Trial Outcomes & Findings for Compassionate Use Study of Methylnaltrexone (NCT NCT01368562)
NCT ID: NCT01368562
Last Updated: 2019-09-04
Results Overview
Opioid induced side effects included nausea, myoclonus, mental clouding (confusional state), vomiting, sedation, pruritus, sweating (hyperhidrosis), constipation, and urinary retention. A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
26 participants
Primary outcome timeframe
From start of treatment until end of study (up to maximum 3.4 years)
Results posted on
2019-09-04
Participant Flow
Participant milestones
| Measure |
Methylnaltrexone
Participants received single dose of methylnaltrexone (MNTX) 0.15 milligrams per kilogram (mg/kg) subcutaneously (SC) initially. Subsequent dosing was adjusted upward (to a maximum of 0.3 mg/kg) to achieve a desired clinical response or decreased to improve tolerability. Median treatment duration was 25 days.
|
|---|---|
|
Overall Study
STARTED
|
26
|
|
Overall Study
Received at Least 1 Dose of Study Drug
|
25
|
|
Overall Study
COMPLETED
|
7
|
|
Overall Study
NOT COMPLETED
|
19
|
Reasons for withdrawal
| Measure |
Methylnaltrexone
Participants received single dose of methylnaltrexone (MNTX) 0.15 milligrams per kilogram (mg/kg) subcutaneously (SC) initially. Subsequent dosing was adjusted upward (to a maximum of 0.3 mg/kg) to achieve a desired clinical response or decreased to improve tolerability. Median treatment duration was 25 days.
|
|---|---|
|
Overall Study
Adverse Event
|
1
|
|
Overall Study
Disease progression
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
|
Overall Study
Death
|
6
|
|
Overall Study
Unresponsive to treatment
|
5
|
|
Overall Study
Other
|
3
|
|
Overall Study
Other than specified
|
2
|
Baseline Characteristics
Mean age data of safety evaluable participants (all enrolled participants who received at least one dose of study drug) was calculated and reported.
Baseline characteristics by cohort
| Measure |
Methylnaltrexone
n=26 Participants
Participants received single dose of MNTX 0.15 mg/kg SC initially. Subsequent dosing was adjusted upward (to a maximum of 0.3 mg/kg) to achieve a desired clinical response or decreased to improve tolerability. Median treatment duration was 25 days.
|
|---|---|
|
Age, Continuous
|
59.4 years
STANDARD_DEVIATION 13.63 • n=25 Participants • Mean age data of safety evaluable participants (all enrolled participants who received at least one dose of study drug) was calculated and reported.
|
|
Sex: Female, Male
Female
|
14 Participants
n=26 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=26 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
24 Participants
n=26 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
2 Participants
n=26 Participants
|
PRIMARY outcome
Timeframe: From start of treatment until end of study (up to maximum 3.4 years)Population: All enrolled participants who provided a signed and dated written ICF.
Opioid induced side effects included nausea, myoclonus, mental clouding (confusional state), vomiting, sedation, pruritus, sweating (hyperhidrosis), constipation, and urinary retention. A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
Outcome measures
| Measure |
Methylnaltrexone
n=26 Participants
Participants received single dose of MNTX 0.15 mg/kg SC initially. Subsequent dosing was adjusted upward (to a maximum of 0.3 mg/kg) to achieve a desired clinical response or decreased to improve tolerability. Median treatment duration was 25 days.
|
|---|---|
|
Number of Participants With Opioid Induced Side Effects
Nausea
|
3 Participants
|
|
Number of Participants With Opioid Induced Side Effects
Myoclonus
|
1 Participants
|
|
Number of Participants With Opioid Induced Side Effects
Vomiting
|
3 Participants
|
|
Number of Participants With Opioid Induced Side Effects
Sedation
|
1 Participants
|
|
Number of Participants With Opioid Induced Side Effects
Constipation
|
1 Participants
|
|
Number of Participants With Opioid Induced Side Effects
Urinary retention
|
3 Participants
|
|
Number of Participants With Opioid Induced Side Effects
Mental clouding
|
4 Participants
|
|
Number of Participants With Opioid Induced Side Effects
Sweating
|
2 Participants
|
|
Number of Participants With Opioid Induced Side Effects
Pruritus
|
0 Participants
|
Adverse Events
Methylnaltrexone
Serious events: 11 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Methylnaltrexone
n=25 participants at risk
Participants received single dose of MNTX 0.15 mg/kg SC initially. Subsequent dosing was adjusted upward (to a maximum of 0.3 mg/kg) to achieve a desired clinical response or decreased to improve tolerability. Median treatment duration was 25 days.
