Trial Outcomes & Findings for Global Phase1 Study to Assess the Safety and Tolerability of AZD1208 in Advanced Solid Tumors and Malignant Lymphoma (NCT NCT01588548)
NCT ID: NCT01588548
Last Updated: 2015-11-04
Results Overview
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), disappearance of all target lesions (TL)s since baseline and any pathological lymph nodes selected as TLs must have a reduction in short axis to \<10 mm; Partial Response (PR), at least a 30% decrease in the sum of diameters of TLs; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD; Progressive Disease (PD), at least a 20% increase in the sum of diameters of TLs and an absolute increase of at least 5 mm; Not Evaluable (NE), this is only relevant if any of the TLs were not assessed or not evaluable or had a lesion intervention at this visit, also note that if the sum of diameters meets the progressive disease criteria, progressive disease overrides not evaluable as a TL response. Best objective response is the best response a patient experiences over the randomised treatment period.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
43 participants
Primary outcome timeframe
Measurements occur at screening (<=28 days before start of study treatment), every 6 weeks (+/-1 week) up to 12 weeks and then every 12 weeks (+/-1 week) until discontinuation of study treatment or withdrawal of consent, starting from Day 1 of Cycle 1
Results posted on
2015-11-04
Participant Flow
43 patients were enrolled to the study, of which 35 recieved doses of AZD1208 between 120mg and 800mg. The other 8 patients did not receive AZD1208.
Participant milestones
| Measure |
AZD1208 120mg
Once daily continuous dosing schedule.
|
AZD1208 240mg
Once daily continuous dosing schedule.
|
AZD1208 360mg
Once daily continuous dosing schedule.
|
AZD1208 540mg
Once daily continuous dosing schedule.
|
AZD1208 700mg
Once daily continuous dosing schedule.
|
AZD1208 800mg
Once daily continuous dosing schedule.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
7
|
6
|
7
|
6
|
6
|
|
Overall Study
Cycle 1 Day 21
|
3
|
5
|
2
|
5
|
3
|
3
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
3
|
7
|
6
|
7
|
6
|
6
|
Reasons for withdrawal
| Measure |
AZD1208 120mg
Once daily continuous dosing schedule.
|
AZD1208 240mg
Once daily continuous dosing schedule.
|
AZD1208 360mg
Once daily continuous dosing schedule.
|
AZD1208 540mg
Once daily continuous dosing schedule.
|
AZD1208 700mg
Once daily continuous dosing schedule.
|
AZD1208 800mg
Once daily continuous dosing schedule.
|
|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
1
|
1
|
2
|
3
|
|
Overall Study
Adverse Event
|
0
|
0
|
1
|
2
|
1
|
0
|
|
Overall Study
Condition Under Investigation Worsened
|
3
|
6
|
4
|
4
|
3
|
3
|
Baseline Characteristics
Global Phase1 Study to Assess the Safety and Tolerability of AZD1208 in Advanced Solid Tumors and Malignant Lymphoma
Baseline characteristics by cohort
| Measure |
AZD1208 120mg
n=3 Participants
Once daily continuous dosing schedule.
|
AZD1208 240mg
n=7 Participants
Once daily continuous dosing schedule.
|
AZD1208 360mg
n=6 Participants
Once daily continuous dosing schedule.
|
AZD1208 540mg
n=7 Participants
Once daily continuous dosing schedule.
|
AZD1208 700mg
n=6 Participants
Once daily continuous dosing schedule.
|
AZD1208 800mg
n=6 Participants
Once daily continuous dosing schedule.
