Trial Outcomes & Findings for Phase I/II Study of KRN330 Plus Irinotecan in Patients With Metastatic Colorectal Cancer (NCT NCT00838578)
NCT ID: NCT00838578
Last Updated: 2024-04-26
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
65 participants
Primary outcome timeframe
Until disease progression, death, or withdrawal post initial KRN330 treatment, assessed up to 100 months
Results posted on
2024-04-26
Participant Flow
Participant milestones
| Measure |
KRN330 + Irinotecan
* Phase 1\_\_\_\_ Biweekly KRN330 (0.5 mg/kg) (N=8) Weekly KRN330 (0.5 mg/kg) (N=7) Biweekly KRN330 (1.0 mg/kg) (N=4) Total (N=19)
* Phase 2\_\_\_\_ Weekly KRN330 (0.5 mg/kg)) (N=46)
Phase 1 and 2Combined (N=65)
|
|---|---|
|
Overall Study
STARTED
|
65
|
|
Overall Study
COMPLETED
|
63
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
KRN330 + Irinotecan
* Phase 1\_\_\_\_ Biweekly KRN330 (0.5 mg/kg) (N=8) Weekly KRN330 (0.5 mg/kg) (N=7) Biweekly KRN330 (1.0 mg/kg) (N=4) Total (N=19)
* Phase 2\_\_\_\_ Weekly KRN330 (0.5 mg/kg)) (N=46)
Phase 1 and 2Combined (N=65)
|
|---|---|
|
Overall Study
Protocol Violation
|
2
|
Baseline Characteristics
Phase I/II Study of KRN330 Plus Irinotecan in Patients With Metastatic Colorectal Cancer
Baseline characteristics by cohort
| Measure |
KRN330 + Irinotecan
n=63 Participants
open label, single arm
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
40 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
23 Participants
n=5 Participants
|
|
Age, Continuous
|
59.83 years
STANDARD_DEVIATION 10.185 • n=5 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
33 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
63 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Until disease progression, death, or withdrawal post initial KRN330 treatment, assessed up to 100 monthsPopulation: ITT population
Outcome measures
| Measure |
Regimen A: KRN330 Biweekly + Irinotecan Biweekly
n=12 Participants
In treatment regimen A, both KRN330 and irinotecan (180 mg/m2) were administered biweekly(Weeks 1, 3, and 5).
Cohort 1: 1 mg/kg KRN330 biweekly and 180 mg/m2 irinotecan biweekly Cohort 2: 0.5 mg/kg KRN330 biweekly and 180 mg/m2 irinotecan biweekly
|
Regimen B: KRN330 Weekly + Irinotecan Biweekly
n=7 Participants
treatment regimen B, KRN330 was administered weekly (Weeks 1, 2, 3, 4 and 5) and irinotecan (180 mg/m2) biweekly (Weeks 1, 3, and 5).
|
PH 2 Treatment: KRN330 Wkly + IRI Biwkly
n=44 Participants
The Phase 2 portion was a single arm study using the regimen and dose selected in Phase 1 (0.5 mg/kg KRN330 weekly and 180 mg/m2 irinotecan biweekly).
|
|---|---|---|---|
|
Number of Participants With Serious and Other (Non-Serious) Adverse Events According to the CTCAE v.3.0
|
12 participants
|
7 participants
|
44 participants
|
Adverse Events
Phase 1 Regimen A: KRN330 Biweekly + IRI Biweekly
Serious events: 6 serious events
Other events: 12 other events
Deaths: 0 deaths
Phase 1 Regimen B: KRN330 Weekly + IRI Biweekly
Serious events: 2 serious events
Other events: 7 other events
Deaths: 0 deaths
Phase 2: KRN330 Weekly + IRI Biweekly
Serious events: 17 serious events
Other events: 42 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Phase 1 Regimen A: KRN330 Biweekly + IRI Biweekly
n=12 participants at risk
In Regimen A, patients received both KRN330 and irinotecan biweekly (Weeks 1, 3, and 5):
Cohort 1: KRN330 1.0 mg/kg + irinotecan 180 mg/m2 Cohort 2: KRN330 0.5 mg/kg + irinotecan 180 mg/m2
|
Phase 1 Regimen B: KRN330 Weekly + IRI Biweekly
n=7 participants at risk
In Regimen B, patients received KRN330 0.5 mg/kg weekly (Weeks 1, 2, 3, 4, and 5) and irinotecan 180 mg/m2 biweekly (Weeks 1, 3, and 5)
|
Phase 2: KRN330 Weekly + IRI Biweekly
n=44 participants at risk
The Phase 2 portion had a single arm in which patients received Regimen B as included in the Phase 1 portion
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/12