|
|---|---|
|
Gastrointestinal disorders
Small intestinal obstruction
|
4.0%
1/25 • From start of treatment until end of study (up to maximum 3.4 years)
Safety evaluable participants included all enrolled participants who received at least one dose of study drug.
|
|
Cardiac disorders
Myocardial infarction
|
4.0%
1/25 • From start of treatment until end of study (up to maximum 3.4 years)
Safety evaluable participants included all enrolled participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
32.0%
8/25 • From start of treatment until end of study (up to maximum 3.4 years)
Safety evaluable participants included all enrolled participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
4.0%
1/25 • From start of treatment until end of study (up to maximum 3.4 years)
Safety evaluable participants included all enrolled participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Ascites
|
4.0%
1/25 • From start of treatment until end of study (up to maximum 3.4 years)
Safety evaluable participants included all enrolled participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
4.0%
1/25 • From start of treatment until end of study (up to maximum 3.4 years)
Safety evaluable participants included all enrolled participants who received at least one dose of study drug.
|
|
General disorders
Asthenia
|
4.0%
1/25 • From start of treatment until end of study (up to maximum 3.4 years)
Safety evaluable participants included all enrolled participants who received at least one dose of study drug.
|
|
General disorders
Pain
|
4.0%
1/25 • From start of treatment until end of study (up to maximum 3.4 years)
Safety evaluable participants included all enrolled participants who received at least one dose of study drug.
|
|
Hepatobiliary disorders
Hepatic failure
|
4.0%
1/25 • From start of treatment until end of study (up to maximum 3.4 years)
Safety evaluable participants included all enrolled participants who received at least one dose of study drug.
|
|
Nervous system disorders
Convulsion
|
4.0%
1/25 • From start of treatment until end of study (up to maximum 3.4 years)
Safety evaluable participants included all enrolled participants who received at least one dose of study drug.
|
Other adverse events
| Measure |
Methylnaltrexone
n=25 participants at risk
Participants received single dose of MNTX 0.15 mg/kg SC initially. Subsequent dosing was adjusted upward (to a maximum of 0.3 mg/kg) to achieve a desired clinical response or decreased to improve tolerability. Median treatment duration was 25 days.
|
|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
20.0%
5/25 • From start of treatment until end of study (up to maximum 3.4 years)
Safety evaluable participants included all enrolled participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
12.0%
3/25 • From start of treatment until end of study (up to maximum 3.4 years)
Safety evaluable participants included all enrolled participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Dyspepsia
|
4.0%
1/25 • From start of treatment until end of study (up to maximum 3.4 years)
Safety evaluable participants included all enrolled participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Dizziness
|
4.0%
1/25 • From start of treatment until end of study (up to maximum 3.4 years)
Safety evaluable participants included all enrolled participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Dysphagia
|
8.0%
2/25 • From start of treatment until end of study (up to maximum 3.4 years)
Safety evaluable participants included all enrolled participants who received at least one dose of study drug.
|
|
Nervous system disorders
Headache
|
8.0%
2/25 • From start of treatment until end of study (up to maximum 3.4 years)
Safety evaluable participants included all enrolled participants who received at least one dose of study drug.
|
|
Nervous system disorders
Tremor
|
8.0%
2/25 • From start of treatment until end of study (up to maximum 3.4 years)
Safety evaluable participants included all enrolled participants who received at least one dose of study drug.
|
|
Nervous system disorders
Dizziness
|
4.0%
1/25 • From start of treatment until end of study (up to maximum 3.4 years)
Safety evaluable participants included all enrolled participants who received at least one dose of study drug.
|
|
Nervous system disorders
Loss of consciousness
|
4.0%
1/25 • From start of treatment until end of study (up to maximum 3.4 years)
Safety evaluable participants included all enrolled participants who received at least one dose of study drug.
|
|
Nervous system disorders
Lethargy
|
8.0%
2/25 • From start of treatment until end of study (up to maximum 3.4 years)
Safety evaluable participants included all enrolled participants who received at least one dose of study drug.
|
|
Nervous system disorders
Dysarthria
|
4.0%
1/25 • From start of treatment until end of study (up to maximum 3.4 years)
Safety evaluable participants included all enrolled participants who received at least one dose of study drug.