|
Total
n=35 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
54.0 Years
STANDARD_DEVIATION 9.00 • n=5 Participants
|
59.4 Years
STANDARD_DEVIATION 9.81 • n=7 Participants
|
63.5 Years
STANDARD_DEVIATION 14.38 • n=5 Participants
|
62.3 Years
STANDARD_DEVIATION 17.01 • n=4 Participants
|
66.5 Years
STANDARD_DEVIATION 12.85 • n=21 Participants
|
60.8 Years
STANDARD_DEVIATION 12.45 • n=10 Participants
|
61.7 Years
STANDARD_DEVIATION 12.70 • n=115 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
18 Participants
n=115 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
17 Participants
n=115 Participants
|
PRIMARY outcome
Timeframe: Measurements occur at screening (<=28 days before start of study treatment), every 6 weeks (+/-1 week) up to 12 weeks and then every 12 weeks (+/-1 week) until discontinuation of study treatment or withdrawal of consent, starting from Day 1 of Cycle 1Population: All patients who were evaluable for Response analysis set for RECIST criteria
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), disappearance of all target lesions (TL)s since baseline and any pathological lymph nodes selected as TLs must have a reduction in short axis to \<10 mm; Partial Response (PR), at least a 30% decrease in the sum of diameters of TLs; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD; Progressive Disease (PD), at least a 20% increase in the sum of diameters of TLs and an absolute increase of at least 5 mm; Not Evaluable (NE), this is only relevant if any of the TLs were not assessed or not evaluable or had a lesion intervention at this visit, also note that if the sum of diameters meets the progressive disease criteria, progressive disease overrides not evaluable as a TL response. Best objective response is the best response a patient experiences over the randomised treatment period.
Outcome measures
| Measure |
AZD1208 120mg
n=3 Participants
Once daily continuous dosing schedule.
|
AZD1208 240mg
n=7 Participants
Once daily continuous dosing schedule.
|
AZD1208 360mg
n=5 Participants
Once daily continuous dosing schedule.
|
AZD1208 540mg
n=7 Participants
Once daily continuous dosing schedule.
|
AZD1208 700mg
n=6 Participants
Once daily continuous dosing schedule.
|
AZD1208 800mg
n=5 Participants
Once daily continuous dosing schedule.
|
|---|---|---|---|---|---|---|
|
Best Objective Response Based on RECIST Criteria (Evaluable for Response Analysis Set for RECIST Criteria)
CR
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Best Objective Response Based on RECIST Criteria (Evaluable for Response Analysis Set for RECIST Criteria)
PR
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Best Objective Response Based on RECIST Criteria (Evaluable for Response Analysis Set for RECIST Criteria)
SD >=6 weeks (unconfirmed CR or PR)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Best Objective Response Based on RECIST Criteria (Evaluable for Response Analysis Set for RECIST Criteria)
SD >=6 weeks (SD)
|
2 Participants
|
5 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
|
Best Objective Response Based on RECIST Criteria (Evaluable for Response Analysis Set for RECIST Criteria)
PD (RECIST progression)
|
1 Participants
|
2 Participants
|
3 Participants
|
3 Participants
|
2 Participants
|
3 Participants
|
|
Best Objective Response Based on RECIST Criteria (Evaluable for Response Analysis Set for RECIST Criteria)
PD (Death)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Best Objective Response Based on RECIST Criteria (Evaluable for Response Analysis Set for RECIST Criteria)
Not evaluable (SD < 6 weeks)
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Best Objective Response Based on RECIST Criteria (Evaluable for Response Analysis Set for RECIST Criteria)
Not evaluable(Incomplete postbaseline assessments)
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
Adverse Events
AZD1208 120mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
AZD1208 240mg
Serious events: 2 serious events
Other events: 7 other events
Deaths: 0 deaths
AZD1208 360mg
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
AZD1208 540mg
Serious events: 2 serious events
Other events: 7 other events
Deaths: 0 deaths
AZD1208 700mg
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
AZD1208 800mg
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
AZD1208 120mg
n=3 participants at risk
Once daily continuous dosing schedule.
|
AZD1208 240mg
n=7 participants at risk
Once daily continuous dosing schedule.
|
AZD1208 360mg
n=6 participants at risk
Once daily continuous dosing schedule.
|
AZD1208 540mg
n=7 participants at risk
Once daily continuous dosing schedule.
|
AZD1208 700mg
n=6 participants at risk
Once daily continuous dosing schedule.
|
AZD1208 800mg
n=6 participants at risk
Once daily continuous dosing schedule.
