilloma virus (HPV) E6 T cell receptor (TCR), followed by high dose aldesleukin Fludarabine: Patients will receive Fludarabine 25 mg/m\^2/day for 5 days. Cyclophosphamide: Patients will receive Cyclophosphamide 60 mg/kg/day x 2 days E6 TCR: On day 0, cells will be infused intravenously (IV) over 20-30 minute (between 1 and 4 days after the last dose of fludarabine) Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).	0 / 1	1 / 1	0 / 1

Group identifiers: EG000: HPV-16 E6 mTCR PBL 1x10^9 + HD IL-2 · EG001: HPV-16 E6 mTCR PBL 1x10^10 + HD IL-2 · EG002: HPV-16 E6 mTCR PBL 1x10^11 + HD IL-2 · EG003: HPV-16 E6 mTCR PBL >1x10^11 up to 2x10^11 + HD IL-2 · EG004: HPV-16 E6 mTCR PBL MTD + HD IL-2 · EG005: HPV-16 E6 mTCR PBL MTD + HD IL-2-Retreatment

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
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
1
num At Risk
2
num Events
1
group Id
EG002
num Affected
0
num At Risk
1
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
0
num At Risk
2
num Events
0
group Id
EG005
num Affected
0
num At Risk
1
num Events
0
term
Dyspnea (shortness of breath)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
1
num At Risk
2
num Events
1
group Id
EG002
num Affected
0
num At Risk
1
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
0
num At Risk
2
num Events
0
group Id
EG005
num Affected
0
num At Risk
1
num Events
0
term
Hemorrhage, pulmonary/upper respiratory::Bronchopulmonary NOS
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
1
num At Risk
2
num Events
1
group Id
EG002
num Affected
0
num At Risk
1
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
0
num At Risk
2
num Events
0
group Id
EG005
num Affected
0
num At Risk
1
num Events
0
term
Hypoxia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
1
num At Risk
2
num Events
1
group Id
EG002
num Affected
0
num At Risk
1
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
0
num At Risk
2
num Events
0
group Id
EG005
num Affected
0
num At Risk
1
num Events
0
term
Obstruction/stenosis of airway::Bronchus
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
1
num At Risk
2
num Events
1
group Id
EG002
num Affected
0
num At Risk
1
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
0
num At Risk
2
num Events
0
group Id
EG005
num Affected
0
num At Risk
1
num Events
0
term
Prolonged intubation after pulmonary resection (>24 hrs after surgery)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
0
num At Risk
1
num Events
0
group Id
EG003
num Affected
1
num At Risk
6
num Events
1
group Id
EG004
num Affected
0
num At Risk
2
num Events
0
group Id
EG005
num Affected
0
num At Risk
1
num Events
0
term
Diarrhea
assessment Type
SYSTEMATIC_ASSESSMENT
notes
with Grade 3 or 4 neutrophils (ANC \<1.0 x 10e9/L)::Blood
organ System
Infections and infestations
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
0
num At Risk
1
num Events
0
group Id
EG003
num Affected
2
num At Risk
6
num Events
2
group Id
EG004
num Affected
0
num At Risk
2
num Events
0
group Id
EG005
num Affected
0
num At Risk
1
num Events
0
term
Infection (documented clinically or microbiologically)
assessment Type
SYSTEMATIC_ASSESSMENT
notes
(fever of unknown origin without clinically or microbiologically documented infection)(ANC \<1.0 x 10e9/L, fever \>=38.5 degrees C)
organ System
Infections and infestations
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
0
num At Risk
1
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
2
num At Risk
2
num Events
2
group Id
EG005
num Affected
0
num At Risk
1
num Events
0
term
Febrile neutropenia

