Trial Outcomes & Findings for Pilot Study of Crenolanib Combined With Standard Salvage Chemotherapy in Subjects With R/R AML (NCT NCT02626338)
NCT ID: NCT02626338
Last Updated: 2023-12-20
Results Overview
To determine the response rate to crenolanib. Complete remission (CR) response criteria include a post-baseline bone marrow (BM) biopsy or aspiration % blasts \<5%, absolute neutrophil count (ANC) \>1×10\^9/L and platelet count \>100×10\^9/L. CRi response included all CR criteria met, except participant did not have either platelet recovery or ANC recovery. CRh response included all CR criteria met, except subject only has partial platelet recovery and ANC recovery. Complete CR (CRc) response includes all subjects who achieve a CR, CRi and CRh. Partial Response (PR) response included a decrease of ≥50% in % blasts in the BM aspirate or biopsy from baseline but \>5%. Morphologic Leukemia-Free State (MLFS) response included ≤5% in % blasts in the BM aspirate or biopsy.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
16 participants
Primary outcome timeframe
1 year
Results posted on
2023-12-20
Participant Flow
Participant milestones
| Measure |
Arm A: HAM Chemotherapy
Participants who had relapsed/refractory AML with FLT3 activating mutations who progressed on one prior chemotherapy received 100 mg crenolanib besylate tablets administered orally three times a day following HAM salvage chemotherapy.
|
Arm B: FLAG-Ida Chemotherapy
Participants who had relapsed/refractory AML with FLT3 activating mutations who progressed on one prior chemotherapy received 100 mg crenolanib besylate tablets administered orally three times a day following FLAG-Ida salvage chemotherapy.
|
Arm C: MEC Chemotherapy
Participants who had relapsed/refractory AML with FLT3 activating mutations who progressed on one prior chemotherapy received 100 mg crenolanib besylate tablets administered orally three times a day following MEC salvage chemotherapy.
|
|---|---|---|---|
|
Overall Study
STARTED
|
9
|
6
|
1
|
|
Overall Study
COMPLETED
|
6
|
4
|
1
|
|
Overall Study
NOT COMPLETED
|
3
|
2
|
0
|
Reasons for withdrawal
| Measure |
Arm A: HAM Chemotherapy
Participants who had relapsed/refractory AML with FLT3 activating mutations who progressed on one prior chemotherapy received 100 mg crenolanib besylate tablets administered orally three times a day following HAM salvage chemotherapy.
|
Arm B: FLAG-Ida Chemotherapy
Participants who had relapsed/refractory AML with FLT3 activating mutations who progressed on one prior chemotherapy received 100 mg crenolanib besylate tablets administered orally three times a day following FLAG-Ida salvage chemotherapy.
|
Arm C: MEC Chemotherapy
Participants who had relapsed/refractory AML with FLT3 activating mutations who progressed on one prior chemotherapy received 100 mg crenolanib besylate tablets administered orally three times a day following MEC salvage chemotherapy.
|
|---|---|---|---|
|
Overall Study
Lack of Efficacy
|
3
|
2
|
0
|
Baseline Characteristics
Pilot Study of Crenolanib Combined With Standard Salvage Chemotherapy in Subjects With R/R AML
Baseline characteristics by cohort
| Measure |
Arm A: HAM Chemotherapy
n=9 Participants
Participants who had relapsed/refractory AML with FLT3 activating mutations who progressed on one prior chemotherapy received 100 mg crenolanib besylate tablets administered orally three times a day following HAM salvage chemotherapy.
|
Arm B: FLAG-Ida Chemotherapy
n=6 Participants
Participants who had relapsed/refractory AML with FLT3 activating mutations who progressed on one prior chemotherapy received 100 mg crenolanib besylate tablets administered orally three times a day following FLAG-Ida salvage chemotherapy.
|
Arm C: MEC Chemotherapy
n=1 Participants
Participants who had relapsed/refractory AML with FLT3 activating mutations who progressed on one prior chemotherapy received 100 mg crenolanib besylate tablets administered orally three times a day following MEC salvage chemotherapy.
|
Total
n=16 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
65 years
n=93 Participants
|
66 years
n=4 Participants
|
31 years
n=27 Participants
|
65 years
n=483 Participants
|
|
Age, Customized
18 to 60 years
|
2 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
5 Participants
n=483 Participants
|
|
Age, Customized
≥ 60 years
|
7 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
11 Participants
n=483 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
5 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
11 Participants
n=483 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
|
Race/Ethnicity, Customized
White
|
7 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
14 Participants
n=483 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
1 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
4 Participants
n=483 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
8 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
12 Participants
n=483 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
ECOG
0
|
2 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
3 Participants
n=483 Participants
|
|
ECOG
1
|
5 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
10 Participants
n=483 Participants
|
|
ECOG
2
|
2 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
3 Participants
n=483 Participants
|
|
Antecedent Hematological Disorder
|
2 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
6 Participants
n=483 Participants
|
|
FLT3 Mutations
ITD only
|
3 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
4 Participants
n=483 Participants
|
|
FLT3 Mutations
TKD only
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
FLT3 Mutations
ITD and TKD
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
|
FLT3 Mutations
FLT3 wildtype
|
5 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
11 Participants
n=483 Participants
|
PRIMARY outcome
Timeframe: 1 yearTo determine the response rate to crenolanib. Complete remission (CR) response criteria include a post-baseline bone marrow (BM) biopsy or aspiration % blasts \<5%, absolute neutrophil count (ANC) \>1×10\^9/L and platelet count \>100×10\^9/L. CRi response included all CR criteria met, except participant did not have either platelet recovery or ANC recovery. CRh response included all CR criteria met, except subject only has partial platelet recovery and ANC recovery. Complete CR (CRc) response includes all subjects who achieve a CR, CRi and CRh. Partial Response (PR) response included a decrease of ≥50% in % blasts in the BM aspirate or biopsy from baseline but \>5%. Morphologic Leukemia-Free State (MLFS) response included ≤5% in % blasts in the BM aspirate or biopsy.
