Time Frame |
[Not Specified]
|
Adverse Event Reporting Description |
[Not Specified]
|
|
Arm/Group Title
|
Erlotinib in Combination With Radiotherapy
|
Arm/Group Description |
Erlotinib (150 mg) administered ora...
|
Arm/Group Description |
Erlotinib (150 mg) administered orally once daily starting day 1 and continued with radiotherapy (RT) and through day 365 (one year therapy duration). RT will be administered day 1-28 (Mon-Fri) in dose of 1.8 Gy per fraction.
|
|
|
Erlotinib in Combination With Radiotherapy
|
|
Affected / at Risk (%) |
|
Total |
--/--
|
|
|
|
Erlotinib in Combination With Radiotherapy
|
|
Affected / at Risk (%) |
# Events
|
Total |
9/17 (52.94%)
|
|
Cardiac disorders |
|
Cardiac failure congestive - Grade 5 |
1/17 (5.88%)
|
1 |
Myocardial infarction - Grade 4 |
1/17 (5.88%)
|
1 |
Gastrointestinal disorders |
|
Diarrhoea - Grade 3 |
3/17 (17.65%)
|
5 |
Ileus - Grade 3 |
2/17 (11.76%)
|
2 |
Oesophageal stenosis - Grade 2 |
1/17 (5.88%)
|
1 |
General disorders |
|
Death - Grade 5 |
2/17 (11.76%)
|
2 |
Fatigue - Grade 3 |
1/17 (5.88%)
|
1 |
Non-cardiac chest pain - Grade 3 |
1/17 (5.88%)
|
1 |
Infections and infestations |
|
Pneumonia - Grade 3 |
1/17 (5.88%)
|
1 |
Investigations |
|
Haemoglobin - Grade 2 |
1/17 (5.88%)
|
1 |
Metabolism and nutrition disorders |
|
Dehydration - Grade 3 |
3/17 (17.65%)
|
4 |
Hyperglycaemia - Grade 2 |
1/17 (5.88%)
|
1 |
Hypoalbuminaemia - Grade 2 |
1/17 (5.88%)
|
1 |
Musculoskeletal and connective tissue disorders |
|
Pain in extremity - Grade 3 |
1/17 (5.88%)
|
1 |
Nervous system disorders |
|
Nervous system disorder - Grade 4 |
1/17 (5.88%)
|
1 |
Respiratory, thoracic and mediastinal disorders |
|
Dyspnoea - Grade 4 |
1/17 (5.88%)
|
1 |
Respiratory distress - Grade 3 |
1/17 (5.88%)
|
1 |
Indicates events were collected by systematic assessment
|
|
Frequency Threshold for Reporting Other Adverse Events
|
0%
|
|
Erlotinib in Combination With Radiotherapy
|
|
Affected / at Risk (%) |
# Events
|
Total |
17/17 (100.00%)
|
|
Blood and lymphatic system disorders |
|
Anaemia - Grade 1 |
1/17 (5.88%)
|
2 |
Anaemia - Grade 2 |
2/17 (11.76%)
|
2 |
Leukopenia - Grade 1 |
3/17 (17.65%)
|
4 |
Leukopenia - Grade 2 |
1/17 (5.88%)
|
1 |
Lymphopenia - Grade 1 |
7/17 (41.18%)
|
10 |
Lymphopenia - Grade 2 |
11/17 (64.71%)
|
17 |
Lymphopenia - Grade 3 |
8/17 (47.06%)
|
10 |
Lymphopenia - Grade 4 |
2/17 (11.76%)
|
2 |
Neutropenia - Grade 1 |
1/17 (5.88%)
|
2 |
Neutropenia - Grade 2 |
1/17 (5.88%)
|
1 |
Thrombocytopenia - Grade 1 |
2/17 (11.76%)
|
2 |
Cardiac disorders |
|
Acute myocardial infarction - Grade 4 |
1/17 (5.88%)
|
1 |
Angina pectoris - Grade 1 |