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
General disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
1
num Events
1
group Id
EG001
num Affected
1
num At Risk
2
num Events
1
group Id
EG002
num Affected
1
num At Risk
1
num Events
1
group Id
EG003
num Affected
1
num At Risk
6
num Events
1
group Id
EG004
num Affected
0
num At Risk
2
num Events
0
group Id
EG005
num Affected
0
num At Risk
1
num Events
0
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
1
num Events
1
group Id
EG001
num Affected
2
num At Risk
2
num Events
2
group Id
EG002
num Affected
1
num At Risk
1
num Events
1
group Id
EG003
num Affected
4
num At Risk
6
num Events
4
group Id
EG004
num Affected
2
num At Risk
2
num Events
2
group Id
EG005
num Affected
1
num At Risk
1
num Events
1
term
Hemoglobin
assessment Type
SYSTEMATIC_ASSESSMENT
notes
with Grade 3 or 4 neutrophils (ANC\<1.0x10e9/L)::Blood
organ System
Infections and infestations
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
1
num Events
1
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
0
num At Risk
1
num Events
0
group Id
EG003
num Affected
1
num At Risk
6
num Events
1
group Id
EG004
num Affected
0
num At Risk
2
num Events
0
group Id
EG005
num Affected
0
num At Risk
1
num Events
0
term
Infection (documented clinically and microbiologically)
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
1
num Events
1
group Id
EG001
num Affected
2
num At Risk
2
num Events
2
group Id
EG002
num Affected
1
num At Risk
1
num Events
1
group Id
EG003
num Affected
6
num At Risk
6
num Events
6
group Id
EG004
num Affected
2
num At Risk
2
num Events
2
group Id
EG005
num Affected
1
num At Risk
1
num Events
1
term
Lymphopenia
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
1
num Events
1
group Id
EG001
num Affected
2
num At Risk
2
num Events
2
group Id
EG002
num Affected
1
num At Risk
1
num Events
1
group Id
EG003
num Affected
6
num At Risk
6
num Events
6
group Id
EG004
num Affected
2
num At Risk
2
num Events
2
group Id
EG005
num Affected
1
num At Risk
1
num Events
1
term
Neutrophils/granulocytes (ANC/AGC)
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
1
num Events
1
group Id
EG001
num Affected
2
num At Risk
2
num Events
2
group Id
EG002
num Affected
1
num At Risk
1
num Events
1
group Id
EG003
num Affected
6
num At Risk
6
num Events
6
group Id
EG004
num Affected
2
num At Risk
2
num Events
2
group Id
EG005
num Affected
1
num At Risk
1
num Events
1
term
Platelets
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
1
num Events
0
group Id
EG001
num Affected
1
num At Risk
2
num Events
1
group Id
EG002
num Affected
0
num At Risk
1
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
0
num At Risk
2
num Events
0
group Id
EG005
num Affected
0
num At Risk
1
num Events
0
term
Bilirubin (hyperbilirubinemia)
assessment Type
SYSTEMATIC_ASSESSMENT
notes
(fever of unknown origin without clinically or microbiologically documented infection)(ANC\<1.0 x 10e9/L, fever\>=38.5 degrees C)
organ System
Infections and infestations
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
1
num At Risk
2
num Events
1
group Id
EG002
num Affected
1
num At Risk
1
num Events
1
group Id
EG003
num Affected
1
num At Risk
6
num Events
1
group Id
EG004
num Affected
2
num At Risk
2
num Events
2
group Id
EG005
num Affected
0
num At Risk
1
num Events
0
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
1
num At Risk
2
num Events
1
group Id
EG002
num Affected
0
num At Risk
1
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
0
num At Risk
2
num Events
0
group Id
EG005
num Affected
0
num At Risk
1
num Events
0
term
Psychosis (hallucinations/delusions)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
1
num At Risk
2
num Events
1
group Id
EG002
num Affected
0
num At Risk
1
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
0
num At Risk
2
num Events
0
group Id
EG005
num Affected
0
num At Risk
1
num Events
0
term
Rash/desquamation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
1
num At Risk
1
num Events
1
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
0
num At Risk
2
num Events
0
group Id
EG005
num Affected
0
num At Risk
1
num Events
0
term
Hypotension
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
1
num Events
0
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
0
num At Risk
1
num Events
0
group Id
EG003
num Affected
1
num At Risk
6
num Events
1
group Id
EG004
num Affected
0
num At Risk
2
num Events
0
group Id
EG005
num Affected
0
num At Risk
1
num Events
0
term
Creatinine

