NCT00112723 · ADVERSE EVENTS

Adverse events

Flavopiridol in Treating Patients With Relapsed or Refractory Lymphoma or Multiple Myeloma · Source last updated 2016-08-08

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: Patients were assessed for clinical response after two, four and six cycles with laboratory studies, physical exam, and CT scans.
Other-event reporting threshold: 5%

NCI Common Toxicity Criteria for Adverse Events (version 3.0) was used to define and grade toxicity.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Treatment (Alvocidib) PHASE I: Patients receive flavopiridol IV over 4½ hours on days 1, 8, 15, and 22. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of flavopiridol until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. PHASE II: Patients receive flavopiridol\* as in phase I at the MTD determined in phase I. alvocidib: Given IV	0 / 35	34 / 35	Not reported / Not reported

Group identifiers: EG000: Treatment (Alvocidib)

Serious adverse events

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

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 version 3.0
stats
group Id
EG000
num Affected
30
num At Risk
35
num Events
30
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE version 3.0
stats
group Id
EG000
num Affected
34
num At Risk
35
num Events
34
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE version 3.0
stats
group Id
EG000
num Affected
25
num At Risk
35
num Events
25
term
Lymphopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE version 3.0
stats
group Id
EG000
num Affected
22
num At Risk
35
num Events
22
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Injury, poisoning and procedural complications
source Vocabulary
CTCAE version 3.0
stats
group Id
EG000
num Affected
13
num At Risk
35
num Events
13
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE version 3.0
stats
group Id
EG000
num Affected
9
num At Risk
35
num Events
9
term
Infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE version 3.0
stats
group Id
EG000
num Affected
4
num At Risk
35
num Events
4
term
Neutropenia fever
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE version 3.0
stats
group Id
EG000
num Affected
12
num At Risk
35
num Events
12
term
Increased ALT/AST
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE version 3.0
stats
group Id
EG000
num Affected
6
num At Risk
35
num Events
6
term
Hyperbilirubinemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE version 3.0
stats
group Id
EG000
num Affected
12
num At Risk
35
num Events
12
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE version 3.0
stats
group Id
EG000
num Affected
10
num At Risk
35
num Events
10
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE version 3.0
stats
group Id
EG000
num Affected
8
num At Risk
35
num Events
8
term
Anorexia

Complete source fields

description

NCI Common Toxicity Criteria for Adverse Events (version 3.0) was used to define and grade toxicity.

event Groups

description
PHASE I: Patients receive flavopiridol IV over 4½ hours on days 1, 8, 15, and 22. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of flavopiridol until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. PHASE II: Patients receive flavopiridol\* as in phase I at the MTD determined in phase I. alvocidib: Given IV
id
EG000
other Num Affected
34
other Num At Risk
35
serious Num Affected
0
serious Num At Risk
35
title
Treatment (Alvocidib)

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE version 3.0
stats
group Id
EG000
num Affected
30
num At Risk
35
num Events
30
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE version 3.0
stats
group Id
EG000
num Affected
34
num At Risk
35
num Events
34
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE version 3.0
stats
group Id
EG000
num Affected
25
num At Risk
35
num Events
25
term
Lymphopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE version 3.0
stats
group Id
EG000
num Affected
22
num At Risk
35
num Events
22
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Injury, poisoning and procedural complications
source Vocabulary
CTCAE version 3.0
stats
group Id
EG000
num Affected
13
num At Risk
35
num Events
13
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE version 3.0
stats
group Id
EG000
num Affected
9
num At Risk
35
num Events
9
term
Infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE version 3.0
stats
group Id
EG000
num Affected
4
num At Risk
35
num Events
4
term
Neutropenia fever
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE version 3.0
stats
group Id
EG000
num Affected
12
num At Risk
35
num Events
12
term
Increased ALT/AST
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE version 3.0
stats
group Id
EG000
num Affected
6
num At Risk
35
num Events
6
term
Hyperbilirubinemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE version 3.0
stats
group Id
EG000
num Affected
12
num At Risk
35
num Events
12
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE version 3.0
stats
group Id
EG000
num Affected
10
num At Risk
35
num Events
10
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE version 3.0
stats
group Id
EG000
num Affected
8
num At Risk
35
num Events
8
term
Anorexia

time Frame

Patients were assessed for clinical response after two, four and six cycles with laboratory studies, physical exam, and CT scans.

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Preserved source evidence · Not medical advice