Trial Outcomes & Findings for Study of Safety and Tolerability of PCI-27483 in Patients With Pancreatic Cancer Patients Receiving Treatment With Gemcitabine (NCT NCT01020006)
NCT ID: NCT01020006
Last Updated: 2014-04-24
Results Overview
Clinically meaningful toxicity adverse events will be defined in accordance with by CTCAE v3.0
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
42 participants
Primary outcome timeframe
First dose until 28 days after last dose of PCI-27483 or gemcitabine whichever occurs last in the assigned part (A or B).
Results posted on
2014-04-24
Participant Flow
Participant milestones
| Measure |
PCI-27483 + Gemcitabine/Part A
Part A is a nonrandomized dose escalation arm. Subjects received PCI-27483 0.8 mg/kg BID as initial dose and may be escalated to 1.2, and 1.5 mg/kg BID. At the same time, subjects received Gemcitabine 1000 mg/m2 weekly intravenous infusion on 3 out of every 4 weeks.
|
PCI-27483 + Gemcitabine/Part B
Part B is a randomized arm to evaluate safety and efficacy. Subjects received PCI-27483 at 1.2 mg/kg BID and Gemcitabine 1000 mg/m2 weekly intravenous infusion.
|
Gemcitabine/Part B
Subjects in this arm of Part B received Gemcitabine 1000 mg/m2 weekly intravenous infusion.
|
|---|---|---|---|
|
Overall Study
STARTED
|
8
|
18
|
16
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
8
|
18
|
16
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of Safety and Tolerability of PCI-27483 in Patients With Pancreatic Cancer Patients Receiving Treatment With Gemcitabine
Baseline characteristics by cohort
| Measure |
(PCI-27483 + Gemcitabine)/Part A
n=8 Participants
|
(PCI-27483 + Gemcitabine)/Part B
n=18 Participants
|
Gemcitabine/Part B
n=16 Participants
|
Total
n=42 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
28 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
8 participants
n=5 Participants
|
18 participants
n=7 Participants
|
16 participants
n=5 Participants
|
42 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: First dose until 28 days after last dose of PCI-27483 or gemcitabine whichever occurs last in the assigned part (A or B).Clinically meaningful toxicity adverse events will be defined in accordance with by CTCAE v3.0
Outcome measures
| Measure |
(PCI-27483 + Gemcitabine)/Part A
n=8 Participants
|
(PCI-27483 + Gemcitabine)/Part B
n=18 Participants
|
Gemcitabine/Part B
n=16 Participants
|
|---|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (AEs)
|
8 participants
|
18 participants
|
16 participants
|
Adverse Events
(PCI-27483 + Gemcitabine)/Part A
Serious events: 5 serious events
Other events: 8 other events
Deaths: 0 deaths
(PCI-27483 + Gemcitabine)/Part B
Serious events: 12 serious events
Other events: 18 other events
Deaths: 0 deaths
Gemcitabine/Part B
Serious events: 7 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
(PCI-27483 + Gemcitabine)/Part A
n=8 participants at risk
Part A is a nonrandomized dose escalation arm. Subjects received PCI-27483 0.8 mg/kg BID as initial dose and may be escalated to 1.2, and 1.5 mg/kg BID. At the same time, patients received Gemcitabine 1000 mg/m2 weekly intravenous infusion on 3 out of every 4 weeks.
All treated subjects in this group experienced at least one "treatment-emergent" adverse event.
|
(PCI-27483 + Gemcitabine)/Part B
n=18 participants at risk
Part B is a randomized arm to evaluate safety and efficacy. Patients received PCI-27483 at 1.2 mg/kg BID and Gemcitabine 1000 mg/m2 weekly intravenous infusion.
All treated subjects in this group experienced at least one "treatment-emergent" adverse event.
|
Gemcitabine/Part B
n=16 participants at risk
Patients in this arm of Part B received Gemcitabine 1000 mg/m2 weekly intravenous infusion.
