NCT00589667 · ADVERSE EVENTS

Adverse events

A Phase II Study of Pemetrexed Plus Gemcitabine for Metastatic/Recurrent Head and Neck Cancer (HNSCC) · Source last updated 2014-04-02

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
Pemetrexed Plus Gemcitabine Patients will receive pemetrexed (500 mg/m2 IV infusion over approximately 10 minutes) followed immediately by gemcitabine (1250 mg/m2 IV infusion given over approximately 30 minutes) on day 1 and day 15 of a 28-day cycle.	12 / 25	23 / 25	Not reported / Not reported

Group identifiers: EG000: Pemetrexed Plus Gemcitabine

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
Metabolism and nutrition disorders
source Vocabulary
CTCAE 3.0
stats
group Id
EG000
num Affected
3
num At Risk
25
num Events
4
term
Hyponatremia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Immune system disorders
source Vocabulary
CTCAE 3.0
stats
group Id
EG000
num Affected
1
num At Risk
25
num Events
1
term
Immune system disorder
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE 3.0
stats
group Id
EG000
num Affected
3
num At Risk
25
num Events
5
term
Hypercalcemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
source Vocabulary
CTCAE 3.0
stats
group Id
EG000
num Affected
1
num At Risk
25
num Events
1
term
Confusion
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE 3.0
stats
group Id
EG000
num Affected
2
num At Risk
25
num Events
2
term
Dehydration
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE 3.0
stats
group Id
EG000
num Affected
3
num At Risk
25
num Events
5
term
Dyspnea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE 3.0
stats
group Id
EG000
num Affected
1
num At Risk
25
num Events
2
term
Edema-Head and Neck
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE 3.0
stats
group Id
EG000
num Affected
1
num At Risk
25
num Events
1
term
Edema-limb
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE 3.0
stats
group Id
EG000
num Affected
2
num At Risk
25
num Events
3
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE 3.0
stats
group Id
EG000
num Affected
1
num At Risk
25
num Events
1
term
Febrile Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE 3.0
stats
group Id
EG000
num Affected
2
num At Risk
25
num Events
3
term
Fever
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE 3.0
stats
group Id
EG000
num Affected
2
num At Risk
25
num Events
2
term
Hemoglobin

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
25
num Events
2
term
Alanine aminotransferase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
3
num At Risk
25
num Events
3
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
10
num At Risk
25
num Events
51
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
2
num At Risk
25
num Events
19
term
INR increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
5
num At Risk
25
num Events
26
term
White blood cell decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
20
num At Risk
25
num Events
166
term
Lymphocyte count decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
3
num At Risk
25
num Events
13
term
Neutrophil count decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
2
num At Risk
25
num Events
7
term
Hypophosphatemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
2
num At Risk
25
num Events
11
term
Platelet count decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
2
num At Risk
25
num Events
2
term
Rash

Complete source fields

event Groups

description
Patients will receive pemetrexed (500 mg/m2 IV infusion over approximately 10 minutes) followed immediately by gemcitabine (1250 mg/m2 IV infusion given over approximately 30 minutes) on day 1 and day 15 of a 28-day cycle.
id
EG000
other Num Affected
23
other Num At Risk
25
serious Num Affected
12
serious Num At Risk
25
title
Pemetrexed Plus Gemcitabine

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
25
num Events
2
term
Alanine aminotransferase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
3
num At Risk
25
num Events
3
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
10
num At Risk
25
num Events
51
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
2
num At Risk
25
num Events
19
term
INR increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
5
num At Risk
25
num Events
26
term
White blood cell decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
20
num At Risk
25
num Events
166
term
Lymphocyte count decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
3
num At Risk
25
num Events
13
term
Neutrophil count decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
2
num At Risk
25
num Events
7
term
Hypophosphatemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
2
num At Risk
25
num Events
11
term
Platelet count decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
2
num At Risk
25
num Events
2
term
Rash

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE 3.0
stats
group Id
EG000
num Affected
3
num At Risk
25
num Events
4
term
Hyponatremia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Immune system disorders
source Vocabulary
CTCAE 3.0
stats
group Id
EG000
num Affected
1
num At Risk
25
num Events
1
term
Immune system disorder
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE 3.0
stats
group Id
EG000
num Affected
3
num At Risk
25
num Events
5
term
Hypercalcemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
source Vocabulary
CTCAE 3.0
stats
group Id
EG000
num Affected
1
num At Risk
25
num Events
1
term
Confusion
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE 3.0
stats
group Id
EG000
num Affected
2
num At Risk
25
num Events
2
term
Dehydration
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE 3.0
stats
group Id
EG000
num Affected
3
num At Risk
25
num Events
5
term
Dyspnea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE 3.0
stats
group Id
EG000
num Affected
1
num At Risk
25
num Events
2
term
Edema-Head and Neck
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE 3.0
stats
group Id
EG000
num Affected
1
num At Risk
25
num Events
1
term
Edema-limb
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE 3.0
stats
group Id
EG000
num Affected
2
num At Risk
25
num Events
3
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE 3.0
stats
group Id
EG000
num Affected
1
num At Risk
25
num Events
1
term
Febrile Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE 3.0
stats
group Id
EG000
num Affected
2
num At Risk
25
num Events
3
term
Fever
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE 3.0
stats
group Id
EG000
num Affected
2
num At Risk
25
num Events
2
term
Hemoglobin

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Preserved source evidence · Not medical advice