Outcome measures
| Measure |
All Subjects
n=16 Participants
Participants who had relapsed/refractory AML with FLT3 activating mutations who progressed on one prior chemotherapy received 100 mg crenolanib besylate tablets administered orally three times a day following either HAM, MEC or FLAG-Ida salvage chemotherapy
|
Arm A: HAM Chemotherapy
n=9 Participants
Participants who had relapsed/refractory AML with FLT3 activating mutations who progressed on one prior chemotherapy received 100 mg crenolanib besylate tablets administered orally three times a day following HAM salvage chemotherapy.
|
Arm B: FLAG-Ida Chemotherapy
n=6 Participants
Participants who had relapsed/refractory AML with FLT3 activating mutations who progressed on one prior chemotherapy received 100 mg crenolanib besylate tablets administered orally three times a day following FLAG-Ida salvage chemotherapy.
|
Arm C: MEC Chemotherapy
n=1 Participants
Participants who had relapsed/refractory AML with FLT3 activating mutations who progressed on one prior chemotherapy received 100 mg crenolanib besylate tablets administered orally three times a day following MEC salvage chemotherapy.
|
|---|---|---|---|---|
|
Clinical Response to Crenolanib With Standard Salvage Chemotherapy
Composite complete remission (CR+CRh+CRi)
|
7 Participants
|
3 Participants
|
4 Participants
|
0 Participants
|
|
Clinical Response to Crenolanib With Standard Salvage Chemotherapy
MLFS
|
3 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Clinical Response to Crenolanib With Standard Salvage Chemotherapy
Clinical benefit (CRc+PR+MLFS)
|
7 Participants
|
3 Participants
|
4 Participants
|
0 Participants
|
Adverse Events
All Patients
Serious events: 6 serious events
Other events: 16 other events
Deaths: 0 deaths
Arm A: HAM Chemotherapy
Serious events: 4 serious events
Other events: 9 other events
Deaths: 0 deaths
Arm B: FLAG-Ida Chemotherapy
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
Arm C: MEC Chemotherapy
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
All Patients
n=16 participants at risk
Participants who had relapsed/refractory AML with FLT3 activating mutations who progressed on one prior chemotherapy received 100 mg crenolanib besylate tablets administered orally three times a day following standard salvage chemotherapy.
|
Arm A: HAM Chemotherapy
n=9 participants at risk
Participants who had relapsed/refractory AML with FLT3 activating mutations who progressed on one prior chemotherapy received 100 mg crenolanib besylate tablets administered orally three times a day following HAM salvage chemotherapy.
|
Arm B: FLAG-Ida Chemotherapy
n=6 participants at risk
Participants who had relapsed/refractory AML with FLT3 activating mutations who progressed on one prior chemotherapy received 100 mg crenolanib besylate tablets administered orally three times a day following FLAG-Ida salvage chemotherapy.
|
Arm C: MEC Chemotherapy
n=1 participants at risk
Participants who had relapsed/refractory AML with FLT3 activating mutations who progressed on one prior chemotherapy received 100 mg crenolanib besylate tablets administered orally three times a day following MEC salvage chemotherapy.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
12.5%
2/16 • From date of first dose up to 30-days after the last dose, 1 year.
|
22.2%
2/9 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/6 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/1 • From date of first dose up to 30-days after the last dose, 1 year.
|
|
Cardiac disorders
Atrial fibrillation
|
6.2%
1/16 • From date of first dose up to 30-days after the last dose, 1 year.
|
11.1%
1/9 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/6 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/1 • From date of first dose up to 30-days after the last dose, 1 year.
|
|
General disorders
Upper gastrointestinal hemorrhage
|
12.5%
2/16 • From date of first dose up to 30-days after the last dose, 1 year.
|
22.2%
2/9 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/6 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/1 • From date of first dose up to 30-days after the last dose, 1 year.
|
|
General disorders
Fatigue
|
6.2%
1/16 • From date of first dose up to 30-days after the last dose, 1 year.
|
11.1%
1/9 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/6 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/1 • From date of first dose up to 30-days after the last dose, 1 year.
|
|
Infections and infestations
Bacteraemia
|
6.2%
1/16 • From date of first dose up to 30-days after the last dose, 1 year.
|
11.1%
1/9 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/6 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/1 • From date of first dose up to 30-days after the last dose, 1 year.
|
|
General disorders
Chills
|
6.2%
1/16 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/9 • From date of first dose up to 30-days after the last dose, 1 year.
|
16.7%
1/6 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/1 • From date of first dose up to 30-days after the last dose, 1 year.
|
|
General disorders
Pyrexia
|
6.2%
1/16 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/9 • From date of first dose up to 30-days after the last dose, 1 year.
|
16.7%
1/6 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/1 • From date of first dose up to 30-days after the last dose, 1 year.
|
|
Injury, poisoning and procedural complications
Fall
|
6.2%
1/16 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/9 • From date of first dose up to 30-days after the last dose, 1 year.
|
16.7%
1/6 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/1 • From date of first dose up to 30-days after the last dose, 1 year.
|
|
Nervous system disorders
Presyncope
|
6.2%
1/16 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/9 • From date of first dose up to 30-days after the last dose, 1 year.
|
16.7%
1/6 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/1 • From date of first dose up to 30-days after the last dose, 1 year.
|
|
Nervous system disorders
Syncope
|
6.2%
1/16 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/9 • From date of first dose up to 30-days after the last dose, 1 year.
|
16.7%
1/6 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/1 • From date of first dose up to 30-days after the last dose, 1 year.
|
|
Psychiatric disorders
Mental status change
|
6.2%
1/16 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/9 • From date of first dose up to 30-days after the last dose, 1 year.
|
16.7%
1/6 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/1 • From date of first dose up to 30-days after the last dose, 1 year.
|
Other adverse events
| Measure |
All Patients
n=16 participants at risk
Participants who had relapsed/refractory AML with FLT3 activating mutations who progressed on one prior chemotherapy received 100 mg crenolanib besylate tablets administered orally three times a day following standard salvage chemotherapy.
|
Arm A: HAM Chemotherapy
n=9 participants at risk
Participants who had relapsed/refractory AML with FLT3 activating mutations who progressed on one prior chemotherapy received 100 mg crenolanib besylate tablets administered orally three times a day following HAM salvage chemotherapy.
|
Arm B: FLAG-Ida Chemotherapy
n=6 participants at risk
Participants who had relapsed/refractory AML with FLT3 activating mutations who progressed on one prior chemotherapy received 100 mg crenolanib besylate tablets administered orally three times a day following FLAG-Ida salvage chemotherapy.
|
Arm C: MEC Chemotherapy
n=1 participants at risk
Participants who had relapsed/refractory AML with FLT3 activating mutations who progressed on one prior chemotherapy received 100 mg crenolanib besylate tablets administered orally three times a day following MEC salvage chemotherapy.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
68.8%
11/16 • Number of events 11 • From date of first dose up to 30-days after the last dose, 1 year.
|
66.7%
6/9 • Number of events 6 • From date of first dose up to 30-days after the last dose, 1 year.
|
66.7%
4/6 • Number of events 4 • From date of first dose up to 30-days after the last dose, 1 year.
|
100.0%
1/1 • Number of events 1 • From date of first dose up to 30-days after the last dose, 1 year.
|
|
Gastrointestinal disorders
Nausea
|
62.5%
10/16 • Number of events 10 • From date of first dose up to 30-days after the last dose, 1 year.
|
55.6%
5/9 • Number of events 5 • From date of first dose up to 30-days after the last dose, 1 year.
|
66.7%
4/6 • Number of events 4 • From date of first dose up to 30-days after the last dose, 1 year.
|
100.0%
1/1 • Number of events 1 • From date of first dose up to 30-days after the last dose, 1 year.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
56.2%
9/16 • Number of events 9 • From date of first dose up to 30-days after the last dose, 1 year.
|
66.7%
6/9 • Number of events 6 • From date of first dose up to 30-days after the last dose, 1 year.
|
50.0%
3/6 • Number of events 3 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/1 • From date of first dose up to 30-days after the last dose, 1 year.
|
|
Gastrointestinal disorders
Constipation
|
43.8%
7/16 • Number of events 7 • From date of first dose up to 30-days after the last dose, 1 year.
|
44.4%
4/9 • Number of events 4 • From date of first dose up to 30-days after the last dose, 1 year.
|
50.0%
3/6 • Number of events 3 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/1 • From date of first dose up to 30-days after the last dose, 1 year.
|
|
Cardiac disorders
Pericardial effusion
|
6.2%
1/16 • Number of events 1 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/9 • From date of first dose up to 30-days after the last dose, 1 year.
|
16.7%
1/6 • Number of events 1 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/1 • From date of first dose up to 30-days after the last dose, 1 year.
|
|
Cardiac disorders
Sinus tachycardia
|
25.0%
4/16 • Number of events 4 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/9 • From date of first dose up to 30-days after the last dose, 1 year.
|
50.0%
3/6 • Number of events 3 • From date of first dose up to 30-days after the last dose, 1 year.
|
100.0%
1/1 • Number of events 1 • From date of first dose up to 30-days after the last dose, 1 year.
|
|
Eye disorders
Eye irritation
|
6.2%
1/16 • Number of events 1 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/9 • From date of first dose up to 30-days after the last dose, 1 year.
|
16.7%
1/6 • Number of events 1 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/1 • From date of first dose up to 30-days after the last dose, 1 year.
|
|
Eye disorders
Eye swelling
|
6.2%
1/16 • Number of events 1 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/9 • From date of first dose up to 30-days after the last dose, 1 year.
|
16.7%
1/6 • Number of events 1 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/1 • From date of first dose up to 30-days after the last dose, 1 year.
|
|
Eye disorders
Lacrimation increased
|
6.2%
1/16 • Number of events 1 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/9 • From date of first dose up to 30-days after the last dose, 1 year.
|
16.7%
1/6 • Number of events 1 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/1 • From date of first dose up to 30-days after the last dose, 1 year.
|
|
Eye disorders
Vision blurred
|
12.5%
2/16 • Number of events 2 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/9 • From date of first dose up to 30-days after the last dose, 1 year.
|
33.3%
2/6 • Number of events 2 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/1 • From date of first dose up to 30-days after the last dose, 1 year.
|
|
Gastrointestinal disorders
Abdominal distension
|
18.8%
3/16 • Number of events 3 • From date of first dose up to 30-days after the last dose, 1 year.
|
11.1%
1/9 • Number of events 1 • From date of first dose up to 30-days after the last dose, 1 year.
|
33.3%
2/6 • Number of events 2 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/1 • From date of first dose up to 30-days after the last dose, 1 year.
|
|
Gastrointestinal disorders
Abdominal pain
|
31.2%
5/16 • Number of events 5 • From date of first dose up to 30-days after the last dose, 1 year.
|
11.1%
1/9 • Number of events 1 • From date of first dose up to 30-days after the last dose, 1 year.
|
50.0%
3/6 • Number of events 3 • From date of first dose up to 30-days after the last dose, 1 year.
|
100.0%
1/1 • Number of events 1 • From date of first dose up to 30-days after the last dose, 1 year.
|
|
Gastrointestinal disorders
Anal skin tags
|
6.2%
1/16 • Number of events 1 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/9 • From date of first dose up to 30-days after the last dose, 1 year.
|
16.7%
1/6 • Number of events 1 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/1 • From date of first dose up to 30-days after the last dose, 1 year.
|
|
Gastrointestinal disorders
Anorectal discomfort
|
6.2%
1/16 • Number of events 1 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/9 • From date of first dose up to 30-days after the last dose, 1 year.
|
16.7%
1/6 • Number of events 1 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/1 • From date of first dose up to 30-days after the last dose, 1 year.
|
|
Gastrointestinal disorders
Colitis
|
6.2%
1/16 • Number of events 1 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/9 • From date of first dose up to 30-days after the last dose, 1 year.
|
16.7%
1/6 • Number of events 1 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/1 • From date of first dose up to 30-days after the last dose, 1 year.
|
|
Gastrointestinal disorders
Dry mouth
|
6.2%
1/16 • Number of events 1 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/9 • From date of first dose up to 30-days after the last dose, 1 year.
|
16.7%
1/6 • Number of events 1 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/1 • From date of first dose up to 30-days after the last dose, 1 year.
|
|
Gastrointestinal disorders
Ileus
|
6.2%
1/16 • Number of events 1 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/9 • From date of first dose up to 30-days after the last dose, 1 year.
|
16.7%
1/6 • Number of events 1 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/1 • From date of first dose up to 30-days after the last dose, 1 year.
|
|
Gastrointestinal disorders
Vomiting
|
25.0%
4/16 • Number of events 4 • From date of first dose up to 30-days after the last dose, 1 year.
|
22.2%
2/9 • Number of events 2 • From date of first dose up to 30-days after the last dose, 1 year.
|
33.3%
2/6 • Number of events 2 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/1 • From date of first dose up to 30-days after the last dose, 1 year.
|
|
General disorders
Chills
|
18.8%
3/16 • Number of events 3 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/9 • From date of first dose up to 30-days after the last dose, 1 year.
|
50.0%
3/6 • Number of events 3 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/1 • From date of first dose up to 30-days after the last dose, 1 year.
