NCT01823198 · ADVERSE EVENTS

Adverse events

Donor Natural Killer Cells and Donor Stem Cell Transplant in Treating Patients With High Risk Myeloid Malignancies · Source last updated 2023-11-07

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 42 days. All-Cause Mortality was monitored/assessed for up to 2 years).
Other-event reporting threshold: 5%

Donor participants only signed the consents and were not part of the results and Adverse events were not collected.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Phase I: NK Cell Dose Level 1_10^6 Allogeneic stem cell transplant for patients with high risk myeloid malignancies conditioned with Fludarabine and Busulfan in combination with ex vivo expanded NK cells from 3 different NK cell sources : KIR mismatched haplo donors, KIR mismatched cord blood donors or HLA matched related donors.	1 / 6	6 / 6	1 / 6
Phase I: NK Cell Dose Level 2_10^7 Allogeneic stem cell transplant for patients with high risk myeloid malignancies conditioned with Fludarabine and Busulfan in combination with ex vivo expanded NK cells from 3 different NK cell sources : KIR mismatched haplo donors, KIR mismatched cord blood donors or HLA matched related donors.	2 / 6	5 / 6	4 / 6
Phase I: NK Cell Dose Level 3_ 3x10^7 Allogeneic stem cell transplant for patients with high risk myeloid malignancies conditioned with Fludarabine and Busulfan in combination with ex vivo expanded NK cells from 3 different NK cell sources : KIR mismatched haplo donors, KIR mismatched cord blood donors or HLA matched related donors.	1 / 4	4 / 4	2 / 4
Phase I: NK Cell Dose Level 4_ 10^8 Allogeneic stem cell transplant for patients with high risk myeloid malignancies conditioned with Fludarabine and Busulfan in combination with phase I/II escalation ex vivo expanded NK cells from 3 different NK cell sources : KIR mismatched haplo donors, KIR mismatched cord blood donors or HLA matched related donors.	0 / 4	4 / 4	1 / 4
Phase II: NK Cell Dose Level 3_3x10^7 Allogeneic stem cell transplant for patients with high risk myeloid malignancies conditioned with Fludarabine and Busulfan in combination with phase I/II escalation ex vivo expanded NK cells from 3 different NK cell sources : KIR mismatched haplo donors, KIR mismatched cord blood donors or HLA matched related donors.	1 / 1	1 / 1	0 / 1
Phase II: NK Cell Dose Level 4_ 10^8 Allogeneic stem cell transplant for patients with high risk myeloid malignancies conditioned with Fludarabine and Busulfan in combination with phase I/II escalation ex vivo expanded NK cells from 3 different NK cell sources : KIR mismatched haplo donors, KIR mismatched cord blood	6 / 21	17 / 21	9 / 21
Donors Donors: KIR mismatched haplo donors, KIR mismatched cord blood donors or HLA matched related donors.	0 / 0	0 / 0	0 / 0

Group identifiers: EG000: Phase I: NK Cell Dose Level 1_10^6 · EG001: Phase I: NK Cell Dose Level 2_10^7 · EG002: Phase I: NK Cell Dose Level 3_ 3x10^7 · EG003: Phase I: NK Cell Dose Level 4_ 10^8 · EG004: Phase II: NK Cell Dose Level 3_3x10^7 · EG005: Phase II: NK Cell Dose Level 4_ 10^8 · EG006: Donors

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
Infections and infestations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
4
group Id
EG004
num Affected
0
num At Risk
1
group Id
EG005
num Affected
0
num At Risk
21
group Id
EG006
num Affected
0
num At Risk
0
term
Viral Infections
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
6
group Id
EG001
num Affected
1
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
4
group Id
EG004
num Affected
0
num At Risk
1
group Id
EG005
num Affected
0
num At Risk
21
group Id
EG006
num Affected
0
num At Risk
0
term
Chronic lung GvHD
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
6
group Id
EG001
num Affected
1
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
4
group Id
EG004
num Affected
0
num At Risk
1
group Id
EG005
num Affected
0
num At Risk
21
group Id
EG006
num Affected
0
num At Risk
0
term
Secondary graft failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
1
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
4
group Id
EG004
num Affected
0
num At Risk
1
group Id
EG005
num Affected
0
num At Risk
21
group Id
EG006
num Affected
0
num At Risk
0
term
Fungal Infections
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Hepatobiliary disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
4
group Id
EG004
num Affected
1
num At Risk
1
group Id
EG005
num Affected
0
num At Risk
21
group Id
EG006
num Affected
0
num At Risk
0
term
Liver GvHD
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
4
group Id
EG004
num Affected
0
num At Risk
1
group Id
EG005
num Affected
1
num At Risk
21
group Id
EG006
num Affected
0
num At Risk
0
term
GI GvHD
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
4
group Id
EG004
num Affected
0
num At Risk
1
group Id
EG005
num Affected
1
num At Risk
21
group Id
EG006
num Affected
0
num At Risk
0
term
Chronic Skin GvHD
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Hepatobiliary disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
4
group Id
EG004
num Affected
0
num At Risk
1
group Id
EG005
num Affected
3
num At Risk
21
group Id
EG006
num Affected
0
num At Risk
0
term
Liver GvHD
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
4
group Id
EG004
num Affected
0
num At Risk
1
group Id
EG005
num Affected
1
num At Risk
21
group Id
EG006
num Affected
0
num At Risk
0
term
Bacterial Infections