|
0.00%
0/7
|
2.3%
1/44 • Number of events 1
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
25.0%
3/12 • Number of events 3
|
0.00%
0/7
|
2.3%
1/44 • Number of events 1
|
|
Blood and lymphatic system disorders
Neutropenia
|
8.3%
1/12 • Number of events 3
|
0.00%
0/7
|
9.1%
4/44 • Number of events 4
|
|
Cardiac disorders
Cardiopulmonary failure
|
0.00%
0/12
|
0.00%
0/7
|
2.3%
1/44 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/12
|
0.00%
0/7
|
2.3%
1/44 • Number of events 1
|
|
Gastrointestinal disorders
Colitis
|
16.7%
2/12 • Number of events 2
|
0.00%
0/7
|
0.00%
0/44
|
|
Gastrointestinal disorders
Diarrhoea
|
25.0%
3/12 • Number of events 3
|
0.00%
0/7
|
0.00%
0/44
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/12
|
0.00%
0/7
|
2.3%
1/44 • Number of events 2
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/12
|
0.00%
0/7
|
2.3%
1/44 • Number of events 1
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/12
|
0.00%
0/7
|
2.3%
1/44 • Number of events 1
|
|
Gastrointestinal disorders
Intestinal obstruction
|
8.3%
1/12 • Number of events 1
|
0.00%
0/7
|
4.5%
2/44 • Number of events 2
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/12
|
14.3%
1/7 • Number of events 2
|
4.5%
2/44 • Number of events 2
|
|
General disorders
Disease progression
|
0.00%
0/12
|
0.00%
0/7
|
18.2%
8/44 • Number of events 8
|
|
Infections and infestations
Pneumonia
|
8.3%
1/12 • Number of events 1
|
0.00%
0/7
|
2.3%
1/44 • Number of events 1
|
|
Infections and infestations
Sepsis
|
0.00%
0/12
|
0.00%
0/7
|
2.3%
1/44 • Number of events 1
|
|
Infections and infestations
Streptococcal infection
|
0.00%
0/12
|
0.00%
0/7
|
2.3%
1/44 • Number of events 1
|
|
Investigations
Clostridium difficile toxin test positive
|
0.00%
0/12
|
0.00%
0/7
|
2.3%
1/44 • Number of events 1
|
|
Metabolism and nutrition disorders
Dehydration
|
8.3%
1/12 • Number of events 1
|
0.00%
0/7
|
2.3%
1/44 • Number of events 1
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/12
|
14.3%
1/7 • Number of events 1
|
0.00%
0/44
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
8.3%
1/12 • Number of events 1
|
0.00%
0/7
|
0.00%
0/44
|
|
Musculoskeletal and connective tissue disorders
Metastatic pain
|
0.00%
0/12
|
0.00%
0/7
|
2.3%
1/44 • Number of events 1
|
|
Renal and urinary disorders
Renal failure acute
|
8.3%
1/12 • Number of events 1
|
0.00%
0/7
|
0.00%
0/44
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/12
|
0.00%
0/7
|
2.3%
1/44 • Number of events 1
|
|
Vascular disorders
Peripheral ischaemia
|
0.00%
0/12
|
0.00%
0/7
|
2.3%
1/44 • Number of events 1
|
Other adverse events
| Measure |
Phase 1 Regimen A: KRN330 Biweekly + IRI Biweekly
n=12 participants at risk
In Regimen A, patients received both KRN330 and irinotecan biweekly (Weeks 1, 3, and 5):
Cohort 1: KRN330 1.0 mg/kg + irinotecan 180 mg/m2 Cohort 2: KRN330 0.5 mg/kg + irinotecan 180 mg/m2
|
Phase 1 Regimen B: KRN330 Weekly + IRI Biweekly
n=7 participants at risk
In Regimen B, patients received KRN330 0.5 mg/kg weekly (Weeks 1, 2, 3, 4, and 5) and irinotecan 180 mg/m2 biweekly (Weeks 1, 3, and 5)
|
Phase 2: KRN330 Weekly + IRI Biweekly
n=44 participants at risk
The Phase 2 portion had a single arm in which patients received Regimen B as included in the Phase 1 portion
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
25.0%
3/12 • Number of events 3
|
14.3%
1/7 • Number of events 2
|
22.7%
10/44 • Number of events 16
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
8.3%
1/12 • Number of events 1
|
0.00%
0/7
|
0.00%
0/44
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/12
|
0.00%
0/7
|
2.3%
1/44 • Number of events 1
|
|
Blood and lymphatic system disorders
Leukopenia
|
25.0%
3/12 • Number of events 4
|
0.00%
0/7
|
18.2%
8/44 • Number of events 16
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/12
|
14.3%
1/7 • Number of events 2