|
|
Nervous system disorders
Myoclonus
|
4.0%
1/25 • From start of treatment until end of study (up to maximum 3.4 years)
Safety evaluable participants included all enrolled participants who received at least one dose of study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
8.0%
2/25 • From start of treatment until end of study (up to maximum 3.4 years)
Safety evaluable participants included all enrolled participants who received at least one dose of study drug.
|
|
Infections and infestations
Bronchitis bacterial
|
4.0%
1/25 • From start of treatment until end of study (up to maximum 3.4 years)
Safety evaluable participants included all enrolled participants who received at least one dose of study drug.
|
|
Infections and infestations
Abdominal distension
|
4.0%
1/25 • From start of treatment until end of study (up to maximum 3.4 years)
Safety evaluable participants included all enrolled participants who received at least one dose of study drug.
|
|
Infections and infestations
Escherichia bacteraemia
|
4.0%
1/25 • From start of treatment until end of study (up to maximum 3.4 years)
Safety evaluable participants included all enrolled participants who received at least one dose of study drug.
|
|
Infections and infestations
Lower respiratory tract infection
|
4.0%
1/25 • From start of treatment until end of study (up to maximum 3.4 years)
Safety evaluable participants included all enrolled participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash
|
4.0%
1/25 • From start of treatment until end of study (up to maximum 3.4 years)
Safety evaluable participants included all enrolled participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
8.0%
2/25 • From start of treatment until end of study (up to maximum 3.4 years)
Safety evaluable participants included all enrolled participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Agitation
|
4.0%
1/25 • From start of treatment until end of study (up to maximum 3.4 years)
Safety evaluable participants included all enrolled participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Anxiety
|
8.0%
2/25 • From start of treatment until end of study (up to maximum 3.4 years)
Safety evaluable participants included all enrolled participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Restlessness
|
8.0%
2/25 • From start of treatment until end of study (up to maximum 3.4 years)
Safety evaluable participants included all enrolled participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Confusional state
|
16.0%
4/25 • From start of treatment until end of study (up to maximum 3.4 years)
Safety evaluable participants included all enrolled participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Depression
|
4.0%
1/25 • From start of treatment until end of study (up to maximum 3.4 years)
Safety evaluable participants included all enrolled participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Oedema peripheral
|
4.0%
1/25 • From start of treatment until end of study (up to maximum 3.4 years)
Safety evaluable participants included all enrolled participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Delirium
|
4.0%
1/25 • From start of treatment until end of study (up to maximum 3.4 years)
Safety evaluable participants included all enrolled participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Hallucination, visual
|
4.0%
1/25 • From start of treatment until end of study (up to maximum 3.4 years)
Safety evaluable participants included all enrolled participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
32.0%
8/25 • From start of treatment until end of study (up to maximum 3.4 years)
Safety evaluable participants included all enrolled participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Faecaloma
|
4.0%
1/25 • From start of treatment until end of study (up to maximum 3.4 years)
Safety evaluable participants included all enrolled participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Flatulence
|
20.0%
5/25 • From start of treatment until end of study (up to maximum 3.4 years)
Safety evaluable participants included all enrolled participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Constipation
|
4.0%
1/25 • From start of treatment until end of study (up to maximum 3.4 years)
Safety evaluable participants included all enrolled participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Stomach discomfort
|
4.0%
1/25 • From start of treatment until end of study (up to maximum 3.4 years)
Safety evaluable participants included all enrolled participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
12.0%
3/25 • From start of treatment until end of study (up to maximum 3.4 years)
Safety evaluable participants included all enrolled participants who received at least one dose of study drug.
|
|
Infections and infestations
Urinary tract infection
|
8.0%
2/25 • From start of treatment until end of study (up to maximum 3.4 years)
Safety evaluable participants included all enrolled participants who received at least one dose of study drug.
