Trial Outcomes & Findings for Assess the Efficacy of AZD8931 in Combination With Paclitaxel Versus Paclitaxel Alone in Patients With Gastric Cancer (NCT NCT01579578)
NCT ID: NCT01579578
Last Updated: 2014-09-12
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
39 participants
Primary outcome timeframe
Baseline and 8 weeks, accessed up to data cut off on 4 December 2012
Results posted on
2014-09-12
Participant Flow
Due to the early stopping of this study as a result of the AZD8931 program being stopped, the full planned enrolment was not carried out. This study was stopped after 39 were enrolled, 25 of whom were treated, which is less than the number planned in the protocol.
Due to the early stopping of this study as a result of the AZD8931 program being stopped, the full planned enrolment was not carried out. This study was stopped after 39 were enrolled, 25 of whom were treated, which is less than the number planned in the protocol.
Participant milestones
| Measure |
AZD8931 40mg + Paclitaxel
AZD8931 40 mg bd (Twice daily) administered orally in combination with paclitaxel 80 mg/m2 administered intravenously \[approximately 1 hour duration\] on D1, 8 and 15 of each 28 day treatment cycle
|
Placebo + Paclitaxel
AZD8931 matching placebo bd administered orally in combination with paclitaxel 80 mg/m2 administered intravenously \[approximately 1 hour duration\] on D1, 8 and 15 of each 28 day treatment cycle
|
|---|---|---|
|
Overall Study
STARTED
|
13
|
12
|
|
Overall Study
Ongoing
|
3
|
0
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
13
|
12
|
Reasons for withdrawal
| Measure |
AZD8931 40mg + Paclitaxel
AZD8931 40 mg bd (Twice daily) administered orally in combination with paclitaxel 80 mg/m2 administered intravenously \[approximately 1 hour duration\] on D1, 8 and 15 of each 28 day treatment cycle
|
Placebo + Paclitaxel
AZD8931 matching placebo bd administered orally in combination with paclitaxel 80 mg/m2 administered intravenously \[approximately 1 hour duration\] on D1, 8 and 15 of each 28 day treatment cycle
|
|---|---|---|
|
Overall Study
Death
|
4
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
2
|
1
|
|
Overall Study
Eligibility criteria
|
3
|
9
|
|
Overall Study
Ongoing
|
3
|
0
|
Baseline Characteristics
Assess the Efficacy of AZD8931 in Combination With Paclitaxel Versus Paclitaxel Alone in Patients With Gastric Cancer
Baseline characteristics by cohort
| Measure |
AZD8931 40mg + Paclitaxel
n=13 Participants
AZD8931 40 mg bd (Twice daily) administered orally in combination with paclitaxel 80 mg/m2 administered intravenously \[approximately 1 hour duration\] on D1, 8 and 15 of each 28 day treatment cycle
|
Placebo + Paclitaxel
n=12 Participants
AZD8931 matching placebo bd administered orally in combination with paclitaxel 80 mg/m2 administered intravenously \[approximately 1 hour duration\] on D1, 8 and 15 of each 28 day treatment cycle
|
Total
n=25 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57.9 Years
STANDARD_DEVIATION 8.71 • n=5 Participants
|
62.7 Years
STANDARD_DEVIATION 13.60 • n=7 Participants
|
60.2 Years
STANDARD_DEVIATION 11.34 • n=5 Participants
|
|
Age, Customized
18 - < 50 years
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Age, Customized
50 - < 65 years
|
7 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Age, Customized
65 - < 75 years
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Age, Customized
>= 75 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
13 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian (Other Than Chinese or Japanese)
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Chinese
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Japanese
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
HER2 Status: HER2/IHC (Local Assessment)
HER2 0 No staining/membrane staining <10% of cells
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
HER2 Status: HER2/IHC (Local Assessment)
HER2 1+ Faint membrane staining ≥10% of cells
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
HER2 Status: HER2/IHC (Local Assessment)
HER2 2+ Weak/moderate membrane staining ≥10% cells
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and 8 weeks, accessed up to data cut off on 4 December 2012Population: Full Analysis Set
Outcome measures
| Measure |
AZD8931 + Paclitaxel
n=8 change from baseline
AZD8931 40 mg bd (Twice daily) administered orally in combination with paclitaxel 80 mg/m2 administered intravenously \[approximately 1 hour duration\] on D1, 8 and 15 of each 28 day treatment cycle
|
Placebo + Paclitaxel
n=9 change from baseline
AZD8931 matching placebo bd administered orally in combination with paclitaxel 80 mg/m2 administered intravenously \[approximately 1 hour duration\] on D1, 8 and 15 of each 28 day treatment cycle
|
|---|---|---|
|
Change in Tumour Size at 8 Weeks Were Analyzed for Comparing Relative Efficacy of AZD8931 Plus Paclitaxel With Paclitaxel Alone
|
-7.7 percentage change
Standard Error 8.60
|
-2.7 percentage change
Standard Error 8.64
|
SECONDARY outcome
Timeframe: Baseline and every 8 weeks, accessed up to data cut off on 4 December 2012Time from the date of randomization until the date of objective disease progression (as per RECIST1.1) or the date of death (by any cause in absence of progression).