Complete source fields

event Groups

deaths Num Affected
0
deaths Num At Risk
1
description
patients will receive cyclophosphamide and fludarabine followed by infusion of the human papilloma virus (HPV) E6 T cell receptor (TCR), followed by high dose aldesleukin Fludarabine: Patients will receive Fludarabine 25 mg/m\^2/day for 5 days. Cyclophosphamide: Patients will receive Cyclophosphamide 60 mg/kg/day x 2 days E6 TCR: On day 0, cells will be infused intravenously (IV) over 20-30 minute (between 1 and 4 days after the last dose of fludarabine) Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).
id
EG000
other Num Affected
1
other Num At Risk
1
serious Num Affected
0
serious Num At Risk
1
title
HPV-16 E6 mTCR PBL 1x10^9 + HD IL-2
deaths Num Affected
0
deaths Num At Risk
2
description
patients will receive cyclophosphamide and fludarabine followed by infusion of the human papilloma virus (HPV) E6 T cell receptor (TCR), followed by high dose aldesleukin Fludarabine: Patients will receive Fludarabine 25 mg/m\^2/day for 5 days. Cyclophosphamide: Patients will receive Cyclophosphamide 60 mg/kg/day x 2 days E6 TCR: On day 0, cells will be infused intravenously (IV) over 20-30 minute (between 1 and 4 days after the last dose of fludarabine) Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).
id
EG001
other Num Affected
2
other Num At Risk
2
serious Num Affected
1
serious Num At Risk
2
title
HPV-16 E6 mTCR PBL 1x10^10 + HD IL-2
deaths Num Affected
0
deaths Num At Risk
1
description
patients will receive cyclophosphamide and fludarabine followed by infusion of the human papilloma virus (HPV) E6 T cell receptor (TCR), followed by high dose aldesleukin Fludarabine: Patients will receive Fludarabine 25 mg/m\^2/day for 5 days. Cyclophosphamide: Patients will receive Cyclophosphamide 60 mg/kg/day x 2 days E6 TCR: On day 0, cells will be infused intravenously (IV) over 20-30 minute (between 1 and 4 days after the last dose of fludarabine) Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).
id
EG002
other Num Affected
1
other Num At Risk
1
serious Num Affected
0
serious Num At Risk
1
title
HPV-16 E6 mTCR PBL 1x10^11 + HD IL-2
deaths Num Affected
0
deaths Num At Risk
6
description
patients will receive cyclophosphamide and fludarabine followed by infusion of the human papilloma virus (HPV) E6 T cell receptor (TCR), followed by high dose aldesleukin Fludarabine: Patients will receive Fludarabine 25 mg/m\^2/day for 5 days. Cyclophosphamide: Patients will receive Cyclophosphamide 60 mg/kg/day x 2 days E6 TCR: On day 0, cells will be infused intravenously (IV) over 20-30 minute (between 1 and 4 days after the last dose of fludarabine) Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).
id
EG003
other Num Affected
6
other Num At Risk
6
serious Num Affected
2
serious Num At Risk
6
title
HPV-16 E6 mTCR PBL >1x10^11 up to 2x10^11 + HD IL-2
deaths Num Affected
0
deaths Num At Risk
2
description
patients will receive cyclophosphamide and fludarabine followed by infusion of the human papilloma virus (HPV) E6 T cell receptor (TCR), followed by high dose aldesleukin Fludarabine: Patients will receive Fludarabine 25 mg/m\^2/day for 5 days. Cyclophosphamide: Patients will receive Cyclophosphamide 60 mg/kg/day x 2 days E6 TCR: On day 0, cells will be infused intravenously (IV) over 20-30 minute (between 1 and 4 days after the last dose of fludarabine) Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).
id
EG004
other Num Affected
2
other Num At Risk
2
serious Num Affected
2
serious Num At Risk
2
title
HPV-16 E6 mTCR PBL MTD + HD IL-2
deaths Num Affected
0
deaths Num At Risk
1
description
patients will receive cyclophosphamide and fludarabine followed by infusion of the human papilloma virus (HPV) E6 T cell receptor (TCR), followed by high dose aldesleukin Fludarabine: Patients will receive Fludarabine 25 mg/m\^2/day for 5 days. Cyclophosphamide: Patients will receive Cyclophosphamide 60 mg/kg/day x 2 days E6 TCR: On day 0, cells will be infused intravenously (IV) over 20-30 minute (between 1 and 4 days after the last dose of fludarabine) Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).
id
EG005
other Num Affected
1
other Num At Risk
1
serious Num Affected
0
serious Num At Risk
1
title
HPV-16 E6 mTCR PBL MTD + HD IL-2-Retreatment

