Study: NCT01414608

Adverse event: General disorders NOS
Serious: yes
Organ System: General disorders
Notes: Specific Adverse Events were not provided, an overall number was provided. Therefore, General disorder is used to satisfy reporting requirements.
Frequency: 98 affected / 453 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 160 affected / 453 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 76 affected / 453 at risk

Adverse event: Allergic reaction/ hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 20 affected / 453 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 36 affected / 453 at risk

Adverse event: Proctalgia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 453 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 293 affected / 453 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 43 affected / 453 at risk

Adverse event: Colitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 453 at risk

Adverse event: Large intestinal obstruction
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 453 at risk

Adverse event: Blood creatinine increased
Serious: no
Organ System: Investigations
Frequency: 53 affected / 453 at risk

Adverse event: Cystitis noninfective
Serious: no
Organ System: Renal and urinary disorders
Frequency: 91 affected / 453 at risk

Adverse event: Dehydration
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 53 affected / 453 at risk

Adverse event: Radiation skin injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 65 affected / 453 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 332 affected / 453 at risk

Adverse event: Enterocolitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 453 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 358 affected / 453 at risk

Adverse event: Febrile neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 9 affected / 453 at risk

Adverse event: Female genital tract fistula
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 10 affected / 453 at risk

Adverse event: Gastrointestinal fistula
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 453 at risk

Adverse event: Hypoacusis
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 41 affected / 453 at risk

Adverse event: Hemorrhage Bladder
Serious: no
Organ System: Renal and urinary disorders
Frequency: 44 affected / 453 at risk

Adverse event: Rectal haemorrhage
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 31 affected / 453 at risk

Adverse event: Lymphoedema
Serious: no
Organ System: Vascular disorders
Frequency: 12 affected / 453 at risk

Adverse event: Lymphocyte count decreased
Serious: no
Organ System: Investigations
Frequency: 320 affected / 453 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 27 affected / 453 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 44 affected / 453 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 346 affected / 453 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Investigations
Frequency: 117 affected / 453 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 72 affected / 453 at risk

Adverse event: Pelvic pain
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 128 affected / 453 at risk

Adverse event: Perineal pain
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 8 affected / 453 at risk

Adverse event: Peripheral motor neuropathy
Serious: no
Organ System: Nervous system disorders
Frequency: 10 affected / 453 at risk

Adverse event: Peripheral sensory neuropathy
Serious: no
Organ System: Nervous system disorders
Frequency: 107 affected / 453 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Frequency: 142 affected / 453 at risk

Adverse event: Proctitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 34 affected / 453 at risk

Adverse event: Rectal obstruction
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 453 at risk

Adverse event: Proctalgia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 18 affected / 453 at risk

Adverse event: Small intestinal obstruction
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 453 at risk

Adverse event: Soft tissue disorder
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 453 at risk

Adverse event: Telangiectasia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 7 affected / 453 at risk

Adverse event: Thrombosis/Thrombus/Embolism
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 26 affected / 453 at risk

Adverse event: Tumour pain
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 10 affected / 453 at risk

Adverse event: Urinary tract pain
Serious: no
Organ System: Renal and urinary disorders
Frequency: 28 affected / 453 at risk

Adverse event: Uterine obstruction
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 453 at risk

Adverse event: Vaginal discharge
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 142 affected / 453 at risk

Adverse event: Vulvovaginal dryness
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 34 affected / 453 at risk

Adverse event: Vulvovaginal pain
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 50 affected / 453 at risk

Adverse event: Vaginal stricture
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 31 affected / 453 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 165 affected / 453 at risk

Adverse event: General disorders NOS
Serious: yes
Organ System: General disorders
Notes: Specific Adverse Events were not provided, an overall number was provided. Therefore, General disorder is used to satisfy reporting requirements.
Frequency: 107 affected / 361 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 164 affected / 361 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 98 affected / 361 at risk

Adverse event: Allergic reaction/ hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 32 affected / 361 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 285 affected / 361 at risk

Adverse event: Proctalgia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 361 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 303 affected / 361 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 84 affected / 361 at risk

Adverse event: Colitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 16 affected / 361 at risk

Adverse event: Large intestinal obstruction
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 361 at risk

Adverse event: Blood creatinine increased
Serious: no
Organ System: Investigations
Frequency: 58 affected / 361 at risk

Adverse event: Cystitis noninfective
Serious: no
Organ System: Renal and urinary disorders
Frequency: 79 affected / 361 at risk

Adverse event: Dehydration
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 57 affected / 361 at risk

Adverse event: Radiation skin injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 65 affected / 361 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 291 affected / 361 at risk

Adverse event: Enterocolitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 361 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 333 affected / 361 at risk

Adverse event: Febrile neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 9 affected / 361 at risk

Adverse event: Female genital tract fistula
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 4 affected / 361 at risk

Adverse event: Hypoacusis
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 52 affected / 361 at risk

Adverse event: Hemorrhage Bladder
Serious: no
Organ System: Renal and urinary disorders
Frequency: 43 affected / 361 at risk

Adverse event: Rectal haemorrhage
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 35 affected / 361 at risk

Adverse event: Lymphoedema
Serious: no
Organ System: Vascular disorders
Frequency: 16 affected / 361 at risk

Adverse event: Lymphocyte count decreased
Serious: no
Organ System: Investigations
Frequency: 287 affected / 361 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 37 affected / 361 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 142 affected / 361 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 303 affected / 361 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Investigations
Frequency: 187 affected / 361 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 91 affected / 361 at risk

Adverse event: Pelvic pain
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 110 affected / 361 at risk

Adverse event: Perineal pain
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 4 affected / 361 at risk

Adverse event: Peripheral motor neuropathy
Serious: no
Organ System: Nervous system disorders
Frequency: 68 affected / 361 at risk

Adverse event: Peripheral sensory neuropathy
Serious: no
Organ System: Nervous system disorders
Frequency: 278 affected / 361 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Frequency: 207 affected / 361 at risk

Adverse event: Proctitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 21 affected / 361 at risk

Adverse event: Proctalgia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 17 affected / 361 at risk

Adverse event: Small intestinal obstruction
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 361 at risk

Adverse event: Soft tissue disorder
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 361 at risk

Adverse event: Telangiectasia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 361 at risk

Adverse event: Thrombosis/Thrombus/Embolism
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 25 affected / 361 at risk

Adverse event: Tumour pain
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 361 at risk

Adverse event: Urinary tract pain
Serious: no
Organ System: Renal and urinary disorders
Frequency: 38 affected / 361 at risk

Adverse event: Uterine obstruction
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 361 at risk

Adverse event: Vaginal discharge
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 131 affected / 361 at risk

Adverse event: Vulvovaginal dryness
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 25 affected / 361 at risk

Adverse event: Vulvovaginal pain
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 34 affected / 361 at risk

Adverse event: Vaginal stricture
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 14 affected / 361 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 174 affected / 361 at risk