Outcome measures
| Measure |
AZD8931 + Paclitaxel
n=8 events
AZD8931 40 mg bd (Twice daily) administered orally in combination with paclitaxel 80 mg/m2 administered intravenously \[approximately 1 hour duration\] on D1, 8 and 15 of each 28 day treatment cycle
|
Placebo + Paclitaxel
n=8 events
AZD8931 matching placebo bd administered orally in combination with paclitaxel 80 mg/m2 administered intravenously \[approximately 1 hour duration\] on D1, 8 and 15 of each 28 day treatment cycle
|
|---|---|---|
|
Progression-free Survival (PFS) Were Analysed for Comparing Relative Efficacy of AZD8931 Plus Paclitaxel With Paclitaxel Alone
|
3.7 months
Interval 1.2 to 5.3
|
3.5 months
Interval 1.7 to 5.1
|
SECONDARY outcome
Timeframe: Baseline and 8 weeks, accessed up to data cut off on 4 December 2012Population: Full analysis set
The number of subjects with at least one visit response of CR or PR. (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; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Progressive disease (PD), A ≥ 20% increase in the sum of diameters of target lesions and an absolute increase of ≥ 5mm; Stable disease (SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD; Not Evaluable (NE), All target lesion measurements are missing or \>1/3 target lesion measurements are missing and sum of diameters of non-missing target lesions does not qualify for PD; Not applicable (NA), No target lesions are recorded at baseline)
Outcome measures
| Measure |
AZD8931 + Paclitaxel
n=13 Participants
AZD8931 40 mg bd (Twice daily) administered orally in combination with paclitaxel 80 mg/m2 administered intravenously \[approximately 1 hour duration\] on D1, 8 and 15 of each 28 day treatment cycle
|
Placebo + Paclitaxel
n=12 Participants
AZD8931 matching placebo bd administered orally in combination with paclitaxel 80 mg/m2 administered intravenously \[approximately 1 hour duration\] on D1, 8 and 15 of each 28 day treatment cycle
|
|---|---|---|
|
The Objective Response Rate (ORR) Was Analysed for Investigating the Efficacy of AZD8931 Plus Paclitaxel With Paclitaxel Alone
Total
|
3 Participants
|
0 Participants
|
|
The Objective Response Rate (ORR) Was Analysed for Investigating the Efficacy of AZD8931 Plus Paclitaxel With Paclitaxel Alone
Complete Response
|
0 Participants
|
0 Participants
|
|
The Objective Response Rate (ORR) Was Analysed for Investigating the Efficacy of AZD8931 Plus Paclitaxel With Paclitaxel Alone
Partial Response
|
3 Participants
|
0 Participants
|
Adverse Events
AZD8931 40mg + Paclitaxel
Serious events: 6 serious events
Other events: 13 other events
Deaths: 0 deaths
Placebo + Paclitaxel
Serious events: 3 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
AZD8931 40mg + Paclitaxel
n=13 participants at risk
AZD8931 40 mg bd (Twice daily) administered orally in combination with paclitaxel 80 mg/m2 administered intravenously \[approximately 1 hour duration\] on D1, 8 and 15 of each 28 day treatment cycle
|
Placebo + Paclitaxel
n=12 participants at risk
AZD8931 matching placebo bd administered orally in combination with paclitaxel 80 mg/m2 administered intravenously \[approximately 1 hour duration\] on D1, 8 and 15 of each 28 day treatment cycle
|
|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/13 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
8.3%
1/12 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
|
Blood and lymphatic system disorders
Neutropenia
|
7.7%
1/13 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
0.00%
0/12 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
|
Gastrointestinal disorders
Diarrhoea
|
15.4%
2/13 • Number of events 3 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
0.00%
0/12 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
|
General disorders
Asthenia
|
7.7%
1/13 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
0.00%
0/12 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
|
General disorders
Pyrexia
|
0.00%
0/13 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
8.3%
1/12 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
|
Hepatobiliary disorders
Bile duct obstruction
|
7.7%
1/13 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
0.00%
0/12 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
|
Infections and infestations
Peritonitis
|
0.00%
0/13 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
8.3%
1/12 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
|
Metabolism and nutrition disorders
Decreased appetite
|
15.4%
2/13 • Number of events 2 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
0.00%
0/12 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/13 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
8.3%
1/12 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
|
Vascular disorders
Hypotension
|
0.00%
0/13 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
8.3%
1/12 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
|
Infections and infestations
Biliary tract infection
|
0.00%
0/13 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
8.3%
1/12 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
7.7%
1/13 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
0.00%
0/12 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
0.00%
0/13 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
8.3%
1/12 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
Other adverse events
| Measure |
AZD8931 40mg + Paclitaxel
n=13 participants at risk
AZD8931 40 mg bd (Twice daily) administered orally in combination with paclitaxel 80 mg/m2 administered intravenously \[approximately 1 hour duration\] on D1, 8 and 15 of each 28 day treatment cycle
|
Placebo + Paclitaxel
n=12 participants at risk
AZD8931 matching placebo bd administered orally in combination with paclitaxel 80 mg/m2 administered intravenously \[approximately 1 hour duration\] on D1, 8 and 15 of each 28 day treatment cycle
