NCT01872819 · ADVERSE EVENTS

Adverse events

Treatment for Relapsed/Refractory AML Based on a High Throughput Drug Sensitivity Assay · Source last updated 2018-07-11

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: 2 years
Other-event reporting threshold: 0%

Other \[Not Including Serious\] Adverse Events were not monitored/assessed.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Treatment (Chemotherapy, Biological Therapy) Patients receive 1 of 160 possible interventions based on high throughput drug sensitivity assay. antitumor drug screening assay: Undergo high throughput drug sensitivity assay chemotherapy: Patients receive 1 of 160 possible interventions biological therapy: Patients receive 1 of 160 possible interventions	11 / 14	0 / 0	Not reported / Not reported

Group identifiers: EG000: Treatment (Chemotherapy, Biological Therapy)

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
notes
due to thrombocytopenia due to underlying disease
organ System
Nervous system disorders
stats
group Id
EG000
num Affected
2
num At Risk
14
num Events
2
term
seizure
assessment Type
SYSTEMATIC_ASSESSMENT
notes
fungal
organ System
Infections and infestations
stats
group Id
EG000
num Affected
1
num At Risk
14
num Events
1
term
pneumonia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
stats
group Id
EG000
num Affected
1
num At Risk
14
num Events
1
term
Hyperglycemia
assessment Type
SYSTEMATIC_ASSESSMENT
notes
secondary to blast crisis
organ System
Nervous system disorders
stats
group Id
EG000
num Affected
1
num At Risk
14
num Events
1
term
headache
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
stats
group Id
EG000
num Affected
1
num At Risk
14
num Events
1
term
malignant neoplasm progression
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
stats
group Id
EG000
num Affected
5
num At Risk
14
num Events
7
term
febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
stats
group Id
EG000
num Affected
1
num At Risk
14
num Events
1
term
Palmar-plantar erythrodysesthesia syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
notes
intermittent
organ System
Investigations
stats
group Id
EG000
num Affected
2
num At Risk
14
num Events
2
term
hypokalemia
assessment Type
SYSTEMATIC_ASSESSMENT
notes
intermittent
organ System
Psychiatric disorders
stats
group Id
EG000
num Affected
1
num At Risk
14
num Events
1
term
confusion
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
stats
group Id
EG000
num Affected
2
num At Risk
14
num Events
2
term
hyperbilirubinemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
stats
group Id
EG000
num Affected
1
num At Risk
14
num Events
1
term
Hypoalbuminemia
assessment Type
SYSTEMATIC_ASSESSMENT
notes
stenotrophomonas maltophilia
organ System
Infections and infestations
stats
group Id
EG000
num Affected
1
num At Risk
14
num Events
1
term
pneumonia

Other reported adverse events

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

Complete source fields

description

Other \[Not Including Serious\] Adverse Events were not monitored/assessed.

event Groups

description
Patients receive 1 of 160 possible interventions based on high throughput drug sensitivity assay. antitumor drug screening assay: Undergo high throughput drug sensitivity assay chemotherapy: Patients receive 1 of 160 possible interventions biological therapy: Patients receive 1 of 160 possible interventions
id
EG000
other Num Affected
0
other Num At Risk
0
serious Num Affected
11
serious Num At Risk
14
title
Treatment (Chemotherapy, Biological Therapy)

frequency Threshold

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
notes
due to thrombocytopenia due to underlying disease
organ System
Nervous system disorders
stats
group Id
EG000
num Affected
2
num At Risk
14
num Events
2
term
seizure
assessment Type
SYSTEMATIC_ASSESSMENT
notes
fungal
organ System
Infections and infestations
stats
group Id
EG000
num Affected
1
num At Risk
14
num Events
1
term
pneumonia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
stats
group Id
EG000
num Affected
1
num At Risk
14
num Events
1
term
Hyperglycemia
assessment Type
SYSTEMATIC_ASSESSMENT
notes
secondary to blast crisis
organ System
Nervous system disorders
stats
group Id
EG000
num Affected
1
num At Risk
14
num Events
1
term
headache
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
stats
group Id
EG000
num Affected
1
num At Risk
14
num Events
1
term
malignant neoplasm progression
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
stats
group Id
EG000
num Affected
5
num At Risk
14
num Events
7
term
febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
stats
group Id
EG000
num Affected
1
num At Risk
14
num Events
1
term
Palmar-plantar erythrodysesthesia syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
notes
intermittent
organ System
Investigations
stats
group Id
EG000
num Affected
2
num At Risk
14
num Events
2
term
hypokalemia
assessment Type
SYSTEMATIC_ASSESSMENT
notes
intermittent
organ System
Psychiatric disorders
stats
group Id
EG000
num Affected
1
num At Risk
14
num Events
1
term
confusion
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
stats
group Id
EG000
num Affected
2
num At Risk
14
num Events
2
term
hyperbilirubinemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
stats
group Id
EG000
num Affected
1
num At Risk
14
num Events
1
term
Hypoalbuminemia
assessment Type
SYSTEMATIC_ASSESSMENT
notes
stenotrophomonas maltophilia
organ System
Infections and infestations
stats
group Id
EG000
num Affected
1
num At Risk
14
num Events
1
term
pneumonia

time Frame

2 years

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Preserved source evidence · Not medical advice