Study: NCT00828672

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Notes: Seizure Gr 2 in a patient with epileptic background - During chemoradiotherapy
Frequency: 1 affected / 43 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Notes: Fever Gr 1 - During chemoradiotherapy
Frequency: 3 affected / 43 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Diarrhea Gr 3 - During chemoradiotherapy
Frequency: 3 affected / 43 at risk

Adverse event: Leak
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Anastomotic leak Gr 3; 2 in arm 1 and 3 in arm 2 - all events also SAE - Postoperative
Frequency: 2 affected / 43 at risk

Adverse event: Obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Obstruction GI Gr 2 and Gr 3; both arm 1 Postoperative
Frequency: 2 affected / 43 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Infections and infestations
Notes: Febrile neutropenia Gr 3 - During chemoradiotherapy
Frequency: 1 affected / 43 at risk

Adverse event: Septic shock
Serious: yes
Organ System: Infections and infestations
Notes: Catheter related infection Gr 4 - During chemoradiotherapy
Frequency: 1 affected / 43 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Notes: Urinary tract infection Gr 2 (1 in each arm) and 1 Urinary tract infection Gr 3 in arm 1 - During chemoradiotherapy
Frequency: 2 affected / 43 at risk

Adverse event: Catheter site infection
Serious: yes
Organ System: Infections and infestations
Notes: Catheter site infection Gr 3 with positive hemocultures - Postoperative
Frequency: 1 affected / 43 at risk

Adverse event: Wound infection
Serious: yes
Organ System: Infections and infestations
Notes: 5 peri-anal wound infections Gr 3 (4 in arm 1; 1 in arm 2) ; 1 wound with evisceration Gr 4 in arm 1 ; 1 Gr 5 wound infection in a patient with tumor break during surgery in arm 2
Frequency: 5 affected / 43 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Fatigue Gr 3 (2 pts in arm 1 and 1 pt in arm 2 - also an SAE for this pt) - during chemoradiotherapy
Frequency: 2 affected / 43 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: General disorders
Notes: Sweating Gr 3 - Postoperative
Frequency: 1 affected / 43 at risk

Adverse event: Hypertension b
Serious: no
Organ System: Cardiac disorders
Notes: Hypertension Gr 3 - baseline
Frequency: 1 affected / 43 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Platelet count decreased Gr 3 - during chemoradiotherapy
Frequency: 1 affected / 43 at risk

Adverse event: Dissiminated Intravascular Coagulation
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Disseminated Intravascular Coagulation Gr 3 - during chemoradiotherapy
Frequency: 1 affected / 43 at risk

Adverse event: Neuropathy sensory
Serious: no
Organ System: Nervous system disorders
Notes: Neuropathy sensory Gr 3 - during chemoradiotherapy
Frequency: 1 affected / 43 at risk

Adverse event: Syncope
Serious: no
Organ System: Nervous system disorders
Notes: Syncope Gr 3 - during chemoradiotherapy
Frequency: 1 affected / 43 at risk

Adverse event: Meniere's disease
Serious: no
Organ System: Ear and labyrinth disorders
Notes: Pt with baseline Meniere's disease Gr 3 (since 1999) - Baseline
Frequency: 1 affected / 43 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Gastrointestinal disorders
Notes: Anorexia Gr 3 - during chemoradiotherapy
Frequency: 1 affected / 43 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Diarrhea Gr 3 in 4 pts in arm 1 (three episodes were an SAE) - during chemoradiotherapy
Frequency: 4 affected / 43 at risk

Adverse event: Leak Gi
Serious: no
Organ System: Gastrointestinal disorders
Notes: Leak GI Gr 3 - postoperative
Frequency: 2 affected / 43 at risk

Adverse event: Obstruction Gi
Serious: no
Organ System: Gastrointestinal disorders
Notes: Obstruction GI Gr 3 in 2 pts in arm 1 (for 1 also an SAE) and in 1 pt in arm 2 (also an SAE) - postoperative
Frequency: 2 affected / 43 at risk