1/17 (5.88%)
|
1 |
Angina pectoris - Grade 2 |
1/17 (5.88%)
|
2 |
Ventricular arrhythmia - Grade 4 |
1/17 (5.88%)
|
1 |
Eye disorders |
|
Vision blurred - Grade 3 |
1/17 (5.88%)
|
1 |
Gastrointestinal disorders |
|
Abdominal distension - Grade 1 |
1/17 (5.88%)
|
1 |
Abdominal pain - Grade 1 |
3/17 (17.65%)
|
3 |
Chapped lips - Grade 1 |
1/17 (5.88%)
|
1 |
Constipation - Grade 1 |
2/17 (11.76%)
|
2 |
Constipation - Grade 2 |
1/17 (5.88%)
|
2 |
Diarrhoea - Grade 1 |
8/17 (47.06%)
|
16 |
Diarrhoea - Grade 2 |
3/17 (17.65%)
|
3 |
Dyspepsia - Grade 1 |
1/17 (5.88%)
|
1 |
Dyspepsia - Grade 2 |
1/17 (5.88%)
|
1 |
Dysphagia - Grade 1 |
2/17 (11.76%)
|
2 |
Dysphagia - Grade 2 |
5/17 (29.41%)
|
5 |
Dysphagia - Grade 3 |
2/17 (11.76%)
|
2 |
Eructation - Grade 1 |
1/17 (5.88%)
|
1 |
Flatulence - Grade 1 |
1/17 (5.88%)
|
1 |
Gastritis - Grade 1 |
1/17 (5.88%)
|
1 |
Gastrooesophageal reflux disease - Grade 1 |
1/17 (5.88%)
|
1 |
Impaired gastric emptying - Grade 2 |
1/17 (5.88%)
|
1 |
Nausea - Grade 1 |
6/17 (35.29%)
|
10 |
Nausea - Grade 2 |
1/17 (5.88%)
|
1 |
Nausea - Grade 3 |
1/17 (5.88%)
|
1 |
Odynophagia - Grade 1 |
1/17 (5.88%)
|
1 |
Odynophagia - Grade 2 |
1/17 (5.88%)
|
1 |
Oesophageal obstruction - Grade 3 |
1/17 (5.88%)
|
1 |
Oesophageal stenosis - Grade 2 |
2/17 (11.76%)
|
2 |
Oesophageal stenosis - Grade 3 |
1/17 (5.88%)
|
1 |
Oesophagitis - Grade 1 |
1/17 (5.88%)
|
1 |
Oesophagitis - Grade 2 |
2/17 (11.76%)
|
2 |
Reflux oesophagitis - Grade 1 |
1/17 (5.88%)
|
1 |
Reflux oesophagitis - Grade 2 |
2/17 (11.76%)
|
2 |
Retching - Grade 1 |
1/17 (5.88%)
|
1 |
Stomatitis - Grade 1 |
2/17 (11.76%)
|
2 |
Stomatitis - Grade 2 |
2/17 (11.76%)
|
2 |
Vomiting - Grade 1 |
4/17 (23.53%)
|
8 |
Vomiting - Grade 2 |
3/17 (17.65%)
|
3 |
General disorders |
|
Chills - Grade 1 |
1/17 (5.88%)
|
1 |
Early satiety - Grade 2 |
1/17 (5.88%)
|
1 |
Fatigue - Grade 1 |
11/17 (64.71%)
|
14 |
Fatigue - Grade 2 |
12/17 (70.59%)
|
12 |
Fatigue - Grade 3 |
1/17 (5.88%)
|
1 |
Mucosal inflammation - Grade 1 |
4/17 (23.53%)
|
6 |
Oedema - Grade 1 |
1/17 (5.88%)
|
1 |
Oedema peripheral - Grade 1 |
3/17 (17.65%)
|
3 |
Oedema peripheral - Grade 2 |
1/17 (5.88%)
|
1 |
Pain - Grade 2 |
3/17 (17.65%)
|
3 |
Hepatobiliary disorders |
|
Hyperbilirubinaemia - Grade 1 |
2/17 (11.76%)
|
4 |
Hyperbilirubinaemia - Grade 2 |
1/17 (5.88%)
|
1 |
Infections and infestations |
|
Fungal skin infection - Grade 1 |
1/17 (5.88%)
|
1 |
Fungal skin infection - Grade 2 |
1/17 (5.88%)
|
2 |
Infection - Grade 2 |
1/17 (5.88%)
|
2 |
Urinary tract infection - Grade 2 |
2/17 (11.76%)
|
2 |
Injury, poisoning and procedural complications |
|
