Trial Outcomes & Findings for A Study to Evaluate Long-term Safety and Clinical Activity of Givosiran (ALN-AS1) in Patient With Acute Intermittent Porphyria (AIP) (NCT NCT02949830)
NCT ID: NCT02949830
Last Updated: 2024-03-12
Results Overview
An AE is any untoward medical occurrence in a participant or clinical investigational patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
16 participants
Primary outcome timeframe
Through Month 49
Results posted on
2024-03-12
Participant Flow
Patients with acute intermittent porphyria (AIP) were enrolled at five sites in Sweden, United Kingdom and the United States.
Patients who completed parent study ALN-AS1-001 (NCT02452372) and met all eligibility criteria for this study (ALN-AS1-002) were enrolled.
Participant milestones
| Measure |
Givosiran
At the beginning of this study, participants received either givosiran 2.5 mg/kg subcutaneous (SC) injection once monthly (QM), givosiran 5.0 mg/kg SC injection QM, or givosiran 5.0 mg/kg SC injection once every 3 months (Q3M). Within a year, all participants were transitioned to givosiran 2.5 mg/kg SC injection QM.
|
|---|---|
|
Overall Study
STARTED
|
16
|
|
Overall Study
COMPLETED
|
14
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Givosiran
At the beginning of this study, participants received either givosiran 2.5 mg/kg subcutaneous (SC) injection once monthly (QM), givosiran 5.0 mg/kg SC injection QM, or givosiran 5.0 mg/kg SC injection once every 3 months (Q3M). Within a year, all participants were transitioned to givosiran 2.5 mg/kg SC injection QM.
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|---|---|
|
Overall Study
Adverse Event
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
A Study to Evaluate Long-term Safety and Clinical Activity of Givosiran (ALN-AS1) in Patient With Acute Intermittent Porphyria (AIP)
Baseline characteristics by cohort
| Measure |
Givosiran
n=16 Participants
At the beginning of this study, participants received either givosiran 2.5 mg/kg subcutaneous (SC) injection once monthly (QM), givosiran 5.0 mg/kg SC injection QM, or givosiran 5.0 mg/kg SC injection once every 3 months (Q3M). Within a year, all participants were transitioned to givosiran 2.5 mg/kg SC injection QM.
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|---|---|
|
Age, Continuous
|
37.4 years
STANDARD_DEVIATION 12.0 • n=93 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=93 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=93 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
2 Participants
n=93 Participants
|
|
Race/Ethnicity, Customized
White
|
13 Participants
n=93 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
15 Participants
n=93 Participants
|
|
Race/Ethnicity, Customized
Not Reported
|
1 Participants
n=93 Participants
|
|
Region of Enrollment
Sweden
|
6 Participants
n=93 Participants
|
|
Region of Enrollment
United Kingdom
|
1 Participants
n=93 Participants
|
|
Region of Enrollment
United States of America
|
9 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: Through Month 49Population: SAS: All patients who received any amount of study drug.
An AE is any untoward medical occurrence in a participant or clinical investigational patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
Outcome measures
| Measure |
Givosiran
n=16 Participants
At the beginning of this study, participants received either givosiran 2.5 mg/kg subcutaneous (SC) injection once monthly (QM), givosiran 5.0 mg/kg SC injection QM, or givosiran 5.0 mg/kg SC injection once every 3 months (Q3M). Within a year, all participants were transitioned to givosiran 2.5 mg/kg SC injection QM.
|
|---|---|
|
Percentage of Participants With Adverse Events (AEs)
|
100 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline; Month 48Population: Patients from the PD Analysis Set (all patients who received any amount of study drug and who had at least 1 post-dose blood sample for PD), who were treated with givosiran 2.5 mg/kg SC injection QM. Values that occurred during a porphyria attack were excluded as a means of controlling for potential confounding by hemin. Overall number of participants analyzed is the number of participants available at the given time point.
The PD effect of givosiran was evaluated by spot urine ALA levels normalized to spot urine creatinine levels.
Outcome measures
| Measure |
Givosiran
n=9 Participants
At the beginning of this study, participants received either givosiran 2.5 mg/kg subcutaneous (SC) injection once monthly (QM), givosiran 5.0 mg/kg SC injection QM, or givosiran 5.0 mg/kg SC injection once every 3 months (Q3M). Within a year, all participants were transitioned to givosiran 2.5 mg/kg SC injection QM.
|
|---|---|
|
The Pharmacodynamic (PD) Effect of Givosiran on Urine Levels of Delta-aminolevulinic Acid (ALA) as Measured by Percent Decrease From Baseline
|
92.531 percent decrease
Standard Error 1.879
|
SECONDARY outcome
Timeframe: Baseline; Month 48Population: Patients from the PD Analysis Set (all patients who received any amount of study drug and who had at least 1 post-dose blood sample for PD), who were treated with givosiran 2.5 mg/kg SC injection QM. Values that occurred during a porphyria attack were excluded as a means of controlling for potential confounding by hemin. Overall number of participants analyzed is the number of participants available at the given time point.
The PD effect of givosiran was evaluated by spot urine PBG levels normalized to spot urine creatinine levels.
Outcome measures
| Measure |
Givosiran
n=9 Participants
At the beginning of this study, participants received either givosiran 2.5 mg/kg subcutaneous (SC) injection once monthly (QM), givosiran 5.0 mg/kg SC injection QM, or givosiran 5.0 mg/kg SC injection once every 3 months (Q3M). Within a year, all participants were transitioned to givosiran 2.5 mg/kg SC injection QM.
|
|---|---|
|
The Pharmacodynamic (PD) Effect of Givosiran on Urine Levels of Porphobilinogen (PBG) as Measured by Percent Decrease From Baseline
|
94.194 percent decrease
Standard Error 2.617
|
SECONDARY outcome
Timeframe: Through Month 48Population: SAS: All patients who received any amount of study drug.
Porphyria attacks were defined as meeting all of the following criteria: an acute episode of neurovisceral pain in the abdomen, back, chest, extremities and/or limbs, no other medically determined cause, and required treatment with intravenous (IV) dextrose or hemin, carbohydrates, or analgesics, or other medications such as antiemetics at a dose or frequency beyond the participant's usual daily porphyria management. Composite porphyria attacks included porphyria attacks that required hospitalization, urgent healthcare visit, or intravenous (IV) hemin administration at home. The annualized attack rate (AAR) was calculated as the number of composite porphyria attacks/total person-years.
Outcome measures
| Measure |
Givosiran
n=16 Participants
At the beginning of this study, participants received either givosiran 2.5 mg/kg subcutaneous (SC) injection once monthly (QM), givosiran 5.0 mg/kg SC injection QM, or givosiran 5.0 mg/kg SC injection once every 3 months (Q3M). Within a year, all participants were transitioned to givosiran 2.5 mg/kg SC injection QM.
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|---|---|
|
Annualized Rate of Composite Porphyria Attacks
|
0.4 composite attacks/total person-years
|
SECONDARY outcome
Timeframe: Through Month 49Population: SAS: All patients who received any amount of study drug.