Adverse event: Pain GI
Serious: no
Organ System: Gastrointestinal disorders
Notes: Stomach pain Gr 3 and pain due to leak Gr 3 - postoperative
Frequency: 2 affected / 43 at risk

Adverse event: Dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Dermatitis associated with radiotherapy Gr 3
Frequency: 1 affected / 43 at risk

Adverse event: Pain musculoskeletal
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Pain musculoskeletal Gr 3 - Postoperative
Frequency: 1 affected / 43 at risk

Adverse event: Pain muskuloskeletal Gr 3
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Pain muskuloskeletal Gr 3 - postoperative
Frequency: 1 affected / 43 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Hypocalcemia Gr 3 - during chemoradiotherapy
Frequency: 1 affected / 43 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Hypokalemia Gr 3 - during chemoradiotherapy
Frequency: 1 affected / 43 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Hyponatremia Gr 3 - during chemoradiotherapy
Frequency: 1 affected / 43 at risk

Adverse event: Febrile neutropenia
Serious: no
Organ System: Infections and infestations
Notes: Febrile neutropenia Gr 3 (also an SAE) - during chemoradiotherapy
Frequency: 1 affected / 43 at risk

Adverse event: Catheter site infection
Serious: no
Organ System: Infections and infestations
Notes: Catheter site infection Gr 3 (also an SAE) - during chemoradiotherapy
Frequency: 1 affected / 43 at risk

Adverse event: Sepsis
Serious: no
Organ System: Infections and infestations
Notes: Sepsis Gr 3 and septic shock Gr 4 - during chemoradiotherapy
Frequency: 2 affected / 43 at risk

Adverse event: Wound infection
Serious: no
Organ System: Infections and infestations
Notes: 5 peri-anal wound infections Gr 3 ; 1 wound infection with evisceration Gr 4 ; 1 Gr 5 wound infection in a patient with tumor break during surgery
Frequency: 5 affected / 43 at risk

Adverse event: Infection due to leak of anastomosis
Serious: no
Organ System: Infections and infestations
Notes: Infection due to leak of anastomosis Gr 3 (part of an SAE) - follow-up
Frequency: 1 affected / 43 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Vascular disorders
Notes: Lung embolism Gr 5 - Postoperative
Frequency: 1 affected / 41 at risk

Adverse event: Neuropathy motor
Serious: yes
Organ System: Nervous system disorders
Notes: Neuropathy, motor (cranial, palate, pharynx) Gr 3 (swallowing problems) - During chemoradiotherapy
Frequency: 1 affected / 41 at risk

Adverse event: Depression
Serious: yes
Organ System: Psychiatric disorders
Notes: Depression Gr 3 - During chemoradiotherapy
Frequency: 1 affected / 41 at risk

Adverse event: Rectal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Rectal haemorrhage Gr 2 following rectal biopsy. During chemoradiotherapy
Frequency: 1 affected / 41 at risk

Adverse event: Fistula
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Fistula Gr 3 - Postoperative
Frequency: 1 affected / 41 at risk

Adverse event: Leak
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Anastomotic leak Gr 3; 2 in arm 1 and 3 in arm 2 - all events also SAE - Postoperative
Frequency: 3 affected / 41 at risk

Adverse event: Presacral hematoma
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Presacral hematoma Gr 2 - Postoperative
Frequency: 1 affected / 41 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Notes: Urinary tract infection Gr 2 (1 in each arm) and 1 Urinary tract infection Gr 3 in arm 1 - During chemoradiotherapy
Frequency: 1 affected / 41 at risk

Adverse event: Wound infection
Serious: yes
Organ System: Infections and infestations
Notes: 5 peri-anal wound infections Gr 3 (4 in arm 1; 1 in arm 2) ; 1 wound with evisceration Gr 4 in arm 1 ; 1 Gr 5 wound infection in a patient with tumor break during surgery in arm 2
Frequency: 2 affected / 41 at risk

Adverse event: Deep venous thrombosis
Serious: no
Organ System: Vascular disorders
Notes: DVT Gr 3 - Postoperative
Frequency: 1 affected / 41 at risk