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
1
num Events
1
group Id
EG001
num Affected
1
num At Risk
2
num Events
1
group Id
EG002
num Affected
1
num At Risk
1
num Events
1
group Id
EG003
num Affected
1
num At Risk
6
num Events
1
group Id
EG004
num Affected
0
num At Risk
2
num Events
0
group Id
EG005
num Affected
0
num At Risk
1
num Events
0
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
1
num Events
1
group Id
EG001
num Affected
2
num At Risk
2
num Events
2
group Id
EG002
num Affected
1
num At Risk
1
num Events
1
group Id
EG003
num Affected
4
num At Risk
6
num Events
4
group Id
EG004
num Affected
2
num At Risk
2
num Events
2
group Id
EG005
num Affected
1
num At Risk
1
num Events
1
term
Hemoglobin
assessment Type
SYSTEMATIC_ASSESSMENT
notes
with Grade 3 or 4 neutrophils (ANC\<1.0x10e9/L)::Blood
organ System
Infections and infestations
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
1
num Events
1
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
0
num At Risk
1
num Events
0
group Id
EG003
num Affected
1
num At Risk
6
num Events
1
group Id
EG004
num Affected
0
num At Risk
2
num Events
0
group Id
EG005
num Affected
0
num At Risk
1
num Events
0
term
Infection (documented clinically and microbiologically)
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
1
num Events
1
group Id
EG001
num Affected
2
num At Risk
2
num Events
2
group Id
EG002
num Affected
1
num At Risk
1
num Events
1
group Id
EG003
num Affected
6
num At Risk
6
num Events
6
group Id
EG004
num Affected
2
num At Risk
2
num Events
2
group Id
EG005
num Affected
1
num At Risk
1
num Events
1
term
Lymphopenia
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
1
num Events
1
group Id
EG001
num Affected
2
num At Risk
2
num Events
2
group Id
EG002
num Affected
1
num At Risk
1
num Events
1
group Id
EG003
num Affected
6
num At Risk
6
num Events
6
group Id
EG004
num Affected
2
num At Risk
2
num Events
2
group Id
EG005
num Affected
1
num At Risk
1
num Events
1
term
Neutrophils/granulocytes (ANC/AGC)
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
1
num Events
1
group Id
EG001
num Affected
2
num At Risk
2
num Events
2
group Id
EG002
num Affected
1
num At Risk
1
num Events
1
group Id
EG003
num Affected
6
num At Risk
6
num Events
6
group Id
EG004
num Affected
2
num At Risk
2
num Events
2
group Id
EG005
num Affected
1
num At Risk
1
num Events
1
term
Platelets
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
1
num Events
0
group Id
EG001
num Affected
1
num At Risk
2
num Events
1
group Id
EG002
num Affected
0
num At Risk
1
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
0
num At Risk
2
num Events
0
group Id
EG005
num Affected
0
num At Risk
1
num Events
0
term
Bilirubin (hyperbilirubinemia)
assessment Type
SYSTEMATIC_ASSESSMENT
notes
(fever of unknown origin without clinically or microbiologically documented infection)(ANC\<1.0 x 10e9/L, fever\>=38.5 degrees C)
organ System
Infections and infestations
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
1
num At Risk
2
num Events
1
group Id
EG002
num Affected
1
num At Risk
1
num Events
1
group Id
EG003
num Affected
1
num At Risk
6
num Events
1
group Id
EG004
num Affected
2
num At Risk
2
num Events
2
group Id
EG005
num Affected
0
num At Risk
1
num Events
0
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
1
num At Risk
2
num Events
1
group Id
EG002
num Affected
0
num At Risk
1
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
0
num At Risk
2
num Events
0
group Id
EG005
num Affected
0
num At Risk
1
num Events
0
term
Psychosis (hallucinations/delusions)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
1
num At Risk
2
num Events
1
group Id
EG002
num Affected
0
num At Risk
1
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
0
num At Risk
2
num Events
0
group Id
EG005
num Affected
0
num At Risk
1
num Events
0
term
Rash/desquamation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
1
num At Risk
1
num Events
1
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
0
num At Risk
2
num Events
0
group Id
EG005
num Affected
0
num At Risk
1
num Events
0
term
Hypotension
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
1
num Events
0
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
0
num At Risk
1
num Events
0
group Id
EG003
num Affected
1
num At Risk
6
num Events
1
group Id
EG004
num Affected
0
num At Risk
2
num Events
0
group Id
EG005
num Affected
0
num At Risk
1
num Events
0
term
Creatinine

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
1
num At Risk
2
num Events
1
group Id
EG002
num Affected
0
num At Risk
1
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
0
num At Risk
2
num Events
0
group Id
EG005
num Affected
0
num At Risk
1
num Events
0
term
Dyspnea (shortness of breath)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
1
num At Risk
2
num Events
1
group Id
EG002
num Affected
0
num At Risk
1
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
0
num At Risk
2
num Events
0
group Id
EG005
num Affected
0
num At Risk
1
num Events
0
term
Hemorrhage, pulmonary/upper respiratory::Bronchopulmonary NOS
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
1
num At Risk
2
num Events
1
group Id
EG002
num Affected
0
num At Risk
1
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
0
num At Risk
2
num Events
0
group Id
EG005
num Affected
0
num At Risk
1
num Events
0
term
Hypoxia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
1
num At Risk
2
num Events
1
group Id
EG002
num Affected
0
num At Risk
1
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
0
num At Risk
2
num Events
0
group Id
EG005
num Affected
0
num At Risk
1
num Events
0
term
Obstruction/stenosis of airway::Bronchus
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
1
num At Risk
2
num Events
1
group Id
EG002
num Affected
0
num At Risk
1
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
0
num At Risk
2
num Events
0
group Id
EG005
num Affected
0
num At Risk
1
num Events
0
term
Prolonged intubation after pulmonary resection (>24 hrs after surgery)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
0
num At Risk
1
num Events
0
group Id
EG003
num Affected
1
num At Risk
6
num Events
1
group Id
EG004
num Affected
0
num At Risk
2
num Events
0
group Id
EG005
num Affected
0
num At Risk
1
num Events
0
term
Diarrhea
assessment Type
SYSTEMATIC_ASSESSMENT
notes
with Grade 3 or 4 neutrophils (ANC \<1.0 x 10e9/L)::Blood
organ System
Infections and infestations
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
0
num At Risk
1
num Events
0
group Id
EG003
num Affected
2
num At Risk
6
num Events
2
group Id
EG004
num Affected
0
num At Risk
2
num Events
0
group Id
EG005
num Affected
0
num At Risk
1
num Events
0
term
Infection (documented clinically or microbiologically)
assessment Type
SYSTEMATIC_ASSESSMENT
notes
(fever of unknown origin without clinically or microbiologically documented infection)(ANC \<1.0 x 10e9/L, fever \>=38.5 degrees C)
organ System
Infections and infestations
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
0
num At Risk
1
num Events
0
group Id
EG003
num Affected
0
num At Risk
6
num Events
0
group Id
EG004
num Affected
2
num At Risk
2
num Events
2
group Id
EG005
num Affected
0
num At Risk
1
num Events
0
term
Febrile neutropenia

time Frame

19 months and 7 days

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Preserved source evidence · Not medical advice