|
|---|---|---|---|---|---|---|
|
Infections and infestations
Bacterial Infection
|
0.00%
0/3
|
14.3%
1/7
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/6
|
|
Nervous system disorders
Balance Disorder
|
0.00%
0/3
|
0.00%
0/7
|
0.00%
0/6
|
14.3%
1/7
|
0.00%
0/6
|
0.00%
0/6
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/3
|
0.00%
0/7
|
16.7%
1/6
|
14.3%
1/7
|
0.00%
0/6
|
0.00%
0/6
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease
|
0.00%
0/3
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/7
|
16.7%
1/6
|
0.00%
0/6
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.00%
0/3
|
0.00%
0/7
|
16.7%
1/6
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/6
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3
|
0.00%
0/7
|
0.00%
0/6
|
14.3%
1/7
|
16.7%
1/6
|
0.00%
0/6
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/3
|
0.00%
0/7
|
16.7%
1/6
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/6
|
|
Gastrointestinal disorders
Intestinal Obstruction
|
0.00%
0/3
|
14.3%
1/7
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/6
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/3
|
0.00%
0/7
|
0.00%
0/6
|
14.3%
1/7
|
0.00%
0/6
|
0.00%
0/6
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/3
|
14.3%
1/7
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/6
|
|
General disorders
Fatigue
|
0.00%
0/3
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/7
|
16.7%
1/6
|
0.00%
0/6
|
|
General disorders
General Physical Health Deterioration
|
0.00%
0/3
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/7
|
16.7%
1/6
|
0.00%
0/6
|
Other adverse events
| Measure |
AZD1208 120mg
n=3 participants at risk
Once daily continuous dosing schedule.
|
AZD1208 240mg
n=7 participants at risk
Once daily continuous dosing schedule.
|
AZD1208 360mg
n=6 participants at risk
Once daily continuous dosing schedule.
|
AZD1208 540mg
n=7 participants at risk
Once daily continuous dosing schedule.
|
AZD1208 700mg
n=6 participants at risk
Once daily continuous dosing schedule.
|
AZD1208 800mg
n=6 participants at risk
Once daily continuous dosing schedule.
|
|---|---|---|---|---|---|---|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/3
|
14.3%
1/7
|
16.7%
1/6
|
14.3%
1/7
|
0.00%
0/6
|
0.00%
0/6
|
|
Infections and infestations
Oral Candidiasis
|
0.00%
0/3
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/7
|
33.3%
2/6
|
0.00%
0/6
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
33.3%
1/3
|
14.3%
1/7
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/6
|
|
Infections and infestations
Bacterial Infection
|
0.00%
0/3
|
14.3%
1/7
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/6
|
|
Infections and infestations
Lower Respiratory Tract Infection
|
0.00%
0/3
|
0.00%
0/7
|
16.7%
1/6
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/6
|
|
Infections and infestations
Lung Infection
|
0.00%
0/3
|
14.3%
1/7
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/6
|
|
Infections and infestations
Paronychia
|
33.3%
1/3
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/6
|
|
Infections and infestations
Vaginal Infection
|
33.3%
1/3
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/6
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer Pain
|
0.00%
0/3
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/7
|
16.7%
1/6
|
0.00%
0/6
|
|
Blood and lymphatic system disorders
Anaemia
|
100.0%
3/3
|
57.1%
4/7
|
33.3%
2/6
|
57.1%
4/7
|
50.0%
3/6
|
33.3%
2/6
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/3
|
0.00%
0/7
|
33.3%
2/6
|
14.3%
1/7
|
16.7%
1/6
|
16.7%
1/6
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/3
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/7
|
16.7%
1/6
|
0.00%
0/6
|
|
Blood and lymphatic system disorders
Lymphadenitis
|
0.00%
0/3
|
0.00%
0/7
|