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
Investigations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
1
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
1
num At Risk
4
group Id
EG004
num Affected
0
num At Risk
1
group Id
EG005
num Affected
0
num At Risk
21
group Id
EG006
num Affected
0
num At Risk
0
term
ABO incompatibility
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Immune system disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
1
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
1
num At Risk
4
group Id
EG004
num Affected
0
num At Risk
1
group Id
EG005
num Affected
0
num At Risk
21
group Id
EG006
num Affected
0
num At Risk
0
term
Allergic reaction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
2
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
2
num At Risk
4
group Id
EG003
num Affected
2
num At Risk
4
group Id
EG004
num Affected
1
num At Risk
1
group Id
EG005
num Affected
7
num At Risk
21
group Id
EG006
num Affected
0
num At Risk
0
term
Bacterial Infections
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
1
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
4
group Id
EG004
num Affected
0
num At Risk
1
group Id
EG005
num Affected
5
num At Risk
21
group Id
EG006
num Affected
0
num At Risk
0
term
BK virus associated hemorrhagic cystitis
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
6
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
1
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
4
group Id
EG004
num Affected
0
num At Risk
1
group Id
EG005
num Affected
0
num At Risk
21
group Id
EG006
num Affected
0
num At Risk
0
term
Bronchiolitis obliterans with organizing pneumonia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
4
group Id
EG004
num Affected
0
num At Risk
1
group Id
EG005
num Affected
0
num At Risk
21
group Id
EG006
num Affected
0
num At Risk
0
term
Chronic Liver GvHD
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
2
num At Risk
6
group Id
EG001
num Affected
1
num At Risk
6
group Id
EG002
num Affected
1
num At Risk
4
group Id
EG003
num Affected
1
num At Risk
4
group Id
EG004
num Affected
0
num At Risk
1
group Id
EG005
num Affected
7
num At Risk
21
group Id
EG006
num Affected
0
num At Risk
0
term
Chronic ocular GvHD
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
6
group Id
EG001
num Affected
2
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
4
group Id
EG004
num Affected
0
num At Risk
1
group Id
EG005
num Affected
6
num At Risk
21
group Id
EG006
num Affected
0
num At Risk
0
term
Chronic oral GvHD
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
2
num At Risk
6
group Id
EG001
num Affected
2
num At Risk
6
group Id
EG002
num Affected
1
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
4
group Id
EG004
num Affected
0
num At Risk
1
group Id
EG005
num Affected
1
num At Risk
21
group Id
EG006
num Affected
0
num At Risk
0
term
Chronic Skin GvHD
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Reproductive system and breast disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
1
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
4
group Id
EG004
num Affected
0
num At Risk
1
group Id
EG005
num Affected
1
num At Risk
21
group Id
EG006
num Affected
0
num At Risk
0
term
Chronic vaginal GvHD
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
1
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
4
group Id
EG004
num Affected
0
num At Risk
1
group Id
EG005
num Affected
2
num At Risk
21
group Id
EG006
num Affected
0
num At Risk
0
term
Creatinine increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
2
num At Risk
6
group Id
EG001
num Affected
2
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
3
num At Risk
4
group Id
EG004
num Affected
0
num At Risk
1
group Id
EG005
num Affected
10
num At Risk
21
group Id
EG006
num Affected
0
num At Risk
0
term
Diarrhea

Complete source fields

description

Donor participants only signed the consents and were not part of the results and Adverse events were not collected.

