Trial Outcomes & Findings for LIONS (PLK4 Inhibitor in Advanced Solid Tumors) (NCT NCT06232408)
NCT ID: NCT06232408
Last Updated: 2025-11-21
Results Overview
Number of participants with TRAE
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
29 participants
Primary outcome timeframe
Start of treatment through up to 6 months post last dose (up to 18 months)
Results posted on
2025-11-21
Participant Flow
Dose Escalation phase only; Dose expansion was not conducted
Participant milestones
| Measure |
10 mg QD RP-1664, 2w on/1w Off
10 mg QD oral (PO) RP-1664 daily, on a 2 weeks on and 1 week of schedule (21-day treatment cycle)
|
30 mg QD RP-1664, 2w on/1w Off
30 mg QD oral (PO) RP-1664 daily, on a 2 weeks on and 1 week of schedule (21-day treatment cycle)
|
40 mg QD RP-1664, 2w on/1w Off
40 mg QD oral (PO) RP-1664 daily, on a 2 weeks on and 1 week of schedule (21-day treatment cycle)
|
60 mg QD RP-1664, 2w on/1w Off
60 mg QD oral (PO) RP-1664 daily, on a 2 weeks on and 1 week of schedule (21-day treatment cycle)
|
60 mg QD RP-1664, 1w on/1w Off
60 mg QD oral (PO) RP-1664 daily, on a 1 week on and 1 week of schedule (28-day treatment cycle)
|
90 mg QD RP-1664, 1w on/1w Off
90 mg QD oral (PO) RP-1664 daily, on a 1 week on and 1 week of schedule (28-day treatment cycle)
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
1
|
1
|
4
|
3
|
16
|
4
|
|
Overall Study
COMPLETED
|
1
|
1
|
0
|
1
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
4
|
2
|
16
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
LIONS (PLK4 Inhibitor in Advanced Solid Tumors)
Baseline characteristics by cohort
| Measure |
40 mg QD RP-1664, 2w on/1w Off
n=4 Participants
40 mg QD oral (PO) RP-1664 daily, on a 2 weeks on and 1 week of schedule (21-day treatment cycle)
|
60 mg QD RP-1664, 2w on/1w Off
n=3 Participants
60 mg QD oral (PO) RP-1664 daily, on a 2 weeks on and 1 week of schedule (21-day treatment cycle)
|
60 mg QD RP-1664, 1w on/1w Off
n=16 Participants
60 mg QD oral (PO) RP-1664 daily, on a 1 week on and 1 week of schedule (28-day treatment cycle)
|
90 mg QD RP-1664, 1w on/1w Off
n=4 Participants
90 mg QD oral (PO) RP-1664 daily, on a 1 week on and 1 week of schedule (28-day treatment cycle)
|
Total
n=29 Participants
Total of all reporting groups
|
10 mg QD RP-1664, 2w on/1w Off
n=1 Participants
10 mg QD oral (PO) RP-1664 daily, on a 2 weeks on and 1 week of schedule (21-day treatment cycle)
|
30 mg QD RP-1664, 2w on/1w Off
n=1 Participants
30 mg QD oral (PO) RP-1664 daily, on a 2 weeks on and 1 week of schedule (21-day treatment cycle)
|
|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
2 Participants
n=60 Participants
|
0 Participants
n=185 Participants
|
2 Participants
n=740 Participants
|
0 Participants
n=3 Participants
|
4 Participants
n=5 Participants
|
0 Participants
n=39 Participants
|
0 Participants
n=29 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=60 Participants
|
2 Participants
n=185 Participants
|
9 Participants
n=740 Participants
|
3 Participants
n=3 Participants
|
16 Participants
n=5 Participants
|
0 Participants
n=39 Participants
|
1 Participants
n=29 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=60 Participants
|
1 Participants
n=185 Participants
|
5 Participants
n=740 Participants
|
1 Participants
n=3 Participants
|
9 Participants
n=5 Participants
|
1 Participants
n=39 Participants
|
0 Participants
n=29 Participants
|
|
Age, Continuous
|
33.3 years
STANDARD_DEVIATION 28.34 • n=60 Participants
|
61.7 years
STANDARD_DEVIATION 14.01 • n=185 Participants
|
45.4 years
STANDARD_DEVIATION 20.71 • n=740 Participants
|
54.5 years
STANDARD_DEVIATION 14.20 • n=3 Participants
|
48.3 years
STANDARD_DEVIATION 21.43 • n=5 Participants
|
84 years
STANDARD_DEVIATION 0 • n=39 Participants
|
53 years
STANDARD_DEVIATION 0 • n=29 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=60 Participants
|
3 Participants
n=185 Participants
|
12 Participants
n=740 Participants
|
3 Participants
n=3 Participants
|
19 Participants
n=5 Participants
|
0 Participants
n=39 Participants
|
0 Participants
n=29 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=60 Participants
|
0 Participants
n=185 Participants
|
4 Participants
n=740 Participants
|
1 Participants
n=3 Participants
|
10 Participants
n=5 Participants
|
1 Participants
n=39 Participants
|
1 Participants
n=29 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=60 Participants
|
0 Participants
n=185 Participants
|
0 Participants
n=740 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=39 Participants
|
0 Participants
n=29 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=60 Participants
|
3 Participants
n=185 Participants
|
16 Participants
n=740 Participants
|
4 Participants
n=3 Participants
|
29 Participants
n=5 Participants
|
1 Participants
n=39 Participants
|
1 Participants
n=29 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=60 Participants
|
0 Participants
n=185 Participants
|
0 Participants
n=740 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=39 Participants
|
0 Participants
n=29 Participants
|
PRIMARY outcome
Timeframe: Start of treatment through up to 6 months post last dose (up to 18 months)Number of participants with TRAE
Outcome measures
| Measure |
10 mg QD RP-1664, 2w on/1w Off
n=1 Participants
10 mg QD oral (PO) RP-1664 daily, on a 2 weeks on and 1 week of schedule (21-day treatment cycle)
|
30 mg QD RP-1664, 2w on/1w Off
n=1 Participants
30 mg QD oral (PO) RP-1664 daily, on a 2 weeks on and 1 week of schedule (21-day treatment cycle)
|
40 mg QD RP-1664, 2w on/1w Off
n=4 Participants
40 mg QD oral (PO) RP-1664 daily, on a 2 weeks on and 1 week of schedule (21-day treatment cycle)
|
60 mg QD RP-1664, 2w on/1w Off
n=3 Participants
60 mg QD oral (PO) RP-1664 daily, on a 2 weeks on and 1 week of schedule (21-day treatment cycle)
|
60 mg QD RP-1664, 1w on/1w Off
n=16 Participants
60 mg QD oral (PO) RP-1664 daily, on a 1 week on and 1 week of schedule (28-day treatment cycle)
|
90 mg QD RP-1664, 1w on/1w Off
n=4 Participants
90 mg QD oral (PO) RP-1664 daily, on a 1 week on and 1 week of schedule (28-day treatment cycle)
|
|---|---|---|---|---|---|---|
|
Treatment Related Treatment-Emergent Adverse Events (TRAE) With ≥3 CTCAE Grade
|
1 Participants
|
0 Participants
|
3 Participants
|
3 Participants
|
9 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: During the first cycle (either 21 or 28 days) following the initiation of the study treatmentThe number of participants with DLTs during the DLT observation period
Outcome measures
| Measure |
10 mg QD RP-1664, 2w on/1w Off
n=1 Participants
10 mg QD oral (PO) RP-1664 daily, on a 2 weeks on and 1 week of schedule (21-day treatment cycle)
|
30 mg QD RP-1664, 2w on/1w Off
n=1 Participants
30 mg QD oral (PO) RP-1664 daily, on a 2 weeks on and 1 week of schedule (21-day treatment cycle)
|
40 mg QD RP-1664, 2w on/1w Off
n=3 Participants
40 mg QD oral (PO) RP-1664 daily, on a 2 weeks on and 1 week of schedule (21-day treatment cycle)
|
60 mg QD RP-1664, 2w on/1w Off
n=3 Participants
60 mg QD oral (PO) RP-1664 daily, on a 2 weeks on and 1 week of schedule (21-day treatment cycle)
|
60 mg QD RP-1664, 1w on/1w Off
n=13 Participants
60 mg QD oral (PO) RP-1664 daily, on a 1 week on and 1 week of schedule (28-day treatment cycle)
|
90 mg QD RP-1664, 1w on/1w Off
n=2 Participants
90 mg QD oral (PO) RP-1664 daily, on a 1 week on and 1 week of schedule (28-day treatment cycle)
|
|---|---|---|---|---|---|---|
|
Dose Limiting Toxicities (DLT) to Determine a Maximum Tolerated Dose and Schedule of RP-1664 Based on Safety and Tolerability
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
Adverse Events
10QD 2/1
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
30QD 2/1
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
40QD 2/1
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