16.7%
1/6
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/6
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
33.3%
1/3
|
42.9%
3/7
|
33.3%
2/6
|
57.1%
4/7
|
33.3%
2/6
|
50.0%
3/6
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
33.3%
1/3
|
28.6%
2/7
|
33.3%
2/6
|
14.3%
1/7
|
50.0%
3/6
|
0.00%
0/6
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
33.3%
1/3
|
0.00%
0/7
|
16.7%
1/6
|
57.1%
4/7
|
0.00%
0/6
|
33.3%
2/6
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/3
|
0.00%
0/7
|
16.7%
1/6
|
42.9%
3/7
|
16.7%
1/6
|
0.00%
0/6
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/3
|
0.00%
0/7
|
0.00%
0/6
|
28.6%
2/7
|
16.7%
1/6
|
16.7%
1/6
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/3
|
14.3%
1/7
|
16.7%
1/6
|
14.3%
1/7
|
0.00%
0/6
|
0.00%
0/6
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/3
|
28.6%
2/7
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/6
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3
|
0.00%
0/7
|
16.7%
1/6
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/6
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/3
|
0.00%
0/7
|
0.00%
0/6
|
14.3%
1/7
|
0.00%
0/6
|
0.00%
0/6
|
|
Metabolism and nutrition disorders
Polydipsia
|
0.00%
0/3
|
0.00%
0/7
|
0.00%
0/6
|
14.3%
1/7
|
0.00%
0/6
|
0.00%
0/6
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/3
|
14.3%
1/7
|
16.7%
1/6
|
14.3%
1/7
|
0.00%
0/6
|
16.7%
1/6
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/3
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/7
|
16.7%
1/6
|
0.00%
0/6
|
|
Nervous system disorders
Lethargy
|
0.00%
0/3
|
0.00%
0/7
|
16.7%
1/6
|
28.6%
2/7
|
0.00%
0/6
|
0.00%
0/6
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/3
|
14.3%
1/7
|
0.00%
0/6
|
14.3%
1/7
|
0.00%
0/6
|
0.00%
0/6
|
|
Nervous system disorders
Headache
|
0.00%
0/3
|
0.00%
0/7
|
0.00%
0/6
|
28.6%
2/7
|
0.00%
0/6
|
0.00%
0/6
|
|
Nervous system disorders
Somnolence
|
0.00%
0/3
|
0.00%
0/7
|
0.00%
0/6
|
14.3%
1/7
|
0.00%
0/6
|
16.7%
1/6
|
|
Nervous system disorders
Ataxia
|
0.00%
0/3
|
0.00%
0/7
|
0.00%
0/6
|
14.3%
1/7
|
0.00%
0/6
|
0.00%
0/6
|
|
Nervous system disorders
Balance Disorder
|
0.00%
0/3
|
0.00%
0/7
|
0.00%
0/6
|
14.3%
1/7
|
0.00%
0/6
|
0.00%
0/6
|
|
Nervous system disorders
Disturbance In Attention
|
0.00%
0/3
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/6
|
16.7%
1/6
|
|
Nervous system disorders
Dizziness
|
0.00%
0/3
|
14.3%
1/7
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/6
|
|
Nervous system disorders
Dysaesthesia
|
0.00%
0/3
|
14.3%
1/7
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/6
|
|
Nervous system disorders
Neuropathy Peripheral
|
0.00%
0/3
|
0.00%
0/7
|
0.00%
0/6
|
14.3%
1/7
|
0.00%
0/6
|
0.00%
0/6
|
|
Nervous system disorders
Sensory Disturbance
|
0.00%
0/3
|
14.3%
1/7
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/6
|
|
Eye disorders
Dry Eye
|
0.00%
0/3
|
14.3%
1/7
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/6
|
|
Eye disorders
Vision Blurred
|
0.00%
0/3
|
0.00%
0/7
|
0.00%
0/6
|
14.3%
1/7
|
0.00%
0/6
|
0.00%
0/6
|
|
Cardiac disorders
Atrial Fibrillation
|
0.00%
0/3
|
0.00%
0/7
|
16.7%
1/6
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/6
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/3
|
14.3%
1/7
|
33.3%
2/6
|
14.3%
1/7
|
0.00%
0/6
|
0.00%
0/6
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/3
|
0.00%
0/7
|
0.00%
0/6
|
28.6%
2/7
|
16.7%
1/6
|
0.00%
0/6
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/3
|
0.00%
0/7
|
16.7%
1/6
|
14.3%
1/7
|
16.7%
1/6
|
0.00%
0/6
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea Exertional
|
0.00%
0/3
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/7
|
33.3%
2/6
|
0.00%
0/6
|
|
Respiratory, thoracic and mediastinal disorders
Productive Cough
|
0.00%
0/3
|
0.00%
0/7
|
16.7%
1/6
|
14.3%
1/7
|
0.00%
0/6
|
0.00%
0/6
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease
|
0.00%
0/3
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/7
|
16.7%
1/6
|
0.00%
0/6
|
|
Respiratory, thoracic and mediastinal disorders
Dysaesthesia Pharynx
|
0.00%
0/3
|
0.00%
0/7
|
0.00%
0/6
|
14.3%
1/7
|
0.00%
0/6
|
0.00%
0/6
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/3
|
0.00%
0/7
|
0.00%
0/6
|
14.3%
1/7
|
0.00%
0/6
|
0.00%
0/6
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/3
|
0.00%
0/7
|
0.00%
0/6
|
14.3%
1/7
|
0.00%
0/6
|
0.00%
0/6
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.00%
0/3
|
0.00%
0/7
|
16.7%
1/6
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/6
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic Pain
|
0.00%
0/3
|
0.00%
0/7
|
0.00%
0/6
|
14.3%
1/7
|
0.00%
0/6
|
0.00%
0/6
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
0.00%
0/3
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/7
|
16.7%
1/6
|
0.00%
0/6
|
|
Respiratory, thoracic and mediastinal disorders
Upper Respiratory Tract Inflammation
|
0.00%
0/3
|
0.00%
0/7
|
0.00%
0/6
|
14.3%
1/7
|
0.00%
0/6
|
0.00%
0/6
|
|
Gastrointestinal disorders
Diarrhoea
|
66.7%
2/3
|
71.4%
5/7
|
83.3%
5/6
|
85.7%
6/7
|
83.3%
5/6
|
100.0%
6/6
|
|
Gastrointestinal disorders
Nausea
|
33.3%
1/3
|
85.7%
6/7
|
50.0%
3/6
|
100.0%
7/7
|
83.3%
5/6
|
66.7%
4/6
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3
|
85.7%
6/7
|
16.7%
1/6
|
71.4%
5/7
|
66.7%
4/6
|
50.0%
3/6
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/3
|
42.9%
3/7
|
33.3%
2/6
|
28.6%
2/7
|
16.7%
1/6
|
0.00%
0/6
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/3
|
0.00%
0/7
|
50.0%
3/6
|
0.00%
0/7
|
33.3%
2/6
|
0.00%
0/6
|
|
Gastrointestinal disorders
Gastrooesophageal Reflux Disease
|
0.00%
0/3
|
0.00%
0/7
|
0.00%
0/6
|
42.9%
3/7
|
0.00%
0/6
|
0.00%
0/6
|
|
Hepatobiliary disorders
Hepatic Pain
|
0.00%
0/3
|
0.00%
0/7
|
16.7%
1/6
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/6
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/3
|
14.3%
1/7
|
16.7%
1/6
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/6
|
|
Gastrointestinal disorders
Abdominal Discomfort
|
0.00%
0/3
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/6
|
16.7%
1/6
|
|
Gastrointestinal disorders
Abdominal Distension
|
0.00%
0/3
|
0.00%
0/7
|
16.7%
1/6
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/6
|
|
Gastrointestinal disorders
Abdominal Tenderness
|
0.00%
0/3
|
0.00%
0/7
|
0.00%
0/6
|
14.3%
1/7
|
0.00%
0/6
|
0.00%
0/6
|
|
Gastrointestinal disorders
Cheilitis
|
0.00%
0/3
|
14.3%
1/7
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/6
|
|
Gastrointestinal disorders
Dry Mouth
|
0.00%
0/3
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/6
|
16.7%
1/6
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/3
|
0.00%
0/7
|
16.7%
1/6
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/6
|
|
Gastrointestinal disorders
Haemorrhoidal Haemorrhage
|
0.00%
0/3
|
14.3%
1/7
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/6
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/3
|
14.3%
1/7
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/6
|
|
Gastrointestinal disorders
Intestinal Obstruction
|
0.00%
0/3
|
14.3%
1/7
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/6
|
|
Gastrointestinal disorders
Stomatitis
|
33.3%
1/3
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/6
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
0.00%
0/3
|
42.9%
3/7
|
16.7%
1/6
|
28.6%
2/7
|
16.7%
1/6
|
0.00%
0/6
|
|
Skin and subcutaneous tissue disorders
Rash Maculo-Papular
|
0.00%
0/3
|
14.3%
1/7
|
0.00%
0/6
|
14.3%
1/7
|
16.7%
1/6
|
0.00%
0/6
|
|
Skin and subcutaneous tissue disorders
Rash Macular
|
0.00%
0/3
|
0.00%
0/7
|
16.7%
1/6
|
0.00%
0/7
|
16.7%
1/6
|
0.00%
0/6
|
|
Skin and subcutaneous tissue disorders
Nail Disorder
|
0.00%
0/3
|
14.3%
1/7
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/6
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
33.3%
1/3
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/6
|
|
Skin and subcutaneous tissue disorders
Purpura
|
0.00%
0/3
|
14.3%
1/7
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/6
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/3
|
0.00%
0/7
|
16.7%
1/6
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/6
|
|
Skin and subcutaneous tissue disorders
Skin Exfoliation
|
0.00%
0/3
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/6
|
16.7%
1/6
|
|
Skin and subcutaneous tissue disorders
Skin Fissures
|
0.00%
0/3
|
14.3%
1/7
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/6
|
|
Skin and subcutaneous tissue disorders
Skin Mass
|
0.00%
0/3
|
0.00%
0/7
|
0.00%
0/6
|
14.3%
1/7
|
0.00%
0/6
|
0.00%
0/6
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/3
|
14.3%
1/7
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/6
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Chest Pain
|
0.00%
0/3
|
0.00%
0/7
|
33.3%
2/6
|
14.3%
1/7
|
16.7%
1/6
|
0.00%
0/6
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/3
|
0.00%
0/7
|
16.7%
1/6
|
0.00%
0/7
|
0.00%
0/6
|
16.7%
1/6
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/3
|
0.00%
0/7
|
0.00%
0/6
|
14.3%
1/7
|
0.00%
0/6
|
16.7%
1/6
|
|
Musculoskeletal and connective tissue disorders
Flank Pain
|
0.00%
0/3
|
14.3%
1/7
|
0.00%
0/6
|
0.00%
0/7
|
16.7%
1/6
|
0.00%
0/6
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
33.3%
1/3
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/7
|
16.7%
1/6
|
0.00%
0/6
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
0.00%
0/3
|
14.3%
1/7
|
16.7%
1/6
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/6
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
0.00%
0/3
|
0.00%
0/7
|
0.00%
0/6
|
14.3%
1/7
|
0.00%
0/6
|
0.00%
0/6
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
0.00%
0/3
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/6
|
16.7%
1/6
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/3
|
42.9%
3/7
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/6
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/3
|
0.00%
0/7
|
0.00%
0/6
|
14.3%
1/7
|
16.7%
1/6
|
0.00%
0/6
|
|
Renal and urinary disorders
Cystitis Noninfective
|
0.00%
0/3
|
14.3%
1/7
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/6
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/3
|
14.3%
1/7
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/6
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/3
|
14.3%
1/7
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/6
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/3
|
14.3%
1/7
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/6
|
|
Renal and urinary disorders
Polyuria
|
0.00%
0/3
|
0.00%
0/7
|
0.00%
0/6
|
14.3%
1/7
|
0.00%
0/6
|
0.00%
0/6
|
|
Renal and urinary disorders
Urinary Incontinence
|
0.00%
0/3
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/6
|
16.7%
1/6
|
|
Reproductive system and breast disorders
Pelvic Pain
|
0.00%
0/3
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/7
|
16.7%
1/6
|
0.00%
0/6
|
|
Reproductive system and breast disorders
Vulvovaginal Pruritus
|
0.00%
0/3
|
0.00%
0/7
|
0.00%
0/6
|
14.3%
1/7
|
0.00%
0/6
|
0.00%
0/6
|
|
General disorders
Fatigue
|
0.00%
0/3
|
28.6%
2/7
|
50.0%
3/6
|
42.9%
3/7
|
66.7%
4/6
|
83.3%
5/6
|
|
General disorders
Pyrexia
|
0.00%
0/3
|
14.3%
1/7
|
50.0%
3/6
|
0.00%
0/7
|
33.3%
2/6
|
0.00%
0/6
|
|
General disorders
Chest Pain
|
0.00%
0/3
|
0.00%
0/7
|
16.7%
1/6
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/6
|
|
General disorders
Chills
|
0.00%
