Trial Outcomes & Findings for A Safety and Tolerability Study of Crenolanib in Combination With Chemotherapy in Newly Diagnosed Acute Myeloid Leukemia Patients With FLT3 Mutations (NCT NCT02283177)
NCT ID: NCT02283177
Last Updated: 2024-02-02
Results Overview
To determine the response rate to crenolanib. Complete remission (CR) response criteria includes a post-baseline bone marrow (BM) biopsy or aspiration % blasts \<5%, the absence of Auer rods and extramedullary leukemia, absolute neutrophil count (ANC) \>1×10\^9/L and platelet count \>100×10\^9/L. Complete remission with incomplete blood count recovery (CRi) response includes all CR criteria met, except participant do not achieve either platelet or ANC recovery. Composite Complete CR response includes all subjects who achieve a CR and CRi. Partial Response (PR) response includes all CR criteria met except a decrease of ≥50% in % blasts in the BM aspirate or biopsy from baseline but within 5-25% or bone marrow blasts \<5% with persistent Auer rods. Refractory Disease response includes subjects who do not satisfy the criteria for CR, CRi or PR.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
44 participants
Primary outcome timeframe
2 years
Results posted on
2024-02-02
Participant Flow
Participant milestones
| Measure |
Participants Less Than or Equal to 60 Years of Age
Participants ≤60yrs old who had AML with FLT3 activating mutations received 7+3 induction therapy with cytarabine and either daunorubicin or idarubicin followed by 100 mg crenolanib besylate administered orally three times a day. The participants then received up to four cycles of consolidation chemotherapy with high dose cytarabine followed by 100 mg crenolanib besylate three times a day. Participants not undergoing hematopoietic stem cell transplant received crenolanib for an additional 12 cycles and participants undergoing transplant received 12 cycles of crenolanib post-transplant.
|
Participants Greater Than 60 Years of Age
Participants \>60yrs old who had AML with FLT3 activating mutations received 7+3 induction therapy with cytarabine and either daunorubicin or idarubicin followed by 100 mg crenolanib besylate administered orally three times a day. The participants then received up to four cycles of consolidation chemotherapy with high dose cytarabine followed by 100 mg crenolanib besylate three times a day. Participants not undergoing hematopoietic stem cell transplant received crenolanib for an additional 12 cycles and participants undergoing transpolant received 12 cycles of crenolanib post-transplant.
|
|---|---|---|
|
Overall Study
STARTED
|
29
|
15
|
|
Overall Study
COMPLETED
|
28
|
14
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Participants Less Than or Equal to 60 Years of Age
Participants ≤60yrs old who had AML with FLT3 activating mutations received 7+3 induction therapy with cytarabine and either daunorubicin or idarubicin followed by 100 mg crenolanib besylate administered orally three times a day. The participants then received up to four cycles of consolidation chemotherapy with high dose cytarabine followed by 100 mg crenolanib besylate three times a day. Participants not undergoing hematopoietic stem cell transplant received crenolanib for an additional 12 cycles and participants undergoing transplant received 12 cycles of crenolanib post-transplant.
|
Participants Greater Than 60 Years of Age
Participants \>60yrs old who had AML with FLT3 activating mutations received 7+3 induction therapy with cytarabine and either daunorubicin or idarubicin followed by 100 mg crenolanib besylate administered orally three times a day. The participants then received up to four cycles of consolidation chemotherapy with high dose cytarabine followed by 100 mg crenolanib besylate three times a day. Participants not undergoing hematopoietic stem cell transplant received crenolanib for an additional 12 cycles and participants undergoing transpolant received 12 cycles of crenolanib post-transplant.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
Baseline Characteristics
A Safety and Tolerability Study of Crenolanib in Combination With Chemotherapy in Newly Diagnosed Acute Myeloid Leukemia Patients With FLT3 Mutations
Baseline characteristics by cohort
| Measure |
Participants Less Than or Equal to 60 Years of Age
n=29 Participants
Participants ≤60yrs old who had AML with FLT3 activating mutations received 7+3 induction therapy with cytarabine and either daunorubicin or idarubicin followed by 100 mg crenolanib besylate administered orally three times a day. The participants then received up to four cycles of consolidation chemotherapy with high dose cytarabine followed by 100 mg crenolanib besylate three times a day. Participants not undergoing hematopoietic stem cell transplant received crenolanib for an additional 12 cycles and participants undergoing transplant received 12 cycles of crenolanib post-transplant.
|
Participants Greater Than 60 Years of Age
n=15 Participants
Participants \>60yrs old who had AML with FLT3 activating mutations received 7+3 induction therapy with cytarabine and either daunorubicin or idarubicin followed by 100 mg crenolanib besylate administered orally three times a day. The participants then received up to four cycles of consolidation chemotherapy with high dose cytarabine followed by 100 mg crenolanib besylate three times a day. Participants not undergoing hematopoietic stem cell transplant received crenolanib for an additional 12 cycles and participants undergoing transplant received 12 cycles of crenolanib post-transplant.
|
Total
n=44 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
51 years
n=5 Participants
|
68 years
n=7 Participants
|
57 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
27 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
22 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
FLT3 Mutations
ITD only
|
23 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
FLT3 Mutations
TKD only
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
FLT3 Mutations
ITD and TKD
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Cytogenetics
Normal
|
21 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Cytogenetics
Abnormal, not complex
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Cytogenetics
Complex
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Cytogenetics
Not Available
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
AML with Antecedent Hematological Disorders
No
|
28 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
AML with Antecedent Hematological Disorders
Yes
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 yearsTo determine the response rate to crenolanib. Complete remission (CR) response criteria includes a post-baseline bone marrow (BM) biopsy or aspiration % blasts \<5%, the absence of Auer rods and extramedullary leukemia, absolute neutrophil count (ANC) \>1×10\^9/L and platelet count \>100×10\^9/L. Complete remission with incomplete blood count recovery (CRi) response includes all CR criteria met, except participant do not achieve either platelet or ANC recovery. Composite Complete CR response includes all subjects who achieve a CR and CRi. Partial Response (PR) response includes all CR criteria met except a decrease of ≥50% in % blasts in the BM aspirate or biopsy from baseline but within 5-25% or bone marrow blasts \<5% with persistent Auer rods. Refractory Disease response includes subjects who do not satisfy the criteria for CR, CRi or PR.
Outcome measures
| Measure |
Participants Less Than or Equal to 60 Years of Age
n=29 Participants
Participants ≤60yrs old who had AML with FLT3 activating mutations received 7+3 induction therapy with cytarabine and either daunorubicin or idarubicin followed by 100 mg crenolanib besylate administered orally three times a day. The participants then received up to four cycles of consolidation chemotherapy with high dose cytarabine followed by 100 mg crenolanib besylate three times a day. Participants not undergoing hematopoietic stem cell transplant received crenolanib for an additional 12 cycles and participants undergoing transplant received 12 cycles of crenolanib post-transplant.
|
Participants Greater Than 60 Years of Age
n=15 Participants
Participants \>60yrs old who had AML with FLT3 activating mutations received 7+3 induction therapy with cytarabine and either daunorubicin or idarubicin followed by 100 mg crenolanib besylate administered orally three times a day. The participants then received up to four cycles of consolidation chemotherapy with high dose cytarabine followed by 100 mg crenolanib besylate three times a day. Participants not undergoing hematopoietic stem cell transplant received crenolanib for an additional 12 cycles and participants undergoing transplant received 12 cycles of crenolanib post-transplant.
|
All Patients
n=44 Participants
Participants who had AML with FLT3 activating mutations received 7+3 induction therapy with cytarabine and either daunorubicin or idarubicin followed by 100 mg crenolanib besylate administered orally three times a day. The participants then received up to four cycles of consolidation chemotherapy with high dose cytarabine followed by 100 mg crenolanib besylate three times a day. Participants not undergoing hematopoietic stem cell transplant received crenolanib for an additional 12 cycles and participants undergoing transplant received 12 cycles of crenolanib post-transplant.
|
|---|---|---|---|
|
Clinical Response to Crenolanib With Standard Induction Chemotherapy
Composite Complete Remission (CR + CRi)
|
26 Participants
|
12 Participants
|
38 Participants
|
|
Clinical Response to Crenolanib With Standard Induction Chemotherapy
Complete Remission (CR)
|
22 Participants
|
12 Participants
|
34 Participants
|
|
Clinical Response to Crenolanib With Standard Induction Chemotherapy
Complete Remission with incomplete count recovery (CRi)
|
4 Participants
|
0 Participants
|
4 Participants
|
|
Clinical Response to Crenolanib With Standard Induction Chemotherapy
Partial Remission (PR)
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Clinical Response to Crenolanib With Standard Induction Chemotherapy
Refractory Disease
|
3 Participants
|
1 Participants
|
4 Participants
|
|
Clinical Response to Crenolanib With Standard Induction Chemotherapy
Not evaluable
|
0 Participants
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 3 yearsOverall survival (OS) was measured from the date of the first dose of treatment to the date of death from any cause or to the last date that the patient was known to be alive. OS at 3-years is presented.
Outcome measures
| Measure |
Participants Less Than or Equal to 60 Years of Age
n=29 Participants
Participants ≤60yrs old who had AML with FLT3 activating mutations received 7+3 induction therapy with cytarabine and either daunorubicin or idarubicin followed by 100 mg crenolanib besylate administered orally three times a day. The participants then received up to four cycles of consolidation chemotherapy with high dose cytarabine followed by 100 mg crenolanib besylate three times a day. Participants not undergoing hematopoietic stem cell transplant received crenolanib for an additional 12 cycles and participants undergoing transplant received 12 cycles of crenolanib post-transplant.
|
Participants Greater Than 60 Years of Age
n=15 Participants
Participants \>60yrs old who had AML with FLT3 activating mutations received 7+3 induction therapy with cytarabine and either daunorubicin or idarubicin followed by 100 mg crenolanib besylate administered orally three times a day. The participants then received up to four cycles of consolidation chemotherapy with high dose cytarabine followed by 100 mg crenolanib besylate three times a day. Participants not undergoing hematopoietic stem cell transplant received crenolanib for an additional 12 cycles and participants undergoing transplant received 12 cycles of crenolanib post-transplant.
|
All Patients
n=44 Participants
Participants who had AML with FLT3 activating mutations received 7+3 induction therapy with cytarabine and either daunorubicin or idarubicin followed by 100 mg crenolanib besylate administered orally three times a day. The participants then received up to four cycles of consolidation chemotherapy with high dose cytarabine followed by 100 mg crenolanib besylate three times a day. Participants not undergoing hematopoietic stem cell transplant received crenolanib for an additional 12 cycles and participants undergoing transplant received 12 cycles of crenolanib post-transplant.
|
|---|---|---|---|
|
3-Year Overall Survival
|
71.4 percentage of participants
Interval 56.5 to 90.3
|
33.3 percentage of participants
Interval 16.3 to 68.2
|
58 percentage of participants
Interval 44.9 to 74.9
|
Adverse Events
Participants Less Than or Equal to 60 Years of Age
Serious events: 18 serious events
Other events: 29 other events
Deaths: 9 deaths
Participants Greater Than 60 Years of Age
Serious events: 12 serious events
Other events: 15 other events
Deaths: 10 deaths
Serious adverse events
| Measure |
Participants Less Than or Equal to 60 Years of Age
n=29 participants at risk
Participants ≤60yrs old who had AML with FLT3 activating mutations received 7+3 induction therapy with cytarabine and either daunorubicin or idarubicin followed by 100 mg crenolanib besylate administered orally three times a day. The participants then received up to four cycles of consolidation chemotherapy with high dose cytarabine followed by 100 mg crenolanib besylate three times a day. Participants not undergoing hematopoietic stem cell transplant received crenolanib for an additional 12 cycles and participants undergoing transplant received 12 cycles of crenolanib post-transplant.
|
Participants Greater Than 60 Years of Age
n=15 participants at risk
Participants \>60yrs old who had AML with FLT3 activating mutations received 7+3 induction therapy with cytarabine and either daunorubicin or idarubicin followed by 100 mg crenolanib besylate administered orally three times a day. The participants then received up to four cycles of consolidation chemotherapy with high dose cytarabine followed by 100 mg crenolanib besylate three times a day. Participants not undergoing hematopoietic stem cell transplant received crenolanib for an additional 12 cycles and participants undergoing transplant received 12 cycles of crenolanib post-transplant.