60QD 2/1
Serious events: 3 serious events
Other events: 3 other events
Deaths: 1 deaths
60QD 1/1
Serious events: 5 serious events
Other events: 15 other events
Deaths: 2 deaths
90QD 1/1
Serious events: 3 serious events
Other events: 4 other events
Deaths: 1 deaths
Total
Serious events: 12 serious events
Other events: 28 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
10QD 2/1
n=1 participants at risk
10 mg QD oral (PO) RP-1664 daily, on a 2 weeks on and 1 week of schedule (21-day treatment cycle)
|
30QD 2/1
n=1 participants at risk
30 mg QD oral (PO) RP-1664 daily, on a 2 weeks on and 1 week of schedule (21-day treatment cycle)
|
40QD 2/1
n=4 participants at risk
40 mg QD oral (PO) RP-1664 daily, on a 2 weeks on and 1 week of schedule (21-day treatment cycle)
|
60QD 2/1
n=3 participants at risk
60 mg QD oral (PO) RP-1664 daily, on a 2 weeks on and 1 week of schedule (21-day treatment cycle)
|
60QD 1/1
n=16 participants at risk
60 mg QD oral (PO) RP-1664 daily, on a 1 week on and 1 week of schedule (28-day treatment cycle)
|
90QD 1/1
n=4 participants at risk
90 mg QD oral (PO) RP-1664 daily, on a 1 week on and 1 week of schedule (28-day treatment cycle)
|
Total
n=29 participants at risk
All patients in study
|
|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/3 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
6.2%
1/16 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
3.4%
1/29 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/3 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
6.2%
1/16 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
3.4%
1/29 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/3 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
6.2%
1/16 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
3.4%
1/29 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
66.7%
2/3 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/16 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
6.9%
2/29 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.00%
0/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
25.0%
1/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/3 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/16 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
3.4%
1/29 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/3 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/16 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
25.0%
1/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
3.4%
1/29 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/3 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
6.2%
1/16 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
3.4%
1/29 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/3 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
6.2%
1/16 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
3.4%
1/29 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
|
Infections and infestations
Pneumonia
|
0.00%
0/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
25.0%
1/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/3 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/16 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
3.4%
1/29 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/3 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
6.2%
1/16 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
3.4%
1/29 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
|
Nervous system disorders
Syncope
|
0.00%
0/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/3 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/16 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
25.0%
1/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
3.4%
1/29 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
|
Product Issues
Device dislocation
|
0.00%
0/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
33.3%
1/3 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/16 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
3.4%
1/29 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/3 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
6.2%
1/16 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
3.4%
1/29 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
33.3%
1/3 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
6.2%
1/16 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
6.9%
2/29 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
33.3%
1/3 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
6.2%
1/16 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
6.9%
2/29 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
25.0%
1/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
33.3%
1/3 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
6.2%
1/16 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
10.3%
3/29 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.00%
0/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/3 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/16 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
25.0%
1/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
3.4%
1/29 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
Other adverse events
| Measure |
10QD 2/1
n=1 participants at risk
10 mg QD oral (PO) RP-1664 daily, on a 2 weeks on and 1 week of schedule (21-day treatment cycle)
|
30QD 2/1
n=1 participants at risk
30 mg QD oral (PO) RP-1664 daily, on a 2 weeks on and 1 week of schedule (21-day treatment cycle)
|
40QD 2/1
n=4 participants at risk
40 mg QD oral (PO) RP-1664 daily, on a 2 weeks on and 1 week of schedule (21-day treatment cycle)
|
60QD 2/1
n=3 participants at risk
60 mg QD oral (PO) RP-1664 daily, on a 2 weeks on and 1 week of schedule (21-day treatment cycle)
|
60QD 1/1
n=16 participants at risk
60 mg QD oral (PO) RP-1664 daily, on a 1 week on and 1 week of schedule (28-day treatment cycle)
|
90QD 1/1
n=4 participants at risk
90 mg QD oral (PO) RP-1664 daily, on a 1 week on and 1 week of schedule (28-day treatment cycle)
|
Total
n=29 participants at risk
All patients in study
|
|---|---|---|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/3 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
12.5%
2/16 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
25.0%
1/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
10.3%
3/29 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
100.0%
1/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
100.0%
1/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
33.3%
1/3 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
18.8%
3/16 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
25.0%
1/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
24.1%
7/29 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/3 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/16 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
25.0%
1/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
3.4%
1/29 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
|
Eye disorders
Dry eye
|
0.00%
0/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/3 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/16 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
25.0%
1/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
3.4%
1/29 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/3 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
6.2%
1/16 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
3.4%
1/29 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
|
Eye disorders
Vision blurred
|
0.00%
0/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/3 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/16 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
25.0%
1/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