The annualized rate of hemin administration was evaluated by annualized days of hemin use, which is calculated as the number of doses of hemin administered/total person-years.
Outcome measures
| Measure |
Givosiran
n=16 Participants
At the beginning of this study, participants received either givosiran 2.5 mg/kg subcutaneous (SC) injection once monthly (QM), givosiran 5.0 mg/kg SC injection QM, or givosiran 5.0 mg/kg SC injection once every 3 months (Q3M). Within a year, all participants were transitioned to givosiran 2.5 mg/kg SC injection QM.
|
|---|---|
|
Annualized Rate of Hemin Administration
|
0.9 hemin doses/total person-years
|
Adverse Events
Givosiran
Serious events: 7 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Givosiran
n=16 participants at risk
At the beginning of this study, participants received either givosiran 2.5 mg/kg subcutaneous (SC) injection once monthly (QM), givosiran 5.0 mg/kg SC injection QM, or givosiran 5.0 mg/kg SC injection once every 3 months (Q3M). Within a year, all participants were transitioned to givosiran 2.5 mg/kg SC injection QM.
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
12.5%
2/16 • Treatment-emergent adverse events (AEs) are any AE with onset after the first administration of study drug through the end of exposure, or any event that was present at Baseline but worsened in severity or was subsequently considered drug-related by the Investigator (up to approximately 52 months).
|
|
General disorders
Pyrexia
|
6.2%
1/16 • Treatment-emergent adverse events (AEs) are any AE with onset after the first administration of study drug through the end of exposure, or any event that was present at Baseline but worsened in severity or was subsequently considered drug-related by the Investigator (up to approximately 52 months).
|
|
Immune system disorders
Anaphylactic reaction
|
6.2%
1/16 • Treatment-emergent adverse events (AEs) are any AE with onset after the first administration of study drug through the end of exposure, or any event that was present at Baseline but worsened in severity or was subsequently considered drug-related by the Investigator (up to approximately 52 months).
|
|
Infections and infestations
Clostridium difficile colitis
|
6.2%
1/16 • Treatment-emergent adverse events (AEs) are any AE with onset after the first administration of study drug through the end of exposure, or any event that was present at Baseline but worsened in severity or was subsequently considered drug-related by the Investigator (up to approximately 52 months).
|
|
Infections and infestations
Respiratory tract infection
|
6.2%
1/16 • Treatment-emergent adverse events (AEs) are any AE with onset after the first administration of study drug through the end of exposure, or any event that was present at Baseline but worsened in severity or was subsequently considered drug-related by the Investigator (up to approximately 52 months).
|
|
Infections and infestations
Sinusitis bacterial
|
6.2%
1/16 • Treatment-emergent adverse events (AEs) are any AE with onset after the first administration of study drug through the end of exposure, or any event that was present at Baseline but worsened in severity or was subsequently considered drug-related by the Investigator (up to approximately 52 months).
|
|
Infections and infestations
Tonsillitis
|
6.2%
1/16 • Treatment-emergent adverse events (AEs) are any AE with onset after the first administration of study drug through the end of exposure, or any event that was present at Baseline but worsened in severity or was subsequently considered drug-related by the Investigator (up to approximately 52 months).
|
|
Injury, poisoning and procedural complications
Forearm fracture
|
6.2%
1/16 • Treatment-emergent adverse events (AEs) are any AE with onset after the first administration of study drug through the end of exposure, or any event that was present at Baseline but worsened in severity or was subsequently considered drug-related by the Investigator (up to approximately 52 months).
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
6.2%
1/16 • Treatment-emergent adverse events (AEs) are any AE with onset after the first administration of study drug through the end of exposure, or any event that was present at Baseline but worsened in severity or was subsequently considered drug-related by the Investigator (up to approximately 52 months).
|
|
Musculoskeletal and connective tissue disorders
Synovitis
|
6.2%
1/16 • Treatment-emergent adverse events (AEs) are any AE with onset after the first administration of study drug through the end of exposure, or any event that was present at Baseline but worsened in severity or was subsequently considered drug-related by the Investigator (up to approximately 52 months).
|
|
Psychiatric disorders
Mental status changes
|
6.2%
1/16 • Treatment-emergent adverse events (AEs) are any AE with onset after the first administration of study drug through the end of exposure, or any event that was present at Baseline but worsened in severity or was subsequently considered drug-related by the Investigator (up to approximately 52 months).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
6.2%
1/16 • Treatment-emergent adverse events (AEs) are any AE with onset after the first administration of study drug through the end of exposure, or any event that was present at Baseline but worsened in severity or was subsequently considered drug-related by the Investigator (up to approximately 52 months).
|
|
Vascular disorders
Deep vein thrombosis
|
6.2%
1/16 • Treatment-emergent adverse events (AEs) are any AE with onset after the first administration of study drug through the end of exposure, or any event that was present at Baseline but worsened in severity or was subsequently considered drug-related by the Investigator (up to approximately 52 months).
|
Other adverse events
| Measure |
Givosiran
n=16 participants at risk
At the beginning of this study, participants received either givosiran 2.5 mg/kg subcutaneous (SC) injection once monthly (QM), givosiran 5.0 mg/kg SC injection QM, or givosiran 5.0 mg/kg SC injection once every 3 months (Q3M). Within a year, all participants were transitioned to givosiran 2.5 mg/kg SC injection QM.
|
|---|---|
|
Blood and lymphatic system disorders
Neutrophilia
|
6.2%
1/16 • Treatment-emergent adverse events (AEs) are any AE with onset after the first administration of study drug through the end of exposure, or any event that was present at Baseline but worsened in severity or was subsequently considered drug-related by the Investigator (up to approximately 52 months).
|
|
Cardiac disorders
Palpitations
|
6.2%
1/16 • Treatment-emergent adverse events (AEs) are any AE with onset after the first administration of study drug through the end of exposure, or any event that was present at Baseline but worsened in severity or was subsequently considered drug-related by the Investigator (up to approximately 52 months).
|
|
Ear and labyrinth disorders
Cerumen impaction
|
6.2%
1/16 • Treatment-emergent adverse events (AEs) are any AE with onset after the first administration of study drug through the end of exposure, or any event that was present at Baseline but worsened in severity or was subsequently considered drug-related by the Investigator (up to approximately 52 months).
|
|
Ear and labyrinth disorders
Ear haemorrhage
|
6.2%
1/16 • Treatment-emergent adverse events (AEs) are any AE with onset after the first administration of study drug through the end of exposure, or any event that was present at Baseline but worsened in severity or was subsequently considered drug-related by the Investigator (up to approximately 52 months).
|
|
Ear and labyrinth disorders
Tinnitus
|
6.2%
1/16 • Treatment-emergent adverse events (AEs) are any AE with onset after the first administration of study drug through the end of exposure, or any event that was present at Baseline but worsened in severity or was subsequently considered drug-related by the Investigator (up to approximately 52 months).
|
|
Eye disorders
Conjunctival haemorrhage
|
12.5%
2/16 • Treatment-emergent adverse events (AEs) are any AE with onset after the first administration of study drug through the end of exposure, or any event that was present at Baseline but worsened in severity or was subsequently considered drug-related by the Investigator (up to approximately 52 months).
|
|
Eye disorders
Eye pain
|
6.2%
1/16 • Treatment-emergent adverse events (AEs) are any AE with onset after the first administration of study drug through the end of exposure, or any event that was present at Baseline but worsened in severity or was subsequently considered drug-related by the Investigator (up to approximately 52 months).
|
|
Eye disorders
Eye pruritus
|
6.2%
1/16 • Treatment-emergent adverse events (AEs) are any AE with onset after the first administration of study drug through the end of exposure, or any event that was present at Baseline but worsened in severity or was subsequently considered drug-related by the Investigator (up to approximately 52 months).
|
|
Eye disorders
Swelling of eyelid
|
6.2%
1/16 • Treatment-emergent adverse events (AEs) are any AE with onset after the first administration of study drug through the end of exposure, or any event that was present at Baseline but worsened in severity or was subsequently considered drug-related by the Investigator (up to approximately 52 months).
|
|
Gastrointestinal disorders
Abdominal discomfort
|
6.2%
1/16 • Treatment-emergent adverse events (AEs) are any AE with onset after the first administration of study drug through the end of exposure, or any event that was present at Baseline but worsened in severity or was subsequently considered drug-related by the Investigator (up to approximately 52 months).
|
|
Gastrointestinal disorders
Abdominal pain
|
37.5%
6/16 • Treatment-emergent adverse events (AEs) are any AE with onset after the first administration of study drug through the end of exposure, or any event that was present at Baseline but worsened in severity or was subsequently considered drug-related by the Investigator (up to approximately 52 months).
|
|
Gastrointestinal disorders
Abdominal pain lower
|
6.2%
1/16 • Treatment-emergent adverse events (AEs) are any AE with onset after the first administration of study drug through the end of exposure, or any event that was present at Baseline but worsened in severity or was subsequently considered drug-related by the Investigator (up to approximately 52 months).
|
|
Gastrointestinal disorders
Abdominal pain upper
|
18.8%
3/16 • Treatment-emergent adverse events (AEs) are any AE with onset after the first administration of study drug through the end of exposure, or any event that was present at Baseline but worsened in severity or was subsequently considered drug-related by the Investigator (up to approximately 52 months).
|
|
Gastrointestinal disorders
Constipation
|
12.5%
2/16 • Treatment-emergent adverse events (AEs) are any AE with onset after the first administration of study drug through the end of exposure, or any event that was present at Baseline but worsened in severity or was subsequently considered drug-related by the Investigator (up to approximately 52 months).
|
|
Gastrointestinal disorders
Diarrhoea
|
25.0%
4/16 • Treatment-emergent adverse events (AEs) are any AE with onset after the first administration of study drug through the end of exposure, or any event that was present at Baseline but worsened in severity or was subsequently considered drug-related by the Investigator (up to approximately 52 months).
|
|
Gastrointestinal disorders
Dyspepsia
|
6.2%
1/16 • Treatment-emergent adverse events (AEs) are any AE with onset after the first administration of study drug through the end of exposure, or any event that was present at Baseline but worsened in severity or was subsequently considered drug-related by the Investigator (up to approximately 52 months).
|
|
Gastrointestinal disorders
Irritable bowel syndrome
|
6.2%
1/16 • Treatment-emergent adverse events (AEs) are any AE with onset after the first administration of study drug through the end of exposure, or any event that was present at Baseline but worsened in severity or was subsequently considered drug-related by the Investigator (up to approximately 52 months).
|
|
Gastrointestinal disorders
Nausea
|
50.0%
8/16 • Treatment-emergent adverse events (AEs) are any AE with onset after the first administration of study drug through the end of exposure, or any event that was present at Baseline but worsened in severity or was subsequently considered drug-related by the Investigator (up to approximately 52 months).
|
|
Gastrointestinal disorders
Stomatitis
|
6.2%
1/16 • Treatment-emergent adverse events (AEs) are any AE with onset after the first administration of study drug through the end of exposure, or any event that was present at Baseline but worsened in severity or was subsequently considered drug-related by the Investigator (up to approximately 52 months).
|
|
Gastrointestinal disorders
Teething
|
6.2%
1/16 • Treatment-emergent adverse events (AEs) are any AE with onset after the first administration of study drug through the end of exposure, or any event that was present at Baseline but worsened in severity or was subsequently considered drug-related by the Investigator (up to approximately 52 months).
|
|
Gastrointestinal disorders
Vomiting
|
25.0%
4/16 • Treatment-emergent adverse events (AEs) are any AE with onset after the first administration of study drug through the end of exposure, or any event that was present at Baseline but worsened in severity or was subsequently considered drug-related by the Investigator (up to approximately 52 months).
|
|
General disorders
Asthenia
|
6.2%
1/16 • Treatment-emergent adverse events (AEs) are any AE with onset after the first administration of study drug through the end of exposure, or any event that was present at Baseline but worsened in severity or was subsequently considered drug-related by the Investigator (up to approximately 52 months).
|
|
General disorders
Chest pain
|
6.2%
1/16 • Treatment-emergent adverse events (AEs) are any AE with onset after the first administration of study drug through the end of exposure, or any event that was present at Baseline but worsened in severity or was subsequently considered drug-related by the Investigator (up to approximately 52 months).
|
|
General disorders
Chills
|
6.2%
1/16 • Treatment-emergent adverse events (AEs) are any AE with onset after the first administration of study drug through the end of exposure, or any event that was present at Baseline but worsened in severity or was subsequently considered drug-related by the Investigator (up to approximately 52 months).
|
|
General disorders
Discomfort
|
6.2%
1/16 • Treatment-emergent adverse events (AEs) are any AE with onset after the first administration of study drug through the end of exposure, or any event that was present at Baseline but worsened in severity or was subsequently considered drug-related by the Investigator (up to approximately 52 months).
|
|
General disorders
Facial pain
|
6.2%
1/16 • Treatment-emergent adverse events (AEs) are any AE with onset after the first administration of study drug through the end of exposure, or any event that was present at Baseline but worsened in severity or was subsequently considered drug-related by the Investigator (up to approximately 52 months).
|
|
General disorders
Fatigue
|
43.8%
7/16 • Treatment-emergent adverse events (AEs) are any AE with onset after the first administration of study drug through the end of exposure, or any event that was present at Baseline but worsened in severity or was subsequently considered drug-related by the Investigator (up to approximately 52 months).
|
|
General disorders
Feeling abnormal
|
6.2%
1/16 • Treatment-emergent adverse events (AEs) are any AE with onset after the first administration of study drug through the end of exposure, or any event that was present at Baseline but worsened in severity or was subsequently considered drug-related by the Investigator (up to approximately 52 months).
|
|
General disorders
Injection site bruising
|
6.2%
1/16 • Treatment-emergent adverse events (AEs) are any AE with onset after the first administration of study drug through the end of exposure, or any event that was present at Baseline but worsened in severity or was subsequently considered drug-related by the Investigator (up to approximately 52 months).
|
|
General disorders
Injection site discolouration
|
12.5%
2/16 • Treatment-emergent adverse events (AEs) are any AE with onset after the first administration of study drug through the end of exposure, or any event that was present at Baseline but worsened in severity or was subsequently considered drug-related by the Investigator (up to approximately 52 months).
|
|
General disorders
Injection site dryness
|
6.2%
1/16 • Treatment-emergent adverse events (AEs) are any AE with onset after the first administration of study drug through the end of exposure, or any event that was present at Baseline but worsened in severity or was subsequently considered drug-related by the Investigator (up to approximately 52 months).
|
|
General disorders
Injection site erythema
|
37.5%
6/16 • Treatment-emergent adverse events (AEs) are any AE with onset after the first administration of study drug through the end of exposure, or any event that was present at Baseline but worsened in severity or was subsequently considered drug-related by the Investigator (up to approximately 52 months).
|
|
General disorders
Injection site indentation
|
6.2%
1/16 • Treatment-emergent adverse events (AEs) are any AE with onset after the first administration of study drug through the end of exposure, or any event that was present at Baseline but worsened in severity or was subsequently considered drug-related by the Investigator (up to approximately 52 months).
|
|
General disorders
Injection site pain
|
6.2%
1/16 • Treatment-emergent adverse events (AEs) are any AE with onset after the first administration of study drug through the end of exposure, or any event that was present at Baseline but worsened in severity or was subsequently considered drug-related by the Investigator (up to approximately 52 months).
|
|
General disorders
Injection site pruritus
|
25.0%
4/16 • Treatment-emergent adverse events (AEs) are any AE with onset after the first administration of study drug through the end of exposure, or any event that was present at Baseline but worsened in severity or was subsequently considered drug-related by the Investigator (up to approximately 52 months).
|
|
General disorders
Injection site rash
|
12.5%
2/16 • Treatment-emergent adverse events (AEs) are any AE with onset after the first administration of study drug through the end of exposure, or any event that was present at Baseline but worsened in severity or was subsequently considered drug-related by the Investigator (up to approximately 52 months).
|
|
General disorders
Injection site swelling
|
12.5%
2/16 • Treatment-emergent adverse events (AEs) are any AE with onset after the first administration of study drug through the end of exposure, or any event that was present at Baseline but worsened in severity or was subsequently considered drug-related by the Investigator (up to approximately 52 months).
|
|
General disorders
Injection site urticaria
|
6.2%
1/16 • Treatment-emergent adverse events (AEs) are any AE with onset after the first administration of study drug through the end of exposure, or any event that was present at Baseline but worsened in severity or was subsequently considered drug-related by the Investigator (up to approximately 52 months).
|
|
General disorders
Malaise
|
6.2%
1/16 • Treatment-emergent adverse events (AEs) are any AE with onset after the first administration of study drug through the end of exposure, or any event that was present at Baseline but worsened in severity or was subsequently considered drug-related by the Investigator (up to approximately 52 months).
|
|
General disorders
Oedema peripheral
|
6.2%
1/16 • Treatment-emergent adverse events (AEs) are any AE with onset after the first administration of study drug through the end of exposure, or any event that was present at Baseline but worsened in severity or was subsequently considered drug-related by the Investigator (up to approximately 52 months).
|
|
General disorders
Pain
|
6.2%
1/16 • Treatment-emergent adverse events (AEs) are any AE with onset after the first administration of study drug through the end of exposure, or any event that was present at Baseline but worsened in severity or was subsequently considered drug-related by the Investigator (up to approximately 52 months).
|
|
General disorders
Peripheral swelling
|
6.2%
1/16 • Treatment-emergent adverse events (AEs) are any AE with onset after the first administration of study drug through the end of exposure, or any event that was present at Baseline but worsened in severity or was subsequently considered drug-related by the Investigator (up to approximately 52 months).
|
|
General disorders
Pyrexia
|
12.5%
2/16 • Treatment-emergent adverse events (AEs) are any AE with onset after the first administration of study drug through the end of exposure, or any event that was present at Baseline but worsened in severity or was subsequently considered drug-related by the Investigator (up to approximately 52 months).
|
|
Immune system disorders
Allergy to animal
|
6.2%
1/16 • Treatment-emergent adverse events (AEs) are any AE with onset after the first administration of study drug through the end of exposure, or any event that was present at Baseline but worsened in severity or was subsequently considered drug-related by the Investigator (up to approximately 52 months).
|
|
Immune system disorders
Drug hypersensitivity
|
6.2%
1/16 • Treatment-emergent adverse events (AEs) are any AE with onset after the first administration of study drug through the end of exposure, or any event that was present at Baseline but worsened in severity or was subsequently considered drug-related by the Investigator (up to approximately 52 months).
|
|
Immune system disorders
Hypersensitivity
|
6.2%
1/16 • Treatment-emergent adverse events (AEs) are any AE with onset after the first administration of study drug through the end of exposure, or any event that was present at Baseline but worsened in severity or was subsequently considered drug-related by the Investigator (up to approximately 52 months).
|
|
Immune system disorders
Oral allergy syndrome
|
6.2%
1/16 • Treatment-emergent adverse events (AEs) are any AE with onset after the first administration of study drug through the end of exposure, or any event that was present at Baseline but worsened in severity or was subsequently considered drug-related by the Investigator (up to approximately 52 months).
|
|
Immune system disorders
Seasonal allergy
|
6.2%
1/16 • Treatment-emergent adverse events (AEs) are any AE with onset after the first administration of study drug through the end of exposure, or any event that was present at Baseline but worsened in severity or was subsequently considered drug-related by the Investigator (up to approximately 52 months).
|
|
Infections and infestations
Bronchitis
|
6.2%
1/16 • Treatment-emergent adverse events (AEs) are any AE with onset after the first administration of study drug through the end of exposure, or any event that was present at Baseline but worsened in severity or was subsequently considered drug-related by the Investigator (up to approximately 52 months).
|
|
Infections and infestations
Conjunctivitis
|
6.2%
1/16 • Treatment-emergent adverse events (AEs) are any AE with onset after the first administration of study drug through the end of exposure, or any event that was present at Baseline but worsened in severity or was subsequently considered drug-related by the Investigator (up to approximately 52 months).
|
|
Infections and infestations
Ear infection
|
18.8%
3/16 • Treatment-emergent adverse events (AEs) are any AE with onset after the first administration of study drug through the end of exposure, or any event that was present at Baseline but worsened in severity or was subsequently considered drug-related by the Investigator (up to approximately 52 months).
|
|
Infections and infestations
Folliculitis
|
6.2%
1/16 • Treatment-emergent adverse events (AEs) are any AE with onset after the first administration of study drug through the end of exposure, or any event that was present at Baseline but worsened in severity or was subsequently considered drug-related by the Investigator (up to approximately 52 months).
|
|
Infections and infestations
Fungal infection
|
6.2%
1/16 • Treatment-emergent adverse events (AEs) are any AE with onset after the first administration of study drug through the end of exposure, or any event that was present at Baseline but worsened in severity or was subsequently considered drug-related by the Investigator (up to approximately 52 months).
|
|
Infections and infestations
Gastroenteritis
|
25.0%
4/16 • Treatment-emergent adverse events (AEs) are any AE with onset after the first administration of study drug through the end of exposure, or any event that was present at Baseline but worsened in severity or was subsequently considered drug-related by the Investigator (up to approximately 52 months).
|
|
Infections and infestations
Gastroenteritis viral
|
12.5%
2/16 • Treatment-emergent adverse events (AEs) are any AE with onset after the first administration of study drug through the end of exposure, or any event that was present at Baseline but worsened in severity or was subsequently considered drug-related by the Investigator (up to approximately 52 months).
|
|
Infections and infestations
Influenza
|
18.8%
3/16 • Treatment-emergent adverse events (AEs) are any AE with onset after the first administration of study drug through the end of exposure, or any event that was present at Baseline but worsened in severity or was subsequently considered drug-related by the Investigator (up to approximately 52 months).
|
|
Infections and infestations
Nasopharyngitis
|
50.0%
8/16 • Treatment-emergent adverse events (AEs) are any AE with onset after the first administration of study drug through the end of exposure, or any event that was present at Baseline but worsened in severity or was subsequently considered drug-related by the Investigator (up to approximately 52 months).
|
|
Infections and infestations
Pharyngitis streptococcal
|
6.2%
1/16 • Treatment-emergent adverse events (AEs) are any AE with onset after the first administration of study drug through the end of exposure, or any event that was present at Baseline but worsened in severity or was subsequently considered drug-related by the Investigator (up to approximately 52 months).
|
|
Infections and infestations
Sinusitis
|
12.5%
2/16 • Treatment-emergent adverse events (AEs) are any AE with onset after the first administration of study drug through the end of exposure, or any event that was present at Baseline but worsened in severity or was subsequently considered drug-related by the Investigator (up to approximately 52 months).
|
|
Infections and infestations
Skin infection
|
6.2%
1/16 • Treatment-emergent adverse events (AEs) are any AE with onset after the first administration of study drug through the end of exposure, or any event that was present at Baseline but worsened in severity or was subsequently considered drug-related by the Investigator (up to approximately 52 months).
|
|
Infections and infestations
Tonsillitis
|
6.2%
1/16 • Treatment-emergent adverse events (AEs) are any AE with onset after the first administration of study drug through the end of exposure, or any event that was present at Baseline but worsened in severity or was subsequently considered drug-related by the Investigator (up to approximately 52 months).
|
|
Infections and infestations
Upper respiratory tract infection
|
18.8%
3/16 • Treatment-emergent adverse events (AEs) are any AE with onset after the first administration of study drug through the end of exposure, or any event that was present at Baseline but worsened in severity or was subsequently considered drug-related by the Investigator (up to approximately 52 months).
|
|
Infections and infestations
Urinary tract infection
|
12.5%
2/16 • Treatment-emergent adverse events (AEs) are any AE with onset after the first administration of study drug through the end of exposure, or any event that was present at Baseline but worsened in severity or was subsequently considered drug-related by the Investigator (up to approximately 52 months).
|
|
Infections and infestations
Varicella
|
6.2%
1/16 • Treatment-emergent adverse events (AEs) are any AE with onset after the first administration of study drug through the end of exposure, or any event that was present at Baseline but worsened in severity or was subsequently considered drug-related by the Investigator (up to approximately 52 months).
|
|
Infections and infestations
Viral infection
|
6.2%
1/16 • Treatment-emergent adverse events (AEs) are any AE with onset after the first administration of study drug through the end of exposure, or any event that was present at Baseline but worsened in severity or was subsequently considered drug-related by the Investigator (up to approximately 52 months).
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
6.2%
1/16 • Treatment-emergent adverse events (AEs) are any AE with onset after the first administration of study drug through the end of exposure, or any event that was present at Baseline but worsened in severity or was subsequently considered drug-related by the Investigator (up to approximately 52 months).
|
|
Injury, poisoning and procedural complications
Fall
|
6.2%
1/16 • Treatment-emergent adverse events (AEs) are any AE with onset after the first administration of study drug through the end of exposure, or any event that was present at Baseline but worsened in severity or was subsequently considered drug-related by the Investigator (up to approximately 52 months).
|
|
Injury, poisoning and procedural complications
Foot fracture
|
6.2%
1/16 • Treatment-emergent adverse events (AEs) are any AE with onset after the first administration of study drug through the end of exposure, or any event that was present at Baseline but worsened in severity or was subsequently considered drug-related by the Investigator (up to approximately 52 months).
|
|
Injury, poisoning and procedural complications
Procedural pain
|
6.2%
1/16 • Treatment-emergent adverse events (AEs) are any AE with onset after the first administration of study drug through the end of exposure, or any event that was present at Baseline but worsened in severity or was subsequently considered drug-related by the Investigator (up to approximately 52 months).
|
|
Injury, poisoning and procedural complications
Rib fracture
|
6.2%
1/16 • Treatment-emergent adverse events (AEs) are any AE with onset after the first administration of study drug through the end of exposure, or any event that was present at Baseline but worsened in severity or was subsequently considered drug-related by the Investigator (up to approximately 52 months).
|
|
Injury, poisoning and procedural complications
Venomous sting
|
6.2%
1/16 • Treatment-emergent adverse events (AEs) are any AE with onset after the first administration of study drug through the end of exposure, or any event that was present at Baseline but worsened in severity or was subsequently considered drug-related by the Investigator (up to approximately 52 months).
|
|
Investigations
Alanine aminotransferase increased
|
12.5%
2/16 • Treatment-emergent adverse events (AEs) are any AE with onset after the first administration of study drug through the end of exposure, or any event that was present at Baseline but worsened in severity or was subsequently considered drug-related by the Investigator (up to approximately 52 months).
|
|
Investigations
Albumin urine present
|
6.2%
1/16 • Treatment-emergent adverse events (AEs) are any AE with onset after the first administration of study drug through the end of exposure, or any event that was present at Baseline but worsened in severity or was subsequently considered drug-related by the Investigator (up to approximately 52 months).
|
|
Investigations
Anticoagulation drug level below therapeutic
|
6.2%
1/16 • Treatment-emergent adverse events (AEs) are any AE with onset after the first administration of study drug through the end of exposure, or any event that was present at Baseline but worsened in severity or was subsequently considered drug-related by the Investigator (up to approximately 52 months).
|
|
Investigations
Aspartate aminotransferase increased
|
12.5%
2/16 • Treatment-emergent adverse events (AEs) are any AE with onset after the first administration of study drug through the end of exposure, or any event that was present at Baseline but worsened in severity or was subsequently considered drug-related by the Investigator (up to approximately 52 months).
|
|
Investigations
Bilirubin conjugated increased
|
6.2%
1/16 • Treatment-emergent adverse events (AEs) are any AE with onset after the first administration of study drug through the end of exposure, or any event that was present at Baseline but worsened in severity or was subsequently considered drug-related by the Investigator (up to approximately 52 months).
|
|
Investigations
Blood bilirubin increased
|
6.2%
1/16 • Treatment-emergent adverse events (AEs) are any AE with onset after the first administration of study drug through the end of exposure, or any event that was present at Baseline but worsened in severity or was subsequently considered drug-related by the Investigator (up to approximately 52 months).
|
|
Investigations
Blood creatinine increased
|
12.5%
2/16 • Treatment-emergent adverse events (AEs) are any AE with onset after the first administration of study drug through the end of exposure, or any event that was present at Baseline but worsened in severity or was subsequently considered drug-related by the Investigator (up to approximately 52 months).
|
|
Investigations
Blood homocysteine increased
|
6.2%
1/16 • Treatment-emergent adverse events (AEs) are any AE with onset after the first administration of study drug through the end of exposure, or any event that was present at Baseline but worsened in severity or was subsequently considered drug-related by the Investigator (up to approximately 52 months).
|
|
Investigations
Blood sodium decreased
|
12.5%
2/16 • Treatment-emergent adverse events (AEs) are any AE with onset after the first administration of study drug through the end of exposure, or any event that was present at Baseline but worsened in severity or was subsequently considered drug-related by the Investigator (up to approximately 52 months).
|
|
Investigations
C-reactive protein increased
|
12.5%
2/16 • Treatment-emergent adverse events (AEs) are any AE with onset after the first administration of study drug through the end of exposure, or any event that was present at Baseline but worsened in severity or was subsequently considered drug-related by the Investigator (up to approximately 52 months).
|
|
Investigations
Carbon dioxide increased
|
6.2%
1/16 • Treatment-emergent adverse events (AEs) are any AE with onset after the first administration of study drug through the end of exposure, or any event that was present at Baseline but worsened in severity or was subsequently considered drug-related by the Investigator (up to approximately 52 months).
|
|
Investigations
Coronavirus test positive
|
6.2%
1/16 • Treatment-emergent adverse events (AEs) are any AE with onset after the first administration of study drug through the end of exposure, or any event that was present at Baseline but worsened in severity or was subsequently considered drug-related by the Investigator (up to approximately 52 months).
|
|
Investigations
Creatinine urine increased
|
12.5%
2/16 • Treatment-emergent adverse events (AEs) are any AE with onset after the first administration of study drug through the end of exposure, or any event that was present at Baseline but worsened in severity or was subsequently considered drug-related by the Investigator (up to approximately 52 months).
|
|
Investigations
Gamma-glutamyltransferase increased
|
18.8%
3/16 • Treatment-emergent adverse events (AEs) are any AE with onset after the first administration of study drug through the end of exposure, or any event that was present at Baseline but worsened in severity or was subsequently considered drug-related by the Investigator (up to approximately 52 months).
|
|
Investigations
Glomerular filtration rate decreased
|
18.8%
3/16 • Treatment-emergent adverse events (AEs) are any AE with onset after the first administration of study drug through the end of exposure, or any event that was present at Baseline but worsened in severity or was subsequently considered drug-related by the Investigator (up to approximately 52 months).
|
|
Investigations
International normalised ratio increased
|
25.0%
4/16 • Treatment-emergent adverse events (AEs) are any AE with onset after the first administration of study drug through the end of exposure, or any event that was present at Baseline but worsened in severity or was subsequently considered drug-related by the Investigator (up to approximately 52 months).
|
|
Investigations
Lipase increased
|
25.0%
4/16 • Treatment-emergent adverse events (AEs) are any AE with onset after the first administration of study drug through the end of exposure, or any event that was present at Baseline but worsened in severity or was subsequently considered drug-related by the Investigator (up to approximately 52 months).
|
|
Investigations
Liver function test increased
|
6.2%
1/16 • Treatment-emergent adverse events (AEs) are any AE with onset after the first administration of study drug through the end of exposure, or any event that was present at Baseline but worsened in severity or was subsequently considered drug-related by the Investigator (up to approximately 52 months).
|
|
Investigations
Protein urine present
|
6.2%
1/16 • Treatment-emergent adverse events (AEs) are any AE with onset after the first administration of study drug through the end of exposure, or any event that was present at Baseline but worsened in severity or was subsequently considered drug-related by the Investigator (up to approximately 52 months).
|
|
Investigations
Prothrombin level increased
|
6.2%
1/16 • Treatment-emergent adverse events (AEs) are any AE with onset after the first administration of study drug through the end of exposure, or any event that was present at Baseline but worsened in severity or was subsequently considered drug-related by the Investigator (up to approximately 52 months).
|
|
Investigations
Transaminases increased
|
6.2%
1/16 • Treatment-emergent adverse events (AEs) are any AE with onset after the first administration of study drug through the end of exposure, or any event that was present at Baseline but worsened in severity or was subsequently considered drug-related by the Investigator (up to approximately 52 months).
|
|
Investigations
Urine ketone body present
|
6.2%
1/16 • Treatment-emergent adverse events (AEs) are any AE with onset after the first administration of study drug through the end of exposure, or any event that was present at Baseline but worsened in severity or was subsequently considered drug-related by the Investigator (up to approximately 52 months).
|
|
Investigations
Urine output decreased
|
6.2%
1/16 • Treatment-emergent adverse events (AEs) are any AE with onset after the first administration of study drug through the end of exposure, or any event that was present at Baseline but worsened in severity or was subsequently considered drug-related by the Investigator (up to approximately 52 months).
|
|
Metabolism and nutrition disorders
Decreased appetite
|
18.8%
3/16 • Treatment-emergent adverse events (AEs) are any AE with onset after the first administration of study drug through the end of exposure, or any event that was present at Baseline but worsened in severity or was subsequently considered drug-related by the Investigator (up to approximately 52 months).
|
|
Metabolism and nutrition disorders
Gluten sensitivity
|
6.2%
1/16 • Treatment-emergent adverse events (AEs) are any AE with onset after the first administration of study drug through the end of exposure, or any event that was present at Baseline but worsened in severity or was subsequently considered drug-related by the Investigator (up to approximately 52 months).
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
6.2%
1/16 • Treatment-emergent adverse events (AEs) are any AE with onset after the first administration of study drug through the end of exposure, or any event that was present at Baseline but worsened in severity or was subsequently considered drug-related by the Investigator (up to approximately 52 months).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
18.8%
3/16 • Treatment-emergent adverse events (AEs) are any AE with onset after the first administration of study drug through the end of exposure, or any event that was present at Baseline but worsened in severity or was subsequently considered drug-related by the Investigator (up to approximately 52 months).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
31.2%
5/16 • Treatment-emergent adverse events (AEs) are any AE with onset after the first administration of study drug through the end of exposure, or any event that was present at Baseline but worsened in severity or was subsequently considered drug-related by the Investigator (up to approximately 52 months).
|
|
Musculoskeletal and connective tissue disorders
Costochondritis
|
6.2%
1/16 • Treatment-emergent adverse events (AEs) are any AE with onset after the first administration of study drug through the end of exposure, or any event that was present at Baseline but worsened in severity or was subsequently considered drug-related by the Investigator (up to approximately 52 months).
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
6.2%
1/16 • Treatment-emergent adverse events (AEs) are any AE with onset after the first administration of study drug through the end of exposure, or any event that was present at Baseline but worsened in severity or was subsequently considered drug-related by the Investigator (up to approximately 52 months).
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
12.5%
2/16 • Treatment-emergent adverse events (AEs) are any AE with onset after the first administration of study drug through the end of exposure, or any event that was present at Baseline but worsened in severity or was subsequently considered drug-related by the Investigator (up to approximately 52 months).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
6.2%
1/16 • Treatment-emergent adverse events (AEs) are any AE with onset after the first administration of study drug through the end of exposure, or any event that was present at Baseline but worsened in severity or was subsequently considered drug-related by the Investigator (up to approximately 52 months).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
31.2%
5/16 • Treatment-emergent adverse events (AEs) are any AE with onset after the first administration of study drug through the end of exposure, or any event that was present at Baseline but worsened in severity or was subsequently considered drug-related by the Investigator (up to approximately 52 months).
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
18.8%
3/16 • Treatment-emergent adverse events (AEs) are any AE with onset after the first administration of study drug through the end of exposure, or any event that was present at Baseline but worsened in severity or was subsequently considered drug-related by the Investigator (up to approximately 52 months).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
25.0%
4/16 • Treatment-emergent adverse events (AEs) are any AE with onset after the first administration of study drug through the end of exposure, or any event that was present at Baseline but worsened in severity or was subsequently considered drug-related by the Investigator (up to approximately 52 months).
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
6.2%
1/16 • Treatment-emergent adverse events (AEs) are any AE with onset after the first administration of study drug through the end of exposure, or any event that was present at Baseline but worsened in severity or was subsequently considered drug-related by the Investigator (up to approximately 52 months).
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
6.2%
1/16 • Treatment-emergent adverse events (AEs) are any AE with onset after the first administration of study drug through the end of exposure, or any event that was present at Baseline but worsened in severity or was subsequently considered drug-related by the Investigator (up to approximately 52 months).
|
|
Nervous system disorders
Dizziness
|
6.2%
1/16 • Treatment-emergent adverse events (AEs) are any AE with onset after the first administration of study drug through the end of exposure, or any event that was present at Baseline but worsened in severity or was subsequently considered drug-related by the Investigator (up to approximately 52 months).
|
|
Nervous system disorders
Dysaesthesia
|
6.2%
1/16 • Treatment-emergent adverse events (AEs) are any AE with onset after the first administration of study drug through the end of exposure, or any event that was present at Baseline but worsened in severity or was subsequently considered drug-related by the Investigator (up to approximately 52 months).
|
|
Nervous system disorders
Headache
|
31.2%
5/16 • Treatment-emergent adverse events (AEs) are any AE with onset after the first administration of study drug through the end of exposure, or any event that was present at Baseline but worsened in severity or was subsequently considered drug-related by the Investigator (up to approximately 52 months).
|
|
Nervous system disorders
Hypoaesthesia
|
6.2%
1/16 • Treatment-emergent adverse events (AEs) are any AE with onset after the first administration of study drug through the end of exposure, or any event that was present at Baseline but worsened in severity or was subsequently considered drug-related by the Investigator (up to approximately 52 months).
|
|
Nervous system disorders
Migraine
|
25.0%
4/16 • Treatment-emergent adverse events (AEs) are any AE with onset after the first administration of study drug through the end of exposure, or any event that was present at Baseline but worsened in severity or was subsequently considered drug-related by the Investigator (up to approximately 52 months).
|
|
Nervous system disorders
Neuropathy peripheral
|
6.2%
1/16 • Treatment-emergent adverse events (AEs) are any AE with onset after the first administration of study drug through the end of exposure, or any event that was present at Baseline but worsened in severity or was subsequently considered drug-related by the Investigator (up to approximately 52 months).
|
|
Nervous system disorders
Paraesthesia
|
18.8%
3/16 • Treatment-emergent adverse events (AEs) are any AE with onset after the first administration of study drug through the end of exposure, or any event that was present at Baseline but worsened in severity or was subsequently considered drug-related by the Investigator (up to approximately 52 months).
|
|
Nervous system disorders
Tremor
|
6.2%
1/16 • Treatment-emergent adverse events (AEs) are any AE with onset after the first administration of study drug through the end of exposure, or any event that was present at Baseline but worsened in severity or was subsequently considered drug-related by the Investigator (up to approximately 52 months).
|
|
Psychiatric disorders
Anxiety
|
6.2%
1/16 • Treatment-emergent adverse events (AEs) are any AE with onset after the first administration of study drug through the end of exposure, or any event that was present at Baseline but worsened in severity or was subsequently considered drug-related by the Investigator (up to approximately 52 months).
|
|
Psychiatric disorders
Attention deficit hyperactivity disorder
|
6.2%
1/16 • Treatment-emergent adverse events (AEs) are any AE with onset after the first administration of study drug through the end of exposure, or any event that was present at Baseline but worsened in severity or was subsequently considered drug-related by the Investigator (up to approximately 52 months).
|
|
Psychiatric disorders
Insomnia
|
12.5%
2/16 • Treatment-emergent adverse events (AEs) are any AE with onset after the first administration of study drug through the end of exposure, or any event that was present at Baseline but worsened in severity or was subsequently considered drug-related by the Investigator (up to approximately 52 months).
|
|
Psychiatric disorders
Panic attack
|
6.2%
1/16 • Treatment-emergent adverse events (AEs) are any AE with onset after the first administration of study drug through the end of exposure, or any event that was present at Baseline but worsened in severity or was subsequently considered drug-related by the Investigator (up to approximately 52 months).
|
|
Renal and urinary disorders
Pollakiuria
|
12.5%
2/16 • Treatment-emergent adverse events (AEs) are any AE with onset after the first administration of study drug through the end of exposure, or any event that was present at Baseline but worsened in severity or was subsequently considered drug-related by the Investigator (up to approximately 52 months).
|
|
Renal and urinary disorders
Renal impairment
|
12.5%
2/16 • Treatment-emergent adverse events (AEs) are any AE with onset after the first administration of study drug through the end of exposure, or any event that was present at Baseline but worsened in severity or was subsequently considered drug-related by the Investigator (up to approximately 52 months).
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
18.8%
3/16 • Treatment-emergent adverse events (AEs) are any AE with onset after the first administration of study drug through the end of exposure, or any event that was present at Baseline but worsened in severity or was subsequently considered drug-related by the Investigator (up to approximately 52 months).
|
|
Reproductive system and breast disorders
Menorrhagia
|
6.2%
1/16 • Treatment-emergent adverse events (AEs) are any AE with onset after the first administration of study drug through the end of exposure, or any event that was present at Baseline but worsened in severity or was subsequently considered drug-related by the Investigator (up to approximately 52 months).
|
|
Reproductive system and breast disorders
Metrorrhagia
|
6.2%
1/16 • Treatment-emergent adverse events (AEs) are any AE with onset after the first administration of study drug through the end of exposure, or any event that was present at Baseline but worsened in severity or was subsequently considered drug-related by the Investigator (up to approximately 52 months).
|
|
Reproductive system and breast disorders
Oligomenorrhoea
|
6.2%
1/16 • Treatment-emergent adverse events (AEs) are any AE with onset after the first administration of study drug through the end of exposure, or any event that was present at Baseline but worsened in severity or was subsequently considered drug-related by the Investigator (up to approximately 52 months).
|
|
Respiratory, thoracic and mediastinal disorders
Allergic bronchitis
|
6.2%
1/16 • Treatment-emergent adverse events (AEs) are any AE with onset after the first administration of study drug through the end of exposure, or any event that was present at Baseline but worsened in severity or was subsequently considered drug-related by the Investigator (up to approximately 52 months).
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
12.5%
2/16 • Treatment-emergent adverse events (AEs) are any AE with onset after the first administration of study drug through the end of exposure, or any event that was present at Baseline but worsened in severity or was subsequently considered drug-related by the Investigator (up to approximately 52 months).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
18.8%
3/16 • Treatment-emergent adverse events (AEs) are any AE with onset after the first administration of study drug through the end of exposure, or any event that was present at Baseline but worsened in severity or was subsequently considered drug-related by the Investigator (up to approximately 52 months).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
18.8%
3/16 • Treatment-emergent adverse events (AEs) are any AE with onset after the first administration of study drug through the end of exposure, or any event that was present at Baseline but worsened in severity or was subsequently considered drug-related by the Investigator (up to approximately 52 months).
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
6.2%
1/16 • Treatment-emergent adverse events (AEs) are any AE with onset after the first administration of study drug through the end of exposure, or any event that was present at Baseline but worsened in severity or was subsequently considered drug-related by the Investigator (up to approximately 52 months).
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
25.0%
4/16 • Treatment-emergent adverse events (AEs) are any AE with onset after the first administration of study drug through the end of exposure, or any event that was present at Baseline but worsened in severity or was subsequently considered drug-related by the Investigator (up to approximately 52 months).
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal erythema
|
6.2%
1/16 • Treatment-emergent adverse events (AEs) are any AE with onset after the first administration of study drug through the end of exposure, or any event that was present at Baseline but worsened in severity or was subsequently considered drug-related by the Investigator (up to approximately 52 months).
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
6.2%
1/16 • Treatment-emergent adverse events (AEs) are any AE with onset after the first administration of study drug through the end of exposure, or any event that was present at Baseline but worsened in severity or was subsequently considered drug-related by the Investigator (up to approximately 52 months).
|
|
Skin and subcutaneous tissue disorders
Acne
|
6.2%
1/16 • Treatment-emergent adverse events (AEs) are any AE with onset after the first administration of study drug through the end of exposure, or any event that was present at Baseline but worsened in severity or was subsequently considered drug-related by the Investigator (up to approximately 52 months).
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
6.2%
1/16 • Treatment-emergent adverse events (AEs) are any AE with onset after the first administration of study drug through the end of exposure, or any event that was present at Baseline but worsened in severity or was subsequently considered drug-related by the Investigator (up to approximately 52 months).
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
6.2%
1/16 • Treatment-emergent adverse events (AEs) are any AE with onset after the first administration of study drug through the end of exposure, or any event that was present at Baseline but worsened in severity or was subsequently considered drug-related by the Investigator (up to approximately 52 months).
|
|
Skin and subcutaneous tissue disorders
Erythema
|
12.5%
2/16 • Treatment-emergent adverse events (AEs) are any AE with onset after the first administration of study drug through the end of exposure, or any event that was present at Baseline but worsened in severity or was subsequently considered drug-related by the Investigator (up to approximately 52 months).
|
|
Skin and subcutaneous tissue disorders
Palmar erythema
|
6.2%
1/16 • Treatment-emergent adverse events (AEs) are any AE with onset after the first administration of study drug through the end of exposure, or any event that was present at Baseline but worsened in severity or was subsequently considered drug-related by the Investigator (up to approximately 52 months).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
18.8%
3/16 • Treatment-emergent adverse events (AEs) are any AE with onset after the first administration of study drug through the end of exposure, or any event that was present at Baseline but worsened in severity or was subsequently considered drug-related by the Investigator (up to approximately 52 months).
|
|
Skin and subcutaneous tissue disorders
Rash
|
18.8%
3/16 • Treatment-emergent adverse events (AEs) are any AE with onset after the first administration of study drug through the end of exposure, or any event that was present at Baseline but worsened in severity or was subsequently considered drug-related by the Investigator (up to approximately 52 months).
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
6.2%
1/16 • Treatment-emergent adverse events (AEs) are any AE with onset after the first administration of study drug through the end of exposure, or any event that was present at Baseline but worsened in severity or was subsequently considered drug-related by the Investigator (up to approximately 52 months).
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
12.5%
2/16 • Treatment-emergent adverse events (AEs) are any AE with onset after the first administration of study drug through the end of exposure, or any event that was present at Baseline but worsened in severity or was subsequently considered drug-related by the Investigator (up to approximately 52 months).
|
|
Vascular disorders
Hypertension
|
25.0%
4/16 • Treatment-emergent adverse events (AEs) are any AE with onset after the first administration of study drug through the end of exposure, or any event that was present at Baseline but worsened in severity or was subsequently considered drug-related by the Investigator (up to approximately 52 months).
|
|
Vascular disorders
Hypotension
|
6.2%
1/16 • Treatment-emergent adverse events (AEs) are any AE with onset after the first administration of study drug through the end of exposure, or any event that was present at Baseline but worsened in severity or was subsequently considered drug-related by the Investigator (up to approximately 52 months).
|
|
Vascular disorders
Superficial vein prominence
|
6.2%
1/16 • Treatment-emergent adverse events (AEs) are any AE with onset after the first administration of study drug through the end of exposure, or any event that was present at Baseline but worsened in severity or was subsequently considered drug-related by the Investigator (up to approximately 52 months).
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
6.2%
1/16 • Treatment-emergent adverse events (AEs) are any AE with onset after the first administration of study drug through the end of exposure, or any event that was present at Baseline but worsened in severity or was subsequently considered drug-related by the Investigator (up to approximately 52 months).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee It is intended that after completion of the study, the data are to be submitted for publication in a scientific journal and/or for reporting at a scientific meeting. A copy of any proposed manuscript must be provided and confirmed received at the Sponsor at least 30 days before its submission, and according to any additional publication details in the Investigator Agreement.
- Publication restrictions are in place
Restriction type: OTHER