All treated subjects in this group experienced at least one "treatment-emergent" adverse event.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/8
|
11.1%
2/18
|
0.00%
0/16
|
|
Blood and lymphatic system disorders
Coagulopathy
|
0.00%
0/8
|
5.6%
1/18
|
0.00%
0/16
|
|
Blood and lymphatic system disorders
Haemorrhagic diathesis
|
0.00%
0/8
|
5.6%
1/18
|
0.00%
0/16
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/8
|
0.00%
0/18
|
6.2%
1/16
|
|
Cardiac disorders
Atrioventricular block complete
|
0.00%
0/8
|
5.6%
1/18
|
0.00%
0/16
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/8
|
5.6%
1/18
|
0.00%
0/16
|
|
Gastrointestinal disorders
Colonic obstruction
|
0.00%
0/8
|
5.6%
1/18
|
0.00%
0/16
|
|
Gastrointestinal disorders
Duodenal stenosis
|
12.5%
1/8
|
0.00%
0/18
|
0.00%
0/16
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/8
|
5.6%
1/18
|
0.00%
0/16
|
|
Gastrointestinal disorders
Gastric varices haemorrhage
|
0.00%
0/8
|
5.6%
1/18
|
0.00%
0/16
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
12.5%
1/8
|
5.6%
1/18
|
6.2%
1/16
|
|
Gastrointestinal disorders
Obstruction gastric
|
0.00%
0/8
|
5.6%
1/18
|
0.00%
0/16
|
|
Gastrointestinal disorders
Oesophageal obstruction
|
0.00%
0/8
|
5.6%
1/18
|
0.00%
0/16
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/8
|
0.00%
0/18
|
6.2%
1/16
|
|
Gastrointestinal disorders
Peritoneal haemorrhage
|
0.00%
0/8
|
0.00%
0/18
|
6.2%
1/16
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/8
|
5.6%
1/18
|
0.00%
0/16
|
|
Infections and infestations
Biliary tract infection
|
0.00%
0/8
|
5.6%
1/18
|
0.00%
0/16
|
|
Infections and infestations
Cellulitis
|
0.00%
0/8
|
0.00%
0/18
|
6.2%
1/16
|
|
Infections and infestations
Device related sepsis
|
12.5%
1/8
|
0.00%
0/18
|
0.00%
0/16
|
|
Infections and infestations
Gastroenteritis
|
12.5%
1/8
|
0.00%
0/18
|
0.00%
0/16
|
|
Infections and infestations
Retroperitoneal abscess
|
0.00%
0/8
|
0.00%
0/18
|
6.2%
1/16
|
|
Infections and infestations
Sepsis
|
0.00%
0/8
|
5.6%
1/18
|
6.2%
1/16
|
|
Infections and infestations
Skin bacterial infection
|
0.00%
0/8
|
5.6%
1/18
|
0.00%
0/16
|
|
Infections and infestations
Staphylococcal sepsis
|
0.00%
0/8
|
5.6%
1/18
|
0.00%
0/16
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/8
|
5.6%
1/18
|
0.00%
0/16
|
|
Investigations
International normalised ratio increased
|
12.5%
1/8
|
0.00%
0/18
|
0.00%
0/16
|
|
Investigations
Prothrombin time prolonged
|
0.00%
0/8
|
5.6%
1/18
|
0.00%
0/16
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
12.5%
1/8
|
0.00%
0/18
|
0.00%
0/16
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.00%
0/8
|
5.6%
1/18
|
6.2%
1/16
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma metastatic
|
0.00%
0/8
|
5.6%
1/18
|
0.00%
0/16
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
12.5%
1/8
|
0.00%
0/18
|
0.00%
0/16
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/8
|
5.6%
1/18
|
0.00%
0/16
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/8
|
0.00%
0/18
|
6.2%
1/16
|
|
Vascular disorders
Hypertension
|
12.5%
1/8
|
0.00%
0/18
|
0.00%
0/16
|
Other adverse events
| Measure |
(PCI-27483 + Gemcitabine)/Part A
n=8 participants at risk
Part A is a nonrandomized dose escalation arm. Subjects received PCI-27483 0.8 mg/kg BID as initial dose and may be escalated to 1.2, and 1.5 mg/kg BID. At the same time, patients received Gemcitabine 1000 mg/m2 weekly intravenous infusion on 3 out of every 4 weeks.