3.4%
1/29 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/3 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/16 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
25.0%
1/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
3.4%
1/29 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
25.0%
1/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/3 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
18.8%
3/16 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
25.0%
1/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
17.2%
5/29 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
25.0%
1/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/3 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
6.2%
1/16 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
6.9%
2/29 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/3 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
6.2%
1/16 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
3.4%
1/29 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
50.0%
2/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/3 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
12.5%
2/16 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
25.0%
1/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
17.2%
5/29 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
25.0%
1/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/3 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/16 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
3.4%
1/29 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
|
Gastrointestinal disorders
Diarrhoea
|
100.0%
1/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
50.0%
2/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
100.0%
3/3 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
68.8%
11/16 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
75.0%
3/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
69.0%
20/29 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
33.3%
1/3 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
12.5%
2/16 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
25.0%
1/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
13.8%
4/29 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/3 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
12.5%
2/16 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
6.9%
2/29 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
25.0%
1/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/3 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/16 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
3.4%
1/29 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/3 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
6.2%
1/16 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
3.4%
1/29 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
0.00%
0/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/3 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
6.2%
1/16 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
3.4%
1/29 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/3 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
6.2%
1/16 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
3.4%
1/29 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/3 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
43.8%
7/16 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
50.0%
2/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
31.0%
9/29 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/3 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
6.2%
1/16 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
3.4%
1/29 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
25.0%
1/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/3 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
37.5%
6/16 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
25.0%
1/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
27.6%
8/29 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
|
General disorders
Chest pain
|
0.00%
0/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/3 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
6.2%
1/16 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
3.4%
1/29 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
|
General disorders
Chills
|
100.0%
1/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/3 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
6.2%
1/16 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
6.9%
2/29 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
|
General disorders
Fatigue
|
100.0%
1/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
25.0%
1/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
33.3%
1/3 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
50.0%
8/16 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
50.0%
2/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
44.8%
13/29 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
|
General disorders
Localised oedema
|
0.00%
0/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/3 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
18.8%
3/16 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
10.3%
3/29 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
|
General disorders
Oedema
|
0.00%
0/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
33.3%
1/3 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/16 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
3.4%
1/29 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
|
General disorders
Oedema peripheral
|
0.00%
0/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
33.3%
1/3 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/16 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
3.4%
1/29 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
|
General disorders
Pain
|
0.00%
0/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/3 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
12.5%
2/16 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
25.0%
1/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
10.3%
3/29 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
|
General disorders
Peripheral swelling
|
0.00%
0/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/3 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/16 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
25.0%
1/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
3.4%
1/29 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
|
General disorders
Pyrexia
|
0.00%
0/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
25.0%
1/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
33.3%
1/3 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
6.2%
1/16 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
25.0%
1/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
13.8%
4/29 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
|
Infections and infestations
Abdominal infection
|
0.00%
0/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/3 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/16 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
25.0%
1/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
3.4%
1/29 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
|
Infections and infestations
COVID-19
|
0.00%
0/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/3 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
6.2%
1/16 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
3.4%
1/29 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
|
Infections and infestations
Clostridium difficile infection
|
0.00%
0/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/3 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
6.2%
1/16 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