0/3
|
0.00%
0/7
|
0.00%
0/6
|
14.3%
1/7
|
0.00%
0/6
|
0.00%
0/6
|
|
General disorders
Device Occlusion
|
0.00%
0/3
|
0.00%
0/7
|
0.00%
0/6
|
14.3%
1/7
|
0.00%
0/6
|
0.00%
0/6
|
|
General disorders
General Physical Health Deterioration
|
0.00%
0/3
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/7
|
16.7%
1/6
|
0.00%
0/6
|
|
General disorders
Hernia
|
0.00%
0/3
|
14.3%
1/7
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/6
|
|
General disorders
Malaise
|
0.00%
0/3
|
14.3%
1/7
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/6
|
|
General disorders
Mucosal Inflammation
|
0.00%
0/3
|
14.3%
1/7
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/6
|
|
General disorders
Oedema Peripheral
|
0.00%
0/3
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/6
|
16.7%
1/6
|
|
General disorders
Suprapubic Pain
|
0.00%
0/3
|
14.3%
1/7
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/6
|
|
Investigations
Platelet Count Decreased
|
66.7%
2/3
|
28.6%
2/7
|
16.7%
1/6
|
28.6%
2/7
|
16.7%
1/6
|
16.7%
1/6
|
|
Investigations
White Blood Cell Count Decreased
|
66.7%
2/3
|
42.9%
3/7
|
16.7%
1/6
|
28.6%
2/7
|
16.7%
1/6
|
0.00%
0/6
|
|
Investigations
Gamma-Glutamyltransferase Increased
|
0.00%
0/3
|
28.6%
2/7
|
16.7%
1/6
|
28.6%
2/7
|
0.00%
0/6
|
16.7%
1/6
|
|
Investigations
Aspartate Aminotransferase Increased
|
0.00%
0/3
|
28.6%
2/7
|
0.00%
0/6
|
14.3%
1/7
|
0.00%
0/6
|
0.00%
0/6
|
|
Investigations
Blood Creatinine Increased
|
0.00%
0/3
|
14.3%
1/7
|
16.7%
1/6
|
0.00%
0/7
|
0.00%
0/6
|
16.7%
1/6
|
|
Investigations
Lymphocyte Count Decreased
|
0.00%
0/3
|
14.3%
1/7
|
33.3%
2/6
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/6
|
|
Investigations
Alanine Aminotransferase Increased
|
0.00%
0/3
|
14.3%
1/7
|
0.00%
0/6
|
14.3%
1/7
|
0.00%
0/6
|
0.00%
0/6
|
|
Investigations
Blood Alkaline Phosphatase Increased
|
0.00%
0/3
|
28.6%
2/7
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/6
|
|
Investigations
Neutrophil Count Decreased
|
0.00%
0/3
|
28.6%
2/7
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/6
|
|
Investigations
Oxygen Saturation Decreased
|
0.00%
0/3
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/7
|
33.3%
2/6
|
0.00%
0/6
|
|
Investigations
Blood Creatine Phosphokinase Increased
|
0.00%
0/3
|
0.00%
0/7
|
0.00%
0/6
|
14.3%
1/7
|
0.00%
0/6
|
0.00%
0/6
|
|
Investigations
Blood Urea Increased
|
0.00%
0/3
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/6
|
16.7%
1/6
|
|
Investigations
Breath Sounds Abnormal
|
0.00%
0/3
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/7
|
16.7%
1/6
|
0.00%
0/6
|
|
Investigations
Electrocardiogram Qt Prolonged
|
0.00%
0/3
|
0.00%
0/7
|
0.00%
0/6
|
14.3%
1/7
|
0.00%
0/6
|
0.00%
0/6
|
|
Investigations
Gastrointestinal Stoma Output Decreased
|
0.00%
0/3
|
14.3%
1/7
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/6
|
|
Investigations
Weight Decreased
|
0.00%
0/3
|
14.3%
1/7
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/6
|
|
Injury, poisoning and procedural complications
Arthropod Bite
|
33.3%
1/3
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/6
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/3
|
0.00%
0/7
|
0.00%
0/6
|
14.3%
1/7
|
0.00%
0/6
|
0.00%
0/6
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee AstraZeneca will manage the publication of the results of the Clinical Trial in partnership with the authors. AstraZeneca recognises that Institutions/Investigators may wish to make publications regarding Clinical Trial results. The Institution/Investigator agrees to collaborate in good faith with AstraZeneca. Prior to any such publication, the Institution/Investigator shall provide AstraZeneca with preliminary data and drafts of proposed publications.
- Publication restrictions are in place
Restriction type: OTHER