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
23.1%
3/13 • Number of events 5 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
33.3%
4/12 • Number of events 9 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
7.7%
1/13 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
0.00%
0/12 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
|
Blood and lymphatic system disorders
Neutropenia
|
46.2%
6/13 • Number of events 8 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
25.0%
3/12 • Number of events 9 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
|
Cardiac disorders
Ventricular extrasystoles
|
7.7%
1/13 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
0.00%
0/12 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
|
Ear and labyrinth disorders
Vertigo
|
15.4%
2/13 • Number of events 2 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
0.00%
0/12 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
|
Eye disorders
Accommodation disorder
|
7.7%
1/13 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
0.00%
0/12 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
|
Eye disorders
Blepharitis
|
7.7%
1/13 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
0.00%
0/12 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
|
Eye disorders
Scleral discolouration
|
7.7%
1/13 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
0.00%
0/12 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
|
Eye disorders
Vision blurred
|
23.1%
3/13 • Number of events 3 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
0.00%
0/12 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
|
Gastrointestinal disorders
Abdominal pain
|
15.4%
2/13 • Number of events 2 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
16.7%
2/12 • Number of events 2 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
|
Gastrointestinal disorders
Abdominal pain upper
|
7.7%
1/13 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
8.3%
1/12 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
|
Gastrointestinal disorders
Constipation
|
30.8%
4/13 • Number of events 4 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
8.3%
1/12 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
|
Gastrointestinal disorders
Diarrhoea
|
46.2%
6/13 • Number of events 13 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
41.7%
5/12 • Number of events 5 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
|
Gastrointestinal disorders
Nausea
|
23.1%
3/13 • Number of events 4 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
16.7%
2/12 • Number of events 2 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
|
Gastrointestinal disorders
Stomatitis
|
46.2%
6/13 • Number of events 6 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
8.3%
1/12 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
|
Gastrointestinal disorders
Vomiting
|
23.1%
3/13 • Number of events 4 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
25.0%
3/12 • Number of events 3 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
|
General disorders
Asthenia
|
30.8%
4/13 • Number of events 4 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
8.3%
1/12 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
|
General disorders
Fatigue
|
38.5%
5/13 • Number of events 5 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
33.3%
4/12 • Number of events 5 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
|
General disorders
Mucosal inflammation
|
15.4%
2/13 • Number of events 2 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
0.00%
0/12 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
|
General disorders
Oedema
|
7.7%
1/13 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
0.00%
0/12 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
|
General disorders
Oedema peripheral
|
15.4%
2/13 • Number of events 2 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
25.0%
3/12 • Number of events 4 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
|
General disorders
Pyrexia
|
15.4%
2/13 • Number of events 2 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
25.0%
3/12 • Number of events 3 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
|
Hepatobiliary disorders
Jaundice
|
7.7%
1/13 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
0.00%
0/12 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
|
Infections and infestations
Bacteriuria
|
7.7%
1/13 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
0.00%
0/12 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
|
Infections and infestations
Cystitis
|
7.7%
1/13 • Number of events 2 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
0.00%
0/12 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
|
Infections and infestations
Lung infection
|
7.7%
1/13 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
0.00%
0/12 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
|
Infections and infestations
Nasopharyngitis
|
7.7%
1/13 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
8.3%
1/12 • Number of events 2 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
|
Infections and infestations
Oral infection
|
7.7%
1/13 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
0.00%
0/12 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
|
Infections and infestations
Paronychia
|
15.4%
2/13 • Number of events 2 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
8.3%
1/12 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
|
Infections and infestations
Urinary tract infection
|
7.7%
1/13 • Number of events 2 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
8.3%
1/12 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
7.7%
1/13 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
0.00%
0/12 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
