Trial Outcomes & Findings for A Phase I/Ib Study of AZD9150 (ISIS-STAT3Rx) in Patients With Advanced/Metastatic Hepatocellular Carcinoma (NCT NCT01839604)
NCT ID: NCT01839604
Last Updated: 2017-03-06
Results Overview
Cycle 1 was defined as 3 loading doses given on Days 1, 3, and 5 followed by 3 weekly doses given on Days 8, 15, and 22.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
58 participants
Primary outcome timeframe
DLT assessment window - Cycle 1 (22 days)
Results posted on
2017-03-06
Participant Flow
The first patient entered the study on 03 May 2013, and the last patient last visit before the DCO was 31 December 2014. The DCO date was 05 January 2015.
Note that 39 patients is the number of patients who were actually assigned to treatment out of the total enrolled. The ecpansion phase consisted of the 3mg/kg group only.
Participant milestones
| Measure |
AZD9150 1mg/kg
Intravenous. Part A.
|
AZD9150 1.5 mg/kg
Intravenous dosing Part A
|
AZD9150 2mg/kg
Intravenous dosing Part A
|
AZD9150 2.5mg/kg
Intravenous dosing Part A
|
AZD9150 3mg/kg
Pooled over parts A \& B
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
7
|
5
|
15
|
|
Overall Study
COMPLETED
|
6
|
6
|
7
|
5
|
15
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Phase I/Ib Study of AZD9150 (ISIS-STAT3Rx) in Patients With Advanced/Metastatic Hepatocellular Carcinoma
Baseline characteristics by cohort
| Measure |
AZD9150 1mg/kg
n=6 Participants
Intravenous. Part A.
|
1.5 mg/kg
n=6 Participants
given intravenously. Part A
|
2 mg/kg
n=7 Participants
given intravenously Part A
|
2.5 mg/kg
n=5 Participants
given intravenously Part A
|
3 mg/kg
n=15 Participants
given intravenously (Part A \& B pooled)
|
Total
n=39 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
59.3 years
STANDARD_DEVIATION 13.0 • n=99 Participants
|
58.3 years
STANDARD_DEVIATION 12.9 • n=107 Participants
|
64.1 years
STANDARD_DEVIATION 10.4 • n=206 Participants
|
58.0 years
STANDARD_DEVIATION 11.0 • n=7 Participants
|
57.5 years
STANDARD_DEVIATION 8.9 • n=31 Participants
|
59.2 years
STANDARD_DEVIATION 10.4 • n=30 Participants
|
|
Gender
Female
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
5 Participants
n=30 Participants
|
|
Gender
Male
|
6 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
15 Participants
n=31 Participants
|
34 Participants
n=30 Participants
|
PRIMARY outcome
Timeframe: DLT assessment window - Cycle 1 (22 days)Population: Safety: All patients who received at least 1 dose of AZD9150
Cycle 1 was defined as 3 loading doses given on Days 1, 3, and 5 followed by 3 weekly doses given on Days 8, 15, and 22.
Outcome measures
| Measure |
AZD9150 1mg/kg
n=6 Participants
Intravenous. Part A.
|
1.5 mg/kg
n=6 Participants
given intravenously. Part A
|
2 mg/kg
n=6 Participants
given intravenously Part A
|
2.5 mg/kg
n=5 Participants
given intravenously Part A
|
3 mg/kg
n=14 Participants
given intravenously (Part A \& B pooled)
|
|---|---|---|---|---|---|
|
Number of Participants With Dose Limiting Toxicities During Cycle 1
|
0 participants with DLT
|
1 participants with DLT
|
1 participants with DLT
|
2 participants with DLT
|
3 participants with DLT
|
SECONDARY outcome
Timeframe: 8 times of PK sampling on Day1 of Cycle1. Additional 6 patients in Japan; 8 times of PK sampling on Day1 of Cycle1.Population: PK: All dosed patients with reportable AZD9150 plasma concentrations and no important adverse events or protocol deviations that may impact PK
8 times (pre-dose, 1.5, 3, 3.5, 4, 6, 8, 24 hours post-dose) on Day1 of Cycle1. For additional 6 patients in Japan, 8 times (pre-dose, 1.5, 3, 3.5, 4, 6, 8, 24 hours post-dose) on Day1 of Cycle1. From the multiple samples a timecourse is obtained of treatment conc in the plasma over time. From this curve the associated PK parameters e.g. Cmax are obtained. For n patients we obtain up to n parameters which can then be averaged.
Outcome measures
| Measure |
AZD9150 1mg/kg
n=6 Participants
Intravenous. Part A.
|
1.5 mg/kg
n=6 Participants
given intravenously. Part A
|
2 mg/kg
n=7 Participants
given intravenously Part A
|
2.5 mg/kg
n=5 Participants
given intravenously Part A
|
3 mg/kg
n=15 Participants
given intravenously (Part A \& B pooled)
|
|---|---|---|---|---|---|
|
Evaluation of Pharmacokinetics (PK) of AZD9150 (Following Single Administrations in Patients With HCC) by Determining Cmax, Using the Plasma Concentration Data.
|
5833 ng/mL
Geometric Coefficient of Variation 28.02
|
5575 ng/mL
Geometric Coefficient of Variation 21.63
|
8984 ng/mL
Geometric Coefficient of Variation 20.28
|
11560 ng/mL
Geometric Coefficient of Variation 15.16
|
16110 ng/mL
Geometric Coefficient of Variation 30.70
|
SECONDARY outcome
Timeframe: Every 6 weeks, assessed up to 12 months.Population: Evaluable for response: Dosed patients with measurable disease at baseline
Tumour response assessment by modified Response Evaluation Criteria in Solid Tumours (RECIST). Overall tumour response: assessed by mRECIST for HCC overall visit response of CR (disappearance of baseline TLs and NTLs), PR (\>=30% decrease in sum of TLs), SD (neither PR nor PD), PD (sum TLs increased \>20%), or NE .
Outcome measures
| Measure |
AZD9150 1mg/kg
n=6 Participants
Intravenous. Part A.
|
1.5 mg/kg
n=6 Participants
given intravenously. Part A
|
2 mg/kg
n=7 Participants
given intravenously Part A
|
2.5 mg/kg
n=5 Participants
given intravenously Part A
|
3 mg/kg
n=15 Participants
given intravenously (Part A \& B pooled)
|
|---|---|---|---|---|---|
|
Preliminary Assessment of the Anti-tumour Activity of AZD9150 by Evaluation of Tumour Response.
|
0 participants with Partial Response
|
0 participants with Partial Response
|
1 participants with Partial Response
|
0 participants with Partial Response
|
0 participants with Partial Response
|
SECONDARY outcome
Timeframe: 8 times of PK sampling on Day1 of Cycle1. Additional 6 patients in Japan; 8 times of PK sampling on Day 1 of Cycle 1.Population: PK: All dosed patients with reportable AZD9150 plasma concentrations and no important adverse events or protocol deviations that may impact PK
8 times (pre-dose, 1.5, 3, 3.5, 4, 6, 8, 24 hours post-dose) on Day1 of Cycle1. For additional 6 patients in Japan, 8 times (pre-dose, 1.5, 3, 3.5, 4, 6, 8, 24 hours post-dose) on Day1 of Cycle1.
Outcome measures
| Measure |
AZD9150 1mg/kg
n=6 Participants
Intravenous. Part A.
|
1.5 mg/kg
n=6 Participants
given intravenously. Part A
|
2 mg/kg
n=7 Participants
given intravenously Part A
|
2.5 mg/kg
n=5 Participants
given intravenously Part A
|
3 mg/kg
n=15 Participants
given intravenously (Part A \& B pooled)
|
|---|---|---|---|---|---|
|
Evaluation of Pharmacokinetics (PK) of AZD9150 (Following Single Administrations in Patients With HCC) by Determining Tmax, Using the Plasma Concentration Data.
|
3.0 h
Interval 1.5 to 3.0
|
3.4 h
Interval 3.0 to 3.7
|
2.8 h
Interval 1.5 to 3.5
|
3.0 h
Interval 2.9 to 3.5
|
3.0 h
Interval 1.3 to 3.0
|
Adverse Events
AZD9150 1mg/kg
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
1.5 mg/kg
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
2 mg/kg
Serious events: 2 serious events
Other events: 7 other events
Deaths: 0 deaths
2.5 mg/kg
Serious events: 2 serious events
Other events: 5 other events
Deaths: 0 deaths
3 mg/kg
Serious events: 4 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
AZD9150 1mg/kg
n=6 participants at risk
Intravenous. Part A.
|
1.5 mg/kg
n=6 participants at risk
given intravenously. Part A
|
2 mg/kg
n=7 participants at risk
given intravenously Part A
|
2.5 mg/kg
n=5 participants at risk
given intravenously Part A
|
3 mg/kg
n=15 participants at risk
given intravenously (Part A \& B pooled)
|
|---|---|---|---|---|---|
|
Infections and infestations
Cellulitis
|
0.00%
0/6 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
0.00%
0/6 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
0.00%
0/7 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
0.00%
0/5 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
6.7%
1/15 • Number of events 1 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
|
Infections and infestations
Liver abscess
|
0.00%
0/6 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
0.00%
0/6 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
14.3%
1/7 • Number of events 1 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
0.00%
0/5 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
0.00%
0/15 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/6 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
0.00%
0/6 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
0.00%
0/7 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
0.00%
0/5 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
6.7%
1/15 • Number of events 1 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/6 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
0.00%
0/6 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
0.00%
0/7 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
20.0%
1/5 • Number of events 1 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
0.00%
0/15 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/6 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
0.00%
0/6 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
0.00%
0/7 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
0.00%
0/5 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
6.7%
1/15 • Number of events 1 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
|
Gastrointestinal disorders
Peritoneal haemorrhage
|
0.00%
0/6 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
0.00%
0/6 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
14.3%
1/7 • Number of events 1 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
0.00%
0/5 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
0.00%
0/15 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
|
Hepatobiliary disorders
Hepatorenal failure
|
0.00%
0/6 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
0.00%
0/6 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
0.00%
0/7 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
20.0%
1/5 • Number of events 1 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
0.00%
0/15 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
|
Investigations
Alanine amonitransferase increased
|
0.00%
0/6 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
0.00%
0/6 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
14.3%
1/7 • Number of events 1 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
0.00%
0/5 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
0.00%
0/15 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/6 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
0.00%
0/6 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
14.3%
1/7 • Number of events 1 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
20.0%
1/5 • Number of events 1 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
0.00%
0/15 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
|
Investigations
Platelet count decreased
|
0.00%
0/6 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
0.00%
0/6 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
0.00%
0/7 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
0.00%
0/5 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
6.7%
1/15 • Number of events 1 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
|
Investigations
Prothrombin time prolonged
|
0.00%
0/6 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
0.00%
0/6 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
0.00%
0/7 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
0.00%
0/5 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
6.7%
1/15 • Number of events 2 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
Other adverse events
| Measure |
AZD9150 1mg/kg
n=6 participants at risk
Intravenous. Part A.
|
1.5 mg/kg
n=6 participants at risk
given intravenously. Part A
|
2 mg/kg
n=7 participants at risk
given intravenously Part A
|
2.5 mg/kg
n=5 participants at risk
given intravenously Part A
|
3 mg/kg
n=15 participants at risk
given intravenously (Part A \& B pooled)
|
|---|---|---|---|---|---|
|
Investigations
Aspartate aminotransferase increased
|
50.0%
3/6 • Number of events 3 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
66.7%
4/6 • Number of events 4 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
71.4%
5/7 • Number of events 5 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
60.0%
3/5 • Number of events 3 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
60.0%
9/15 • Number of events 9 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
|
Investigations
Platelet count decreased
|
50.0%
3/6 • Number of events 3 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
50.0%
3/6 • Number of events 3 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
71.4%
5/7 • Number of events 5 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
20.0%
1/5 • Number of events 1 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
66.7%
10/15 • Number of events 10 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
|
Investigations
Alanine aminotransferase increased
|
33.3%
2/6 • Number of events 2 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
50.0%
3/6 • Number of events 3 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
57.1%
4/7 • Number of events 4 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
60.0%
3/5 • Number of events 3 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
60.0%
9/15 • Number of events 9 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/6 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
0.00%
0/6 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
14.3%
1/7 • Number of events 1 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
0.00%
0/5 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
26.7%
4/15 • Number of events 4 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/6 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
0.00%
0/6 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
14.3%
1/7 • Number of events 1 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
20.0%
1/5 • Number of events 1 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
13.3%
2/15 • Number of events 2 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
|
Investigations
Gamma-glutamylytransferase increased
|
0.00%
0/6 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
33.3%
2/6 • Number of events 2 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
14.3%
1/7 • Number of events 1 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
0.00%
0/5 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
0.00%
0/15 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
|
Investigations
White blod cell count decreased
|
0.00%
0/6 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
16.7%
1/6 • Number of events 1 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
14.3%
1/7 • Number of events 1 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
0.00%
0/5 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
6.7%
1/15 • Number of events 1 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
|
Investigations
Prothrombin time prolonged
|
0.00%
0/6 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
0.00%
0/6 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
0.00%
0/7 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
20.0%
1/5 • Number of events 1 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
6.7%
1/15 • Number of events 1 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/6 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
16.7%
1/6 • Number of events 1 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
0.00%
0/7 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
40.0%
2/5 • Number of events 2 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
26.7%
4/15 • Number of events 4 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/6 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
0.00%
0/6 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
28.6%
2/7 • Number of events 2 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
20.0%
1/5 • Number of events 1 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
13.3%
2/15 • Number of events 2 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/6 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
16.7%
1/6 • Number of events 1 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
0.00%
0/7 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
40.0%
2/5 • Number of events 2 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
13.3%
2/15 • Number of events 2 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/6 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
16.7%
1/6 • Number of events 1 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
14.3%
1/7 • Number of events 1 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
20.0%
1/5 • Number of events 1 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
6.7%
1/15 • Number of events 1 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/6 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
0.00%
0/6 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
14.3%
1/7 • Number of events 1 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
20.0%
1/5 • Number of events 1 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
6.7%
1/15 • Number of events 1 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
16.7%
1/6 • Number of events 1 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
16.7%
1/6 • Number of events 1 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
14.3%
1/7 • Number of events 1 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
20.0%
1/5 • Number of events 1 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
13.3%
2/15 • Number of events 2 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
33.3%
2/6 • Number of events 2 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
0.00%
0/6 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
0.00%
0/7 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
20.0%
1/5 • Number of events 1 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
13.3%
2/15 • Number of events 2 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/6 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
16.7%
1/6 • Number of events 1 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
0.00%
0/7 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
20.0%
1/5 • Number of events 1 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
20.0%
3/15 • Number of events 3 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/6 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
0.00%
0/6 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
14.3%
1/7 • Number of events 1 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
0.00%
0/5 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
13.3%
2/15 • Number of events 2 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/6 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
16.7%
1/6 • Number of events 1 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
0.00%
0/7 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
20.0%
1/5 • Number of events 1 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
0.00%
0/15 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/6 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
16.7%
1/6 • Number of events 1 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
0.00%
0/7 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
20.0%
1/5 • Number of events 1 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
0.00%
0/15 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
|
Blood and lymphatic system disorders
Neutropenia
|
16.7%
1/6 • Number of events 1 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
0.00%
0/6 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
28.6%
2/7 • Number of events 2 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
0.00%
0/5 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
20.0%
3/15 • Number of events 3 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/6 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
0.00%
0/6 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
14.3%
1/7 • Number of events 1 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
20.0%
1/5 • Number of events 1 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
20.0%
3/15 • Number of events 3 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/6 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