All treated subjects in this group experienced at least one "treatment-emergent" adverse event.
|
(PCI-27483 + Gemcitabine)/Part B
n=18 participants at risk
Part B is a randomized arm to evaluate safety and efficacy. Patients received PCI-27483 at 1.2 mg/kg BID and Gemcitabine 1000 mg/m2 weekly intravenous infusion.
All treated subjects in this group experienced at least one "treatment-emergent" adverse event.
|
Gemcitabine/Part B
n=16 participants at risk
Patients in this arm of Part B received Gemcitabine 1000 mg/m2 weekly intravenous infusion.
All treated subjects in this group experienced at least one "treatment-emergent" adverse event.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
50.0%
4/8
|
66.7%
12/18
|
50.0%
8/16
|
|
Blood and lymphatic system disorders
Anaemia macrocytic
|
0.00%
0/8
|
5.6%
1/18
|
0.00%
0/16
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/8
|
5.6%
1/18
|
0.00%
0/16
|
|
Blood and lymphatic system disorders
Leukocytosis
|
12.5%
1/8
|
0.00%
0/18
|
0.00%
0/16
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/8
|
16.7%
3/18
|
18.8%
3/16
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/8
|
0.00%
0/18
|
6.2%
1/16
|
|
Blood and lymphatic system disorders
Macrocytosis
|
0.00%
0/8
|
5.6%
1/18
|
0.00%
0/16
|
|
Blood and lymphatic system disorders
Neutropenia
|
37.5%
3/8
|
11.1%
2/18
|
31.2%
5/16
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
37.5%
3/8
|
22.2%
4/18
|
31.2%
5/16
|
|
Blood and lymphatic system disorders
Thrombocytosis
|
0.00%
0/8
|
0.00%
0/18
|
6.2%
1/16
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/8
|
0.00%
0/18
|
6.2%
1/16
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/8
|
5.6%
1/18
|
0.00%
0/16
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/8
|
0.00%
0/18
|
6.2%
1/16
|
|
Cardiac disorders
Tachycardia
|
12.5%
1/8
|
0.00%
0/18
|
0.00%
0/16
|
|
Ear and labyrinth disorders
Deafness unilateral
|
12.5%
1/8
|
0.00%
0/18
|
0.00%
0/16
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/8
|
5.6%
1/18
|
0.00%
0/16
|
|
Eye disorders
Conjunctivitis
|
12.5%
1/8
|
0.00%
0/18
|
0.00%
0/16
|
|
Eye disorders
Erythema of eyelid
|
0.00%
0/8
|
5.6%
1/18
|
0.00%
0/16
|
|
Eye disorders
Eye irritation
|
12.5%
1/8
|
0.00%
0/18
|
0.00%
0/16
|
|
Eye disorders
Eye swelling
|
0.00%
0/8
|
0.00%
0/18
|
6.2%
1/16
|
|
Eye disorders
Vision blurred
|
0.00%
0/8
|
5.6%
1/18
|
0.00%
0/16
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/8
|
5.6%
1/18
|
6.2%
1/16
|
|
Gastrointestinal disorders
Abdominal distension
|
25.0%
2/8
|
11.1%
2/18
|
6.2%
1/16
|
|
Gastrointestinal disorders
Abdominal mass
|
0.00%
0/8
|
0.00%
0/18
|
6.2%
1/16
|
|
Gastrointestinal disorders
Abdominal pain
|
50.0%
4/8
|
33.3%
6/18
|
18.8%
3/16
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/8
|
5.6%
1/18
|
0.00%
0/16
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/8
|
11.1%
2/18
|
6.2%
1/16
|
|
Gastrointestinal disorders
Abdominal tenderness
|
0.00%
0/8
|
0.00%
0/18
|
6.2%
1/16
|
|
Gastrointestinal disorders