|
0.00%
0/44
|
|
Blood and lymphatic system disorders
Neutropenia
|
8.3%
1/12 • Number of events 2
|
0.00%
0/7
|
15.9%
7/44 • Number of events 16
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
8.3%
1/12 • Number of events 1
|
0.00%
0/7
|
6.8%
3/44 • Number of events 3
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/12
|
0.00%
0/7
|
2.3%
1/44 • Number of events 1
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/12
|
0.00%
0/7
|
2.3%
1/44 • Number of events 1
|
|
Cardiac disorders
Tachycardia
|
8.3%
1/12 • Number of events 1
|
0.00%
0/7
|
15.9%
7/44 • Number of events 7
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/12
|
0.00%
0/7
|
2.3%
1/44 • Number of events 1
|
|
Eye disorders
Cataract
|
0.00%
0/12
|
0.00%
0/7
|
2.3%
1/44 • Number of events 1
|
|
Eye disorders
Diplopia
|
0.00%
0/12
|
0.00%
0/7
|
2.3%
1/44 • Number of events 1
|
|
Eye disorders
Eye pain
|
0.00%
0/12
|
0.00%
0/7
|
2.3%
1/44 • Number of events 1
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/12
|
14.3%
1/7 • Number of events 1
|
0.00%
0/44
|
|
Eye disorders
Ocular hyperaemia
|
0.00%
0/12
|
0.00%
0/7
|
2.3%
1/44 • Number of events 1
|
|
Eye disorders
Swollen tear duct
|
0.00%
0/12
|
0.00%
0/7
|
2.3%
1/44 • Number of events 1
|
|
Eye disorders
Vision blurred
|
0.00%
0/12
|
0.00%
0/7
|
2.3%
1/44 • Number of events 1
|
|
Eye disorders
Visual impairment
|
0.00%
0/12
|
0.00%
0/7
|
2.3%
1/44 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/12
|
0.00%
0/7
|
2.3%
1/44 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal distension
|
8.3%
1/12 • Number of events 1
|
0.00%
0/7
|
4.5%
2/44 • Number of events 2
|
|
Gastrointestinal disorders
Abdominal pain
|
33.3%
4/12 • Number of events 7
|
42.9%
3/7 • Number of events 7
|
31.8%
14/44 • Number of events 22
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/12
|
0.00%
0/7
|
4.5%
2/44 • Number of events 3
|
|
Gastrointestinal disorders
Abdominal wall mass
|
0.00%
0/12
|
0.00%
0/7
|
2.3%
1/44 • Number of events 1
|
|
Gastrointestinal disorders
Anorectal discomfort
|
8.3%
1/12 • Number of events 1
|
0.00%
0/7
|
0.00%
0/44
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/12
|
0.00%
0/7
|
2.3%
1/44 • Number of events 1
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/12
|
0.00%
0/7
|
2.3%
1/44 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
25.0%
3/12 • Number of events 4
|
14.3%
1/7 • Number of events 3
|
29.5%
13/44 • Number of events 24
|
|
Gastrointestinal disorders
Diarrhoea
|
83.3%
10/12 • Number of events 17
|
71.4%
5/7 • Number of events 12
|
75.0%
33/44 • Number of events 73
|
|
Gastrointestinal disorders
Diarrhoea haemorrhagic
|
0.00%
0/12
|
0.00%
0/7
|
2.3%
1/44 • Number of events 1
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/12
|
0.00%
0/7
|
4.5%
2/44 • Number of events 3
|
|
Gastrointestinal disorders
Dyspepsia
|
8.3%
1/12 • Number of events 1
|
0.00%
0/7
|
9.1%
4/44 • Number of events 5
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/12
|
0.00%
0/7
|
4.5%
2/44 • Number of events 2
|
|
Gastrointestinal disorders
Faeces discoloured
|
0.00%
0/12
|
0.00%
0/7
|
2.3%
1/44 • Number of events 1
|
|
Gastrointestinal disorders
Flatulence
|
8.3%
1/12 • Number of events 1
|
14.3%
1/7 • Number of events 1
|
9.1%
4/44 • Number of events 4
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/12
|
0.00%
0/7
|
2.3%
1/44 • Number of events 1
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
16.7%
2/12 • Number of events 2
|
0.00%
0/7
|
2.3%
1/44 • Number of events 1
|
|
Gastrointestinal disorders
Gingival pain
|
0.00%
0/12
|
0.00%
0/7
|
2.3%
1/44 • Number of events 1
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/12
|
0.00%
0/7
|
4.5%
2/44 • Number of events 3
|
|
Gastrointestinal disorders
Intestinal obstruction
|
8.3%
1/12 • Number of events 1
|
0.00%
0/7
|
0.00%
0/44
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/12