event Groups

deaths Num Affected
1
deaths Num At Risk
6
description
Allogeneic stem cell transplant for patients with high risk myeloid malignancies conditioned with Fludarabine and Busulfan in combination with ex vivo expanded NK cells from 3 different NK cell sources : KIR mismatched haplo donors, KIR mismatched cord blood donors or HLA matched related donors.
id
EG000
other Num Affected
6
other Num At Risk
6
serious Num Affected
1
serious Num At Risk
6
title
Phase I: NK Cell Dose Level 1_10^6
deaths Num Affected
4
deaths Num At Risk
6
description
Allogeneic stem cell transplant for patients with high risk myeloid malignancies conditioned with Fludarabine and Busulfan in combination with ex vivo expanded NK cells from 3 different NK cell sources : KIR mismatched haplo donors, KIR mismatched cord blood donors or HLA matched related donors.
id
EG001
other Num Affected
5
other Num At Risk
6
serious Num Affected
2
serious Num At Risk
6
title
Phase I: NK Cell Dose Level 2_10^7
deaths Num Affected
2
deaths Num At Risk
4
description
Allogeneic stem cell transplant for patients with high risk myeloid malignancies conditioned with Fludarabine and Busulfan in combination with ex vivo expanded NK cells from 3 different NK cell sources : KIR mismatched haplo donors, KIR mismatched cord blood donors or HLA matched related donors.
id
EG002
other Num Affected
4
other Num At Risk
4
serious Num Affected
1
serious Num At Risk
4
title
Phase I: NK Cell Dose Level 3_ 3x10^7
deaths Num Affected
1
deaths Num At Risk
4
description
Allogeneic stem cell transplant for patients with high risk myeloid malignancies conditioned with Fludarabine and Busulfan in combination with phase I/II escalation ex vivo expanded NK cells from 3 different NK cell sources : KIR mismatched haplo donors, KIR mismatched cord blood donors or HLA matched related donors.
id
EG003
other Num Affected
4
other Num At Risk
4
serious Num Affected
0
serious Num At Risk
4
title
Phase I: NK Cell Dose Level 4_ 10^8
deaths Num Affected
0
deaths Num At Risk
1
description
Allogeneic stem cell transplant for patients with high risk myeloid malignancies conditioned with Fludarabine and Busulfan in combination with phase I/II escalation ex vivo expanded NK cells from 3 different NK cell sources : KIR mismatched haplo donors, KIR mismatched cord blood donors or HLA matched related donors.
id
EG004
other Num Affected
1
other Num At Risk
1
serious Num Affected
1
serious Num At Risk
1
title
Phase II: NK Cell Dose Level 3_3x10^7
deaths Num Affected
9
deaths Num At Risk
21
description
Allogeneic stem cell transplant for patients with high risk myeloid malignancies conditioned with Fludarabine and Busulfan in combination with phase I/II escalation ex vivo expanded NK cells from 3 different NK cell sources : KIR mismatched haplo donors, KIR mismatched cord blood
id
EG005
other Num Affected
17
other Num At Risk
21
serious Num Affected
6
serious Num At Risk
21
title
Phase II: NK Cell Dose Level 4_ 10^8
deaths Num Affected
0
deaths Num At Risk
0
description
Donors: KIR mismatched haplo donors, KIR mismatched cord blood donors or HLA matched related donors.
id
EG006
other Num Affected
0
other Num At Risk
0
serious Num Affected
0
serious Num At Risk
0
title
Donors