|
|
General disorders
Face oedema
|
6.2%
1/16 • Number of events 1 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/9 • From date of first dose up to 30-days after the last dose, 1 year.
|
16.7%
1/6 • Number of events 1 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/1 • From date of first dose up to 30-days after the last dose, 1 year.
|
|
General disorders
Fatigue
|
37.5%
6/16 • Number of events 6 • From date of first dose up to 30-days after the last dose, 1 year.
|
22.2%
2/9 • Number of events 2 • From date of first dose up to 30-days after the last dose, 1 year.
|
66.7%
4/6 • Number of events 4 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/1 • From date of first dose up to 30-days after the last dose, 1 year.
|
|
General disorders
Mucosal inflammation
|
6.2%
1/16 • Number of events 1 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/9 • From date of first dose up to 30-days after the last dose, 1 year.
|
16.7%
1/6 • Number of events 1 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/1 • From date of first dose up to 30-days after the last dose, 1 year.
|
|
General disorders
Non-cardiac chest pain
|
6.2%
1/16 • Number of events 1 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/9 • From date of first dose up to 30-days after the last dose, 1 year.
|
16.7%
1/6 • Number of events 1 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/1 • From date of first dose up to 30-days after the last dose, 1 year.
|
|
General disorders
Oedema
|
18.8%
3/16 • Number of events 3 • From date of first dose up to 30-days after the last dose, 1 year.
|
22.2%
2/9 • Number of events 2 • From date of first dose up to 30-days after the last dose, 1 year.
|
16.7%
1/6 • Number of events 1 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/1 • From date of first dose up to 30-days after the last dose, 1 year.
|
|
General disorders
Oedema peripheral
|
31.2%
5/16 • Number of events 5 • From date of first dose up to 30-days after the last dose, 1 year.
|
22.2%
2/9 • Number of events 2 • From date of first dose up to 30-days after the last dose, 1 year.
|
33.3%
2/6 • Number of events 2 • From date of first dose up to 30-days after the last dose, 1 year.
|
100.0%
1/1 • Number of events 1 • From date of first dose up to 30-days after the last dose, 1 year.
|
|
General disorders
Pyrexia
|
31.2%
5/16 • Number of events 5 • From date of first dose up to 30-days after the last dose, 1 year.
|
33.3%
3/9 • Number of events 3 • From date of first dose up to 30-days after the last dose, 1 year.
|
33.3%
2/6 • Number of events 2 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/1 • From date of first dose up to 30-days after the last dose, 1 year.
|
|
Immune system disorders
Graft versus host disease in gastrointestinal tract
|
6.2%
1/16 • Number of events 1 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/9 • From date of first dose up to 30-days after the last dose, 1 year.
|
16.7%
1/6 • Number of events 1 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/1 • From date of first dose up to 30-days after the last dose, 1 year.
|
|
Immune system disorders
Graft versus host disease in skin
|
6.2%
1/16 • Number of events 1 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/9 • From date of first dose up to 30-days after the last dose, 1 year.
|
16.7%
1/6 • Number of events 1 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/1 • From date of first dose up to 30-days after the last dose, 1 year.
|
|
Immune system disorders
Hypogammaglobulinaemia
|
6.2%
1/16 • Number of events 1 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/9 • From date of first dose up to 30-days after the last dose, 1 year.
|
16.7%
1/6 • Number of events 1 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/1 • From date of first dose up to 30-days after the last dose, 1 year.
|
|
Infections and infestations
Clostridium difficile colitis
|
12.5%
2/16 • Number of events 2 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/9 • From date of first dose up to 30-days after the last dose, 1 year.
|
33.3%
2/6 • Number of events 2 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/1 • From date of first dose up to 30-days after the last dose, 1 year.
|
|
Infections and infestations
Escherichia bacteraemia
|
6.2%
1/16 • Number of events 1 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/9 • From date of first dose up to 30-days after the last dose, 1 year.
|
16.7%
1/6 • Number of events 1 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/1 • From date of first dose up to 30-days after the last dose, 1 year.
|
|
Infections and infestations
Oral herpes
|
6.2%
1/16 • Number of events 1 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/9 • From date of first dose up to 30-days after the last dose, 1 year.
|
16.7%
1/6 • Number of events 1 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/1 • From date of first dose up to 30-days after the last dose, 1 year.
|
|
Injury, poisoning and procedural complications
Fall
|
6.2%
1/16 • Number of events 1 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/9 • From date of first dose up to 30-days after the last dose, 1 year.
|
16.7%
1/6 • Number of events 1 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/1 • From date of first dose up to 30-days after the last dose, 1 year.
|
|
Investigations
Blood bilirubin increased
|
6.2%
1/16 • Number of events 1 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/9 • From date of first dose up to 30-days after the last dose, 1 year.
|
16.7%
1/6 • Number of events 1 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/1 • From date of first dose up to 30-days after the last dose, 1 year.
|
|
Investigations
Weight increased
|
6.2%
1/16 • Number of events 1 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/9 • From date of first dose up to 30-days after the last dose, 1 year.
|
16.7%
1/6 • Number of events 1 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/1 • From date of first dose up to 30-days after the last dose, 1 year.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
25.0%
4/16 • Number of events 4 • From date of first dose up to 30-days after the last dose, 1 year.
|
11.1%
1/9 • Number of events 1 • From date of first dose up to 30-days after the last dose, 1 year.
|
33.3%
2/6 • Number of events 2 • From date of first dose up to 30-days after the last dose, 1 year.
|
100.0%
1/1 • Number of events 1 • From date of first dose up to 30-days after the last dose, 1 year.
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
6.2%
1/16 • Number of events 1 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/9 • From date of first dose up to 30-days after the last dose, 1 year.
|
16.7%
1/6 • Number of events 1 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/1 • From date of first dose up to 30-days after the last dose, 1 year.
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
6.2%
1/16 • Number of events 1 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/9 • From date of first dose up to 30-days after the last dose, 1 year.
|
16.7%
1/6 • Number of events 1 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/1 • From date of first dose up to 30-days after the last dose, 1 year.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
31.2%
5/16 • Number of events 5 • From date of first dose up to 30-days after the last dose, 1 year.
|
33.3%
3/9 • Number of events 3 • From date of first dose up to 30-days after the last dose, 1 year.
|
33.3%
2/6 • Number of events 2 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/1 • From date of first dose up to 30-days after the last dose, 1 year.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
25.0%
4/16 • Number of events 4 • From date of first dose up to 30-days after the last dose, 1 year.
|
11.1%
1/9 • Number of events 1 • From date of first dose up to 30-days after the last dose, 1 year.
|
33.3%
2/6 • Number of events 2 • From date of first dose up to 30-days after the last dose, 1 year.
|
100.0%
1/1 • Number of events 1 • From date of first dose up to 30-days after the last dose, 1 year.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
6.2%
1/16 • Number of events 1 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/9 • From date of first dose up to 30-days after the last dose, 1 year.
|
16.7%
1/6 • Number of events 1 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/1 • From date of first dose up to 30-days after the last dose, 1 year.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
6.2%
1/16 • Number of events 1 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/9 • From date of first dose up to 30-days after the last dose, 1 year.
|
16.7%
1/6 • Number of events 1 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/1 • From date of first dose up to 30-days after the last dose, 1 year.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
12.5%
2/16 • Number of events 2 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/9 • From date of first dose up to 30-days after the last dose, 1 year.
|
33.3%
2/6 • Number of events 2 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/1 • From date of first dose up to 30-days after the last dose, 1 year.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.2%
1/16 • Number of events 1 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/9 • From date of first dose up to 30-days after the last dose, 1 year.
|
16.7%
1/6 • Number of events 1 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/1 • From date of first dose up to 30-days after the last dose, 1 year.
|
|
Nervous system disorders
Dizziness
|
18.8%
3/16 • Number of events 3 • From date of first dose up to 30-days after the last dose, 1 year.
|
11.1%
1/9 • Number of events 1 • From date of first dose up to 30-days after the last dose, 1 year.
|
16.7%
1/6 • Number of events 1 • From date of first dose up to 30-days after the last dose, 1 year.
|
100.0%
1/1 • Number of events 1 • From date of first dose up to 30-days after the last dose, 1 year.
|
|
Nervous system disorders
Headache
|
25.0%
4/16 • Number of events 4 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/9 • From date of first dose up to 30-days after the last dose, 1 year.
|
50.0%
3/6 • Number of events 3 • From date of first dose up to 30-days after the last dose, 1 year.
|
100.0%
1/1 • Number of events 1 • From date of first dose up to 30-days after the last dose, 1 year.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
6.2%
1/16 • Number of events 1 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/9 • From date of first dose up to 30-days after the last dose, 1 year.
|
16.7%
1/6 • Number of events 1 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/1 • From date of first dose up to 30-days after the last dose, 1 year.
|
|
Nervous system disorders
Presyncope
|
6.2%
1/16 • Number of events 1 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/9 • From date of first dose up to 30-days after the last dose, 1 year.
|
16.7%
1/6 • Number of events 1 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/1 • From date of first dose up to 30-days after the last dose, 1 year.
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
6.2%
1/16 • Number of events 1 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/9 • From date of first dose up to 30-days after the last dose, 1 year.
|
16.7%
1/6 • Number of events 1 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/1 • From date of first dose up to 30-days after the last dose, 1 year.
|
|
Nervous system disorders
Syncope
|
6.2%
1/16 • Number of events 1 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/9 • From date of first dose up to 30-days after the last dose, 1 year.
|
16.7%
1/6 • Number of events 1 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/1 • From date of first dose up to 30-days after the last dose, 1 year.
|
|
Psychiatric disorders
Confusional state
|
6.2%
1/16 • Number of events 1 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/9 • From date of first dose up to 30-days after the last dose, 1 year.
|
16.7%
1/6 • Number of events 1 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/1 • From date of first dose up to 30-days after the last dose, 1 year.
|
|
Psychiatric disorders
Insomnia
|
18.8%
3/16 • Number of events 3 • From date of first dose up to 30-days after the last dose, 1 year.
|
11.1%
1/9 • Number of events 1 • From date of first dose up to 30-days after the last dose, 1 year.
|
16.7%
1/6 • Number of events 1 • From date of first dose up to 30-days after the last dose, 1 year.
|
100.0%
1/1 • Number of events 1 • From date of first dose up to 30-days after the last dose, 1 year.
|
|
Psychiatric disorders
Mental status changes
|
6.2%
1/16 • Number of events 1 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/9 • From date of first dose up to 30-days after the last dose, 1 year.
|
16.7%
1/6 • Number of events 1 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/1 • From date of first dose up to 30-days after the last dose, 1 year.
|
|
Renal and urinary disorders
Dysuria
|
6.2%
1/16 • Number of events 1 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/9 • From date of first dose up to 30-days after the last dose, 1 year.
|
16.7%
1/6 • Number of events 1 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/1 • From date of first dose up to 30-days after the last dose, 1 year.
|
|
Renal and urinary disorders
Urinary incontinence
|
6.2%
1/16 • Number of events 1 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/9 • From date of first dose up to 30-days after the last dose, 1 year.
|
16.7%
1/6 • Number of events 1 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/1 • From date of first dose up to 30-days after the last dose, 1 year.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
25.0%
4/16 • Number of events 4 • From date of first dose up to 30-days after the last dose, 1 year.
|
33.3%
3/9 • Number of events 3 • From date of first dose up to 30-days after the last dose, 1 year.
|
16.7%
1/6 • Number of events 1 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/1 • From date of first dose up to 30-days after the last dose, 1 year.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
12.5%
2/16 • Number of events 2 • From date of first dose up to 30-days after the last dose, 1 year.
|
11.1%
1/9 • Number of events 1 • From date of first dose up to 30-days after the last dose, 1 year.
|
16.7%
1/6 • Number of events 1 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/1 • From date of first dose up to 30-days after the last dose, 1 year.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
18.8%
3/16 • Number of events 3 • From date of first dose up to 30-days after the last dose, 1 year.
|
11.1%
1/9 • Number of events 1 • From date of first dose up to 30-days after the last dose, 1 year.
|
33.3%
2/6 • Number of events 2 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/1 • From date of first dose up to 30-days after the last dose, 1 year.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
18.8%
3/16 • Number of events 3 • From date of first dose up to 30-days after the last dose, 1 year.
|
22.2%
2/9 • Number of events 2 • From date of first dose up to 30-days after the last dose, 1 year.
|
16.7%
1/6 • Number of events 1 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/1 • From date of first dose up to 30-days after the last dose, 1 year.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
6.2%
1/16 • Number of events 1 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/9 • From date of first dose up to 30-days after the last dose, 1 year.
|
16.7%
1/6 • Number of events 1 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/1 • From date of first dose up to 30-days after the last dose, 1 year.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
6.2%
1/16 • Number of events 1 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/9 • From date of first dose up to 30-days after the last dose, 1 year.
|
16.7%
1/6 • Number of events 1 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/1 • From date of first dose up to 30-days after the last dose, 1 year.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
6.2%
1/16 • Number of events 1 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/9 • From date of first dose up to 30-days after the last dose, 1 year.
|
16.7%
1/6 • Number of events 1 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/1 • From date of first dose up to 30-days after the last dose, 1 year.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
6.2%
1/16 • Number of events 1 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/9 • From date of first dose up to 30-days after the last dose, 1 year.
|
16.7%
1/6 • Number of events 1 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/1 • From date of first dose up to 30-days after the last dose, 1 year.
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
6.2%
1/16 • Number of events 1 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/9 • From date of first dose up to 30-days after the last dose, 1 year.
|
16.7%
1/6 • Number of events 1 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/1 • From date of first dose up to 30-days after the last dose, 1 year.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
6.2%
1/16 • Number of events 1 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/9 • From date of first dose up to 30-days after the last dose, 1 year.
|
16.7%
1/6 • Number of events 1 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/1 • From date of first dose up to 30-days after the last dose, 1 year.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
6.2%
1/16 • Number of events 1 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/9 • From date of first dose up to 30-days after the last dose, 1 year.
|
16.7%
1/6 • Number of events 1 • From date of first dose up to 30-days after the last dose, 1 year.
|
100.0%
1/1 • Number of events 1 • From date of first dose up to 30-days after the last dose, 1 year.
|
|
Skin and subcutaneous tissue disorders
Rash
|
12.5%
2/16 • Number of events 2 • From date of first dose up to 30-days after the last dose, 1 year.
|
11.1%
1/9 • Number of events 1 • From date of first dose up to 30-days after the last dose, 1 year.
|
16.7%
1/6 • Number of events 1 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/1 • From date of first dose up to 30-days after the last dose, 1 year.
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
6.2%
1/16 • Number of events 1 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/9 • From date of first dose up to 30-days after the last dose, 1 year.
|
16.7%
1/6 • Number of events 1 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/1 • From date of first dose up to 30-days after the last dose, 1 year.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
12.5%
2/16 • Number of events 2 • From date of first dose up to 30-days after the last dose, 1 year.
|
11.1%
1/9 • Number of events 1 • From date of first dose up to 30-days after the last dose, 1 year.
|
16.7%
1/6 • Number of events 1 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/1 • From date of first dose up to 30-days after the last dose, 1 year.
|
|
Vascular disorders
Hypertension
|
31.2%
5/16 • Number of events 5 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/9 • From date of first dose up to 30-days after the last dose, 1 year.
|
66.7%
4/6 • Number of events 4 • From date of first dose up to 30-days after the last dose, 1 year.
|
100.0%
1/1 • Number of events 1 • From date of first dose up to 30-days after the last dose, 1 year.
|
|
Blood and lymphatic system disorders
Anaemia
|
31.2%
5/16 • Number of events 5 • From date of first dose up to 30-days after the last dose, 1 year.
|
44.4%
4/9 • Number of events 4 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/6 • From date of first dose up to 30-days after the last dose, 1 year.
|
100.0%
1/1 • Number of events 1 • From date of first dose up to 30-days after the last dose, 1 year.
|
|
Blood and lymphatic system disorders
Neutropenia
|
6.2%
1/16 • Number of events 1 • From date of first dose up to 30-days after the last dose, 1 year.
|
11.1%
1/9 • Number of events 1 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/6 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/1 • From date of first dose up to 30-days after the last dose, 1 year.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
6.2%
1/16 • Number of events 1 • From date of first dose up to 30-days after the last dose, 1 year.
|
11.1%
1/9 • Number of events 1 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/6 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/1 • From date of first dose up to 30-days after the last dose, 1 year.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
18.8%
3/16 • Number of events 3 • From date of first dose up to 30-days after the last dose, 1 year.
|
22.2%
2/9 • Number of events 2 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/6 • From date of first dose up to 30-days after the last dose, 1 year.
|
100.0%
1/1 • Number of events 1 • From date of first dose up to 30-days after the last dose, 1 year.
|
|
Cardiac disorders
Acute myocardial infarction
|
6.2%
1/16 • Number of events 1 • From date of first dose up to 30-days after the last dose, 1 year.
|
11.1%
1/9 • Number of events 1 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/6 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/1 • From date of first dose up to 30-days after the last dose, 1 year.
|
|
Cardiac disorders
Atrial fibrillation
|
6.2%
1/16 • Number of events 1 • From date of first dose up to 30-days after the last dose, 1 year.
|
11.1%
1/9 • Number of events 1 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/6 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/1 • From date of first dose up to 30-days after the last dose, 1 year.
|
|
Eye disorders
Conjunctival haemorrhage
|
6.2%
1/16 • Number of events 1 • From date of first dose up to 30-days after the last dose, 1 year.
|
11.1%
1/9 • Number of events 1 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/6 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/1 • From date of first dose up to 30-days after the last dose, 1 year.
|
|
Gastrointestinal disorders
Anal incontinence
|
6.2%
1/16 • Number of events 1 • From date of first dose up to 30-days after the last dose, 1 year.
|
11.1%
1/9 • Number of events 1 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/6 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/1 • From date of first dose up to 30-days after the last dose, 1 year.
|
|
Gastrointestinal disorders
Dyspepsia
|
12.5%
2/16 • Number of events 2 • From date of first dose up to 30-days after the last dose, 1 year.
|
22.2%
2/9 • Number of events 2 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/6 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/1 • From date of first dose up to 30-days after the last dose, 1 year.
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
12.5%
2/16 • Number of events 2 • From date of first dose up to 30-days after the last dose, 1 year.
|
11.1%
1/9 • Number of events 1 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/6 • From date of first dose up to 30-days after the last dose, 1 year.
|
100.0%
1/1 • Number of events 1 • From date of first dose up to 30-days after the last dose, 1 year.
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
6.2%
1/16 • Number of events 1 • From date of first dose up to 30-days after the last dose, 1 year.
|
11.1%
1/9 • Number of events 1 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/6 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/1 • From date of first dose up to 30-days after the last dose, 1 year.
|
|
Gastrointestinal disorders
Melaena
|
6.2%
1/16 • Number of events 1 • From date of first dose up to 30-days after the last dose, 1 year.
|
11.1%
1/9 • Number of events 1 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/6 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/1 • From date of first dose up to 30-days after the last dose, 1 year.
|
|
Gastrointestinal disorders
Oral disorder
|
12.5%
2/16 • Number of events 2 • From date of first dose up to 30-days after the last dose, 1 year.
|
22.2%
2/9 • Number of events 2 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/6 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/1 • From date of first dose up to 30-days after the last dose, 1 year.
|
|
Gastrointestinal disorders
Small intestinal haemorrhage
|
6.2%
1/16 • Number of events 1 • From date of first dose up to 30-days after the last dose, 1 year.
|
11.1%
1/9 • Number of events 1 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/6 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/1 • From date of first dose up to 30-days after the last dose, 1 year.
|
|
Gastrointestinal disorders
Tongue blistering
|
6.2%
1/16 • Number of events 1 • From date of first dose up to 30-days after the last dose, 1 year.
|
11.1%
1/9 • Number of events 1 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/6 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/1 • From date of first dose up to 30-days after the last dose, 1 year.
|
|
Gastrointestinal disorders
Toothache
|
6.2%
1/16 • Number of events 1 • From date of first dose up to 30-days after the last dose, 1 year.
|
11.1%
1/9 • Number of events 1 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/6 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/1 • From date of first dose up to 30-days after the last dose, 1 year.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
12.5%
2/16 • Number of events 2 • From date of first dose up to 30-days after the last dose, 1 year.
|
22.2%
2/9 • Number of events 2 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/6 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/1 • From date of first dose up to 30-days after the last dose, 1 year.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
6.2%
1/16 • Number of events 1 • From date of first dose up to 30-days after the last dose, 1 year.
|
11.1%
1/9 • Number of events 1 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/6 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/1 • From date of first dose up to 30-days after the last dose, 1 year.
|
|
Infections and infestations
Bacteraemia
|
6.2%
1/16 • Number of events 1 • From date of first dose up to 30-days after the last dose, 1 year.
|
11.1%
1/9 • Number of events 1 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/6 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/1 • From date of first dose up to 30-days after the last dose, 1 year.
|
|
Infections and infestations
Cellulitis
|
12.5%
2/16 • Number of events 2 • From date of first dose up to 30-days after the last dose, 1 year.
|
22.2%
2/9 • Number of events 2 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/6 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/1 • From date of first dose up to 30-days after the last dose, 1 year.
|
|
Infections and infestations
Pneumonia bacterial
|
12.5%
2/16 • Number of events 2 • From date of first dose up to 30-days after the last dose, 1 year.
|
11.1%
1/9 • Number of events 1 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/6 • From date of first dose up to 30-days after the last dose, 1 year.
|
100.0%
1/1 • Number of events 1 • From date of first dose up to 30-days after the last dose, 1 year.
|
|
Infections and infestations
Streptococcal bacteraemia
|
6.2%
1/16 • Number of events 1 • From date of first dose up to 30-days after the last dose, 1 year.
|
11.1%
1/9 • Number of events 1 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/6 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/1 • From date of first dose up to 30-days after the last dose, 1 year.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
6.2%
1/16 • Number of events 1 • From date of first dose up to 30-days after the last dose, 1 year.
|
11.1%
1/9 • Number of events 1 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/6 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/1 • From date of first dose up to 30-days after the last dose, 1 year.
|
|
Investigations
Aspartate aminotransferase increased
|
6.2%
1/16 • Number of events 1 • From date of first dose up to 30-days after the last dose, 1 year.
|
11.1%
1/9 • Number of events 1 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/6 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/1 • From date of first dose up to 30-days after the last dose, 1 year.
|
|
Investigations
Blood alkaline phosphatase increased
|
6.2%
1/16 • Number of events 1 • From date of first dose up to 30-days after the last dose, 1 year.
|
11.1%
1/9 • Number of events 1 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/6 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/1 • From date of first dose up to 30-days after the last dose, 1 year.
|
|
Investigations
Blood chloride increased
|
6.2%
1/16 • Number of events 1 • From date of first dose up to 30-days after the last dose, 1 year.
|
11.1%
1/9 • Number of events 1 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/6 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/1 • From date of first dose up to 30-days after the last dose, 1 year.
|
|
Investigations
Blood creatinine increased
|
6.2%
1/16 • Number of events 1 • From date of first dose up to 30-days after the last dose, 1 year.
|
11.1%
1/9 • Number of events 1 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/6 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/1 • From date of first dose up to 30-days after the last dose, 1 year.
|
|
Investigations
Blood urea increased
|
6.2%
1/16 • Number of events 1 • From date of first dose up to 30-days after the last dose, 1 year.
|
11.1%
1/9 • Number of events 1 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/6 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/1 • From date of first dose up to 30-days after the last dose, 1 year.
|
|
Investigations
Lymphocyte count decreased
|
6.2%
1/16 • Number of events 1 • From date of first dose up to 30-days after the last dose, 1 year.
|
11.1%
1/9 • Number of events 1 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/6 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/1 • From date of first dose up to 30-days after the last dose, 1 year.
|
|
Investigations
Neutrophil count decreased
|
6.2%
1/16 • Number of events 1 • From date of first dose up to 30-days after the last dose, 1 year.
|
11.1%
1/9 • Number of events 1 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/6 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/1 • From date of first dose up to 30-days after the last dose, 1 year.
|
|
Investigations
Platelet count decreased
|
6.2%
1/16 • Number of events 1 • From date of first dose up to 30-days after the last dose, 1 year.
|
11.1%
1/9 • Number of events 1 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/6 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/1 • From date of first dose up to 30-days after the last dose, 1 year.
|
|
Investigations
White blood cell count decreased
|
6.2%
1/16 • Number of events 1 • From date of first dose up to 30-days after the last dose, 1 year.
|
11.1%
1/9 • Number of events 1 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/6 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/1 • From date of first dose up to 30-days after the last dose, 1 year.
|
|
Metabolism and nutrition disorders
Gout
|
6.2%
1/16 • Number of events 1 • From date of first dose up to 30-days after the last dose, 1 year.
|
11.1%
1/9 • Number of events 1 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/6 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/1 • From date of first dose up to 30-days after the last dose, 1 year.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
6.2%
1/16 • Number of events 1 • From date of first dose up to 30-days after the last dose, 1 year.
|
11.1%
1/9 • Number of events 1 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/6 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/1 • From date of first dose up to 30-days after the last dose, 1 year.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
6.2%
1/16 • Number of events 1 • From date of first dose up to 30-days after the last dose, 1 year.
|
11.1%
1/9 • Number of events 1 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/6 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/1 • From date of first dose up to 30-days after the last dose, 1 year.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
6.2%
1/16 • Number of events 1 • From date of first dose up to 30-days after the last dose, 1 year.
|
11.1%
1/9 • Number of events 1 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/6 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/1 • From date of first dose up to 30-days after the last dose, 1 year.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
6.2%
1/16 • Number of events 1 • From date of first dose up to 30-days after the last dose, 1 year.
|
11.1%
1/9 • Number of events 1 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/6 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/1 • From date of first dose up to 30-days after the last dose, 1 year.
|
|
Musculoskeletal and connective tissue disorders
Soft tissue swelling
|
6.2%
1/16 • Number of events 1 • From date of first dose up to 30-days after the last dose, 1 year.
|
11.1%
1/9 • Number of events 1 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/6 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/1 • From date of first dose up to 30-days after the last dose, 1 year.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Seborrhoeic keratosis
|
6.2%
1/16 • Number of events 1 • From date of first dose up to 30-days after the last dose, 1 year.
|
11.1%
1/9 • Number of events 1 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/6 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/1 • From date of first dose up to 30-days after the last dose, 1 year.
|
|
Nervous system disorders
Neuropathy peripheral
|
6.2%
1/16 • Number of events 1 • From date of first dose up to 30-days after the last dose, 1 year.
|
11.1%
1/9 • Number of events 1 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/6 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/1 • From date of first dose up to 30-days after the last dose, 1 year.
|
|
Renal and urinary disorders
Acute kidney injury
|
6.2%
1/16 • Number of events 1 • From date of first dose up to 30-days after the last dose, 1 year.
|
11.1%
1/9 • Number of events 1 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/6 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/1 • From date of first dose up to 30-days after the last dose, 1 year.
|
|
Renal and urinary disorders
Pollakiuria
|
6.2%
1/16 • Number of events 1 • From date of first dose up to 30-days after the last dose, 1 year.
|
11.1%
1/9 • Number of events 1 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/6 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/1 • From date of first dose up to 30-days after the last dose, 1 year.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
6.2%
1/16 • Number of events 1 • From date of first dose up to 30-days after the last dose, 1 year.
|
11.1%
1/9 • Number of events 1 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/6 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/1 • From date of first dose up to 30-days after the last dose, 1 year.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
6.2%
1/16 • Number of events 1 • From date of first dose up to 30-days after the last dose, 1 year.
|
11.1%
1/9 • Number of events 1 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/6 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/1 • From date of first dose up to 30-days after the last dose, 1 year.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
6.2%
1/16 • Number of events 1 • From date of first dose up to 30-days after the last dose, 1 year.
|
11.1%
1/9 • Number of events 1 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/6 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/1 • From date of first dose up to 30-days after the last dose, 1 year.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
6.2%
1/16 • Number of events 1 • From date of first dose up to 30-days after the last dose, 1 year.
|
11.1%
1/9 • Number of events 1 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/6 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/1 • From date of first dose up to 30-days after the last dose, 1 year.
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
6.2%
1/16 • Number of events 1 • From date of first dose up to 30-days after the last dose, 1 year.
|
11.1%
1/9 • Number of events 1 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/6 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/1 • From date of first dose up to 30-days after the last dose, 1 year.
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
6.2%
1/16 • Number of events 1 • From date of first dose up to 30-days after the last dose, 1 year.
|
11.1%
1/9 • Number of events 1 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/6 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/1 • From date of first dose up to 30-days after the last dose, 1 year.
|
|
Vascular disorders
Hypotension
|
31.2%
5/16 • Number of events 5 • From date of first dose up to 30-days after the last dose, 1 year.
|
55.6%
5/9 • Number of events 5 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/6 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/1 • From date of first dose up to 30-days after the last dose, 1 year.
|
|
Blood and lymphatic system disorders
Leukopenia
|
12.5%
2/16 • Number of events 2 • From date of first dose up to 30-days after the last dose, 1 year.
|
11.1%
1/9 • Number of events 1 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/6 • From date of first dose up to 30-days after the last dose, 1 year.
|
100.0%
1/1 • Number of events 1 • From date of first dose up to 30-days after the last dose, 1 year.
|
|
Gastrointestinal disorders
Haemorrhoids
|
6.2%
1/16 • Number of events 1 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/9 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/6 • From date of first dose up to 30-days after the last dose, 1 year.
|
100.0%
1/1 • Number of events 1 • From date of first dose up to 30-days after the last dose, 1 year.
|
|
Gastrointestinal disorders
Proctalgia
|
6.2%
1/16 • Number of events 1 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/9 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/6 • From date of first dose up to 30-days after the last dose, 1 year.
|
100.0%
1/1 • Number of events 1 • From date of first dose up to 30-days after the last dose, 1 year.
|
|
Gastrointestinal disorders
Proctitis
|
6.2%
1/16 • Number of events 1 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/9 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/6 • From date of first dose up to 30-days after the last dose, 1 year.
|
100.0%
1/1 • Number of events 1 • From date of first dose up to 30-days after the last dose, 1 year.
|
|
Infections and infestations
Pneumonia fungal
|
6.2%
1/16 • Number of events 1 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/9 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/6 • From date of first dose up to 30-days after the last dose, 1 year.
|
100.0%
1/1 • Number of events 1 • From date of first dose up to 30-days after the last dose, 1 year.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.2%
1/16 • Number of events 1 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/9 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/6 • From date of first dose up to 30-days after the last dose, 1 year.
|
100.0%
1/1 • Number of events 1 • From date of first dose up to 30-days after the last dose, 1 year.
|
|
Psychiatric disorders
Anxiety
|
6.2%
1/16 • Number of events 1 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/9 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/6 • From date of first dose up to 30-days after the last dose, 1 year.
|
100.0%
1/1 • Number of events 1 • From date of first dose up to 30-days after the last dose, 1 year.
|
|
Renal and urinary disorders
Urinary retention
|
6.2%
1/16 • Number of events 1 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/9 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/6 • From date of first dose up to 30-days after the last dose, 1 year.
|
100.0%
1/1 • Number of events 1 • From date of first dose up to 30-days after the last dose, 1 year.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
6.2%
1/16 • Number of events 1 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/9 • From date of first dose up to 30-days after the last dose, 1 year.
|
0.00%
0/6 • From date of first dose up to 30-days after the last dose, 1 year.
|
100.0%
1/1 • Number of events 1 • From date of first dose up to 30-days after the last dose, 1 year.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place