NCT00957905 · ADVERSE EVENTS

Adverse events

Alvocidib and Oxaliplatin With or Without Fluorouracil and Leucovorin Calcium in Treating Patients With Relapsed or Refractory Germ Cell Tumors · Source last updated 2017-03-10

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: 5%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Part A (Alvocidib and Oxaliplatin) Patients receive alvocidib IV over 1 hour and oxaliplatin IV over 2 hours on days 1, 15, and 29. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.	4 / 7	5 / 7	Not reported / Not reported
Part B (Alvocidib and FOLFOX) Patients receive alvocidib IV over 1 hour, oxaliplatin IV over 2 hours, and leucovorin calcium IV over 2 hours followed by fluorouracil IV continuously over 48 hours on days 1, 15, and 29. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.	7 / 29	23 / 29	Not reported / Not reported

Group identifiers: EG000: Part A (Alvocidib and Oxaliplatin) · EG001: Part B (Alvocidib and FOLFOX)

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
General disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
7
num Events
1
group Id
EG001
num Affected
0
num At Risk
29
num Events
0
term
Fever
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
7
num Events
1
group Id
EG001
num Affected
0
num At Risk
29
num Events
0
term
Intracranial hemorrhage
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
7
num Events
1
group Id
EG001
num Affected
0
num At Risk
29
num Events
0
term
Hypophosphatemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
7
num Events
1
group Id
EG001
num Affected
0
num At Risk
29
num Events
0
term
Infective myositis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
7
num Events
1
group Id
EG001
num Affected
0
num At Risk
29
num Events
0
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
2
num At Risk
7
num Events
2
group Id
EG001
num Affected
0
num At Risk
29
num Events
0
term
Neoplasms ben/mal/unk (inc cyst/polyp) Other, spec
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
7
num Events
1
group Id
EG001
num Affected
0
num At Risk
29
num Events
0
term
Headache
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
7
num Events
1
group Id
EG001
num Affected
0
num At Risk
29
num Events
0
term
Platelet count decrease
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
7
num Events
1
group Id
EG001
num Affected
0
num At Risk
29
num Events
0
term
Hypokalemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
7
num Events
1
group Id
EG001
num Affected
0
num At Risk
29
num Events
0
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
7
num Events
0
group Id
EG001
num Affected
1
num At Risk
29
num Events
1
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
7
num Events
0
group Id
EG001
num Affected
2
num At Risk
29
num Events
2
term
Anemia

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 (3.0)
stats
group Id
EG000
num Affected
2
num At Risk
7
num Events
5
group Id
EG001
num Affected
2
num At Risk
29
num Events
7
term
Alkaline phosphatase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
2
num At Risk
7
num Events
18
group Id
EG001
num Affected
8
num At Risk
29
num Events
46
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
7
num Events
3
group Id
EG001
num Affected
0
num At Risk
29
num Events
0
term
Blood bilirubin increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
7
num Events
3
group Id
EG001
num Affected
1
num At Risk
29
num Events
1
term
Creatinine increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
7
num Events
1
group Id
EG001
num Affected
4
num At Risk
29
num Events
10
term
Diarrhea
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
7
num Events
1
group Id
EG001
num Affected
5
num At Risk
29
num Events
10
term
Hyperglycemia
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
7
num Events
1
group Id
EG001
num Affected
0
num At Risk
29
num Events
0
term
Hypermagnesemia
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
7
num Events
1
group Id
EG001
num Affected
4
num At Risk
29
num Events
9
term
Hypoalbuminemia
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
7
num Events
12
group Id
EG001
num Affected
6
num At Risk
29
num Events
16
term
Hypocalcemia
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
7
num Events
2
group Id
EG001
num Affected
1
num At Risk
29
num Events
1
term
Hypokalemia
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
7
num Events
13
group Id
EG001
num Affected
6
num At Risk
29
num Events
15
term
Hypophosphatemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
7
num Events
1
group Id
EG001
num Affected
0
num At Risk
29
num Events
0
term
Insomnia

Complete source fields

event Groups

description
Patients receive alvocidib IV over 1 hour and oxaliplatin IV over 2 hours on days 1, 15, and 29. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.
id
EG000
other Num Affected
5
other Num At Risk
7
serious Num Affected
4
serious Num At Risk
7
title
Part A (Alvocidib and Oxaliplatin)
description
Patients receive alvocidib IV over 1 hour, oxaliplatin IV over 2 hours, and leucovorin calcium IV over 2 hours followed by fluorouracil IV continuously over 48 hours on days 1, 15, and 29. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.
id
EG001
other Num Affected
23
other Num At Risk
29
serious Num Affected
7
serious Num At Risk
29
title
Part B (Alvocidib and FOLFOX)

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
2
num At Risk
7
num Events
5
group Id
EG001
num Affected
2
num At Risk
29
num Events
7
term
Alkaline phosphatase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
2
num At Risk
7
num Events
18
group Id
EG001
num Affected
8
num At Risk
29
num Events
46
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
7
num Events
3
group Id
EG001
num Affected
0
num At Risk
29
num Events
0
term
Blood bilirubin increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
7
num Events
3
group Id
EG001
num Affected
1
num At Risk
29
num Events
1
term
Creatinine increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
7
num Events
1
group Id
EG001
num Affected
4
num At Risk
29
num Events
10
term
Diarrhea
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
7
num Events
1
group Id
EG001
num Affected
5
num At Risk
29
num Events
10
term
Hyperglycemia
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
7
num Events
1
group Id
EG001
num Affected
0
num At Risk
29
num Events
0
term
Hypermagnesemia
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
7
num Events
1
group Id
EG001
num Affected
4
num At Risk
29
num Events
9
term
Hypoalbuminemia
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
7
num Events
12
group Id
EG001
num Affected
6
num At Risk
29
num Events
16
term
Hypocalcemia
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
7
num Events
2
group Id
EG001
num Affected
1
num At Risk
29
num Events
1
term
Hypokalemia
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
7
num Events
13
group Id
EG001
num Affected
6
num At Risk
29
num Events
15
term
Hypophosphatemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
7
num Events
1
group Id
EG001
num Affected
0
num At Risk
29
num Events
0
term
Insomnia

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
7
num Events
1
group Id
EG001
num Affected
0
num At Risk
29
num Events
0
term
Fever
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
7
num Events
1
group Id
EG001
num Affected
0
num At Risk
29
num Events
0
term
Intracranial hemorrhage
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
7
num Events
1
group Id
EG001
num Affected
0
num At Risk
29
num Events
0
term
Hypophosphatemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
7
num Events
1
group Id
EG001
num Affected
0
num At Risk
29
num Events
0
term
Infective myositis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
7
num Events
1
group Id
EG001
num Affected
0
num At Risk
29
num Events
0
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
2
num At Risk
7
num Events
2
group Id
EG001
num Affected
0
num At Risk
29
num Events
0
term
Neoplasms ben/mal/unk (inc cyst/polyp) Other, spec
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
7
num Events
1
group Id
EG001
num Affected
0
num At Risk
29
num Events
0
term
Headache
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
7
num Events
1
group Id
EG001
num Affected
0
num At Risk
29
num Events
0
term
Platelet count decrease
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
7
num Events
1
group Id
EG001
num Affected
0
num At Risk
29
num Events
0
term
Hypokalemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
7
num Events
1
group Id
EG001
num Affected
0
num At Risk
29
num Events
0
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
7
num Events
0
group Id
EG001
num Affected
1
num At Risk
29
num Events
1
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
7
num Events
0
group Id
EG001
num Affected
2
num At Risk
29
num Events
2
term
Anemia

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Preserved source evidence · Not medical advice