0.00%
0/6 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
14.3%
1/7 • Number of events 1 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
0.00%
0/5 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
13.3%
2/15 • Number of events 2 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
|
General disorders
Fatigue
|
0.00%
0/6 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
0.00%
0/6 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
0.00%
0/7 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
20.0%
1/5 • Number of events 1 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
20.0%
3/15 • Number of events 3 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
|
General disorders
Pyrexia
|
0.00%
0/6 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
16.7%
1/6 • Number of events 1 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
14.3%
1/7 • Number of events 1 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
20.0%
1/5 • Number of events 1 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
6.7%
1/15 • Number of events 1 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
|
General disorders
Asthenia
|
16.7%
1/6 • Number of events 1 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
0.00%
0/6 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
14.3%
1/7 • Number of events 1 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
20.0%
1/5 • Number of events 1 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
0.00%
0/15 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
|
General disorders
Malaise
|
0.00%
0/6 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
0.00%
0/6 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
0.00%
0/7 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
20.0%
1/5 • Number of events 1 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
6.7%
1/15 • Number of events 1 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
|
Metabolism and nutrition disorders
Decreased apetite
|
16.7%
1/6 • Number of events 1 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
16.7%
1/6 • Number of events 1 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
14.3%
1/7 • Number of events 1 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
0.00%
0/5 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
26.7%
4/15 • Number of events 4 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/6 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
16.7%
1/6 • Number of events 1 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
0.00%
0/7 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
20.0%
1/5 • Number of events 1 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
0.00%
0/15 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
33.3%
2/6 • Number of events 2 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
0.00%
0/6 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
0.00%
0/7 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
0.00%
0/5 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
0.00%
0/15 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/6 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
16.7%
1/6 • Number of events 1 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
28.6%
2/7 • Number of events 2 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
0.00%
0/5 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
6.7%
1/15 • Number of events 1 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
|
Musculoskeletal and connective tissue disorders
Flank Pain
|
0.00%
0/6 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
16.7%
1/6 • Number of events 1 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
14.3%
1/7 • Number of events 1 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
0.00%
0/5 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
0.00%
0/15 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/6 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
0.00%
0/6 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
14.3%
1/7 • Number of events 1 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
20.0%
1/5 • Number of events 1 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
0.00%
0/15 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
|
Nervous system disorders
Headache
|
0.00%
0/6 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
0.00%
0/6 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
14.3%
1/7 • Number of events 1 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
0.00%
0/5 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
13.3%
2/15 • Number of events 2 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
|
Nervous system disorders
Dizziness
|
16.7%
1/6 • Number of events 1 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
0.00%
0/6 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
14.3%
1/7 • Number of events 1 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
0.00%
0/5 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
0.00%
0/15 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
|
Vascular disorders
Hypertension
|
0.00%
0/6 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
33.3%
2/6 • Number of events 2 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
14.3%
1/7 • Number of events 1 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
0.00%
0/5 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
13.3%
2/15 • Number of events 2 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.00%
0/6 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
0.00%
0/6 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
0.00%
0/7 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
0.00%
0/5 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
13.3%
2/15 • Number of events 2 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
|
Renal and urinary disorders
Haematuria
|
16.7%
1/6 • Number of events 1 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
0.00%
0/6 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
0.00%
0/7 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
0.00%
0/5 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
6.7%
1/15 • Number of events 1 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/6 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
16.7%
1/6 • Number of events 1 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
0.00%
0/7 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
20.0%
1/5 • Number of events 1 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
0.00%
0/15 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/6 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
0.00%
0/6 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
0.00%
0/7 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
60.0%
3/5 • Number of events 3 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
6.7%
1/15 • Number of events 1 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
|
Skin and subcutaneous tissue disorders
Rash
|
16.7%
1/6 • Number of events 1 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
33.3%
2/6 • Number of events 2 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
0.00%
0/7 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
0.00%
0/5 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
6.7%
1/15 • Number of events 1 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
16.7%
1/6 • Number of events 1 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
0.00%
0/6 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
14.3%
1/7 • Number of events 1 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
0.00%
0/5 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
0.00%
0/15 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/6 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
0.00%
0/6 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
14.3%
1/7 • Number of events 1 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
0.00%
0/5 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
6.7%
1/15 • Number of events 1 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/6 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
0.00%
0/6 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
14.3%
1/7 • Number of events 1 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
0.00%
0/5 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
6.7%
1/15 • Number of events 1 • AEs will be collected throughout the study, from informed consent until the end of the follow up period. The follow-up period is defined as 28 +/-7 days after study treatment is discontinued.
|
Additional Information
Martin Scott, MD/PhD
AstraZeneca Pharmaceuticals LP
Phone: [email protected]
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60