Study: NCT00642746

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Patient admitted with GI hemorrhage and malignant ascites, attributed to his underlying disease.
Frequency: 1 affected / 9 at risk

Adverse event: Malignant ascites
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Patient admitted with GI hemorrhage and malignant ascites, attributed to his underlying disease.
Frequency: 1 affected / 9 at risk

Adverse event: Asthenia
Serious: yes
Organ System: General disorders
Notes: Patient admitted for weakness, fatigue, leukopenia, hyperbilirubinemia, and thrombocytopenia. All related to Fluorouracil, Leucovorin, and Irinotecan , and possibly related to Erlotinib, per the Investigator.
Frequency: 1 affected / 9 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Notes: Patient admitted for weakness, fatigue, leukopenia, hyperbilirubinemia, and thrombocytopenia. All related to Fluorouracil, Leucovorin, and Irinotecan , and possibly related to Erlotinib, per the Investigator.
Frequency: 1 affected / 9 at risk

Adverse event: Leukopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Patient admitted for weakness, fatigue, leukopenia, hyperbilirubinemia, and thrombocytopenia. All related to Fluorouracil, Leucovorin, and Irinotecan, and possibly related to Erlotinib, per the Investigator.
Frequency: 1 affected / 9 at risk

Adverse event: Hyperbilirubinaemia
Serious: yes
Organ System: Investigations
Notes: Patient admitted for weakness, fatigue, leukopenia, hyperbilirubinemia, and thrombocytopenia. All related to Fluorouracil, Leucovorin, and Irinotecan, and possibly related to Erlotinib, per the Investigator.
Frequency: 1 affected / 9 at risk

Adverse event: Thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Patient admitted for weakness, fatigue, leukopenia, hyperbilirubinemia, and thrombocytopenia. All related to Fluorouracil, Leucovorin, and Irinotecan, and possibly related to Erlotinib, per the Investigator.
Frequency: 1 affected / 9 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Grade 3 or 4 Neutropenia while on trial.
Frequency: 6 affected / 9 at risk

Adverse event: Oral pain
Serious: no
Organ System: General disorders
Notes: Grade 3 or 4 Oral Pain
Frequency: 2 affected / 9 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 3 or 4 Diarrhea
Frequency: 1 affected / 9 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 3 or 4 Nausea
Frequency: 1 affected / 9 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Grade 3 or 4 Rash
Frequency: 1 affected / 9 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Grade 3 or 4 Hyponatremia
Frequency: 1 affected / 9 at risk

Adverse event: International Normalized Ratio Elevation
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Grade 3 or 4
Frequency: 1 affected / 9 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: General disorders
Notes: Grade 3 or 4 Abdominal Pain
Frequency: 1 affected / 9 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 3 or 4 GI Bleed
Frequency: 1 affected / 9 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Grade 3 or 4 Fatigue
Frequency: 1 affected / 9 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Grade 3 or 4 Leukopenia
Frequency: 1 affected / 9 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Grade 3 or 4 Neutropenia while on trial.
Frequency: 1 affected / 1 at risk