NCT01087970 · ADVERSE EVENTS

Adverse events

A Study for Participants With Recurrent or Metastatic Squamous Cell Head and Neck Cancer · Source last updated 2014-05-19

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%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Cetuximab + Pemetrexed + Carboplatin Cetuximab loading dose of 400 mg/m² administered intravenously on Day 1 of Cycle 1; subsequently 250 mg/m² administered intravenously weekly. Pemetrexed 500 mg/m² administered intravenously on Day 1 of every 21-day cycle, 1 hour after cetuximab. Carboplatin AUC 5 administered intravenously on Day 1 of every 21-day cycle, 30 minutes after pemetrexed. Maximum 6 cycles. Participants who did not experience disease progression after 6 cycles continued on cetuximab (250 mg/m² intravenously weekly) monotherapy until disease progression.	23 / 63	63 / 63	Not reported / Not reported
Cetuximab + Pemetrexed + Cisplatin Cetuximab loading dose of 400 mg/m² administered intravenously on Day 1 of Cycle 1; subsequently 250 mg/m² administered intravenously weekly. Pemetrexed 500 mg/m² administered intravenously on Day 1 of every 21-day cycle, 1 hour after cetuximab. Cisplatin 75 mg/m² administered intravenously on Day 1 of every 21-day cycle, 30 minutes after pemetrexed. Maximum 6 cycles. Participants who did not experience disease progression after 6 cycles continued on cetuximab (250 mg/m² intravenously weekly) monotherapy until disease progression.	3 / 6	6 / 6	Not reported / Not reported

Group identifiers: EG000: Cetuximab + Pemetrexed + Carboplatin · EG001: Cetuximab + Pemetrexed + Cisplatin

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
Blood and lymphatic system disorders
source Vocabulary
MedDRA 16.1
stats
group Id
EG000
num Affected
2
num At Risk
63
num Events
2
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 16.1
stats
group Id
EG000
num Affected
4
num At Risk
63
num Events
4
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 16.1
stats
group Id
EG000
num Affected
1
num At Risk
63
num Events
1
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
term
Haemorrhagic disorder
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 16.1
stats
group Id
EG000
num Affected
2
num At Risk
63
num Events
2
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 16.1
stats
group Id
EG000
num Affected
1
num At Risk
63
num Events
3
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 16.1
stats
group Id
EG000
num Affected
1
num At Risk
63
num Events
1
group Id
EG001
num Affected
1
num At Risk
6
num Events
1
term
Myocardial infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 16.1
stats
group Id
EG000
num Affected
1
num At Risk
63
num Events
1
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 16.1
stats
group Id
EG000
num Affected
1
num At Risk
63
num Events
1
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 16.1
stats
group Id
EG000
num Affected
1
num At Risk
63
num Events
1
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
term
Dysphagia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 16.1
stats
group Id
EG000
num Affected
1
num At Risk
63
num Events
1
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
term
Gastrointestinal haemorrhage
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 16.1
stats
group Id
EG000
num Affected
1
num At Risk
63
num Events
1
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 16.1
stats
group Id
EG000
num Affected
1
num At Risk
63
num Events
1
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
term
Oesophageal obstruction

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
Blood and lymphatic system disorders
source Vocabulary
MedDRA 16.1
stats
group Id
EG000
num Affected
40
num At Risk
63
num Events
60
group Id
EG001
num Affected
1
num At Risk
6
num Events
1
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 16.1
stats
group Id
EG000
num Affected
8
num At Risk
63
num Events
8
group Id
EG001
num Affected
1
num At Risk
6
num Events
4
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 16.1
stats
group Id
EG000
num Affected
22
num At Risk
63
num Events
33
group Id
EG001
num Affected
2
num At Risk
6
num Events
2
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 16.1
stats
group Id
EG000
num Affected
31
num At Risk
63
num Events
58
group Id
EG001
num Affected
3
num At Risk
6
num Events
6
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 16.1
stats
group Id
EG000
num Affected
1
num At Risk
63
num Events
1
group Id
EG001
num Affected
1
num At Risk
6
num Events
1
term
Angina pectoris
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 16.1
stats
group Id
EG000
num Affected
1
num At Risk
63
num Events
1
group Id
EG001
num Affected
1
num At Risk
6
num Events
1
term
Tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA 16.1
stats
group Id
EG000
num Affected
2
num At Risk
63
num Events
2
group Id
EG001
num Affected
1
num At Risk
6
num Events
1
term
Tinnitus
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 16.1
stats
group Id
EG000
num Affected
2
num At Risk
63
num Events
2
group Id
EG001
num Affected
1
num At Risk
6
num Events
1
term
Dry eye
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 16.1
stats
group Id
EG000
num Affected
0
num At Risk
63
num Events
0
group Id
EG001
num Affected
1
num At Risk
6
num Events
1
term
Growth of eyelashes
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 16.1
stats
group Id
EG000
num Affected
6
num At Risk
63
num Events
6
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 16.1
stats
group Id
EG000
num Affected
1
num At Risk
63
num Events
1
group Id
EG001
num Affected
1
num At Risk
6
num Events
1
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 16.1
stats
group Id
EG000
num Affected
6
num At Risk
63
num Events
6
group Id
EG001
num Affected
1
num At Risk
6
num Events
1
term
Cheilitis