|
|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
24.1%
7/29 • 3 years
|
26.7%
4/15 • 3 years
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/29 • 3 years
|
6.7%
1/15 • 3 years
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/29 • 3 years
|
6.7%
1/15 • 3 years
|
|
Gastrointestinal disorders
Diarrhoea
|
3.4%
1/29 • 3 years
|
13.3%
2/15 • 3 years
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
6.9%
2/29 • 3 years
|
13.3%
2/15 • 3 years
|
|
Gastrointestinal disorders
Nausea
|
3.4%
1/29 • 3 years
|
13.3%
2/15 • 3 years
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/29 • 3 years
|
6.7%
1/15 • 3 years
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
3.4%
1/29 • 3 years
|
6.7%
1/15 • 3 years
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/29 • 3 years
|
6.7%
1/15 • 3 years
|
|
General disorders
Pyrexia
|
6.9%
2/29 • 3 years
|
13.3%
2/15 • 3 years
|
|
Infections and infestations
Bacteraemia
|
3.4%
1/29 • 3 years
|
6.7%
1/15 • 3 years
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/29 • 3 years
|
6.7%
1/15 • 3 years
|
|
Infections and infestations
Enterocolitis infectious
|
0.00%
0/29 • 3 years
|
6.7%
1/15 • 3 years
|
|
Infections and infestations
Lung infection
|
0.00%
0/29 • 3 years
|
6.7%
1/15 • 3 years
|
|
Infections and infestations
Pneumonia
|
10.3%
3/29 • 3 years
|
6.7%
1/15 • 3 years
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/29 • 3 years
|
6.7%
1/15 • 3 years
|
|
Infections and infestations
Pneumonia fungal
|
0.00%
0/29 • 3 years
|
6.7%
1/15 • 3 years
|
|
Infections and infestations
Sepsis
|
13.8%
4/29 • 3 years
|
20.0%
3/15 • 3 years
|
|
Infections and infestations
Septic shock
|
0.00%
0/29 • 3 years
|
6.7%
1/15 • 3 years
|
|
Investigations
Liver function test abnormal
|
0.00%
0/29 • 3 years
|
6.7%
1/15 • 3 years
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/29 • 3 years
|
6.7%
1/15 • 3 years
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/29 • 3 years
|
20.0%
3/15 • 3 years
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/29 • 3 years
|
6.7%
1/15 • 3 years
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/29 • 3 years
|
6.7%
1/15 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/29 • 3 years
|
6.7%
1/15 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/29 • 3 years
|
6.7%
1/15 • 3 years
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/29 • 3 years
|
6.7%
1/15 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/29 • 3 years
|
6.7%
1/15 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/29 • 3 years
|
6.7%
1/15 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
6.9%
2/29 • 3 years
|
6.7%
1/15 • 3 years
|
|
Vascular disorders
Hypotension
|
0.00%
0/29 • 3 years
|
6.7%
1/15 • 3 years
|
|
Blood and lymphatic system disorders
Anaemia
|
3.4%
1/29 • 3 years
|
0.00%
0/15 • 3 years
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
3.4%
1/29 • 3 years
|
0.00%
0/15 • 3 years
|
|
Cardiac disorders
Cardiomyopathy
|
3.4%
1/29 • 3 years
|
0.00%
0/15 • 3 years
|
|
Cardiac disorders
Myocardial infarction
|
3.4%
1/29 • 3 years
|
0.00%
0/15 • 3 years
|
|
Gastrointestinal disorders
Abdominal pain
|
6.9%
2/29 • 3 years
|
0.00%
0/15 • 3 years
|
|
Gastrointestinal disorders
Melaena
|
3.4%
1/29 • 3 years
|
0.00%
0/15 • 3 years
|
|
Hepatobiliary disorders
Hepatic failure
|
3.4%
1/29 • 3 years
|
0.00%
0/15 • 3 years
|
|
Infections and infestations
Aspergillus infection
|
3.4%
1/29 • 3 years
|
0.00%
0/15 • 3 years
|
|
Infections and infestations
Cellulitis of male external genital organ
|
3.4%
1/29 • 3 years
|
0.00%
0/15 • 3 years
|
|
Infections and infestations
Corona virus infection
|
3.4%
1/29 • 3 years
|
0.00%
0/15 • 3 years
|
|
Infections and infestations
Endocarditis
|
3.4%
1/29 • 3 years
|
0.00%
0/15 • 3 years
|
|
Infections and infestations
Influenza
|
3.4%
1/29 • 3 years
|
0.00%
0/15 • 3 years
|
|
Infections and infestations
Pseudomonas infection
|
3.4%
1/29 • 3 years
|
0.00%
0/15 • 3 years
|
|
Infections and infestations
Sinusitis fungal
|
3.4%
1/29 • 3 years
|
0.00%
0/15 • 3 years
|
|
Infections and infestations
Vulval cellulitis
|
3.4%
1/29 • 3 years
|
0.00%
0/15 • 3 years
|
|
Investigations
Blood creatinine increased
|
3.4%
1/29 • 3 years
|
0.00%
0/15 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
3.4%
1/29 • 3 years
|
0.00%
0/15 • 3 years
|
|
Nervous system disorders
Headache
|
3.4%
1/29 • 3 years
|
0.00%
0/15 • 3 years
|
|
Renal and urinary disorders
Renal tubular necrosis
|
3.4%
1/29 • 3 years
|
0.00%
0/15 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
3.4%
1/29 • 3 years
|
0.00%
0/15 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
3.4%
1/29 • 3 years
|
0.00%
0/15 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
3.4%
1/29 • 3 years
|
0.00%
0/15 • 3 years
|
|
Skin and subcutaneous tissue disorders
Drug reaction with eosinophilia and systemic symptoms
|
3.4%
1/29 • 3 years
|
0.00%
0/15 • 3 years
|
Other adverse events
| Measure |
Participants Less Than or Equal to 60 Years of Age
n=29 participants at risk
Participants ≤60yrs old who had AML with FLT3 activating mutations received 7+3 induction therapy with cytarabine and either daunorubicin or idarubicin followed by 100 mg crenolanib besylate administered orally three times a day. The participants then received up to four cycles of consolidation chemotherapy with high dose cytarabine followed by 100 mg crenolanib besylate three times a day. Participants not undergoing hematopoietic stem cell transplant received crenolanib for an additional 12 cycles and participants undergoing transplant received 12 cycles of crenolanib post-transplant.
|
Participants Greater Than 60 Years of Age
n=15 participants at risk
Participants \>60yrs old who had AML with FLT3 activating mutations received 7+3 induction therapy with cytarabine and either daunorubicin or idarubicin followed by 100 mg crenolanib besylate administered orally three times a day. The participants then received up to four cycles of consolidation chemotherapy with high dose cytarabine followed by 100 mg crenolanib besylate three times a day. Participants not undergoing hematopoietic stem cell transplant received crenolanib for an additional 12 cycles and participants undergoing transplant received 12 cycles of crenolanib post-transplant.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
20.7%
6/29 • 3 years
|
6.7%
1/15 • 3 years
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
44.8%
13/29 • 3 years
|
73.3%
11/15 • 3 years
|
|
Blood and lymphatic system disorders
Leukopenia
|
6.9%
2/29 • 3 years
|
0.00%
0/15 • 3 years
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
3.4%
1/29 • 3 years
|
0.00%
0/15 • 3 years
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/29 • 3 years
|
13.3%
2/15 • 3 years
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/29 • 3 years
|
6.7%
1/15 • 3 years
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
17.2%
5/29 • 3 years
|
20.0%
3/15 • 3 years
|
|
Cardiac disorders
Atrial fibrillation
|
6.9%
2/29 • 3 years
|
6.7%
1/15 • 3 years
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/29 • 3 years
|
6.7%
1/15 • 3 years
|
|
Cardiac disorders
Cardiomyopathy
|
3.4%
1/29 • 3 years
|
0.00%
0/15 • 3 years
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/29 • 3 years
|
6.7%
1/15 • 3 years
|
|
Cardiac disorders
Myocardial infarction
|
3.4%
1/29 • 3 years
|
0.00%
0/15 • 3 years
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/29 • 3 years
|
13.3%
2/15 • 3 years
|
|
Cardiac disorders
Sinus tachycardia
|
6.9%
2/29 • 3 years
|
6.7%
1/15 • 3 years
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/29 • 3 years
|
6.7%
1/15 • 3 years
|
|
Cardiac disorders
Tachycardia
|
6.9%
2/29 • 3 years
|
13.3%
2/15 • 3 years
|
|
Cardiac disorders
Ventricular arrhythmia
|
0.00%
0/29 • 3 years
|
6.7%
1/15 • 3 years
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/29 • 3 years
|
6.7%
1/15 • 3 years
|
|
Ear and labyrinth disorders
Hypoacusis
|
3.4%
1/29 • 3 years
|
0.00%
0/15 • 3 years
|
|
Ear and labyrinth disorders
Tinnitus
|
3.4%
1/29 • 3 years
|
0.00%
0/15 • 3 years
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/29 • 3 years
|
6.7%
1/15 • 3 years
|
|
Endocrine disorders
Hypothyroidism
|
3.4%
1/29 • 3 years
|
0.00%
0/15 • 3 years
|
|
Eye disorders
Conjunctival haemorrhage
|
0.00%
0/29 • 3 years
|
6.7%
1/15 • 3 years
|
|
Eye disorders
Dry eye
|
10.3%
3/29 • 3 years
|
6.7%
1/15 • 3 years
|
|
Eye disorders
Erythema of eyelid
|
0.00%
0/29 • 3 years
|
6.7%
1/15 • 3 years
|
|
Eye disorders
Eye haemorrhage
|
3.4%
1/29 • 3 years
|
0.00%
0/15 • 3 years
|
|
Eye disorders
Periorbital oedema
|
10.3%
3/29 • 3 years
|
46.7%
7/15 • 3 years
|
|
Eye disorders
Vision blurred
|
3.4%
1/29 • 3 years
|
0.00%
0/15 • 3 years
|
|
Eye disorders
Visual impairment
|
3.4%
1/29 • 3 years
|
0.00%
0/15 • 3 years
|
|
Gastrointestinal disorders
Abdominal distension
|
13.8%
4/29 • 3 years
|
13.3%
2/15 • 3 years
|
|
Gastrointestinal disorders
Abdominal pain
|
24.1%
7/29 • 3 years
|
33.3%
5/15 • 3 years
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/29 • 3 years
|
6.7%
1/15 • 3 years
|
|
Gastrointestinal disorders
Angina bullosa haemorrhagica
|
0.00%
0/29 • 3 years
|
6.7%
1/15 • 3 years
|
|
Gastrointestinal disorders
Colitis
|
3.4%
1/29 • 3 years
|
0.00%
0/15 • 3 years
|
|
Gastrointestinal disorders
Constipation
|
27.6%
8/29 • 3 years
|
33.3%
5/15 • 3 years
|
|
Gastrointestinal disorders
Diarrhoea
|
62.1%
18/29 • 3 years
|
80.0%
12/15 • 3 years
|
|
Gastrointestinal disorders
Dry mouth
|
3.4%
1/29 • 3 years
|
6.7%
1/15 • 3 years
|
|
Gastrointestinal disorders
Dyspepsia
|
3.4%
1/29 • 3 years
|
6.7%
1/15 • 3 years
|
|
Gastrointestinal disorders
Enlarged uvula
|
0.00%
0/29 • 3 years
|
6.7%
1/15 • 3 years
|
|
Gastrointestinal disorders
Enterocolitis
|
6.9%
2/29 • 3 years
|
0.00%
0/15 • 3 years
|
|
Gastrointestinal disorders
Flatulence
|
3.4%
1/29 • 3 years
|
0.00%
0/15 • 3 years
|
|
Gastrointestinal disorders
Gastritis
|
3.4%
1/29 • 3 years
|
0.00%
0/15 • 3 years
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
3.4%
1/29 • 3 years
|
0.00%
0/15 • 3 years
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
6.9%
2/29 • 3 years
|
13.3%
2/15 • 3 years
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
6.9%
2/29 • 3 years
|
13.3%
2/15 • 3 years
|
|
Gastrointestinal disorders
Gingival bleeding
|
3.4%
1/29 • 3 years
|
6.7%
1/15 • 3 years
|
|
Gastrointestinal disorders
Gingival pain
|
3.4%
1/29 • 3 years
|
6.7%
1/15 • 3 years
|
|
Gastrointestinal disorders
Glossodynia
|
0.00%
0/29 • 3 years
|
6.7%
1/15 • 3 years
|
|
Gastrointestinal disorders
Haematemesis
|
6.9%
2/29 • 3 years
|
6.7%
1/15 • 3 years
|
|
Gastrointestinal disorders
Haemorrhoids
|
3.4%
1/29 • 3 years
|
0.00%
0/15 • 3 years
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.00%
0/29 • 3 years
|
13.3%
2/15 • 3 years
|
|
Gastrointestinal disorders
Lip dry
|
0.00%
0/29 • 3 years
|
6.7%
1/15 • 3 years
|
|
Gastrointestinal disorders
Lip pain
|
0.00%
0/29 • 3 years
|
6.7%
1/15 • 3 years
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
3.4%
1/29 • 3 years
|
6.7%
1/15 • 3 years
|
|
Gastrointestinal disorders
Melaena
|
6.9%
2/29 • 3 years
|
0.00%
0/15 • 3 years
|
|
Gastrointestinal disorders
Nausea
|
55.2%
16/29 • 3 years
|
73.3%
11/15 • 3 years
|
|
Gastrointestinal disorders
Oral dysaesthesia
|
0.00%
0/29 • 3 years
|
6.7%
1/15 • 3 years
|
|
Gastrointestinal disorders
Oral pain
|
10.3%
3/29 • 3 years
|
0.00%
0/15 • 3 years
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/29 • 3 years
|
6.7%
1/15 • 3 years
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
3.4%
1/29 • 3 years
|
0.00%
0/15 • 3 years
|
|
Gastrointestinal disorders
Stomatitis
|
24.1%
7/29 • 3 years
|
26.7%
4/15 • 3 years
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/29 • 3 years
|
6.7%
1/15 • 3 years
|
|
Gastrointestinal disorders
Tongue discolouration
|
3.4%
1/29 • 3 years
|
0.00%
0/15 • 3 years
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
10.3%
3/29 • 3 years
|
33.3%
5/15 • 3 years
|
|
Gastrointestinal disorders
Vomiting
|
51.7%
15/29 • 3 years
|
46.7%
7/15 • 3 years
|
|
General disorders
Asthenia
|
0.00%
0/29 • 3 years
|
13.3%
2/15 • 3 years
|
|
General disorders
Catheter site erythema
|
3.4%
1/29 • 3 years
|
0.00%
0/15 • 3 years
|
|
General disorders
Catheter site haemorrhage
|
3.4%
1/29 • 3 years
|
0.00%
0/15 • 3 years
|
|
General disorders
Catheter site inflammation
|
0.00%
0/29 • 3 years
|
6.7%
1/15 • 3 years
|
|
General disorders
Catheter site pain
|
6.9%
2/29 • 3 years
|
13.3%
2/15 • 3 years
|
|
General disorders
Chest discomfort
|
3.4%
1/29 • 3 years
|
0.00%
0/15 • 3 years
|
|
General disorders
Chest pain
|
3.4%
1/29 • 3 years
|
6.7%
1/15 • 3 years
|
|
General disorders
Chills
|
3.4%
1/29 • 3 years
|
0.00%
0/15 • 3 years
|
|
General disorders
Face oedema
|
3.4%
1/29 • 3 years
|
20.0%
3/15 • 3 years
|
|
General disorders
Fatigue
|
17.2%
5/29 • 3 years
|
46.7%
7/15 • 3 years
|
|
General disorders
Generalised oedema
|
6.9%
2/29 • 3 years
|
0.00%
0/15 • 3 years
|
|
General disorders
Influenza like illness
|
3.4%
1/29 • 3 years
|
0.00%
0/15 • 3 years
|
|
General disorders
Localised oedema
|
3.4%
1/29 • 3 years
|
0.00%
0/15 • 3 years
|
|
General disorders
Mucosal inflammation
|
10.3%
3/29 • 3 years
|
0.00%
0/15 • 3 years
|
|
General disorders
Non-cardiac chest pain
|
17.2%
5/29 • 3 years
|
13.3%
2/15 • 3 years
|
|
General disorders
Oedema
|
6.9%
2/29 • 3 years
|
6.7%
1/15 • 3 years
|
|
General disorders
Oedema due to cardiac disease
|
0.00%
0/29 • 3 years
|
6.7%
1/15 • 3 years
|
|
General disorders
Oedema peripheral
|
34.5%
10/29 • 3 years
|
60.0%
9/15 • 3 years
|
|
General disorders
Pain
|
3.4%
1/29 • 3 years
|
0.00%
0/15 • 3 years
|
|
General disorders
Pyrexia
|
27.6%
8/29 • 3 years
|
53.3%
8/15 • 3 years
|
|
General disorders
Systemic inflammatory response syndrome
|
0.00%
0/29 • 3 years
|
6.7%
1/15 • 3 years
|
|
General disorders
Xerosis
|
3.4%
1/29 • 3 years
|
0.00%
0/15 • 3 years
|
|
Hepatobiliary disorders
Hepatic failure
|
3.4%
1/29 • 3 years
|
0.00%
0/15 • 3 years
|
|
Hepatobiliary disorders
Hepatosplenomegaly
|
3.4%
1/29 • 3 years
|
0.00%
0/15 • 3 years
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
13.8%
4/29 • 3 years
|
0.00%
0/15 • 3 years
|
|
Hepatobiliary disorders
Pneumobilia
|
0.00%
0/29 • 3 years
|
6.7%
1/15 • 3 years
|
|
Immune system disorders
Graft versus host disease
|
3.4%
1/29 • 3 years
|
0.00%
0/15 • 3 years
|
|
Immune system disorders
Graft versus host disease in gastrointestinal tract
|
3.4%
1/29 • 3 years
|
0.00%
0/15 • 3 years
|
|
Immune system disorders
Graft versus host disease in liver
|
3.4%
1/29 • 3 years
|
0.00%
0/15 • 3 years
|
|
Immune system disorders
Graft versus host disease in skin
|
3.4%
1/29 • 3 years
|
0.00%
0/15 • 3 years
|
|
Immune system disorders
Hypersensitivity
|
3.4%
1/29 • 3 years
|
0.00%
0/15 • 3 years
|
|
Infections and infestations
Aspergillus infection
|
6.9%
2/29 • 3 years
|
0.00%
0/15 • 3 years
|
|
Infections and infestations
Bacteraemia
|
6.9%
2/29 • 3 years
|
20.0%
3/15 • 3 years
|
|
Infections and infestations
Bacterial rhinitis
|
3.4%
1/29 • 3 years
|
0.00%
0/15 • 3 years
|
|
Infections and infestations
Bronchitis
|
3.4%
1/29 • 3 years
|
0.00%
0/15 • 3 years
|
|
Infections and infestations
Candida infection
|
6.9%
2/29 • 3 years
|
0.00%
0/15 • 3 years
|
|
Infections and infestations
Catheter site cellulitis
|
3.4%
1/29 • 3 years
|
0.00%
0/15 • 3 years
|
|
Infections and infestations
Cellulitis
|
17.2%
5/29 • 3 years
|
20.0%
3/15 • 3 years
|
|
Infections and infestations
Cellulitis of male external genital organ
|
3.4%
1/29 • 3 years
|
0.00%
0/15 • 3 years
|
|
Infections and infestations
Clostridium difficile colitis
|
6.9%
2/29 • 3 years
|
0.00%
0/15 • 3 years
|
|
Infections and infestations
Clostridium difficile infection
|
0.00%
0/29 • 3 years
|
6.7%
1/15 • 3 years
|
|
Infections and infestations
Conjunctivitis
|
3.4%
1/29 • 3 years
|
0.00%
0/15 • 3 years
|
|
Infections and infestations
Corona virus infection
|
3.4%
1/29 • 3 years
|
0.00%
0/15 • 3 years
|
|
Infections and infestations
Cytomegalovirus infection
|
3.4%
1/29 • 3 years
|
0.00%
0/15 • 3 years
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/29 • 3 years
|
13.3%
2/15 • 3 years
|
|
Infections and infestations
Endocarditis
|
3.4%
1/29 • 3 years
|
0.00%
0/15 • 3 years
|
|
Infections and infestations
Enterococcal bacteraemia
|
0.00%
0/29 • 3 years
|
6.7%
1/15 • 3 years
|
|
Infections and infestations
Enterococcal infection
|
0.00%
0/29 • 3 years
|
6.7%
1/15 • 3 years
|
|
Infections and infestations
Enterocolitis infectious
|
0.00%
0/29 • 3 years
|
6.7%
1/15 • 3 years
|
|
Infections and infestations
Escherichia infection
|
0.00%
0/29 • 3 years
|
6.7%
1/15 • 3 years
|
|
Infections and infestations
Folliculitis
|
6.9%
2/29 • 3 years
|
0.00%
0/15 • 3 years
|
|
Infections and infestations
Hepatic infection fungal
|
0.00%
0/29 • 3 years
|
6.7%
1/15 • 3 years
|
|
Infections and infestations
Infected cyst
|
3.4%
1/29 • 3 years
|
0.00%
0/15 • 3 years
|
|
Infections and infestations
Influenza
|
3.4%
1/29 • 3 years
|
6.7%
1/15 • 3 years
|
|
Infections and infestations
Lung infection
|
0.00%
0/29 • 3 years
|
6.7%
1/15 • 3 years
|
|
Infections and infestations
Oesophageal candidiasis
|
0.00%
0/29 • 3 years
|
6.7%
1/15 • 3 years
|
|
Infections and infestations
Oral candidiasis
|
10.3%
3/29 • 3 years
|
6.7%
1/15 • 3 years
|
|
Infections and infestations
Otitis media
|
3.4%
1/29 • 3 years
|
0.00%
0/15 • 3 years
|
|
Infections and infestations
Pharyngitis
|
6.9%
2/29 • 3 years
|
0.00%
0/15 • 3 years
|
|
Infections and infestations
Pneumonia
|
13.8%
4/29 • 3 years
|
13.3%
2/15 • 3 years
|
|
Infections and infestations
Pneumonia bacterial
|
3.4%
1/29 • 3 years
|
13.3%
2/15 • 3 years
|
|
Infections and infestations
Pneumonia fungal
|
6.9%
2/29 • 3 years
|
20.0%
3/15 • 3 years
|
|
Infections and infestations
Pneumonia viral
|
3.4%
1/29 • 3 years
|
0.00%
0/15 • 3 years
|
|
Infections and infestations
Pseudomonas infection
|
3.4%
1/29 • 3 years
|
0.00%
0/15 • 3 years
|
|
Infections and infestations
Sepsis
|
13.8%
4/29 • 3 years
|
20.0%
3/15 • 3 years
|
|
Infections and infestations
Septic shock
|
0.00%
0/29 • 3 years
|
6.7%
1/15 • 3 years
|
|
Infections and infestations
Sinusitis
|
3.4%
1/29 • 3 years
|
6.7%
1/15 • 3 years
|
|
Infections and infestations
Sinusitis fungal
|
3.4%
1/29 • 3 years
|
0.00%
0/15 • 3 years
|
|
Infections and infestations
Staphylococcal bacteraemia
|
3.4%
1/29 • 3 years
|
0.00%
0/15 • 3 years
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/29 • 3 years
|
6.7%
1/15 • 3 years
|
|
Infections and infestations
Streptococcal bacteraemia
|
3.4%
1/29 • 3 years
|
0.00%
0/15 • 3 years
|
|
Infections and infestations
Tooth infection
|
0.00%
0/29 • 3 years
|
6.7%
1/15 • 3 years
|
|
Infections and infestations
Upper respiratory tract infection
|
6.9%
2/29 • 3 years
|
6.7%
1/15 • 3 years
|
|
Infections and infestations
Vaginal infection
|
3.4%
1/29 • 3 years
|
0.00%
0/15 • 3 years
|
|
Infections and infestations
Vulval abscess
|
3.4%
1/29 • 3 years
|
0.00%
0/15 • 3 years
|
|
Infections and infestations
Vulval cellulitis
|
3.4%
1/29 • 3 years
|
0.00%
0/15 • 3 years
|
|
Injury, poisoning and procedural complications
Contusion
|
10.3%
3/29 • 3 years
|
6.7%
1/15 • 3 years
|
|
Injury, poisoning and procedural complications
Fall
|
6.9%
2/29 • 3 years
|
13.3%
2/15 • 3 years
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
3.4%
1/29 • 3 years
|
6.7%
1/15 • 3 years
|
|
Injury, poisoning and procedural complications
Procedural pain
|
6.9%
2/29 • 3 years
|
0.00%
0/15 • 3 years
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
3.4%
1/29 • 3 years
|
0.00%
0/15 • 3 years
|
|
Injury, poisoning and procedural complications
Transfusion reaction
|
0.00%
0/29 • 3 years
|
6.7%
1/15 • 3 years
|
|
Investigations
Alanine aminotransferase increased
|
24.1%
7/29 • 3 years
|
40.0%
6/15 • 3 years
|
|
Investigations
Aspartate aminotransferase increased
|
20.7%
6/29 • 3 years
|
46.7%
7/15 • 3 years
|
|
Investigations
Blood alkaline phosphatase increased
|
24.1%
7/29 • 3 years
|
33.3%
5/15 • 3 years
|
|
Investigations
Blood bilirubin increased
|
10.3%
3/29 • 3 years
|
0.00%
0/15 • 3 years
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/29 • 3 years
|
6.7%
1/15 • 3 years
|
|
Investigations
Blood creatinine increased
|
13.8%
4/29 • 3 years
|
6.7%
1/15 • 3 years
|
|
Investigations
Blood testosterone decreased
|
3.4%
1/29 • 3 years
|
0.00%
0/15 • 3 years
|
|
Investigations
Electrocardiogram QT prolonged
|
3.4%
1/29 • 3 years
|
6.7%
1/15 • 3 years
|
|
Investigations
Heart rate increased
|
3.4%
1/29 • 3 years
|
0.00%
0/15 • 3 years
|
|
Investigations
International normalised ratio increased
|
3.4%
1/29 • 3 years
|
0.00%
0/15 • 3 years
|
|
Investigations
Transaminases increased
|
6.9%
2/29 • 3 years
|
0.00%
0/15 • 3 years
|
|
Investigations
Troponin increased
|
0.00%
0/29 • 3 years
|
6.7%
1/15 • 3 years
|
|
Investigations
Weight decreased
|
3.4%
1/29 • 3 years
|
0.00%
0/15 • 3 years
|
|
Investigations
Weight increased
|
6.9%
2/29 • 3 years
|
6.7%
1/15 • 3 years
|
|
Metabolism and nutrition disorders
Decreased appetite
|
27.6%
8/29 • 3 years
|
60.0%
9/15 • 3 years
|
|
Metabolism and nutrition disorders
Dehydration
|
6.9%
2/29 • 3 years
|
33.3%
5/15 • 3 years
|
|
Metabolism and nutrition disorders
Fluid overload
|
3.4%
1/29 • 3 years
|
6.7%
1/15 • 3 years
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
3.4%
1/29 • 3 years
|
13.3%
2/15 • 3 years
|
|
Investigations
Hyperlipidaemia
|
3.4%
1/29 • 3 years
|
0.00%
0/15 • 3 years
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
6.9%
2/29 • 3 years
|
0.00%
0/15 • 3 years
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/29 • 3 years
|
20.0%
3/15 • 3 years
|
|
Metabolism and nutrition disorders
Hypermagnasaemia
|
0.00%
0/29 • 3 years
|
6.7%
1/15 • 3 years
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.00%
0/29 • 3 years
|
13.3%
2/15 • 3 years
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/29 • 3 years
|
13.3%
2/15 • 3 years
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
6.9%
2/29 • 3 years
|
6.7%
1/15 • 3 years
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
10.3%
3/29 • 3 years
|
0.00%
0/15 • 3 years
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
27.6%
8/29 • 3 years
|
40.0%
6/15 • 3 years
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
13.8%
4/29 • 3 years
|
33.3%
5/15 • 3 years
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
17.2%
5/29 • 3 years
|
13.3%
2/15 • 3 years
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
6.9%
2/29 • 3 years
|
0.00%
0/15 • 3 years
|
|
Metabolism and nutrition disorders
Metabolic alkalosis
|
3.4%
1/29 • 3 years
|
0.00%
0/15 • 3 years
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
3.4%
1/29 • 3 years
|
0.00%
0/15 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
10.3%
3/29 • 3 years
|
13.3%
2/15 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
20.7%
6/29 • 3 years
|
20.0%
3/15 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
6.9%
2/29 • 3 years
|
0.00%
0/15 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/29 • 3 years
|
6.7%
1/15 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
3.4%
1/29 • 3 years
|
0.00%
0/15 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Lower extremity mass
|
3.4%
1/29 • 3 years
|
0.00%
0/15 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
3.4%
1/29 • 3 years
|
0.00%
0/15 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/29 • 3 years
|
6.7%
1/15 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
6.9%
2/29 • 3 years
|
6.7%
1/15 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
3.4%
1/29 • 3 years
|
13.3%
2/15 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
10.3%
3/29 • 3 years
|
0.00%
0/15 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/29 • 3 years
|
20.0%
3/15 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Osteopenia
|
0.00%
0/29 • 3 years
|
6.7%
1/15 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
13.8%
4/29 • 3 years
|
13.3%
2/15 • 3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
3.4%
1/29 • 3 years
|
0.00%
0/15 • 3 years
|
|
Nervous system disorders
Aphasia
|
0.00%
0/29 • 3 years
|
6.7%
1/15 • 3 years
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/29 • 3 years
|
6.7%
1/15 • 3 years
|
|
Nervous system disorders
Dizziness
|
17.2%
5/29 • 3 years
|
26.7%
4/15 • 3 years
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/29 • 3 years
|
6.7%
1/15 • 3 years
|
|
Nervous system disorders
Dysguesia
|
10.3%
3/29 • 3 years
|
20.0%
3/15 • 3 years
|
|
Nervous system disorders
Headache
|
31.0%
9/29 • 3 years
|
13.3%
2/15 • 3 years
|
|
Nervous system disorders
Neuropathy peripheral
|
3.4%
1/29 • 3 years
|
0.00%
0/15 • 3 years
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
10.3%
3/29 • 3 years
|
0.00%
0/15 • 3 years
|
|
Nervous system disorders
Peroneal nerve palsy
|
3.4%
1/29 • 3 years
|
0.00%
0/15 • 3 years
|
|
Nervous system disorders
Somnolence
|
3.4%
1/29 • 3 years
|
0.00%
0/15 • 3 years
|
|
Nervous system disorders
Tremor
|
0.00%
0/29 • 3 years
|
20.0%
3/15 • 3 years
|
|
Psychiatric disorders
Abnormal dreams
|
3.4%
1/29 • 3 years
|
0.00%
0/15 • 3 years
|
|
Psychiatric disorders
Agitation
|
10.3%
3/29 • 3 years
|
0.00%
0/15 • 3 years
|
|
Psychiatric disorders
Anxiety
|
10.3%
3/29 • 3 years
|
6.7%
1/15 • 3 years
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/29 • 3 years
|
6.7%
1/15 • 3 years
|
|
Psychiatric disorders
Delirium
|
0.00%
0/29 • 3 years
|
6.7%
1/15 • 3 years
|
|
Psychiatric disorders
Depression
|
10.3%
3/29 • 3 years
|
40.0%
6/15 • 3 years
|
|
Psychiatric disorders
Insomnia
|
24.1%
7/29 • 3 years
|
6.7%
1/15 • 3 years
|
|
Psychiatric disorders
Mental status changes
|
6.9%
2/29 • 3 years
|
6.7%
1/15 • 3 years
|
|
Renal and urinary disorders
Acute kidney injury
|
20.7%
6/29 • 3 years
|
40.0%
6/15 • 3 years
|
|
Renal and urinary disorders
Cystitis noninfective
|
3.4%
1/29 • 3 years
|
0.00%
0/15 • 3 years
|
|
Renal and urinary disorders
Dysuria
|
3.4%
1/29 • 3 years
|
0.00%
0/15 • 3 years
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/29 • 3 years
|
13.3%
2/15 • 3 years
|
|
Renal and urinary disorders
Micturition urgency
|
3.4%
1/29 • 3 years
|
0.00%
0/15 • 3 years
|
|
Renal and urinary disorders
Renal tubular necrosis
|
3.4%
1/29 • 3 years
|
0.00%
0/15 • 3 years
|
|
Renal and urinary disorders
Urinary retention
|
3.4%
1/29 • 3 years
|
13.3%
2/15 • 3 years
|
|
Reproductive system and breast disorders
Breast mass
|
3.4%
1/29 • 3 years
|
0.00%
0/15 • 3 years
|
|
Reproductive system and breast disorders
Menorrhagia
|
6.9%
2/29 • 3 years
|
0.00%
0/15 • 3 years
|
|
Reproductive system and breast disorders
Oedema genital
|
0.00%
0/29 • 3 years
|
6.7%
1/15 • 3 years
|
|
Reproductive system and breast disorders
Pelvic pain
|
3.4%
1/29 • 3 years
|
0.00%
0/15 • 3 years
|
|
Reproductive system and breast disorders
Scrotal oedema
|
0.00%
0/29 • 3 years
|
6.7%
1/15 • 3 years
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
6.9%
2/29 • 3 years
|
0.00%
0/15 • 3 years
|
|
Reproductive system and breast disorders
Vulvovaginal erythema
|
3.4%
1/29 • 3 years
|
0.00%
0/15 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
3.4%
1/29 • 3 years
|
0.00%
0/15 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/29 • 3 years
|
6.7%
1/15 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
20.7%
6/29 • 3 years
|
26.7%
4/15 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
10.3%
3/29 • 3 years
|
20.0%
3/15 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
20.7%
6/29 • 3 years
|
26.7%
4/15 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
3.4%
1/29 • 3 years
|
0.00%
0/15 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
3.4%
1/29 • 3 years
|
20.0%
3/15 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal haemorrhage
|
0.00%
0/29 • 3 years
|
6.7%
1/15 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Lung infiltration
|
3.4%
1/29 • 3 years
|
0.00%
0/15 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
6.9%
2/29 • 3 years
|
13.3%
2/15 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
13.8%
4/29 • 3 years
|
0.00%
0/15 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/29 • 3 years
|
13.3%
2/15 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal inflammation
|
3.4%
1/29 • 3 years
|
0.00%
0/15 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/29 • 3 years
|
6.7%
1/15 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
3.4%
1/29 • 3 years
|
13.3%
2/15 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
0.00%
0/29 • 3 years
|
6.7%
1/15 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
6.9%
2/29 • 3 years
|
6.7%
1/15 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/29 • 3 years
|
6.7%
1/15 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/29 • 3 years
|
6.7%
1/15 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
0.00%
0/29 • 3 years
|
6.7%
1/15 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
3.4%
1/29 • 3 years
|
0.00%
0/15 • 3 years
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
10.3%
3/29 • 3 years
|
13.3%
2/15 • 3 years
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
3.4%
1/29 • 3 years
|
0.00%
0/15 • 3 years
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
3.4%
1/29 • 3 years
|
0.00%
0/15 • 3 years
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
3.4%
1/29 • 3 years
|
6.7%
1/15 • 3 years
|
|
Skin and subcutaneous tissue disorders
Dermatitis psoriasiform
|
3.4%
1/29 • 3 years
|
0.00%
0/15 • 3 years
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
3.4%
1/29 • 3 years
|
0.00%
0/15 • 3 years
|
|
Skin and subcutaneous tissue disorders
Drug reaction with eosinophilia and systemic symptoms
|
3.4%
1/29 • 3 years
|
0.00%
0/15 • 3 years
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
3.4%
1/29 • 3 years
|
13.3%
2/15 • 3 years
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
3.4%
1/29 • 3 years
|
0.00%
0/15 • 3 years
|
|
Skin and subcutaneous tissue disorders
Erythema
|
3.4%
1/29 • 3 years
|
0.00%
0/15 • 3 years
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
3.4%
1/29 • 3 years
|
6.7%
1/15 • 3 years
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
3.4%
1/29 • 3 years
|
0.00%
0/15 • 3 years
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
10.3%
3/29 • 3 years
|
6.7%
1/15 • 3 years
|
|
Skin and subcutaneous tissue disorders
Rash
|
17.2%
5/29 • 3 years
|
13.3%
2/15 • 3 years
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
6.9%
2/29 • 3 years
|
6.7%
1/15 • 3 years
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
41.4%
12/29 • 3 years
|
40.0%
6/15 • 3 years
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
3.4%
1/29 • 3 years
|
6.7%
1/15 • 3 years
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
6.9%
2/29 • 3 years
|
0.00%
0/15 • 3 years
|
|
Skin and subcutaneous tissue disorders
Red man syndrome
|
3.4%
1/29 • 3 years
|
0.00%
0/15 • 3 years
|
|
Skin and subcutaneous tissue disorders
Skin hypopigmentation
|
3.4%
1/29 • 3 years
|
0.00%
0/15 • 3 years
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
3.4%
1/29 • 3 years
|
6.7%
1/15 • 3 years
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
3.4%
1/29 • 3 years
|
0.00%
0/15 • 3 years
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/29 • 3 years
|
13.3%
2/15 • 3 years
|
|
Vascular disorders
Embolism venuous
|
0.00%
0/29 • 3 years
|
6.7%
1/15 • 3 years
|
|
Vascular disorders
Flushing
|
3.4%
1/29 • 3 years
|
0.00%
0/15 • 3 years
|
|
Vascular disorders
Hypertension
|
13.8%
4/29 • 3 years
|
6.7%
1/15 • 3 years
|
|
Vascular disorders
Hypotension
|
10.3%
3/29 • 3 years
|
26.7%
4/15 • 3 years
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/29 • 3 years
|
13.3%
2/15 • 3 years
|
|
Vascular disorders
Penetrating aortic ulcer
|
0.00%
0/29 • 3 years
|
6.7%
1/15 • 3 years
|
|
Vascular disorders
Thrombophlebitis superficial
|
0.00%
0/29 • 3 years
|
6.7%
1/15 • 3 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place