Contusion - Grade 1 |
1/17 (5.88%)
|
1 |
Facial bones fracture - Grade 2 |
1/17 (5.88%)
|
1 |
Procedural site reaction - Grade 2 |
1/17 (5.88%)
|
1 |
Rib fracture - Grade 2 |
1/17 (5.88%)
|
1 |
Skin laceration - Grade 2 |
1/17 (5.88%)
|
1 |
Investigations |
|
Alanine aminotransferase increased - Grade 1 |
3/17 (17.65%)
|
3 |
Aspartate aminotransferase - Grade 1 |
2/17 (11.76%)
|
2 |
Aspartate aminotransferase increased - Grade 1 |
5/17 (29.41%)
|
7 |
Aspartate aminotransferase increased - Grade 2 |
1/17 (5.88%)
|
1 |
Blood alkaline phosphatase - Grade 1 |
2/17 (11.76%)
|
3 |
Blood alkaline phosphatase - Grade 2 |
1/17 (5.88%)
|
1 |
Blood alkaline phosphatase increased - Grade 1 |
1/17 (5.88%)
|
1 |
Blood bilirubin - Grade 1 |
2/17 (11.76%)
|
2 |
Blood bilirubin - Grade 2 |
2/17 (11.76%)
|
2 |
Blood bilirubin increased - Grade 1 |
1/17 (5.88%)
|
1 |
Blood bilirubin increased - Grade 2 |
1/17 (5.88%)
|
2 |
Blood calcium decreased - Grade 1 |
1/17 (5.88%)
|
1 |
Blood creatine - Grade 2 |
1/17 (5.88%)
|
1 |
Blood creatine increased - Grade 1 |
1/17 (5.88%)
|
1 |
Blood creatinine - Grade 1 |
3/17 (17.65%)
|
3 |
Blood creatinine - Grade 2 |
1/17 (5.88%)
|
5 |
Haemoglobin - Grade 1 |
6/17 (35.29%)
|
7 |
International normalised ratio increased - Grade 1 |
1/17 (5.88%)
|
1 |
International normalised ratio increased - Grade 2 |
1/17 (5.88%)
|
1 |
International normalised ratio increased - Grade 3 |
1/17 (5.88%)
|
2 |
Platelet count decreased - Grade 1 |
4/17 (23.53%)
|
6 |
Troponin I increased - Grade 4 |
1/17 (5.88%)
|
1 |
Weight decreased - Grade 1 |
10/17 (58.82%)
|
11 |
Weight decreased - Grade 2 |
5/17 (29.41%)
|
5 |
Metabolism and nutrition disorders |
|
Anorexia - Grade 1 |
4/17 (23.53%)
|
6 |
Anorexia - Grade 2 |
5/17 (29.41%)
|
6 |
Anorexia - Grade 3 |
1/17 (5.88%)
|
1 |
Dehydration - Grade 1 |
1/17 (5.88%)
|
1 |
Dehydration - Grade 2 |
5/17 (29.41%)
|
6 |
Gout - Grade 2 |
1/17 (5.88%)
|
1 |
Hypercalcaemia - Grade 1 |
1/17 (5.88%)
|
2 |
Hyperglycaemia - Grade 1 |
4/17 (23.53%)
|
7 |
Hyperglycaemia - Grade 2 |
4/17 (23.53%)
|
5 |
Hyperkalaemia - Grade 1 |
3/17 (17.65%)
|
4 |
Hypernatraemia - Grade 1 |
1/17 (5.88%)
|
1 |
Hypoalbuminaemia - Grade 1 |
5/17 (29.41%)
|
5 |
Hypoalbuminaemia - Grade 2 |
4/17 (23.53%)
|
6 |
Hypocalcaemia - Grade 1 |
2/17 (11.76%)
|
4 |
Hypocalcaemia - Grade 2 |
1/17 (5.88%)
|
1 |
Hypoglycaemia - Grade 1 |
1/17 (5.88%)
|
1 |
Hypokalaemia - Grade 1 |
2/17 (11.76%)
|
2 |
Hypomagnesaemia - Grade 1 |
1/17 (5.88%)
|
1 |
Hyponatraemia - Grade 1 |
6/17 (35.29%)
|
8 |
Hyponatraemia - Grade 3 |
1/17 (5.88%)
|
1 |
Musculoskeletal and connective tissue disorders |
|