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
1
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
1
num At Risk
4
group Id
EG004
num Affected
0
num At Risk
1
group Id
EG005
num Affected
0
num At Risk
21
group Id
EG006
num Affected
0
num At Risk
0
term
ABO incompatibility
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Immune system disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
1
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
1
num At Risk
4
group Id
EG004
num Affected
0
num At Risk
1
group Id
EG005
num Affected
0
num At Risk
21
group Id
EG006
num Affected
0
num At Risk
0
term
Allergic reaction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
2
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
2
num At Risk
4
group Id
EG003
num Affected
2
num At Risk
4
group Id
EG004
num Affected
1
num At Risk
1
group Id
EG005
num Affected
7
num At Risk
21
group Id
EG006
num Affected
0
num At Risk
0
term
Bacterial Infections
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
1
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
4
group Id
EG004
num Affected
0
num At Risk
1
group Id
EG005
num Affected
5
num At Risk
21
group Id
EG006
num Affected
0
num At Risk
0
term
BK virus associated hemorrhagic cystitis
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
6
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
1
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
4
group Id
EG004
num Affected
0
num At Risk
1
group Id
EG005
num Affected
0
num At Risk
21
group Id
EG006
num Affected
0
num At Risk
0
term
Bronchiolitis obliterans with organizing pneumonia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
4
group Id
EG004
num Affected
0
num At Risk
1
group Id
EG005
num Affected
0
num At Risk
21
group Id
EG006
num Affected
0
num At Risk
0
term
Chronic Liver GvHD
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
2
num At Risk
6
group Id
EG001
num Affected
1
num At Risk
6
group Id
EG002
num Affected
1
num At Risk
4
group Id
EG003
num Affected
1
num At Risk
4
group Id
EG004
num Affected
0
num At Risk
1
group Id
EG005
num Affected
7
num At Risk
21
group Id
EG006
num Affected
0
num At Risk
0
term
Chronic ocular GvHD
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
6
group Id
EG001
num Affected
2
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
4
group Id
EG004
num Affected
0
num At Risk
1
group Id
EG005
num Affected
6
num At Risk
21
group Id
EG006
num Affected
0
num At Risk
0
term
Chronic oral GvHD
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
2
num At Risk
6
group Id
EG001
num Affected
2
num At Risk
6
group Id
EG002
num Affected
1
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
4
group Id
EG004
num Affected
0
num At Risk
1
group Id
EG005
num Affected
1
num At Risk
21
group Id
EG006
num Affected
0
num At Risk
0
term
Chronic Skin GvHD
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Reproductive system and breast disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
1
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
4
group Id
EG004
num Affected
0
num At Risk
1
group Id
EG005
num Affected
1
num At Risk
21
group Id
EG006
num Affected
0
num At Risk
0
term
Chronic vaginal GvHD
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
1
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
4
group Id
EG004
num Affected
0
num At Risk
1
group Id
EG005
num Affected
2
num At Risk
21
group Id
EG006
num Affected
0
num At Risk
0
term
Creatinine increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
2
num At Risk
6
group Id
EG001
num Affected
2
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
3
num At Risk
4
group Id
EG004
num Affected
0
num At Risk
1
group Id
EG005
num Affected
10
num At Risk
21
group Id
EG006
num Affected
0
num At Risk
0
term
Diarrhea

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
4
group Id
EG004
num Affected
0
num At Risk
1
group Id
EG005
num Affected
0
num At Risk
21
group Id
EG006
num Affected
0
num At Risk
0
term
Viral Infections
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
6
group Id
EG001
num Affected
1
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
4
group Id
EG004
num Affected
0
num At Risk
1
group Id
EG005
num Affected
0
num At Risk
21
group Id
EG006
num Affected
0
num At Risk
0
term
Chronic lung GvHD
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
6
group Id
EG001
num Affected
1
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
4
group Id
EG004
num Affected
0
num At Risk
1
group Id
EG005
num Affected
0
num At Risk
21
group Id
EG006
num Affected
0
num At Risk
0
term
Secondary graft failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
1
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
4
group Id
EG004
num Affected
0
num At Risk
1
group Id
EG005
num Affected
0
num At Risk
21
group Id
EG006
num Affected
0
num At Risk
0
term
Fungal Infections
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Hepatobiliary disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
4
group Id
EG004
num Affected
1
num At Risk
1
group Id
EG005
num Affected
0
num At Risk
21
group Id
EG006
num Affected
0
num At Risk
0
term
Liver GvHD
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
4
group Id
EG004
num Affected
0
num At Risk
1
group Id
EG005
num Affected
1
num At Risk
21
group Id
EG006
num Affected
0
num At Risk
0
term
GI GvHD
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
4
group Id
EG004
num Affected
0
num At Risk
1
group Id
EG005
num Affected
1
num At Risk
21
group Id
EG006
num Affected
0
num At Risk
0
term
Chronic Skin GvHD
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Hepatobiliary disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
4
group Id
EG004
num Affected
0
num At Risk
1
group Id
EG005
num Affected
3
num At Risk
21
group Id
EG006
num Affected
0
num At Risk
0
term
Liver GvHD
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
4
group Id
EG003
num Affected
0
num At Risk
4
group Id
EG004
num Affected
0
num At Risk
1
group Id
EG005
num Affected
1
num At Risk
21
group Id
EG006
num Affected
0
num At Risk
0
term
Bacterial Infections

time Frame

Up to 42 days. All-Cause Mortality was monitored/assessed for up to 2 years).

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

Preserved source evidence · Not medical advice