|
14.3%
1/7 • Number of events 1
|
2.3%
1/44 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
75.0%
9/12 • Number of events 13
|
85.7%
6/7 • Number of events 17
|
65.9%
29/44 • Number of events 55
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/12
|
0.00%
0/7
|
2.3%
1/44 • Number of events 1
|
|
Gastrointestinal disorders
Oral pain
|
8.3%
1/12 • Number of events 1
|
0.00%
0/7
|
0.00%
0/44
|
|
Gastrointestinal disorders
Proctalgia
|
0.00%
0/12
|
0.00%
0/7
|
4.5%
2/44 • Number of events 2
|
|
Gastrointestinal disorders
Rectal discharge
|
0.00%
0/12
|
0.00%
0/7
|
2.3%
1/44 • Number of events 1
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/12
|
0.00%
0/7
|
6.8%
3/44 • Number of events 3
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/12
|
0.00%
0/7
|
4.5%
2/44 • Number of events 3
|
|
Gastrointestinal disorders
Vomiting
|
41.7%
5/12 • Number of events 9
|
85.7%
6/7 • Number of events 12
|
38.6%
17/44 • Number of events 28
|
|
General disorders
Application site rash
|
8.3%
1/12 • Number of events 1
|
0.00%
0/7
|
0.00%
0/44
|
|
General disorders
Asthenia
|
0.00%
0/12
|
0.00%
0/7
|
11.4%
5/44 • Number of events 7
|
|
General disorders
Catheter site pain
|
0.00%
0/12
|
0.00%
0/7
|
2.3%
1/44 • Number of events 1
|
|
General disorders
Chest discomfort
|
8.3%
1/12 • Number of events 1
|
0.00%
0/7
|
2.3%
1/44 • Number of events 1
|
|
General disorders
Chills
|
8.3%
1/12 • Number of events 1
|
0.00%
0/7
|
4.5%
2/44 • Number of events 3
|
|
General disorders
Discomfort
|
0.00%
0/12
|
0.00%
0/7
|
2.3%
1/44 • Number of events 1
|
|
General disorders
Fatigue
|
41.7%
5/12 • Number of events 5
|
57.1%
4/7 • Number of events 11
|
65.9%
29/44 • Number of events 54
|
|
General disorders
Gait disturbance
|
0.00%
0/12
|
0.00%
0/7
|
4.5%
2/44 • Number of events 2
|
|
General disorders
Hypothermia
|
0.00%
0/12
|
0.00%
0/7
|
2.3%
1/44 • Number of events 1
|
|
General disorders
Infusion related reaction
|
0.00%
0/12
|
14.3%
1/7 • Number of events 1
|
0.00%
0/44
|
|
General disorders
Malaise
|
0.00%
0/12
|
0.00%
0/7
|
2.3%
1/44 • Number of events 1
|
|
General disorders
Mucosal inflammation
|
8.3%
1/12 • Number of events 1
|
0.00%
0/7
|
2.3%
1/44 • Number of events 1
|
|
General disorders
Oedema peripheral
|
8.3%
1/12 • Number of events 1
|
28.6%
2/7 • Number of events 2
|
20.5%
9/44 • Number of events 13
|
|
General disorders
Pain
|
0.00%
0/12
|
0.00%
0/7
|
6.8%
3/44 • Number of events 3
|
|
General disorders
Pyrexia
|
16.7%
2/12 • Number of events 3
|
0.00%
0/7
|
15.9%
7/44 • Number of events 7
|
|
General disorders
Thirst
|
0.00%
0/12
|
0.00%
0/7
|
2.3%
1/44 • Number of events 1
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/12
|
0.00%
0/7
|
2.3%
1/44 • Number of events 1
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
8.3%
1/12 • Number of events 1
|
0.00%
0/7
|
0.00%
0/44
|
|
Hepatobiliary disorders
Portal vein thrombosis
|
0.00%
0/12
|
0.00%
0/7
|
2.3%
1/44 • Number of events 2
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/12
|
0.00%
0/7
|
4.5%
2/44 • Number of events 4
|
|
Infections and infestations
Bronchitis
|
0.00%
0/12
|
0.00%
0/7
|
2.3%
1/44 • Number of events 1
|
|
Infections and infestations
Fungal skin infection
|
8.3%
1/12 • Number of events 1
|
0.00%
0/7
|
0.00%
0/44
|
|
Infections and infestations
Furuncle
|
0.00%
0/12
|
0.00%
0/7
|
2.3%
1/44 • Number of events 1
|
|
Infections and infestations
Hordeolum
|
0.00%
0/12
|
0.00%
0/7
|
2.3%
1/44 • Number of events 1
|
|
Infections and infestations
Laryngitis
|
16.7%
2/12 • Number of events 2
|
0.00%
0/7
|
0.00%
0/44
|
|
Infections and infestations
Lice infestation
|
0.00%
0/12
|
0.00%
0/7
|
2.3%
1/44 • Number of events 1
|
|
Infections and infestations
Nasopharyngitis
|
8.3%
1/12 • Number of events 1
|
0.00%
0/7
|
0.00%
0/44
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/12
|
0.00%
0/7
|
4.5%