3.4%
1/29 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
|
Infections and infestations
Hordeolum
|
0.00%
0/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
25.0%
1/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/3 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/16 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
3.4%
1/29 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
|
Infections and infestations
Rhinovirus infection
|
0.00%
0/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
25.0%
1/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/3 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/16 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
3.4%
1/29 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
50.0%
2/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/3 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/16 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
6.9%
2/29 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/3 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
6.2%
1/16 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
3.4%
1/29 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/3 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
6.2%
1/16 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
3.4%
1/29 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
66.7%
2/3 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/16 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
6.9%
2/29 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
33.3%
1/3 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
6.2%
1/16 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
6.9%
2/29 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
100.0%
1/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
33.3%
1/3 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
6.2%
1/16 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
10.3%
3/29 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
33.3%
1/3 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/16 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
3.4%
1/29 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
|
Investigations
Blood creatinine increased
|
0.00%
0/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/3 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
6.2%
1/16 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
25.0%
1/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
6.9%
2/29 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
|
Investigations
Weight decreased
|
0.00%
0/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
25.0%
1/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
33.3%
1/3 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
6.2%
1/16 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
25.0%
1/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
13.8%
4/29 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
|
Metabolism and nutrition disorders
Decreased appetite
|
100.0%
1/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
25.0%
1/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/3 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
18.8%
3/16 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
50.0%
2/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
24.1%
7/29 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
100.0%
1/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
33.3%
1/3 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/16 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
6.9%
2/29 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
66.7%
2/3 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/16 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
25.0%
1/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
10.3%
3/29 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
100.0%
1/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
33.3%
1/3 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/16 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
6.9%
2/29 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/3 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
12.5%
2/16 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
6.9%
2/29 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/3 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
6.2%
1/16 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
3.4%
1/29 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
25.0%
1/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/3 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/16 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
25.0%
1/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
6.9%
2/29 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/3 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/16 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
25.0%
1/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
3.4%
1/29 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
100.0%
1/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
33.3%
1/3 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/16 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
25.0%
1/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
10.3%
3/29 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
100.0%
1/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/3 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/16 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
3.4%
1/29 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/3 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
6.2%
1/16 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
3.4%
1/29 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/3 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
6.2%
1/16 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
25.0%
1/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
6.9%
2/29 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/3 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
6.2%
1/16 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
3.4%
1/29 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/3 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/16 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
25.0%
1/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
3.4%
1/29 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
|
Nervous system disorders
Dizziness
|
100.0%
1/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
25.0%
1/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/3 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
6.2%
1/16 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
25.0%
1/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
13.8%
4/29 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
|
Nervous system disorders
Headache
|
0.00%
0/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
25.0%
1/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
33.3%
1/3 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
12.5%
2/16 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
25.0%
1/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
17.2%
5/29 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
33.3%
1/3 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/16 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
3.4%
1/29 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/3 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
6.2%
1/16 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
3.4%
1/29 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/3 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/16 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
25.0%
1/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
3.4%
1/29 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
|
Nervous system disorders
Syncope
|
0.00%
0/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/3 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/16 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
25.0%
1/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
3.4%
1/29 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
|
Product Issues
Device dislocation
|
0.00%
0/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
33.3%
1/3 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/16 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
3.4%
1/29 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/3 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
6.2%
1/16 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
3.4%
1/29 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/3 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
6.2%
1/16 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
3.4%
1/29 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/3 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/16 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
25.0%
1/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
3.4%
1/29 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/3 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
6.2%
1/16 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
3.4%
1/29 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/3 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
6.2%
1/16 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
3.4%
1/29 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
|
Reproductive system and breast disorders
Breast pain
|
0.00%
0/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/3 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
6.2%
1/16 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
3.4%
1/29 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/3 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
6.2%
1/16 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
3.4%
1/29 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
50.0%
2/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/3 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
43.8%
7/16 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
75.0%
3/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
41.4%
12/29 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
66.7%
2/3 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
18.8%
3/16 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
25.0%
1/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
20.7%
6/29 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
50.0%
2/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
33.3%
1/3 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
18.8%
3/16 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
20.7%
6/29 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/3 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
6.2%
1/16 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
3.4%
1/29 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/3 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
6.2%
1/16 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
3.4%
1/29 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.00%
0/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
25.0%
1/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/3 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/16 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
3.4%
1/29 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
0.00%
0/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/3 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/16 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
25.0%
1/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
3.4%
1/29 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/3 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/16 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
25.0%
1/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
3.4%
1/29 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
33.3%
1/3 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
37.5%
6/16 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
50.0%
2/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
31.0%
9/29 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/3 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
12.5%
2/16 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
6.9%
2/29 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/3 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
6.2%
1/16 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
3.4%
1/29 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
0.00%
0/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/3 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
6.2%
1/16 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
3.4%
1/29 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/3 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
6.2%
1/16 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
3.4%
1/29 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
|
Vascular disorders
Hypertension
|
0.00%
0/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/3 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/16 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
25.0%
1/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
3.4%
1/29 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
|
Vascular disorders
Hypotension
|
0.00%
0/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
25.0%
1/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/3 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/16 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
25.0%
1/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
6.9%
2/29 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
|
Blood and lymphatic system disorders
Anaemia
|
100.0%
1/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
100.0%
1/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
50.0%
2/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
66.7%
2/3 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
37.5%
6/16 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
75.0%
3/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
51.7%
15/29 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
25.0%
1/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
33.3%
1/3 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/16 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
25.0%
1/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
10.3%
3/29 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
|
Blood and lymphatic system disorders
Lymphopenia
|
100.0%
1/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
25.0%
1/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
33.3%
1/3 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/16 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
10.3%
3/29 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
|
Blood and lymphatic system disorders
Neutropenia
|
100.0%
1/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
0.00%
0/1 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
75.0%
3/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
66.7%
2/3 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
12.5%
2/16 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
75.0%
3/4 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
37.9%
11/29 • Start of treatment through up to 6 months post last dose (up to 18 months)
|
Additional Information
Repare Therapeutics Medical Monitor
Repare Therapeutics Inc
Phone: 1 (857) 340-5402
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place