Arthralgia - Grade 1 |
1/17 (5.88%)
|
2 |
Back pain - Grade 1 |
3/17 (17.65%)
|
3 |
Buttock pain - Grade 1 |
1/17 (5.88%)
|
1 |
Gouty arthritis - Grade 1 |
1/17 (5.88%)
|
1 |
Groin pain - Grade 1 |
2/17 (11.76%)
|
2 |
Groin pain - Grade 2 |
1/17 (5.88%)
|
1 |
Muscle spasms - Grade 1 |
1/17 (5.88%)
|
1 |
Musculoskeletal chest pain - Grade 1 |
1/17 (5.88%)
|
1 |
Musculoskeletal chest pain - Grade 2 |
1/17 (5.88%)
|
1 |
Musculoskeletal pain - Grade 2 |
2/17 (11.76%)
|
2 |
Pain in extremity - Grade 1 |
1/17 (5.88%)
|
1 |
Pain in extremity - Grade 2 |
2/17 (11.76%)
|
2 |
Nervous system disorders |
|
Dizziness - Grade 1 |
1/17 (5.88%)
|
3 |
Dizziness - Grade 2 |
1/17 (5.88%)
|
1 |
Dysgeusia - Grade 1 |
4/17 (23.53%)
|
5 |
Headache - Grade 1 |
1/17 (5.88%)
|
1 |
Syncope - Grade 3 |
2/17 (11.76%)
|
2 |
Tremor - Grade 1 |
1/17 (5.88%)
|
1 |
Psychiatric disorders |
|
Depression - Grade 1 |
1/17 (5.88%)
|
1 |
Depression - Grade 2 |
2/17 (11.76%)
|
2 |
Insomnia - Grade 1 |
1/17 (5.88%)
|
1 |
Insomnia - Grade 2 |
2/17 (11.76%)
|
2 |
Renal and urinary disorders |
|
Pollakiuria - Grade 2 |
1/17 (5.88%)
|
1 |
Respiratory, thoracic and mediastinal disorders |
|
Cough - Grade 1 |
4/17 (23.53%)
|
5 |
Dysphonia - Grade 1 |
2/17 (11.76%)
|
2 |
Dysphonia - Grade 2 |
1/17 (5.88%)
|
1 |
Dyspnoea - Grade 1 |
2/17 (11.76%)
|
2 |
Dyspnoea - Grade 3 |
2/17 (11.76%)
|
2 |
Epistaxis - Grade 1 |
1/17 (5.88%)
|
1 |
Epistaxis - Grade 2 |
1/17 (5.88%)
|
1 |
Hiccups - Grade 1 |
1/17 (5.88%)
|
1 |
Skin and subcutaneous tissue disorders |
|
Decubitus ulcer - Grade 2 |
1/17 (5.88%)
|
1 |
Dermatitis acneiform - Grade 1 |
1/17 (5.88%)
|
1 |
Dermatitis acneiform - Grade 2 |
1/17 (5.88%)
|
1 |
Drug eruption - Grade 1 |
3/17 (17.65%)
|
3 |
Drug eruption - Grade 2 |
3/17 (17.65%)
|
4 |
Hyperhidrosis - Grade 2 |
1/17 (5.88%)
|
1 |
Palmar-plantar erythrodysaesthesia syndrome - Grade 1 |
2/17 (11.76%)
|
4 |
Palmar-plantar erythrodysaesthesia syndrome - Grade 2 |
2/17 (11.76%)
|
2 |
Pruritus - Grade 1 |
1/17 (5.88%)
|
1 |
Pruritus - Grade 2 |
1/17 (5.88%)
|
1 |
Rash - Grade 1 |
6/17 (35.29%)
|
14 |
Rash - Grade 2 |
7/17 (41.18%)
|
8 |
Rash pruritic - Grade 2 |
1/17 (5.88%)
|
1 |
Skin disorder - Grade 2 |
1/17 (5.88%)
|
1 |
Skin exfoliation - Grade 1 |
1/17 (5.88%)
|
1 |
Skin ulcer - Grade 1 |
1/17 (5.88%)
|
1 |
Vascular disorders |
|
Deep vein thrombosis - Grade 3 |
1/17 (5.88%)
|
1 |
Hypotension - Grade 2 |
1/17 (5.88%)
|
1 |
Hypotension - Grade 4 |
1/17 (5.88%)
|
1 |
Orthostatic hypotension - Grade 1 |
1/17 (5.88%)
|
2 |
Orthostatic hypotension - Grade 2 |
1/17 (5.88%)
|
1 |
Indicates events were collected by systematic assessment
|