2/44 • Number of events 2
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/12
|
0.00%
0/7
|
2.3%
1/44 • Number of events 1
|
|
Infections and infestations
Parotitis
|
0.00%
0/12
|
0.00%
0/7
|
2.3%
1/44 • Number of events 1
|
|
Infections and infestations
Perirectal abscess
|
0.00%
0/12
|
0.00%
0/7
|
2.3%
1/44 • Number of events 2
|
|
Infections and infestations
Pneumonia
|
8.3%
1/12 • Number of events 1
|
0.00%
0/7
|
0.00%
0/44
|
|
Infections and infestations
Sinusitis
|
0.00%
0/12
|
0.00%
0/7
|
6.8%
3/44 • Number of events 3
|
|
Infections and infestations
Skin infection
|
0.00%
0/12
|
0.00%
0/7
|
2.3%
1/44 • Number of events 1
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/12
|
0.00%
0/7
|
2.3%
1/44 • Number of events 1
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/12
|
14.3%
1/7 • Number of events 2
|
0.00%
0/44
|
|
Infections and infestations
Urinary tract infection
|
16.7%
2/12 • Number of events 3
|
14.3%
1/7 • Number of events 1
|
13.6%
6/44 • Number of events 6
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
0.00%
0/12
|
0.00%
0/7
|
2.3%
1/44 • Number of events 2
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/12
|
0.00%
0/7
|
2.3%
1/44 • Number of events 1
|
|
Surgical and medical procedures
Procedural pain
|
0.00%
0/12
|
0.00%
0/7
|
2.3%
1/44 • Number of events 1
|
|
Surgical and medical procedures
Procedural site reaction
|
0.00%
0/12
|
0.00%
0/7
|
2.3%
1/44 • Number of events 1
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/12
|
0.00%
0/7
|
2.3%
1/44 • Number of events 1
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/12
|
0.00%
0/7
|
2.3%
1/44 • Number of events 2
|
|
Injury, poisoning and procedural complications
Wound secretion
|
0.00%
0/12
|
0.00%
0/7
|
2.3%
1/44 • Number of events 1
|
|
Investigations
Activated partial thromboplastin time prolonged
|
8.3%
1/12 • Number of events 2
|
0.00%
0/7
|
0.00%
0/44
|
|
Investigations
Alanine aminotransferase increased
|
8.3%
1/12 • Number of events 1
|
0.00%
0/7
|
4.5%
2/44 • Number of events 2
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/12
|
0.00%
0/7
|
2.3%
1/44 • Number of events 1
|
|
Investigations
Blood alkaline phosphatase increased
|
8.3%
1/12 • Number of events 1
|
0.00%
0/7
|
11.4%
5/44 • Number of events 5
|
|
Investigations
Blood bicarbonate decreased
|
0.00%
0/12
|
0.00%
0/7
|
2.3%
1/44 • Number of events 1
|
|
Investigations
Blood creatinine increased
|
16.7%
2/12 • Number of events 3
|
0.00%
0/7
|
2.3%
1/44 • Number of events 2
|
|
Investigations
Blood magnesium decreased
|
0.00%
0/12
|
0.00%
0/7
|
2.3%
1/44 • Number of events 1
|
|
Investigations
Blood potassium decreased
|
0.00%
0/12
|
0.00%
0/7
|
6.8%
3/44 • Number of events 4
|
|
Investigations
Blood pressure decreased
|
0.00%
0/12
|
0.00%
0/7
|
2.3%
1/44 • Number of events 1
|
|
Investigations
Blood pressure increased
|
0.00%
0/12
|
0.00%
0/7
|
2.3%
1/44 • Number of events 2
|
|
Investigations
Blood sodium decreased
|
0.00%
0/12
|
0.00%
0/7
|
2.3%
1/44 • Number of events 1
|
|
Investigations
Blood uric acid increased
|
0.00%
0/12
|
0.00%
0/7
|
2.3%
1/44 • Number of events 1
|
|
Investigations
Body temperature increased
|
0.00%
0/12
|
0.00%
0/7
|
6.8%
3/44 • Number of events 3
|
|
Investigations
Breath sounds abnormal
|
0.00%
0/12
|
0.00%
0/7
|
4.5%
2/44 • Number of events 2
|
|
Investigations
Clostridium difficile toxin test positive
|
8.3%
1/12 • Number of events 1
|
0.00%
0/7
|
0.00%
0/44
|
|
Investigations
Haemoglobin decreased
|
8.3%
1/12 • Number of events 1
|
0.00%
0/7
|
6.8%
3/44 • Number of events 6
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/12
|
14.3%
1/7 • Number of events 2
|
2.3%
1/44 • Number of events 1
|
|
Investigations
Platelet count decreased
|
0.00%
0/12
|
0.00%
0/7
|
2.3%
1/44 • Number of events 1
|
|
Investigations
Skin turgor decreased
|
0.00%
0/12
|
0.00%
0/7
|
2.3%
1/44 • Number of events 1
|
|
Investigations
Weight decreased
|
16.7%
2/12 • Number of events 2
|
28.6%
2/7 • Number of events 3
|
11.4%
5/44 • Number of events 9
|
|
Investigations
Weight increased
|
0.00%
0/12
|
0.00%
0/7
|
2.3%
1/44 • Number of events 1
|
|
Investigations
White blood cell count decreased
|
0.00%
0/12
|
14.3%
1/7 • Number of events 1
|
2.3%
1/44 • Number of events 2
|
|
Metabolism and nutrition disorders
Anorexia
|
25.0%
3/12 • Number of events 3
|
28.6%
2/7 • Number of events 4
|
0.00%
0/44
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/12
|
0.00%
0/7
|
34.1%
15/44 • Number of events 25
|
|
Metabolism and nutrition disorders
Dehydration
|
8.3%
1/12 • Number of events 1
|
14.3%
1/7 • Number of events 1
|
31.8%
14/44 • Number of events 27
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/12
|
0.00%
0/7
|
2.3%
1/44 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperamylasaemia
|
0.00%
0/12
|
0.00%
0/7
|
2.3%
1/44 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/12
|
0.00%
0/7
|
4.5%
2/44 • Number of events 3
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/12
|
0.00%
0/7
|
6.8%
3/44 • Number of events 4
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/12
|
0.00%
0/7
|
2.3%
1/44 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
16.7%
2/12 • Number of events 2
|
0.00%
0/7
|
0.00%
0/44
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
25.0%
3/12 • Number of events 4
|
0.00%
0/7
|
2.3%
1/44 • Number of events 2
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
8.3%
1/12 • Number of events 2
|
0.00%
0/7
|
2.3%
1/44 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
8.3%
1/12 • Number of events 2
|
0.00%
0/7
|
6.8%
3/44 • Number of events 5
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
8.3%
1/12 • Number of events 1
|
0.00%
0/7
|
0.00%
0/44
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
8.3%
1/12 • Number of events 1
|
0.00%
0/7
|
4.5%
2/44 • Number of events 2
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
8.3%
1/12 • Number of events 3
|
0.00%
0/7
|
0.00%
0/44
|
|
Metabolism and nutrition disorders
Lactic acidosis
|
0.00%
0/12
|
0.00%
0/7
|
2.3%
1/44 • Number of events 1
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.00%
0/12
|
0.00%
0/7
|
2.3%
1/44 • Number of events 1
|
|
Metabolism and nutrition disorders
Vitamin B12 deficiency
|
0.00%
0/12
|
0.00%
0/7
|
2.3%
1/44 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/12
|
28.6%
2/7 • Number of events 2
|
6.8%
3/44 • Number of events 5
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
8.3%
1/12 • Number of events 1
|
14.3%
1/7 • Number of events 1
|
11.4%
5/44 • Number of events 11
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
8.3%
1/12 • Number of events 1
|
0.00%
0/7
|
2.3%
1/44 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/12
|
14.3%
1/7 • Number of events 1
|
0.00%
0/44
|
|
Musculoskeletal and connective tissue disorders
Jaw disorder
|
0.00%
0/12
|
0.00%
0/7
|
2.3%
1/44 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/12
|
0.00%
0/7
|
2.3%
1/44 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/12
|
0.00%
0/7
|
6.8%
3/44 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
8.3%
1/12 • Number of events 1
|
0.00%
0/7
|
0.00%
0/44
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/12
|
0.00%
0/7
|
2.3%
1/44 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
0.00%
0/12
|
0.00%
0/7
|
4.5%
2/44 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
16.7%
2/12 • Number of events 2
|
0.00%
0/7
|
2.3%
1/44 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/12
|
0.00%
0/7
|
4.5%
2/44 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/12
|
0.00%
0/7
|
2.3%
1/44 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/12
|
14.3%
1/7 • Number of events 1
|
4.5%
2/44 • Number of events 2
|
|
Nervous system disorders
Ageusia
|
0.00%
0/12
|
14.3%
1/7 • Number of events 1