Adverse event: Embolism
Serious: no
Organ System: Vascular disorders
Notes: Embolism Gr 4 and embolism Gr 5 - both in arm 2
Frequency: 2 affected / 41 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Fatigue Gr 3 (2 pts in arm 1 and 1 pt in arm 2 - also an SAE for this pt) - during chemoradiotherapy
Frequency: 1 affected / 41 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Notes: Depression Gr 3 - also an SAE - during chemoradiotherapy
Frequency: 1 affected / 41 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Notes: Hypertension Gr 3 in 2 pts in arm 2 - during chemoradiotherapy
Frequency: 2 affected / 41 at risk

Adverse event: Cardio-respiratory arrest
Serious: no
Organ System: Cardiac disorders
Notes: Cardiopulmonary arrest Gr 5 - FU post EOT visit
Frequency: 1 affected / 41 at risk

Adverse event: Pain pumonary/respiratory
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Sore throat Gr 3 and laryngeal pain Gr 3 in one patient in arm 2 - during chemoradiotherapy
Frequency: 1 affected / 41 at risk

Adverse event: Haemorrhage
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Hemorrhage with surgery Gr 3
Frequency: 1 affected / 41 at risk

Adverse event: Post procedural haematoma
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Hematoma Gr 3 in 1 pt in arm 2 (also SAE) - postoperative
Frequency: 1 affected / 41 at risk

Adverse event: Haematoma
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Hematoma Gr 3 (also an SAE) - FU post EOT visit
Frequency: 1 affected / 41 at risk

Adverse event: Neuropathy - cranial
Serious: no
Organ System: Nervous system disorders
Notes: Neuropathy -cranial Gr 3 (also an SAE) - FU post EOT visit
Frequency: 1 affected / 41 at risk

Adverse event: Proctalgia
Serious: no
Organ System: Gastrointestinal disorders
Notes: Pain gastro-intestinal - anal pain Gr 3
Frequency: 1 affected / 41 at risk

Adverse event: Leak Gi
Serious: no
Organ System: Gastrointestinal disorders
Notes: Leak GI Gr 3 - postoperative
Frequency: 3 affected / 41 at risk

Adverse event: Obstruction Gi
Serious: no
Organ System: Gastrointestinal disorders
Notes: Obstruction GI Gr 3 in 2 pts in arm 1 (for 1 also an SAE) and in 1 pt in arm 2 (also an SAE) - postoperative
Frequency: 1 affected / 41 at risk

Adverse event: Discharge from the anus
Serious: no
Organ System: Gastrointestinal disorders
Notes: Purulent discharge from the anus Gr - - postoperative
Frequency: 1 affected / 41 at risk

Adverse event: Ascites
Serious: no
Organ System: Gastrointestinal disorders
Notes: Ascites Gr 5 - FU post EOT visit
Frequency: 1 affected / 41 at risk

Adverse event: Dysphagia
Serious: no
Organ System: Gastrointestinal disorders
Notes: Dysphagia Gr 3 - FU post EOT visit
Frequency: 1 affected / 41 at risk

Adverse event: Leak GU
Serious: no
Organ System: Renal and urinary disorders
Notes: Leak GU Gr 5 - postoperative
Frequency: 1 affected / 41 at risk

Adverse event: Dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Dermatitis associated with radiotherapy Gr 3
Frequency: 3 affected / 41 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Rash Gr 3 - during chemoradiotherapy
Frequency: 1 affected / 41 at risk

Adverse event: Wound infection
Serious: no
Organ System: Infections and infestations
Notes: 5 peri-anal wound infections Gr 3 ; 1 wound infection with evisceration Gr 4 ; 1 Gr 5 wound infection in a patient with tumor break during surgery
Frequency: 2 affected / 41 at risk

Adverse event: Peritonitis
Serious: no
Organ System: Infections and infestations
Notes: Peritonitis Gr 5 (tumor break during surgery) - part of SAE
Frequency: 1 affected / 41 at risk