Complete source fields

event Groups

description
Cetuximab loading dose of 400 mg/m² administered intravenously on Day 1 of Cycle 1; subsequently 250 mg/m² administered intravenously weekly. Pemetrexed 500 mg/m² administered intravenously on Day 1 of every 21-day cycle, 1 hour after cetuximab. Carboplatin AUC 5 administered intravenously on Day 1 of every 21-day cycle, 30 minutes after pemetrexed. Maximum 6 cycles. Participants who did not experience disease progression after 6 cycles continued on cetuximab (250 mg/m² intravenously weekly) monotherapy until disease progression.
id
EG000
other Num Affected
63
other Num At Risk
63
serious Num Affected
23
serious Num At Risk
63
title
Cetuximab + Pemetrexed + Carboplatin
description
Cetuximab loading dose of 400 mg/m² administered intravenously on Day 1 of Cycle 1; subsequently 250 mg/m² administered intravenously weekly. Pemetrexed 500 mg/m² administered intravenously on Day 1 of every 21-day cycle, 1 hour after cetuximab. Cisplatin 75 mg/m² administered intravenously on Day 1 of every 21-day cycle, 30 minutes after pemetrexed. Maximum 6 cycles. Participants who did not experience disease progression after 6 cycles continued on cetuximab (250 mg/m² intravenously weekly) monotherapy until disease progression.
id
EG001
other Num Affected
6
other Num At Risk
6
serious Num Affected
3
serious Num At Risk
6
title
Cetuximab + Pemetrexed + Cisplatin

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 16.1
stats
group Id
EG000
num Affected
40
num At Risk
63
num Events
60
group Id
EG001
num Affected
1
num At Risk
6
num Events
1
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 16.1
stats
group Id
EG000
num Affected
8
num At Risk
63
num Events
8
group Id
EG001
num Affected
1
num At Risk
6
num Events
4
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 16.1
stats
group Id
EG000
num Affected
22
num At Risk
63
num Events
33
group Id
EG001
num Affected
2
num At Risk
6
num Events
2
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 16.1
stats
group Id
EG000
num Affected
31
num At Risk
63
num Events
58
group Id
EG001
num Affected
3
num At Risk
6
num Events
6
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 16.1
stats
group Id
EG000
num Affected
1
num At Risk
63
num Events
1
group Id
EG001
num Affected
1
num At Risk
6
num Events
1
term
Angina pectoris
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 16.1
stats
group Id
EG000
num Affected
1
num At Risk
63
num Events
1
group Id
EG001
num Affected
1
num At Risk
6
num Events
1
term
Tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA 16.1
stats
group Id
EG000
num Affected
2
num At Risk
63
num Events
2
group Id
EG001
num Affected
1
num At Risk
6
num Events
1
term
Tinnitus
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 16.1
stats
group Id
EG000
num Affected
2
num At Risk
63
num Events
2
group Id
EG001
num Affected
1
num At Risk
6
num Events
1
term
Dry eye
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 16.1
stats
group Id
EG000
num Affected
0
num At Risk
63
num Events
0
group Id
EG001
num Affected
1
num At Risk
6
num Events
1
term
Growth of eyelashes
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 16.1
stats
group Id
EG000
num Affected
6
num At Risk
63
num Events
6
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 16.1
stats
group Id
EG000
num Affected
1
num At Risk
63
num Events
1
group Id
EG001
num Affected
1
num At Risk
6
num Events
1
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 16.1
stats
group Id
EG000
num Affected
6
num At Risk
63
num Events
6
group Id
EG001
num Affected
1
num At Risk
6
num Events
1
term
Cheilitis

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 16.1
stats
group Id
EG000
num Affected
2
num At Risk
63
num Events
2
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 16.1
stats
group Id
EG000
num Affected
4
num At Risk
63
num Events
4
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 16.1
stats
group Id
EG000
num Affected
1
num At Risk
63
num Events
1
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
term
Haemorrhagic disorder
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 16.1
stats
group Id
EG000
num Affected
2
num At Risk
63
num Events
2
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 16.1
stats
group Id
EG000
num Affected
1
num At Risk
63
num Events
3
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 16.1
stats
group Id
EG000
num Affected
1
num At Risk
63
num Events
1
group Id
EG001
num Affected
1
num At Risk
6
num Events
1
term
Myocardial infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 16.1
stats
group Id
EG000
num Affected
1
num At Risk
63
num Events
1
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 16.1
stats
group Id
EG000
num Affected
1
num At Risk
63
num Events
1
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 16.1
stats
group Id
EG000
num Affected
1
num At Risk
63
num Events
1
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
term
Dysphagia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 16.1
stats
group Id
EG000
num Affected
1
num At Risk
63
num Events
1
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
term
Gastrointestinal haemorrhage
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 16.1
stats
group Id
EG000
num Affected
1
num At Risk
63
num Events
1
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 16.1
stats
group Id
EG000
num Affected
1
num At Risk
63
num Events
1
group Id
EG001
num Affected
0
num At Risk
6
num Events
0
term
Oesophageal obstruction

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