|
|
Infections and infestations
Sedation
|
4.0%
1/25 • From start of treatment until end of study (up to maximum 3.4 years)
Safety evaluable participants included all enrolled participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Haematuria
|
4.0%
1/25 • From start of treatment until end of study (up to maximum 3.4 years)
Safety evaluable participants included all enrolled participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Bladder spasm
|
4.0%
1/25 • From start of treatment until end of study (up to maximum 3.4 years)
Safety evaluable participants included all enrolled participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Urinary hesitation
|
4.0%
1/25 • From start of treatment until end of study (up to maximum 3.4 years)
Safety evaluable participants included all enrolled participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Nocturia
|
4.0%
1/25 • From start of treatment until end of study (up to maximum 3.4 years)
Safety evaluable participants included all enrolled participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Urinary retention
|
12.0%
3/25 • From start of treatment until end of study (up to maximum 3.4 years)
Safety evaluable participants included all enrolled participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Dysuria
|
4.0%
1/25 • From start of treatment until end of study (up to maximum 3.4 years)
Safety evaluable participants included all enrolled participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
16.0%
4/25 • From start of treatment until end of study (up to maximum 3.4 years)
Safety evaluable participants included all enrolled participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Yawning
|
8.0%
2/25 • From start of treatment until end of study (up to maximum 3.4 years)
Safety evaluable participants included all enrolled participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
12.0%
3/25 • From start of treatment until end of study (up to maximum 3.4 years)
Safety evaluable participants included all enrolled participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Increased bronchial secretion
|
4.0%
1/25 • From start of treatment until end of study (up to maximum 3.4 years)
Safety evaluable participants included all enrolled participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
4.0%
1/25 • From start of treatment until end of study (up to maximum 3.4 years)
Safety evaluable participants included all enrolled participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
4.0%
1/25 • From start of treatment until end of study (up to maximum 3.4 years)
Safety evaluable participants included all enrolled participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
4.0%
1/25 • From start of treatment until end of study (up to maximum 3.4 years)
Safety evaluable participants included all enrolled participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
4.0%
1/25 • From start of treatment until end of study (up to maximum 3.4 years)
Safety evaluable participants included all enrolled participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
4.0%
1/25 • From start of treatment until end of study (up to maximum 3.4 years)
Safety evaluable participants included all enrolled participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract congestion
|
8.0%
2/25 • From start of treatment until end of study (up to maximum 3.4 years)
Safety evaluable participants included all enrolled participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
4.0%
1/25 • From start of treatment until end of study (up to maximum 3.4 years)
Safety evaluable participants included all enrolled participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary congestion
|
4.0%
1/25 • From start of treatment until end of study (up to maximum 3.4 years)
Safety evaluable participants included all enrolled participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Sputum retention
|
4.0%
1/25 • From start of treatment until end of study (up to maximum 3.4 years)
Safety evaluable participants included all enrolled participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
4.0%
1/25 • From start of treatment until end of study (up to maximum 3.4 years)
Safety evaluable participants included all enrolled participants who received at least one dose of study drug.
|
|
Eye disorders
Lacrimation increased
|
4.0%
1/25 • From start of treatment until end of study (up to maximum 3.4 years)
Safety evaluable participants included all enrolled participants who received at least one dose of study drug.
|
|
General disorders
Catheter related complication
|
4.0%
1/25 • From start of treatment until end of study (up to maximum 3.4 years)
Safety evaluable participants included all enrolled participants who received at least one dose of study drug.
|
|
General disorders
Chest discomfort
|
4.0%
1/25 • From start of treatment until end of study (up to maximum 3.4 years)
Safety evaluable participants included all enrolled participants who received at least one dose of study drug.
|
|
General disorders
Secretion discharge
|
8.0%
2/25 • From start of treatment until end of study (up to maximum 3.4 years)
Safety evaluable participants included all enrolled participants who received at least one dose of study drug.
|
|
General disorders
Oedema peripheral
|
4.0%
1/25 • From start of treatment until end of study (up to maximum 3.4 years)
Safety evaluable participants included all enrolled participants who received at least one dose of study drug.
|
|
General disorders
Pyrexia
|
8.0%
2/25 • From start of treatment until end of study (up to maximum 3.4 years)
Safety evaluable participants included all enrolled participants who received at least one dose of study drug.
|
|
General disorders
Feeling abnormal
|
4.0%
1/25 • From start of treatment until end of study (up to maximum 3.4 years)
Safety evaluable participants included all enrolled participants who received at least one dose of study drug.
|
|
General disorders
Fatigue
|
8.0%
2/25 • From start of treatment until end of study (up to maximum 3.4 years)
Safety evaluable participants included all enrolled participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
8.0%
2/25 • From start of treatment until end of study (up to maximum 3.4 years)
Safety evaluable participants included all enrolled participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
8.0%
2/25 • From start of treatment until end of study (up to maximum 3.4 years)
Safety evaluable participants included all enrolled participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
4.0%
1/25 • From start of treatment until end of study (up to maximum 3.4 years)
Safety evaluable participants included all enrolled participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
4.0%
1/25 • From start of treatment until end of study (up to maximum 3.4 years)
Safety evaluable participants included all enrolled participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Anorexia
|
4.0%
1/25 • From start of treatment until end of study (up to maximum 3.4 years)
Safety evaluable participants included all enrolled participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Arthralgia
|
4.0%
1/25 • From start of treatment until end of study (up to maximum 3.4 years)
Safety evaluable participants included all enrolled participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Dehydration
|
4.0%
1/25 • From start of treatment until end of study (up to maximum 3.4 years)
Safety evaluable participants included all enrolled participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Oral intake reduced
|
4.0%
1/25 • From start of treatment until end of study (up to maximum 3.4 years)
Safety evaluable participants included all enrolled participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
4.0%
1/25 • From start of treatment until end of study (up to maximum 3.4 years)
Safety evaluable participants included all enrolled participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Haemarthrosis
|
4.0%
1/25 • From start of treatment until end of study (up to maximum 3.4 years)
Safety evaluable participants included all enrolled participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Bursa disorder
|
4.0%
1/25 • From start of treatment until end of study (up to maximum 3.4 years)
Safety evaluable participants included all enrolled participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
12.0%
3/25 • From start of treatment until end of study (up to maximum 3.4 years)
Safety evaluable participants included all enrolled participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
8.0%
2/25 • From start of treatment until end of study (up to maximum 3.4 years)
Safety evaluable participants included all enrolled participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Fall
|
4.0%
1/25 • From start of treatment until end of study (up to maximum 3.4 years)
Safety evaluable participants included all enrolled participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
8.0%
2/25 • From start of treatment until end of study (up to maximum 3.4 years)
Safety evaluable participants included all enrolled participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Endotracheal intubation complication
|
4.0%
1/25 • From start of treatment until end of study (up to maximum 3.4 years)
Safety evaluable participants included all enrolled participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Hand fracture
|
4.0%
1/25 • From start of treatment until end of study (up to maximum 3.4 years)
Safety evaluable participants included all enrolled participants who received at least one dose of study drug.
|
|
Investigations
Creatinine renal clearance decreased
|
4.0%
1/25 • From start of treatment until end of study (up to maximum 3.4 years)
Safety evaluable participants included all enrolled participants who received at least one dose of study drug.
|
|
Investigations
Blood potassium increased
|
4.0%
1/25 • From start of treatment until end of study (up to maximum 3.4 years)
Safety evaluable participants included all enrolled participants who received at least one dose of study drug.
|
|
Investigations
Blood magnesium decreased
|
4.0%
1/25 • From start of treatment until end of study (up to maximum 3.4 years)
Safety evaluable participants included all enrolled participants who received at least one dose of study drug.
|
|
Cardiac disorders
Cyanosis
|
4.0%
1/25 • From start of treatment until end of study (up to maximum 3.4 years)
Safety evaluable participants included all enrolled participants who received at least one dose of study drug.
|
|
Cardiac disorders
Bradycardia
|
4.0%
1/25 • From start of treatment until end of study (up to maximum 3.4 years)
Safety evaluable participants included all enrolled participants who received at least one dose of study drug.
|
|
Cardiac disorders
Atrial fibrillation
|
4.0%
1/25 • From start of treatment until end of study (up to maximum 3.4 years)
Safety evaluable participants included all enrolled participants who received at least one dose of study drug.
|
|
Cardiac disorders
Angina pectoris
|
4.0%
1/25 • From start of treatment until end of study (up to maximum 3.4 years)
Safety evaluable participants included all enrolled participants who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Anaemia
|
4.0%
1/25 • From start of treatment until end of study (up to maximum 3.4 years)
Safety evaluable participants included all enrolled participants who received at least one dose of study drug.
|
|
Vascular disorders
Pallor
|
4.0%
1/25 • From start of treatment until end of study (up to maximum 3.4 years)
Safety evaluable participants included all enrolled participants who received at least one dose of study drug.
|
|
Hepatobiliary disorders
Jaundice
|
4.0%
1/25 • From start of treatment until end of study (up to maximum 3.4 years)
Safety evaluable participants included all enrolled participants who received at least one dose of study drug.
|
|
Endocrine disorders
Hyperthyroidism
|
4.0%
1/25 • From start of treatment until end of study (up to maximum 3.4 years)
Safety evaluable participants included all enrolled participants who received at least one dose of study drug.
|
|
General disorders
Asthenia
|
4.0%
1/25 • From start of treatment until end of study (up to maximum 3.4 years)
Safety evaluable participants included all enrolled participants who received at least one dose of study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Please contact Sponsor directly for additional information.
- Publication restrictions are in place
Restriction type: OTHER