NCT00369317 · ADVERSE EVENTS

Adverse events

Combination Chemotherapy in Treating Young Patients With Down Syndrome and Acute Myeloid Leukemia or Myelodysplastic Syndromes · Source last updated 2022-01-28

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: Not reported
Other-event reporting threshold: 0%

SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Treatment (Combination Chemotherapy) INDUCTION THERAPY COURSE I: Patients receive cytarabine IT on day 1 and cytarabine IV continuously over 96 hours, daunorubicin hydrochloride IV continuously, and oral thioguanine BID on days 1-4. COURSE II: Patients receive high-dose cytarabine IV over 3 hours BID on days 1, 2, 8, and 9 and asparaginase (IM) on days 2 and 9. COURSE III: Patients receive treatment as in course I. COURSE IV: Patients receive cytarabine IV, daunorubicin hydrochloride IV, and oral thioguanine as in course I INTENSIFICATION THERAPY: Patients receive cytarabine IV continuously over 168 hours on days 1-7 and etoposide IV over 1 hour on days 1-3. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. asparaginase: Given IM daunorubicin hydrochloride: Given IV cytarabine: Given IV or IT thioguanine: Given orally etoposide: Given IV laboratory biomarker analysis: Correlative studies	3 / 204	185 / 204	Not reported / Not reported

Group identifiers: EG000: Treatment (Combination Chemotherapy)

Serious adverse events

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

organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
204
term
Ascites
organ System
Hepatobiliary disorders
stats
group Id
EG000
num Affected
1
num At Risk
204
term
Hepatic failure
organ System
Respiratory, thoracic and mediastinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
204
term
Hypoxia
organ System
Immune system disorders
stats
group Id
EG000
num Affected
1
num At Risk
204
term
Immune system disorders - Other
organ System
Respiratory, thoracic and mediastinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
204
term
Respiratory, thoracic and mediastinal disorders - Other
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
204
term
Typhlitis

Other reported adverse events

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

organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
2
num At Risk
204
term
Abdominal pain
organ System
Metabolism and nutrition disorders
stats
group Id
EG000
num Affected
4
num At Risk
204
term
Acidosis
organ System
Investigations
stats
group Id
EG000
num Affected
2
num At Risk
204
term
Activated partial thromboplastin time prolonged
organ System
Renal and urinary disorders
stats
group Id
EG000
num Affected
1
num At Risk
204
term
Acute kidney injury
organ System
Respiratory, thoracic and mediastinal disorders
stats
group Id
EG000
num Affected
2
num At Risk
204
term
Adult respiratory distress syndrome
organ System
Investigations
stats
group Id
EG000
num Affected
23
num At Risk
204
term
Alanine aminotransferase increased
organ System
Metabolism and nutrition disorders
stats
group Id
EG000
num Affected
1
num At Risk
204
term
Alkalosis
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
204
term
Anal pain
organ System
Immune system disorders
stats
group Id
EG000
num Affected
5
num At Risk
204
term
Anaphylaxis
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
2
num At Risk
204
term
Anemia
organ System
Infections and infestations
stats
group Id
EG000
num Affected
1
num At Risk
204
term
Anorectal infection
organ System
Metabolism and nutrition disorders
stats
group Id
EG000
num Affected
24
num At Risk
204
term
Anorexia

Complete source fields

description

SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.

event Groups

description
INDUCTION THERAPY COURSE I: Patients receive cytarabine IT on day 1 and cytarabine IV continuously over 96 hours, daunorubicin hydrochloride IV continuously, and oral thioguanine BID on days 1-4. COURSE II: Patients receive high-dose cytarabine IV over 3 hours BID on days 1, 2, 8, and 9 and asparaginase (IM) on days 2 and 9. COURSE III: Patients receive treatment as in course I. COURSE IV: Patients receive cytarabine IV, daunorubicin hydrochloride IV, and oral thioguanine as in course I INTENSIFICATION THERAPY: Patients receive cytarabine IV continuously over 168 hours on days 1-7 and etoposide IV over 1 hour on days 1-3. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. asparaginase: Given IM daunorubicin hydrochloride: Given IV cytarabine: Given IV or IT thioguanine: Given orally etoposide: Given IV laboratory biomarker analysis: Correlative studies
id
EG000
other Num Affected
185
other Num At Risk
204
serious Num Affected
3
serious Num At Risk
204
title
Treatment (Combination Chemotherapy)

frequency Threshold

other Events

organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
2
num At Risk
204
term
Abdominal pain
organ System
Metabolism and nutrition disorders
stats
group Id
EG000
num Affected
4
num At Risk
204
term
Acidosis
organ System
Investigations
stats
group Id
EG000
num Affected
2
num At Risk
204
term
Activated partial thromboplastin time prolonged
organ System
Renal and urinary disorders
stats
group Id
EG000
num Affected
1
num At Risk
204
term
Acute kidney injury
organ System
Respiratory, thoracic and mediastinal disorders
stats
group Id
EG000
num Affected
2
num At Risk
204
term
Adult respiratory distress syndrome
organ System
Investigations
stats
group Id
EG000
num Affected
23
num At Risk
204
term
Alanine aminotransferase increased
organ System
Metabolism and nutrition disorders
stats
group Id
EG000
num Affected
1
num At Risk
204
term
Alkalosis
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
204
term
Anal pain
organ System
Immune system disorders
stats
group Id
EG000
num Affected
5
num At Risk
204
term
Anaphylaxis
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
2
num At Risk
204
term
Anemia
organ System
Infections and infestations
stats
group Id
EG000
num Affected
1
num At Risk
204
term
Anorectal infection
organ System
Metabolism and nutrition disorders
stats
group Id
EG000
num Affected
24
num At Risk
204
term
Anorexia

serious Events

organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
204
term
Ascites
organ System
Hepatobiliary disorders
stats
group Id
EG000
num Affected
1
num At Risk
204
term
Hepatic failure
organ System
Respiratory, thoracic and mediastinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
204
term
Hypoxia
organ System
Immune system disorders
stats
group Id
EG000
num Affected
1
num At Risk
204
term
Immune system disorders - Other
organ System
Respiratory, thoracic and mediastinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
204
term
Respiratory, thoracic and mediastinal disorders - Other
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
204
term
Typhlitis

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice