NCT00446225 · ADVERSE EVENTS

Adverse events

Phase III Study (Tarceva®) vs Chemotherapy to Treat Advanced Non-Small Cell Lung Cancer in Patients With Mutations in the TK Domain of EGFR · Source last updated 2025-03-05

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: 36 months
Other-event reporting threshold: 5%

The severity of AE will be determined using CTCAE version 3.0

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
A: Erlotinib Group Erlotinib (Tarceva)150 mg /day Patients will receive treatment until disease progression or unacceptable toxicity. For all practical effects a treatment cycle will be defined as three weeks of continuous treatment with erlotinib Erlotinib: 150 mg/day Patients will receive treatment until disease progression or unacceptable toxicity. For all practical effects a treatment cycle will be defined as three weeks of continuous treatment with erlotinib	27 / 86	70 / 86	55 / 86
B: Standard Chemotherapy Group 4 cycles of Chemotherapy: Cisplatin / Gemcitabine; Cisplatin /Docetaxel; Carboplatin / Gemcitabine; Carboplatin / Docetaxel. 3 week cycles of standard intravenous chemotherapy * 75 mg/m² cisplatin plus 75 mg/m² docetaxel on day 1 or * 75 mg/m² cisplatin on day 1 plus 1250 mg/m² gemcitabine on days 1 and 8 Patients who were ineligible for cisplatin treatment received intra venous carboplatin chemotherapy instead: * 3 week cycles of carboplatin AUC 6 on day 1 with 75 mg/m² docetaxel on day 1 or * 3 week cycles carboplatin AUC 5 on day 1 with 1000 mg/m² gemcitabine on days 1 and 8 Patients in the chemotherapy arm will receive the treatment until disease progression or unacceptable toxicity occurs, or until a maximum of 4 treatment cycles are given.	25 / 87	65 / 87	54 / 87

Group identifiers: EG000: A: Erlotinib Group · EG001: B: Standard Chemotherapy Group

Serious adverse events

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

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
86
num Events
1
group Id
EG001
num Affected
3
num At Risk
87
num Events
3
term
Respiratory tract infection
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
stats
group Id
EG000
num Affected
2
num At Risk
86
num Events
2
group Id
EG001
num Affected
1
num At Risk
87
num Events
1
term
Pneumonia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
0
num At Risk
86
num Events
0
group Id
EG001
num Affected
1
num At Risk
87
num Events
1
term
Gastroenteritis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
stats
group Id
EG000
num Affected
1
num At Risk
86
num Events
1
group Id
EG001
num Affected
1
num At Risk
87
num Events
1
term
Infection
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
stats
group Id
EG000
num Affected
1
num At Risk
86
num Events
1
group Id
EG001
num Affected
0
num At Risk
87
num Events
0
term
Pyelonephritis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
stats
group Id
EG000
num Affected
1
num At Risk
86
num Events
1
group Id
EG001
num Affected
1
num At Risk
87
num Events
1
term
Sepsis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
stats
group Id
EG000
num Affected
1
num At Risk
86
num Events
1
group Id
EG001
num Affected
0
num At Risk
87
num Events
0
term
Subcutaneous abscess
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
stats
group Id
EG000
num Affected
1
num At Risk
86
num Events
1
group Id
EG001
num Affected
0
num At Risk
87
num Events
0
term
Upper respiratory tract infection
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
stats
group Id
EG000
num Affected
1
num At Risk
86
num Events
1
group Id
EG001
num Affected
0
num At Risk
87
num Events
0
term
Urinary tract infection
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
stats
group Id
EG000
num Affected
3
num At Risk
86
num Events
3
group Id
EG001
num Affected
1
num At Risk
87
num Events
1
term
Pulmonary embolism
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
stats
group Id
EG000
num Affected
2
num At Risk
86
num Events
2
group Id
EG001
num Affected
1
num At Risk
87
num Events
1
term
Pneumonitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
stats
group Id
EG000
num Affected
2
num At Risk
86
num Events
2
group Id
EG001
num Affected
1
num At Risk
87
num Events
1
term
Dyspnoea

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
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
48
num At Risk
86
num Events
48
group Id
EG001
num Affected
56
num At Risk
87
num Events
56
term
Fatigue
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
stats
group Id
EG000
num Affected
66
num At Risk
86
num Events
66
group Id
EG001
num Affected
4
num At Risk
87
num Events
4
term
Rash
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
10
num At Risk
86
num Events
10
group Id
EG001
num Affected
40
num At Risk
87
num Events
40
term
Anaemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
stats
group Id
EG000
num Affected
12
num At Risk
86
num Events
12
group Id
EG001
num Affected
15
num At Risk
87
num Events
15
term
Alopecia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
5
num At Risk
86
num Events
5
group Id
EG001
num Affected
5
num At Risk
87
num Events
5
term
Aminotransferase rise
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
stats
group Id
EG000
num Affected
8
num At Risk
86
num Events
8
group Id
EG001
num Affected
12
num At Risk
87
num Events
12
term
Neuropathy

Complete source fields

description

The severity of AE will be determined using CTCAE version 3.0

event Groups

deaths Num Affected
55
deaths Num At Risk
86
description
Erlotinib (Tarceva)150 mg /day Patients will receive treatment until disease progression or unacceptable toxicity. For all practical effects a treatment cycle will be defined as three weeks of continuous treatment with erlotinib Erlotinib: 150 mg/day Patients will receive treatment until disease progression or unacceptable toxicity. For all practical effects a treatment cycle will be defined as three weeks of continuous treatment with erlotinib
id
EG000
other Num Affected
70
other Num At Risk
86
serious Num Affected
27
serious Num At Risk
86
title
A: Erlotinib Group
deaths Num Affected
54
deaths Num At Risk
87
description
4 cycles of Chemotherapy: Cisplatin / Gemcitabine; Cisplatin /Docetaxel; Carboplatin / Gemcitabine; Carboplatin / Docetaxel. 3 week cycles of standard intravenous chemotherapy * 75 mg/m² cisplatin plus 75 mg/m² docetaxel on day 1 or * 75 mg/m² cisplatin on day 1 plus 1250 mg/m² gemcitabine on days 1 and 8 Patients who were ineligible for cisplatin treatment received intra venous carboplatin chemotherapy instead: * 3 week cycles of carboplatin AUC 6 on day 1 with 75 mg/m² docetaxel on day 1 or * 3 week cycles carboplatin AUC 5 on day 1 with 1000 mg/m² gemcitabine on days 1 and 8 Patients in the chemotherapy arm will receive the treatment until disease progression or unacceptable toxicity occurs, or until a maximum of 4 treatment cycles are given.
id
EG001
other Num Affected
65
other Num At Risk
87
serious Num Affected
25
serious Num At Risk
87
title
B: Standard Chemotherapy Group

frequency Threshold

other Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
48
num At Risk
86
num Events
48
group Id
EG001
num Affected
56
num At Risk
87
num Events
56
term
Fatigue
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
stats
group Id
EG000
num Affected
66
num At Risk
86
num Events
66
group Id
EG001
num Affected
4
num At Risk
87
num Events
4
term
Rash
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
10
num At Risk
86
num Events
10
group Id
EG001
num Affected
40
num At Risk
87
num Events
40
term
Anaemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
stats
group Id
EG000
num Affected
12
num At Risk
86
num Events
12
group Id
EG001
num Affected
15
num At Risk
87
num Events
15
term
Alopecia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
5
num At Risk
86
num Events
5
group Id
EG001
num Affected
5
num At Risk
87
num Events
5
term
Aminotransferase rise
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
stats
group Id
EG000
num Affected
8
num At Risk
86
num Events
8
group Id
EG001
num Affected
12
num At Risk
87
num Events
12
term
Neuropathy

serious Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
86
num Events
1
group Id
EG001
num Affected
3
num At Risk
87
num Events
3
term
Respiratory tract infection
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
stats
group Id
EG000
num Affected
2
num At Risk
86
num Events
2
group Id
EG001
num Affected
1
num At Risk
87
num Events
1
term
Pneumonia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
0
num At Risk
86
num Events
0
group Id
EG001
num Affected
1
num At Risk
87
num Events
1
term
Gastroenteritis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
stats
group Id
EG000
num Affected
1
num At Risk
86
num Events
1
group Id
EG001
num Affected
1
num At Risk
87
num Events
1
term
Infection
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
stats
group Id
EG000
num Affected
1
num At Risk
86
num Events
1
group Id
EG001
num Affected
0
num At Risk
87
num Events
0
term
Pyelonephritis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
stats
group Id
EG000
num Affected
1
num At Risk
86
num Events
1
group Id
EG001
num Affected
1
num At Risk
87
num Events
1
term
Sepsis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
stats
group Id
EG000
num Affected
1
num At Risk
86
num Events
1
group Id
EG001
num Affected
0
num At Risk
87
num Events
0
term
Subcutaneous abscess
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
stats
group Id
EG000
num Affected
1
num At Risk
86
num Events
1
group Id
EG001
num Affected
0
num At Risk
87
num Events
0
term
Upper respiratory tract infection
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
stats
group Id
EG000
num Affected
1
num At Risk
86
num Events
1
group Id
EG001
num Affected
0
num At Risk
87
num Events
0
term
Urinary tract infection
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
stats
group Id
EG000
num Affected
3
num At Risk
86
num Events
3
group Id
EG001
num Affected
1
num At Risk
87
num Events
1
term
Pulmonary embolism
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
stats
group Id
EG000
num Affected
2
num At Risk
86
num Events
2
group Id
EG001
num Affected
1
num At Risk
87
num Events
1
term
Pneumonitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
stats
group Id
EG000
num Affected
2
num At Risk
86
num Events
2
group Id
EG001
num Affected
1
num At Risk
87
num Events
1
term
Dyspnoea

time Frame

36 months

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Preserved source evidence · Not medical advice