Anal fissure
|
0.00%
0/8
|
0.00%
0/18
|
12.5%
2/16
|
|
Gastrointestinal disorders
Ascites
|
37.5%
3/8
|
5.6%
1/18
|
6.2%
1/16
|
|
Gastrointestinal disorders
Constipation
|
37.5%
3/8
|
33.3%
6/18
|
37.5%
6/16
|
|
Gastrointestinal disorders
Diarrhoea
|
37.5%
3/8
|
16.7%
3/18
|
18.8%
3/16
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/8
|
5.6%
1/18
|
0.00%
0/16
|
|
Gastrointestinal disorders
Dyspepsia
|
12.5%
1/8
|
11.1%
2/18
|
0.00%
0/16
|
|
Gastrointestinal disorders
Dysphagia
|
12.5%
1/8
|
5.6%
1/18
|
0.00%
0/16
|
|
Gastrointestinal disorders
Faeces discoloured
|
0.00%
0/8
|
0.00%
0/18
|
12.5%
2/16
|
|
Gastrointestinal disorders
Flatulence
|
12.5%
1/8
|
5.6%
1/18
|
6.2%
1/16
|
|
Gastrointestinal disorders
Gastric antral vascular ectasia
|
0.00%
0/8
|
0.00%
0/18
|
6.2%
1/16
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/8
|
5.6%
1/18
|
0.00%
0/16
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/8
|
5.6%
1/18
|
6.2%
1/16
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
37.5%
3/8
|
11.1%
2/18
|
6.2%
1/16
|
|
Gastrointestinal disorders
Gingival bleeding
|
12.5%
1/8
|
0.00%
0/18
|
0.00%
0/16
|
|
Gastrointestinal disorders
Gingival erythema
|
0.00%
0/8
|
0.00%
0/18
|
6.2%
1/16
|
|
Gastrointestinal disorders
Glossodynia
|
0.00%
0/8
|
0.00%
0/18
|
6.2%
1/16
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
25.0%
2/8
|
0.00%
0/18
|
0.00%
0/16
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/8
|
5.6%
1/18
|
0.00%
0/16
|
|
Gastrointestinal disorders
Nausea
|
25.0%
2/8
|
27.8%
5/18
|
37.5%
6/16
|
|
Gastrointestinal disorders
Oral pain
|
12.5%
1/8
|
5.6%
1/18
|
0.00%
0/16
|
|
Gastrointestinal disorders
Proctalgia
|
0.00%
0/8
|
0.00%
0/18
|
6.2%
1/16
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/8
|
11.1%
2/18
|
0.00%
0/16
|
|
Gastrointestinal disorders
Vomiting
|
50.0%
4/8
|
27.8%
5/18
|
31.2%
5/16
|
|
General disorders
Asthenia
|
0.00%
0/8
|
16.7%
3/18
|
25.0%
4/16
|
|
General disorders
Catheter site discharge
|
12.5%
1/8
|
0.00%
0/18
|
0.00%
0/16
|
|
General disorders
Catheter site erythema
|
12.5%
1/8
|
0.00%
0/18
|
0.00%
0/16
|
|
General disorders
Catheter site haematoma
|
12.5%
1/8
|
0.00%
0/18
|
0.00%
0/16
|
|
General disorders
Catheter site haemorrhage
|
0.00%
0/8
|
5.6%
1/18
|
0.00%
0/16
|
|
General disorders
Catheter site pain
|
12.5%
1/8
|
0.00%
0/18
|
0.00%
0/16
|
|
General disorders
Chest pain
|
0.00%
0/8
|
0.00%
0/18
|
6.2%
1/16
|
|
General disorders
Chills
|
12.5%
1/8
|
5.6%
1/18
|
12.5%
2/16
|
|
General disorders
Early satiety
|
0.00%
0/8
|
5.6%
1/18
|
0.00%
0/16
|
|
General disorders
Fatigue
|
37.5%
3/8
|
44.4%
8/18
|
31.2%
5/16
|
|
General disorders
Generalised oedema
|
0.00%
0/8
|
0.00%
0/18
|
6.2%
1/16
|
|
General disorders
Influenza like illness
|
12.5%
1/8
|
0.00%
0/18
|
0.00%
0/16
|
|
General disorders
Injection site erythema
|
0.00%
0/8
|
5.6%
1/18
|
0.00%
0/16
|
|
General disorders
Injection site haematoma
|
62.5%
5/8
|
27.8%
5/18
|
0.00%
0/16
|
|
General disorders
Injection site haemorrhage
|
0.00%
0/8
|
5.6%
1/18
|
0.00%
0/16
|
|
General disorders
Injection site pain
|
12.5%
1/8
|
16.7%
3/18
|
0.00%
0/16
|
|
General disorders
Injection site reaction
|
0.00%
0/8
|
5.6%
1/18
|
0.00%
0/16
|
|
General disorders
Malaise
|
0.00%
0/8
|
5.6%
1/18
|
0.00%
0/16
|
|
General disorders
Oedema
|
12.5%
1/8
|
0.00%
0/18
|
6.2%
1/16
|
|
General disorders
Oedema peripheral
|
50.0%
4/8
|
33.3%
6/18
|
25.0%
4/16
|
|
General disorders
Pain
|
0.00%
0/8
|
0.00%
0/18
|
6.2%
1/16
|
|
General disorders
Pelvic mass
|
12.5%
1/8
|
0.00%
0/18
|
0.00%
0/16
|
|
General disorders
Pyrexia
|
12.5%
1/8
|
11.1%
2/18
|
18.8%
3/16
|
|
General disorders
Suprapubic pain
|
12.5%
1/8
|
0.00%
0/18
|
0.00%
0/16
|
|
Hepatobiliary disorders
Bile duct obstruction
|
0.00%
0/8
|
0.00%
0/18
|
6.2%
1/16
|
|
Hepatobiliary disorders
Hepatomegaly
|
0.00%
0/8
|
0.00%
0/18
|
6.2%
1/16
|
|
Hepatobiliary disorders
Jaundice
|
0.00%
0/8
|
5.6%
1/18
|
0.00%
0/16
|
|
Hepatobiliary disorders
Jaundice cholestatic
|
0.00%
0/8
|
0.00%
0/18
|
6.2%
1/16
|
|
Hepatobiliary disorders
Portal vein thrombosis
|
0.00%
0/8
|
0.00%
0/18
|
6.2%
1/16
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/8
|
5.6%
1/18
|
0.00%
0/16
|
|
Infections and infestations
Bronchitis
|
0.00%
0/8
|
5.6%
1/18
|
0.00%
0/16
|
|
Infections and infestations
Candidiasis
|
0.00%
0/8
|
0.00%
0/18
|
6.2%
1/16
|
|
Infections and infestations
Catheter site infection
|
0.00%
0/8
|
5.6%
1/18
|
0.00%
0/16
|
|
Infections and infestations
Eye infection bacterial
|
0.00%
0/8
|
5.6%
1/18
|
0.00%
0/16
|
|
Infections and infestations
Gastroenteritis
|
12.5%
1/8
|
0.00%
0/18
|
0.00%
0/16
|
|
Infections and infestations
Helicobacter infection
|
0.00%
0/8
|
5.6%
1/18
|
0.00%
0/16
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/8
|
5.6%
1/18
|
0.00%
0/16
|
|
Infections and infestations
Nasopharyngitis
|
12.5%
1/8
|
0.00%
0/18
|
0.00%
0/16
|
|
Infections and infestations
Oral herpes
|
0.00%
0/8
|
11.1%
2/18
|
0.00%
0/16
|
|
Infections and infestations
Post procedural infection
|
0.00%
0/8
|
5.6%
1/18
|
0.00%
0/16
|
|
Infections and infestations
Skin bacterial infection
|
0.00%
0/8
|
5.6%
1/18
|
0.00%
0/16
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/8
|
0.00%
0/18
|
6.2%
1/16
|
|
Infections and infestations
Tooth infection
|
0.00%
0/8
|
5.6%
1/18
|
0.00%
0/16
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/8
|
16.7%
3/18
|
0.00%
0/16
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
12.5%
1/8
|
0.00%
0/18
|
0.00%
0/16
|
|
Injury, poisoning and procedural complications
Contusion
|
12.5%
1/8
|
5.6%
1/18
|
0.00%
0/16
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/8
|
5.6%
1/18
|
0.00%
0/16
|
|
Injury, poisoning and procedural complications
Femur fracture
|
12.5%
1/8
|
0.00%
0/18
|
0.00%
0/16
|
|
Injury, poisoning and procedural complications
Gastrointestinal stoma complication
|
12.5%
1/8
|
0.00%
0/18
|
0.00%
0/16
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/8
|
11.1%
2/18
|
0.00%
0/16
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/8
|
5.6%
1/18
|
0.00%
0/16
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/8
|
5.6%
1/18
|
0.00%
0/16
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/8
|
5.6%
1/18
|
0.00%
0/16
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/8
|
5.6%
1/18
|
0.00%
0/16
|
|
Investigations
Blood alkaline phosphatase
|
12.5%
1/8
|
0.00%
0/18
|
0.00%
0/16
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/8
|
5.6%
1/18
|
6.2%
1/16
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/8
|
5.6%
1/18
|
0.00%
0/16
|
|
Investigations
Blood creatinine decreased
|
0.00%
0/8
|
5.6%
1/18
|
0.00%
0/16
|
|
Investigations
Blood uric acid increased
|
0.00%
0/8
|
5.6%
1/18
|
0.00%
0/16
|
|
Investigations
International normalised ratio increased
|
50.0%
4/8
|
44.4%
8/18
|
0.00%
0/16
|
|
Investigations
Liver function test abnormal
|
0.00%
0/8
|
0.00%
0/18
|
6.2%
1/16
|
|
Investigations
Platelet count decreased
|
0.00%
0/8
|
5.6%
1/18
|
6.2%
1/16
|
|
Investigations
Platelet count increased
|
0.00%
0/8
|
5.6%
1/18
|
0.00%
0/16
|
|
Investigations
Prothrombin level increased
|
0.00%
0/8
|
5.6%
1/18
|
0.00%
0/16
|
|
Investigations
Prothrombin time prolonged
|
0.00%
0/8
|
11.1%
2/18
|
0.00%
0/16
|
|
Investigations
Transaminases increased
|
0.00%
0/8
|
0.00%
0/18
|
6.2%
1/16
|
|
Investigations
Waist circumference increased
|
0.00%
0/8
|
0.00%
0/18
|
6.2%
1/16
|
|
Investigations
Weight decreased
|
25.0%
2/8
|
11.1%
2/18
|
25.0%
4/16
|
|
Investigations
White blood cell count decreased
|
0.00%
0/8
|
5.6%
1/18
|
0.00%
0/16
|
|
Metabolism and nutrition disorders
Decreased appetite
|
12.5%
1/8
|
27.8%
5/18
|
31.2%
5/16
|
|
Metabolism and nutrition disorders
Dehydration
|
37.5%
3/8
|
16.7%
3/18
|
31.2%
5/16
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/8
|
0.00%
0/18
|
6.2%
1/16
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.00%
0/8
|
0.00%
0/18
|
6.2%
1/16
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/8
|
5.6%
1/18
|
12.5%
2/16
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
12.5%
1/8
|
0.00%
0/18
|
0.00%
0/16
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
12.5%
1/8
|
0.00%
0/18
|
0.00%
0/16
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
12.5%
1/8
|
5.6%
1/18
|
6.2%
1/16
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
12.5%
1/8
|
0.00%
0/18
|
0.00%
0/16
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
25.0%
2/8
|
16.7%
3/18
|
12.5%
2/16
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
12.5%
1/8
|
5.6%
1/18
|
6.2%
1/16
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
12.5%
1/8
|
0.00%
0/18
|
12.5%
2/16
|
|
Metabolism and nutrition disorders
Hypouricaemia
|
0.00%
0/8
|
0.00%
0/18
|
6.2%
1/16
|
|
Metabolism and nutrition disorders
Iron deficiency
|
12.5%
1/8
|
5.6%
1/18
|
0.00%
0/16
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.00%
0/8
|
5.6%
1/18
|
12.5%
2/16
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
12.5%
1/8
|
0.00%
0/18
|
0.00%
0/16
|
|
Metabolism and nutrition disorders
Vitamin K deficiency
|
0.00%
0/8
|
5.6%
1/18
|
0.00%
0/16
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
25.0%
2/8
|
5.6%
1/18
|
0.00%
0/16
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
25.0%
2/8
|
11.1%
2/18
|
6.2%
1/16
|
|
Musculoskeletal and connective tissue disorders
Limb discomfort
|
0.00%
0/8
|
5.6%
1/18
|
0.00%
0/16
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
12.5%
1/8
|
5.6%
1/18
|
0.00%
0/16
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/8
|
0.00%
0/18
|
6.2%
1/16
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
12.5%
1/8
|
11.1%
2/18
|
0.00%
0/16
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
12.5%
1/8
|
0.00%
0/18
|
0.00%
0/16
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/8
|
5.6%
1/18
|
0.00%
0/16
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/8
|
0.00%
0/18
|
6.2%
1/16
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/8
|
5.6%
1/18
|
12.5%
2/16
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.00%
0/8
|
0.00%
0/18
|
6.2%
1/16
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.00%
0/8
|
0.00%
0/18
|
6.2%
1/16
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Seborrhoeic keratosis
|
0.00%
0/8
|
5.6%
1/18
|
0.00%
0/16
|
|
Nervous system disorders
Balance disorder
|
0.00%
0/8
|
5.6%
1/18
|
0.00%
0/16
|
|
Nervous system disorders
Dizziness
|
0.00%
0/8
|
33.3%
6/18
|
0.00%
0/16
|
|
Nervous system disorders
Drooling
|
0.00%
0/8
|
0.00%
0/18
|
6.2%
1/16
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/8
|
11.1%
2/18
|
6.2%
1/16
|
|
Nervous system disorders
Formication
|
12.5%
1/8
|
0.00%
0/18
|
0.00%
0/16
|
|
Nervous system disorders
Headache
|
0.00%
0/8
|
5.6%
1/18
|
18.8%
3/16
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/8
|
0.00%
0/18
|
6.2%
1/16
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/8
|
5.6%
1/18
|
0.00%
0/16
|
|
Nervous system disorders
Resting tremor
|
0.00%
0/8
|
0.00%
0/18
|
6.2%
1/16
|
|
Nervous system disorders
Restless legs syndrome
|
0.00%
0/8
|
5.6%
1/18
|
0.00%
0/16
|
|
Nervous system disorders
Syncope
|
0.00%
0/8
|
5.6%
1/18
|
0.00%
0/16
|
|
Psychiatric disorders
Adjustment disorder
|
0.00%
0/8
|
0.00%
0/18
|
6.2%
1/16
|
|
Psychiatric disorders
Anxiety
|
12.5%
1/8
|
11.1%
2/18
|
6.2%
1/16
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/8
|
0.00%
0/18
|
6.2%
1/16
|
|
Psychiatric disorders
Depression
|
0.00%
0/8
|
11.1%
2/18
|
18.8%
3/16
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/8
|
11.1%
2/18
|
0.00%
0/16
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/8
|
5.6%
1/18
|
6.2%
1/16
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/8
|
5.6%
1/18
|
0.00%
0/16
|
|
Renal and urinary disorders
Nocturia
|
0.00%
0/8
|
5.6%
1/18
|
0.00%
0/16
|
|
Renal and urinary disorders
Renal failure acute
|
12.5%
1/8
|
0.00%
0/18
|
0.00%
0/16
|
|
Renal and urinary disorders
Urine odour abnormal
|
0.00%
0/8
|
5.6%
1/18
|
0.00%
0/16
|
|
Reproductive system and breast disorders