|
0.00%
0/44
|
|
Nervous system disorders
Altered state of consciousness
|
0.00%
0/12
|
0.00%
0/7
|
2.3%
1/44 • Number of events 1
|
|
Nervous system disorders
Cholinergic syndrome
|
0.00%
0/12
|
0.00%
0/7
|
2.3%
1/44 • Number of events 1
|
|
Nervous system disorders
Dizziness
|
8.3%
1/12 • Number of events 1
|
14.3%
1/7 • Number of events 1
|
18.2%
8/44 • Number of events 11
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/12
|
0.00%
0/7
|
2.3%
1/44 • Number of events 1
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/12
|
0.00%
0/7
|
2.3%
1/44 • Number of events 1
|
|
Nervous system disorders
Headache
|
0.00%
0/12
|
28.6%
2/7 • Number of events 2
|
9.1%
4/44 • Number of events 6
|
|
Nervous system disorders
Hyperaesthesia
|
0.00%
0/12
|
14.3%
1/7 • Number of events 1
|
0.00%
0/44
|
|
Nervous system disorders
Lethargy
|
0.00%
0/12
|
0.00%
0/7
|
2.3%
1/44 • Number of events 1
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/12
|
0.00%
0/7
|
2.3%
1/44 • Number of events 1
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/12
|
14.3%
1/7 • Number of events 1
|
2.3%
1/44 • Number of events 1
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/12
|
0.00%
0/7
|
2.3%
1/44 • Number of events 1
|
|
Nervous system disorders
Poor quality sleep
|
0.00%
0/12
|
0.00%
0/7
|
2.3%
1/44 • Number of events 1
|
|
Nervous system disorders
Presyncope
|
0.00%
0/12
|
0.00%
0/7
|
2.3%
1/44 • Number of events 1
|
|
Nervous system disorders
Syncope
|
0.00%
0/12
|
14.3%
1/7 • Number of events 1
|
0.00%
0/44
|
|
Psychiatric disorders
Agitation
|
0.00%
0/12
|
0.00%
0/7
|
2.3%
1/44 • Number of events 1
|
|
Psychiatric disorders
Anxiety
|
8.3%
1/12 • Number of events 1
|
0.00%
0/7
|
6.8%
3/44 • Number of events 3
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/12
|
0.00%
0/7
|
9.1%
4/44 • Number of events 4
|
|
Psychiatric disorders
Depression
|
0.00%
0/12
|
0.00%
0/7
|
4.5%
2/44 • Number of events 2
|
|
Psychiatric disorders
Insomnia
|
25.0%
3/12 • Number of events 3
|
0.00%
0/7
|
11.4%
5/44 • Number of events 6
|
|
Psychiatric disorders
Restlessness
|
0.00%
0/12
|
0.00%
0/7
|
2.3%
1/44 • Number of events 1
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/12
|
0.00%
0/7
|
6.8%
3/44 • Number of events 3
|
|
Renal and urinary disorders
Incontinence
|
0.00%
0/12
|
0.00%
0/7
|
4.5%
2/44 • Number of events 2
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/12
|
14.3%
1/7 • Number of events 1
|
0.00%
0/44
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/12
|
0.00%
0/7
|
6.8%
3/44 • Number of events 4
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/12
|
0.00%
0/7
|
2.3%
1/44 • Number of events 1
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/12
|
14.3%
1/7 • Number of events 4
|
4.5%
2/44 • Number of events 2
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.00%
0/12
|
14.3%
1/7 • Number of events 1
|
0.00%
0/44
|
|
Reproductive system and breast disorders
Haematospermia
|
0.00%
0/12
|
14.3%
1/7 • Number of events 1
|
0.00%
0/44
|
|
Reproductive system and breast disorders
Pruritus genital
|
0.00%
0/12
|
0.00%
0/7
|
2.3%
1/44 • Number of events 1
|
|
Reproductive system and breast disorders
Scrotal erythema
|
0.00%
0/12
|
0.00%
0/7
|
2.3%
1/44 • Number of events 1
|
|
Reproductive system and breast disorders
Vulvovaginal burning sensation
|
8.3%
1/12 • Number of events 1
|
0.00%
0/7
|
0.00%
0/44
|
|
Immune system disorders
Asthma
|
0.00%
0/12
|
0.00%
0/7
|
2.3%
1/44 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/12
|
0.00%
0/7
|
4.5%
2/44 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.3%
1/12 • Number of events 2
|
57.1%
4/7 • Number of events 5
|
15.9%
7/44 • Number of events 8
|
|
Ear and labyrinth disorders
Dysphonia
|
8.3%
1/12 • Number of events 1
|
0.00%
0/7
|
6.8%
3/44 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
8.3%
1/12 • Number of events 1
|
0.00%