|
Investigations
Alanine aminotransferase increased
|
7.7%
1/13 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
8.3%
1/12 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
|
Investigations
Aspartate aminotransferase increased
|
15.4%
2/13 • Number of events 2 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
8.3%
1/12 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
|
Investigations
Blood bilirubin increased
|
7.7%
1/13 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
0.00%
0/12 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
|
Investigations
Blood creatinine increased
|
7.7%
1/13 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
8.3%
1/12 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
|
Investigations
Gamma-glutamyltransferase increased
|
7.7%
1/13 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
16.7%
2/12 • Number of events 4 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
|
Investigations
Haemoglobin decreased
|
7.7%
1/13 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
0.00%
0/12 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
|
Investigations
Neutrophil count decreased
|
15.4%
2/13 • Number of events 3 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
16.7%
2/12 • Number of events 4 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
|
Investigations
Weight decreased
|
15.4%
2/13 • Number of events 2 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
0.00%
0/12 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
|
Investigations
White blood cell count decreased
|
7.7%
1/13 • Number of events 3 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
16.7%
2/12 • Number of events 3 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
|
Metabolism and nutrition disorders
Decreased appetite
|
38.5%
5/13 • Number of events 6 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
25.0%
3/12 • Number of events 4 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
7.7%
1/13 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
8.3%
1/12 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
7.7%
1/13 • Number of events 3 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
0.00%
0/12 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
7.7%
1/13 • Number of events 2 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
0.00%
0/12 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
38.5%
5/13 • Number of events 8 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
25.0%
3/12 • Number of events 4 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
15.4%
2/13 • Number of events 3 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
16.7%
2/12 • Number of events 2 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
7.7%
1/13 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
8.3%
1/12 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
7.7%
1/13 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
0.00%
0/12 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
7.7%
1/13 • Number of events 2 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
8.3%
1/12 • Number of events 2 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
|
Nervous system disorders
Dizziness
|
15.4%
2/13 • Number of events 2 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
0.00%
0/12 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
|
Nervous system disorders
Dysgeusia
|
15.4%
2/13 • Number of events 2 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
0.00%
0/12 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
|
Nervous system disorders
Hypoaesthesia
|
7.7%
1/13 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
16.7%
2/12 • Number of events 2 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
|
Nervous system disorders
Neuropathy peripheral
|
15.4%
2/13 • Number of events 2 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
8.3%
1/12 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
30.8%
4/13 • Number of events 4 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
16.7%
2/12 • Number of events 2 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
|
Psychiatric disorders
Insomnia
|
7.7%
1/13 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
25.0%
3/12 • Number of events 3 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
|
Renal and urinary disorders
Haematuria
|
7.7%
1/13 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
8.3%
1/12 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
|
Renal and urinary disorders
Proteinuria
|
7.7%
1/13 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
0.00%
0/12 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
|
Renal and urinary disorders
Renal failure acute
|
7.7%
1/13 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
0.00%
0/12 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
7.7%
1/13 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
0.00%
0/12 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
15.4%
2/13 • Number of events 2 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
8.3%
1/12 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
46.2%
6/13 • Number of events 6 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
25.0%
3/12 • Number of events 3 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
38.5%
5/13 • Number of events 6 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
16.7%
2/12 • Number of events 2 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
23.1%
3/13 • Number of events 3 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
0.00%
0/12 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
15.4%
2/13 • Number of events 2 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
0.00%
0/12 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
15.4%
2/13 • Number of events 2 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
16.7%
2/12 • Number of events 2 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
|
Skin and subcutaneous tissue disorders
Rash
|
38.5%
5/13 • Number of events 6 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
0.00%
0/12 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
15.4%
2/13 • Number of events 2 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
8.3%
1/12 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
|
Skin and subcutaneous tissue disorders
Skin fissures
|
7.7%
1/13 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
0.00%
0/12 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
|
Vascular disorders
Flushing
|
7.7%
1/13 • Number of events 2 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
0.00%
0/12 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
|
Vascular disorders
Hypotension
|
7.7%
1/13 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
16.7%
2/12 • Number of events 2 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/13 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
8.3%
1/12 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/13 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
16.7%
2/12 • Number of events 7 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
|
Gastrointestinal disorders
Anal inflammation
|
0.00%
0/13 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
8.3%
1/12 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/13 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
16.7%
2/12 • Number of events 3 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/13 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
8.3%
1/12 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/13 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
8.3%
1/12 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
|
General disorders
Gait disturbance
|
0.00%
0/13 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
8.3%
1/12 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
|
General disorders
Irritability
|
0.00%
0/13 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
8.3%
1/12 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
0/13 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
8.3%
1/12 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
|
Infections and infestations
Biliary tract infection
|
0.00%
0/13 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
8.3%
1/12 • Number of events 2 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
|
Infections and infestations
Gastroenteritis norovirus
|
0.00%
0/13 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
8.3%
1/12 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/13 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
8.3%
1/12 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.00%
0/13 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
8.3%
1/12 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/13 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
8.3%
1/12 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
|
Investigations
Platelet count decreased
|
0.00%
0/13 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
8.3%
1/12 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/13 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
8.3%
1/12 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/13 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
8.3%
1/12 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/13 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
8.3%
1/12 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/13 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
8.3%
1/12 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant peritoneal neoplasm
|
0.00%
0/13 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
8.3%
1/12 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
|
Nervous system disorders
Syncope
|
0.00%
0/13 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
8.3%
1/12 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/13 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
8.3%
1/12 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
|
Reproductive system and breast disorders
Vulval oedema
|
0.00%
0/13 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
8.3%
1/12 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/13 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
8.3%
1/12 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/13 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
8.3%
1/12 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/13 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
8.3%
1/12 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
|
Skin and subcutaneous tissue disorders
Purpura
|
0.00%
0/13 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
8.3%
1/12 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
|
Vascular disorders
Hypertension
|
0.00%
0/13 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
8.3%
1/12 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
|
Hepatobiliary disorders
Bile duct obstruction
|
0.00%
0/13 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
8.3%
1/12 • Number of events 2 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
|
Eye disorders
Meibomian gland dysfunction
|
7.7%
1/13 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
0.00%
0/12 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
|
Injury, poisoning and procedural complications
Postoperative wound complication
|
0.00%
0/13 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
8.3%
1/12 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
|
Respiratory, thoracic and mediastinal disorders
Nasal inflammation
|
7.7%
1/13 • Number of events 1 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
0.00%
0/12 • AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60