Prostatitis
|
0.00%
0/8
|
5.6%
1/18
|
0.00%
0/16
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
12.5%
1/8
|
0.00%
0/18
|
0.00%
0/16
|
|
Respiratory, thoracic and mediastinal disorders
Alveolitis fibrosing
|
0.00%
0/8
|
5.6%
1/18
|
0.00%
0/16
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
12.5%
1/8
|
16.7%
3/18
|
0.00%
0/16
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/8
|
11.1%
2/18
|
6.2%
1/16
|
|
Respiratory, thoracic and mediastinal disorders
Emphysema
|
0.00%
0/8
|
5.6%
1/18
|
0.00%
0/16
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
25.0%
2/8
|
5.6%
1/18
|
0.00%
0/16
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/8
|
5.6%
1/18
|
0.00%
0/16
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/8
|
0.00%
0/18
|
6.2%
1/16
|
|
Respiratory, thoracic and mediastinal disorders
Nasal ulcer
|
0.00%
0/8
|
5.6%
1/18
|
0.00%
0/16
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/8
|
0.00%
0/18
|
6.2%
1/16
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
0.00%
0/8
|
11.1%
2/18
|
0.00%
0/16
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/8
|
5.6%
1/18
|
0.00%
0/16
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
37.5%
3/8
|
0.00%
0/18
|
0.00%
0/16
|
|
Skin and subcutaneous tissue disorders
Cold sweat
|
0.00%
0/8
|
5.6%
1/18
|
0.00%
0/16
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.00%
0/8
|
0.00%
0/18
|
6.2%
1/16
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/8
|
0.00%
0/18
|
6.2%
1/16
|
|
Skin and subcutaneous tissue disorders
Erythema
|
12.5%
1/8
|
0.00%
0/18
|
6.2%
1/16
|
|
Skin and subcutaneous tissue disorders
Hidradenitis
|
0.00%
0/8
|
5.6%
1/18
|
0.00%
0/16
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/8
|
0.00%
0/18
|
6.2%
1/16
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/8
|
5.6%
1/18
|
12.5%
2/16
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
12.5%
1/8
|
0.00%
0/18
|
0.00%
0/16
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/8
|
11.1%
2/18
|
0.00%
0/16
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.00%
0/8
|
11.1%
2/18
|
0.00%
0/16
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
50.0%
4/8
|
5.6%
1/18
|
0.00%
0/16
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/8
|
5.6%
1/18
|
0.00%
0/16
|
|
Vascular disorders
Embolism
|
0.00%
0/8
|
5.6%
1/18
|
0.00%
0/16
|
|
Vascular disorders
Haematoma
|
12.5%
1/8
|
0.00%
0/18
|
0.00%
0/16
|
|
Vascular disorders
Hot flush
|
12.5%
1/8
|
0.00%
0/18
|
0.00%
0/16
|
|
Vascular disorders
Hypertension
|
25.0%
2/8
|
11.1%
2/18
|
6.2%
1/16
|
|
Vascular disorders
Hypotension
|
12.5%
1/8
|
0.00%
0/18
|
12.5%
2/16
|
|
Vascular disorders
Intra-abdominal haematoma
|
12.5%
1/8
|
0.00%
0/18
|
0.00%
0/16
|
|
Vascular disorders
Phlebitis
|
0.00%
0/8
|
0.00%
0/18
|
6.2%
1/16
|
|
Vascular disorders
Thrombophlebitis superficial
|
0.00%
0/8
|
0.00%
0/18
|
6.2%
1/16
|
|
Vascular disorders
Thrombosis
|
0.00%
0/8
|
0.00%
0/18
|
6.2%
1/16
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place