0/7
|
15.9%
7/44 • Number of events 8
|
|
Vascular disorders
Epistaxis
|
0.00%
0/12
|
0.00%
0/7
|
2.3%
1/44 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/12
|
0.00%
0/7
|
4.5%
2/44 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Increased upper airway secretion
|
0.00%
0/12
|
0.00%
0/7
|
2.3%
1/44 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.00%
0/12
|
0.00%
0/7
|
2.3%
1/44 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Lung infiltration
|
0.00%
0/12
|
0.00%
0/7
|
2.3%
1/44 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/12
|
14.3%
1/7 • Number of events 1
|
4.5%
2/44 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/12
|
0.00%
0/7
|
6.8%
3/44 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal sinus hypersecretion
|
0.00%
0/12
|
0.00%
0/7
|
2.3%
1/44 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/12
|
0.00%
0/7
|
4.5%
2/44 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/12
|
0.00%
0/7
|
4.5%
2/44 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Rales
|
0.00%
0/12
|
0.00%
0/7
|
2.3%
1/44 • Number of events 2
|
|
Infections and infestations
Rhinorrhoea
|
0.00%
0/12
|
0.00%
0/7
|
2.3%
1/44 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
8.3%
1/12 • Number of events 1
|
0.00%
0/7
|
0.00%
0/44
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/12
|
14.3%
1/7 • Number of events 1
|
0.00%
0/44
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
33.3%
4/12 • Number of events 4
|
42.9%
3/7 • Number of events 3
|
38.6%
17/44 • Number of events 20
|
|
Skin and subcutaneous tissue disorders
Dandruff
|
8.3%
1/12 • Number of events 1
|
0.00%
0/7
|
0.00%
0/44
|
|
Skin and subcutaneous tissue disorders
Dermatitis exfoliative
|
0.00%
0/12
|
0.00%
0/7
|
2.3%
1/44 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/12
|
14.3%
1/7 • Number of events 1
|
4.5%
2/44 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/12
|
0.00%
0/7
|
4.5%
2/44 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Erythema
|
8.3%
1/12 • Number of events 2
|
0.00%
0/7
|
2.3%
1/44 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Exfoliative rash
|
0.00%
0/12
|
0.00%
0/7
|
2.3%
1/44 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/12
|
0.00%
0/7
|
9.1%
4/44 • Number of events 4
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/12
|
0.00%
0/7
|
4.5%
2/44 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
8.3%
1/12 • Number of events 1
|
42.9%
3/7 • Number of events 4
|
9.1%
4/44 • Number of events 9
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
0.00%
0/12
|
0.00%
0/7
|
4.5%
2/44 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Rash
|
8.3%
1/12 • Number of events 1
|
14.3%
1/7 • Number of events 6
|
18.2%
8/44 • Number of events 22
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/12
|
0.00%
0/7
|
2.3%
1/44 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Rash generalised
|
0.00%
0/12
|
0.00%
0/7
|
2.3%
1/44 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.00%
0/12
|
14.3%
1/7 • Number of events 1
|
0.00%
0/44
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/12
|
14.3%
1/7 • Number of events 1
|
2.3%
1/44 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
0.00%
0/12
|
0.00%
0/7
|
2.3%
1/44 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/12
|
0.00%
0/7
|
2.3%
1/44 • Number of events 1
|
|
Vascular disorders
Flushing
|
16.7%
2/12 • Number of events 2
|
0.00%
0/7
|
0.00%
0/44
|
|
Vascular disorders
Hypertension
|
0.00%
0/12
|
0.00%
0/7
|
4.5%
2/44 • Number of events 2
|
|
Vascular disorders
Hypotension
|
8.3%
1/12 • Number of events 1
|
14.3%
1/7 • Number of events 1
|
13.6%
6/44 • Number of events 6
|
|
Vascular disorders
Pallor
|
0.00%
0/12
|
0.00%
0/7
|
2.3%
1/44 • Number of events 1
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.00%
0/12
|
0.00%
0/7
|
2.3%
1/44 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER