NCT00095875 · ADVERSE EVENTS

Adverse events

Combination Chemotherapy and Radiation in Treating Patients With Stage III or IV Head and Neck Cancer (Paradigm Trial) · Source last updated 2013-11-19

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%

Only the following adverse events were records: mucositis, febrile neutropenia, pain, xerostomia, feeding tube placement, and neuropathy which was deemed pertinent to the comparision of regimens in this setting.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Arm I Patients receive induction chemotherapy comprising docetaxel, cisplatin, and fluorouracil. Treatment repeats every 21 days for 3 courses. Patients achieving a pathologic complete response at the primary site and a clinical complete response in the neck then receive carboplatin once weekly and undergo concurrent radiotherapy once daily, 5 days a week, for 7 weeks. Patients with a partial response at the primary site (i.e., positive biopsy), stable disease, or radiographic evidence of persistent disease in the neck receive docetaxel once weekly for 4 weeks and undergo concurrent radiotherapy once or twice daily, 5 days a week, for 6 weeks. cisplatin : Given IV radiation therapy : Patients undergo radiation therapy once or twice daily, 5 days a week, for up to 7 weeks carboplatin : Given IV fluorouracil : Given IV docetaxel : Given IV	56 / 70	70 / 70	Not reported / Not reported
Arm II Patients receive cisplatin IV on weeks 1 and 4 and undergo concurrent radiotherapy once or twice daily, 5 days a week, for 6 weeks. cisplatin : Given IV radiation therapy : Patients undergo radiation therapy once or twice daily, 5 days a week, for up to 7 weeks	29 / 75	75 / 75	Not reported / Not reported

Group identifiers: EG000: Arm I · EG001: Arm II

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
33
num At Risk
70
group Id
EG001
num Affected
12
num At Risk
75
term
Mucositis
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
16
num At Risk
70
group Id
EG001
num Affected
1
num At Risk
75
term
Febrile Neutropenia
organ System
General disorders
stats
group Id
EG000
num Affected
2
num At Risk
70
group Id
EG001
num Affected
9
num At Risk
75
term
Pain
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
5
num At Risk
70
group Id
EG001
num Affected
5
num At Risk
75
term
Xerostomia
organ System
Nervous system disorders
stats
group Id
EG000
num Affected
0
num At Risk
70
group Id
EG001
num Affected
2
num At Risk
75
term
Neurpathy

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
29
num At Risk
70
group Id
EG001
num Affected
44
num At Risk
75
term
Mucositis
organ System
General disorders
stats
group Id
EG000
num Affected
41
num At Risk
70
group Id
EG001
num Affected
35
num At Risk
75
term
Pain
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
42
num At Risk
70
group Id
EG001
num Affected
46
num At Risk
75
term
Xerostomia
organ System
Immune system disorders
stats
group Id
EG000
num Affected
22
num At Risk
70
group Id
EG001
num Affected
18
num At Risk
75
term
Neuropathy

Complete source fields

description

event Groups

description
Patients receive induction chemotherapy comprising docetaxel, cisplatin, and fluorouracil. Treatment repeats every 21 days for 3 courses. Patients achieving a pathologic complete response at the primary site and a clinical complete response in the neck then receive carboplatin once weekly and undergo concurrent radiotherapy once daily, 5 days a week, for 7 weeks. Patients with a partial response at the primary site (i.e., positive biopsy), stable disease, or radiographic evidence of persistent disease in the neck receive docetaxel once weekly for 4 weeks and undergo concurrent radiotherapy once or twice daily, 5 days a week, for 6 weeks. cisplatin : Given IV radiation therapy : Patients undergo radiation therapy once or twice daily, 5 days a week, for up to 7 weeks carboplatin : Given IV fluorouracil : Given IV docetaxel : Given IV
id
EG000
other Num Affected
70
other Num At Risk
70
serious Num Affected
56
serious Num At Risk
70
title
Arm I
description
Patients receive cisplatin IV on weeks 1 and 4 and undergo concurrent radiotherapy once or twice daily, 5 days a week, for 6 weeks. cisplatin : Given IV radiation therapy : Patients undergo radiation therapy once or twice daily, 5 days a week, for up to 7 weeks
id
EG001
other Num Affected
75
other Num At Risk
75
serious Num Affected
29
serious Num At Risk
75
title
Arm II

frequency Threshold

other Events

organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
29
num At Risk
70
group Id
EG001
num Affected
44
num At Risk
75
term
Mucositis
organ System
General disorders
stats
group Id
EG000
num Affected
41
num At Risk
70
group Id
EG001
num Affected
35
num At Risk
75
term
Pain
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
42
num At Risk
70
group Id
EG001
num Affected
46
num At Risk
75
term
Xerostomia
organ System
Immune system disorders
stats
group Id
EG000
num Affected
22
num At Risk
70
group Id
EG001
num Affected
18
num At Risk
75
term
Neuropathy

serious Events

organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
33
num At Risk
70
group Id
EG001
num Affected
12
num At Risk
75
term
Mucositis
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
16
num At Risk
70
group Id
EG001
num Affected
1
num At Risk
75
term
Febrile Neutropenia
organ System
General disorders
stats
group Id
EG000
num Affected
2
num At Risk
70
group Id
EG001
num Affected
9
num At Risk
75
term
Pain
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
5
num At Risk
70
group Id
EG001
num Affected
5
num At Risk
75
term
Xerostomia
organ System
Nervous system disorders
stats
group Id
EG000
num Affected
0
num At Risk
70
group Id
EG001
num Affected
2
num At Risk
75
term
Neurpathy

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice